(90 days)
The BIP VacuFlash® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument 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 BIP VacuFlash® Biopsy System is a mechanical device that may be used with imaging quidance (such as ultrasound, X-Ray, stereotaxy, CT, or MR) to provide breast tissue samples for histologic examination with partial or complete removal of the imaged abnormality.
The VacuFlash® Biopsy System consists of three major components: a disposable trocar tipped needle with a vacuum cylinder, a disposable introducer with stylette, and a reusable device housing containing the control module, touch pad with control buttons and LEDs indicating device status, and vacuum/air pressure generators. The disposable needle/vacuum cylinder will be available in several different lengths. A battery recharger/table top stand is the only provided accessory. Mounting brackets to attach the VacuFlash® Biopsy System to the Fischer Mammotest® and to the Lorad stereotactic tables are optional accessories. In addition, brackets to attaché the VacuFlash to the Siemens stereotactic mammography and to the Siemens MR Mammography Biopsy systems are available. Sterile bushings for the above devices, including CytoGuide stereotactic and GE DMR Mammography systems are also available.
The needle inner cannula incorporates a distal sampling with sharpened edges. During the biopsy procedure, tissue is vacuum aspirated into the inner cannula and cut using both the sampling window edges and the rotating edge of the outer cannula. Once the needle is removed from the patient's body, the sampling window is opened and the specimen removed. Tissue samples may be collected in radial order so that when imaging guidance is used, sampling positions may be retrospectively correlated with the imaging display.
This document, a 510(k) Summary of Safety and Effectiveness for the VacuFlash® Biopsy System, does not describe specific acceptance criteria and a study proving the device meets those criteria in a quantitative manner as would typically be found for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through qualitative statements and preclinical testing.
Here's an analysis based on the provided text, highlighting what is and is not present:
Missing Information (Typical for AI/ML device studies):
- Specific performance metrics (e.g., sensitivity, specificity, accuracy, AUC).
- Quantitative acceptance criteria for those metrics.
- Detailed study design, including a defined test set sample size with associated data provenance.
- Information on ground truth establishment for the test set (number/qualifications of experts, adjudication methods).
- Any mention of AI, machine learning, or algorithms.
- Multi-reader multi-case (MRMC) comparative effectiveness study or standalone performance study in the context of AI.
- Sample size or ground truth establishment for a training set (as this is not an AI device).
Analysis of the Provided Text (in the context of a non-AI medical device submission):
The submission for the VacuFlash® Biopsy System is a 510(k) Pre-Market Notification, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices. For mechanical devices like this, detailed performance metrics against specific acceptance criteria (as you might expect for AI) are often replaced by comparisons of intended use, technological characteristics, and qualitative performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a table of quantitative acceptance criteria. Instead, it relies on a qualitative statement of performance relative to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as intended for breast tissue biopsy. | "Preclinical testing demonstrated satisfactory performance in breast tissue biopsy." |
| Quality of samples obtained is equivalent to predicate devices. | "Preclinical testing confirms the quality of samples obtained with the BIP VacuFlash® Biopsy System is equivalent to those obtained with the predicate devices." |
| Does not raise significant new questions of safety and effectiveness. | "Based on the indications for use, technological characteristics and testing results, the BIP VacuFlash® Biopsy System does not raise significant new questions of safety and effectiveness." |
| Equivalent to predicate devices in intended use and technological characteristics. | The document explicitly states: "The BIP VacuFlash® Biopsy System has similar indications for use and technological characteristics as the predicate devices. The patient contact components and component materials for obtaining core biopsy samples in both the new and predicate devices are equivalent. The packaging materials, packaging configuration, sterilization methods and sterility assurance level are also equivalent." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated. The document refers to "Preclinical testing" but does not give a number of cases or samples.
- Data provenance: Not specified. It's implied to be preclinical data, likely from an in-vitro or ex-vivo setting, rather than patient data. No country of origin is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Since it's a mechanical device and not an AI interpreting images, this type of ground truth establishment by experts is not described. The "quality of samples" likely refers to histological evaluation, which would implicitly involve pathologists, but details are absent.
4. Adjudication method for the test set:
- Not applicable/Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this type of study is not mentioned. This is a mechanical biopsy device, not an image analysis or diagnostic AI tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, an algorithm is not involved in this device.
7. The type of ground truth used:
- The "quality of samples" likely refers to histologic examination of tissue samples obtained by the device. This would be the "ground truth" for assessing the device's ability to acquire sufficient and high-quality tissue. The statement "Preclinical testing confirms the quality of samples obtained with the BIP VacuFlash® Biopsy System is equivalent to those obtained with the predicate devices" supports this inference.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set in the typical sense.
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.