FUNNEL TROCAR by PATTON MEDICAL CORP.

The Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general, gynecologic, thoracic, and urological procedures.

Device Description

The Funnel Trocar™ is a disposable single patient use device fabricated from surgical grade stainless steel, and biocompatible medical grade polymers. The device is available in a variety of diameters (5mm. 7/8mm. 12mm) and lengths (55mm. 70mm, and 100mm). The Funnel Trocar™ is supplied with either a shielded cutting obturator (trocar). The cannula is equipped with a luer fitting to provide access for insufflation of the operative area. The cannula is available with or without stability threads.

AI/ML Overview

The provided text is a 510(k) summary for the Funnel Trocar™ and the FDA's clearance letter. This type of document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study with the elements you've requested for AI/software devices.

Therefore, most of the information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies will not be present in this document. The Funnel Trocar™ is a physical surgical device, not an AI or software-based medical device.

Here's a breakdown based on the information available and the nature of the device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicit in this document. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This is typically achieved by comparing design, materials, intended use, and performance characteristics (e.g., mechanical strength, sterility, biocompatibility if applicable) to the predicate.	The FDA determined the Funnel Trocar™ is substantially equivalent to the predicate devices listed (Sabre Ultimate Shielded Trocar System K943976 and various Core Dynamics, Inc. Laparoscopic Trocars K901407, K911813, K950457, K953409, K953903).

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For physical devices, testing typically involves mechanical, material, and biocompatibility tests rather than clinical studies with "test sets" in the context of AI/software. If such tests were performed, the details would be in supporting documentation not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable and not provided. This concept relates to ground truth establishment for analytical or diagnostic software, which is not relevant to a physical surgical trocar.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable and not provided. Similarly, this is a concept used for human review in studies, especially for diagnostic accuracy, and is not relevant to the clearance of a physical surgical instrument like a trocar.

5. 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

This is not applicable for this device. An MRMC study is designed for evaluating diagnostic algorithms, typically AI or software, and is not relevant to a physical surgical trocar.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable for this device. This refers to the performance of an AI algorithm independently, which is not what the Funnel Trocar™ is.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This is not applicable and not provided. For physical devices, "ground truth" would relate to engineering specifications, material properties, and functionality testing, not a diagnostic outcome. The "truth" for substantial equivalence is met by demonstrating the device performs as intended and is as safe and effective as its predicates.

8. The sample size for the training set

This is not applicable and not provided. "Training set" refers to data used to train AI/machine learning models, which is not involved in the development or clearance of this physical medical device.

9. How the ground truth for the training set was established

This is not applicable and not provided for the same reasons as point 8.

In summary: The provided document is a 510(k) premarket notification for a physical medical device. The focus is on demonstrating substantial equivalence to already legally marketed devices, not on proving performance through clinical studies with the highly specific criteria you've outlined for AI/software devices. Therefore, most of your requested information is not relevant or present in this context.

Summary

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. G 19 1999

99324

510(k) Summarv as required by 807.92(c) for Funnel Trocar™ Prepared July 9, 1999

Submitted by:	Patton Medical Corporation1000 Westbank Drive, Suite 5A200Austin, Texas 78746512 916-4880 Fax 512 916-4881
Contact Person:	Michael T. PattonPresident
Device Trade Name:	Funnel Trocar™
Common Name:	Disposable Surgical Trocar/Cannula
Classification:	Laparoscope, General & Plastic Surgery, § 876.1500, Class II
Predicate Devices:	Sabre Ultimate Shielded Trocar System (K943976), manufacturedby Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon,MA 01756.Laparoscopic Trocar (K901407, K911813, K950457, K953409,K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351,Jacksonville, FL 32245.

Description of Device:

Intended Use of Device:

Substantial Equivalence to Predicate Device:

The Funnel Trocar™ shielded version is substantially equivalent to the Sabre Ultimate Shielded Trocar System (K943976), manufactured by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon, MA 01756. The Funnel Trocar™ non-shielded version is substantially equivalent to the Laparoscopic Trocar (K901407, K911813, K950457, K953409, K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351, Jacksonville, FL 32245.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 1999

Mr. Michael T. Patton President Patton Medical Corporation 1000 Westbank Drive Suite 5A200 Austin, Texas 78746

Re: K992324

Trade Name: Funnel Trocar™ Regulatory Class: II Product Code: GCJ Dated: July 9, 1999 Received: July 12, 1999

Dear Mr. Patton:

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. Michael T. Patton

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,

Russell Jayson

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

Enclosure

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Page

510(k) NUMBER (IF KNOWN): K992324

DEVICE NAME: FUNNEL TROCAR
TM

INDICATIONS FOR USE:

Intended Use of Device:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR ·

Over-The-Counter-(Optional Forma

Russell S. Pagan. 801,255

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_1_9523

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.