(29 days)
Not Found
No
The summary describes a mechanical biopsy forceps and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is used for the collection of tissue samples, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure a disease or condition.
No
The device is described as biopsy forceps for tissue collection. Its purpose is to obtain samples, not to analyze them or provide a diagnosis.
No
The device description clearly states it is a physical medical device (biopsy forceps) used for tissue collection, not a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information about a person's health.
- Device Function: The Olympus biopsy forceps are a surgical instrument used to collect tissue samples from within the body (in vivo) during an endoscopic procedure. They are not used to perform a diagnostic test on the collected sample. The diagnostic testing would be performed separately on the tissue sample after it has been collected by the forceps.
Therefore, the biopsy forceps are a tool for sample collection, not a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Olympus biopsy forceps are intended to be used for the collection of tissue samples under endoscopic observation.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The respiratory organs.
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 FB Series of Reusable Biopsy Forceps (K955065)
Reference Device(s)
Not Found
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)
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
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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 Accessories |
| 21 CFR 884.4680, Class II | |
| Predicate Device: | Olympus pre-Amendment and 510(k) cleared reusable biopsy |
| forceps. | |
| Olympus FB Series of Reusable Biopsy Forceps (K955065) | |
| Contact Person: | Barry Sands |
| Olympus America, Inc. | |
| Endoscope Division | |
| 2 Corporate Center Drive | |
| Melville, 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 the |
| collection of tissue samples under endoscopic observation. | |
| Device Description: | 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. |