(58 days)
The Boston Surgical Products, Inc. Model 50 Coagulator General purposes solid state bipolar generator to supply the RF signal to electrosurycal handpieces used to coagulate soft body tissues where a wide range of tissue types, patient conditions, and load impediances are encountered.
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms).
A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation.
The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators.
This device is identical to an existing approved device.
The provided documents describe a 510(k) submission for the Model 50 Coagulation Generator. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving effectiveness through clinical studies with acceptance criteria based on human or algorithm performance.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the effectiveness of AI/ML-based diagnostic devices, is not applicable to this submission.
The document states: "This device is identical to an existing approved device." and the FDA's letter confirms: "we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976..."
Instead of clinical studies, the submission focuses on demonstrating that the new device meets established performance and safety standards, and that its design and specifications are identical or substantially similar to a legally marketed predicate device.
Here's why each of your points is not directly addressed or required for this 510(k) submission:
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A table of acceptance criteria and the reported device performance: Not applicable. The "performance" described relates to technical specifications and safety standards, not diagnostic accuracy or clinical outcomes.
- Digital display power setting indicator: +/- 5 watts, full scale (@ 100 ohms). This is a technical specification, not a clinical acceptance criterion.
- Bar graph display output current monitor: Provides relative measure and denotes output energy. This is a functional description.
- Handswitch power: Independent low voltage (7 Vdc) isolated power supply. Safety feature.
- Audio and Visual monitors: In accord with IEC 601-1-2 and ANSI HF-18 guidelines. Safety and functional compliance.
- RF and Low Frequency leakages: Well within IEC 601-1-2 and ANSI HF-18 safety guidelines. Safety compliance.
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Sample sized used for the test set and the data provenance: Not applicable. There's no "test set" in the context of diagnostic performance evaluation. Testing would involve engineering verification and validation against technical specifications and safety standards, not patient data sets.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a diagnostic sense is mentioned.
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Adjudication method for the test set: Not applicable. No diagnostic test set requiring adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical generator, not a diagnostic imaging or AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a surgical instrument, not an algorithm.
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The type of ground truth used: Not applicable. No diagnostic ground truth is established or required for this type of device.
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The sample size for the training set: Not applicable. This device does not involve machine learning or a training set.
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How the ground truth for the training set was established: Not applicable.
In conclusion, the provided documents pertain to a traditional medical device (an electrosurgical generator) undergoing a 510(k) clearance process based on substantial equivalence. The criteria and studies you've outlined are relevant for devices with diagnostic functions, particularly those leveraging AI/ML, which this device is not.
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U.S. Food and Drug Administration 510K Document Mail Center HFZ-401 Center for Medical Devices 1390 Piccard Drive Rockville, Maryland 20850
<972350
AUG 21 1997
l
To: Document Control Clerk
This summary of 510K safety and effectiveness for the Model 50 Coagulation Generator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms).
A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation.
The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators.
This device is identical to an existing approved device.
Sincerely,
Charles Vursello
Date
12 JUN 97
Charles Vassallo Boston Surgical Products, Inc. 17 Old Country Road Oxford, Connecticutt 06478 Telephone/FAX (203) 888 0149
3
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Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Charles Vassallo Boston SurgicalProducts, Inc. 17 Old Country Road Oxford, Connecticut 06478
AUG 21 1991
Re: K972350 Trade Name: Model 50 Bipolar Coagulator Regulatory Class: II Product Code: GEI Dated:June 12, 1997 Received: June 24, 1997
Dear Mr. Vassallo:
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 (OS) 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. Charles Vassallo
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,
[signature]
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 1
S10K Number (if known):
Device Name: Model 50 Bipolar Coaguiator Generator
Indications for Use: -- -
The Boston Surgical Products, Inc. Model 50 Coagulator General purposes solid state bipolar generator to supply the RF signal to clectrosurycal handpieces used to coagulate soft body tissues where a wide range of tissue types, patient conditions, and load impediances are encountered.
(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 | k9722350 |
| Prescription UsePer 21 CFR 801 109) | OR | Over The Counter Use:(Optional Format 1-2-96) |
|---|---|---|
| ----------------------------------------- | ---- | --------------------------------------------------- |
§ 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.