Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. December 6, 2018 Contego Medical, LLC % Debra Cogan Regulatory Consultant ORAC. LLC 14906 Conway Avenue San Jose, California 95124 Re: K181529 Trade/Device Name: Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, NTE Dated: November 6, 2018 Received: November 8, 2018 Dear Ms. Cogan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181529 #### Device Name Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection Indications for Use (Describe) The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|---------------------------------------------| | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary [per 21 CFR 807.92] | Date<br>Prepared: | November 05, 2018 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Contego Medical, LLC<br>3921 Sunset Ridge Rd., Suite 102<br>Raleigh, NC 27607 | | Contact<br>Person: | Debra Cogan<br>Regulatory Affairs Consultant to Contego Medical, LLC<br>Phone: (408) 515-0820<br>Fax: (408) 273-6047<br>dcogan@contegomedical.com | | Proprietary<br>Name: | Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection | | Common<br>Name: | Percutaneous Transluminal Angioplasty Balloon Catheter | | Device<br>Classification: | Class II (special controls) | | Regulation<br>Number: | 870.1250 | | Classification<br>Name: | Catheter, Percutaneous | | Product Code: | LIT, NTE | | Device<br>Description: | The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection<br>platform is similar to a catheter with a typical angioplasty balloon, but between the distal end<br>of the balloon and the distal tip of the catheter, there is a nitinol-based filter. The device is<br>over-the-wire (OTW) and is 0.018" guidewire compatible. The balloon catheter comes in sizes<br>of 5 and 6 mms outside diameter (OD) and lengths 40, 80, 120 and 200 mms. The filter<br>component is composed of a nitinol filter frame with an overlying membrane perforated with a<br>set pattern of drilled holes. The balloon catheter shaft consists of a dual lumen inner shaft<br>placed inside a single lumen outer shaft. The inner shaft extends beyond the balloon up to<br>the distal catheter tip. Radiopaque markers placed on either side of the balloon and the distal<br>tip of the filter assist with accurate placement. The nitinol filter frame has radiopaque<br>markers, making the diameter of the filter visible when opened. The proximal end of the<br>nitinol frame slides freely over the distal shaft. A pull-wire attaches the handle to the filter<br>frame to activate the filter. | | Indications for<br>Use: | The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection<br>is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of<br>embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The<br>System is not intended for use in the renal, cerebral, coronary or carotid vasculature. | | Predicate<br>Device(s): | 1. Proteus ™ (AngioSlide) (K172494) - Primary Predicate<br>2. SpiderFX Embolic Protection Device (Medtronic) (K111010) | {4}------------------------------------------------ Reference - 3. Sterling Monorail PTA Balloon Dilatation Catheter (K141150, Boston Scientific) Predicates: - 4. RX Accunet (K153086, Abbott Vascular) Substantial Equivalency Table | Parameters | Subject Device<br>Vanguard IEP® | Primary Predicate<br>Proteus ™ | Secondary Predicate<br>SpiderFX™ | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K181529 | K172494 | K111010 | | Manufacturer | Contego Medical | AngioSlide | Medtronic | | Trade Name | Vanguard IEP®<br>Peripheral Balloon<br>Angioplasty System with<br>Integrated Embolic<br>Protection | Proteus PTA Catheter<br>with Embolic Capture<br>Feature | SpiderFX Embolic<br>Protection Device | | Common name | Percutaneous<br>Transluminal Angioplasty<br>Balloon Catheter | Percutaneous<br>Transluminal Angioplasty<br>Balloon Catheter | Embolic Protection<br>Device | | Classification | Class II (21 CFR<br>870.1250) | Class II (21 CFR<br>870.1250) | Class II (21 CFR<br>870.1250) | | Classification<br>name | Catheter, Percutaneous | Catheter, Percutaneous | Percutaneous Catheter | | Product code | LIT | LIT | NTE | | Intended use /<br>Indications for<br>use | The Vanguard IEP®<br>Peripheral Balloon<br>Angioplasty System with<br>Integrated Embolic<br>Protection is indicated for<br>percutaneous<br>transluminal angioplasty<br>(PTA) and capture and<br>removal of embolic<br>material during<br>angioplasty, for the<br>femoral, iliac, popliteal<br>and profunda arteries. | The PROTEUS™<br>Percutaneous<br>Transluminal Angioplasty<br>(PTA) Balloon Catheter<br>with Embolic Capture<br>Feature is indicated for<br>peripheral transluminal<br>angioplasty and for<br>capture and removal of<br>embolic material (e.g.