(15 days)
The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.
The Transvaginal Doppler Probe is a ring-handled instrument with integrated Doppler sensors, which allow for bilateral blood flow sensing of the uterine blood vessels by connecting to a commercially available portable transceiver box. The Transvaginal Doppler Probe is manufactured from stainless steel.
The provided document for K023024, "Vascular Control Systems, Inc. Transvaginal Doppler Probe," is a 510(k) premarket notification. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies.
Therefore, the document does not contain information on:
- Acceptance criteria and reported device performance in a table. No specific quantitative performance metrics or acceptance thresholds are provided.
- A study proving the device meets acceptance criteria. The document references nonclinical tests for electrical, thermal, and acoustic safety, but not a study demonstrating clinical performance or meeting specific acceptance criteria.
- Sample size used for the test set or data provenance. No test set for clinical performance is described.
- Number of experts used to establish ground truth or their qualifications. Ground truth for clinical performance is not discussed.
- Adjudication method for the test set. No test set or adjudication process is mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is not mentioned.
- Standalone (algorithm only) performance. This device is a probe, not an algorithm.
- Type of ground truth used. No ground truth for clinical performance is mentioned.
- Sample size for the training set. No training set for an algorithm is applicable.
- How the ground truth for the training set was established. Not applicable.
What the document does include regarding performance:
The document states under "Brief summary of nonclinical tests and results" (Section 7 from {1}) that:
- The Transvaginal Doppler Probe was "designed and tested to comply with the requirements of IEC 60601-1 for electrical and thermal safety."
- "Acoustic output power measurements were performed in accordance with the FDA Guidance document 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'."
- "Test results indicate reliable performance when the device is used in accordance with the Instructions for Use."
- "The Transvaginal Doppler Probe does not raise new issues of safety, effectiveness, or performance of the product."
In the FDA's clearance letter ( {3} and {4}), there's a condition for clearance:
- "This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a post clearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.' If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded."
This indicates that while initial acoustic output measurements were submitted, further confirmation from production units was required post-clearance. The "unacceptable values" here refer to regulatory limits for acoustic output, not clinical performance acceptance criteria in the sense of a diagnostic accuracy study.
In summary, the 510(k) submission for the Vascular Control Systems, Inc. Transvaginal Doppler Probe relies on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and nonclinical safety testing, rather than presenting a clinical study with specific acceptance criteria and performance metrics.
§ 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.