NON-SHIELDED SURGICAL TROCAR AND SLEEVE

K963760 · Ethicon Endo-Surgery, Inc. · GCJ · Jan 8, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963760
• Device Name: NON-SHIELDED SURGICAL TROCAR AND SLEEVE
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

To establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.

Device Story

Non-shielded surgical trocar; consists of obturator sub-assembly with flat blade and sleeve sub-assembly with integral threads. Protective sheath covers blade during insertion; retracts upon engagement with sleeve. Inner/outer gaskets maintain pneumoperitoneum during instrument exchange. Threaded cannula stabilizes sleeve in tissue. Used in thoracic, general, and gynecologic minimally invasive surgery. Operated by surgeons to create secondary ports under direct visualization. Benefits include stable access to operative cavity while maintaining insufflation.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations confirmed device performance in mating, insertion, removal, tissue security, and pneumoperitoneum maintenance compared to predicate.

Technological Characteristics

Non-shielded surgical trocar; sizes 3mm-12mm diameter, 75mm-150mm length. Features flat blade, protective sheath, inner/outer gaskets, and threaded cannula for tissue retention. Mechanical device; no energy source or software.

Indications for Use

Indicated for thoracic, general, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. Intended for insertion under direct visualization for secondary port locations.

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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ETHICON ENDO-SURGERY, INC.
a johnson-johnson company
JAN 8 1997
K963760

4545 CREEK ROAD
CINCINNATI, OH 45242-2839

# 510(k) Summary of Safety and Effectiveness

## Statement

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency’s final rule “...510(k) Summaries and 510(k) Statements...” (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

## Device description

The (TRADE NAME) Non-shielded Surgical Trocar consists of two main sub-assemblies: a non-shielded obturator sub-assembly and the sleeve sub-assembly.

The non-shielded obturator sub-assembly is designed with a protective sheath to cover the flat blade. This protective sheath protects the gaskets on the sleeve assembly when the obturator and sleeve are mated together for insertion into the operative cavity. When the sleeve and obturator are properly engaged, the protective sheath is retracted so that the blade is exposed when it extends from the trocar sleeve.

An inner and outer gasket seals to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through cannula during a surgical procedure. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue.

The (TRADE NAME) Non-shielded Surgical Trocar shall be provided in a variety of sizes from 3mm to 12mm in diameter and 75mm to 150mm in length.

This device is designed to create secondary trocar sites and is labeled to be used only under direct visualization of the insertion site.

## Intended use

To establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.

Continued on next page

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# 510(k) Summary of Safety and Effectiveness, Continued

| Indications statement | The (TRADE NAME) Non-shielded Surgical Trocar with Threaded Sleeve has application in thoracic, general, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. The instrument is intended for insertion under direct visualization for secondary port locations. |
| --- | --- |
| Technological characteristics | The technological characteristics of the New Device are the same as the Predicate Device. |
| Performance data | Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in mating the obturator with the sleeve, insertion into the operative cavity, removal of the obturator from the sleeve, security of the 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 information provided herein, we conclude that the New Device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act. |
| Contact | Ivan S. Placko
Regulatory Affairs Project Manager
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | December 9, 1996 |