(70 days)
Not Found
Not Found
No
The summary describes a physical electrode for surgical use and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of software, algorithms, or data processing typically associated with AI/ML.
Yes
The device is used for "resection/coagulation of urinary tract soft tissue," which directly treats a medical condition in the body.
No
The device is used for resection/coagulation of soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an "electrode," which is a hardware component used for resection/coagulation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resection/coagulation of urinary tract soft tissue." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "electrode" used with a "Resectoscope" for "resection/coagulation." This further confirms its use in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used for treatment (resection/coagulation) directly within the body.
N/A
Intended Use / Indications for Use
Northgate Technologies Inc. Resectoscope Sled™ Electrodes are intended to be used for resection/coagulation of urinary tract soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Northgate's Resectoscope Sled™ Electrode is designed to be used with most major brands of Resectoscopes. The electrodes are used for resection/ coagulation of urinary tract soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the word "NORTECH" in bold, sans-serif font. The word is centered and underlined by a thick line. The background is dark and textured, which makes the text stand out. The overall impression is that of a logo or brand name.
EXHIBIT # (PREVIOUSLY EXHIBIT #6)
SUMMARY OF SAFETY AND EFFECTIVENESS
| Common/Usual Name: | Resectoscope Sled™ Electrode |
|---|---|
| Proprietary Name: | Vapor-Tech Sled™ Electrosurgical Electrode |
| Classification: | CLASS II |
| MAY - 8 1997 |
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 Resectoscope Sled™ Electrode is designed to be used with most major brands of Resectoscopes. The electrodes are used for resection/ coagulation of urinary tract soft tissue.
Substantial Equivalence:
Northgate's Resectoscope Sled™ Electrodes are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Circon/ACMI and the Greenwald Surgical Company, Inc.
Intended Use:
Northgate Technologies Inc. Resectoscope Sled™ Electrodes are intended to be used for resection/coagulation of urinary tract soft tissue.