The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. 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 multiple 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 describes a 510(k) premarket notification for the Serranator® PTA Serration Balloon Catheter. This notification is a "consolidation (i.e., bundling) of previously cleared 510(k) indication statements and labeling." The key takeaway is that the device described in this submission (K220704) is identical to previously cleared devices (K213728 and K203437) in terms of "purpose, design, materials, energy source, function, or any other feature." Therefore, no new performance data or studies were conducted for this specific submission.

The document does not contain any information about acceptance criteria or a new study proving the device meets new acceptance criteria for this K220704 submission. It explicitly states: "No new data are included in this bundled 510(K) application. The Serranator® PTA Serration Balloon Catheters represented in this bundled submission do not differ in purpose, design, materials, energy source, function, or any other feature. Performance data previously provided in K213728 and K203437 demonstrate that the devices function as intended."

Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study that proves the device meets them, as no new study was performed for this specific submission to demonstrate compliance with new acceptance criteria. The device's substantial equivalence is based on its identity to previously cleared devices and the previous performance data.

To answer your request, one would need to refer to the original 510(k) submissions (K213728 and K203437) to find the acceptance criteria and study details.

Summary

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May 4, 2022

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

Re: K220704

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: March 8, 2022 Received: March 10, 2022

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. 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,

For

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) K220704

Device Name Serranator® 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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1 K220704

Image /page/3/Picture/1 description: The image shows the logo for Cagent Vascular. The logo features the word "CAGENT" in a bold, blue font, with the exclamation point in "CAGENT" being red. Below "CAGENT" is the word "VASCULAR" in a smaller, blue font. To the right of "CAGENT" is the registered trademark symbol. The logo is surrounded by a broken circle made of small, light green dashes.

Cagent Vascular, Inc.
150 Strafford Avenue #315 Wayne, PA 19087

510(k) Summary

Serranator® PTA Serration Balloon Catheter Cagent Vascular, Inc.

K220704

DATE PREPARED	May 4, 2022
APPLICANT INFORMATION	Carol Burns/President & CEO150 Strafford Avenue #315Wayne, PA 19087
CONTACT INFORMATION	Carol A. Burns, President and CEOPhone: (610) 688-2006Fax: (610) 688-2667Email: cburns@cagentvascular.com
TRADE NAME	Serranator® PTA Serration Balloon Catheter
DEVICE CLASSIFICATION	Class 2 per 21 CFR §870.1250
CLASSIFICATION NAME	Percutaneous Catheter
PRODUCT CODE	PNO
PREDICATE DEVICE	Predicate Device: Serranator® PTA Serration Balloon Catheter (K213728)Reference Device: Serranator® PTA Serration Balloon Catheter (K203437)

5.1 Intended Use/Indications for Use

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal arteries and for the treatment of obstructive

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lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

5.2 Device Description

This 510(k) Summary represents a consolidation (i.e., bundling) of previously cleared 510(k) indication statements and labeling. Bundled devices are identical to previously cleared devices, the predicate device Serranator® PTA Serration Balloon Catheter (K213728) and reference device Serranator® PTA Serration Balloon Catheter (K203437). The bundled device sizes are shown in Table 5.1.

	BalloonNominal OD[mm]	Balloon Length[mm]
		40	80	120
Subject Device Serranator® PTASerration Balloon Catheter	2.5	✓	✓	✓	Reference DeviceSerranator® PTASerration BalloonCatheter (K203437)
	3.0	✓	✓	✓
	3.5	✓	✓	✓
	4.0	✓		✓	Predicate Device
	5.0	✓	N.A.*	✓	Serranator® PTASerration BalloonCatheter (K213728)
	6.0	✓		✓

.1>	TableU
---------	------------	--

*The 80mm length size is commercially available for the below the knee sizes only.

5.3 Comparison to Predicate and Reference Devices

A comparison of the Serranator® PTA Serration Balloon Catheter (Serranator) to the predicate device shows that the technological characteristics such as the components, design, materials,

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sterilization method, and operating principle of the Serranator are identical to the currently marketed Serranator® PTA Serration Balloon Catheter (Serranator) (K213728) and the Serranator® PTA Serration Balloon Catheter (Serranator) (K203437).

The intended use of the subject device is identical to the combination of the predicate device, Serranator® PTA Serration Balloon Catheter (K213728) and the Serranator® PTA Serration Balloon Catheter (Serranator) (K203437), as shown in Table 5.2.

Table 5.2
Indications for Use statements of the Subject and Predicate Device

	Device Name	Indications For Use
Subject Device	Serranator®PTA SerrationBalloon Catheter	The Serranator® PTA Serration Balloon Catheter isintended for dilatation of lesions in the iliac, femoral,iliofemoral, popliteal, infrapopliteal arteries and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. Not for use in thecoronary or neuro-vasculature.
PredicateDevice	Serranator®PTA SerrationBalloon Catheter(K213728)	The Serranator® PTA Serration Balloon Catheter isintended for dilatation of lesions in the iliac, femoral,iliofemoral, and popliteal arteries and for the treatment ofobstructive lesions of native or synthetic arteriovenousdialysis fistulae. Not for use in the coronary or neuro-vasculature.
ReferenceDevice	Serranator®PTA SerrationBalloon Catheter(K203437)	The Serranator® PTA Serration Balloon Catheter isintended for dilatation of lesions in infrapopliteal arteries.Not for use in the coronary or neuro-vasculature.

5.4 Previous Non-Clinical and Pre-Clinical Testing

The devices represented herein are identical to the predicate and reference devices (Serranator® PTA Serration Balloon Catheter (Serranator) (K213728) and the Serranator® PTA Serration Balloon Catheter (Serranator) (K203437). All non-clinical and pre-clinical testing has been leveraged from those submissions.

5.5 Conclusion

No new data are included in this bundled 510(K) application. The Serranator® PTA Serration Balloon Catheters represented in this bundled submission do not differ in purpose, design, materials, energy source, function, or any other feature. Performance data previously provided in K213728 and K203437 demonstrate that the devices function as intended.

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).