(57 days)
Radionics CBC-1 Bipolar Coagulator and Bipolar Forceps, Codman Malis CMC-III and Bipolar Forceps, Valleylab Force 40 with Current Monitor, Bipolar and Monopolar Forceps, F.L. Fischer G50 Bipolator and Bipolar Forceps, Somnus Model 3000 Tri-Needle Electrode, Zomed Model 30-6 Multielectrode Array
Not Found
No
The description mentions a microprocessor and software self-tests, but there is no mention of AI, ML, or related concepts like training/test sets, image processing, or performance metrics typically associated with AI/ML algorithms. The device features are described as being present in predicate devices, suggesting established technology.
No
The device is described as an electrosurgical device indicated for "gene" (likely an incomplete phrase which would be gene therapy or gene ablation, etc.), not explicitly for therapeutic purposes. Electrosurgery can be used for both diagnostic and therapeutic procedures; however, without further clarification, it's categorized as an electrosurgical device rather than broadly as a therapeutic device.
No
The device description indicates it is an "electrosurgical device" used for "coagulation," and its features relate to controlling power, temperature, and current for surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is an "electrosurgical device with a microprocessor and accessory electrodes" and a "radiofrequency generator." This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is stated as "indicated for gene". While this is incomplete, it clearly points towards a therapeutic or surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The description details an "electrosurgical device" used for "coagulation". This is a procedure performed directly on tissue within the body, not a test on a biological sample.
- Lack of IVD Characteristics: The description does not mention any components or functions typically associated with IVDs, such as reagents, assays, sample handling, or analysis of biological specimens.
Therefore, the Cosman Coagulator (CC-1) is an electrosurgical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To coagulate tissue.
The Cosman Coagulator (CC-1) and accessories વે઼઼ indicated for gene
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Radionics CC-1 Cosman Coagulator is an electrosurgical device with a microprocessor and accessory electrodes. The features of the CC-1 are included in one or more of the predicate devices. The system and unit testing results provided in this premarket notification verify that the CC-1 is accurate and reliable. Audio and visual indicators and displays inform the user regarding the proper function of the CC-1. In addition, self-test routines check the software and front panel LEDs upon power-up.
The CC-1. addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available Radionics CBC-1, Codman Malis CMC-III, Fischer G50 and Valleylab Force 40 devices. Like these devices, the CC-1 is comprised of a radiofrequency generator with a microprocessor and accessory electrodes. The features of the generator include manual, timed, automatic temperature and automatic power control. The CC-1 also displays and/or monitors: impedance, temperature, power and current. The maximum power output is 200 Watts. Electrodes include monopolar, bipolar, reusable, disposable, irrigating and non-irrigating types. These features are all included in one or more of the predicate devices.
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)
The system and unit testing results provided in this premarket notification verify that the CC-1 is accurate and reliable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Radionics CBC-1 Bipolar Coagulator and Bipolar Forceps, Codman Malis CMC-III and Bipolar Forceps, Valleylab Force 40 with Current Monitor, Bipolar and Monopolar Forceps, F.L. Fischer G50 Bipolator and Bipolar Forceps, Somnus Model 3000 Tri-Needle Electrode, Zomed Model 30-6 Multielectrode Array
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 2 9 1997
Appendix 1
| General Information | |
|---|---|
| Classification: | Class II |
| Common Name | Electrosurgical Device and Accessories |
| Device Trade Name: | Cosman Coagulator CC-1 |
| Intended Uses | To coagulate tissue. |
| Predicates Device: | Radionics CBC-1 Bipolar Coagulator and Bipolar Forceps; |
| Codman Malis CMC-III and Bipolar Forceps; | |
| Valleylab Force 40 with Current Monitor, Bipolar and | |
| Monopolar Forceps; | |
| F.L. Fischer G50 Bipolator and Bipolar Forceps; | |
| Somnus Model 3000 Tri-Needle Electrode; | |
| Zomed Model 30-6 Multielectrode Array; | |
| Establishment Name and Address: | Radionics, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Contact Name and Phone: | William Rittman (781) 272-1233 |
| Establishment Registration Number: | 1219140 |
| Performance Standard | None established under Section 514. |
Summary of Safety and Effectiveness
Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
Safety Summary
The Radionics CC-1 Cosman Coagulator is an electrosurgical device with a microprocessor and accessory electrodes. The features of the CC-1 are included in one or more of the predicate devices. The system and unit testing results provided in this premarket notification verify that the CC-1 is accurate and reliable. Audio and visual indicators and displays inform the user regarding the proper function of the CC-1. In addition, self-test routines check the software and front panel LEDs upon power-up.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use. It includes indications for use, cautions, warnings and error conditions as well as general instructions for the proper operation of the device. This information promotes safe and effective use of the device.
Description of the Device and Basis for Substantial Equivalence
The CC-1. addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available Radionics CBC-1, Codman Malis CMC-III, Fischer G50 and Valleylab Force 40 devices. Like these devices, the CC-1 is comprised of a radiofrequency generator with a microprocessor and accessory electrodes. The features of the generator include manual, timed, automatic temperature and automatic power control. The CC-1 also displays and/or monitors: impedance, temperature, power and current. The maximum power output is 200 Watts. Electrodes include monopolar, bipolar, reusable, disposable, irrigating and non-irrigating types. These features are all included in one or more of the predicate devices. Radionics believes that the information and testing provided in this premarket notification clearly describe the CC-1 Cosman Coagulator and accessories and demonstrate that it is equivalent to the mentioned commercially marketed predicate devices.
1
Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1997
Mr. William Rittman President Radionics Instruments, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516
Re: K973297
Trade Name: Cosman Coagulator (CC-1) System Regulatory Class: II - _ _ _ . . . . . . . Product Code: GEI Dated: August 29, 1997 Received: September 2, 1997
Dear Mr Rittman:
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.
2
Page 2 - Mr. William Rittman
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
3
Page 5 of 55
510(k) Number (if known): ¥973297 Device Name: C C - I Cosmon Coagulator
Indications For Use:
The Cosman Coagulator (CC-1) and accessories વ્યવસ indicated for gene
(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 General Restorative Devices
510(k) Number K973297
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)