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

This document is a 510(k) summary for the Serranator® PTA Serration Balloon Catheter. It describes non-clinical testing performed to demonstrate that the device meets design input requirements and is substantially equivalent to predicate devices. It does not contain information about acceptance criteria or a study with human readers with or without AI assistance. It also does not discuss standalone algorithm performance, or ground truth for training data in the context of an AI-powered device.

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

Based on the provided document, the acceptance criteria are implicit in the "Pass" results for various tests. The reported device performance is that it met all these acceptance criteria.

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Shipping, environmental stresses	Device maintains integrity and function after exposure to shipping and environmental stresses.	Pass
Flex/Kink	Device maintains patency and integrity when subjected to flexing and kinking.	Pass
Visual Inspection	Device meets visual quality standards (e.g., no defects, proper assembly).	Pass
Delivery, Deployment, Retraction	Device can be safely and effectively delivered, deployed, and retracted.	Pass
Fatigue	Device maintains integrity and function over its expected lifespan under repeated stresses.	Pass
Rated Burst/Compliance	Balloon inflates to specified pressure and dimensions without bursting prematurely and complies as expected.	Pass
Torsion	Device can withstand torsional forces without damage or loss of function.	Pass
Corrosion	Device materials do not corrode under specified conditions.	Pass
Tensile Test of Joints	Joints of the device meet specified tensile strength requirements.	Pass
Cytotoxicity	Device materials are not toxic to cells.	Pass
Sensitization	Device materials do not cause allergic reactions.	Pass
Irritation	Device materials do not cause irritation.	Pass
Systemic Toxicity (acute)	Device materials do not cause acute systemic toxicity.	Pass
Pyrogenicity	Device materials do not cause fever (are non-pyrogenic).	Pass
Hemocompatibility	Device materials are compatible with blood.	Pass
Thrombogenicity (P. Porcine Study)	Device does not induce thrombus formation.	Confirmed (No thrombus formation or other adverse events)
Usability, Performance (Porcine Study)	Device is usable and performs as intended in vivo.	Confirmed (No adverse events)

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/Performance & Biocompatibility: The document states that "Bench testing... was performed on sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples" and "Biocompatibility testing was conducted on sterile, finished devices". Specific sample sizes for each bench or biocompatibility test are not provided. The data provenance is from laboratory testing, not human subjects or real-world clinical data.
Animal Studies: A total of two porcine test subjects were used for the animal study. This is a prospective animal study.
Cadaver Studies: A diseased cadaver study was not performed for this specific device. However, a cadaver study was performed for the reference device (Serranator® Alto PTA Serration Balloon Catheter, K163380) to determine medial thickness of non-diseased infrapopliteal arteries. The sample size for this cadaver study is not specified, nor is the provenance beyond "cadaver artery assessment."
- Data Provenance for device performance: Lab/bench testing, animal studies, and cadaver studies (for reference device). No country of origin is specified for the animal or cadaver studies.

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 device is not an AI/ML device, and therefore, there is no mention of experts establishing ground truth for a test set in the context of diagnostic or interpretive performance. The "ground truth" for the non-clinical and animal studies would be the objective measurements and observations made by laboratory personnel and veterinarians/pathologists during the respective tests, based on established protocols and standards. No specific number or qualifications are provided as this is a traditional medical device submission.

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

Not applicable, as this is not an AI/ML device requiring human adjudication of results for a test set. The non-clinical and animal studies are assessed against predefined pass/fail criteria.

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, as this is not an AI/ML device and there is no mention of human readers or AI assistance.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for this device's performance is established through:

Objective measurements and observations from bench testing against engineering specifications and regulatory standards (e.g., burst pressure, tensile strength, dimension checks).
Biological responses observed in biocompatibility tests (e.g., cell viability, immune response, blood compatibility).
In vivo observations in animal studies (e.g., absence of thrombus, dissection, perforations, successful deployment/retraction).
Anatomical measurements from cadaver studies (for the reference device) to inform design parameters.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. There is no concept of a "training set" for physical device testing as described.

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

Not applicable, as this is not an AI/ML device.

Summary

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April 15, 2020

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

Re: K193181

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 18, 2020 Received: March 19, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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) K193181

Device Name

Serranator® PTA Serration Balloon Catheter

Indications for Use (Describe)

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

X 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 large, bold, blue font. Below the word "CAGENT" is the word "VASCULAR" in a smaller font. The logo also includes a circular design around the top and bottom of the text, made up of small, dashed lines.

