(58 days)
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No
The device description focuses on standard electrical and display components for a bipolar coagulator and explicitly states no mention of AI, DNN, or ML.
Yes
The device is a bipolar generator used for electrosurgical handpieces to coagulate soft body tissues, which is a therapeutic intervention.
No
Explanation: The device is described as a "Coagulator General purposes solid state bipolar generator to supply the RF signal to electrosurycal handpieces used to coagulate soft body tissues." Its function is to coagulate tissues, which is a therapeutic intervention, not a diagnostic one. There is no mention of it being used to identify or predict a disease or medical condition.
No
The device description clearly details hardware components such as a digital display, bar graph display, handswitch powered by an independent power supply, and mentions RF and low frequency leakages, indicating it is a physical device with electrical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "coagulate soft body tissues" using an electrosurgical generator. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a bipolar generator and handpieces used for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device performs a surgical function directly on the patient.
N/A
Intended Use / 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.
Product codes
GEI
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.
This device is identical to an existing approved device.
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
soft body tissues
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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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