(31 days)
The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.
The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.
The provided text describes the SonoTip II Ultrasound Needle System and its 510(k) clearance. However, it does not contain detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or details about the studies (e.g., standalone, MRMC, or training set specifics) that would allow for a comprehensive breakdown as requested.
The document states:
- "Design verification data has demonstrated that the SonoTip II Ultrasonic Needle System meets design requirements and is as safe and effective as the predicate device."
- "The SonoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the predicate Medi-Globe Ultrasound Needle System (K990220)."
This indicates that the clearance was based on substantial equivalence to a predicate device (GIP/Medi-Globe GI Ultrasound Needle System (K990220)) rather than a detailed clinical performance study with specific acceptance criteria and metrics. The "Performance Data" section primarily asserts equivalence.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution, penetration depth, or specific force thresholds) | Not specified. The document states: "Design verification data has demonstrated that the SonoTip II Ultrasonic Needle System meets design requirements and is as safe and effective as the predicate device." |
| Comparison to predicate for equivalence | The device is "considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the predicate Medi-Globe Ultrasound Needle System (K990220)." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document refers to "Design verification data" but does not detail its source or nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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; an MRMC study was not done. This device is a manual medical instrument (a needle system), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device (needle system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. Given the nature of the device (FNA needle), a typical "ground truth" for its performance might involve mechanical testing (e.g., needle sharpness, bend resistance, fluid aspiration efficiency) and biocompatibility, as well as a comparison of histological samples obtained with the device vs. the predicate, but these details are not provided.
8. The sample size for the training set
- Not applicable. This device is a physical instrument, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
Summary of available information:
The 510(k) clearance for the SonoTip II Ultrasound Needle System was based on demonstrating substantial equivalence to a legally marketed predicate device (Medi-Globe Ultrasound Needle System, K990220). The documentation does not provide specific performance metrics, detailed study designs, sample sizes, or information about expert involvement typically associated with a human-AI performance study. Instead, it relies on "design verification data" to assert that the device meets design requirements and is as safe and effective as the predicate.
§ 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.