The CVSi™ Peripheral Balloon Catheter and the CVSi™ Inflator are indicated for percutaneous, transluminal angioplasty of stenotic lesions in 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, CVSi™ Inflator, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 12 gr cylinder.

AI/ML Overview

The provided 510(k) Premarket Notification for the CVSi™ Peripheral Balloon Catheter System outlines functional and biocompatibility testing, but it does not include the detailed performance metrics, acceptance criteria, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) that would typically be associated with AI/ML device evaluations. This document describes a traditional medical device submission, focusing on equivalence to predicate devices rather than AI performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies for an AI device cannot be extracted from this document.

However, based on the information provided, here's what can be stated:

Acceptance Criteria and Device Performance (Limited Information for AI/ML)

Since this is a submission for a traditional medical device (a balloon catheter system), not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" in the AI/ML context (e.g., sensitivity, specificity, AUC) is not applicable here.

The document states that:

Functional Performance Testing: "All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended."
Biocompatibility Evaluation: "The CVSi Peripheral Balloon Catheter System materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1..."

Table of Acceptance Criteria and Reported Device Performance (as far as can be inferred for a traditional device):

Acceptance Criteria Category	Specific Criterion (Inferred from Text)	Reported Device Performance
Functional Performance	Device functions according to its Instructions for Use.	"All testing conducted confirmed the acceptability... to perform as intended."
Biocompatibility	Materials are biocompatible for intended use (external communicating device, <24 hrs contact).	"Materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1..."
Safety and Effectiveness (Overall)	Substantial equivalence to predicate devices.	Determined to be "substantially equivalent" for the stated indications.

Study Details (Applicable to Traditional Device, Not AI/ML)

As this is not an AI/ML device, the following points are addressed in the context of a traditional medical device submission for substantial equivalence:

Sample size used for the test set and the data provenance:
- The document mentions "Human clinical experience collected in conformance with an IDE study and additional case studies" and "Data from animal studies conducted in conformance with GLP regulations and additional animal studies."
- Sample sizes for these studies are NOT provided.
- Data Provenance: Not explicitly stated, but clinical and animal studies would typically be conducted in a prospective or retrospective manner specific to the study design. The country of origin is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device submission. The "ground truth" for a balloon catheter is its physical performance and biological safety, assessed through engineering tests and biocompatibility panels, and clinical outcomes for human studies, not expert consensus on image interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for a traditional medical device. Adjudication methods are relevant for subjective data interpretation, typically in AI/ML performance evaluation.
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, an MRMC comparative effectiveness study was NOT done (or at least not reported in this context). This is a traditional device, not an AI-assisted diagnostic tool. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functional testing: Engineering specifications and measurements; adherence to physical performance parameters.
- For biocompatibility: ISO 10993 standards and laboratory test results.
- For clinical/animal studies: Patient outcomes, physiological measurements, and histological findings (for animal studies) would form the basis of "ground truth" for safety and effectiveness comparisons.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.

Summary

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SEP 2 0 2002

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

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)Injector and Syringe, Angiographic (21 CFR § 870.1650)

PREDICATE DEVICES

FOCUS PV Balloon Dilatation Catheter by CardioVascular Dynamics (K944016) (1)
OPTA LP PTA Catheter Cordis/A Johnson & Johnson Company (K971448) (2)
ACS 20/20 Indeflator by Guidant/Advanced Cardiovascular Systems, Inc. (K896849) (3)
Breeze Digital Balloon Inflation Device by NAMIC USA (K953676) (4)

INTENDED USE

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

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).

HUMAN CLINICAL EXPERIENCE / ANIMAL STUDIES

Human clinical experience collected in conformance with an IDE study and additional case studies were supplied in the 510(k) Premarket Notification to provide reasonable assurance of the safety and effectiveness of the CVSi Peripheral Balloon Catheter System to predicate devices. Data from animal studies conducted in conformance with GLP regulations and additional animal studies were supplied in the 510(k) Premarket Notification, which together with the human clinical data, provided comparative safety and effectiveness informantion of the new characteristics of the device compared to the predicate devices.

CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the CVSi Peripheral 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2002

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

Re: K022061

Trade Name: CVSi™ Peripheral Balloon Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY and LIT Dated: Juen 20, 2002 Received: June 25, 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. Insting 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 - 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 vour 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 vour 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) 594-4646. 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 vours.

Elisa Diaz for

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): K ஜூ२० اے (

Device Name: CVSi™ Peripheral Balloon Catheter System

Indications for Use: The CVSi™ Peripheral Balloon Catheter and the CVSi™ Inflator 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 of Cardiovascular & Respiratory Devices
510(k) Number K220061

for BD2 3/20/02

Prescription Use (Per 21 C.F.R. § 801.109

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

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).