LAPARETTE, MODEL LAP J L S H N

• K Number: K022979
• Device Name: LAPARETTE, MODEL LAP J L S H N
• Manufacturer: INSTRUMENTS MEDICAUX G.B., INC.
• Date Cleared: 2002-12-18 ( 100 days)
• Product Code: KNF
• Regulation Number: 884.4160

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 Description

The LAPARETTE is a hybrid device consisting of three reusable 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.

Predicate Devices

K971146

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical and electrical components for surgical functions.

Therapeutic

No.
Explanation: The device is intended for use in minimally invasive surgery to cut tissue, control bleeding, irrigate, and suction fluids. These actions are surgical interventions, not therapeutic treatments in themselves, but rather tools used during a surgical procedure. It does not provide a direct therapy to treat a disease or improve health condition.

Diagnostic

No
The device is described as an instrument for cutting tissue, controlling bleeding, irrigating, and suctioning during surgery, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hybrid device consisting of three reusable component and one single use component," which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the LAPARETTE is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use clearly states that the LAPARETTE is used in minimally invasive surgery to cut tissue, control bleeding, irrigate, and suction fluids. This is a direct interaction with the patient's body during a surgical procedure.
• IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health.

The LAPARETTE is a surgical instrument used in vivo (within the living body), not in vitro (in glass/outside the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

85 KNF

Device Description

The LAPARETTE is a hybrid device consisting of three reusable 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

minimally invasive surgery, including laparoscopy

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K971146

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

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

2

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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Page 2

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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Image /page/4/Picture/0 description: The image shows a logo or emblem that appears to be related to medicine or healthcare. It features a heart-shaped outline formed by intertwined branches or vines. Inside the heart, there is a caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine. The letters 'P' and 'B' are prominently displayed above the caduceus, possibly representing an organization or initials related to the medical field.

Instruments médicaux G.B.3

Indications for Use Statement

: Instruments Medicaux G.B. inc

known) K022979

Name parette

ndications For Use

RETTE is an electrosurgical instrument with integral suction and irngation capability. It is intended for use in minimally invasive surgery ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ ncluding laparoscopy, to cut tissue and control bleeding by use of high ency electrical ourrent, to imgate tissue and cavilies, as well as to suction fluids from the wound. This device is not intended for use in tubal sterlization orge dure

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

Page 6.2

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