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TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare SystemSSCP 0902-001REVISION 002This Summary of Safety and Clinical Performance (SSCP) is intended to provide public access to an up-to-date summary of the main aspects of thesafety and clinical performance of the EN Snare Endovascular System and EMPOWER Tri-Loop Snare System. These systems will be referred tohereafter under the term EN Snare System.The SSCP is not intended to replace the Instructions for Use (IFU) as the main document to ensure the safe use of the EN Snare, nor is it intended toprovide diagnostic or therapeutic suggestions to intended users or patients.The following information is intended for users/healthcare professionals. A supplemental SSCP with information for patients was not establishedsince the EN Snare System is not an implantable device for which patients are provided an implant card, nor is the device intended to be used directlyby patients.The English version of this SSCP document (SSCP-0902-001) has been validated by the notified body (#2797).1.0Device identification and general information1.1Device trade name(s)The device(s) and model numbers covered by this SSCP are presented in Table 1.1.1.Table 1.1.1 Devices Included in this SSCPDevice Name and DescriptionProduct NumbersEN Snare Mini Snare 2–4 mmEN1003004EN Snare Mini Snare 4–8 mmEN1003008EN Snare Standard Snare 6–10 mmEN2006010EN Snare Standard Snare 9–15 mmEN2006015EN Snare Standard Snare 12–20 mmEN2006020EN Snare Standard Snare 18–30 mmEN2007030EN Snare Standard Snare 27–45 mmEN2007045EMPOWER Tri-Loop Snare System8785Electronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 1 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare System1.2SSCP 0902-001REVISION 002Manufacturer Name and AddressThe name and address of the manufacturer of the EN Snare System are provided in Table 1.2.1.Table 1.2.1 Manufacturer Information1.3Manufacturer NameAddress of ManufacturerMerit Medical Systems, Inc.1600 West Merit Parkway, South Jordan, Utah84095, USAManufacturer Single Registration Number (SRN)The Manufacturer Single Registration Number (SRN) for the manufacturer is included in Table 1.6.1.1.4Basic UDI-DIThe basic Unique Device Identifier (UDI) key is provided in Table 1.6.1.1.5Medical Device Nomenclature Description / TextThe Classificazione Nazionale dei Dispositivi medici (CND) code and descriptors for the subject device(s) are listed in Table 1.6.1.1.6Class of DeviceThe EU device risk classification(s) for the EN Snare System are listed in Table 1.6.1.Table 1.6.1 Device Identification InformationDevice Name and descriptionEUDeviceClassProductNumberBasic UDI-DISingle RegistrationNumber (SRN)CND CodeCND TermsEN Snare Mini Snare 2–4 VASCULAR FOREIGNRETRIEVING SYSTEMSBODIES,EN Snare Mini Snare 4–8 VASCULARBODIES,Electronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.FOREIGNECN139683PAGE 2 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare SystemDevice Name and descriptionEUDeviceClassProductNumberBasic UDI-DIEN Snare Standard Snare 6–10 mmIIIEN2006010EN Snare Standard Snare 9–15 mmIIIEN Snare Standard Snare 12–20 mmSSCP 0902-001REVISION 002Single RegistrationNumber (SRN)CND Code088445048408DHUS-MF-000001366C019005VASCULAR FOREIGNRETRIEVING 66C019005VASCULAR FOREIGNRETRIEVING 01366C019005VASCULAR FOREIGNRETRIEVING SYSTEMSBODIES,EN Snare Standard Snare 18–30 VASCULAR FOREIGNRETRIEVING SYSTEMSBODIES,EN Snare Standard Snare 27–45 VASCULAR FOREIGNRETRIEVING C019005VASCULAR FOREIGNRETRIEVING SYSTEMSBODIES,CND TermsRETRIEVING SYSTEMSEMPOWER Tri-Loop Snare System1.7Year of EU Market IntroductionThe year that the EN Snare System received CE marking and was first placed on the EU market is presented in Table 1.9.1.1.8Authorised Representative (if applicable)The name of the authorised representative(s) and, if applicable, the authorised representative(s) SRN are provided in Table 1.9.1.1.9Notified BodyThe Notified Body (NB) involved in the conformity assessment of the EN Snare System in accordance with Annex IX or Annex X of the MDR (Regulation(EU) 2017/745) and responsible for validating the SSCP is listed in Table 1.9.1. The NB Single Identification Number is also provided in Table 1.9.1.Electronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 3 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare SystemSSCP 0902-001REVISION 002Table 1.9.1 Authorised Representative and Notified Body InformationDevice NameYear Placed onEU MarketAuthorised RepresentativeNameSRNEN Snare Mini Snare 2–4 mm2009Merit