(32 days)
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. k-wires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.
This document describes the regulatory submission for the "Imbibe Needle" and its substantial equivalence to a predicate device. It primarily focuses on the device's design and intended use, rather than a clinical study evaluating its performance against specific acceptance criteria in the context of an AI-powered device.
Therefore, many of the requested categories related to acceptance criteria, device performance, a study design (like sample size, ground truth, expert involvement, and MRMC studies) are not applicable or cannot be extracted from the provided text for this specific device. This is a medical device clearance, not an AI/software as a medical device (SaMD) submission.
Here's an analysis based on the provided text, indicating where information is present and where it is not applicable for this type of submission:
Acceptance Criteria and Device Performance
Since this is a submission for a physical medical device (a needle) and not an AI/software device, the concept of "acceptance criteria" and "device performance" as measured by metrics like sensitivity, specificity, or accuracy in a diagnostic context (which is typical for AI devices) does not directly apply here. Instead, the "performance" relates to its physical characteristics, safety, and functionality.
The document states: "Previous testing of the predicate device (i.e. mechanical, cadaveric testing and biocompatibility) has demonstrated that Imbibe Needle is safe and effective for its intended use." This indicates that the predicate device met certain performance criteria through those types of tests. The current submission's "performance data" is the assertion that the new device is the same as the predicate and therefore inherits its safety and effectiveness profile.
| Category | Description / N/A (for this document) |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not directly applicable in the AI/diagnostic sense. The document states "Previous testing of the predicate device (i.e. mechanical, cadaveric testing and biocompatibility) has demonstrated that Imbibe Needle is safe and effective for its intended use." This implies that the predicate device met performance criteria for its physical function, safety, and compatibility, which the new device is asserted to match. Specific numerical acceptance criteria (e.g., in terms of force, duration, material compatibility) for these tests are not provided in this summary but would have been part of the predicate's original submission. The reported "performance" for the new device is that it is identical to the predicate and thus "safe and effective for its intended use." |
| 2. Sample size and data provenance for test set | Not applicable for this type of submission. No "test set" in the context of diagnostic performance data for an algorithm is described. The "cadaveric testing" for the predicate device would have involved a sample of cadavers, but the size is not specified in this document. |
| 3. Number of experts and qualifications for ground truth | Not applicable for this type of submission. No "ground truth" establishment by experts for diagnostic performance is described. |
| 4. Adjudication method for test set | Not applicable for this type of submission. |
| 5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study | No. This type of study is not relevant for a physical biopsy needle. |
| 6. Standalone (algorithm only) performance study | No. This is a physical device, not an algorithm. |
| 7. Type of ground truth used | Not applicable for this type of submission. For the predicate, "mechanical, cadaveric testing and biocompatibility" would have relied on objective measurements and established scientific/engineering principles for ground truth. |
| 8. Sample size for training set | Not applicable for this type of submission. There is no "training set" for an algorithm discussed. |
| 9. How training set ground truth was established | Not applicable for this type of submission. |
In summary, this document is a 510(k) summary for a physical medical device (Imbibe Needle) seeking substantial equivalence to a previously cleared predicate device. The primary "study" proving it meets criteria is the assertion that it is "the same device as the predicate" with only a packaging change, and thus inherits the safety and effectiveness demonstrated by the predicate through "mechanical, cadaveric testing and biocompatibility." The detailed aspects of an AI/SaMD performance study are not present.
§ 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.