CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS

K050272 · Cryomedical Instruments, Ltd. · GXH · Mar 24, 2005 · Neurology

Device Facts

• Record ID: K050272
• Device Name: CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
• Applicant: Cryomedical Instruments, Ltd.
• Product Code: GXH · Neurology
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Cryo-PaC™ systems (console, cryoprobes, footswitch, procedure kit) provide cryoanalgesia; used by clinicians to block pain. System utilizes compressed nitrous oxide or carbon dioxide gas directed to cryoprobe tip; gas expansion via Joule-Thompson effect cools tip to freeze target nerve fibers. Peripheral nerve stimulator integrated into console assists clinicians in locating nerves prior to ablation. Warmer incoming gas maintains outer probe stem above freezing to prevent collateral tissue damage. Console features user interface, error detection, and warning systems. Plus/Ultra models include mobile pedestal housing gas tanks. Output is localized nerve freezing; effect is non-permanent, requiring potential repeat treatment for long-term pain management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, materials, and performance characteristics compared to legally marketed predicate devices.

Technological Characteristics

Cryoanalgesia system using Joule-Thompson effect for cooling. Consoles (base, Plus, Ultra) control gas flow (N2O or CO2). Includes peripheral nerve stimulator for nerve localization. Cryoprobes feature insulated stems to prevent unwanted tissue freezing. System includes footswitch and disposable procedure kits. Console provides error detection and warning systems.

Indications for Use

Indicated for blocking pain via temporary ablation of peripheral nerves in patients requiring cryoanalgesia.

Regulatory Classification

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.

Predicate Devices

• Cryomedical Instruments CryoStarTM (K031482)
• Spermbly Lloyd Neurostat® (K781302)
• Wallach Painblocker WA5000 (K854334)

Submission Summary (Full Text)

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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: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

#### 2 Name of Device

| Proprietary Name: | Cryo-PaCTM systems, comprising:<br>a) Cryo-PaCTM console, Cryo-PaCTM Plus console<br>and Cryo-PaCTM Ultra console<br>b) Cryo-PaCTM 1.3 mm cryoprobe<br>d) Cryo-PaCTM 2.0 mm cryoprobe<br>e) Cryo-PaCTM 2.1 mm cryoprobe<br>f) Cryo-PaCTM 2.6 mm cryoprobe<br>g) 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

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.

#### 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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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 [phone]. 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 [phone] or [phone] 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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