BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM

K960810 · Marlo Surgical Technology · HET · Oct 21, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K960810
• Device Name: BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
• Applicant: Marlo Surgical Technology
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Oct 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Device Story

Single-use, disposable trocar and sleeve system; provides access for surgical/diagnostic instruments during minimally invasive procedures. Device utilizes balloon and control disc for abdominal wall anchoring; incorporates tamponade effect, trap door, and seals to maintain pneumoperitoneum by minimizing CO2 loss. Operated by surgeons in clinical/OR settings. Output is physical access port for instrumentation. Benefits include stable instrument access and maintenance of insufflation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Silicone balloon, thermoplastic body, aluminum trocar. Sterilization: Gamma radiation (SAL 10^-6). Function: Balloon-based anchoring with control disc; gas-tight seals and trap door for CO2 retention. Dimensions: 2-15mm range.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring access for operative and diagnostic instrumentation; provides anchor via balloon and control disc; minimizes CO2 gas loss via tamponade effect, trap door, and seals.

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

• Hasson Stabilizing Access Cannula (SAC™)

Submission Summary (Full Text)

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OCT 21 1996
K960810

# SUMMARY OF SAFETY AND EFFECTIVENESS BALLOON CANNULA

The Summary of Safety and Effectiveness on Laparoscopic surgery and the instruments used reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

## Intended Use

The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.

## Indications

The ability of the Family of Balloon Cannulas to meet its intended function includes the function and employment of the balloon and the control disc to assure an adequate anchor to allow for instrumentation access and removal during minimally invasive surgery. Furthermore, the balloon's tamponage effect, trap door and seals minimize the loss of $\mathrm{CO}_{2}$ gas during minimally invasive operative procedures.

## Caution

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

## Substantial Equivalency Information

The Family of Balloon Cannula are similar to the Hasson Stabilizing Access Cannula (SAC™).

| | Hasson SAC™ | Balloon Cannula |
| --- | --- | --- |
| Materials | | |
| - Balloon | Silicone | Silicone |
| - Cannula/Body | Thermoplastic | Thermoplastic |
| - Trocar | Stainless Steel | Aluminum |
| Sizes | 10/12 and 5mm | Range: 2-15mm |
| Functions | | |
| - Anchor System | Balloon / Cone | Balloon Disc |
| Sterilization | Gamma
SAL 10^{-6} | Gamma
SAL 10^{-6} |

The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Family of Balloon Cannula are comparable to that of the Hasson Stabilizing Access Cannula (SAC™).