(90 days)
No
The summary describes a standard electrosurgical generator and explicitly states it is technically identical to a predicate device from 1988. There is no mention of AI, ML, or any related technologies.
Yes
The device is a Coagulation Generator used to supply RF signals to electrosurgical handpieces for use on soft body tissues, which directly implies a therapeutic function (coagulation) during surgical procedures.
No
The device is described as a coagulation generator used to supply RF signals for electrosurgical handpieces to coagulate soft body tissues. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly mentions hardware components such as a solid state bipolar generator, handswitch, power supply, and enclosure. It is a physical medical device that utilizes RF signals for electrosurgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues". This describes a device used on the body for surgical procedures, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description focuses on the electrical and safety aspects of a surgical generator.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
This device is an electrosurgical generator used for coagulation during surgery.
N/A
Intended Use / Indications for Use
The Boston Surgical Products, Inc. Model 20 Coagulation Generator is a solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where low impedance or wetfield conditions exist.
Product codes
GEI
Device Description
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 technically identical to an existing approved device (Kirwan Model 25 1000, 510k K880863) but repackaged in e new style enclosure and relabeled Boston Surgical Products Model 20.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft body tissues
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)
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
U.S. Food and Drug Administration 510K Document Mail Center HFZ-401 Center for Medical Devices 1390 Piccard Drive Rockville, Maryland 20850
SEP 1 8 1997
To: Document Control Clerk
This summary of 510K safety and effectiveness for the Model 20 generator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.
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 technically identical to an existing approved device (Kirwan Model 25 1000, 510k K880863) but repackaged in e new style enclosure and relabeled Boston Surgical Products Model 20.
Sincerely,
Charles Vassallo
Charles Vassallo Boston Surgical Supply, Inc. 17 Old Country Road Oxford, Connecticutt 06478 Telephone/FAX (203) 888 0149
( 17 JUN 97
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Charles Vassallo Boston Surgical Supply, Inc. 17 Old Country Road Oxford. Connecticut 06478
SFP 1 8 1997
Re: K972311 Trade Name: Model 20 Bipolar Coagulator Regulatory Class: II Product Code: GEI Dated: June 17, 1997 Received: June 20, 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 (OS) 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. 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,
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____ l_of_____ 1
510(k) Number (if known)
Device Name: Model 20 Bipolar Coagulation Generator
Indications for use:
The Boston Surgical Products, Inc. Model 20 Coagulation Generator is a solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where low impedance or wetfield conditions exist.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
celly
(Division Sign-O
Division of General Restorative Devices K972311
510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)