(78 days)
Used to assist doctors when performing a prostate biopsy. Used to guide a needle, biopsy or catheter into the prostate gland. Used as an accessory in conjunction with an ultrasound transducer (892.1570). Used to improve needle placement vs. guiding needle with the finger. Needle Guides for Rectal Ultrasound Transducers used in prostate biopsies.
A tube, a cannula that is an accessory that snaps or rests (depending on configuration) onto an ultrasound transducer (892.1570). A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system. A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers.
This document describes the Premarket Notification (510(k)) for a Transrectal Needle Guide, an accessory for ultrasound transducers. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study to prove acceptance criteria through performance metrics.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical performance targets and reported device performance data in the way one might expect for a diagnostic or therapeutic device with measurable outcomes (e.g., sensitivity, specificity, accuracy).
Instead, the "acceptance criteria" are implied by the Substantial Equivalence Comparison Chart (Appendix D), which compares the new device (PROTEK Medical Products Inc.) with a predicate device (Civco Medical K875128/A) across various characteristics to demonstrate that the new device is as safe and effective as the predicate.
Here's a re-interpretation of the Appendix D chart in the context of "acceptance criteria" through substantial equivalence:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Indications for use (Ultrasound transducer needle guide) | Same as predicate |
| Target Population (Doctor's) | Same as predicate |
| Designed by (OEM, Doctor, PROTEK/Civco) | Similar (OEM, Doctor, PROTEK) |
| Design (Sizes & Shapes Varies) | Similar (Sizes & Shapes Varies) |
| Materials (Stainless steel, Medical grade plastic) | Same as predicate |
| Performance (Target fixtures, Mil Std 105E) | Same as predicate (Refers to manufacturing and quality standards, not clinical performance) |
| Sterility (ETO) | Same as predicate |
| Biocompatibility (ISO-10993) | Same as predicate |
| Mechanical Safety (end product tests) | Same as predicate |
| Chemical Safety (No Hazardous Components, 29CFR 1910,1200) | Same as predicate |
| Anatomical Sites (Where Ultrasound is Used) | Same as predicate |
| Disposition (Disposable) | Same as predicate |
| Where Used (Hospitals & Clinics) | Same as predicate |
| Standards Met (Mil Std 105E on voluntary standards) | Same as predicate |
| Electrical Safety (No Electrical Components) | Same as predicate |
| Manufacturing Method (Injection molded clips and purchased surgical tube) | Same as predicate |
| Packaging (TYVEK "Chevron Peel Pouch") | Same as predicate |
| Human Factor (No Known Adverse Effects) | Same as predicate |
Key takeaway: This 510(k) relies on demonstrating that the new device is the same as or very similar to existing, legally marketed devices, rather than providing novel performance data against specific, quantitative acceptance criteria via a clinical study. The "study" here is primarily a comparison analysis against predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the traditional sense of a dataset used for clinical evaluation of a device's performance (e.g., images for an AI algorithm, patient outcomes). The "study" is a comparison against predicate devices.
- Sample Size for Test Set: Not applicable/not provided for clinical performance
- Data Provenance: Not applicable/not provided for clinical performance. The comparison is based on the specifications, design, materials, and intended use of existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the clinical performance sense (e.g., confirmed disease status) is not established or used in this submission. The "ground truth" for the comparison is the established characteristics and regulatory status of the predicate devices. The "experts" involved are the device manufacturers and potentially regulatory bodies who approved the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (MRMC) is typically performed for diagnostic devices (e.g., imaging software) to assess the impact of AI assistance on human reader performance. The device in question is a simple mechanical accessory (needle guide), not a diagnostic algorithm.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
No. The device is a physical accessory and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the new device's characteristics are substantially equivalent to these predicates, it shares the same safety and effectiveness profile.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is described.
Summary of the "Study" and "Acceptance Criteria" for K971115:
For this 510(k) submission, the "study" is primarily a comparison analysis against well-established, legally marketed predicate devices. The "acceptance criteria" are met by demonstrating substantial equivalence in terms of:
- Intended Use: The device shares the same intended use as the predicate (guiding needles/catheters in conjunction with ultrasound for prostate biopsies).
- Technological Characteristics: The device is made of similar materials (stainless steel, medical grade plastic), manufactured using similar methods, and designed to meet similar fundamental quality and safety standards (e.g., sterilization, biocompatibility, mechanical safety as confirmed by "end product tests" which are not detailed but are assumed to be similar to the predicate's). The only stated deviation is in "size and shape," which is considered a minor modification that doesn't alter the fundamental safety or effectiveness.
- Performance: The document mentions "Performance: Target fixtures, Mil Std 105E." This refers to manufacturing quality control standards and the ability to accurately guide a needle to a target, presumably demonstrated through standard manufacturing and design verification activities, rather than a clinical outcome study. The reference to "Mil Std 105E" implies statistical sampling plans for inspection, typical for manufacturing acceptance.
The FDA's decision (Section 4) of "substantial equivalence" confirms that the device meets the regulatory acceptance criteria by demonstrating it is as safe and effective as devices already on the market, without requiring new clinical performance data.
§ 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.