(76 days)
The Rabbit is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The Candidate Device is a coaxial breast biopsy system, which is intended to retrieve tissue samples from the breast for histological analysis .The device is provided sterile for single use only. The system includes a disposable biopsy device, Localization needle, stylet, and hook wire. The biopsy device includes a circular scalpel and a Garrote wire to transect the specimen.
This document focuses on the Rabbit breast biopsy instrument, a conventional medical device, rather than an AI-powered system. Therefore, most of the requested information regarding AI-specific criteria (like acceptance criteria for AI performance, MRMC studies, standalone AI performance, or training set details) is not applicable.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a non-AI device relying on substantial equivalence, there are no explicit quantitative "acceptance criteria" for diagnostic performance in the way one would define them for an AI algorithm (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance is based on demonstrating equivalence to predicate devices and meeting general device safety and performance standards.
| Acceptance Criteria Category | Device Performance (Based on Substantial Equivalence Review) |
|---|---|
| Intended Use | Provides breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination. |
| Design | Coaxial breast biopsy system with disposable biopsy device, localization needle, stylet, and hook wire. Includes a circular scalpel and a Garrote wire. |
| Material Safety | Materials conform to ISO Standard # 10993-1. |
| Sterility | Provided sterile for single use only. |
| Substantial Equivalence | Found substantially equivalent to: K983296 (Auto Suture ABBI System), K011575 (SiteSelect Breast Biopsy Device), K003297 (Mammotome). |
| General Controls | Subject to general controls provisions of the Act (registration, listing, GMP, labeling, no misbranding/adulteration). |
2. Sample size used for the test set and the data provenance:
- Not applicable for this type of device. The provided text does not describe a clinical study with a "test set" for diagnostic performance in the context of an AI algorithm. Substantial equivalence for this device relies on demonstrating that its design, materials, and intended use are comparable to legally marketed predicate devices, implying similar safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. As above, there's no diagnostic test set in the AI sense for which ground truth would need to be established by experts for this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is described for a test set.
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. This device is a biopsy instrument, not an AI diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical biopsy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Pathology/Histology: The primary "ground truth" related to the device's function is the histological examination of the tissue samples it retrieves. The device's purpose is to provide these samples, which are then analyzed by pathologists. The K-number does not detail specific studies proving the accuracy of the biopsy in comparison to a gold standard, but rather establishes equivalence to predicate devices that are accepted for providing such samples.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
Summary of Device and 510(k) Process:
The provided documents detail a 510(k) premarket notification for the "Rabbit" breast biopsy instrument. The FDA reviewed this submission and determined the device to be substantially equivalent to three predicate biopsy devices already on the market (Auto Suture ABBI System, SiteSelect Breast Biopsy Device, Mammotome).
For conventional medical devices under a 510(k) pathway, "acceptance criteria" largely revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves comparing:
- Indications for Use: The "Rabbit" is indicated for providing breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination, identical or very similar to predicate devices.
- Technological Characteristics: The device description details its coaxial design, components (scalpel, Garrote wire), and single-use sterile nature. This is compared to the predicate devices.
- Performance Data: While not explicitly detailed as specific diagnostic performance metrics in this summary, the submission would have included verification and validation testing (e.g., mechanical strength, cutting performance, material biocompatibility per ISO 10993-1, sterility) to demonstrate that the device performs as intended and is safe. The FDA's finding of substantial equivalence implies these tests were sufficient.
§ 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.