The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.

Device Description

The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with three embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

AI/ML Overview

The provided text is a 510(k) summary for the Serranator® PTA Serration Balloon Catheter and focuses on demonstrating substantial equivalence to a previously cleared predicate device. It does not describe a clinical study or detailed acceptance criteria for device performance based on clinical outcomes. Instead, it relies on non-clinical bench testing to demonstrate that the new device performs as intended and is comparable to the predicate.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding a study with human subjects, ground truth, and training sets are not applicable to the information provided.

Here's a breakdown of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "acceptance criteria" generally for non-clinical testing but does not provide specific quantitative criteria or detailed performance results in a table format. It states generally that "The subject device meets all acceptance criteria" and "In vitro bench testing demonstrated that the subject device performed as intended."

Acceptance Criteria Category	Reported Device Performance
Catheter Delivery, Deployment, and Retraction	Performed as intended
Balloon Fatigue	Performed as intended
Catheter Torsion	Performed as intended
Catheter Flex/Kink	Performed as intended
Catheter Tensile Test	Performed as intended
Biocompatibility	Biocompatible (based on no new materials or manufacturing changes compared to predicate)

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

Not applicable. The study was non-clinical bench testing, not involving a test set of human data.

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

Not applicable. Ground truth for human data is not relevant for this non-clinical bench testing.

4. Adjudication Method for the Test Set

Not applicable. No test set involving human data or expert review.

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

Not applicable. This device is a physical medical device (balloon catheter), not an AI-powered diagnostic tool.

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

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

7. The Type of Ground Truth Used

Not applicable. Ground truth as typically defined for clinical or AI studies (e.g., pathology, outcomes data) is not relevant for this non-clinical bench testing. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards which the device was tested against.

8. The Sample Size for the Training Set

Not applicable. This is not referring to an AI device or a study with a training set of data.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 22, 2020

Cagent Vascular, LLC Carol Burns CEO 150 Strafford Avenue #315 Wayne, Pennsylvania 19087

Re: K203437

Trade/Device Name: Serranator PTA Serration Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: November 20, 2020 Received: November 23, 2020

Dear Carol 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. 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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203437

Device Name Serranator® PTA Serration Balloon Catheter

Indications for Use (Describe)

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapoplited arteries. Not for use in the coronary or neuro-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.

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Image /page/3/Picture/1 description: The image shows the logo for Cagent Vascular. The word "CAGENT" is in large, bold, dark blue letters. Below that, the word "VASCULAR" is in smaller, light blue letters. The logo also includes a curved line made of small, light blue squares that wraps around the left and bottom of the text.

510(k) Summary

[as required by 21 CFR 807.92(c)]

Serranator® PTA Serration Balloon Catheter 510(k) K203437

DATE PREPARED:	November 20, 2020
APPLICANT:	Carol Burns/ President & CEO150 Strafford Avenue, #315Wayne, PA 19087
CONTACT:	Carol A. Burns, President and CEOPhone: (610) 688-2006Fax: (610) 688-2667Email: cburns@cagentvascular.com
TRADE NAME:	Serranator® PTA Serration Balloon Catheter
COMMON NAME:	Percutaneous Catheter
CLASSIFICATION	21CFR 870.1250
REGULATION:
DEVICE CLASS:	Class II
PANEL CODE:	PNO
PREDICATE DEVICE:	K193181

INTENDED USE/INDICATIONS FOR USE:

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.

DEVICE DESCRIPTION:

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COMPARISON WITH PREDICATE DEVICE:

Comparison of the subject device (Serranator) and the predicate device (Serranator, K193181) show that the technological characteristics of the subject device such as components, design, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate device.

The intended use/indications for use between the subject device and the predicate device are identical.

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COMPARISON WITH PREDICATE DEVICE:

	Subject Device	Predicate Device
Device Name	Serranator® PTA SerrationBalloon Catheter	Same
Manufacturer	Cagent Vascular, LLC
510(k)		K193181
Intended Use/Indication forUse	The Serranator® PTASerration BalloonCatheter is intended fordilatation of lesions ininfrapopliteal arteries.Not for use in thecoronary or neuro-vasculature.
Regulation	21CFR870.1250
Regulation Name	Percutaneous catheter
Regulation Class	Class 2	Same
Product Code	PNO
Prescription/OTC	Prescription
Catheter Design	OTW
Balloon diameter (mm)	2.5, 3.0, 3.5
Balloon length (mm)	40, 80, 120
Effective Length (cm)	150
Balloon Compliance	Semi Compliant
Sterilization Method	Ethylene Oxide Gas
Nominal Pressure (atm)	6
Rated Burst Pressure (atm)	12
Dispenser	Yes (unchanged)
Pouch	Yes (unchanged)

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NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical bench testing was performed on the subject device to determine substantial equivalence. The following tests were performed:

. Catheter Delivery, Deployment and Retraction
Balloon Fatigue
. Catheter Torsion
. Catheter Flex/Kink
Catheter Tensile Test

In vitro bench testing demonstrated that the subject device performed as intended.

BIOCOMPATIBILITY:

Biocompatibility testing was not repeated for the subject device as there were no new materials and no manufacturing process changes as compared to the predicate device.

The subject device meets all acceptance criteria and is biocompatible.

CONCLUSION:

The Serranator® PTA Serration Balloon Catheter included in this notification is substantially equivalent to the previously cleared predicate device in terms of intended use and technological characteristics as demonstrated by bench testing.

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).