(86 days)
Not Found
No
The device description and performance studies focus on the mechanical components and sterilization of a surgical access system, with no mention of AI or ML capabilities.
No.
The device description and intended use indicate it is an access tool for surgical procedures, not a device that provides a specific therapy or treatment to a patient.
No
The device provides access for instruments during surgical procedures, which is a therapeutic or interventional function, not diagnostic.
No
The device description clearly outlines physical components such as cannulas, trocars, sealing caps, and valves, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "provides access for instruments during laproscopic/endoscopic surgical procedures." This describes a surgical tool used in vivo (within the body) to facilitate a procedure.
- Device Description: The description details components like cannulas, trocars, sealing caps, and valves, which are all physical instruments used to create and maintain access during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside the body to provide diagnostic information. This device is a surgical instrument used inside the body.
N/A
Intended Use / Indications for Use
The LQET Cannula/Trocar System provides access for instruments during laproscopic/endoscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
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
Not Found
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)
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.
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.
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
§ 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.
0
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 1300 |
| San Antonio, TX. 78216 | ||
| c. | Company Phone: | |
| Company Facsimile: | (210) 496-7332 | |
| (210) 496-1908 | ||
| d. | Contact Person: | Jeffrey Scott |
| Director, Regulatory Affairs | ||
| and Quality Systems | ||
| LifeQuest 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 Surgery |
| 21 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 Surgical | |||
| Corporation | GSC Seal Tight | K944103 | September 12, 1994 |
1
19.4 DEVICE DESCRIPTION
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.
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.
2
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.
3
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
5
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 for |
| instruments 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 _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)