AUTO SUTURE LAPAROSCOPES DEVICE by UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The U.S. Surgical Auto Suture* Laparoscope** device has indication solely for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thoracoscopic procedures.

Device Description

The U.S. Surgical Laparoscope** device is a reusable and rigid laparoscope based on existing laparoscopy technology.

AI/ML Overview

The provided text is a 510(k) summary for the Auto Suture* Laparoscope** Device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Imagyn MicroLap™ Laparoscope K965055) rather than presenting a detailed study with acceptance criteria and specific performance metrics.

Therefore, the document does not contain information to construct a table of acceptance criteria and reported device performance, nor does it describe a study proving the device meets particular acceptance criteria.

Here's why and what information is missing:

Acceptance Criteria and Device Performance: The summary does not define any specific performance metrics (e.g., optical resolution, field of view, illumination intensity, durability, safety parameters) or corresponding acceptance criteria. It broadly states the device is "a reusable and rigid laparoscope based on existing laparoscopy technology" and intends for "illumination and visualization."
Study Description: The document is a regulatory submission for substantial equivalence, not a clinical or engineering study report. It states that "All component materials of the laparoscope are comprised of materials which are in accordance with ISO Standard # 10993-1," which refers to biocompatibility, but this isn't a performance study.

Missing Information:

Table of Acceptance Criteria and Reported Device Performance: Not present in the document.
Sample size used for the test set and the data provenance: Not mentioned as no specific test set study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth establishment for a test set is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated. The document focuses on device characteristics and intended use, not clinical efficacy or reader performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
The type of ground truth used: Not applicable as no ground truth for performance evaluation is described.
The sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary serves to demonstrate substantial equivalence by comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than providing detailed performance study results with specific acceptance criteria.

Summary

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K983293 Auto Suture* Laparoscope** Device

IX. 510(k) Summary of Safety and Effectiveness

United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856

LAVELLI VICTOR CONTACT PERSON: Jamie Vich 430

DATE PREPARED: September 18, 1998

CLASSIFICATION NAME: Endoscope and accessories

COMMON NAME: Laparoscope

Not yet determined PROPRIETARY NAME:

Imagyn MicroLap™ Laparoscope (K965055) PREDICATE DEVICES:

The U.S. Surgical Laparoscope** device is a reusable and DEVICE DESCRIPTION: rigid laparoscope based on existing laparoscopy technology.

The U.S. Surgical Auto Suture* Laparoscope** device is INTENDED USE: intended for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thorascopic procedures.

MATERIALS: All component materials of the laparoscope are comprised of materials which are in accordance with ISO Standard # 10993-1.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 1998

Re:

Mr. Victor M. Clavelli Manager, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

K983293 Trade Name: Auto Suture* Laparoscope** Device Regulatory Class: II Product Code: GCJ Dated: September 18, 1998 Received: September 21, 1998

Dear Mr. Clavelli:

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 (Special Controls) or class III (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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Victor M. Clavelli

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 (301) 594-4595. 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 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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IV. Indications For Use:

983293 510(k) Number (if known):

Name: Laparoscope

Indications For Use:

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Evaluation (ODE)

OR Over-The-Counter Use: Prescription Use: (Per 21 CFR §801.109)

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(Division Sign-Off) Division of General Restorative De 510(k) Number

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.