(49 days)
The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission:
| MODEL | INTENDED USE |
|---|---|
| Ultra-Pro II™ Needle Guides | The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. |
| Ultra-Pro 3™ Needle Guides | |
| AccuSITE Transverse Needle Guides | |
| Infiniti™ Needle Guides | |
| Multi-Pro 2000™ Needle Guides | |
| MAGGI II Plus™ Needle Guides |
The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. The guide facilitates directing the device to a target to improve accuracy and repeatability.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided information, the 510(k) summary for the "Ultrasound General Purpose Guidance System" (K093713) does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantitative performance metrics like accuracy, precision, or sensitivity/specificity.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The primary "acceptance criteria" and "reported device performance" can be inferred as:
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence and Verification) |
|---|---|
| Equivalent Intended Use: The device must have the same intended use as legally marketed predicate devices. | The proposed devices (Ultra-Pro II™, Ultra-Pro 3™, AccuSITE Transverse, Infiniti™, Multi-Pro 2000™, MAGGI II Plus™ Needle Guides) have the same intended use: guiding instruments into targeted anatomical locations for percutaneous procedures using diagnostic ultrasound transducers. This is equivalent to the predicate devices (K882383, K071204, K030064). |
| Equivalent Manufacturing Materials: The device must be constructed from materials similar to predicate devices, ensuring comparable safety and efficacy. | "Equivalent... manufacturing materials" is claimed. No specific material details are provided in this summary. |
| Equivalent Operating Principles: The fundamental mechanism by which the device functions must be the same as predicate devices. | "Equivalent... operating principles" is claimed. The description indicates it provides a tool for performing needle-guided procedures, which aligns with the function of similar guides. |
| Equivalent Physical Operational Specifications: The physical characteristics and performance limits of the device must be comparable to predicate devices. | "Equivalent... physical operational specifications" is claimed. |
| Meets Specified Tolerances and Works in Conjunction with Designed Adapter Clip Area: The device must fit and function correctly with its intended adaptors, and operate within design tolerances. (This is the only explicitly mentioned "verification" item, suggesting it's an internal acceptance criterion for manufacturing and design.) | "Verification was performed to ensure that device meets specified tolerances and works in conjunction with specifically designed adapter clip area." |
| Differences have no effect on safety and effectiveness: Any minor differences from predicate devices must not negatively impact the safety or effectiveness of the device. | "These differences have no effect on safety and effectiveness" is stated after a comparison matrix (not included in the provided text). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention any specific sample size for a test set or the provenance of data (e.g., country of origin, retrospective/prospective). This submission is based on a demonstration of substantial equivalence, which often relies on demonstrating that the new device operates similarly to existing, cleared devices, rather than conducting new clinical trials with patient data. The "Performance Testing" section mentions "Verification was performed to ensure that device meets specified tolerances and works in conjunction with specifically designed adapter clip area," but this is a technical/engineering verification, not a clinical study on a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no clinical test set is explicitly described in the provided text, there is no information about the number of experts or their qualifications used to establish a ground truth.
4. Adjudication Method for the Test Set
As no clinical test set is described, there is no information about an adjudication method.
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 done as this device (Ultrasound General Purpose Guidance System / Needle Guides) is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No standalone algorithm performance study was done. This device is a physical needle guide, not a standalone algorithm.
7. The type of ground truth used
For the engineering/technical verification mentioned ("meets specified tolerances and works in conjunction with specifically designed adapter clip area"), the "ground truth" would be the design specifications and engineering measurements. For the clinical use, the "ground truth" for predicate devices would have been established through prior clinical experience and regulatory clearances that confirmed their safety and effectiveness in guiding instruments.
8. The Sample Size for the Training Set
There is no mention of a training set sample size. This submission is for a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI algorithm, the concept of establishing ground truth for a training set is not applicable.
§ 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.