Medical Ireland Ltd.IE-AR-000001011 BSI2797EN Snare Mini Snare 4–8 mm2009Merit Medical Ireland Ltd.IE-AR-000001011 BSI2797EN Snare Standard Snare 6–10 mm2009Merit Medical Ireland Ltd.IE-AR-000001011 BSI2797EN Snare Standard Snare 9–15 mm2009Merit Medical Ireland Ltd.IE-AR-000001011 BSI2797EN Snare Standard Snare 12–20 mm2009Merit Medical Ireland Ltd.IE-AR-000001011 BSI2797EN Snare Standard Snare 18–30 mm2009Merit Medical Ireland Ltd.IE-AR-000001011 BSI2797EN Snare Standard Snare 27–45 mm2009Merit Medical Ireland Ltd.IE-AR-000001011 BSI2797EMPOWER Tri-Loop Snare System2017Merit Medical Ireland Ltd.IE-AR-000001011 BSI27972.0Notified Body (NB)NameID NumberIntended Use of the Device2.1Intended PurposeThe EN Snare System is intended for use in the cardiovascular system to retrieve and manipulate foreign objects. Retrieval and manipulationprocedures include indwelling venous catheter fibrin sheath stripping.2.2Indications and Target PopulationsThe EN Snare System is indicated for patients requiring the retrieval or manipulation of foreign bodies in the cardiovascular system. Device use andsizing are based upon patient vascular anatomy and clinician preference. The EN Snare System is utilized in adult patients in accordance withappropriate vessel sizing.2.3Contraindications and/or LimitationsContraindications for the EN Snare System are listed below. Limitations on the use and sizing of the EN Snare System are dictated by patient vascularanatomy. This device is not intended for the removal of foreign objects entrapped by tissue growth.Electronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 4 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare System 3.0SSCP 0902-001REVISION 002This device should not be used for fibrin sheath stripping in the presence of septal defects or Patent Foramen Ovale (PFO).This device is not intended for removal of implanted pacing leads.This device is not intended for use in the neurovasculature.Device Description3.1Description of the DeviceThe EN Snare System is a tri-looped snare comprised of stranded platinum (Pt) and nitinol (NiTi) coupled to a NiTi shaft wire. When combined withthe delivery catheter or compatible guide catheter, the triple loop snare can be used for retrieval and manipulation of foreign bodies (includingtissue/thrombus) within the cardiovascular system. Procedures are typically performed under fluoroscopic guidance. A radiopaque marker at thedelivery catheter tip facilitates position of the snare adjacent to the target foreign body. The flexibility of the nitinol shape-memory loop materialallows the pre-shaped snare configuration to be withdrawn into a catheter for delivery and then deployed in the desired vascular location vesselswhile minimizing the potential for vascular injury during device manipulation (Figure 3.1.1). Foreign-body capture is achieved by placing the nitinolsnare loop(s) around the free end or edge of the object, and then pulling the snare loop(s) down around the object by advancing the delivery catheterwhile holding the snare in position (Figure 3.1.2). As the catheter is advanced over the snare, the object is pulled into or against the distal portion ofthe catheter. The tensile strength of the loop(s) is sufficient to retrieve or manipulate foreign objects without damaging the snare. Various loop sizesare available to accommodate different target vessel sizing. EN Snare System configurations are summarized in Table 3.1.1.Electronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 5 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare SystemSSCP 0902-001REVISION 002Figure 3.1.1. Snare Deployment in a VesselFigure 3.1.2. Snare Withdrawal to Achieve Device CaptureThe devices and components in the EN Snare System are packaged as sterile, single-use devices. The catheter as well as the snare device, InsertionTool, and torque device are loaded in polypropylene spiral dispensers. The components are then sealed in 2 separate Tyvek/Nylon pouches. BothElectronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 6 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare SystemSSCP 0902-001REVISION 002pouches are packaged with an IFU in a carton. Merit utilizes ethylene oxide (EtO) sterilization for the EN Snare System.Table 3.1.1. EN Snare System Device ConfigurationsCatalogNumberDescriptionSnare DiameterSnare Length(cm)SnareCollapsedDiameter in (mm)CatheterSizeCatheterLengthEN1003004EN Snare Mini Snare 2–4 mm2–4 mm175 cm0.028 in (0.71 mm)3.2 Fr150 cmEN1003008EN Snare Mini Snare 4–8 mm4–8 mm175 cm0.028 in (0.71 mm)3.2 Fr150 cmEN2006010EN