LAPARETTE, MODEL LAP J L S H N

K022979 · Instruments Medicaux G.B., Inc. · KNF · Dec 18, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022979
• Device Name: LAPARETTE, MODEL LAP J L S H N
• Applicant: Instruments Medicaux G.B., Inc.
• Product Code: KNF · Obstetrics/Gynecology
• Decision Date: Dec 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.4160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of high-frequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound. This device is not intended for use in tubal sterilisation procedures.

Device Story

The Laparette is a hybrid electrosurgical instrument designed for minimally invasive surgery and laparoscopy. It functions as a monopolar device to cut tissue and control bleeding using high-frequency electrical current, while simultaneously providing irrigation and suction capabilities. The device consists of three reusable components (protective sheath, electrode-cannula, and insulated sleeve) and a single-use component (cartridge and handle). It is supplied non-sterile and requires sterilization by the healthcare facility before initial use and subsequent reuses. The device is operated by a surgeon in a clinical or surgical setting. The surgeon controls the electrosurgical output and fluid management to perform surgical tasks. The device benefits patients by integrating three essential surgical functions—cutting, coagulation, and fluid management—into a single instrument, potentially streamlining surgical workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hybrid electrosurgical instrument; monopolar; reusable components (protective sheath, electrode-cannula, insulated sleeve) and single-use components (cartridge and handle). Energy source: high-frequency electrical current. Sterilization: ethylene oxide. Connectivity: none. Form factor: endoscopic instrument with integrated suction/irrigation channels.

Indications for Use

Indicated for use in minimally invasive surgery, including laparoscopy, for tissue cutting, hemostasis via high-frequency electrical current, irrigation, and suction. Contraindicated for tubal sterilization procedures.

Regulatory Classification

Identification

A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

Predicate Devices

• Laparette (K971146) RD CHUS, Inc.

Submission Summary (Full Text)

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# DEC 1 8 2002

510(k) Summary Instruments Médicaux G.B. Inc. (LAPARETTE) (per 21 CFR 807. 92)

### 1. DATE of PREPARATION: August 22, 2002

### 2. SPONSOR/APPLICANT: Instruments Médicaux G.B. Inc. 425, des Jonquilles street Sherbrooke, Quebec, Canada, J 1 E 2Z9

3. CONTACT NAME: Germain Béland Telephone [phone]

4. DEVICE NAME: LAPARETTE

5. IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICES) TO WHICH EQUIVALENCE IS BEING CLAIMED:

Laparette (K971146) RD CHUS, Inc.

6. DEVICE DESCRIPTION:

INTENDED USE: The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of high-frequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound. This device is not intended for use in tubal sterilisation procedures.

The LAPARETTE is a hybrid device consisting of three reusable OVERVIEW: component (Protective sheath, Electrode-Cannula, and Insulated Sleeve) and one single use component(Cartridge and Handle all together). All LAPARETTE components are supplied non sterile, requiring sterilization by health care facility before first use and reuse of the reusable components. The LAPARETTE is sold as a set. The only option possible for the customer is the form of the cautery tip.

- 7. BASIS FOR SUBSTANTIAL EQUIVALENCE: Instruments médicaux G.B. Inc. makes the claim of substantial equivalence to the above devices based on intended use, design considerations, and general operating characteristics. Also, the LAPARETTE of Instruments Médicaux G.B. inc. is exactly the same because the patent and ownership has been transfer from RD CHUS inc. to Instruments Médicaux G.B. Inc.
All two devices share the same intended use of electrocautery, irrigation, and suction using the same instrument. All two products are designated for monopolar use only. While the RD CHUS LAPARETTE was sold non sterile, Instruments Médicaux G.B. Inc. will sell it non sterile but nine time reusable. The recommended sterilization technique for the LAPARETTE is ethylene oxide sterilization. The RD CHUS LAPARETTE has the possibilities to be sold separately from the accessories, the LAPARETTE from

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*KOZZ9791 p. 2 of 2

Instruments Médicaux G.B. Inc. only give the option to the customer to choose the tip form.

To be able to have a nine time reusable devices, Instruments Médicaux G.B. Inc. include nine separate single use non sterile handle..

Martin Paquette

Official Correspondent of Instruments Médicaux G.B. Inc.

August 22, 2002 Date

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

#### Public Health Service

# OFC 1 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Instruments médicaux G. B., Inc. c/o Mr. Martin Paquette Official Correspondent Groupe Horzone 1184 Blvd. Alexandre Sherbrooke, Quebec CANADA

Re: K022979 Trade/Device Name: Laparette, Model . ' . . Lap J, L, S, H, & N Regulation Number: 21 CFR §884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: 85 KNF Dated: November 4, 2002 Received: November 18, 2002

Dear Mr. Paquette:

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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# Instruments médicaux G.B.3

Indications for Use Statement

: Instruments Medicaux G.B. inc

known) K022979

Name parette

ndications For Use

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Control and the count of the contribution of the program of the

MATATA

Martin Paquette Official Correspondent

David A. Seppam

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 022979 510(k) Number _

August 22, 2002 Date

*Prescription Use*

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425, rue des Jonquilles, Sherbrooke (Québec) JIE 229 Téléphone [phone] • Télécopieur [phone]