(34 days)
The primary indication for use of biopsy forceps is endoscopic tissue collection for histologic examination in GI/Urology, Bronchoscopy, Nasopharingoscopy, Esophagoscopy and Hysteroscopy. Non-electric biopsy forceps are not intended for use in conjunction with an electrocautery unit.
Not Found
The provided document is a 510(k) premarket notification for the LSVP International Biopsy Forceps. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through clinical studies with specific acceptance criteria and detailed performance reports.
Therefore, the document does not contain the information requested in points 1 through 9 regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment.
Here's why and what the document does provide:
- Nature of the Submission: A 510(k) submission typically relies on non-clinical performance testing (e.g., mechanical testing, biocompatibility) and a comparison to a predicate device. It generally does not require or include extensive clinical studies with human subjects that would involve establishing specific acceptance criteria for diagnostic performance (like sensitivity/specificity), ground truth, or MRMC studies.
- Focus: The focus of this document is to establish that the LSVP Biopsy Forceps are "substantially equivalent" in design, function, and intended use to existing predicate devices (Reusable Biopsy Forceps manufactured by Olympus, Portlyn Corp., and American Endoscopy, Corp.).
- Intended Use: The device is intended "specifically to collect tissue endoscopically for histologic examination." This is a tissue collection tool, not a diagnostic algorithm that would have performance metrics like sensitivity, specificity, or reader improvement.
In summary, none of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, or ground truth establishment for a diagnostic performance study is present because this is a 510(k) submission for a medical device (biopsy forceps) and not a diagnostic algorithm or a software as a medical device (SaMD) that would typically generate such data.
§ 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.