The LifeQuest Endoscopic Technologies, Inc., (LQET) CannulaTrocar System is composed of several components: cannula system, trocar/obturator, sealing caps, valve, and accessories. The cannulas are have working lengths of 40-110mm and internal diameters of 3-20mm. Single and Multi Port Caps are available. The trocars are available in pyramidal, blunt and conical shaped configurations with lengths and diameters to fir the cannulas. Both shielded and non-shielded trocar configurations are available. Cannula Accessories such as Hassan Suture Anchors, Stopcocks and Sealing Caps are available with the LQET Cannula/Trocar System. All devices that are provided sterile to the user are sterilized by ethylene oxide by the manufacturer. Reusable devices are recommended for sterilization by autoclave at the user facility.

AI/ML Overview

The provided text does not contain acceptance criteria or a study that establishes device performance against such criteria.

The document is a 510(k) summary for the LQET Cannula/Trocar System, focusing on demonstrating substantial equivalence to predicate devices rather than proving a specific performance level of the device itself through a formal clinical study.

Here's what the document does mention regarding "performance data," and why it doesn't fit your request:

"The LQET Cannula/Trocar System was subjected to performance bench testing in accordance with applicable industry and clinical standards." This is a general statement.
"A study to determine the effectiveness of the recommended cleaning procedures was performed and found to be acceptable." This relates to cleaning protocols, not the primary function or safety of the device in a clinical setting.
"The effectiveness of the recommended steam sterilization cycle for reusable components was performed and found to be acceptable." Again, this relates to sterilization, not the device's functional performance.
"Several bench tests were performed to verify that the device performs as intended and that repeat sterilization of the components showed no effect to the device function." This is the closest statement to performance, but it lacks any specific metrics, acceptance criteria, or quantitative results. It's a high-level summary of verification testing.

Therefore, I cannot populate the table or answer the specific questions about the study, sample sizes, experts, or ground truth, as that information is not present in the provided text.

The document's purpose is to show that the LQET Cannula/Trocar System is "substantially equivalent" to existing, legally marketed devices. This means it has similar intended use, technological characteristics, and safety/effectiveness profiles, based on a comparison to predicate devices, rather than through a a de novo clinical performance study with predefined acceptance criteria.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 19:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

19.1 SUBMITTER INFORMATION

a.	Company Name:	LifeQuest Endoscopic Technologies, Inc.
b.	Company Address:	12961 Park Central, Suite 1300San Antonio, TX. 78216
c.	Company Phone:Company Facsimile:	(210) 496-7332(210) 496-1908
d.	Contact Person:	Jeffrey ScottDirector, Regulatory Affairsand Quality SystemsLifeQuest Endoscopic Technologies, Inc.
e.	Date Summary Prepared:	October 30, 1997

19.2. DEVICE IDENTIFICATION

a. Trade/Proprietary Name:	LQET Cannula/Trocar System
b. Classification Name:	Laproscope, General and Plastic Surgery21 CFR 876.1500

IDENTIFICATION OF PREDICATE DEVICE 19.3

Company	Device	510(k) No.	Date Cleared
GM Engineering	Ultra-Light Cannula/Trocar System	K942703	August 19, 1994
Gabris SurgicalCorporation	GSC Seal Tight	K944103	September 12, 1994

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19.4 DEVICE DESCRIPTION

19:5 SUBSTANTIAL EQUIVALENCE

The LOET Cannula/Trocar System is substantially equivalent to other laproscopic cannulas and trocars currently in commercial distribution by GM Engineering and Gabris Surgical Corporation in terms of intended use of providing a safe and access for instruments during laproscopic/endoscopic surgical procedures.

The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison chart provided in this 510(k) submission. The same materials are used in the LOET Cannula/Trocar System as used in the predicate devices. The cannulas and trocars are available in a variety of lengths and diameters. Single and MultiPort Caps are available for both the LQET System and the predicate devices.

INTENDED USE 19.6

The LQET Cannula/Trocar provides access for instruments during laproscopic/endoscopic surgical procedures.

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TECHNOLOGICAL CHARACTERISTICS 19.7

A comparison of the technological characteristics of the LQET Cannula/Trocar System with the predicate and legally marketed devices is provided within this submission. Both the LQET Cannula/Trocar System and the predicate devices are composed of cannulas, trocars and accessories. The materials used in the devices are same and the inner diameters and working lengths are within the same range. Single Port and Multi Port Caps are available with both the LQET and the predicate device. Trocars are available with and without shields, as found in the predicate device systems. The accessories for the LQET Cannula/Trocar System, such as the Hassan Suture Anchors, are similar to the accessories available with the predicate devices. Both the LQET Cannula/Trocar System and the predicate devices are reusable.

19.8 PERFORMANCE DATA

The LQET Cannula/Trocar System was subjected to performance bench testing in accordance with applicable industry and clinical standards. A study to determine the effectiveness of the recommended cleaning procedures was performed and found to be acceptable. The effectiveness of the recommended steam sterilization cycle for reusable components was performed and found to be acceptable. Several bench tests were performed to verify that the device performs as intended and that repeat sterilization of the components showed no effect to the device function.

19.9 510(K) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1998

Mr. Jeffrey Scott · Director, Regulatory Affairs and Quality Systems LifeQuest Endoscopic Technologies, Inc. 12961 Park Central, Suite 1300 78216 San Antonio, Texas

Re: K974139 LQET Cannula/Trocar System Trade Name: Regulatory Class: II Product Code: GCJ October 30, 1997 Dated: Received: November 3, 1997

Dear Mr. Scott:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ಗ 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 In addition, FDA may publish further announcements action. 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. Jeffrey Scott

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

ia 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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INDICATION FOR USE

510(k) Number:	To Be Assigned By FDA K974139
Device Name:	LQET Cannula/Trocar System
Indications For Use:	The LQET Cannula/Trocar System provides access forinstruments during laproscopic/endoscopic surgical procedures

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Picollo

(Division Sign-Off) Division of General Restorative Devices & C174139 510(k) Number

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

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.