CANNULA

K965121 · Origin Medsystems, Inc. · HET · Mar 20, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K965121
• Device Name: CANNULA
• Applicant: Origin Medsystems, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.

Device Story

Single-use multi-port cannula for minimally invasive endoscopic surgery; provides access ports for endoscopic tools. Device consists of two movable working cannulas, two stationary cannulas, stabilizer, seals, luer fitting, and insufflation tube. Stabilizer seals against tissue at incision site; stationary cannulas casted to stabilizer. User advances device through incision; inserts endoscopic tools through working or stationary cannulas. Used by surgeons in clinical settings to facilitate endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness are established through the use of materials previously cleared for biocompatibility in other predicate devices.

Technological Characteristics

Single-use manual surgical instrument. Materials: Polycarbonate (cannulas), Sponge (stabilizer), Silicone Rubber (seals), Polyurethane (luer fitting, insufflation tube), Silicone Adhesive. Features two movable working cannulas, two stationary cannulas, and stabilizer. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing endoscopic surgery, including laparoscopy and thoracoscopy, where minimally invasive access is required. 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 Endoscopic Visualization and Space Maintenance Cannula (K964632)
• Carwild Corp. Disposable Specialty Sponges (K913302)
• Respoable Trocar (T5) (K960936)
• Blunt Tip Surgical Trocar (K924011)
• Airlift™ Balloon Retraction System (K942678)

Submission Summary (Full Text)

{0}

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
MAR 20 1997
K965121
Multi-Port Cannula
Class I
p1 of 4

# 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: December 20, 1996

## 21 CFR §807.92 a(2)

Trade name: To Be Determined

Common name: Cannula

Classification name: Manual Surgical Instrument

## 21 CFR §807.92 a(3)

Identification of predicate(s): Substantial equivalence for the Multi-Port Cannula is based on its similarities to predicate device : the ORIGIN Endoscopic Visualization and Space Maintenance Cannula. It shares the identical material, and technological characteristics as the predicate device. The Multi-Port Cannula is also similar in intended use.

## 21 CFR §807.92 a(4)

Device Description-parts and function/concept: The Multi-Port Cannula is a single-use device which consists of two movable working cannulas, seals, a stabilizer, two stationary cannulas, leur fitting, and an insufflation tube. The two movable working cannulas passes completely through the stationary cannulas which are casted to the stabilizer. The seals within the inner wall of the cannulas seal on surgical devices that are inserted through the cannulas. The stabilizer provides a seal against the tissue at the incision site and acts to stabilize the cannulas. Surgical access is achieved via standard incision. The Multi-Port Cannula is assembled and advanced

Page 6

{1}

K965121 P 2 of 4

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION

Multi-Port Cannula

Class I

through the incision site. The user may then advance endoscopic tools through the working cannulas or stationary cannulas to perform the procedure. The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.

Page 7

{2}

K965121 P 384

ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION

Multi-Port Cannula

Class I

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

| Component Name | Patient Contact | Material | Predicate |
| --- | --- | --- | --- |
| Stabilizer | yes | Sponge | Carwild Corp. Disposable Specialty Sponges k913302 |
| Stationary Cannulas | yes | Polycarbonate | Endoscopic Visualization and Space Maintenance Cannula k964632 |
| Working Cannulas | yes | Polycarbonate | Endoscopic Visualization and Space Maintenance Cannula k964632 |
| Stationary Cannula Seals | yes | Silicone Rubber | Respoable Trocar (T5) k960936 |
| Working Cannula Seals | no | Silicone Rubber | Respoable Trocar (T5) k960936 |
| Adhesive | no | Silicone Adhesive | Blunt Tip Surgical Trocar k924011 |
| Leur Fitting | no | Polyurethane | Airlift™ Balloon Retraction System k942678 |
| Insufflation Tube | yes | Polyurethane | Airlift™ Balloon Retraction System k942678 |

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

Page 8

{3}

KR65121 P 4 of 4
ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION
Multi-Port Cannula
Class I

## 21 CFR §807.92 a(5)

*Intended use and relationship to predicate(s):* The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.

The predicate device (Endoscopic Visualization and Space Maintenance Cannula) has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery including laparoscopy and thoracoscopy.

The Multi-Port Cannula is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

## CFR §807.92 a(6)

*Technological characteristics and relationship to predicate(s):*

The Multi-Port Cannula is substantially equivalent to the Endoscopic Visualization and Space Maintenance Cannula previously exempted product. The Multi-Port Cannula shares the, technological characteristics and materials as the predicate device.

## 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.

Page 9