(379 days)
Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use. To be used with Percutaneous Breast Biopsy Instrument Accessories (Instrument Holder, Needle Holder, and Stop), which are attached to a stereotactic table and used in conjunction with stereotactic mammographic imaging systems.
The PBB, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These similar devices are marketed by United States Surgical Corporation (USSC), C.R. Bard, and Biopsys Medical. PBB, USSC, C.R. Bard and Biopsys devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are all used with stereotactic mammographic imaging systems. The PBB device is like the C.R. Bard and Biopsys devices in that they all remove a localized biopsy. These devices obturate up to the lesion, leaving intact the tissue in route to the target area. The PBB Instrument Accessories (Instrument Holder, and Stop) are similar to the instrument holding devices marketed by USSC, Biopsys, and C.R. Bard Magnum devices in that they are all reusable devices. All of these devices are used to mount their biopsy instrument on stereotactic tables. The PBB and similar devices on the market have components that are of similar materials that are well known and extensively used by device manufacturers. Materials which have patient contact consist of surgical stainless steel and thermoplastics. The PBB device is available with and without electrosurgery capability. The PBB device with electrosurgery capability and the USSC ABBI device both have monopolar electrosurgical capability. Both are equipped with a 4mm male plug to allow their use with standard monopolar electrosurgical generators.
The provided text describes a 510(k) premarket notification for a Percutaneous Breast Biopsy (PBB) device, indicating its substantial equivalence to existing devices. As such, it does not contain information about a study to prove the device meets specific acceptance criteria in the comprehensive manner you requested.
The document focuses on establishing substantial equivalence based on:
- Similar intended use: obtaining biopsies within breast tissue.
- Similar technology/design: used with stereotactic tables, removes localized biopsies, obturates up to the lesion.
- Similar materials: surgical stainless steel and thermoplastics with biocompatibility testing planned.
- Similar electrosurgery capability (if applicable): comparable to USSC ABBI device, complying with ANSI/AAMI standards.
- Similar sterilization method: complying with ANSI/AAMI/ISO 11135-1994.
Therefore, I cannot fill out the requested table and answer many of your questions as the document does not present a performance study with specific acceptance criteria, sample sizes, expert involvement, or ground truth details.
Here's what can be inferred or explicitly stated from the provided text regarding regulatory compliance rather than performance study results:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Criteria (Based on Regulatory Compliance) |
|---|---|
| Intended Use | Diagnostic device used to obtain localized biopsies within breast tissue. For diagnostic purposes only, not therapeutic use. To be used with PBB Instrument Accessories, attached to a stereotactic table, and in conjunction with stereotactic mammographic imaging systems. |
| Substantial Equivalence | Device determined to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, or reclassified devices. This implies similarity in safety and effectiveness. |
| Biocompatibility | Compliant with ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Testing to include Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity. (Planned, not reported as completed in this summary). Device categorized as Body Contact - Tissue/Bone/Dentin Communicating for a limited duration (≤ 24 hours). |
| Electrosurgical Safety | For devices with electrosurgery capability, compliance with applicable safety, performance, and labeling requirements of ANSI/AAMI ES1-1993 (Safe current limits for electromedical apparatus) and ANSI/AAMI HF18-1993 (Electrosurgical devices). (Stated as compliant, implies meeting these standards for performance and safety). |
| Sterilization | Compliance with ANSI/AAMI/ISO 11135-1994 Medical Devices - Validation and routine control of ethylene oxide sterilization. (Stated as compliant, implies the method and validation meet the standard). |
| Manufacturing Practice | Assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820). This is an ongoing regulatory requirement. |
Reported Device Performance: The document does not report specific quantitative performance metrics such as accuracy, sensitivity, specificity, or successful biopsy rates. It states that the device is "substantially equivalent to like devices in commercial distribution," implying that its performance is expected to be similar to its predicates.
2. Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a clinical performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a clinical performance study.
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-assisted diagnostic tool for image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a performance study for the device itself based on the provided text. The "ground truth" here relies on the established safety and effectiveness of predicate devices and compliance with relevant standards.
8. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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.