(57 days)
The EnCor Enspire™ Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.
It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the EnCor Enspire™ Breast Biopsy Systems may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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 subject device is the EnCor Enspire™ Breast Biopsy System, an automated directional vacuum-assisted biopsy device consisting of an integrated control module and vacuum system with a detachable touch screen display. The key functional components of the EnCor Enspire™ Breast Biopsy System are integrated into a single console.
Control Module - The control module is designed to provide control operations and serve as an interface for drivers, probes and foot pedals.
- Inputs are delivered to the control module via either a driver or foot pedal.
- Based on the input received, the control module adjusts the motor speed of drivers and probes.
- System status is provided to the physician via an integrated LCD screen.
Vacuum System - During a breast biopsy procedure, the vacuum system draws the target tissue into the biopsy probe tissue acquisition chamber by creating a negative pressure differential at the tip of the probe being used. A disposable vacuum canister and disposable vacuum tubing cassette (with or without optional rinse tubing) is installed in the vacuum system at the time of each breast biopsy procedure.
Touch Screen Display – The touch Screen Display provides an intuitive user interface for the EnCor Enspire™ Breast Biopsy System. The display provides the system status and initiates operation of the installed driver and probe based on information and options entered or selected by the user.
The provided text describes the EnCor Enspire™ Breast Biopsy System, which is a medical device for obtaining breast tissue samples. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device. As such, the study design focuses on verifying that the new device performs comparably to the predicate, rather than establishing clinical efficacy against a "ground truth" in the way one might for an AI diagnostic device.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document details performance testing to demonstrate equivalence to the predicate device, not necessarily "acceptance criteria" in the sense of accuracy/sensitivity/specificity against a clinical gold standard. The criteria are related to the functional performance of the device components.
| Acceptance Criteria (Performance Test) | Reported Device Performance |
|---|---|
| Vacuum Level | Met criteria. (Implied by conclusion of substantial equivalence) |
| Joint Tensile Strength | Met criteria. (Implied by conclusion of substantial equivalence) |
| Cassette Functionality | Met criteria. (Implied by conclusion of substantial equivalence) |
| Rinse Volume | Met criteria. (Implied by conclusion of substantial equivalence) |
| Cassette and Vacuum Reliability | Met criteria. (Implied by conclusion of substantial equivalence) |
| Packaging Validation | Met criteria. (Implied by conclusion of substantial equivalence) |
| User Validation | Met criteria. (Implied by conclusion of substantial equivalence) |
| Software Verification and Validation | Met criteria. (Implied by conclusion of substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical data for diagnostic accuracy. The testing is focused on the functionality and safety of the device itself. Therefore, sample sizes and data provenance in the context of patient data (e.g., country of origin, retrospective/prospective) are not applicable here. The tests were likely performed on components and the system in a lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study is not evaluating diagnostic performance against a clinical ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biopsy system, not an AI diagnostic tool that assists human readers. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance evaluation of an algorithm was not done. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the expected functional performance and safety parameters of the device, rather than a clinical outcome (e.g., pathology, outcomes data). The testing was against design specifications and predicate device performance. Therefore, the types of ground truth listed (expert consensus, pathology, outcomes data) are not applicable.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" for an AI algorithm mentioned in this document.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" and corresponding ground truth in the context of AI.
Summary of the Study:
The study described is a non-clinical 510(k) submission, primarily focusing on demonstrating that the EnCor Enspire™ Breast Biopsy System is substantially equivalent to a previously cleared predicate device (EnCor® Breast Biopsy System, K093512). The "study" consisted of engineering and functional performance tests to ensure the new device met its design specifications and performed comparably to the predicate device in terms of vacuum level, mechanical strength, functionality of components, software, and user interaction. The objective was to show that the minor design changes (integrated console, large touch screen, adjustable tray, redesigned tubing sets) do not alter the safety or effectiveness of the device compared to the predicate. The FDA's clearance (JUN 16 2011) indicates that these non-clinical tests were sufficient to establish substantial equivalence for the specified indications for use.
§ 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.