<br>debris, thrombus) during<br>angioplasty, for the<br>femoral, iliac, ilio-<br>femoral, popliteal, tibial,<br>peroneal, and profunda<br>arteries.<br>The PROTEUS™ PTA<br>Balloon Catheter with<br>Embolic Capture Feature<br>is not intended for use in<br>the renal, cerebral,<br>coronary or carotid<br>vasculature. | The SpiderFX™ Embolic<br>Protection Device is<br>indicated for use as a<br>guidewire and embolic<br>protection system to<br>contain and remove<br>embolic material in<br>conjunction with the<br>TurboHawk™ Peripheral<br>Plaque Excision System,<br>either during standalone<br>procedures or together<br>with PTA and/or stenting,<br>in the treatment of<br>severely calcified lesions<br>in arteries of the lower<br>extremities. The vessel<br>diameter at the filter<br>basket placement site<br>should be between 3.0<br>mm and 6.0 mm. | | Principles of<br>Operation | Combines balloon<br>angioplasty and distal<br>embolic particle capture<br>and removal.<br>During balloon dilation,<br>embolic debris is<br>captured by the filter.<br>Upon completion of the<br>intervention the filter is<br>allowed to collapse and<br>the entire system is<br>withdrawn through the<br>introducer sheath or<br>guide catheter. | Combines balloon<br>angioplasty and proximal<br>embolic particle capture<br>and removal.<br>During balloon dilation,<br>negative pressure<br>creates suction to<br>capture embolic debris.<br>Upon completion of the<br>intervention the balloon<br>is collapsed and the<br>entire system is<br>withdrawn through the<br>introducer sheath or<br>guide catheter. | The device serves as<br>both guidewire for<br>interventional devices<br>and a distal embolic<br>capture and removal<br>filter. The filter is<br>removed following<br>angioplasty through a<br>custom removal catheter<br>that is also used to<br>deliver the filter at the<br>onset of the procedure<br>(dual-ended SpiderFX<br>Catheter). | | Sterilization | EO gas | EO gas | EO gas | | Sterility<br>Assurance<br>Level (SAL) | 10-6 | 10-6 | 10-6 | | Single use | Yes | Yes | Yes | | Shelf life | 1 year | 3 years | 2 years | | Packaging<br>system | Packaged in a PET/G<br>thermoformed tray with<br>lid, sealed in a sterile<br>pouch and single unit<br>box. | Information is not<br>available. | Packaged in a protective<br>hoop, tray, sterile pouch<br>and in a single unit box. | | Catheter<br>Platform | OTW | OTW | OTW, converts to RX | | Radiopaque<br>Markers | Two markers distal and<br>proximal to both filter and<br>balloon.<br>Five gold circumferential<br>markers on the proximal<br>perimeter of the filter<br>frame are visible when<br>filter is open. | Two balloon markers<br>distal and proximal to<br>balloon. | Two marker bands distal<br>and proximal to the filter.<br>A gold radiopaque<br>Proximal Mouth Indicator<br>is visible when filter is<br>open. | | Angioplasty<br>Balloon<br>Characteristics | Nylon, semi-compliant<br>PTA balloon | Semi-compliant PTA<br>balloon | N/A | | Usable Catheter<br>Length | 135 cm | 135 cm | 140 cm | | Guidewire<br>compatibility | 0.018" | 0.014" and 0.035" | 0.014" and 0.018" | | Introducer<br>sheath<br>compatibility | All sizes 6F except for<br>8 mm diameter balloon<br>sizes are 7F | various: 5F, 6F and 7F | 6 F | | Embolic<br>Capture<br>Mechanism | Distal embolic protection.<br>Adjustable nitinol filter<br>frame covered with a<br>porous polyurethane<br>membrane captures<br>embolic debris during<br>PTA procedure. | Proximal occlusion.<br>Negative pressure<br>creates suction to<br>capture embolic debris in<br>the inverted balloon. | Distal embolic protection.<br>Self-expanding nitinol<br>filter captures embolic<br>debris during<br>interventional<br>procedures. | | Filter Size<br>(diameter) | Adjustable up to 8 mm<br>diameter | N/A | 5.0 mm, 6.0 mm, 7.0 mm | | Filter Length | 16 mm | N/A | 23 mm, 24 mm (7.0<br>diameter)1 | | Reference<br>Vessel<br>Diameters | up to 8 mm | 3 mm -6 mm | 3 mm -6 mm | | Pore Size<br>Filter Materials | 150 micron<br>nitinol, polyurethane | N/A<br>N/A | < 200 micron2<br>nitinol mesh | | Balloon<br>diameter [mm] | 5 mm – 6 mm | 3 mm – 6 mm | N/A | | Balloon length<br>[mm] | 40 mm, 80 mm, 120 mm<br>and 200 mm | 20 mm, 40 mm, 60 mm,<br>80 mm, 100 mm | N/A | | Balloon RBP<br>[atm] | Various: 12 and 14 atm | Various: 12 and 14 atm | N/A | {5}------------------------------------------------ ¹ Per SpiderFX IFU, these diameters when delivered at maximum vessel size. ² Nii, K., et al., Comparison of Flow Impairment during Carotid Artery Stenting Using Two Types of Eccentric Filter Embolic Protection Devices. Neurol Med Chir (Tokyo), 2016. 