(117 days)
To gently dissect planes of soft tissue using controlled bursts of CO2 gas. The device may be used in both open and endoscopic procedures in which gentle, blunt dissection of soft tissue planes is desired.
The Carbodissecting Endoscope consists of two components: The Spatula is a surgical tool used in combination with CO2 and saline, and is designed to be used with the supplied Scope to provide accurate visual feedback during a carbodissection procedure. The tip allows the surgeon to slide between the tissue planes. The front of the tip is slightly curved and has multiple CO2 outlets. The multiple CO2 outlets are used to fan the gas out along the entire front of the tip to help peel apart the two layers, to aid in the separation of the tissue The Scope is a flexible fiberscope intended for use with the Spatula.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) premarket notification summary for a "Carbodissecting Endoscope," indicating it has been deemed substantially equivalent to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The requested information regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details are not present.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2002 MAR
Endo Surgical Devices, Inc. c/o Debbie Iampietro. ORC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748
Re: K013680
Trade Name: Carbodissecting Endoscope Regulation Number: 876.1500 Regulation Name: Laparoscope, General and Plastic Surgery Regulatory Class: II Product Code: GCJ Dated: February 6, 2002 Received: February 11, 2002
Dear Ms. Iampietro:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Debbie Iampietro
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
(ar Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Endo Surgical Devices, Inc. Carbodissecting Endoscope
510(k) Number (if known):
Device Name:
Carbodissecting Endoscope
Indications For Use:
To gently dissect planes of soft tissue using controlled bursts of CO2 gas. The device To gently dissect planes of soft trisue using controlled button of of 5-1-2
may be used in both open and endoscopic 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)
L Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
Mark A. Millican
OR
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013680
000010
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Ko13680
Endo Surgical Devices, Inc. Carbodissecting Endoscope
Premarket Notification
510K Summary of Safety and Effectiveness
-
- Sponsor Name Endo Surgical Devices, Inc. 4400 Rte 9 So., Suite 1000 Freehold, NJ 07728 Telephone: 732 409-5151
2. Device Name
Proprietary Name: Carbodissecting Endoscope Common/Usual Name: Endoscope and Accessories Classification Name: : Endoscope and Accessories
- Identification of Predicate or Legally Marketed Device 3.
- Sobel-Kaplitt-Sawyer Gas Spatula Becton Dickenson and O Company - Preamendments Device
- Cook Urological CO2 Pneumo-Dissector O
- Guidant Corporation Origin Medsystems VasoView Balloon o Dissection System
-
- Device Description
The Carbodissecting Endoscope consists of two components:
The Spatula is a surgical tool used in combination with CO2 and saline, and is designed to be used with the supplied Scope to provide accurate visual feedback during a carbodissection procedure. The tip allows the surgeon to slide between the tissue planes. The front of the tip is slightly curved and has multiple CO2 outlets. The multiple CO2 outlets are used to fan the gas out along the entire front of the tip to help peel apart the two layers, to aid in the separation of the tissue
The Scope is a flexible fiberscope intended for use with the Spatula.
- న్. Intended Use
To gently dissect planes of soft tissue using controlled bursts of CO2 gas. The device may be used in both open and endoscopic procedures in which gentle, blunt dissection of soft tissue planes is desired.
000149
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.