(76 days)
The electrosurgical probes and devices are to be used with commercially availbale R.F. Generators, endoscopes, and suction/irrigation sytems. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.
Isolated Electrosurgical Probe/Device-Salinetrode
The provided document is a 510(k) clearance letter from the FDA for an electrosurgical device (Salinetrode™) from February 1998. It primarily addresses the regulatory status (substantial equivalence) of the device to previously marketed predicate devices.
This type of document (a 510(k) clearance letter) does not contain the detailed technical study information you are asking for.
Specifically, a 510(k) clearance letter:
- Does not include acceptance criteria for device performance. It confirms that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.
- Does not include specific study data, sample sizes, expert qualifications, or ground truth methodologies. These details would be found in the 510(k) submission itself, which is typically a much more extensive document that includes performance data, bench testing, and potentially clinical studies, depending on the device and its risk profile.
- Does not discuss multi-reader multi-case (MRMC) studies or standalone algorithm performance, as this device is a physical electrosurgical probe, not an AI/software device.
Therefore, I cannot provide the requested information based on the input text. The document only confirms the device's regulatory clearance based on substantial equivalence, not its specific performance metrics or the studies backing them up.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ashvin Desai President Ximed Medical System 2195 Trade Zone Boulevard San Jose, California 95131
FEB 1 0 1998
Re: K974484
Trade Name: Isolated Electrosurgical Probes and Devices-Salinetrode™ Regulatory Class: II Product Code: GEI Dated: November 25, 1997 Received: November 26, 1997
Dear Mr. Desai:
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 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
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Page 2 - Mr. Desai
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
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
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K974484 510(k) Number (if known):
Device Name: Isolated Electrosurgical Probe/Device-Salinetrode
Indications For Use:
The electrosurgical probes and devices are to be used with commercially availbale R.F. Generators, endoscopes, and suction/irrigation sytems. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.
(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 | K974484 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 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.