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

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

Serranator® PTA Serration Balloon Catheter Cagent Vascular, LLC

510(k): K193181

DATE PREPARED	April 15, 2020
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 DEVICES	Predicate Device:AngioSculpt® PTA Scoring Balloon Catheter (K142983)Reference Device:Serranator® Alto PTA Serration Balloon Catheter (K163380)

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5.1 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.

5.2 Device Description

5.3 Comparison with Predicate Devices

A comparison of the Serranator® PTA Serration Balloon Catheter (Serranator) and predicate device shows that the technological characteristics such as the components, design, materials, sterilization method, and operating principle of the Serranator are identical or similar to the currently marketed AngioSculpt® PTA Scoring Balloon Catheter (AngioSculpt) (K142983) and the Serranator® Alto PTA Serration Balloon Catheter (Serranator Alto) (K163380), predicate and reference devices respectively.

The technological differences are that the scoring elements of Serranator® are interrupted, rather than a continuous metal configuration such as the AngioSculpt device. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface.

The intended use of the subject device and the predicate device is similar. The indications for use of the Serranator® PTA Serration Balloon Catheter are similar to that of the Serranator Alto reference device.

5.4 Non-Clinical Testing/Performance

The Serranator® PTA Serration Balloon Catheter has been tested through the design verification activities to demonstrate that the device meets design input requirements. The following tests were conducted and passed all requirements (see Table 3.1 below).

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Test	Result
Shipping, environmental stresses	Pass
Flex/Kink	Pass
Visual Inspection	Pass
Delivery, Deployment, Retraction	Pass
Fatigue	Pass
Rated Burst/Compliance	Pass
Torsion	Pass
Corrosion	Pass
Tensile Test of Joints	Pass

Table: 5.1 Summary of Non-Clinical/Performance Testing

Bench testing in accordance with FDA guidance[1], ASTM and ISO standards was performed on sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples of Serranator® PTA Serration Balloon Catheter.

The non-clinical testing demonstrated that the Serranator® met all acceptance criteria. Performance data demonstrate that the device functions as intended and has an acceptable safety and effectiveness profile.

5.5 Biocompatibility

FDA guidance document Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" Guidance for Industry and Food and Drug Administration Staff, June 16, 2016, 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 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. Testing confirmed that the Serranator is non-cytotoxic, non-sensitizing, not systemically toxic, nonthrombogenic, and non-hemolytic.

[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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Table 3.2 provides a list of the various tests completed and passed.

Test	Results
Cytotoxicity	Pass
Sensitization	Pass
Irritation	Pass
Systemic Toxicity (acute)	Pass
Pyrogenicity	Pass
Hemocompatibility	Pass

Table 5.2: Biocompatibility Tests

In addition to the tests indicated in Table 5.2, thrombogenicity evaluation was conducted as part of the Acute Porcine Study.

5.6 Animal Studies

An animal study was performed to assess usability, performance and acute thromboresistance of the Serranator® PTA Serration Balloon Catheter in swine peripheral arteries. In accordance with general FDA animal study guidelines and ISO-10993-4 methodology, a total of two porcine test subjects were used for assessment. No adverse events including filling defects, dissections, thrombus formation or perforations occurred in this study.

5.7 Cadaver Studies

A diseased cadaver study was not performed using the Serranator® PTA Serration Balloon Catheter (Serranator) as this testing was conducted in the reference device, the Serranator® Alto PTA Serration Balloon Catheter (Serranator Alto) submission (K163380). The results between the subject device and the Serranator Alto (reference) were not expected to differ as both devices have the same function, design and mechanism of action.

A cadaver artery assessment was performed to determine the medial thickness of non-diseased infrapopliteal arteries. These data were used to determine an appropriate strip height for safety. Arteries assessed showed minimal atherosclerotic disease ranging from mild disease to no calcification. Average medial thickness varied significantly between popliteal, anterior tibial, posterior tibial, tibial-peroneal, and peroneal sections.

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5.7 Conclusion

The Serranator® PTA Serration Balloon Catheter has similar intended use and similar technological characteristics such as components, design, materials, sterilization method, 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® PTA Serration Balloon Catheter is substantially equivalent to the predicate AngioSculpt® PTA Scoring Balloon Catheter and reference Serranator® Alto PTA Serration 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).