(204 days)
The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical 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 pyramidal 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: - Clear casing for visualization of instrument and tissue passage. .
- Reverse trapezoidal fascia threads, they provide an easier insertion while a positive anchoring . during instrument use.
- . Extended 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.
Valve: - . A tapered membrane assembly provides a more positive seal around the instrument, while the silicon membrane was designed to reduce friction during instrument use.
- . A pull-tab was added to facilitate removal of the valve during specimen retrieval.
The provided text is a 510(k) summary for the GeniCon Trocar/Cannula System, which describes the device, its intended use, and a comparison to predicate devices. However, it does not contain the detailed information needed to answer the questions about acceptance criteria and a study proving those criteria are met.
Here's a breakdown of why this information is missing from the provided document:
- Acceptance Criteria Table: The document states that "Engineering testing has demonstrated that the valve assembly performs better than that of the Apple and Core trocar valve assembly," and that it "performed equal to if not superior in pressure testing, ease of use and insertion." However, specific numerical acceptance criteria (e.g., "pressure testing must maintain X pressure for Y duration") and the corresponding reported device performance values are not provided.
- Sample Size and Data Provenance (Test Set): The document mentions "Engineering testing," but does not specify the sample size of devices tested or the data provenance (e.g., where the testing was conducted, if retrospective or prospective data was used, etc.).
- Number and Qualifications of Experts (Ground Truth): This type of device (trocar/cannula) is used for surgical access. Its performance is assessed through engineering tests and usability, rather than through interpretation of complex data by experts to establish a "ground truth" in the way, for example, a diagnostic AI would. Therefore, the concept of a "ground truth" established by experts in the context of radiology or pathology, and their number/qualifications, does not apply here.
- Adjudication Method: Since there isn't a "ground truth" established by multiple experts in a diagnostic context, there's no adjudication method described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for diagnostic devices where human readers interpret medical images or data. It is not applicable to a surgical instrument like a trocar/cannula system. Therefore, no information on an MRMC study or effect size is present.
- Standalone (Algorithm Only) Performance: A trocar/cannula system is a physical surgical instrument, not a software algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.
- Type of Ground Truth Used: As explained above, the "ground truth" for a surgical instrument's performance is typically established through objective engineering tests (e.g., pressure, friction, insertion force) and usability assessments rather than expert consensus on diagnostic interpretations or pathology.
- Sample Size for Training Set: Since this is a physical device and not an AI/ML algorithm, there is no "training set."
- How Ground Truth for Training Set was Established: Not applicable due to the nature of the device.
In summary, the provided document describes a traditional medical device (surgical instrument) and its performance relative to predicate devices through engineering tests and mentions of ease of use. It does not present information as would be expected for a diagnostic AI/ML device.
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Section II. 510(k) Summary
GeniCon L.C. Contact: Gary Haberland 573 Waterscape Wav Orlando, FL 32828 Phone: (407) 273-7619 Fax: (407) 306-9356
Date Prepared: October 20, 1998
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 Apple Medical Hunt/Reich Trocar and the Core Dynamics Entree II both in sizes 5, 7/8, 10 and 12mm systems.
Engineering testing has demonstrated that the valve assembly performs better than that of the Apple 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 pyramidal 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:
- Clear casing for visualization of instrument and tissue passage. .
- Reverse trapezoidal fascia threads, they provide an easier insertion while a positive anchoring . during instrument use.
- . Extended 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.
Valve:
- . A tapered membrane assembly provides a more positive seal around the instrument, while the silicon membrane was designed to reduce friction during instrument use.
- . A pull-tab was added to facilitate removal of the valve during specimen retrieval.
Image /page/0/Picture/22 description: The image shows the logo for Genicon. The logo is in black and white and features the company name in a stylized font. Above the "o" in Genicon are two surgical instruments. Below the company name is the tagline "New Ideas for Modern Health Care".
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and progress.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1999 EEB
Mr. Gary Haberland Product Manager Genicon 573 Waterscape Way Orlando, Florida 32828
Re: K982472
Trade Name: Genicon Trocar/Cannula System Regulatory Class: II Product Code: GEA Dated: January 19, 1999 Received: January 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.
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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 vours.
Styph Rhodes
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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Section I. Indications for Use
510 (k) Number: K982472
Device Name: Trocar
Indications for Use:
The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical 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_ X OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Styt Durbe
(Division Sign-Off) (Division of General Restorative Devices K9P2472 510(k) Number -
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.