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This product will be used to detect fetal heart tones transvaginally as an aid for determining fetal viability.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal (N= new indication)

The EchoHeart Transvaginal Doppler is an interchangeable transvaginal Doppler probe used with the handheld LifeDop Doppler System. It is designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient - such as early gestations. obese patients and retroverted uterine positions.

The provided text is a 510(k) premarket notification for the Summit Doppler Systems, Inc. EchoHeart Transvaginal Doppler. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study with acceptance criteria and device performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test/training sets, number and qualifications of experts, adjudication method, MRMC study, standalone performance, ground truth types, and how ground truth was established) cannot be fully populated as they are not explicitly present in the provided document.

However, I can extract information related to the device's intended use and the basis for its clearance.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, formal acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) are not provided in the document. The "acceptance criteria" here is implicitly assumed to be "substantial equivalence" to predicate devices, meaning it performs as well as or better than the predicate for its intended use without raising new questions of safety or effectiveness.

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

The provided document does not describe a specific clinical test set (i.e., a study involving human subjects or data collected specifically to test the performance of the EchoHeart Transvaginal Doppler against a defined ground truth). The clearance is based on substantial equivalence, which primarily relies on comparing the new device's features and technological principles to existing, legally marketed devices.

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

Not applicable, as no specific test set requiring expert ground truth establishment is described in the document for the EchoHeart Transvaginal Doppler.

4. Adjudication Method for the Test Set

Not applicable, as no specific test set requiring adjudication is described.

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

Not applicable. The device is a transvaginal Doppler probe, not an AI-powered diagnostic system. No MRMC study is mentioned.

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

Not applicable. The device is a hardware probe used by a human practitioner. It is not an algorithm evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the purpose of this 510(k) submission, the "ground truth" for demonstrating the device's functionality and safety is implicitly tied to the established safety and effectiveness of the predicate devices it is compared against. There is no specific, independent ground truth described as being used for a novel study of the EchoHeart probe itself.

8. The Sample Size for the Training Set

Not applicable, as this is a hardware device (Doppler probe) and not an AI/machine learning algorithm that would require a "training set."

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

Not applicable for the same reason as above.

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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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