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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the CO2 Pneumo-Dissector, a surgical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance characteristics or clinical study results as one might find for a more complex diagnostic or AI-driven device.

Therefore, much of the requested information about acceptance criteria, specific performance metrics, sample sizes for testing sets, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this type of regulatory submission.

However, I can extract the information that is available and indicate where the requested details are absent.

Acceptance Criteria and Study for CO2 Pneumo-Dissector

This 510(k) Premarket Notification for the CO2 Pneumo-Dissector primarily relies on demonstrating substantial equivalence to existing predicate devices based on design, construction, materials, and intended use, rather than presenting a detailed study with specific acceptance criteria in the manner one would for a novel diagnostic or AI-based device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance
Device specifications	"Testing to evaluate performance characteristics showed the CO2 Pneumo-Dissector to meet device specifications..."
Safe and effective blunt tissue dissection	"...and accomplish safe and effective blunt tissue dissection."
Biocompatibility	"Biocompatibility is assured."
Substantial Equivalence to Predicate Devices	"This device meets the requirements for section 510(k) substantial equivalence" based on "indications for use, materials and physical construction to predicate devices."

Note: The specific numerical or qualitative "specifications" for the device are not detailed in this document. The assessment mentioned is qualitative.

Sample Size Used for Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "Testing to evaluate performance characteristics" but does not detail the size or nature of this testing (e.g., in-vitro bench testing, animal studies, or human clinical cases).
- Data Provenance: Not specified.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. This type of submission for a surgical instrument does not typically involve ground truth established by experts in the context of diagnostic performance. The focus is on functionality and safety.
Adjudication Method for the Test Set:
- Not applicable/Not specified.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done or reported. This type of study is relevant for assessing human performance (e.g., radiologists) with and without AI assistance, which is not pertinent to a CO2 surgical dissector.
Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- No, a standalone algorithm performance study was not done or reported. This device is a physical surgical instrument and does not involve an algorithm. The "performance characteristics" testing would refer to the mechanical and functional aspects of the dissector itself.
Type of Ground Truth Used:
- Not applicable in the context of diagnostic performance. For this device, the "ground truth" implicitly refers to the expected functional performance of a surgical dissector (e.g., successful dissection, controlled pressure, biocompatibility). These are assessed against internal device specifications and general surgical requirements.
Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or require a "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable.

Summary

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

Pinl

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 (812) 829-4891 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:

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Over-The-Counter Use

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.