(35 days)
Not Found
No
The summary describes a smoke evacuation attachment for an electrosurgical pencil and does not mention any AI or ML capabilities.
No
The device is described as an accessory intended to remove smoke generated by electrosurgery, not to provide therapeutic treatment itself.
No
Explanation: The device is intended to remove smoke generated by electrosurgery, indicating it is an accessory for surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is a "Smoke Evacuation Attachment" used in conjunction with an electrosurgical pencil, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove smoke generated by electrosurgery." This is a function performed during a surgical procedure on a patient, not on a sample taken from a patient for diagnostic purposes.
- Device Description: The device is described as a "Smoke Evacuation Attachment." This aligns with its intended use during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
Therefore, this device is a surgical accessory used to manage the environment during an electrosurgical procedure, not a device used for in vitro diagnosis.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with a bird-like shape above them.
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.
1
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
2
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