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.

AI/ML Overview

This document describes a 510(k) premarket notification for the "LAPARETTE" device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Laparette K971146) based on intended use, design considerations, and operating characteristics. The key point of the submission is that the new LAPARETTE is "exactly the same because the patent and ownership has been transfer from RD CHUS inc. to Instruments Médicaux G.B. Inc." and it will now be sold as a nine-time reusable device, whereas the predicate was sold non-sterile and without explicit reusability claims.

Since the submission claims the device is "exactly the same" and the changes relate to reusability and commercial aspects (e.g., selling as a set), the document does not contain information about specific performance acceptance criteria or a study proving that the device meets those criteria in the way a clinical trial or performance study for a novel device would. Instead, the "proof" is the substantial equivalence to the previously cleared device, assuming the reusability doesn't compromise its performance, which would typically be addressed through cleaning, disinfection, and sterilization validation, and possibly biocompatibility for repeated use.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness are not present in this type of 510(k) submission.

Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific performance metrics for cutting tissue, controlling bleeding, irrigation, or suction) or corresponding reported device performance values. The basis for substantial equivalence is primarily design, intended use, and general operating characteristics being identical or highly similar to the predicate device.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate K971146)	Reported Device Performance (Implied by Substantial Equivalence to Predicate K971146)
Ability to cut tissue using high-frequency electrical current	Equivalent to Laparette (K971146)
Ability to control bleeding using high-frequency electrical current	Equivalent to Laparette (K971146)
Ability to irrigate tissue and cavities	Equivalent to Laparette (K971146)
Ability to suction fluids from the wound	Equivalent to Laparette (K971146)
Suitable for use in minimally invasive surgery (e.g., laparoscopy)	Equivalent to Laparette (K971146)
Not intended for use in tubal sterilization procedures	Equivalent to Laparette (K971146)
Monopolar use only	Equivalent to Laparette (K971146)
Reusability for nine times (after sterilization)	Claimed for the new device; predicate was sold non-sterile. Revalidation of reusability (cleaning/sterilization) would be part of engineering testing, not typically presented as clinical performance in this context.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The submission is a claim of substantial equivalence based on the device being "exactly the same" as a previously cleared predicate and a change in reusability (from non-sterile, no reusability claim to nine-time reusable). It does not describe a performance study with a test set of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No performance study with ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No performance study with a test set is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is not an AI/imaging diagnostic device. It is an electrosurgical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. No performance study with ground truth is described.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device that uses a training set.

Summary

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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

CONTACT NAME: Germain Béland Telephone 819-566-5689
DEVICE NAME: LAPARETTE
IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICES) TO WHICH EQUIVALENCE IS BEING CLAIMED:

Laparette (K971146) RD CHUS, Inc.

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.

1. 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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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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 (819) 572-0372 • Télécopieur (819) 566-3769

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).