(35 days)
Used in conjunction with the electrosurgical pencil of 510(k) Notification K791137, the accessory is intended to remove smoke generated by electrosurgery.
Smoke Evacuation Attachment
Based on the provided documents, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria.
The documents are a 510(k) premarket notification letter from the FDA to Conmed Corporation regarding a "Smoke Evacuation Attachment." This letter grants specific approval to market the device based on its substantial equivalence to a predicate device.
The information requested in your prompt (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) pertains to clinical performance studies and detailed validation processes that are typically part of a 510(k) submission. However, this particular letter and its associated enclosure only provide the FDA's decision, the device name, and its indications for use. It does not contain any of the underlying data, study designs, or performance metrics from Conmed's submission.
Therefore, I cannot answer any of the questions from your prompt based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1698 ઠા નિ
Mr. Ira D. Duesler, Jr. Conmed Corporation 310 Broad Street Utica, New York 13501
Re: K982309 Trade Name: Smoke Evacuation Attachment Regulatory Class: II Product Code: GEI Dated: June 30, 1998 Received: July 1, 1998
Dear Mr. Duesler:
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 (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 - Mr. Ira D. Duesler, Jr.
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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K982309 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
CONMED Smoke Evacuation Attachment Device Name:
Indications for Use:
Used in conjunction with the electrosurgical pencil of 510(k) Notification K791137, the accessory is intended to remove smoke generated by electrosurgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109) ✓
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982309 Su
OR Over-The-Counter
K-19
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.