(71 days)
Purpose: Performing ultrasound guided biopsies of the prostate.
Indications for Use: Performing ultrasound guided biopsies of the prostate
The biopsy guides are designed to be used with B-K Medical's ultrasound systems to guide needles for taking biopsies of the prostate and similar soft tissue. The biopsy guides are fixed to the ultrasonic probe, and provide a predetermined path for a biopsy needle. The biopsy guides are similar to previously used biopsy guides delivered non sterile. The new biopsy guides are delivered sterile.
This appears to be a 510(k) summary and FDA clearance letter for a medical device, specifically biopsy needle guides. This type of document is about regulatory clearance based on substantial equivalence to a predicate device, not typically a detailed study proving performance against acceptance criteria in the way an AI/software as a medical device (SaMD) study would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set, ground truth for training set) are not applicable to this type of submission. This submission primarily focuses on comparing the technological characteristics of the new device to a legally marketed predicate device to demonstrate substantial equivalence, particularly regarding a change in delivery (from non-sterile to sterile).
However, I can extract information related to the device's characteristics and intended use, and frame the "acceptance criteria" based on the comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description (Based on Predicate Device) | Reported Device Performance |
|---|---|---|
| Intended Use | Performing ultrasound-guided biopsies of the prostate. | The subject device performs ultrasound-guided biopsies of the prostate. |
| Target Organ | Prostate and similar soft tissue. | Designed for biopsies of the prostate and similar soft tissue. |
| Mechanism of Action | Fixed to ultrasonic probe, provides a predetermined path for a biopsy needle. | Functions by being fixed to the ultrasonic probe and providing a predetermined path for a biopsy needle. |
| Sterility | Not explicitly stated as a separate criterion for the predicate in this text, but the predicate was "delivered non sterile." | The new biopsy guides are "delivered sterile." (This is the primary difference and a key characteristic.) |
| Compatibility | Used with B-K Medical's ultrasound systems. | Compatible with B-K Medical's ultrasound systems. |
| Patient Population | Adult patients. | Intended for adult patients. |
| Environment of Use | Physician office or hospital environment. | For use by medical professionals in a physician office or hospital environment. |
| Technological Characteristics | Same major technological characteristics as the predicate device (e.g., materials, design, dimensions for guiding needles) with the exception of sterility. | The device maintains the "same major technological characteristics as the subject device" compared to the predicate, with the key difference being sterility. |
Study Proving Device Meets Acceptance Criteria:
The document describes a 510(k) premarket notification submission. The "study" in this context is a comparison of the subject device (new biopsy guides) to a legally marketed predicate device (Targetscan biopsy kit, Targetscan biopsy needle guide - K073399) to establish substantial equivalence.
The core of the "proof" is the declaration that: "The predicate device has the same major technological characteristics as the subject device, see comparison below." The only mentioned difference is that the new biopsy guides are delivered sterile, whereas the predicate was delivered non sterile. This sterility change would typically involve validation studies (e.g., sterilization validation) which are part of the overall submission but not detailed in this summary.
Further Requested Information (Not Applicable to this type of 510(k) Summary):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a substantial equivalence submission for a physical medical device, not an AI/SaMD performance study using a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth for image interpretation or diagnosis is not relevant to this device's regulatory review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not an AI/SaMD 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
- N/A. This device is a biopsy guide, not an AI/software product that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this submission is that the predicate device is legally marketed and safe/effective for its intended use, and the new device is functionally identical with an added sterility benefit.
8. The sample size for the training set
- N/A. Not an AI/SaMD.
9. How the ground truth for the training set was established
- N/A. Not an AI/SaMD.
§ 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.