(86 days)
Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.
- . Prostate - Biopsy and minimally invasive puncture
- . Surgical (Prostate) - Biopsy and minimally invasive puncture
The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.
The FDA Summary for the TP Pivot Pro™ Needle Guide (K233109) does not include specific acceptance criteria or detailed study results in the format typically used for performance claims of diagnostic or AI-powered devices. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data like clinical trials.
The information provided describes non-clinical tests to ensure design functionality and biocompatibility. Here's a breakdown based on your request, with missing information noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Not Explicitly Stated as Numerical) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 requirements for limited contact duration. | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogen testing performed in accordance with ISO 10993. |
| Guide Tangential Clocking force testing | Guide adequately attaches to round probe such that it will not rotate. | Confirmed adequate attachment and no rotation in typical use. |
| Guide Axial Loading force testing | Guide adequately attaches to round probe such that it will not slide forward. | Confirmed adequate attachment and no sliding forward in typical use. |
| Guide Dislodge Force Test | Guide adequately attaches to round probe such that it will not dislodge under force. | Confirmed adequate attachment and no dislodgement under worst-case force. |
| Needle Holder Force (horizontal) Test | Force to dislodge needle holder from clamped horizontal position meets requirements. | Confirmed force to dislodge meets requirements at worst-case position. |
| Needle Holder Force (angled) Test | Force to dislodge needle holder from clamped, angled position meets requirements. | Confirmed force to dislodge meets requirements at worst-case position and approximately 20° angle. |
| Assemble/Removal Force with Neoguard Cover Test | Force required to assemble/remove guide with Neoguard cover meets requirements. | Tested force required; implicitly meets established requirements. |
| Guide Clamp Knob Torque Test | Guide not damaged when user applies torque to clamp knob. | Confirmed guide is not damaged with user-applied torque to clamp knob. |
| Extract/Insert Needle Holder in Tower Force | Force to extract/insert needle holder meets requirements. | Tested force to extract/insert, implicitly meets established requirements. |
| Introducer needle initial insertion force | Initial insertion force of introducer needle meets requirements. | Tested force, implicitly meets established requirements. |
| Introducer needle In and out of the needle holder force test | Force to move introducer needle meets requirements. | Tested force, implicitly meets established requirements. |
| Simulated Usability Testing | Design conforms to user needs and intended use. | Evaluations performed by customers to ensure conformity to user needs and intended use. |
| Guidance Standards | Complies with BS EN ISO 9626:1995. | Introducer needle evaluated and believed to comply with the standard. |
(Note: The acceptance criteria for the design specification tests are not quantified in this summary, but are described in terms of meeting established requirements for adequate function and integrity.)
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. The document mentions "Simulated use evaluations were performed by customers," but the number of customers/evaluations is not specified.
- Data Provenance: The biocompatibility tests are conducted in accordance with ISO standards, implying laboratory testing. The design specification tests and simulated usability testing are described as "tested internally" or "performed by customers," suggesting in-house and potentially external user tests, respectively. No information on country of origin for test data or whether it was retrospective/prospective is provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable / Not provided. The document describes non-clinical engineering and usability tests. There is no mention of "ground truth" in the clinical sense (e.g., disease diagnosis) or involvement of experts for establishing clinical ground truth for the performance evaluations described. The "customers" in simulated usability testing are users, not necessarily experts establishing ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. Since there is no clinical "ground truth" determination described, no adjudication method like 2+1 or 3+1 is relevant for the reported tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a mechanical needle guide, not an AI-powered diagnostic system or imaging device, so such a study comparing human reader performance with and without AI assistance is not relevant or described.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done. This device is a mechanical needle guide, not an algorithm or AI system.
7. Type of Ground Truth Used
- Not a clinical ground truth. For the biocompatibility tests, ground truth is based on established ISO standards. For the design specification tests, ground truth refers to the engineering requirements and functional specifications (e.g., "adequately attaches," "not damaged," "meets established requirements"). For simulated usability testing, ground truth is conformity to user needs.
8. Sample Size for the Training Set
- Not applicable / Not provided. This device is a mechanical device, not an AI or machine learning model, so there is no concept of a "training set" in the context of algorithm development.
9. How Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As there is no training set for an algorithm, there is no ground truth establishment for a training set.
§ 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.