The Serranator™ Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

Device Description

The Serranator™ Alto PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral vasculature as described in the Indications for Use statement. The Serranator™ has a nylon semi-compliant balloon with four embedded external metal strips, or scoring elements. The scoring elements are designed to create linear, interrupted scoring along the endoluminal surface that occurs during balloon angioplasty.

AI/ML Overview

The given text is a 510(k) Summary for the Serranator™ Alto PTA Serration Balloon Catheter. It describes the device, its intended use, and provides non-clinical testing, biocompatibility, animal, and cadaver study results to support its substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly provide a table of acceptance criteria alongside the reported device performance in a quantitative manner. Instead, it states that:

"The non-clinical testing results demonstrated that the Serranator™ met all acceptance criteria." (Page 6)
"All testing passed the required acceptance criteria and the product is biocompatible for human use." (Page 6)

The tests performed include: Shipping, environmental stresses, Flex/Kink, Peel Strength, Visual Inspection, Particulates, Delivery, Deployment, Retraction, Fatigue, Rated Burst/Compliance, Torsion, Corrosion, Tensile Test of Joints, Lubricious Coating Integrity, and Biocompatibility (following ISO-10993).

While the tests are listed, the specific quantitative acceptance criteria (e.g., "flex strength must be > X Newtons") and the quantitative results for each test are not detailed in this summary. The statement "met all acceptance criteria" is a blanket declaration.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Non-clinical testing: The document mentions "sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples." No specific sample sizes for these tests are provided. Data provenance is implied to be from the manufacturer's testing facilities (Cagent Vascular).
Biocompatibility testing: "sterile, finished devices." No specific sample size is provided. Data provenance is implied to be from the manufacturer's testing or contracted labs.
Animal Studies: "Peripheral vessels in a porcine model were treated with a Serranator™ Alto PTA Serration Balloon Catheter or control, AngioSculpt® PTA Scoring Balloon Catheter." No specific number of animals or vessels is given. The model is porcine. (Prospective study, likely a controlled experiment).
Cadaver Studies: "Cadaver testing was performed comparing the Serranator™ to the predicate device." No specific number of cadavers or tests is given. (Prospective study).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies described are primarily technical device performance, biocompatibility, and comparative morphological studies in animal models and cadavers. There is no mention of human expert-established ground truth as would be relevant for an AI/diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the studies are not clinical trials or diagnostic performance studies requiring adjudication of human expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, nor any evaluation of human readers with or without AI assistance. This device is a physical medical device (balloon catheter), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is a physical medical device and not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the animal studies, the "ground truth" or primary endpoints appear to be morphometric measurements (e.g., neointimal areas, thickness, percent stenosis) derived from analyzing treated vessels. These measurements would likely be obtained via histological analysis or imaging post-treatment.

For non-clinical and biocompatibility testing, the "ground truth" is adherence to pre-defined engineering specifications, material properties, and biological safety standards (e.g., ASTM, ISO standards).

8. The sample size for the training set

This is not applicable as the device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 13, 2017

Cagent Vascular, LLC Ms. Carol A. Burns President and CEO 150 Strafford Avenue #315 Wayne, PA 19087

Re: K163380

Trade/Device Name: Serranator Alto PTA Serration Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: December 1, 2016 Received: December 2, 2016

Dear Ms. Burns:

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando Aguel-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) K163380

Device Name

Serranator Alto PTA Serration Balloon Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Cagent Vascular. The logo features the word "CAGENT" in a bold, blue sans-serif font, with an exclamation point replacing the "I". Below "CAGENT" is the word "VASCULAR" in a smaller, red sans-serif font. The words are surrounded by a broken circle made of small, light-green dashes. To the right of the word "CAGENT" is the registered trademark symbol.

