The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

Device Description

The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSj™ 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 cylinder.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CVSi™ Peripheral Balloon Catheter System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for AI/ML-based devices.

Therefore, many of the requested details, such as sample sizes for test/training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for the training set, are NOT applicable to this submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in the format typically seen for AI/ML device performance. Instead, it relies on demonstrating function and safety through a series of tests and showing substantial equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance:	"All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended."
- Device functions according to its Instructions for Use.
Biocompatibility:	"The CVSi Peripheral Balloon Catheter System materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1..."
- Materials are acceptable for contact duration A-Limited (< 24 hours) with circulating blood.
Substantial Equivalence:	"The CVSi Peripheral Balloon Catheter System is substantially equivalent to the predicate devices with regard to intended use, function, materials, and sterilization method."
- Device is comparable to predicate devices (K022061 and K971448) in intended use, function, materials, and sterilization.	"Testing performed... demonstrates the device is substantially equivalent... and does not raise new questions regarding safety and effectiveness..."

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

Sample Size for Test Set: Not applicable. This submission describes testing for substantial equivalence of a physical medical device, not a diagnostic algorithm with a "test set" of data. The "testing" refers to functional and biocompatibility tests on the physical catheter system.
Data Provenance: Not applicable. The "data" are results from engineering and biocompatibility tests, not clinical data from patients.

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

Not applicable. This is not an AI/ML diagnostic device where ground truth is established by experts for a test set.

4. Adjudication method for the test set

Not applicable.

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 is not an AI-assisted device.

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

Not applicable. This is a physical medical device (balloon catheter).

7. The type of ground truth used

The "ground truth" for this device's acceptance would be derived from:
- Engineering specifications and standards: For functional tests (e.g., balloon inflation/deflation times, burst pressure, trackability).
- ISO 10993-1 Biocompatibility Standards: For chemical and biological safety.
- Predicate Device Characteristics: For comparison of design, materials, and intended use to establish substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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K023463

CVSi™ Peripheral Balloon Catheter System 510(k) Premarket Notification

FEB 1 9 2003

510(k) Summary CryoVascular Systems, Incorporated CVSi™ Peripheral Balloon Catheter System

This 510(k) summary for the CVSi™ Peripheral Balloon Catheter System is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

GENERAL INFORMATION

Manufacturer:	CryoVascular Systems, Inc.160 Knowles DriveLos Gatos, California 95032(408) 376-3675 (phone)(408) 376-3677 (fax)Est. Reg. No. (to be applied for)
Contact Person:	R. Michael CromptonVice President, Regulatory / Clinical Affairsand Quality Assurance
DEVICE DESCRIPTION
Classification:	Class II
Trade Name:	CVSi™ Peripheral Balloon Catheter System
Generic/Common Name:	Balloon Dilatation Catheter (21 CFR § 870.1250)

PREDICATE DEVICES

CVSi Peripheral Balloon Catheter System; CryoVascular Systems, Inc. (K022061) (1)

OPTA LP PTA Catheter; Cordis/A Johnson & Johnson Company (K971448) (2)

INTENDED USE

The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in superficial femoral and popliteal arteries.

Injector and Syringe, Angiographic (21 CFR § 870.1650)

DEVICE DESCRIPTION

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SUBSTANTIAL EQUIVALENCE

The CVSi Peripheral Balloon Catheter System is substantially equivalent to the predicate devices identified previously. The CVSi Peripheral Balloon Catheter System is substantially equivalent to the predicate devices with regard to intended use, function, materials, and sterilization method.

Testing performed on the CVSi Peripheral Balloon Catheter System demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to balloon dilatation catheters.

FUNCTIONAL PERFORMANCE TESTING

Functional testing was conducted on the CVSi Peripheral Balloon Catheter System to ensure that the product will function according to its Instructions for Use. All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended.

BIOCOMPATIBILITY EVALUATION

Biocompatibility testing was conducted on the CVSi Peripheral Balloon Catheter System materials to ensure acceptability when used as directed. The CVSi Peripheral Balloon Catheter System materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for an External Communicating Device in contact with Circulating Blood for a contact duration of A-Limited (< 24 hours).

CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the CVSi Perioheral Balloon Catheter System to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features the department's symbol, which consists of three stylized human profiles facing to the right, stacked on top of each other. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

Cryovascular Systems, Inc. c/o Mr. R. Michael Crompton Vice President, Regulatory/Clinical Affairs and Quality Assurance 160 Knowles Drive Los Gatos, CA 95032

Re: K023463

Trade Name: CVSi™ Peripheral Balloon Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Balloon Dilatation Catheter Regulatory Class: Class II (two) Product Code: DQY, LIT Dated: December 16, 2002 Received: December 23, 2002

Dear Mr. Crompton:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 - Mr. R. Michael Crompton

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 (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. 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

AR D.Z. MD

Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known): KO23-16

Device Name: CVSi™ Peripheral Balloon Catheter System

Indications for Use: The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K023463

Prescription Use(Per 21 C.F.R. § 801.109)	OR	Over-the-Counter Use
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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).