Snare Standard Snare 6–10 mm6–10 mm120 cm0.045 in (1.14 mm)6 Fr100 cmEN2006015EN Snare Standard Snare 9–15 mm9–15 mm4120 cm0.055 in (1.40 mm)6 Fr100 cmEN2006020EN Snare Standard Snare 12–20 mm12–20 mm120 cm0.055 in (1.40 mm)6 Fr100 cmEN2007030EN Snare Standard Snare 18–30 mm18–30 mm120 cm0.055 in (1.40 mm)7 Fr100 cmEN2007045EN Snare Standard Snare 27–45 mm27–45 mm120 cm0.055 in (1.40 mm)7 Fr100 cm668785-300EN Snare Merit OEM Standard Snare9-15 mm150 cm0.055 in (1.40 mm)6 Fr130 cmA biocompatibility assessment has been completed for the EN Snare System, and biocompatibility testing was performed according torecommendations set forth in the ISO 10993 Biological Evaluation of Medical Devices series standards. The tissue contact categorizations for the ENSnare System are summarized in Table 3.1.2.Table 3.1.2. Tissue Contact Categorization: EN Snare SystemDeviceCategorizationSnareExternally communicatingCirculating BloodLimited contact duration ( 24 hours)CatheterExternally communicatingCirculating BloodLimited contact duration ( 24 hours)Insertion ToolNo patient contactTorque DeviceNo patient contactThe general operational steps associated with procedural use of the devices in the EN Snare System are summarized in Table 3.1.33.Electronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 7 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare SystemSSCP 0902-001REVISION 002Table 3.1.3. Principles of Operation: EN Snare SystemProcedureOperational StepsSnarePreparation andDeliverySelect the appropriate snare diameter range for the site in which the foreign body is located. The snare diameter range should approximatethe size of the vessel in which it will be used.Remove the Insertion Tool and torque device from the proximal end of the snare shaft, and insert the proximal end of the snare into thedistal (non-hubbed) end of the snare catheter until the proximal end of the snare shaft exits the hub and the loop can be retracted into thedistal end of the snare catheter. Advance the snare and snare catheter system to the desired site.In cases where a snare catheter is already positioned within the vasculature, advance the Insertion Tool toward the distal end of the snareuntil the snare loop(s) are captured within the Insertion Tool tubing. Insert the distal end of the Insertion Tool into the hub of the snarecatheter until resistance is felt, and then back-load the snare into the catheter. The Insertion Tool can be removed by grasping the bluetab and peeling it away from the snare shaft.SnareDeploymentGently push the snare shaft forward to completely open the loop(s) of the snare. The snare is then either advanced around the proximalend of the foreign body or brought back around the distal end of the foreign body.Object RetrievalAdvancing the snare catheter to close the loop(s) of the snare and capture the foreign body. Attempting to close the loop by pulling thesnare into the snare catheter will move the position of the loop(s) with respect to the foreign body. Maintain tension on the snare catheterand move the snare and snare catheter assembly together proximally such that they are positioned at or within a guide catheter or sheath.The foreign body is then withdrawn through or together with the guiding catheter or introducer sheath. Withdrawal of large foreign bodiesmay require the insertion of larger sheaths, guiding catheters, or a peripheral access site cut-down.ObjectManipulationMaintain tension on the snare catheter to retain the foreign body, and move the snare and snare catheter together to manipulate theforeign body to the desired position.FibrinSheathRemovalUsing a femoral venous approach, advance the snare into the inferior vena cava or right atrium. Advance an 0.035” guidewire through theindwelling catheter and into the inferior vena cava or right atrium. Position the snare loop(s) around the guidewire and advance the snareover the distal end of the catheter to a position proximal to the fibrin sheath. Close the snare around the catheter and continue applyinglight traction while gently pulling the snare down toward the distal end of the catheter over the end ports. Repeat until the catheter is freeof fibrin sheath.3.2Previous Generation(s) or Variant(s)The EN Snare System was acquired by Merit from Medical Device Technologies (MD Tech) in 2009. Following the acquisition, Merit beganmanufacturing the “Original” EN Snare System and obtained CE-marking and 510(k) clearance (K092343) in the third and fourth quarter of 2009,respectively. The fluoroethylene propylene (FEP) catheter and coaxial