(43 days)
Olympus FG-2
Not Found
No
The description focuses on the mechanical function of grasping forceps and explicitly states that AI/ML is not mentioned.
No
The device is described as being used to retrieve foreign bodies and excised tissue specimens, which is a diagnostic or collection function, not a therapeutic one. It does not treat a disease or condition.
No
Explanation: The device is intended for retrieving foreign bodies and tissue specimens, not for diagnosing medical conditions. It is a tool for collection, not for analysis or diagnosis.
No
The device description clearly outlines a physical medical device with a flexible shaft, control handle, and grasping mechanism, indicating it is hardware-based.
Based on the provided information, the Olympus FG-45/46-1 Grasping Forceps is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retrieve foreign bodies and excised tissue specimens endoscopically." This describes a procedure performed within the body (in vivo) to collect samples or remove objects.
- Device Description: The description details a tool for physical manipulation and collection during an endoscopic procedure.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples outside the body (in vitro).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or treatment decisions based on laboratory analysis.
The device is a surgical instrument used for collection during an endoscopic procedure, not for laboratory analysis of samples.
N/A
Intended Use / Indications for Use
The Olympus FG-45/46-1 Grasping Forceps is intended to be used to retrieve foreign bodies and excised tissue specimens endoscopically.
Product codes
Not Found
Device Description
The Olympus FG-45/46-1 Grasping Forceps is specifically designed for foreign body and tissue specimen collection under endoscopic visualization. The FG-45/46-1 consists of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping prong mechanism.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Olympus FG-2 Reusable Grasping Forceps
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
AUG - 2 1996
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510(k) SUMMARY FOR OLYMPUS FG-45/46-1 GRASPING FORCEPS
| Device Name: | Olympus FG-45/46-1 Grasping Forceps |
|---|---|
| Common/Usual Name: | Grasping Forceps |
| Classification Name: | Bronchoscope and Accessories |
| 21 CFR 876.4680, Class II | |
| Predicate Device: | Olympus FG-2 Reusable Grasping Forceps |
| Contact Person: | Barry Sands |
| Olympus America, Inc. | |
| Endoscope Division | |
| 2 Corporate Center Drive | |
| Melville, NY 11747-3157 | |
| (516) 844-5747 | |
| Summary Preparation Date: | June 13, 1996 |
| Statement of Intended Use: | The Olympus FG-45/46-1 Grasping Forceps is intended to be |
| used to retrieve foreign bodies and excised tissue specimens | |
| endoscopically. | |
| Device Description: | The Olympus FG-45/46-1 Grasping Forceps is specifically |
| designed for foreign body and tissue specimen collection under | |
| endoscopic visualization. The FG-45/46-1 consists of a flexible | |
| shaft and a proximal control handle. Operation of the proximal | |
| control handle actuates the distal tip grasping prong mechanism. |