TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE

K965045 · Ethicon Endo-Surgery, Inc. · HET · May 5, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K965045
• Device Name: TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: May 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The intended use of the New Device is to establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.

Device Story

TRISTAR™ LP Trocar with Low Profile Threaded Sleeve; consists of obturator sub-assembly with sharp pyramidal tip and spring-loaded safety shield; sleeve sub-assembly with inner/outer gasket seals and integral external threads for tissue retention. Used in thoracic, general, and gynecologic surgery to create secondary ports for minimally invasive instruments. Operated by surgeons under direct visualization. Safety shield protects internal structures post-entry; gasket seals maintain pneumoperitoneum during instrument exchange; threaded sleeve stabilizes device in tissue. Sizes range 3mm-12mm diameter, 65mm-150mm length.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations demonstrated acceptable performance compared to predicate device regarding mechanical function, insertion, and pneumoperitoneum maintenance.

Technological Characteristics

Mechanical trocar system; obturator with pyramidal tip and spring-loaded safety shield; sleeve with dual gasket seals and external retention threads. Sizes: 3mm-12mm diameter, 65mm-150mm length. Non-powered, manual surgical instrument.

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

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Submission Summary (Full Text)

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K945045

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# Appendix A 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 TRISTAR™ LP Trocar with Low Profile Threaded Sleeve consists of two main sub-assemblies: an obturator sub-assembly and a sleeve sub-assembly.

The obturator consists of a sharp pyramidal tip and a spring loaded safety shield. The safety shield is designed to cover the pyramidal tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered.

The sleeve subassembly has an inner gasket seal and an outer gasket seal 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 TRISTAR™ LP Trocar with Low Profile Threaded Sleeve shall be provided in a variety of sizes from 3mm to 12mm in diameter and 65mm 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

The intended use of the New Device is to establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.

## Indications statement

The TRISTAR™ LP Trocar with Low Profile 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.

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Ethicon Endo-Surgery, Inc.

TRISTAR™ LP Trocar with Low Profile

Threaded Sleeve

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K 965045
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# Appendix A 510(k) Summary of Safety and Effectiveness, Continued

| 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
Project Manager
Regulatory Affairs Department
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | December 16, 1996 |

Ethicon Endo-Surgery, Inc. TRISTAR™ LP Trocar with Low Profile Threaded Sleeve 40