56(12): p. 759-765. {6}------------------------------------------------ Summary of Non- Clinical Data In vitro bench testing of the Vanguard IEP System was conducted in accordance with Contego Medical's risk analysis and all applicable FDA guidance documents and international standards, including: - ISO 10555-1 Sterile. Single Use Intravascular Catheters Part 1: General ● Requirements - . ISO 10555-4 - Sterile, Single Use Intravascular Catheters - Part 4: Balloon Dilatation Catheters - Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices ● - Premarket Notification [510(k)] Submissions, February 15, 2008 - . Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended labeling for Intravascular Stents and Associated Delivery Systems, April 18, 2010. Bench testing was conducted on sterilized, finished devices, unless otherwise specified. The following testing was completed: - Dimensional Verification ● - Simulated Use . - Torque Response - Stent Compatibility ● - Balloon Rated Burst Pressure / Balloon Compliance - Balloon Fatigue - Balloon Inflation and Deflation . - Filter flow characterization ● - Embolic Capture Efficiency and Retrieval Ability ● - Filter Capacity ● - . Resistance to Filter Rupture during removal of a fully loaded filter - Balloon Rated Burst Pressure (constrained and unconstrained) ● - . Balloon Fatigue (constrained and unconstrained) ### Packaging Packaging validation was performed following environmental conditioning, per recognized standards, ASTM D4169, ASTM F2096-11 and ASTM F88/F88M. ### Biocompatibility Biocompatibility testing, per ISO 10993-1 included the following tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogen, Hemolysis, Complement Activation, Thrombogenicity. ### Sterilization Sterilization validation has been performed per ISO 11135:2014 for products sterilized with Ethylene Oxide. EO residuals were tested per ISO 10993-7. ### Animal Testing Three GLP animal studies with acute and 28-day endpoints assessed the safety and performance of the Contego Medical catheter platform in the swine model. The ability to capture iniected thrombus and successfully retrieve the thrombus was demonstrated. Acute and 28-day histological analysis showed no local injury in the treated arteries and optimal local toleration. There was no evidence of embolization in the dependent tissues from either the Day 0 or Day 28 animal. {7}------------------------------------------------ Clinical Study A prospective, multicenter study to evaluate acute safety and clinical performance of the nine centers in Belgium and Germany. The conduct of this study is in compliance with ISO Study 14155:2011, Good Clinical Practices (GCP) and the Declaration of Helsinki. > The study enrolled and treated 113 subjects, of which 112 were available for 30-day followup. All subjects presented with evidence of peripheral vascular disease. Mean age was 67.4 ± 10.3 years. The study population was predominantly male (63.7 %). Among the major risk factors, 28.3% of subjects had diabetes, 54% had hyperlipidemia, and 70.8% were hypertensive. 71.7% were either past or current smokers. The vessels treated included superficial femoral arteries (75.2%), external iliac arteries (9.7%), common iliac arteries (8.9%), popliteal arteries (4.4%) and common femoral arteries (1.8%) All enrolled subjects were successfully treated with the study device. Both primary endpoints, assessing safety (Freedom from MAE, defined as death, amputation and target vessel revascularization at 30 days post-procedure) as well as effectiveness (Procedural Success is defined as <50% residual stenosis without any MAE prior to hospital discharge), were met. The 30-day rate of freedom from MAE was 100.0% with a corresponding exact 97.5% lower confident limit of 0.9616 (i.e. 96.2%) which is lower than the prespecified PG of 88%. Conclusion The Vanguard IEP System is substantially equivalent to the predicate devices with respect to indications for use, labeling, materials, mode of operation and technological characteristics.