(26 days)
No
The description mentions "automatically adjusting energy delivery" based on temperature and impedance monitoring, which is a form of automated control, but there is no mention of AI, ML, or any learning algorithms. The system appears to use pre-programmed logic based on sensor data.
Yes
The device is described as an "electrothermal generator" intended for "coagulation of soft tissues" and designed to "maintain effective tissue heating during temperature-controlled applications," which indicates a therapeutic rather than diagnostic function.
No
The device description states its purpose is for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues, and it is an electrothermal generator. Its function is to deliver energy for tissue heating and cutting, not to diagnose conditions.
No
The device description explicitly states it is an "electrothermal generator" and mentions "radiofrequency output," indicating it is a hardware device that generates energy, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details an "electrothermal generator" used with "cutting and temperature controlled probes" for "tissue heating." This is consistent with surgical equipment, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to provide information about a patient's health status through the examination of these types of samples.
Therefore, the ORA-50 ElectroThermal System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ORA-50 ElectroThermal System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Product codes
HRX, GEI
Device Description
The ORATEC Interventions ORA-50 ElectroThermal System ("ORA-50") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for use during a variety of arthroscopic procedures. The ORATEC ORA-50 is specifically designed for use with ORATEC cutting and temperature controlled probes.
Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues (in orthopedic and arthroscopic applications)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgical equipment.
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)
Reference Device(s)
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
JAN | 8 2000
510(k) Summary
Image /page/0/Picture/2 description: The image shows a black and white logo. The logo features a stylized depiction of a human back with curved lines suggesting muscles or contours. Below the image is partial text that appears to be the beginning of a word, with the letters 'O R A T E C' visible.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K994333
Submitter: A.
Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025
phone: (650) 369-9904 (650) 369-9902 fax:
Contact: Sheila Ramerman
Date Prepared: December 16, 1999
- B. Device Names:
Classification name Common/usual name Proprietary name
Electrosurgical and Coagulation Unit and Accessories Electrosurgical generator and accessories ORA-50 ElectroThermal System and Accessories
- C. Predicate Device: Model ORA-50 ElectroThermal Generator, K964071
- Device Description: D.
The ORATEC Interventions ORA-50 ElectroThermal System ("ORA-50") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for use during a variety of arthroscopic procedures. The ORATEC ORA-50 is specifically designed for use with ORATEC cutting and temperature controlled probes.
Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use.
ORATEC Interventions, lnc.
3700 Haven Court Mento Park. (A 94025
Phone (650) 369-9904 fax: (650) 369-9902
1
Intended Use: E.
The ORA-50 ElectroThermal System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications for Use: The ORA-50 ElectroThermal System and Accessories are contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.
F. Comparison with the Predicate Device:
The ORA-50 System is a hardware and software modification of the Model ORA-50 Generator (K964071). The ORA-50 System and the Model ORA-50 ElectroThermal Generator have the same intended use and use the same operating principle.
Based on the data and information presented here, the modified ORA-50 System and Accessories are substantially equivalent to the ORA-50 ElectroThermal System and Accessories currently manufactured and distributed by ORATEC Interventions, Inc.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
JAN 18 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheila Ramerman Director, Regulatory and Clinical Affairs Oratec Interventions, Inc. 3700 Haven Court Menlo Park, California 94025
K994333 Re: Trade Name: ORA-50 ElectroThermal System and Accessories Regulatory Class: II Product Code: HRX and GEI Dated: December 20, 1999 Received: December 23, 1999
Dear Ms. Ramerman:
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 requirement, 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.
3
Page 2 - Ms. Sheila Ramerman
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 vour 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.
Stipts Charles
James E. Dillard III Acting Director Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page of
510(k) number (if known): K994333
Device Name: ORATEC Interventions ORA-50 ElectroThermal System and Accessories
Indications for Use:
The ORA-50 ElectroThermal System ("ORA-50") and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical generators.
Contraindications for Use: The ORA-50 ElectroThermal System and Accessories are contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interests of the patient.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Stigh Plody
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| Division of General Restorative Devices | |
| 510(k) Number | K994333 |
| Prescription Use | or | Over-The-Counter Use (Optional format 1-2-96) |
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