(75 days)
Not Found
Not Found
No
The summary describes an electrothermal coagulator for hemostasis and tissue coagulation, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as an “Electrothermal Coagulator” designed for “hemostasis” and “coagulation of soft tissues during general arthroscopic procedures,” which are therapeutic actions.
No
The device is described as a "coagulator" designed for "hemostasis, and for coagulation of soft tissues," which are therapeutic functions, not diagnostic ones.
No
The device is described as an "Electrothermal Coagulator," which inherently implies a hardware component that uses electricity and heat for coagulation. The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemostasis, and for coagulation of soft tissues during general arthroscopic procedures." This describes a device used on the patient's body during a surgical procedure, not a device used to test samples outside the body (in vitro).
- Anatomical Site: The anatomical site is "soft tissues during general arthroscopic procedures," which again points to a device used directly on the patient.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in a lab setting, or providing diagnostic information based on sample analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is therapeutic (hemostasis and coagulation) and performed directly on the patient during surgery.
N/A
Intended Use / Indications for Use
Model OrastatTM Electrothermal Coagulator is designed for hemostasis, and for coagulation of soft tissues during general arthroscopic procedures.
Product codes
GEI
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues (during general arthroscopic procedures)
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)
Not Found
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1997
Michael Kwan, Ph.D. Oratec Interventions, Inc. 3700 Haven Court Menlo Park, California 94025
Re: K973158
Trade Name: Oratec Interventions Model Orastat Electrothermal Coagulator Regulatory Class: II Product Code: GEI Dated: August 21, 1977 Received: August 22, 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 mayor 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 (QS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Michael Kwan, Ph.D.
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,
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
2
INDICATIONS FOR USE
| k97 3158 | |
|---|---|
| 510(k) Number (if known): | Not yet assigned |
| Device Name: | Model Orastat TM Electrothermal Coagulator |
Indication For Use:
Model Orastat™ Electrothermal Coagulator is designed for hemostasis, and for coagulation of soft tissues during general arthroscopic procedures.
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 | K973158 |
| 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 Orace Interventions, Inc.
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