GSI CANNULA WITH INTRODUCER

K970201 · General Surgical Innovations · DYB · Apr 21, 1997 · Cardiovascular

Device Facts

• Record ID: K970201
• Device Name: GSI CANNULA WITH INTRODUCER
• Applicant: General Surgical Innovations
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The intended use of the GSI Cannula with Introducer is the same as the predicate devices (Hasson Stable Access Cannula K903078). The intended use of the predicate device and the GSI Cannula with Introducer is to provide access for surgical and diagnostic instruments for the duration of a surgical procedure.

Device Story

Hand-held cannula with introducer; used in minimally invasive surgery. Device consists of cannula body, inflatable valve/seal, and stopcock. Introducer (sharp or blunt tip) facilitates placement into surgical space. Inflatable valve/seal provides access port for surgical/diagnostic instruments while maintaining pneumoperitoneum via gas insufflation. Operated by surgeons in clinical/OR settings. Provides stable access for instruments; enables minimally invasive procedures; benefits patient by facilitating endoscopic access.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: molded rigid plastic, elastomeric polymer, stainless steel. Components: cannula body, inflatable valve/seal, stopcock, sharp/blunt tip introducer. Disposable, sterile. No specific ASTM standards cited.

Indications for Use

Indicated for patients undergoing minimally invasive surgical or diagnostic procedures requiring instrument access to an endoscopic or laparoscopic surgical space.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Hasson Stable Access Cannula (K903078)

Submission Summary (Full Text)

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K970201

# Section 10.0: 510(K) Summary

# APR 21 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

## 10.1 Contact Person

Cathleen Mantor
General Surgical Innovations, Inc.
3172A Porter Drive
Palo Alto, CA 94304
[phone] extension 292
[phone] fax

## 10.2 Date Summary Prepared

January 14, 1997

## 10.3 Trade Name

To Be Determined

## 10.4 Common Name

Cannula with Introducer

## 10.5 Predicate Device

K903078 Hasson Stable Access Cannula. Manufacturer: Marlow Surgical Technology.

## 10.6 Device Description

GSI’s Cannula with Introducer is a hand held device comprised of a Cannula with an Introducer. The Cannula is comprised of a cannula body, an inflatable valve/seal and a stopcock. The inflatable valve/seal is inflated and deflated through the stopcock. The inflatable valve/seal provides a seal for surgical tools and diagnostic instruments during minimally invasive procedures using gas insufflation. The Cannula may be supplied with either a Sharp Tip or Blunt Tip Introducer. The Introducer is used for placement of the Cannula into an endoscopic or laparoscopic surgical space.

January 17, 1997

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# 10.7 Intended Use

The intended use of the GSI Cannula with Introducer is the same as the predicate devices (Hasson Stable Access Cannula K903078). The intended use of the predicate device and the GSI Cannula with Introducer is to provide access for surgical and diagnostic instruments for the duration of a surgical procedure.

# 10.8 Comparison to Predicate Devices

| | Predicate Device Stable Access Cannula (K903078) | GSI’s Cannula with Introducer |
| --- | --- | --- |
| Intended Use | Access for minimally invasive procedures | Access for minimally invasive procedures |
| Principles of Operation | Insertion through incision, under direct visualization (when possible) when using sharp tip | Insertion through incision, under direct visualization (when possible) when using sharp tip |
| Design:
-cannula
-valve/seal
-anchoring
-method
-insufflation port | rigid
flexible valve and seal
inflatable balloon type
included | flexible
inflatable, flexible valve/seal screw type
not included |
| Materials | molded rigid plastic, elastomeric polymer and stainless steel | molded rigid plastic, elastomeric polymer and stainless steel |
| Supplied | Sterile, 5 devices/box w/5mm reducer, disposable | Sterile, 5 devices/box, inflatable valve/seal provides reducer function, disposable |
| Introducer Type | blunt & sharp | blunt & sharp |
| Cannula Lumen | 10/12 mm | 10 mm |
| Compliance w/Standards | No known standards | No known standards |

# 10.9 Testing in Support of Substantial Equivalence Determination

Results of performance bench tests verify that the differences between the Cannula with Introducer and the predicate device do not affect the safety or efficacy of the GSI Cannula with Introducer.

January 17, 1997