The Cryo-PaCTM systems comprise a choice of three versions of a cryoanalgesia console: the base model Cryo-PaCTM, and the Cryo-PaCTM Plus and Cryo-PaCTM Ultra; all based on the same control module but providing a range of features for the control of the cryogen gas. The consoles are complemented by a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. The Cryo-PaC™ console is used to 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 Cryo-PaC™ systems, 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 Joule 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 freczing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the Cryo-PaC™ consoles facilitate 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 Cryo-PaC™ consoles have been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. In the Cryo-PaCTM Plus and Ultra models the console includes a pedestal that provides a convenient small footprint mobile base for the system, and houses the gas tanks. A simple footswitch completes the system.

AI/ML Overview

This 510(k) summary (K050272) describes a cryoanalgesia system for blocking pain by temporarily ablating peripheral nerves. It's important to note that this submission is from 2005, and regulatory requirements and the typical structure of performance studies have evolved significantly since then. For devices approved today, the level of detail regarding clinical study design, acceptance criteria, and statistical methods would be much more comprehensive.

Based on the provided document, there are no specific acceptance criteria or a detailed study description provided for this device that would typically be found in a modern 510(k) summary. The document primarily focuses on establishing substantial equivalence to predicate devices based on design, intended use, and performance characteristics without explicitly detailing those performance characteristics or the studies used to demonstrate them.

Here's an attempt to answer your questions based only on the provided text, acknowledging the limitations due to the age and nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission focuses on substantial equivalence to predicate devices, implying performance is "similar" or "equivalent" to those devices without quantifiable metrics.	The Cryo-PaCTM systems are intended for use in blocking pain by temporarily ablating peripheral nerves. The device's mechanism involves cooling by the Joule Thompson effect and uses a peripheral nerve stimulator to facilitate location. The effect is usually non-permanent.

2. Sample Size for Test Set and Data Provenance

No dedicated test set or clinical study with a specific sample size is described in the provided document. The submission relies on establishing substantial equivalence.

3. Number of Experts used to establish Ground Truth & Qualifications

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set or ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned or implied in this submission. The device is a surgical tool, not an imaging or diagnostic device where human reader performance with and without AI assistance would be relevant.

6. Standalone Performance Study

No detailed standalone performance study (e.g., a clinical trial with efficacy endpoints) is described in the provided summary. The submission emphasizes substantial equivalence to predicate devices, implying that the performance of the new device is comparable to these established devices without requiring a full de novo performance study. The statement "There are now new issues of safety or effectiveness raised by the subject device" implies that no new safety or effectiveness concerns were identified, suggesting that direct comparative performance data might not have been deemed necessary beyond similarities to predicates.

7. Type of Ground Truth Used

Not applicable. No ground truth is described for a performance study.

8. Sample Size for the Training Set

Not applicable. The device is a surgical instrument, not an AI/ML driven diagnostic or assistive technology that would typically involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary of Limitations based on the Document:

The provided document is a 510(k) summary from 2005 for a cryoanalgesia system. It relies heavily on demonstrating substantial equivalence to previously cleared predicate devices (K031482, K781302, K854334). This type of submission, particularly from this era, often focuses on comparing design, materials, and intended use. Detailed clinical performance acceptance criteria, test set sizes, ground truth establishment methods, or studies demonstrating specific quantitative performance metrics (like sensitivity, specificity, accuracy) were not commonly included or required in the same depth for devices cleared through the substantial equivalence pathway as they are for novel devices or AI/ML-driven technologies today. The "study that proves the device meets the acceptance criteria" is implicitly the comparison to the predicate devices, rather than a formally described clinical trial with explicit endpoints and acceptance thresholds.

Summary

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K050272 510(k) Summary

February 1" 2005

1 Submitter

MAR 2 4 2005

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

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

2 Name of Device

Proprietary Name:	Cryo-PaCTM systems, comprising:a) Cryo-PaCTM console, Cryo-PaCTM Plus consoleand Cryo-PaCTM Ultra consoleb) Cryo-PaCTM 1.3 mm cryoprobed) Cryo-PaCTM 2.0 mm cryoprobee) Cryo-PaCTM 2.1 mm cryoprobef) Cryo-PaCTM 2.6 mm cryoprobeg) Convenience procedure kit for probe placement
Common Name:	Cryoanalgesia System

Cryogenic surgical devices have been placed in Class II as per Classification: 21 CFR Regulation Number 882.4250 and assigned the Product Code GXH

Predicate Devices 3

The components of the Cryo-PaC™ system are substantially equivalent to the following legally marketed devices:

K031482	Cryomedical Instruments CryoStarTM
K781302	Spermbly Lloyd 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.

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Device Description 4

5 Intended Use

The Cryo-PaCTM systems are a series of cryoanalgesia devices intended for use in blocking pain by temporarily ablating the peripheral nerves.

6 Summary of Substantial Equivalence

The Cryo-PaC™ systems are 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2005

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

Re: K050272

K020272 Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic surgical device Regulatory Class: II Product Code: GXH Dated: February 28, 2005 Received: March 1, 2005

Dear Mr. Copping:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device Amendments. or to commence prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval approval application (PMA). allu Cosmetic Act (Tel) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration. Insting of general controls provisions of the rist lessent miss 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 is classified (soo abore) this. Existing major regulations affecting your device can thay be subject to suen additional bonations, Title 21, Parts 800 to 898. In addition, FLA may be found in the Outs acements concerning your device in the Federal Register.

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Page 2 - Mr. Gareth Copping

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease ve advisod that i Dr Shatian that your device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or any I cueral statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 007); adoling (21 CFR Part 820); and if applicable, the electronic form in the quality bywell be (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) I ms lotter will and will your he FDA finding of substantial equivalence of your device to a legally premative notifications "ceresults 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 in you active of Compliance at (240) 276-0115. 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 other golfiners, 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/industry/support/index.html.

Sincerely yours.

Euth

Miriam C. Provost, Ph Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if Known):	K050272
Device Name:	Cryomedical Instruments Cryo-PaC™ Systems
Indications for Use:	The Cryo-PaC™ systems are a series of cryoanalgesia devices intended for use in blocking pain by temporarily ablating the peripheral nerves.

X Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFGR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

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Signature

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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).