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The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal

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.

This document describes a 510(k) premarket notification for a Vascular Control Systems, Inc. Transvaginal Doppler Probe (K031358). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data for new claims. Therefore, the information regarding acceptance criteria and detailed study performance as typically found for novel devices with specific performance claims is limited.

However, based on the provided text, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific clinical "test set" in the context of efficacy or diagnostic performance. The testing mentioned (electrical, thermal, acoustic output) are non-clinical engineering and safety tests. Thus, this information is not applicable or provided for a clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the document does not describe a clinical study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a clinical study requiring adjudication for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, not a comparative clinical trial.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an algorithm, but rather a physical probe (transducer) that connects to a transceiver box. Therefore, the concept of "standalone algorithm performance" is not applicable. The device's performance is inherently linked to its use by a human operator with the transceiver.

7. The Type of Ground Truth Used

For the non-clinical tests (electrical, thermal, acoustic output), the "ground truth" would be established by physical measurements and adherence to international standards (IEC 60601-1) and FDA guidance documents for acoustic output.
For the substantial equivalence claim, the "ground truth" is the established characteristics and performance of the predicate device (K023024).

8. The Sample Size for the Training Set

This information is not applicable as this device does not involve a machine learning algorithm that requires a training set. The "training" here refers to manufacturing and design to meet specified engineering and safety standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above. The "ground truth" for manufacturing and design would be engineering specifications and regulatory standards.

Summary of Device and Evidence:

The Vascular Control Systems, Inc. Transvaginal Doppler Probe is an 8 MHz pulsed-wave Doppler sensor intended for bilateral detection of uterine blood vessels. Its 510(k) clearance was based on demonstrating substantial equivalence to its own previously cleared device (K023024).

The primary evidence presented for meeting "acceptance criteria" (though not explicitly framed as such with specific numerical targets in the summary) is:

• Compliance with IEC 60601-1 for electrical and thermal safety.
• Acoustic output measurements performed in accordance with FDA guidance, which implicitly met acceptable levels to ensure "reliable performance" and no "new issues of safety, effectiveness, or performance."
• Technological similarity to the predicate device, including the 8 MHz pulsed-wave Doppler sensor, distal crystal location, and stainless steel construction, which supports the claim of similar performance for the stated intended use.

The submission is a regulatory pathway for devices considered substantially equivalent, and therefore, it does not typically involve detailed clinical studies with specific performance metrics against clinical ground truth, expert adjudication, or MRMC studies for human reader improvement. The focus is on demonstrating that the new device is as safe and effective as a legally marketed one.

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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.

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