(142 days)
The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the 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). The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. ClearTip is offered in various needle gauges for insertion and aspiration. The available needle gauge sizes of 19, 22, and 25 gauge. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the length of the coil sheath and the needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human gastrointestinal tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
This FDA 510(k) clearance letter pertains to a medical device, and as such, it does not detail acceptance criteria or a study that would demonstrate the device meets those criteria in the way typically seen for AI/software-as-medical-device (SaMD) products. This document describes a traditional medical device (a biopsy instrument), not an AI system.
The "acceptance criteria" and "device performance" mentioned in your request are usually quantifiable metrics (e.g., sensitivity, specificity, AUC) for SaMD products, often against a ground truth for diagnostic accuracy. For a physical device like the ClearTip FNA and FNB Types, acceptance criteria typically relate to physical properties, functionality, safety, and compatibility, which are assessed through non-clinical (engineering, bench) tests rather than clinical performance studies against a diagnostic "ground truth."
Therefore, I will extract the information provided based on the context of a physical medical device submission, focusing on the nearest equivalents to your requested categories.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical device, the "acceptance criteria" are implied by the performance standards for the non-clinical tests conducted. The reported "device performance" is typically that the device met these standards. The document does not provide specific numerical acceptance criteria or performance metrics for each test, but rather lists the types of tests performed.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Sterility Validation | Validated (device is sterilizable by EO) |
| Shelf-Life | 3 Years (device maintains integrity for this period) |
| Appearance | Met (device's visual characteristics are acceptable) |
| Dimensions | Met (device dimensions are within specified limits) |
| Operability | Met (device functions as intended) |
| Elasticity | Met (device's elastic properties are acceptable) |
| Bending Strength | Met (device withstands specified bending forces) |
| Pull-out | Met (device components withstand specified pull-out forces) |
| Tensile Force | Met (device components withstand specified tensile forces) |
| Biocompatibility | Met (device materials are biocompatible) |
| Endoscope Compatibility | Met (device is compatible with specified endoscope channels) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical data for diagnostic performance. The "tests" mentioned are non-clinical (bench/engineering) tests conducted on the physical device itself. Therefore, information on sample size for a "test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided given the nature of the device and the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not an AI/SaMD product requiring expert-established ground truth for diagnostic accuracy. The "ground truth" for a physical device's performance often relates to engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication in a clinical context is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is typically for evaluating diagnostic performance of imaging or AI systems with human readers. This clearance is for a physical biopsy instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and regulatory requirements (e.g., for sterility, biocompatibility, mechanical strength). It is not pathology, outcomes data, or expert consensus in the diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/machine learning system.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
§ 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.