(151 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 quided 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 VitroPRO 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 FDA 510(k) summary for the VitroPRO device (K231783) outlines the acceptance criteria and the study performed to demonstrate the device meets these criteria, specifically in relation to the added indication for oocyte retrieval.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Mouse Embryo Assay (MEA) | ≥80% embryos expanded to blastocyst at 96 hours | Met acceptance threshold requirements and showed passing results |
| Limulus Amebocyte Lysate (LAL) | ≤ 20 EU/device | Met acceptance threshold requirements and showed passing results |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the MEA and LAL tests. For the MEA, it mentions "One-cell mouse embryos" were incubated, implying a certain number of embryos were used, but the precise count is not provided. For LAL, it refers to "EU/device," meaning a certain number of devices were tested, but the exact quantity is not stated.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a premarket notification for an FDA submission, the studies would typically be prospective and conducted under controlled laboratory conditions to demonstrate safety and effectiveness for regulatory clearance in the US.
3. Number of Experts and Qualifications for Ground Truth:
- This device is a medical instrument (needle guide) and not an AI or diagnostic imaging device that requires interpretation by human experts (e.g., radiologists) for ground truth establishment.
- The ground truth for the performance tests (MEA and LAL) is established through standardized laboratory assays with objective, measurable endpoints (e.g., percentage of blastocyst development, endotoxin units). Therefore, no "experts" in the sense of clinical reviewers (like radiologists) were utilized to establish ground truth for this type of testing.
4. Adjudication Method:
- Not applicable as the tests are laboratory-based assays with objective measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This device is a passive medical instrument (needle guide) and not a diagnostic imaging or AI-powered device that aids human interpretation, which would typically necessitate an MRMC study to evaluate improved reader performance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Not applicable. This is not an algorithm or AI device. The tests performed (MEA and LAL) evaluate the biological safety and pyrogenicity of the device material, which are inherent properties of the device itself.
7. Type of Ground Truth Used:
- The ground truth used is based on objective laboratory assay results against predefined biological and chemical thresholds.
- For MEA: The objective metric is the percentage of embryos developed to the expanded blastocyst stage, compared to a control group.
- For LAL: The objective metric is the endotoxin units (EU) per device.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
In summary, the VitroPRO device demonstrates its safety and effectiveness for the expanded indication of oocyte retrieval through established biological and chemical material compatibility tests (MEA and LAL), rather than clinical performance studies involving human readers or AI algorithms. The acceptance criteria are objective thresholds for these laboratory tests.
§ 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.