(133 days)
This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers.
- Transvaginal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy fluid aspiration, catheter placement, treatment, and oocyte retrieval.
- Transrectal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.
The disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.
The provided text describes a 510(k) summary for the VitroPRO, a disposable endocavity needle guide. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria based on human-in-the-loop and algorithm-only performance metrics typical for AI/ML devices. Therefore, much of the requested information regarding AI/ML study design, such as MRMC studies, effect sizes, training set details, and ground truth establishment methods for AI, is not applicable or present in this specific document, as the VitroPRO is a mechanical device, not an AI/ML diagnostic tool.
However, based on the information provided, here's what can be extracted and presented to align with the prompt, focusing on the available non-clinical test data which serves as the "study" proving the device meets its "acceptance criteria" for substantial equivalence.
Device Name: VitroPRO / Disposable Endocavity Needle Guide (K222052)
Device Type: Mechanical Accessory (Needle Guide), not an AI/ML diagnostic device.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are implicitly tied to demonstrating the same safety and effectiveness as the predicate device, K970514, through non-clinical performance testing. The "reported device performance" refers to the results of these non-clinical tests.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Implied from testing purpose) | Reported Device Performance (Test Results) |
|---|---|
| Biocompatibility: Device materials meet ISO 10993-1 requirements for specified contact duration with human tissue. | All materials met ISO 10993-1 biocompatibility requirements. |
- Cytotoxicity (ISO 10993-5): Met.
- Sensitization (ISO 10993-10): Met.
- Irritation (ISO 10993-10): Met.
(Note: "Not labeled non-pyrogenic" compared to predicate's "non-pyrogenic" but deemed not to affect safety/effectiveness given the application). |
| Cover Breach and Probe Damage: Device attachment to ultrasound cover/probe does not cause damage. | Water leak testing demonstrated material attachment of needle guide to cover did not cause damage to cover or probe. |
| Retention and Movement: Minimum force required to dislodge the guide from the transducer. | Force testing demonstrated a minimum force of 8N would not cause the guide to dislodge. |
| Needle Drag: Force required to pass a cannula through the guide is below a specified threshold, preventing binding. | Force testing demonstrated binding would not occur and force was less than a 1.5N threshold. |
| Needle Path Verification: Needle path falls within design tolerances. | Needle guides were tested on test fixtures to ensure needle path falls within the design tolerances specified for the design. |
| Usability: Design conforms to user needs and intended use. | Simulated use evaluations were performed by customers to ensure the design of the needle guide conforms to the user needs and intended use. (Details on specific metrics or acceptance thresholds for usability are not provided beyond general conformance). |
Study Details (Non-Clinical Performance Testing)
Given that this is a mechanical device submission, the "study" refers to non-clinical performance testing rather than clinical trials or AI/ML specific studies.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a numerical 'sample size' in the context of distinct cases or images like an AI dataset. Instead, the tests involved physical samples of the VitroPRO device and its components. For instance:
- Biocompatibility: Samples of materials used in the device.
- Cover breach/probe damage, Retention/movement, Needle drag, Needle path verification: Likely multiple physical units of the device tested under controlled conditions.
- Data Provenance: The data comes from internal non-clinical performance testing conducted by CIVCO Medical Instruments Co., Inc. The country of origin of the data would be the US, as the company is based in Kalona, IA. The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate performance.
- Sample Size: Not explicitly stated as a numerical 'sample size' in the context of distinct cases or images like an AI dataset. Instead, the tests involved physical samples of the VitroPRO device and its components. For instance:
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable in the context of establishing "ground truth" for diagnostic interpretation in the way it is used for AI/ML or image analysis. These tests are engineering performance validations, where "ground truth" is established by physical measurement standards and engineering specifications rather than expert interpretation of medical data.
- For "Simulated Usability Testing," it states "customers" performed evaluations. The number and specific qualifications (beyond being target users/clinicians) are not detailed.
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Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements among human reviewers (e.g., radiologists) in diagnostic studies, especially for establishing ground truth from image interpretations. For mechanical performance testing, results are typically objective measurements against predefined engineering specifications.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. As the VitroPRO is a mechanical needle guide and not an AI/ML diagnostic tool, an MRMC study is not relevant or required for its clearance.
- Therefore, there is no effect size reported for human readers improving with or without AI assistance.
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If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No, a standalone assessment was not done. This type of assessment is for AI/ML algorithms operating independently. The VitroPRO is a mechanical device, not an algorithm.
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The Type of Ground Truth Used:
- For the non-clinical performance tests, "ground truth" refers to engineering specifications, physical measurements, and well-defined pass/fail criteria established through standard testing methodologies (e.g., ISO, internal engineering standards).
- For Biocompatibility: Adherence to ISO 10993 standards and a "bio-response" indicating safety.
- For Mechanical Tests (e.g., Retention, Needle Drag, Needle Path): Measured forces, paths, or absence of damage against predefined numerical thresholds and design specifications.
- For Usability: User feedback and confirmation that the design meets user needs, although specific metrics are not detailed.
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The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
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How the Ground Truth for the Training Set was Established:
- Not applicable. There is no "training set."
In summary, the provided document is a 510(k) summary for a mechanical medical device, not an AI/ML-driven diagnostic tool. Therefore, the "acceptance criteria" and "study" are defined by non-clinical engineering and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device, rather than the complex clinical or artificial intelligence performance metrics often associated with AI/ML systems.
§ 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.