RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]

K960936 · Origin Medsystems, Inc. · HET · Jul 24, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K960936
• Device Name: RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
• Applicant: Origin Medsystems, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jul 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The Resposable Trocar System has applications in endoscopic surgery, for establishment of a port of entry for endoscopic instruments. It may be used for endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures. The Reusable Cannula must be used in conjunction with a complete Origin Trocar of the same size.

Device Story

Resposable Trocar System provides port of access for endoscopic instruments during surgery; used in endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic, or abdominal procedures. System comprises single-use sterile obturator and seal, and non-sterile reusable stainless steel cannula. Obturator features sharp pyramidal tip; Sensing Tip version includes integral safety mechanism where tip withdraws into cannula upon tissue penetration to protect internal organs. Disposable seal includes internal valve to prevent gas leakage; 10/12mm versions include converter cap for varying instrument diameters. Cannula may include external valve for gas insufflation and gripping mechanism for incision retention. Operated by surgeons in clinical/OR settings. Device facilitates instrument passage while maintaining pneumoperitoneum.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and technological similarities to the predicate device.

Technological Characteristics

Components: Stainless steel cannula, polycarbonate obturator shaft, stainless steel obturator point. Sizes: 5mm, 5mm short, 10mm, 12mm. Features: Pyramidal tip, integral safety mechanism (Sensing Tip model), internal valve seal, optional gas insufflation valve, optional external gripping mechanism. Materials previously cleared for biocompatibility in existing ORIGIN products.

Indications for Use

Indicated for patients undergoing endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic, or abdominal procedures requiring a port of entry for endoscopic instruments. Contraindicated for patients where endoscopic surgery is contraindicated.

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.

Predicate Devices

• ORIGIN Sensing Tip Trocar (OMS-T5S, OMS-T10S, OMST1112S)

Submission Summary (Full Text)

{0}

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
Resposable Trocar System
Class II

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.

## 21 CFR §807.92 a(1)

Submitter: ORIGIN® Medsystems, Inc.
135 Constitution Avenue
Menlo Park, CA 94025
[phone]
contact person: Anthony Durso
date prepared: March 6, 1996
JUL 24 1996

## 21 CFR §807.92 a(2)

Trade name: Resposable Trocar System
[5mm, 5mm short, 10mm and 12 mm sizes]
Common name: Resposable Surgical Trocar
Classification name: Laparoscope, Gynecologic and Accessories

## 21 CFR §807.92 a(3)

Identification of predicate(s): Substantial equivalence for the Resposable Trocar System is based on its similarities to predicate device: the ORIGIN Sensing Tip Trocar (OMS-T5S, OMS-T10S, OMST1112S). The Resposable Trocar System, shares the identical intended use, and technological characteristics as the predicate device. The Resposable Trocar System is also identical in materials except for the reusable cannula. It is stainless steel versus a polycarbonate on the 10mm and 12mm and liquid crystal polerm (LCP) on the 5mm cannula of the Sensing Tip Trocar.

## 21 CFR §807.92 a(4)

Device Description-parts and function/concept: The Origin Sensing Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic

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14960936

ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION

Responsible Trocar System

Class II

# 21 CFR §807.92 a(4)

**Device Description-parts and function/concept:** continued

instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle, with an integral safety mechanism. As the tissue is penetrated, the tip withdraws into the cannula to help protect internal organs from exposure to the sharp tip. The disposable seal consists of an internal valve to prevent gas leakage when instruments are inserted or withdrawn. The 10mm and 12mm seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision site. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.

**Device Description-parts and function/concept:** The Origin Classic Tip Responsible Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle. The disposable seal consists of an internal valve and seal to prevent gas leakage when instruments are inserted or withdrawn. The 10/12mm Seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision site. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.

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4960236

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION

Resposable Trocar System
Class II

**Device Description-materials/physical properties**: a table of the patient contact component parts, with their respective materials, is provided below.

| Component Name | Material(s) |
| --- | --- |
| Cannula | stainless steel |
| Obturator Shaft | polycarbonate |
| Obturator Point | stainless steel |

The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.

## 21 CFR §807.92 a(5)

**Intended use and relationship to predicate(s)**: The Resposable Trocar System has applications in endoscopic surgery, for establishment of a port of entry for endoscopic instruments. It may be used for endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures. The Reusable Cannula must be used in conjunction with a complete Origin Trocar of the same size. The Sensing Tip Trocar has applications in gynecologic and abdominal surgery for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.

During abdominal surgery the Resposable Trocar is inserted through the abdominal wall and the trocar cannula is left in place to allow the passage of endoscopes and other endoscopic instruments. This function is equivalent to those described for the predicate device: the Sensing Tip Surgical Trocar.

The Resposable Trocar System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

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1e 96 09.36

ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION

Resposable Trocar System

Class II

## CFR §807.92 a(6)

Technological characteristics and relationship to predicate(s):

The Resposable Trocar System is substantially equivalent to the Sensing Tip Surgical Trocar previously cleared product. The new device shares the identical technological characteristics as the predicate device. The Reposable Trocar is also identical in materials except for the reusable cannula. It is stainless steel versus a polycarbonate cannula on the 10mm and 12mm and liquid crystal polermer (LCP) on the 5mm Sensing Tip Trocar.

## 21 CFR §807.92 b

This submission’s determination of substantial equivalence is based on similarities to the predicate devices in terms of intended uses, materials, and technological characteristics.

## 21 CFR §807.92 c

In accordance with the specifications of this subsection, this summary (4 pages) is its own section, and has been clearly identified as such.

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