(77 days)
This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound system.
This device is indicated for performing planned and targeted ultrasound guided transrectal many I his device is indicated for performing plantive and with the Envisioneering TargetScan model TS-360-P probe.
The sterile TargetScan™ biopsy kit is designed to be used with the Targetscan™ Transrectal Ultrasound system. This kit includes a needle guide containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. This needle guide is the subject of a separate submission. The biopsy needle in this kit is specially designed to negotiate the curved needle guide. This needle is intended to be used with the Manan Pro-Mag Automatic Biopsy System (K980226). This biopsy kit is intended for use with the TargetScan™ transrectal probe Model #TS-360-P, which is the subject of a separate submission.
An anesthesia administration needle which can negotiate the curved needle guide and a latex probe cover are included in the kit as well.
The provided text describes the 510(k) summary for the TargetScan™ Biopsy kit (K041638). However, it does not contain detailed information about specific acceptance criteria or a comprehensive study proving the device meets stated acceptance criteria in the format requested.
The document primarily focuses on:
- Device Description: What the TargetScan™ Biopsy kit is, its components (needle guide, biopsy needle, anesthesia needle, probe cover), and how it's intended to be used with the TargetScan™ Transrectal Ultrasound system.
- Intended Use: For performing planned and targeted ultrasound-guided transrectal biopsies of the prostate in adult patients by medical professionals.
- Technological Characteristics Compared to Predicate Devices: It highlights that the subject device (biopsy needle) uses a nitinol stylet and polyolefin cannula to negotiate a curved biopsy guide, distinguishing it from the predicate's stainless steel stylet and cannula.
- Non-Clinical Performance Data (Bench Testing): It states that the biopsy needle advances 22mm, and can protrude up to 2cm, allowing for a total advance of 42mm. It also mentions a bench test using calves' liver where the subject needle achieved "comparable sample size lengths and weights" to the predicate needle.
Based on the provided text, here's what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Needle advance during actuation | 22mm (both predicate and subject device) |
| Needle protrusion beyond biopsy guide prior to firing | Up to 2cm |
| Total needle advancement capacity beyond disposable guide exit | As much as 42mm |
| Sample size length and weight in bench testing (compared to predicate) | Comparable to the predicate needle (Manan Biopsy needle K980122) in calves' liver |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing using calves' liver" but does not specify the sample size for this test set nor the data provenance (country of origin, retrospective/prospective).
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)
This information is not provided in the document. The bench test likely relied on objective measurements rather than expert reads for "sample size lengths and weights."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of a bench test comparing physical characteristics (sample length/weight), an adjudication method in the context of expert review would not be applicable.
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
No MRMC comparative effectiveness study was mentioned. The device is a biopsy kit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned, as the device is a physical biopsy kit and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench test, the "ground truth" was likely direct physical measurement of the sample size lengths and weights achieved from the calves' liver.
8. The sample size for the training set
This information is not applicable/provided, as this is a physical medical device and not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated above.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.