(94 days)
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No
The device description focuses on basic electrical and display components, with no mention of AI or ML terms or functionalities.
No
The device description mentions it is a "bipolar coagulator", which is a surgical tool used to stop bleeding, indicating it is an active medical device but doesn't explicitly state it is used for therapeutic purposes. Without further information on its intended use/indications for use, it cannot be definitively classified as a therapeutic device.
No
The device description outlines a power setting indicator and output current monitor, describing elements consistent with an electrosurgical unit (e.g., "bipolar coagulators"), which is a therapeutic device, not a diagnostic one. There is no mention of analysis, measurement, or interpretation of physiological data to identify a condition or disease.
No
The device description explicitly mentions hardware components such as a digital display, bar graph display, handswitch, and power supply. It also discusses electrical characteristics like power settings, output current, and leakages, which are associated with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on the device's power settings, current monitoring, safety features, and compliance with electrical safety standards. There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Likely an electrosurgical or similar device: The description of power settings, output current monitoring, handswitch, and safety standards (IEC 601-1-2, ANSI HF-18) strongly suggests this is an electrosurgical device used for coagulation or similar procedures during surgery. These are typically considered medical devices, but not IVDs.
- Lack of IVD-specific information: The absence of information about intended use for diagnosis, analysis of biological samples, or any mention of reagents or assays further supports that it's not an IVD.
Therefore, based on the provided text, this device is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- 5watts, 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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 enter for Medical Devices 390 Piccard Drive Rockville, Maryland 20850
FEB 27 1997
November 15, 1996
To: Document Control Clerk
This summary of 510K safety and effectiveness for the BERGEN 610 Coagulator 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 (+/- 5watts, 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.
his device is substantially equivalent to existing approved devices.
Sincerely,
Roger Costin
Roger Oosten Bergen Mfg 9345 Rookery Road New Port Richey, Florida 34654
Date 11/15/96