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.

Device Description

The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection platform is similar to a catheter with a typical angioplasty balloon, but between the distal end of the balloon and the distal tip of the catheter, there is a nitinol-based filter. The device is over-the-wire (OTW) and is 0.018" guidewire compatible. The balloon catheter comes in sizes of 5 and 6 mms outside diameter (OD) and lengths 40, 80, 120 and 200 mms. The filter component is composed of a nitinol filter frame with an overlying membrane perforated with a set pattern of drilled holes. The balloon catheter shaft consists of a dual lumen inner shaft placed inside a single lumen outer shaft. The inner shaft extends beyond the balloon up to the distal catheter tip. Radiopaque markers placed on either side of the balloon and the distal tip of the filter assist with accurate placement. The nitinol filter frame has radiopaque markers, making the diameter of the filter visible when opened. The proximal end of the nitinol frame slides freely over the distal shaft. A pull-wire attaches the handle to the filter frame to activate the filter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Contego Medical Vanguard IEP Peripheral Balloon Angioplasty System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Value (Target)	Reported Device Performance
Safety: Freedom from Major Adverse Events (MAE) at 30 days post-procedure	> 88% (pre-specified performance goal, PG)	100.0% (with a 97.5% lower confidence limit of 96.2%)
Effectiveness: Procedural Success (defined as <50% residual stenosis without any MAE prior to hospital discharge)	(Explicit target not stated, but implied to be achieved)	Met

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 113 subjects enrolled, 112 available for 30-day follow-up.
Data Provenance: Prospective, multicenter study conducted across nine centers in Belgium and Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. Clinical endpoints like MAE and procedural success are typically assessed by the treating clinicians and/or adjudicated by an independent clinical events committee (CEC), but details on this are not provided in the summary.

4. Adjudication Method for the Test Set

The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). It states that the "conduct of this study is in compliance with ISO Study 14155:2011, Good Clinical Practices (GCP) and the Declaration of Helsinki," which implies rigorous oversight, but the specific adjudication process is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a medical device for angioplasty and embolic protection, not an AI or imaging diagnostic device that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth was established through clinical outcomes data (e.g., occurrence of death, amputation, target vessel revascularization at 30 days, and residual stenosis). This would be based on clinical assessments, imaging results, and patient follow-up during the clinical study.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" of the device itself would refer to its design and manufacturing processes, which are informed by engineering principles, bench testing (in-vitro), and animal studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as it's not an AI/ML device. For physical devices, validation comes from:

Bench Testing (in-vitro): Evaluating various physical and mechanical properties against pre-defined engineering standards and performance requirements (e.g., dimensional verification, balloon integrity, filter capture efficiency).
Animal Testing: Assessing safety and performance in a relevant physiological environment (e.g., in a swine model for thrombus capture and histological analysis of treated arteries).

Summary

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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.

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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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Misti L. Malone -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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)

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)

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510(k) Summary [per 21 CFR 807.92]

DatePrepared:	November 05, 2018
Applicant:	Contego Medical, LLC3921 Sunset Ridge Rd., Suite 102Raleigh, NC 27607
ContactPerson:	Debra CoganRegulatory Affairs Consultant to Contego Medical, LLCPhone: (408) 515-0820Fax: (408) 273-6047dcogan@contegomedical.com
ProprietaryName:	Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection
CommonName:	Percutaneous Transluminal Angioplasty Balloon Catheter
DeviceClassification:	Class II (special controls)
RegulationNumber:	870.1250
ClassificationName:	Catheter, Percutaneous
Product Code:	LIT, NTE
DeviceDescription:	The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protectionplatform is similar to a catheter with a typical angioplasty balloon, but between the distal endof the balloon and the distal tip of the catheter, there is a nitinol-based filter. The device isover-the-wire (OTW) and is 0.018" guidewire compatible. The balloon catheter comes in sizesof 5 and 6 mms outside diameter (OD) and lengths 40, 80, 120 and 200 mms. The filtercomponent is composed of a nitinol filter frame with an overlying membrane perforated with aset pattern of drilled holes. The balloon catheter shaft consists of a dual lumen inner shaftplaced inside a single lumen outer shaft. The inner shaft extends beyond the balloon up tothe distal catheter tip. Radiopaque markers placed on either side of the balloon and the distaltip of the filter assist with accurate placement. The nitinol filter frame has radiopaquemarkers, making the diameter of the filter visible when opened. The proximal end of thenitinol frame slides freely over the distal shaft. A pull-wire attaches the handle to the filterframe to activate the filter.
Indications forUse:	The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protectionis indicated for percutaneous transluminal angioplasty (PTA) and capture and removal ofembolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. TheSystem is not intended for use in the renal, cerebral, coronary or carotid vasculature.
PredicateDevice(s):	1. Proteus ™ (AngioSlide) (K172494) - Primary Predicate2. SpiderFX Embolic Protection Device (Medtronic) (K111010)

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Reference

1. Sterling Monorail PTA Balloon Dilatation Catheter (K141150, Boston Scientific)
  Predicates:
1. RX Accunet (K153086, Abbott Vascular)
  Substantial Equivalency Table

