KSEA PLASTIC TROCARS

K974366 · Karl Storz Endoscopy · GCJ · Jan 8, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974366
• Device Name: KSEA PLASTIC TROCARS
• Applicant: Karl Storz Endoscopy
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

These instruments are manually operated surgical devices intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Device Story

Manually operated surgical trocar and cannula system; used by qualified surgeons in general endoscopic and laparoscopic procedures. Device creates incisions in patient body to facilitate insertion of endoscopes and endoscopic accessories. Composed of surgical grade stainless steel and PEEK. No automated processing or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manually operated surgical trocar and cannula. Materials: surgical grade stainless steel and PEEK. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing general endoscopic and laparoscopic procedures requiring incision for endoscope or accessory insertion. For use by qualified surgeons.

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.

Submission Summary (Full Text)

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K974366
Jan. 8, 1998

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

## Applicant:

Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
[phone]

## Contact:

Kevin Kennan
Senior Regulatory Affairs Specialist

## Device Identification:

**Common Name:**
Trocar and Cannula

**Trade Name:** (optional)
Karl Storz Plastic Trocar

## Indication:

The KSEA Plastic Trocars are intended for use by qualified surgeons during general endoscopic and laparoscopic procedures.

## Device Description:

The Karl Storz Plastic Trocars are manually operated surgical devices. The body contact portions of the KSEA Plastic Trocars are composed of surgical grade stainless steel and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.

## Substantial Equivalence:

The Karl Storz Plastic Trocars are substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Plastic Trocars and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

## Signed:

Kevin Kennan
Senior Regulatory Affairs Specialist

60
107

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Kevin Kennan
Senior Regulatory Affairs Specialist
Karl Storz Endoscopy
600 Corporate Pointe
Culver City, California 90230-7600

Re: K974366
Trade Name: KSEA Plastic Trocars
Regulatory Class: II
Product Code: GCJ
Dated: November 19, 1997
Received: November 20, 1997

Dear Mr. Kennan:

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 requirements, 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

JAN - 8 1998

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Page 2 - Mr. Kennan

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,


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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DEC-10-1997 11:09 FROM EXEL LEGAL REG 410-5519 TO 913014803002 P.07

510(k) Number (if known): K974366

Device Name: KSEA Plastic Trocars

Indications for Use: These instruments are manually operated surgical devices intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use: ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use: ☐

(Optional Format 1-2-96)