(18 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The description is consistent with a standard electrosurgical unit.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit."
No
Explanation: The device is described as an electrosurgical unit used for the "controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit," which indicates a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states "System 7500 Electrosurgical Unit," which is a hardware device used for surgical procedures. The summary does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit." This describes a device used on the patient's body during a surgical procedure for treatment, not a device used to test samples from the body in a lab setting.
- Device Description: "Electrosurgical Unit" is a type of device used in surgery for cutting and coagulating tissue.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Use in a laboratory setting
Therefore, this device falls under the category of a surgical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.
Product codes
GEI
Device Description
System 7500 Electrosurgical Unit
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles a stylized caduceus, with three lines representing the snakes and a base representing the staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 1998
Mr. Charles M. Hart Director of Quality Assurance and Requlatory Affairs ConMed Corporation 14603 East Fremont Avenue Englewood, Colorado 80112
K981220 Re: System 7500 Electrosurgical Unit Trade Name: Requlatory Class: II Product Code: GEI March 31, 1998 Dated: Received: April 3, 1998
Dear Mr. Hart:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 (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 In addition, FDA may publish further announcements action. 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. Hart
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbeing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets 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 ene regaracion chercica) (11825anding m) 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,
Ph.D., M.D. ia M. Witten, Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K981220 510(k) Number:
System 7500 ABC Electrosurgical Unit Device Name:
Indications for Use:
Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) OR Over-the-Counter Use __
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices