(59 days)
The Clear Tip is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).
The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract) and tracheobronchial tree. The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. This device passes through a working channel of an endoscope, and the average contact time with the submucosal or external lesions of a gastrointestinal tract or a tracheobronchial tree is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.
The provided document does not contain information regarding the acceptance criteria of a study that proves the device meets specific performance metrics. It's a 510(k) summary for a medical device (ClearTip) seeking substantial equivalence to predicate devices, not a study report demonstrating specific performance against acceptance criteria.
The document discusses substantial equivalence based on:
- Indications for Use: The ClearTip is intended for Ultrasonically Guided Fine Needle Aspiration (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.
- Comparison to Predicate Devices: The document provides a detailed comparison table between the subject device (ClearTip) and two predicate devices (SonoTip Pro and Pro Flex EBUS-TBNA Needle System, and Clear-Tip EUS-FNA) regarding various characteristics like device name, classification, product code, regulation number, indications for use, needle gauge, material, length, sheath material, accessory channel diameter, endoscope compatibility, use with syringe/stopcock, principle of operation, shelf life, sterility, and single use.
- Non-clinical Tests: The following tests were performed on the subject device to support substantial equivalence: Sterilization Validation Test, Shelf-Life Test, Appearance, Dimensions, Operability, Elasticity, Bending Strength, Pull-out, Tensile Force, and Biocompatibility Tests. The document states that the test results support the device's substantial equivalence but does not provide specific acceptance criteria or reported performance values for these tests.
Therefore, the requested information for a table of acceptance criteria and reported device performance, sample sizes, ground truth establishment, adjudication methods, or MRMC/standalone study results cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing primary performance metrics through a clinical or non-clinical study with defined acceptance criteria.
§ 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.