(69 days)
Not Found
Not Found
No
The summary describes a simple accessory device for smoke evacuation, with no mention of AI, ML, image processing, or data-driven features.
No
Explanation: The device is an accessory used to reduce gasses, fluids, and smoke during electro-cauterization, not to directly treat a medical condition.
No
The device is described as an accessory for reducing gasses, body fluids, and smoke during electro-cauterization, not for diagnosing conditions.
No
The device description explicitly states it is an "accessory device used to provide an air suction path," which implies a physical component for suction, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to reduce gasses, body fluids, and smoke associated with the use of electro-cauterization systems. This is a device used during a surgical procedure to manage the byproducts of that procedure.
- Device Description: The description reinforces the intended use as an accessory for electro-cauterization systems and operating room suction systems.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or diagnostic purposes.
The device is a surgical accessory designed to improve the operating environment by removing smoke and other byproducts. It does not perform any diagnostic function.
N/A
Intended Use / Indications for Use
The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.
Prescription Use (Per 21 CFR 801.109)
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)
Not Found
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas W. Parkinson Leader-Ouality Assurance/Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway Cleveland, Ohio 44128
JUL 21 1997
Re: K971758
Trade Name: Cauterization Smoke Evacuator Regulatory Class: II Product Code: GEI Dated: May 10, 1997 Received: May 13, 1997
Dear Mr. Parkinson:
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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Thomas W. Parkinson
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,
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
9717158
SECTION - I
1.5. - INDICATIONS FOR USE STATEMENT
The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.
Prescription Use (Per 21 CFR 801.109)
Dcostello
Applied Medical Technology, Inc. - 510(k) Submission Cauterization Smoke Evacuator Section 1 - Page 1.7.