(27 days)
The EnCor™ Breast Biopsy Probe with Rinse Tube is indicated to acquire tissue for diagnostic sampling of breast abnormalities and saline rinse the tissue samples collected within the tissue chamber during a biopsy procedure. It is intended 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 EnCor™ Breast Biopsy Probe with Rinse Tube is a handheld, single use, sterile (irradiation) biopsy probe used as part of a vacuum-assisted biopsy system (EnCor™ or EnCor Enspire™) and is intended to be used with ultrasound or stereotactic guidance. The probe is used for diagnostic sampling during a breast biopsy procedure. The device consists of a cutter/cannula with a sharp trocar tip, housing, sample container, vacuum and rinse tubing, and a rinse subcassette. A stainless steel cutter acquires the tissue samples, which are transported by vacuum to the probe's sample container, where they may be rinsed with saline. The EnCor™ Breast Biopsy Probe with Rinse Tube is available in 7 gauge, and 12 gauge, in both standard and vertical orientations for each qauge size.
This document is a 510(k) Premarket Notification from the FDA for the "EnCor Breast Biopsy Probe with Rinse Tube." As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the same way a clinical trial for a standalone AI algorithm would.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or reported device performance metrics in the format you might expect for an AI algorithm. Instead, it lists performance testing summaries designed to show equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance Summary |
|---|---|
| Functional Equivalence | The results demonstrate that the technological characteristics and performance criteria of the EnCor™ Breast Biopsy Probe with Rinse Tube are comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device. This implies meeting the functional performance of the predicate. |
| Cassette Functionality and Switch Activation | Test performed. Details of results not provided beyond "comparable." |
| Vacuum Testing | Test performed. Details of results not provided beyond "comparable." |
| Rinse Testing | Test performed. Details of results not provided beyond "comparable." |
| Tensile Testing | Test performed. Details of results not provided beyond "comparable." |
| Sub-cassette Reliability | Test performed. Details of results not provided beyond "comparable." |
| Packaging Validation | Test performed. Details of results not provided beyond "comparable." |
| Safety and Effectiveness | The subject device performs as safely and as effectively as the legally marketed predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical tests performed on the device itself (e.g., vacuum testing, tensile testing), not on patient data. Therefore, there is no "test set" in the context of patient data, nor is there data provenance (country of origin, retrospective/prospective). The study is essentially an engineering verification and validation study comparing the new device to the predicate device and established performance standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a physical breast biopsy probe, not an AI diagnostic tool. "Ground truth" in this context would relate to the physical properties and performance of the device components, which are typically assessed through engineering measurements and established test methods, not expert clinical consensus on images or pathology.
4. Adjudication Method
Not applicable. There is no clinical imaging or pathology data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical device, not an AI algorithm intended to assist human readers in interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device. This term is relevant for AI algorithms.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests would be the established engineering specifications, design requirements, and performance characteristics of the predicate device, as well as industry standards for medical device components and functionality. For example, a vacuum test would compare the device's vacuum pressure against a specified range or the predicate's measured pressure.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
Summary of the Study:
The study described is a non-clinical performance testing summary aimed at demonstrating substantial equivalence to a predicate device per FDA 510(k) requirements. The tests performed were engineering-based evaluations of the physical device's functionality, such as "Cassette functionality and switch activation," "Vacuum testing," "Rinse testing," "Tensile testing," "Sub-cassette reliability," and "Packaging validation." These tests likely involved comparing the performance of the new device to pre-defined specifications and/or the performance of the predicate device. The conclusion is that the device's technological characteristics and performance are "comparable" to the predicate, making it as safe and effective.
§ 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.