(212 days)
Model EndoTAC™ Monopolar Cautery Probe is designed for hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc.
Not Found
This looks like a 510(k) premarket notification letter, which typically does not contain the detailed study information you're asking for. This document is a regulatory clearance letter from the FDA stating that the device is substantially equivalent to a predicate device. It confirms that the device can be marketed but does not include the specifics of the clinical or technical studies performed to demonstrate that equivalence or to establish acceptance criteria and performance metrics.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on the regulatory approval of the "Oratec Model Endotac Probe" for specific indications for use: "hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc."
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 1998
Michael Kwan, Ph.D. Oratec Interventions, Incorporated 3700 Haven Court Menlo Park, California 94025
K972358 Re:
Trade Name: Oratec Model Endotac Probe Regulatory Class: II Product Code: GEI Dated: October 30, 1997 Received: October 31, 1997
Dear Dr. Kwan:
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 531 through 542 of the Act for
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Page 2 - Dr. Kwan
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) 594-4595. 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/cdrh/dsmamain.html".
Sincerely yours.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): __________________ Not yet assigned
Device Name:
Indication For Use:
Model EndoTAC™ Monopolar Cautery Probe is designed for hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc.
Contraindications for Use:
None known.
. .
.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | 2972358 |
| Prescription Use(Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR
Over-The-Counter Use
(Optional Format 1-2-96)Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Oratec Interventions, Inc.
§ 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.