(17 days)
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung. It is composed of a echogenic spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The placement position of the needle may be visualized by either x-ray or ultrasonography.
This submission, K974814, is for the Manan™ Super-Core Biopsy Needle. It is a traditional 510(k) submission, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and performance data in the same way a software AI/ML device would.
Therefore, the requested information cannot be fully provided in the typical format for AI/ML device studies because this submission refers to a hardware medical device.
Here's an explanation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
- Not Applicable in the AI/ML context. This device is a manual, spring-loaded biopsy needle. The "performance" is demonstrated through substantial equivalence to a legally marketed predicate device (Manan Medical Products Super-Core Biopsy Needle, K950732) and through adherence to general controls and good manufacturing practices. There are no "acceptance criteria" or "reported device performance" in the sense of accuracy, sensitivity, or specificity metrics derived from a clinical study for an AI/ML algorithm.
- The FDA letter confirms the device is substantially equivalent for its stated indications for use, which implies its performance is considered comparable to the predicate device for obtaining soft tissue biopsies.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. The document does not describe a clinical performance study with a test set of data (images, etc.) that would typically be used for an AI/ML device. The "test" for this device would relate to its physical attributes, such as needle sharpness, deployment mechanism reliability, echogenicity, etc., usually assessed through engineering tests and comparison to standards, not a clinical data set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. There is no "ground truth" establishment in the context of an AI/ML diagnostic or prognostic study. The function of the device is to collect tissue samples, not to interpret them. The "truth" in this context would be the successful collection of a viable tissue sample, which is a functional outcome achieved by the clinician using the device.
4. Adjudication Method for the Test Set:
- Not Applicable. As there is no "test set" in the AI/ML sense, there is no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is not an AI/ML device designed to assist human readers in interpretation. It is a physical instrument for biopsy collection. Therefore, an MRMC study is irrelevant.
7. Type of Ground Truth Used:
- Not Applicable/Implied Functional Equivalence. For a physical biopsy device, the "ground truth" related to its primary function is its ability to reliably obtain a tissue sample suitable for pathological examination. This is implicitly demonstrated by substantial equivalence to a predicate device that has already established this functional capability. The "truth" about the tissue itself (e.g., presence of disease) is determined by subsequent pathology, which is enabled by the device but not part of the device's diagnostic function.
8. Sample Size for the Training Set:
- Not Applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
In summary, the provided 510(k) summary for the Manan™ Super-Core Biopsy Needle is for a physical medical device, not an AI/ML software device. Therefore, the questions related to AI/ML device performance studies (acceptance criteria, test/training sets, ground truth, expert adjudication, MRMC studies) are not applicable to this document. The safety and effectiveness of this device are established through substantial equivalence to a predicate device and compliance with general controls.
§ 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.