(154 days)
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No
The summary describes a standard electrosurgical device and generator, with no mention of AI or ML capabilities in its function, design, or performance studies.
Yes
The device is described as an electrosurgical device intended for ablation and hemostasis of soft tissues, which are therapeutic actions.
No
Explanation: The device is an electrosurgical device intended for ablation and hemostasis of soft tissues, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, disposable electrosurgical probe with an insulated shaft, electrodes, and a handle, designed to be used with a separate RF generator. This indicates it is a hardware device, 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 hemostasis of soft tissues in arthroscopic procedures." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The description details a surgical tool ("disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues") used in conjunction with an RF generator to deliver energy for tissue modification.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens in this manner.
Therefore, the Bipolar Ablation Probes are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bipolar Ablation Probes are disposable, bipolar 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 EAS generator.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ORATEC Bipolar Ablation Probes are disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues. They provide minimally invasive access to the targeted tissues. The Bipolar Ablation Probes are used in conjunction with the ORATEC Vulcan™ EAS™ RF generator to deliver bipolar radiofrequency (RF) energy for ablation of soft tissues.
The probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Probes may incorporate suction capability for the removal of ablated tissue from the surgical site.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissues in arthroscopic procedures
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ORATEC Bipolar Ablation Probes performed equivalently to the predicate devices in bench and in clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image is a black and white graphic of the back of a woman. The woman's back is curved, and her hair is long. The image is simple and elegant. There is a registered trademark symbol in the bottom right corner of the image.
RA
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Additional Information, K991218 ORATEC Bipolar Probes
SEP 1 3 1999
510(k) Summary
ORATEC Interventions, Inc. Bipolar 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: _______________________________________________________________________________________________________________________________________________
A. Submitter:
Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025
phone: (650) 369-9904 (650) 369-9902 fax:
Sheila Ramerman Contact: Date Prepared: June 25, 1999
B. Device Names:
| Proprietary Name: | Bipolar Ablation Probes |
|---|---|
| Common/usual Name: | Electrosurgical Accessory |
| Classification Name: | Electrosurgical Device |
ArthroCare Ablation Probes, ArthroCare Corporation C. Predicate Device:
D. Device Description:
The ORATEC Bipolar Ablation Probes are disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues. They provide minimally invasive access to the targeted tissues. The Bipolar Ablation Probes are used in conjunction with the ORATEC Vulcan™ EAS™ RF generator to deliver bipolar radiofrequency (RF) energy for ablation of soft tissues.
Interventions, Inc. 3700 Haven Court
Menlo Park, CA
94025
ነ' በሰክፉ
ORATEC
The probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Probes may incorporate suction capability for the removal of ablated tissue from the surgical site.
(650) 369-9904 Fax: (650) 369-9905
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E. Intended Use:
The Bipolar Ablation Probes are disposable, bipolar 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 EAS generator.
Comparison with the Predicate Device: F.
The ORATEC Interventions Bipolar Ablation Probes and the ArthroCare Ablation Probes are the same in that:
- both provide minimally invasive access to targeted tissues; .
- both deliver bipolar radiofrequency energy for ablation of soft tissues; .
- . both are capable of suction;
- both are provided sterile and are designed for single-use only. .
The ORATEC Bipolar Ablation Probes and the ArthroCare Ablation Probes differ in that:
- The ORATEC probes may be of different physical dimensions than the ArthroCare . probes;
- the ORATEC probes may use different electrode, shaft, or insulating materials than . the ArthroCare probe;
- the ORATEC probe shafts may have a malleable distal end to allow orientation of the . tip during use, whereas the ArthroCare probe does not;
- the ORATEC probes typically consist of one electrode to deliver RF energy whereas . the ArthroCare probes typically consist of multiple electrodes.
These design differences do not raise any new questions of safety or effectiveness. The ORATEC Bipolar Ablation Probes performed equivalently to the predicate devices in bench and in clinical testing.
Based on the information presented here, the ORATEC Bipolar Ablation Probes are substantially equivalent to the ArthroCare Ablation Probes manufactured and distributed by ArthroCare Corporation.
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Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a wing-like shape above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 1999
Ms. Sheila Ramerman Director, Regulatory and Clinical Affairs ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, California 94025
Re: K991218 Trade Name: ORATEC® Bipolar Ablation Probes Regulatory Class: II Product Code: GEI Dated: July 28, 1999 Received: July 29, 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.
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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 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,
picollaza
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
4
Additional Information, K991218 ORATEC Bipolar Probes
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ORATEC Interventions Bipolar Ablation Probes
Indications for Use:
The Bipolar Ablation Probes are disposable, bipolar 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™ EAS™ generator.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | code |
|---|---|
| Division of General Restorative Devices | K991218 |
| 510(k) Number |
| Prescription Use _
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use _ |
|---|---|---|
| -------------------------------------------- | ---- | ------------------------ |
(Optional Format 1-2-96)