(73 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on the intended use of a radiofrequency ablation system for tissue coagulation.
Yes
The device is intended to coagulate tissue during surgical procedures, which is a therapeutic intervention.
No
The device is described as a system intended to "coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures," which points to a therapeutic or surgical function rather than a diagnostic one.
No
The 510(k) summary describes a "Cool-Tip RF System," which is explicitly stated as a system intended to "coagulate tissue." This function inherently requires hardware components (like an RF generator and electrodes) to deliver energy and perform the tissue coagulation. The lack of information about software, image processing, or AI further supports that this is a hardware-based device, not a software-only one.
Based on the provided information, the Radionics, Inc. Cool-Tip RF System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures." This describes a device used on the patient's body during surgery, not a device used to test samples outside the body (in vitro).
- 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 based on sample analysis
- Testing for diseases, conditions, or biomarkers
Therefore, the Radionics, Inc. Cool-Tip RF System is a surgical device used for tissue coagulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
Product codes
GEI
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 an eagle or other bird with outstretched wings, depicted in a simple, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1999
Mr. Jeffrey R. Mannion Senior Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803
Re: K984552 Trade Name: Cool-Tip RF System Regulatory Class: II Product Code: GEI Dated: December 21, 1998 Received: December 22, 1998
Dear Mr. Mannion:
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 (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.
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Page 2 - Mr. Jeffrey R. Mannion
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 vours.
Stupt Rlvedys
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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Page 1 of l
| 510(k) NUMBER (IF KNOWN): | K984552 |
|---|---|
| DEVICE NAME: | Cool-Tip RF System |
INDICATIONS FOR USE:
:
The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
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 Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number | K984552 |
|---|---|
| --------------- | --------- |
| | Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| -- | ------------------------------------------ | ---- | -------------------------------------------------- |
|---|