(168 days)
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.
The devices described in this 510(k) are sterile, disposable devices designed for use with the ORATEC Vulcan™ EASTM RF generator.
This submission is a 510(k) Pre-market Notification for a medical device called the ORATEC® Ablator™-S Probe (Monopolar Ablation Suction Probe). The purpose of this type of submission is to demonstrate that the new device is substantially equivalent to existing legally marketed predicate devices. It typically does not involve new clinical studies to prove effectiveness or establish acceptance criteria based on performance. Instead, it relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness profiles as legally marketed predicate devices.
Therefore, the provided document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as it's a 510(k) summary focused on substantial equivalence.
Based on the content, here's what can be inferred or stated about the requested information:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) summary does not define specific performance-based acceptance criteria for this new device in the way a clinical trial would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices in areas like intended use, materials, design, and operating principles. Performance is assessed in comparison to these predicates, not against novel, pre-defined quantitative thresholds in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or associated data provenance is described for proving new performance claims. The 510(k) submission primarily relies on comparisons to known predicate devices and non-clinical testing (which is not detailed here).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No expert-established ground truth for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a surgical probe, not an AI software/diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a surgical probe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No new ground truth is established or used for the purpose of this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a hardware medical device, not an AI or machine learning algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML algorithm is relevant to this submission.
Summary of the 510(k) Conclusion:
The 510(k) summary concludes that the ORATEC® Ablator™-S Probe is substantially equivalent to the predicate devices listed:
- ORATEC Electrosurgical Probes (K965007 and K992408)
- ORATEC Bipolar Ablation Suction Probes (K991218)
- ArthroCare Ablation Probes (K943450, K961747, and K962321)
This substantial equivalence determination is the primary "proof" for a 510(k) submission, indicating that the device is as safe and effective as existing devices on the market, rather than meeting specific performance criteria demonstrated through a de novo study.
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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.
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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.
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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
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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.
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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 |
|---|---|
| --------------- | --------- |
§ 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.