(269 days)
Not Found
Not Found
No
The description focuses on mechanical and gas-based dissection, with no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is used for soft tissue dissection, which is a surgical procedure, not a therapeutic treatment.
No
The device is described as a surgical tool used for dissecting soft tissue, not for identifying, monitoring, or diagnosing a medical condition.
No
The device description explicitly states the primary materials used are stainless steel, acetal, and polyvinylchloride, indicating it is a physical device with hardware components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "gently dissect planes of soft tissue using short, pressure regulated, trigger-controlled pulses of CO2 gas." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description reinforces the surgical nature of the device, mentioning its use in "open and laparoscopic procedures" and its function in "blunt tissue dissection."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a surgical purpose.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HET
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing to evaluate performance characteristics showed the CO, Pneumo-Dissector to meet device specifications, and accomplish safe and effective blunt tissue dissection.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features the department's name in a vertical orientation on the left side. To the right of the text is a stylized symbol consisting of three curved lines that resemble human profiles or abstract shapes. The logo is presented in black and white.
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
2
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