(124 days)
GI forceps are designed for insertion through an appropriate sized endoscopy channel for removal and histological sampling of tissue. Biopsy forceps are intended for removal of polyps and/or tissue within the gastrointestinal tract.
Vanguard Reprocessed Non-Electric Biopsy Forceps consist of a flexible sheath with distal grasping cups controlled by a proximal control handle. When used with a compatible endoscope, GI biopsy forceps are intended for removal of polyps and/or tissue within the gastrointestinal tract. Biopsy forceps are designed for insertion through a predetermined diameter biopsy channel. Vanguard receives previously used non-electric GI biopsy forceps from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
The provided text describes the 510(k) summary for the Vanguard Reprocessed Non-Electric Biopsy Forceps and does not contain the specific information requested about acceptance criteria, device performance tables, study designs (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone), or training set details.
The document focuses on:
- Device Description: Reprocessed non-electric GI biopsy forceps.
- Intended Use: Removal and histological sampling of tissue/polyps within the GI tract.
- Technological Characteristics: "Essentially identical" to OEM devices with no changes to materials or specifications.
- Predicate Devices: Various OEM non-electric biopsy forceps (Class I, 510(k) exempt).
- Test Data: States that "Cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
Therefore, I cannot fulfill your request for the detailed acceptance criteria and study information as it is not present in the provided text.
The document only broadly states that "performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective," but does not give any specifics on:
- Quantitative acceptance criteria (e.g., minimum tensile strength, maximum residual protein).
- Reported device performance against those criteria.
- Sample sizes for test sets.
- Data provenance.
- Number/qualifications of experts.
- Adjudication methods.
- MRMC or standalone studies.
- Types of ground truth.
- Training set details.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.