Parameters	Subject DeviceVanguard IEP®	Primary PredicateProteus ™	Secondary PredicateSpiderFX™
510(k) Number	K181529	K172494	K111010
Manufacturer	Contego Medical	AngioSlide	Medtronic
Trade Name	Vanguard IEP®Peripheral BalloonAngioplasty System withIntegrated EmbolicProtection	Proteus PTA Catheterwith Embolic CaptureFeature	SpiderFX EmbolicProtection Device
Common name	PercutaneousTransluminal AngioplastyBalloon Catheter	PercutaneousTransluminal AngioplastyBalloon Catheter	Embolic ProtectionDevice
Classification	Class II (21 CFR870.1250)	Class II (21 CFR870.1250)	Class II (21 CFR870.1250)
Classificationname	Catheter, Percutaneous	Catheter, Percutaneous	Percutaneous Catheter
Product code	LIT	LIT	NTE
Intended use /Indications foruse	The Vanguard IEP®Peripheral BalloonAngioplasty System withIntegrated EmbolicProtection is indicated forpercutaneoustransluminal angioplasty(PTA) and capture andremoval of embolicmaterial duringangioplasty, for thefemoral, iliac, poplitealand profunda arteries.	The PROTEUS™PercutaneousTransluminal Angioplasty(PTA) Balloon Catheterwith Embolic CaptureFeature is indicated forperipheral transluminalangioplasty and forcapture and removal ofembolic material (e.g.debris, thrombus) duringangioplasty, for thefemoral, iliac, ilio-femoral, popliteal, tibial,peroneal, and profundaarteries.The PROTEUS™ PTABalloon Catheter withEmbolic Capture Featureis not intended for use inthe renal, cerebral,coronary or carotidvasculature.	The SpiderFX™ EmbolicProtection Device isindicated for use as aguidewire and embolicprotection system tocontain and removeembolic material inconjunction with theTurboHawk™ PeripheralPlaque Excision System,either during standaloneprocedures or togetherwith PTA and/or stenting,in the treatment ofseverely calcified lesionsin arteries of the lowerextremities. The vesseldiameter at the filterbasket placement siteshould be between 3.0mm and 6.0 mm.
Principles ofOperation	Combines balloonangioplasty and distalembolic particle captureand removal.During balloon dilation,embolic debris iscaptured by the filter.Upon completion of theintervention the filter isallowed to collapse andthe entire system iswithdrawn through theintroducer sheath orguide catheter.	Combines balloonangioplasty and proximalembolic particle captureand removal.During balloon dilation,negative pressurecreates suction tocapture embolic debris.Upon completion of theintervention the balloonis collapsed and theentire system iswithdrawn through theintroducer sheath orguide catheter.	The device serves asboth guidewire forinterventional devicesand a distal emboliccapture and removalfilter. The filter isremoved followingangioplasty through acustom removal catheterthat is also used todeliver the filter at theonset of the procedure(dual-ended SpiderFXCatheter).
Sterilization	EO gas	EO gas	EO gas
SterilityAssuranceLevel (SAL)	10-6	10-6	10-6
Single use	Yes	Yes	Yes
Shelf life	1 year	3 years	2 years
Packagingsystem	Packaged in a PET/Gthermoformed tray withlid, sealed in a sterilepouch and single unitbox.	Information is notavailable.	Packaged in a protectivehoop, tray, sterile pouchand in a single unit box.
CatheterPlatform	OTW	OTW	OTW, converts to RX
RadiopaqueMarkers	Two markers distal andproximal to both filter andballoon.Five gold circumferentialmarkers on the proximalperimeter of the filterframe are visible whenfilter is open.	Two balloon markersdistal and proximal toballoon.	Two marker bands distaland proximal to the filter.A gold radiopaqueProximal Mouth Indicatoris visible when filter isopen.
AngioplastyBalloonCharacteristics	Nylon, semi-compliantPTA balloon	Semi-compliant PTAballoon	N/A
Usable CatheterLength	135 cm	135 cm	140 cm
Guidewirecompatibility	0.018"	0.014" and 0.035"	0.014" and 0.018"
Introducersheathcompatibility	All sizes 6F except for8 mm diameter balloonsizes are 7F	various: 5F, 6F and 7F	6 F
EmbolicCaptureMechanism	Distal embolic protection.Adjustable nitinol filterframe covered with aporous polyurethanemembrane capturesembolic debris duringPTA procedure.	Proximal occlusion.Negative pressurecreates suction tocapture embolic debris inthe inverted balloon.	Distal embolic protection.Self-expanding nitinolfilter captures embolicdebris duringinterventionalprocedures.
Filter Size(diameter)	Adjustable up to 8 mmdiameter	N/A	5.0 mm, 6.0 mm, 7.0 mm
Filter Length	16 mm	N/A	23 mm, 24 mm (7.0diameter)1
ReferenceVesselDiameters	up to 8 mm	3 mm -6 mm	3 mm -6 mm
Pore SizeFilter Materials	150 micronnitinol, polyurethane	N/AN/A	< 200 micron2nitinol mesh
Balloondiameter [mm]	5 mm – 6 mm	3 mm – 6 mm	N/A
Balloon length[mm]	40 mm, 80 mm, 120 mmand 200 mm	20 mm, 40 mm, 60 mm,80 mm, 100 mm	N/A
Balloon RBP[atm]	Various: 12 and 14 atm	Various: 12 and 14 atm	N/A

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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.

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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.

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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.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).