The CryoStar™ system consists of a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. A console is used to house and control the supply of gas to the cryoprobe and to provide an electrical nerve location device. A footswitch completes the system. A convenience procedure kit for probe placement is also provided as a single use disposable.

In the CryoStar™ system, compressed nitrous oxide or carbon dioxide is directed to the tip of the cryoprobe where it is allowed to expand through a fine annular space. The expansion of the gas to near atmospheric pressure causes cooling by the loule Thompson effect. The design of the cryoprobes is such that the warmer incoming gas maintains the outer stem of the cryoprobe above freezing temperatures to prevent freezing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the CryoStar™ console facilitates the location of the peripheral nerve prior to freezing. Freezing of the nerve fibers creates a block which prevents the conduction of pain. The effect is usually non-permanent, and a repeat of the treatment may be necessary to deal with long term pain.

The CryoStar™ console has been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. The pedestal of the console provides a convenient small footprint mobile base for the system, and houses up to four gas tanks. A simple footswitch completes the system.

AI/ML Overview

This 510(k) premarket notification for the CryoStar™ system is a substantial equivalence submission, not a de novo submission. Therefore, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way one might expect for a novel device undergoing a rigorous performance evaluation.

Here's why and what information can be gleaned from the provided text:

Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and either the same technological characteristics or, if different technological characteristics, that those differences do not raise new questions of safety or effectiveness.
Focus on Predicate Devices: The document primarily focuses on comparing the CryoStar™ system to existing, legally marketed predicate devices (Spembly Lloyd Neurostat, Cryomedics Neurostat, Wallach Painblocker WA5000). The argument for safety and effectiveness is built on the proven track record and characteristics of these predecessors.
Lack of De Novo Performance Study Details: Since the device is considered substantially equivalent, there isn't a need for a new, extensive clinical or performance study to establish novel acceptance criteria or prove its efficacy from scratch. The FDA simply acknowledges that it's equivalent to devices already on the market.

Based on the provided text, the following information is either not present or not applicable in the context of a 510(k) substantial equivalence submission:

Table of acceptance criteria and reported device performance: Not provided because this is a substantial equivalence claim, not a de novo approval requiring new performance benchmarks.
Sample size for the test set and data provenance: No specific test set or study data is presented, as the claim is based on equivalence to existing devices.
Number of experts used to establish ground truth and qualifications: Not applicable.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this submission for the reasons stated above.
Standalone (algorithm-only) performance: Not applicable, as this is a medical device, not a standalone algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

What the document does provide pertinent to the request (though not in the requested format):

Intended Use: The CryoStar™ system is a cryoanalgesia device intended for use in blocking pain by temporarily ablating the peripheral nerves. This is a crucial "acceptance criterion" in the sense that the device must fulfill this purpose, and its equivalence to predicates implicitly suggests it does.
Device Description and Principle of Operation: The document describes how the device works (Joule Thompson effect to freeze nerves, nerve stimulator for location) and its components. This implies that the device functions as intended, similar to the predicate devices.
Safety and Effectiveness: The submission explicitly states: "There are now new issues of safety of [or] effectiveness raised by the subject device." This is the core claim of substantial equivalence, meaning no new risks or concerns are identified compared to the predicate devices.
Predicate Devices: The specific predicate devices are listed (K781302 Spembly Lloyd Neurostat, K831963 Cryomedics Neurostat, K854334 Wallach Painblocker WA5000). The "proof" of meeting criteria relies on the regulatory approval and established performance of these devices.

In summary, this 510(k) submission successfully argued for substantial equivalence, meaning the FDA agreed it was similar enough to already-approved devices that no new, detailed performance studies or elaborate acceptance criteria (beyond those implicitly met by the predicates) were necessary.

Summary

{0}------------------------------------------------

lof 2 K031482

2

JUL 1 0 2003

510(k) Summary

June 4" 2003

1 Submitter

Cryomedical Instruments Itd Cryomed House Grove Way Mansfield Woodhouse Mansficid Nottinghamshirc NG19 8BW United Kingdom

Mr. Gareth Copping, Technical Director Contact Person: +44 1623 424200 Tel: +44 1623 424777 Hax: E-mail: gareth.copping@cryomed.co.uk

2 Name of Device

Proprietary Name:	CryoStar™ system, comprising:a) CryoStar™ consoleb) CryoStar™ 1mm cryoprobed) CryoStar™ 2mm cryoprobec) Convenience procedure kit for probe placement
Common Name:	Cryoanalgesia System
Device Classification:	Cryogenic surgical devices have been placed in Class II as per21 CFR Regulation Number 882.4250 and assigned theProduct Code GXI

3 Predicate Devices

The components of the CryoStar™ system are substantially equivalent to the following legally marketed devices:

K781302	Spembly Lloyd Neurostat
K831963	Cryomedics Neurostat
K854334	Wallach Painblocker WA5000

This statement is based on the similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation.

{1}------------------------------------------------

KO31482

4 Device Description

Intended Use 5

The CryoStar™ system is a cryoanalgesia device intended for use in blocking pain by temporatily ablating the peripheral nerves.

Summary of Substantial Equivalence 6

The CryoStar™ system is similar in design, intended use and performance characteristics to the predicate devices. There are now new issues of safety of effectiveness raised by the subject device.

{2}------------------------------------------------

Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird with three wavy lines above it. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2003

Mr. Gareth Copping Technical Director Cryomedical Instruments Ltd Cryomed House Grove Way Mansfield Woodhouse Mansfield Nottinghamshire United Kingdom NG19 8BW

Re: K031482

Trade/Device Name: CryoStar™ Cryoanalgesia System Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic surgical device Regulatory Class: II Product Code: GXH Dated: June 10, 2003 Received: June 25, 2003

Dear Mr. Copping:

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.

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.

{3}------------------------------------------------

Page 2 - Mr. Gareth Copping

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) 594-4659. 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) you may obtain. 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,

Miriam C. Provost

Ca Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Cryomedical Instruments Ltd

510(k) Number (if known): K031482

Device Name: CryoStar™ Cryoanalgesia System

Indications For Use:

The CryoStar™ System is a cryoanalgesia device intended for use in blocking pain by
temporarily ablating the peripheral nerves.

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

Concurrence of CDRH, Office of Device Evaluation (ODE):

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Miriam C. Provost

ion Sign-Off) sion of General, Restorative and Neurological Devices

510(k) Number K031482

Regulation Number and Section

§ 882.4250 Cryogenic surgical device.

(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).