(111 days)
When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.
Biopsy forceps are devices used to collect tissue samples and/or remove polyps within the gastrointestinal tract via the operating channel of endoscopic instruments.
Electric biopsy forceps include an electrocautery function when used with a compatible electrosurgical unit.
The devices consist of flexible, electrically isolated sheaths with distal grasping cups that are controlled by a proximal handle. The forceps are guided by endoscopy through a biopsy channel with a minimum dimension of 2.8 mm. Monopolar electrocautery requires electrical connection of the forceps to a compatible electrosurgical unit and use of an appropriate patient grounding pad.
Vanguard receives previously used electric biopsy forceps from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the forceps; and returns them to the healthcare facility.
The provided text describes a submission for reprocessed electric biopsy forceps and does not contain information about acceptance criteria, device performance, or a study design in the context of medical device AI or diagnostic performance measurements. The document is a 510(k) summary for a medical device (reprocessed electric biopsy forceps) and focuses on substantial equivalence to predicate devices, rather than a study evaluating the diagnostic performance of a device against specific acceptance criteria.
Therefore, I cannot provide the requested information. The text discusses:
- Device Name: Vanguard Reprocessed Electric Biopsy Forceps
- Indications for Use: Electrocautery and removal of polyps and/or tissue within the gastrointestinal tract when used with a compatible electrosurgical unit, endoscope, and patient grounding pad.
- Technological Characteristics: Stated to be the same as the predicate devices, with unchanged materials and dimensions, and essentially identical physical characteristics and performance specifications.
- Test Data: Mentions "Decontamination and cleaning, packaging and sterilization validations and functional/performance, shelf life and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." This is related to the reprocessing procedure's validation, not a study to establish diagnostic performance or AI effectiveness.
There is no information on:
- A table of acceptance criteria and reported device performance in the context of diagnostic accuracy.
- Sample sizes for test sets, data provenance, or retrospective/prospective study design for diagnostic performance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).