SHIELDED SURGICAL TROCAR

K971475 · Ethicon Endo-Surgery, Inc. · GCJ · Aug 21, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971475
• Device Name: SHIELDED SURGICAL TROCAR
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The intended use of the New Device is to establish a path of entry for minimally invasive instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.

Device Story

ENDOPATH® Dilating Tip Trocar consists of obturator and sleeve sub-assemblies. Obturator features sharp flat blade or pyramidal tip with spring-loaded shield to protect internal structures post-entry. Sleeve includes inner gasket/flapper door and outer gasket to maintain pneumoperitoneum; some models include stopcock for insufflation and lever for desufflation. Integral threads on cannula exterior provide tissue retention. Used in OR by surgeons during minimally invasive procedures to provide access for instruments. Device facilitates entry and maintains operative space pressure, benefiting patient by enabling minimally invasive access.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations demonstrated acceptable performance in device functionality, including insertion, tissue security, and maintenance of pneumoperitoneum.

Technological Characteristics

Trocar sizes 3mm to 12mm diameter, 65mm to 150mm length. Features spring-loaded shield, gasket/flapper door seals, and external cannula threads for retention. Stopcock included on select models for insufflation. Mechanical device; no software or energy source.

Indications for Use

Indicated for use in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.

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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AUG 21

K97/475

## 510(k) Summary of Safety and Effectiveness Appendix A

| Statement | Information supporting claims of substantial equivalence, as defined under the Federal<br>Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized<br>below. For the convenience of the Reviewer, this summary is formatted in accordance<br>with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR<br>§807) and can be used to provide a substantial equivalence summary to anyone<br>requesting it from the Agency. |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>description | The ENDOPATH® Dilating Tip Trocar consists of two main sub-assemblies:<br>an obturator sub-assembly and a sleeve sub-assembly. |
| | The obturator consists of a sharp flat blade tip or pyramidal tip and a spring<br>loaded shield. The shield is designed to cover the flat blade or pyramidal tip to<br>protect internal structures from puncture or laceration once the abdominal or<br>thoracic cavity has been entered. |
| | The sleeve subassembly has an inner gasket seal or flapper door seal and an<br>outer gasket seal to maintain pneumoperitoneum when instrumentation is<br>inserted and withdrawn through the cannula during a surgical procedure.<br>Some instruments are provided with a stopcock for insufflating the operative<br>space and a flapper door lever to allow quick desufflation. Integral threads<br>along the outside diameter of the cannula portion of the sleeve provide a<br>retention mechanism to stabilize the sleeve in tissue. |
| | The ENDOPATH® Dilating Tip Trocar shall be provided in a variety of sizes<br>from 3mm to 12mm in diameter and 65mm to 150mm in length. |
| Intended use | The intended use of the New Device is to establish a path of entry for<br>minimally invasive instruments. Instruments provided with a stopcock are<br>intended for insufflation of the operative space when the trocar is in place. |
| Indications<br>statement | The ENDOPATH® Dilating Tip Trocar has application in general, thoracic,<br>gynecologic, or other minimally invasive surgical procedures to establish a<br>path of entry for minimally invasive instruments. |

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| Appendix A<br>Continued | 510(k) Summary of Safety and Effectiveness, |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>characteristics | The technological characteristics of the New Device are the same as the<br>Predicate Device. |
| Performance<br>data | Pre-clinical laboratory evaluations were performed to ensure that the device<br>can be used as designed. The studies demonstrated acceptable performance to<br>the Predicate Device in mating the obturator with the sleeve, insertion into the<br>operative cavity, removal of the obturator from the sleeve, security of the<br>sleeve in tissue, and maintenance of pneumoperitoneum of the operative space. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the<br>information provided herein, we conclude that the New Device is substantially<br>equivalent to the Predicate Device under the Federal Food, Drug and<br>Cosmetic Act. |
| Contact | Ivan S. Placko<br>Project Manager<br>Regulatory Affairs Department<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
| Date | April 21, 1997 |

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ed Billips, RAC Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839

AUG 21 1997

Re: K971475 Trade Name: ENDOPATH® Dilating Tip Trocar Regulatory Class: II Product Code: GCJ Dated: July 30, 1997 Received: July 31, 1997

Dear Mr. Billips:

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

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Page 2 - Mr. Ed Billips, RAC

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,

Sincerely yours,

coope

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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## Appendix B Indications for Use Statement

Following is the Indications for Use Statement: Statement

510(k) Number: K 971475

Device Name: ENDOPATH® Dilating Tip Trocar

## Indications for Use:

The ENDOPATH® Dilating Tip Trocar has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.

Aciolo

on Sign-Off) IDivis Division of General Restorative Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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