(108 days)
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Not Found
No
The description focuses on mechanical and electrosurgical mechanisms for tissue resection and does not mention any AI/ML components or functions.
Yes
The device is designed to resect tissue from within the GI tract using mechanical strangulation and electrosurgical current, which are therapeutic actions aimed at treating a condition.
No
This device is described as an electrosurgical snare designed to resect tissue (remove it) from the GI tract. Its function is to perform a therapeutic procedure (tissue removal), not to diagnose a condition.
No
The device description explicitly details physical components such as a control handle, electrical connection cord, flexible catheter-like tube, and a distal end snare loop, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states that this device is used to "endoscopically resect tissue from within the GI tract." This is a surgical procedure performed inside the body (in vivo) to remove tissue.
- Lack of Diagnostic Testing: The device's purpose is tissue removal, not the analysis of samples for diagnostic purposes.
Therefore, based on the provided information, this device is a surgical instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract.
Product codes
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Device Description
The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract. The SD snares consist of a proximal end control handle, an electrical connection cord (A-cord), a flexible catheter-like tube, and a distal end snare loop. The detachable control handle contains the electrical connections which permit the snare loop to be connected to an electrosurgical generator via the A-cord. The distal end snare loop may be positioned around the target tissue by movement of a slider on the control handle. The tissue is resected by a combination of mechanical strangulation and electrosurgical current.
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
GI tract
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)
Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares, Olympus SD-14/15 sterile disposable snares
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
દર્શાય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખ
510(k) Summary for Olympus SD Series of Reusable Electrosurgical snares
| Device Name: | Olympus SD snares MAR 29 1996 |
|---|---|
| Common/Usual Name: | Snares |
| Classification Name: | Endoscope Electrosurgical Unit and Accessories |
| 21 CFR 876.4300 | |
| Predicate Devices: | Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares |
| and Olympus SD-14/15 sterile disposable snares. | |
| Contact Person: | Barry Sands |
| Olympus America, Inc. | |
| Medical Instrument Division | |
| 2 Corporate Center Drive | |
| Melville, NY 11747-3157 | |
| (516) 844-5474 | |
| Summary Preparation Date: | November 10, 1995 |
| Summary Revision Date: | February 27, 1996 |
| Statement of Intended Use: | The SD series of snares and the predicated snares are all |
| designed to endoscopically resect tissue from within the GI tract. | |
| Device Description: | The SD series of snares and the predicated snares are all |
| designed to endoscopically resect tissue from within the GI tract. | |
| The SD snares consist of a proximal end control handle, an | |
| electrical connection cord (A-cord), a flexible catheter-like tube, | |
| and a distal end snare loop. | |
| The detachable control handle contains the electrical connections | |
| which permit the snare loop to be connected to an electrosurgical | |
| generator via the A-cord. | |
| The distal end snare loop may be positioned around the target | |
| tissue by movement of a slider on the control handle. The tissue | |
| is resected by a combination of mechanical strangulation and | |
| electrosurgical current. |