CRYOPROBE

K024009 · H&O Equipments, Nv/Sa · GEH · Mar 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024009
• Device Name: CRYOPROBE
• Applicant: H&O Equipments, Nv/Sa
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Mar 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To destroy tissue during surgical procedures by applying extreme cold.

Device Story

CryoProbe™ is a hand-held, pencil-shaped cryosurgical instrument used by clinicians to destroy tissue. It utilizes a replaceable N2O gas cylinder housed within the device body. Upon activation, liquid nitrous oxide is delivered to the treatment site at -89° C. Flow rate is controlled by selecting specific microapplicators (high or low flow). The device is intended for use in surgical settings to effect cellular destruction through direct cold application.

Clinical Evidence

No clinical data provided. Device safety and performance supported by risk analysis and market usage data from the European market, where over 3,000 units were distributed without reported adverse effects.

Technological Characteristics

Hand-held, pencil-shaped cryosurgical instrument. Energy source: N2O gas cylinder. Cooling principle: direct application of liquid N2O at -89° C. Flow control: selectable via microapplicators. Non-electronic, mechanical device.

Indications for Use

Indicated for the destruction of tissue during surgical procedures via the application of extreme cold.

Regulatory Classification

Identification

(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

Predicate Devices

• Wallach Surgical Ultra Freeze and Cold Soaker
• Erbokryo CA Cryosurgical System

Submission Summary (Full Text)

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Trade Name: CryoProbe™

K024009
10F2

Common Name: Unit, Cryosurgical, Accessories

Classification: 878.4350 Cryosurgical Unit, Class II

MAR 2 0 2003

## Predicate Devices:

- a) Wallach Surgical Ultra Freeze and Cold Soaker
- b) Erbokryo CA Cryosurgical System

## Device Description:

The CryoProbe™ is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold gas (N2O). The device is based on direct application of nitrous oxide in the liquid phase to the selected area. The N2O gas is delivered to the treatment site at -89° C to effect cellular destruction.

The hand-held device is shaped like a pencil to afford maximum user control and comfort. An N2O gas cylinder, commercially available, is held within the pencil body. The gas cylinder is punctured at its intended nozzle by the CryoProbe™ gas guidance tube and retained by the safety valve (handle) until treatment begins. The gas flow is controlled by the microapplicators, high or low flow. This flow rate is selectable when a gas cylinder is installed by selecting the appropriate microapplicator for the assembly.

The CryoProbe™ is designed for safety, performance, and convenience for the user. The design is confirmed by Risk Analysis and actual market usage in the European market. Over 3,000 units are in distribution and use with no adverse effects reported.

## Intended Use:

To destroy tissue during surgical procedures by applying extreme cold.

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## 510(k) Summary

H&O Equipments NV/SA Ninovesteenweg 198 9320 Aalst (Erembodegem) Belgium +32-53-76.17.40 Telephone [phone] Fax

Contact Person: Mr. Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 Telephone [phone] Fax

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, with three human profiles incorporated into the design of the bird's body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

H & O Equipments NV/SA c/o Lewis Ward L. W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301

MAR 2 0 2003

Re: K024009

Trade/Device Name: CryoProbeTM Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: March 14, 2003 Received: March 17, 2003

Dear Mr. Ward:

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

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Page 2 -- Mr. Lewis Ward

(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. 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 [phone]. 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 [phone] or [phone] or at its Internet address

http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Mulkeran

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

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Initial 510(k): ______________________________________________________________________________________________________________________________________________________________

Device Name: CryoProbeTM

Indications for Use:

To destroy tissue during surgical procedures by applying extreme cold.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark n Melkuse
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K024009
10(k) Number***_***_

Prescription Use
(Per 21 CFR 801.109)
X
OR Over-the-Counter Use***_***_