(62 days)
Accessory-Needle Guides used for Vaginal Ultrasound Transducers for performing Vaginal Biopsies.
A tube, a cannula that is an accessory that snaps or rests(depending on configuration) onto an ultrasound transducer(884.2960)
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
The provided document is a 510(k) premarket notification for a Transvaginal Needle Guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data to prove novel safety and effectiveness. Therefore, the information typically found in a study proving acceptance criteria for a new medical device (like detailed performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies) is largely absent.
Instead, the document highlights that the new device (PROTEK Medical Products Inc.'s Transvaginal Needle Guide) is "substantially equivalent" to existing, legally marketed devices, primarily those by Civco Medical Instruments and Amedic. The equivalence is based on similar design, materials, manufacturing, intended use, and performance claims rather than a new clinical study.
Here's an analysis based on the information provided, explicitly noting what is not available as it's not typically required for a 510(k) of this nature:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Indications for use | "Ultrasound transducer needle guide (accessory)" |
| Target Population | "Doctors" |
| Design | "Sizes & Shapes Varies" (similar to predicate) |
| Materials | "Stainless steel, Medical grade plastic" |
| Performance | "Target fixtures, Mil Std 105E" (same as predicate) |
| Sterility | "ETO" (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" (similar to predicate) |
| Packaging | "TYVEK 'Chevron Peel Pouch'" (similar to predicate) |
| Human Factor | "No Known Adverse Effects" (same as predicate) |
Explanation: The "acceptance criteria" for this 510(k) submission are implicitly defined by the characteristics and performance of the predicate devices. The "reported device performance" is essentially a claim of identical or highly similar characteristics and performance to these predicates. The document explicitly states: "These new devices are the same as devices being legally marketed by several companies." and "The new devices design, manufacturing, labeling and its intended uses are the same as many existing devices currently being marketed by Civco Medical Instruments, and Amedic among others."
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided: The document does not describe a new clinical "test set" or study in the traditional sense with specific sample sizes. The claim of equivalence is based on the known performance and design of predicate devices already on the market. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a new study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: No new clinical test set is described, so there's no mention of experts establishing a ground truth for such a set. The "ground truth" for the device's functionality is assumed to be established by the long-standing use and acceptance of the predicate devices in clinical practice. The document does mention "Doctor" as a designer for both the new and predicate devices, implying clinical input in the initial design of similar devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: No new clinical test set is described, so no adjudication method is mentioned.
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:
- Not Applicable / Not Provided: This device is a mechanical needle guide accessory for ultrasound transducers, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness data is irrelevant and not provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided: This is a mechanical device, not an algorithm. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Ground Truth: The ground truth is implicitly based on the established safety and efficacy of the predicate devices in clinical use, which would have been validated through their own historical regulatory pathways, including clinical experience and potentially outcomes data over time (though not explicitly detailed in this document for those devices). For the PROTEK device, the ground truth is that it performs "the same" as these predicate devices.
8. The sample size for the training set:
- Not Applicable / Not Provided: As this is a mechanical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: See point 8.
In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence to predicate devices already on the market. It does not present novel study data to prove the device meets acceptance criteria because the criteria are based on the established performance of its legally marketed counterparts. The safety and effectiveness are argued to be the same due to similar design, materials, intended use, and manufacturing processes.
§ 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.