(155 days)
The SonoTip Pro and Pro Flex - TBNA Needle System 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 SonoTip Pro and Pro Flex EBUS-TBNA Needle System is a complete onepiece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only. The SonoTip Pro Flex EBUS-TBNA Needle System is coupled to the working channel of a legally marketed ultrasound endoscope. The needle is then ultrasonically guided and imbedded into the desired target lesion for aspiration of the required biopsy sample. A 2-way stop-cock valve and self-locking aspiration syringe are supplied as procedural aids to provide suction to through the needle lumen and assist in sample acquisition.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SonoTip Pro and Pro Flex EBUS-TBNA Needle System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Demonstrated to be "as safe" as the currently cleared predicate device (SonoTip II EBUS-TBNA Needle System, K091257). |
| Effectiveness | Demonstrated to be "as effective" as the currently cleared predicate device (SonoTip II EBUS-TBNA Needle System, K091257). |
| Performance Requirements | Meets the "same performance requirements" as the predicate device. |
| Intended Use | Has the "same intended use" as the predicate device (Ultrasonically Guided Fine Needle Aspiration (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract). |
| Diagnostic/Therapeutic Effect | Has the "same diagnostic/therapeutic effect" as the predicate device. |
| Method of Introduction/Use | Has the "same method of introduction/use" as the predicate device. |
| Technical Characteristics | Possesses "same technical characteristics" as the predicate device, with identified improvements (Nitinol needle material to reduce deformation). |
| General Range of Descriptive Features | Possesses the "same general range of descriptive features" as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Design verification data and biocompatibility testing has demonstrated..." but does not provide details on the sample size used for any specific test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). This information refers to non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or clinicians used to establish ground truth in the provided text. The evaluation is based on non-clinical data and comparison to a predicate device.
4. Adjudication Method for the Test Set
Since there is no mention of human expert evaluation or a test set involving human judgment, there is no adjudication method described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or is mentioned in the document. The device is a biopsy needle system, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical biopsy needle. No standalone algorithm performance study was performed or is relevant to this type of medical device.
7. The Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" seems to be derived from engineering design verification data and biocompatibility testing results, which likely adhere to established industry standards and internal specifications, allowing for direct comparison to the predicate device's performance.
8. The Sample Size for the Training Set
Since this is a physical medical device and not an AI/software product, there is no concept of a "training set" in the context of the provided information.
9. How the Ground Truth for the Training Set was Established
As there is no training set mentioned, this question is not applicable. The device's performance is established through non-clinical testing and comparison to a predicate device, as described in point 7.
§ 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.