(55 days)
No
The device description and intended use describe a purely mechanical grasping tool. There is no mention of any computational or analytical capabilities, including AI or ML.
No
The device is described as grasping forceps for retrieving tissue or foreign bodies, and its intended use does not involve treating or diagnosing a disease or condition, which are typical functions of a therapeutic device.
No
The device is described as grasping forceps for tissue and foreign body retrieval, not for diagnosing conditions.
No
The device description clearly outlines physical components like a flexible shaft, proximal control handle, and distal tip grasping jaws, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "grasp tissue and/or retrieve foreign body, and excised tissue endoscopically." This describes a physical manipulation of tissue and objects within the body, not a test performed on samples outside the body to diagnose a condition.
- Device Description: The description details a mechanical tool for grasping and retrieving, not a reagent, instrument, or system used for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a surgical/endoscopic tool.
N/A
Intended Use / Indications for Use
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue endoscopically.
Product codes
Not Found
Device Description
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed for grasping tissue and/or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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)
Olympus Pre-Amendment and 510(k) cleared grasping forceps, Olympus FG-Series Rat tooth Grasping Forceps (K955051)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
510(k) SUMMARY FOR OLYMPUS FG GRASPING FORCEPS
AUG 20 1996
1
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| Device Name: | Olympus FG-4/14/20/21/22/26/32/38/40/##-1 Grasping Forceps |
|---|---|
| Common/Usual Name: | Grasping Forceps |
| Classification Name: | Bronchoscope and Accessories |
| 21 CFR 874.4680, Class II | |
| Predicate Device: | Olympus Pre-Amendment and 510(k) cleared grasping forceps |
| Olympus FG-Series Rat tooth Grasping Forceps (K955051) | |
| Contact Person: | Barry Sands |
| Olympus America, Inc. | |
| Endoscope Division | |
| 2 Corporate Center Drive | |
| Melville, NY 11747-3157 | |
| (516) 844-5474 | |
| Summary Preparation Date: | June 25, 1996 |
| Statement of Intended Use: | The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended |
| to be used to grasp tissue and/or retrieve foreign body, and | |
| excised tissue endoscopically. | |
| Device Description: | The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed |
| for grasping tissue and/or retrieving foreign body, and excised | |
| tissue under endoscopic visualization. These forceps consist of | |
| a flexible shaft and a proximal control handle. Operation of the | |
| proximal control handle actuates the distal tip grasping jaws. |