CO2 GAS WARMING UNIT (6-800-00)

K972675 · Northgate Technologies, Inc. · HIF · Sep 30, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K972675
• Device Name: CO2 GAS WARMING UNIT (6-800-00)
• Applicant: Northgate Technologies, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Nortech CO2 Gas Warming Unit shall be used as a means of supplying warm gas for the distention of the abdomen for diagnostic and / or operative laparoscopy.

Device Story

Device consists of control unit, heat exchanger (disposable or reusable), and power cords. Used in conjunction with insufflator to provide continuous, non-adjustable heating of CO2 gas. Operated by clinical staff in surgical settings. Heated gas delivered to laparoscopic instrument for abdominal distention. Benefits patient by maintaining body temperature during laparoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes control unit and heat exchanger. Materials are non-toxic. Provides continuous, non-adjustable gas heating (35-41°C).

Indications for Use

Indicated for warming gas (35-41°C) used for abdominal distention during diagnostic or operative laparoscopy.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• Snoden Pencer (unspecified 510(k))
• Wisap (unspecified 510(k))

Submission Summary (Full Text)

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SEP 3 0 1998

# SUMMARY OF SAFETY AND EFFECTIVENESS

Common/Usual Name: Insufflator, Laparoscopic Accessory

CO2 Gas Warming Unit Proprietary Name:

Classification: CLASS II

### Materials:

All materials used to manufacture the Northgate Technologies Inc. CO2 Gas Warming Unit are non-toxic and have been previously used to manufacture other medical devices.

# Description:

The CO2 Gas Warming Unit is designed to be used in conjunction with an insufflator to provide continuous non-adiustable heating of gas to a laparoscopic instrument. The CO2 Gas Warming Unit is comprised of a control unit and heat exchanger(available as disposable or re-usable) and power cords.

## Substantial Equivalence:

Northgate's CO2 Gas Warming Unit which is comprised of a control unit/heat exchanger and power cords are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Snoden Pencer and Wisap.

### Intended Use:

The Nortech CO2 Gas Warming Unit shall be used as a means of supplying warm gas for the distention of the abdomen for diagnostic and / or operative laparoscopy.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

Mr. Casey Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Road Elgin, IL 60123

Re: K972675

CO, Gas Warming Unit Dated: August 12, 1998 Received: August 14, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF

Dear Mr. Kurek:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation i entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director. Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972675 510(k) Number (if known):

CO2 GAS WARMING UNIT Device Name:

Indications For Use:

THE NORTECH GAS WARMING UNIT IS INDICATED FOR WARMING GAS (95-1069F / 35-41℃) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.

Lacey Kink

C. Kurek, Regulatory Manager

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

్ర Prescription Use _ (Per 21 CFR 801.109)

OR

Over-the-Counter Use

Vorril A. Segner

(Division Sign-Off) _ Division of Reproductive, Abdominal, ENT, and Radiological Devices Ka124 510(k) Number _