Cagent Vascular, LLC 150 Strafford Avenue #315 Wayne, PA 19087

510(k) Summary [as required by 21 CFR 807.92(c)]

Serranator™ Alto PTA Serration Balloon Catheter Cagent Vascular, LLC

510(k) M3855: 2__

DATE PREPARED	November 28, 2016
APPLICANT INFORMATION	Carol Burns/President & CEO150 Strafford Avenue #315Wayne, PA 19087
CONTACT INFORMATION	Carol A. Burns, President and CEOPhone: 610-688-2006Email: cburns@cagentvascular.com
TRADE NAME	Serranator™ Alto PTA Serration Balloon Catheter
DEVICE CLASSIFICATION	Class 2 per 21 CFR §870.1250
CLASSIFICATION NAME	Percutaneous Catheter
PRODUCT CODE	PNO
PREDICATE DEVICE	AngioSculpt® Scoring Balloon Catheter (K122685)

INTENDED USE/INDICATIONS FOR USE

The Serranator™ Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

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DEVICE DESCRIPTION

COMPARISON WITH PREDICATE DEVICE

A comparison of the Serranator™ Alto PTA Serration Balloon Catheter and predicate device shows that the technological characteristics such as the components, design, materials, sterilization method, shelf life and operating principle of the Serranator™ are identical or similar to the currently marketed AngioSculpt® Scoring Balloon Catheter , the predicate device.

The intended use of the Subject Device and its primary predicate is identical. The indications for use of the Serranator™ Alto PTA Serration Balloon Catheter are similar (a subset) to that of the predicate device.

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	Item	Subject Device	Predicate Device
	Name	Serranator™ AltoPTA SerrationBalloon Catheter	AngioSculpt® ScoringBalloon Catheter
	Manufacturer	Cagent Vascular	Spectranetics
	510(k) Number	Current Application	K122685
	Intended Use	Dilatation of lesionsin the iliac, femoral,ilio-femoral, andpopliteal arteries, andfor the treatment ofobstructive lesions ofnative or syntheticarteriovenous dialysisfistulae. Not for usein the coronary orneuro-vasculature.	Dilatation of lesions in theiliac, femoral, ilio-femoral,popliteal and renal arteries, andfor the treatment of obstructivelesions of native or syntheticarteriovenous dialysis fistulae.Not for use in the coronary orneuro-vasculature.
	Target Body Location	Peripheral	Peripheral
	Principle of Operation	Balloon dilatationwith interrupted,axial scoring	Balloon dilatation withcontinuous helical scoring
	Platform	Over-The-Wire(OTW)	Over-The-Wire (OTW)
Design	Maximum OD	6 Fr	6 Fr
	Effective Length[cm]	150	137
BalloonCharacteristic	Balloon Diameters[mm]	4.0, 5.0, and 6.0	3.5 through 6.0
	Balloon lengths[mm]	40, 80, and 120	40 through 200

NON CLINICAL TESTING / PERFORMANCE DATA

Bench testing in accordance with FDA guidance[]', ASTM and ISO standards was performed
on sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples of Serranator™ Alto PTA Serration Balloon Catheter.

[1] Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, April 2010. Only the sections associated with Delivery Systems were applied to Serranator.

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The following testing/assessments were performed:

Shipping, environmental stresses ●
Flex/Kink ●
Peel Strength ●
Visual Inspection ●
Particulates ●
Delivery, Deployment. Retraction ●
Fatigue
Rated Burst/Compliance
Torsion
Corrosion
Tensile Test of Joints ●
Lubricious Coating Integrity ●

The non-clinical testing results demonstrated that the Serranator™ met all acceptance criteria. Performance data demonstrate that the device functions as intended.

BIOCOMPATIBILITY

FDA guidance document Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" Draft Guidance for Industry and Food and Drug Administration Staff, April 23, 2013, ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and ISO-10993 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials were followed in selecting and conducting the biocompatibility testing of the Serranator™ Alto PTA Serration Balloon Catheter.

Biocompatibility testing was conducted on sterile, finished devices manufactured using the manufacturing processes which will be used for the cleared devices. All testing passed the required acceptance criteria and the product is biocompatible for human use.

ANIMAL STUDIES

Peripheral vessels in a porcine model were treated with a Serranator™ Alto PTA Serration Balloon Catheter or control, AngioSculpt® PTA Scoring Balloon Catheter.

Morphometric measurements were similar between Serranator™ and AngioSculpt. Neointimal areas, thickness and percent stenosis were minimal and similar in both groups.

CADAVER STUDIES

Cadaver testing was performed comparing the Serranator™ to the predicate device and was found to have similar performance.

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CONCLUSION

The Serranator™ Alto PTA Serration Balloon Catheter has identical intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference devices. Performance data demonstrates that the device functions as intended.

Data presented in this 510(k) Submission support that the Serranator™ Alto PTA Serration Balloon Catheter is substantially equivalent to the predicate device AngioSculpt® PTA Scoring Balloon Catheter.

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).