(195 days)
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No
The summary describes a standard electrosurgical device for urological procedures and makes no mention of AI or ML capabilities.
Yes
The device is used to cut and coagulate soft tissue during electrosurgical urological procedures, indicating a therapeutic function.
No
The device is described as electrodes used to cut and coagulate soft tissue during electrosurgical procedures, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical electrode used in surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "urological procedures" to "cut and coagulate soft tissue during electrosurgical procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details electrodes used with resectoscopes for cutting and coagulation. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) in vitro (outside the body) to diagnose a condition.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Northgate Technologies Inc. Resectoscope Electrodes are intended to be used in urological procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Northgate's Cutting Loops and Knife Resectoscope Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures.
The Vapor-Tech Series Electrodes are designed with several tip configurations: roller, grooved roller, ball, and scoop.
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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§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
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EXHIBIT
SUMMARY OF SAFETY AND EFFECTIVENES
VENESS
K954710
Resectoscope Electrodes Common/Usual Name: APR 2 4 1996 Vapor-Tech Roller, Vapor-Tech Grooved Roller, Proprietary Name: Vapor-Tech Ball, Vapor-Tech Scoop CLASS II Classification:
Materials:
All materials used to manufacture the Northgate Technologies Inc. Electrodes are non-toxic and have been previously used to manufacture other medical devices.
Description:
Northgate's Cutting Loops and Knife Resectoscope Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures.
The Vapor-Tech Series Electrodes are designed with several tip configurations: roller, grooved roller, ball, and scoop.
Substantial Equivalence:
Northgate's Resectoscope Electrodes are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Circon/ACMI, Olympus, Storz Products, Inc., and Richard Wolf.
Intended Use:
Northgate Technologies Inc. Resectoscope Electrodes are intended to be used in urological procedures.