The PolarCath Peripheral Dilatation System is indicated to dilate 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 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 consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

AI/ML Overview

This submission (K051916) by CryoVascular Systems, Inc. for the PolarCath™ Peripheral Dilatation System does not include detailed acceptance criteria or a dedicated study report proving the device meets specific performance criteria in the way typically seen for a new or significantly modified device requiring extensive clinical trials.

Instead, the submission relies heavily on substantial equivalence to a predicate device. This is a common pathway for 510(k) clearances where the new device is "as safe and effective as" an already legally marketed device.

Here's an analysis based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided documents, there isn't a table of specific acceptance criteria (e.g., specific lumens, burst pressures, deployment times) and corresponding reported performance from a formal study. The primary statement regarding performance is:

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness demonstrated	Demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc. (Specific metrics not provided in this summary)
Substantially Equivalent to predicate device	Design, materials, manufacturing process, and intended use are substantially equivalent to the predicate device and other marketed PTA catheters.

Explanation: In a substantial equivalence submission like this, the "acceptance criteria" are implicitly met if the device can demonstrate it is as safe and effective as a legally marketed predicate device, often through a combination of design controls, bench testing data, and sometimes animal or clinical data if the differences are significant. This summary explicitly states that the safety and effectiveness are demonstrated with design control activities and bench testing, but the specifics of those findings are "on file" and not detailed in the provided K document.

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

Test Set Sample Size: Not specified in the provided documents. The filing mentions "bench testing" but doesn't detail the number of units tested or specific parameters.
Data Provenance: The data provenance is internal, originating from CryoVascular Systems, Inc. It appears to be primarily retrospective in the sense that it relies on existing design controls and bench testing, rather than a prospective clinical trial designed to collect specific performance data for this submission. The origin is the USA (California, based on the sponsor's address).

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

This information is not applicable and not provided in the context of this 510(k) summary. For a device like a angioplasty catheter primarily relying on bench testing and substantial equivalence, there isn't an "expert" review of a clinical test set to establish ground truth in the way there would be for an AI diagnostic device. The "ground truth" here relates to engineering specifications and performance against those specifications, which are typically evaluated by internal engineers and quality control personnel.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret medical images or data against a reference standard. For a device primarily cleared based on bench testing and substantial equivalence, this type of adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:

No, a MRMC comparative effectiveness study was not done according to the provided documents. This type of study is common for AI systems that assist human readers in diagnosing or detecting conditions on medical images. This 510(k) is for a medical device (catheter), not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

No, a standalone study was not done. This is not an AI algorithm. The device is a physical medical device (catheter) used by a human operator, making the concept of a "standalone" algorithm study irrelevant.

7. The Type of Ground Truth Used:

The "ground truth" for this device, as implied by the submission, would be based on:

Engineering Specifications: The design and performance parameters the catheter is intended to meet (e.g., catheter dimensions, inflation pressure, burst pressure, material integrity).
Bench Test Results: Direct measurements and observations from laboratory testing verifying these specifications.
Predicate Device Performance: The known safety and effectiveness profile of the legally marketed predicate device, which the PolarCath is demonstrated to be substantially equivalent to.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This 510(k) is for a physical medical device and does not involve AI or machine learning.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided, as there is no training set for an AI algorithm in this context.

Summary of the K051916 Submission Approach:

The K051916 submission primarily relies on the substantial equivalence pathway. This means the applicant demonstrated that the PolarCath™ Peripheral Dilatation System is "as safe and as effective" as a legally marketed predicate device. This demonstration is typically achieved through:

Comparison of Device Characteristics: Showing that the design, materials, manufacturing process, and intended use are similar to the predicate.
Bench Testing: Laboratory tests to ensure the device meets its own engineering specifications and performs comparably to the predicate for critical parameters (e.g., burst pressure, inflation/deflation times, guidewire compatibility).
Risk Analysis and Design Controls: Ensuring that potential risks have been identified and mitigated through the design and manufacturing process.

The provided documents explicitly state: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates that studies were conducted, but the detailed results and specific acceptance criteria used in those studies are retained by the manufacturer and summarized in this high-level document. They are not typically elaborated in the public 510(k) summary if substantial equivalence is the primary basis for clearance.

Summary

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K051916
p. 1 of 1

4. 510(k) Summary

Sponsor:	CryoVascular Systems, Inc.
	160 Knowles Drive
	Los Gatos, CA 95032
Contact Person:	Elaine Aplaon
Phone Number:	408 866 3204
Fax Number:	408 376 3677
Prepared:	July 12, 2005
Trade Name:	PolarCath™ Peripheral Dilatation System
Common Name:	Percutaneous Transluminal Angioplasty Catheter
Classification:	II
Product Code:	LIT/DQY
	21 CRF 870.1250

Predicate Devices: PolarCath Peripheral Dilatation System

Device Description

Indications for Use

Substantial Equivalence

The PolarCath Peripheral Dilatation System design, materials, manufacturing process and intended use are substantially equivalent to the predicate device and other marketed PTA catheters.

Performance Data

The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 - 2005

CryoVascular Systems, Inc. c/o Ms.Elaine Aplaon 160 Knowles Drive Los Gatos, CA 95032

Re: K051916

Trade/Device Name: PolarCath™ Peripheral Dilation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: LIT Dated: July 14, 2005 Received: July 15, 2005

Dear Ms. Aplaon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications forchered above and harrsure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) 70 ttg enactment date of the Medical Device Amendments, or to conniner of they 20, 2017, 12:53 in accordance with the provisions of the Federal Food, Drug, de noos mat hat o occir voat do not require approval of a premarket approval application (PMA). and Cosmetic Frev (110) 210, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device to such 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.

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Page 2 - Ms.Elaine Aplaon

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Kulmer

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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510(k) Indications for Use 3.

510(k) Number (if known):	K051916
Device Name:	PolarCath™ Peripheral Dilatation System

Indications for use:

The PolarCath Peripheral Dilatation System is indicated to dilate 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Van Auken

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K0519| 6 - - - - - - - -

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).