The device contains an elastomeric mechanism, which tethers the device to the inside of the abdominal wall. This mechanism affords the device a known insertion depth as well as a conductive path to the abdominal wall.

AI/ML Overview

This is an FDA premarket notification (510(k)) for a medical device called the "Port Site Protector". This document is a clearance letter, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical trial report or a performance validation study.

The FDA 510(k) pathway is primarily to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through extensive clinical trials.

Therefore, I cannot provide the requested information based solely on the provided input. The input is a clearance letter, not a scientific study or a detailed technical documentation with performance metrics.

To answer your questions accurately, I would need access to the actual 510(k) submission document (which is usually much more extensive than this clearance letter) or publicly available summaries of its contents, if they exist and include performance data.

Based on the provided clearance letter (K992182) for the "Port Site Protector", I can state the following, but cannot fill in the details regarding acceptance criteria and study particulars because they are not present in this document:

Device Name: Port Site Protector
Regulatory Class: II
Product Code: GCJ
Regulatory Pathway: 510(k) Premarket Notification
FDA Determination: Substantially Equivalent to predicate devices. This means the FDA agreed that the device is as safe and effective as a legally marketed device that existed before May 28, 1976, or has been reclassified.

I cannot create the requested table or answer the specific questions about sample size, ground truth, expert qualifications, etc., because those details are not in the provided clearance letter. These are generally found in the actual 510(k) submission, which would have included performance data or rationale for substantial equivalence.

In summary, the provided document does not contain the information requested to describe the acceptance criteria and the study that proves the device meets them. The letter confirms the FDA's decision but does not detail the evidence presented in the submission.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being in the United States.

Public Health Service

JUL 1 8 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stephen P. Moenning, M.D. President CA Guard Ltd. 610 East Olympia Avenue, #201 Punta Gorda, Florida 33950

Re: K992182 Trade Name: Port Site Protector Regulatory Class: II Product Code: GCJ Dated: April 14, 2000 Received: April 19, 2000

Dear Dr. Moenning:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have love for booker be 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 Costiner Fee (110). I The general controls provisions of the Act include requirements for provisions of ation, 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 (1 remairies i fpproval), we 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

{1}------------------------------------------------

Page 2 - Stephen P. Moenning, M.D.

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,

e R. lochner.

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

Enclosure

{2}------------------------------------------------

Appendix V - Indications for Use

Page_1_of_1

K992182 510(k) Number (if known):

Port-site Protector Device Name:

Indications for Use:

Protector may be utilized in conjunction with The Port-site devices intended for general laparoscopic cannula/trocar procedures. The device contains an elastomeric mechanism, which tethers the device to the inside of the abdominal wall. This mechanism affords the device a known insertion depth as well as a conductive path to the abdominal wall.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana R. Lochner.

(Division Sig Off) Restorative Devices Division of C K99218 510(k) Numbu

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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.