(185 days)
To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only.
The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures.
The Evacore Fully Disposable Vacuum Assist Biopsy Device is a gamma sterilized, single-use percutaneous biopsy device. The working end of the device consist of a stainless steel outer needle with a lateral aperture for sample acquisition (sample aperture), a stainless steel inner cutting cannula with a sharp edge, and a solid stainless steel stylet located inside the cutting cannula. The handle of the device contains (2) release buttons, a reset handle for the vacuum generator (thumb), a reset handle for the cutting cannula (two fingers), and a needle hub to adjust the needle aperture orientation based on the location of the lesion. When the release buttons are depressed (consecutively or concurrently) a vacuum is generated at the needle sample aperture drawing tissue into the needle, then the cutting cannula is activated automatically, traversing across the sample aperture dissevering the tissue sample. The solid stainless steel stylet prevents the tissue sample from migrating towards the handle once it has been separated from the patient. The device is then removed from the patient and reset via the reset handles allowing the tissue sample to be removed.
The provided text describes a 510(k) premarket notification for the "Evacore Fully Disposable Vacuum Assist Biopsy Device." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report of the device's performance against specific clinical acceptance criteria.
The acceptance criteria and reported device performance are related to the physical characteristics of the biopsy samples obtained, specifically their volume or mass.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 7 gauge 115mm & 145mm needle: Average volume of a sample > 0.105 cm³ | PASS |
| 11 gauge 115mm & 145mm needle: Average volume of a samples > 0.033 cm³ | PASS |
| 14 gauge 115mm & 145mm needle: Average mass of 8 samples > 0.018 cm³ | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the testing was "Simulated and supported with bench testing." It does not specify the sample size (number of tests or tissues) used for the bench testing or the origin/provenance of the data (e.g., country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for the bench testing. The "ground truth" in this context appears to be the quantitative measurement of sample volume/mass from the bench tests.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the testing described is direct mechanical/physical measurement rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This device is a biopsy instrument, not an diagnostic imaging or interpretation device that would typically involve human readers.
6. Standalone Performance Study
Yes, a standalone performance assessment was conducted through "empirical testing" and "bench testing" focusing on the physical characteristics of the biopsy samples (volume/mass).
7. Type of Ground Truth Used
The ground truth used was based on quantitative physical measurements (average volume or mass) of samples obtained during simulated bench testing.
8. Sample Size for the Training Set
The document does not mention a training set. The descriptions of performance testing relate to a physical device, not an algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is discussed for this type of device and testing.
§ 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.