CO2 PNEUMO-DISSECTOR

K972647 · Cook Urological, Inc. · HET · Apr 10, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K972647
• Device Name: CO2 PNEUMO-DISSECTOR
• Applicant: Cook Urological, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Apr 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CO2 Pneumo-Dissector is used to gently dissect planes of soft tissue using short, pressure regulated, trigger-controlled pulses of CO2 gas. The device may be used in both open and laparoscopic procedures in which gentle, blunt dissection of soft tissue planes is desired.

Device Story

CO2 Pneumo-Dissector performs blunt tissue dissection; utilizes short, pressure-regulated, trigger-controlled pulses of CO2 gas. Used in open and laparoscopic surgical procedures; operated by clinicians. Device facilitates gentle separation of soft tissue planes; provides controlled gas delivery to target site. Benefits include atraumatic tissue dissection; reduced risk of damage to surrounding structures compared to mechanical methods. Device design relies on pneumatic pressure regulation; no complex electronic processing or software involved.

Clinical Evidence

Bench testing only. Performance characteristics evaluated to confirm device meets specifications and achieves safe, effective blunt tissue dissection.

Technological Characteristics

Materials: stainless steel, acetal, polyvinylchloride. Energy source: CO2 gas. Mechanism: pressure-regulated, trigger-controlled pneumatic pulses. Form factor: handheld surgical instrument for open/laparoscopic use. No software or electronic components.

Indications for Use

Indicated for patients undergoing open or laparoscopic surgical procedures requiring gentle, blunt dissection of soft tissue planes.

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

• Plus and III with PAL (Probe for Aspiration/Lavage) (Marlow Surgical Technologies, Inc.)
• Nezhat-Dorsey Hydrodissection System (American Surgical Instruments, Inc.)
• Cabot Irrigation/Aspiration System with Corson Hydrodissection Insert (Cabot Medical)

Submission Summary (Full Text)

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510(k) Premarket Notification CO. Pneumo-Dissector Cook Urological, Incorporated and Cook OB/GYN®

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APR 1 0 1998

# J. 510(k) SUMMARY

## Submitted By:

Tammy Bacon Cook Urological, Incorporated and Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 [phone] July 14, 1997

Device:

Trade Name:

CO., Pneumo-Dissector

Proposed Classification Name:

Laparoscope, Gynecologic (And Accessories) 85 HET

## Predicate Devices:

The CO, Pneumo-Dissector is substantially equivalent to predicate fluid dissectors in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Plus and III) with PAL™ (Probe for Aspiration/Lavage) manufactured by Marlow Surgical Technologies, Inc., 1810 Joseph Lloyd Parkway. Willoughby. OH 44094, the Nezhat-Dorsey Hydrodissection System manufactured by American Surgical Instruments, Inc., 901 E. Sample Road, Suite C, Pompano Beach, FL 33064, and the Cabot Irrieation/Aspiration System with Corson Hydrodissection Insert™ manufactured by Cabot Medical, 2021 Cabot Boulevard West, Langhorne, PA 19047.

#### Device Description:

The CO, Pneumo-Dissector is used to gently dissect planes of soft tissue using short, pressure regulated, triggercontrolled pulses of CO, gas. The device may be used in both open and laparoscopic procedures. The primary materials used in this device are stainless steel, acetal, polyvinylchloride. These materials are widely used in the medical field and biocompatibility is assured. Testing to evaluate performance characteristics showed the CO, Pneumo-Dissector to meet device specifications, and accomplish safe and effective blunt tissue dissection.

#### Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Urological, Incorporated and Cook OB/GYN, Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 1998

Ms. Brenda Davis Regulatory Affairs Cook Urological, Inc. 1100 West Morgan Street Spencer, IN 47460

Re: K972647

CO2 Pneumo-Dissector Dated: January 19, 1998 Received: January 20, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET

Dear Ms. Davis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K972647

Device Name: CO2 Pneumo-Dissector

Indications for Use: The CO2 Pneumo-Dissector is used to gently dissect planes of soft tissue using short, pressure regulated, trigger-controlled pulses of CO2 gas. The device may be used in both open and laparoscopic procedures in which gentle, blunt dissection of soft tissue planes is desired.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Atting/

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972647

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use