(42 days)
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No
The summary describes a mechanical grasping device with no mention of AI or ML capabilities.
No.
The device is used to grasp and retrieve tissue/foreign bodies, which is a diagnostic/interventional procedure, not a therapeutic one.
No
Explanation: The device is described as grasping forceps used to grasp tissue, retrieve foreign bodies, and excised tissue. Its intended use focuses on mechanical manipulation rather than providing information for diagnosis.
No
The device description clearly outlines a physical medical device (grasping forceps with a flexible shaft and control handle) and does not mention any software components as the primary or sole function.
Based on the provided information, the Olympus FG series of grasping forceps is not an IVD (In Vitro Diagnostic) device.
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 within the body during an endoscopic procedure.
- Device Description: The description details a mechanical device with a flexible shaft, handle, and grasping jaws. This is consistent with a surgical or procedural tool, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests on biological specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Olympus FG series of grasping forceps is a tool used in vivo (within the body) for physical manipulation and retrieval.
N/A
Intended Use / Indications for Use
The Olympus FG series of grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body and excised tissue endoscopically.
Product codes
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Device Description
The Olympus FG series of 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
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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)
Olympus pre-Amendment and 510(k) cleared grasping forceps, Olympus FG Reusable Grasping Forceps (K955066)
Reference Device(s)
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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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§ 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 - 9 199
510(k) SUMMARY FOR OLYMPUS FG GRASPING FORCEPS
- Device Name: Olympus FG-4/14/20/21/22/26/32/38/40/##-1 Grasping Forceps (Urology) Common/Usuai Name: Grasping Forceps for bronchoscopy Classification Name: Bronchoscope and Accessories 21 CFR 874.4680, Class II Predicate Device: Olympus pre-Amendment and 510(k) cleared grasping forceps Olympus FG Reusable Grasping Forceps (K955066) for GI Contact Person: Barry Sands Olympus America, Inc. Endoscope Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5474 Summary Preparation Date: June 26, 1996 Statement of Intended Use: The Olympus FG series of grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body and excised tissue endoscopically. Device Description: The Olympus FG series of 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.