FEP introducer components of the Original EN Snare System were purchasedfrom a supplier. In 2015, Merit assumed manufacturing for the entire EN Snare System, and a “Modified” device configuration was subsequentlyimplemented. The Modified device includes a catheter comprised of a polyether block amide (PEBAX) outer and polytetrafluoroethylene (PTFE) inner,embedded marker band, and replacement of the introducer with a peel-away insertion tool. Please refer to the Table 3.2.1.Electronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 8 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare SystemSSCP 0902-001REVISION 002Table 3.2.1. Overview of Modifications to the EN Snare SystemComponentEN Snare System (Modified)EN Snare System (Original)CommentsSnareSnare unchangedTorque DeviceTorque device unchangedCatheterPt/Ir marker band is embedded in the Modified ENSnare SystemEmbedded markerbandSwaged markertbandHub design modified to include integral strain reliefin the Modified EN Snare SystemHub with integral strain reliefHub without strain reliefMaterials:Materials:Shaft: PEBAX outer with PTFE innerHub: PEBAX with polycarbonate luerShaft: Fluorinated ethylene propylene(FEP)Hub: High density polyethylene (HDPE)InsertionTool/IntroducerPEBAX materials selected for improved catheterperformance and manufacturability. Original ENSnare System catheter purchased from supplier.Modified EN Snare System catheter manufacturedin-house by Merit Medical Systems.Peel-away design avoids need for over-the-snarewire withdrawal required for coaxial introducerdesign.Introducer: Coaxial configurationElectronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 9 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare SystemComponentEN Snare System (Modified)SSCP 0902-001REVISION 002EN Snare System (Original)CommentsMaterials:Materials:Tubing: PolypropyleneTubing: Fluorinated ethylene propylene(FEP)Polypropylene materials selected for improvedperformance and manufacturability. Original ENSnare System Introducer purchased from supplier.Modified EN Snare System Insertion Toolmanufactured in-house by Merit Medical Systems.Insertion Tool: Peel-away configurationHub: Purple polypropyleneHub: High density polyethylene (HDPE)Abbreviations: FEP fluorinated ethylene propylene, HDPE high density polyethylene, PEBAX polyether block amide, PTFE polytetrafluoroethylene3.3AccessoriesThe accessories utilized with the EN Snare System are the Torque Device, introducer (Original EN Snare System), and Insertion Tool (Modified ENSnare System). Additional accessories associated with conventional percutaneous vascular access include, but are not limited to, access needle,introducer, dilator, guidewire, and contrast solution.Table 3.3.1 Accessory DevicesDevice GenerationAccessory DescriptionOriginal and Modified EN Snare SystemTorque Device: Easy-to-grip torque device supports snare torqueabilityOriginal EN Snare SystemIntroducer: facilitates insertion of the snare into the snare catheter.Modified EN Snare SystemInsertion Tool: facilitates insertion of the snare into the snare catheter.Peel-away design avoids need for over-the-snare-wire withdrawal requiredfor coaxial introducer design.Electronically Generated from L:/DOC/FormsFORM 7.345 Rev 002The information in this document is proprietary to Merit Medical Systems, Inc.ECN139683PAGE 10 of 37
TITLE: Summary of Safety and Clinical Performance (SSCP)EN Snare Endovascular Snare System3.4SSCP 0902-001REVISION 002Description of Other Devices Used in CombinationIn addition to the accessories listed above (Table 3.4.1), the EN Snare System is used in combination with devices including, but are not limited to,catheters and sheaths.4.0Risks and Warnings4.1Residual Risks and Undesirable EffectsDescription of risksThe Merit Risk Management process is conducted in accordance with EN ISO 14971:2019. Risk assessment processes are utilized to analyse risksassociated with the use of Merit devices, including possible misuses of a device. This ensures that all foreseeable potential failure modes andassociated risks have been considered and addressed in the device design and/or production quality system. The process involves the following keyaspects: Identifying potential failure modes, and their likely causes and effect
EN Snare Endovascular Snare System REVISION 002 Figure 3.1.1. Snare Deployment in a Vessel. Figure 3.1.2. Snare Withdrawal to Achieve Device Capture. The devices and components in the EN Snare System are packaged as sterile, single-use devices. The catheter as well as the snare device, Insertion
