(85 days)
The intended use of this device is for laparoscopic surgery by general, thoracic, gynecologic and urological surgeons.
The GeniCon trocar is available in 2.5, 5, 7/8, 10 and 12mm diameter with a mono-slit stainless tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.
This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated.
Trocar Tip:
- A modified single slit tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula.
Trocar Handle: - Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion.
Cannula: - Trapezoidal fascia threads, they provide an easier insertion while a positive anchoring during . instrument use.
- CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer . cap is easier to remove and replace than the Apple silicone cap.
- . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product.
The provided text describes a medical device submission (510(k)) for a trocar/cannula system, not an AI or software device. Therefore, many of the requested criteria such as sample size for test/training sets, expert qualifications, and MRMC studies are not applicable.
However, I can extract the information that is relevant to the device validation as described.
Device: GeniCon Trocar/Cannula System
Predicate Devices: LifeQuest Point Gard and Dexide trocars
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pressure Testing | Performed equal to or superior to predicate devices (LifeQuest and Core trocar valve assembly). |
| Ease of Use | Performed equal to or superior to predicate devices. |
| Ease of Insertion | Performed equal to or superior to predicate devices. Specifically, the modified single slit tip provides easier insertion by minimally incising tissue. |
| Valve Assembly Performance | Performs better than the Life Quest and Core trocar valve assembly. |
| Maintaining Valve Position | Double wall valve lock assists in maintaining valve position and alleviating premature release (compared to Apple product). |
| CO2 Port Accessibility | Male luer cap is easier to remove and replace than the Apple silicone cap. |
| Anchoring during instrument use | Trapezoidal fascia threads provide positive anchoring. |
Study Details (Applicable to a Mechanical Device)
- Sample size used for the test set and the data provenance: Not explicitly stated as a numerical sample size. The text mentions "Engineering testing" that incorporated "a simulated human abdominal cavity" and observed "the method of insertion of the device and use with various common laparoscopic instruments." No information on data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The testing was engineering-based, not involving human expert assessment for "ground truth" in the diagnostic sense.
- Adjudication method: Not applicable. The testing was engineering-based performance comparison.
- 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 is a mechanical surgical device, not an AI or diagnostic imaging device with human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical surgical device.
- The type of ground truth used: Performance comparison against predicate devices in a simulated environment using engineering metrics (e.g., pressure, ease of use/insertion observations).
- The sample size for the training set: Not applicable. This is a mechanical device, so there is no "training set" in the context of AI/machine learning.
- How the ground truth for the training set was established: Not applicable.
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89914382
JUL 15 1999
Page: II-1
Section II. 510(k) Summary
GeniCon L.C. Contact: Gary Haberland 573 Waterscape Way Orlando, FL 32828 Phone: (407) 273-7619 Fax: (407) 306-9356
Date Prepared: April 19, 1999
Trade Name: GeniCon Trocar/Cannula System Common Name: Trocar Classification Name: Trocar (per CFR 870.1390)
The intended use of this device is for laparoscopic surgery by general, thoracic, gynecologic and urological surgeons.
The legally marketed device to which we are claiming previous acceptance of predicate device is the LifeQuest Point Gard and Dexide trocars both in sizes 2.5,5, 7/8, 10, 12mm systems.
Engineering testing has demonstrated that the valve assembly performs better than that of the Life Quest and Core trocar valve assembly. This testing incorporated a simulated human abdominal cavity and the method of insertion of the device and use with various common laparoscopic instruments. In all areas of performance, this device performed equal to if not superior in pressure testing, ease of use and insertion.
This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated.
Trocar Tip:
-
A modified single slit tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula.
Trocar Handle: -
Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion.
Cannula: -
Trapezoidal fascia threads, they provide an easier insertion while a positive anchoring during . instrument use.
-
CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer . cap is easier to remove and replace than the Apple silicone cap.
-
. Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1999
Mr. Gary Haberland Product Manager GeniCon, L.C. 573 Waterscape Way Orlando, Florida 32828
Re: K991382 Trade Name: GeniCon Trocar Cannula System Regulatory Class: II Product Code: GCJ Dated: April 19, 1999 Received: April 21, 1999
Dear Mr. Haberland:
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 (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.
{2}------------------------------------------------
Page 2 - Mr. Gary Haberland
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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K94/382
Section I. Indications for Use
510 (k) Number: unassigned
Device Name: Trocar
Indications for Use:
The GeniCon trocar is available in 2.5, 5, 7/8, 10 and 12mm diameter with a mono-slit stainless tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
D. O'Dell
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991382
Page: I-I
ﺍﻟﻌﺮﺑﻲ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
§ 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.