(29 days)
The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.
The biopsy instrument is a sterile disposable device which features a stainless steel cannula with an echogenic tip, and a stainless steel stylet which is spring loaded and fitted into a plastic handle permitting single handed specimen collection. Sizes are available in 14 - 20 gauge needles. The length of the needles ranges between 9 and 20 cm. The needle is used by advancing the entire device to the site of soft tissue sampling. The needle is advanced with gentle but firm pressure. Once the needle is in position, the sample is taken and the device is removed from the sampling site. The sample can then be expelled from the stylet notch.
The provided text describes a Special 510(k) Premarket Notification for the Manan Bio-Cut Soft Tissue Biopsy Needle. However, it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria and a study proving the device meets them. The document focuses on establishing substantial equivalence to predicate devices and outlines the device's description and intended use.
Here's an attempt to answer the questions based on the available information and, where information is missing, to explicitly state that it is not provided in the text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify quantifiable acceptance criteria or reported device performance metrics from a study. It focuses on the device's description, intended use, and substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document | Not specified in the provided document |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set, its sample size, or its data provenance. This type of information would typically be found in a detailed study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention any experts used to establish ground truth or their qualifications. This is because no specific performance study with a test set is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As no specific test set or ground truth establishment method is described, there is no information on an adjudication method.
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
The device described is a physical medical instrument (a biopsy needle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned in the document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical biopsy needle, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since no specific performance study is detailed, the document does not describe the type of ground truth used. For a biopsy needle, performance might be evaluated by factors like sample adequacy (confirmed by pathology), ease of use, or mechanical properties, but these are not specified here.
8. The sample size for the training set
The document does not mention a training set. This is irrelevant for a physical medical device that is not an AI/machine learning product.
9. How the ground truth for the training set was established
This question is not applicable as no training set is mentioned for this physical device.
Summary of Study Information in the Document:
The provided 510(k) summary for the Manan Bio-Cut Soft Tissue Biopsy Needle, K052802, is a regulatory submission focused on demonstrating substantial equivalence to predicate devices (Manan Super-Core Biopsy Needle K950732 and Medical Device Technologies Super-Core Biopsy Needle K974814). It describes the device, its intended use, and technological characteristics. The document does not include details about specific performance studies, clinical trials, acceptance criteria, or expert evaluations related to device performance in the way often associated with AI/software devices or more complex diagnostic tools. The FDA's letter confirms that the device is substantially equivalent, allowing it to be marketed under 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.