The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

Device Description

The PolarCath™ Peripheral Dilatation System (PolarCath System) consists of a disposable catheter, a reusable Cryoplasty inflation unit, a disposable nitrous oxide cartridge, and a disposable catheter extension.

The PolarCath System is designed for dilatation of stenotic lesions in peripheral arteries. The procedure consists of inserting a catheter over a quidewire to the target lesion, attaching the catheter to the catheter extension, attaching the catheter extension to the Inflation Unit, inserting a nitrous oxide cartridge into the Inflation Unit, and inflating the balloon catheter for a set time at a set pressure, using the controls on the Inflation Unit.

The Cryoplasty inflation unit functions to: a) deliver the inflation media (liquid nitrous oxide) to the balloon; b) control the pressure inside the inner balloon; c) provide a vacuum between the inner and outer balloons; and d) control the length of time for delivery of the inflation media which is manually extracted at the end of the inflation time. The inflation unit monitors the temperature inside the balloon. Excess pressure is prevented by the presence of a relief valve in the inflation unit.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the PolarCath Peripheral Dilatation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving device performance against specific acceptance criteria in a clinical context.

Therefore, many of the requested sections regarding clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies) cannot be fulfilled from this document. The document describes non-clinical testing.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance & The Study that Proves the Device Meets Acceptance Criteria:

Testing Type	Acceptance Criteria (Implied)	Reported Device Performance
Performance Bench Testing	Pass all functional testing; meet all product specification requirements; demonstrate equivalent performance to the predicate device.	The PolarCath System passed all functional testing and met all product specification requirements and demonstrated equivalent performance to the predicate device.
Software Verification Validation Testing	Meet all requirements of the Software Requirements Specification (SRS).	PolarCath System Software met all requirements of the SRS.
Electromagnetic Compatibility & Electrical Safety	Meet all acceptance criteria in accordance with IEC 60601-1:2005 and IEC 60601-1-2:2007.	The PolarCath System met all acceptance criteria in accordance with: IEC 60601-1:2005 and IEC 60601-1-2:2007.

The Study that Proves the Device Meets Acceptance Criteria:

The document describes "non-clinical testing" as the study. This involved "Performance Bench Testing," "Software Verification Validation Testing," and "Electromagnetic Compatibility and Electrical Safety" testing. These tests were conducted to demonstrate that the materials chosen, manufacturing processes, and design meet established specifications and do not raise new questions of safety or effectiveness compared to the predicate device. No animal or clinical testing was required or performed for this submission.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the non-clinical tests. For bench testing, it refers to multiple aspects (Catheter Extension, Inflation Unit, Simulated Use, Transit Testing), implying a series of tests on various components/systems, but specific quantities are not given.
Data Provenance: Not applicable as these are non-clinical, bench-level tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this was non-clinical and did not involve expert-established ground truth in a clinical diagnostic sense. Performance was measured against engineering specifications and industry standards.

4. Adjudication method for the test set:

Not applicable as this was non-clinical and did not involve expert adjudication.

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:

No. This is a medical device for physical intervention (dilatation system), not an AI-powered diagnostic or assistive tool for human readers.

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

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

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" was established by engineering specifications, product requirements, and recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2). For the software, it was the Software Requirements Specification (SRS). For performance, it was also equivalent performance to the predicate device.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would have a training set.

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

Not applicable.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

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

October 26, 2015

NuCryo Vascular, LLC % Michael Billig Regulatory Consultant Experien Group, LLC 755 N. Mathilda Ave. Suite 100 Sunnyvale, CA 94085

Re: K152665

Trade/Device Name: PolarCath Peripheral Dilatation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: September 16, 2015 Received: September 17, 2015

Dear Mr. Billig:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 yours,

Kenneth J. Cavanaugh -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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K152665
Device Name	PolarCath Peripheral Dilatation System
Indications for Use
Indications for Use (Describe)	The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
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)
	CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
	"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
	Page 1 of 1
	FORM FDA 3881 (8/14)

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GENERAL INFORMATION

Submitter:

NuCryo Vascular, LLC A Subsidiary of Gemini Interventional Technologies, LLC 746 San Aleso Ave. Sunnyvale, CA. 94085 U.S.A. Phone: (408) 541-1414 Fax: (408) 541-1448

Contact Person:

Michael J. Billig CEO, Experien Group, LLC Regulatory Consultant for NuCryo Vascular, LLC 746 San Aleso Ave. Sunnyvale, CA. 94085 U.S.A. Phone: (408) 400-0856 Cell: (650) 245-3439 Fax: (408) 400-0865

Date Prepared: September 17, 2015

Device Information

Device Name:

PolarCath Peripheral Dilatation System

Common or Usual Name:

Catheter, Percutaneous

Classification Name:

21 CFR§870.1250, Percutaneous catheter

Regulatory Class:

Class II

Product Code:

LIT/DQY

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Predicate Device(s)

PolarCath Peripheral Dilatation System (K092455) .
This predicate has not been subject to a design-related recall.

Indications for use

The Indications for Use statement for the PolarCath Peripheral Dilatation System is identical to the predicate device.

Product Description

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the PolarCath System are similar to the predicate device. Available performance data support the determination of substantial equivalence.

SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the proposed device is substantially equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the PolarCath System is substantially equivalent to the predicate device.

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TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the PolarCath System to support a determination of substantial equivalence to the predicate device. The following table lists the non-clinical testing performed and the results for each test.

Testing Type	Test Description	Result
PerformanceBench Testing	The nonclinical testing assessedthe following aspects of thedevice:• Catheter ExtensionVerification Testing• Inflation Unit Verification• Simulated Use• Transit Testing	The PolarCath Systempassed all functionaltesting and met allproduct specificationrequirements anddemonstrated equivalentperformance to thepredicate device.
SoftwareVerificationValidation Testing	PolarCath System SoftwareTesting (The Level of Concern forPolarCath System software wasdetermined to be "Moderate".)	PolarCath SystemSoftware met allrequirements of the SRS.
ElectromagneticCompatibility andElectrical Safety	Testing in accordance with thefollowing standards:• IEC 60601-1:2005• IEC 60601-1-2:2007	The PolarCath Systemmet all acceptancecriteria in accordancewith:• IEC 60601-1:2005• IEC 60601-1-2:2007

The collective results of performance testing demonstrate that the materials chosen, the manufacturing processes, and design of the PolarCath System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the PolarCath System does not raise new questions of safety or effectiveness when compared to the predicate device.

CONCLUSION

As demonstrated in the nonclinical testing summaries, no new issues of safety or effectiveness are raised by using the PolarCath System to dilate stenotic lesions in the peripheral vasculature. No animal or clinical testing was required.

SUMMARY

The PolarCath Peripheral Dilatation System is substantially equivalent to the predicate device.

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).