FUNNEL TROCAR

K992324 · Patton Medical Corp. · GCJ · Aug 19, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992324
• Device Name: FUNNEL TROCAR
• Applicant: Patton Medical Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

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 Story

Funnel Trocar™ is a disposable, single-patient-use surgical access device. Composed of surgical-grade stainless steel and biocompatible polymers; available in various diameters (5mm, 7/8mm, 12mm) and lengths (55mm, 70mm, 100mm). Features include a shielded cutting obturator and a cannula with a luer fitting for insufflation; optional stability threads available. Used in OR settings by surgeons to create and maintain a passageway for laparoscopic instruments. Device facilitates minimally invasive surgery by providing stable access to the operative site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: surgical grade stainless steel and biocompatible medical grade polymers. Form factor: disposable trocar/cannula assembly with luer fitting for insufflation. Available in diameters 5mm, 7/8mm, 12mm and lengths 55mm, 70mm, 100mm. Features shielded cutting obturator and optional stability threads. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing laparoscopic procedures requiring access for instruments during general, gynecologic, thoracic, and urological surgeries.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sabre Ultimate Shielded Trocar System (K943976)
• Laparoscopic Trocar (K901407, K911813, K950457, K953409, K953903)

Submission Summary (Full Text)

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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 Corporation<br>1000 Westbank Drive, Suite 5A200<br>Austin, Texas 78746<br>512 916-4880 Fax [phone] |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael T. Patton<br>President |
| 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), manufactured<br>by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon,<br>MA 01756.<br>Laparoscopic Trocar (K901407, K911813, K950457, K953409,<br>K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351,<br>Jacksonville, FL 32245. |

Description of Device:

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.

Intended Use of Device:

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

> (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