40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0

K022052 · Northgate Technologies, Inc. · HIF · Jan 24, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K022052
• Device Name: 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
• Applicant: Northgate Technologies, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The Nortech® 40LPM Abdominal Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.

Device Story

The 40LPM Abdominal Insufflator (catalog # 72-00203-0) is a medical device used to provide CO2 gas for abdominal distention during laparoscopic surgery. It features an adjustable flow rate of 0-40 LPM and utilizes membrane switches for user control. The device supports CO2 supply from either a central source or an E-Cylinder tank. It includes a direct patient pressure monitoring feature, which is activated by connecting a specific tubing set to the device's patient monitoring connector and then to a cannula or trocar. The device is intended for use by clinicians in a surgical setting. By maintaining controlled abdominal pressure and gas flow, it facilitates visualization and access for the surgeon during diagnostic or operative procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Adjustable gas flow rate 0-40 LPM; membrane switch interface; CO2 gas source (central or E-Cylinder); direct patient pressure monitoring via tubing set; non-toxic materials previously used in medical devices.

Indications for Use

Indicated for gas distention of the abdomen during diagnostic or operative laparoscopic procedures.

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

• Omniflator model #7640 (Northgate Technologies Inc.)

Reference Devices

• Snowden – Penser (manufacturer of similar devices)
• W.O.M GmbH (manufacturer of similar devices)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

K022052

Laparoscopic Insufflator Common/Usual Name:

Proprietary Name: 40LPM Abdominal Insufflator

Classification: CLASS II

### Materials:

All materials used to manufacture the Northgate Technologies Inc. Abdominal Insufflator catalog # 72-00203-0 and tubing sets are non-toxic and have been previously used to manufacture other medical devices.

#### Description:

The Abdominal CO, Gas Insufflator (catalog # 72-00203-0) incorporates front panel controls similar to our current Omniflator® model #7640, although it utilizes membrane switches. The Abdominal Insufflator has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank.

#### Substantial Equivalence:

Northgate's Abdominal Insufflator / tubing sets are substantially equivalent in design, materials, and intended use to other currently marked devices. Other manufacturers of similar devices are Snowden – Penser, and W.O.M GmbH

#### Intended Use:

The Nortech® 40LPM Abdominal Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 2 4 2003

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

Re: K022052

Trade/Device Name: 40 LPM Abdominal Insufflator . Regulation Number: 21 CFR 884.1730 Regulation Name: Insufflator, Laparoscopic Regulatory Class: II Product Code: 85 HIF Dated: December 26, 2002 Received: December 27, 2002

Dear Mr. Kurek:

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 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Controllarial

510(k) Number (if known):

K022052

40LPM ABDOMINAL INSUFFLATOR® CATALOG # 72-00203-0 Device Name:

Indications For Use:

The NORTECH 40LPM ABDOMINAL INSUFFLATOR®, 72-00203-0 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.

Casey Kurek
C. Kurek, Regulatory Manager

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)

✓

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Nancy C. Brogdon
Division Sign-Off
Division of Reproductive, Abdominal

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022052

(Optional Format 1-2-96)

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