(168 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrosurgical ablation, not data processing or analysis.
Yes
The device is used for ablation and hemostasis of soft tissues, which are therapeutic actions.
No
The device is described as an electrosurgical device for ablation and hemostasis of soft tissues, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states the devices are "sterile, disposable devices" and "monopolar electrosurgical devices," indicating they are physical 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 clearly states the device is for "ablation, and hernostasis of soft tissues in arthroscopic procedures." This describes a surgical intervention performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
- Device Description: The description confirms it's a "disposable devices designed for use with the ORATEC Vulcan™ EASTM RF generator," further indicating a surgical tool.
The information provided consistently points to a surgical device used in vivo (within the living body), not an in vitro diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EASTM generator.
Product codes
GEI, HRX
Device Description
The devices described in this 510(k) are sterile, disposable devices designed for use with the ORATEC Vulcan™ EASTM RF generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues in 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)
ORATEC Electrosurgical Probes (K965007 and K992408), ORATEC Bipolar Ablation Suction Probes (K991218), ArthroCare Ablation Probes (K943450, K961747, and K962321)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 4 2000
510(k) Summary ORATEC Interventions, Inc. Monopolar Suction Ablation Probes
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: | K992805 |
|---|---|
| Submitter: | ORATEC® Interventions, Inc. |
| 3700 Haven Court | |
| Menlo Park, CA 94025 | |
| Establishment Registration # 2953127 | |
| Contact: | Jennifer Brennan |
| Regulatory Affairs Associate | |
| Telephone: (650) 369-9904 | |
| Fax: (650) 369-9902 | |
| Date Prepared: | October 18, 1999 |
| Device Names: | |
| Classification Name: | Electrosurgical device |
| Common/usual Name: | Electrosurgical accessory |
| Proprietary Name: | ORATEC® Ablator™-S Probe (Monopolar Ablation Suction Probe) |
| Predicate Devices: | ORATEC Electrosurgical Probes (K965007 and K992408) |
| ORATEC Bipolar Ablation Suction Probes (K991218) | |
| ArthroCare Ablation Probes (K943450, K961747, and K962321) |
Device Description:
The devices described in this 510(k) are sterile, disposable devices designed for use with the ORATEC Vulcan™ EASTM RF generator.
Intended Use:
The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EASTM generator.
Conclusion:
Based on the information provided the Ablator™-S Probe is substantially equivalent to the predicate devices: ORATEC Electrosurgical Probes, ORATEC Bipolar Ablation Suction Probes, and ArthroCare Ablation Probes under the Federal, Food, Drug and Cosmetic Act. The Ablator™ S Probe is manufactured and distributed by ORATEC Interventions, Inc.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human figures, with three wavy lines emanating from the right side of the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Ms. Jennifer Brennan Regulatory Affairs ORATEC® Interventions, Inc. 3700 Haven Court Menlo Park, California 94025
Re: K992805
Trade Name: ORATEC® Ablator™ Suction Probes Regulatory Class: II Product Code: GEI, HRX Dated: December 28, 1999 Received: December 29, 1999
Dear Ms. Brennan:
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 maior 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 (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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Jennifer Brennan
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,
Stupka Purdy
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Additional Information, K992805 ORATEC Monopolar Suction Probes
__ of _ l ---Page _
510(k) Number (if known): K992805
Device Name: ORATEC Interventions Monopolar Suction Ablation Probes
Indications for Use:
The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hernostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Per 21 CFR | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Res
| 510(k) Number | K992805 |
|---|---|
| --------------- | --------- |