(174 days)
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No
The summary describes a physical electrosurgical device with aspiration capabilities and makes no mention of AI or ML.
Yes
The device's intended use is to "allay excessive bleeding by fulgurating and desiccating tissue damaged in electrosurgical procedures," which describes a direct medical intervention to treat a physiological condition.
No
The device is described as a tool for "allaying excessive bleeding by fulgurating and desiccating tissue damaged in electrosurgical procedures," which indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it consists of a stainless steel spherical ball electrode and an attached external PEBAX® aspiration tube, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "allay excessive bleeding by fulgurating and desiccating tissue damaged in electrosurgical procedures." This describes a surgical procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The device is an "Aspiration/Coag Electrode" used with an electrosurgical generator and vacuum suction system. This is consistent with a surgical tool, not an IVD.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue samples, etc.), reagents, or diagnostic testing.
Therefore, this device is a surgical instrument used for electrosurgical procedures, not an in vitro diagnostic device.
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
The Aspiration/Coag Electrode is substantially equivalent to Utah Medical Products, Inc.'s DBL-311 and DBL-511 ball electrodes used for coagulation, combined with aspiration of the Valleylab E2505-10FR disposable electrode. The device consists of a stainless steel spherical ball electrode and an attached external PEBAX® aspiration tube.
The posterior end of the device fits snugly into a standard electrosurgical pen which is connected to an FDA approved electrosurgical generator and standard vacuum suction system. When used according to the instructions for use, in the hands of a trained user, the device provides an effective tool for allaying excessive bleeding by fulgurating and desiccating tissue damaged in electrosurgical procedures.
Materials that comprise the Aspiration/Coag Electrode are essentially the same as those used in other similar devices, and were selected based on properties of biocompatibility, compatibility with gamma sterilization, conformance with commonly used medical grade plastics and other materials, ease of processing and low cost.
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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§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).
0
APR 2 9 1996
Image /page/0/Picture/2 description: The image shows the logo for Utah Medical Products Inc. The logo features the company name in all caps above a horizontal line. Below the line is a stylized symbol that resembles a "U" shape with a curved top, or an "M" shape with a curved bottom.
Summary of Safety and Effectiveness
The Aspiration/Coag Electrode is substantially equivalent to Utah Medical Products, Inc.'s DBL-311 and DBL-511 ball electrodes used for coagulation, combined with aspiration of the Valleylab E2505-10FR disposable electrode. The device consists of a stainless steel spherical ball electrode and an attached external PEBAX® aspiration tube.
The posterior end of the device fits snugly into a standard electrosurgical pen which is connected to an FDA approved electrosurgical generator and standard vacuum suction system. When used according to the instructions for use, in the hands of a trained user, the device provides an effective tool for allaying excessive bleeding by fulgurating and desiccating tissue damaged in electrosurgical procedures.
Materials that comprise the Aspiration/Coag Electrode are essentially the same as those used in other similar devices, and were selected based on properties of biocompatibility, compatibility with gamma sterilization, conformance with commonly used medical grade plastics and other materials, ease of processing and low cost.
Biocompatibility and sterilization information is available from Utah Medical Products, Inc. upon request.
K-Howell
Kevin L. Cornwell President & CEO