(80 days)
Sterile, single-patient-use electrosurgical accessory having applications in general endoscopy and laparoscopy such as cholecystectomy and are intended to deliver electrosurgical current for cutting and coagulation of tissue and suction/irrigation functions to the surgical site.
Not Found
The provided document is a 510(k) clearance letter for a medical device (ConMed UniversalPLUS® Laparoscopic ABC®/Electrosurgical Electrode) from the FDA dated January 2, 1998. This letter grants permission to market the device based on a determination of substantial equivalence to a legally marketed predicate device.
This type of document (a 510(k) clearance letter) typically does not contain detailed information about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness. This often involves comparing the new device against the predicate device based on its design, materials, and performance specifications, rather than comprehensive clinical trials with detailed acceptance criteria and standalone performance metrics presented in the format requested.
Therefore, I cannot extract the requested information from this document. The document confirms the device's regulatory classification, its intended use, and that it has been cleared for marketing.
To answer your questions, one would need to refer to the original 510(k) submission (which is not provided) and potentially any associated design verification and validation documents, or clinical study reports if such studies were performed to demonstrate substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ira D. Duesler Quality Engineer Conmed Corporation 310 Broad Street Utica, New York 13501-1203
JAN - 2 1998
K973890 Re:
Trade Name: ConMed UniversalPLUS® Laparoscopic ABC®/Electosurgical Electrode Regulatory Class: II Product Code: GEI Dated: October 10, 1997 Received: October 14, 1997
Dear Mr. Duesler:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (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. In addition, FDA may publish further announcements concerning your ' devices in the Federal Register. Please note: this response to your premarket notification
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Page 2 - Mr. Duesler
submissions 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.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
tocallydor
M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): __ K 9 7 3 8 9 0 ___ CONMED UniversalPLUS® Laparoscopic ABC® / Electrosurgical Device Name:
Electrode
Indications for Use:
Sterile, single-patient-use electrosurgical accessory having applications in general endoscopy and laparoscopy such as cholecystectomy and are intended to deliver electrosurgical current for cutting and coagulation of tissue and suction/irrigation functions to the surgical site.
(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 | K973890 |
| Prescription Use | OR | Over-The-Counter |
|---|---|---|
| (Per 21 CFR 801.109) |
Su
Class
II
§ 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.