(78 days)
The Lateral Access Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
The Ranfac Lateral Access BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is comprised of a 7-gauge outer cannula and an 11-gauge inner cannula with an overall length of 6.5 inches when the inner cannula is fully extended. The outer cannula has an adjustable grip, and a blunt tip that rests on the surface of the bone. The inner cannula has a ground point for bone/bone marrow penetration and side ports for marrow aspiration. When the molded grip of the Access Needle is turned clockwise the inner cannula is withdrawn into the outer cannula exposing the tip to a different location within the needle tract allowing for additional bone marrow aspiration acquisition without having to reposition the needle. During use, the Access Needle is inserted into bone with the aid of a sharp or drillable stylet. Once the needle is properly positioned and the stylet removed, a 14-gauge Aspiration Cannula is inserted into the Access Needle. The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). A white indicator on both the Access Needle and the Aspiration Cannula is provided in order to allow for alignment of the two components' side ports (for aspiration of bone marrow). An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed. The device is also packaged with a commercially available, 510k cleared standard 10mL luer lock hypodermic syringe for collection of bone marrow aspirate.
The provided document is a 510(k) Premarket Notification for the Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA). It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic performance study. The document focuses on demonstrating substantial equivalence to a predicate device primarily through comparison of design, materials, and functional characteristics for a physical medical device (a needle), and basic performance testing for structural integrity and sterility.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and study data for an AI/ML device, as it is not present in the provided text.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions "All samples met or exceeded acceptance criteria" for structural integrity testing, but does not detail these criteria or performance metrics. This is for the physical device's robustness, not diagnostic performance.
- 2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML device's test set. For the physical device, it mentions "All samples" for structural integrity testing, without specifying the number of samples or data provenance (e.g., country of origin, retrospective/prospective).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical medical device (a needle), not an AI/ML algorithm or diagnostic tool where ground truth would be established by experts.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The "Performance Testing" section states: "Structural integrity testing was conducted on the Ranfac LA BMA Needle demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Strength specifications (resistance to breakage and torque) are similar to those of the predicate Ranfac Marrow Cellution Bone Marrow Aspiration Needle. Additionally, simulated use testing was performed to validate that the design output of the Ranfac LA BMA Needle met design input requirements." This refers to mechanical and design performance, not diagnostic accuracy or AI/ML performance.
§ 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.