(29 days)
The Olympus biopsy forceps are intended to be used for the collection of tissue samples under endoscopic observation.
The Olympus biopsy forceps are specifically designed for tissue collection within the respiratory organs. The FB series of biopsy forceps are substantially equivalent in intended use, method of operation, and safety to pre-Amendment and 510(k) cleared reusable biopsy forceps.
The provided text is a 510(k) summary for Olympus Biopsy Forceps. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt.
The 510(k) summary focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study as would be described for an AI/software as a medical device (SaMD).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets it, as this information is not present in the provided document.
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510(k) SUMMARY FOR
OLYMPUS BIOPSY FORCEPS
| Device Name: | Olympus FB series biopsy forceps |
|---|---|
| Common/Usual Name: | Biopsy Forceps for use with bronchoscopes (ENT) |
| Classification Name: | Bronchoscopes and Accessories21 CFR 884.4680, Class II |
| Predicate Device: | Olympus pre-Amendment and 510(k) cleared reusable biopsyforceps.Olympus FB Series of Reusable Biopsy Forceps (K955065) |
| Contact Person: | Barry SandsOlympus America, Inc.Endoscope Division2 Corporate Center DriveMelville, NY 11747-3157(516) 844-5474 |
| Summary Preparation Date: | June 27, 1996 |
| Statement of Intended Use: | The Olympus biopsy forceps are intended to be used for thecollection of tissue samples under endoscopic observation. |
| Device Description: | The Olympus biopsy forceps are specifically designed for tissuecollection within the respiratory organs. The FB series of biopsyforceps are substantially equivalent in intended use, method ofoperation, and safety to pre-Amendment and 510(k) clearedreusable biopsy forceps. |
§ 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.