(18 days)
The EnCor® Introducer is used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.
The ENCOR® MRI Introducer Set consists of a Trocar, Obturator, Cannula and Needle Guide Block. The Trocar, Obturator, and ENCOR® MRI probes can be used co-axially with the Cannula. When inserted in the cannula, the tip of the Obturator approximates the center of the sample aperture of the ENCOR® MRI Probe. Markings on the Cannula indicate the distance to the center of the ENCOR® MRI probe sample aperture.
The ENCOR® Probe Introducer is sterile, disposable and consists of an Introducer and Adapter. The ENCOR® Probe Introducer is used co-axially with the ENCOR® biopsy probe. The same Introducer allows for both tissue acquisition with an ENCOR® probe and subsequent marking of the biopsy site with GEL MARK ULTRACOR® Biopsy site marker.
The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the context of AI/ML, clinical performance, or diagnostic accuracy. Instead, the document is a 510(k) premarket notification for a medical device (EnCor® MRI Introducer Set, EnCor® Probe Introducer) with a summary of changes and performance testing.
The key points from the provided text are:
- Device: EnCor® MRI Introducer Set, EnCor® Probe Introducer.
- Purpose: These devices are used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway for diagnostic biopsy.
- Regulatory Submission: This is a 510(k) submission for a change in the printing ink material used on the outer cannula of the device.
- Predicate Device: SenoRx, Inc. Introducers (K042098).
- Performance Testing Summary (related to the change):
- Biocompatibility testing of the new ink (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogen Testing).
- Functional testing after Accelerated Shelf Life and T=0 (Ink adhesion and ink adhesion IPA wiping).
- Conclusion: The testing demonstrated that the technological characteristics and performance criteria of the EnCor® Introducers are comparable to the predicate device, and it performs as safely and effectively.
Based on the nature of the document, which pertains to a minor material change in an accessory device and its substantial equivalence to a predicate, the typical elements you requested (like AI/ML performance, sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) are not applicable or present.
Therefore, I cannot provide the requested table or detailed information on acceptance criteria and a study proving device performance using those criteria, as the document focuses on regulatory approval for an updated component (ink) of a physical medical device, not a diagnostic AI/ML algorithm.
§ 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.