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510(k) Data Aggregation
(105 days)
Deltex Medical KDP72 Doppler Probe
The probe is for use with the Deltex Medical CardioQ-EDM and CardioQ-EDM+ for Monitoring of cardiac output and fluid status. The probe is only approved for oral placement into the esophagus of a single anesthetized patient 15 years of age or younger, 50cm (20") to 170cm (67") in height.
The Deltex Medical Ltd KDP72 Pediatric Doppler Probe is an oral extravascular blood flow probe designed to work with the CardioQ-EDM and CardioQ-EDM+ Systems (K111542 and K132139 respectively). It consists of a shaft, which is a spring reinforced silicone tube, with an electrical connector on the machine end and an ultrasonic transmitting and receiving tip on the patient end. The tip is fully covered and sealed to the shaft with a silicone rubber boot and by wires running through the shaft to the connector. Visual product identification is provided at the machine end and the device is provided single packed sterile for single patient use.
The provided document is a 510(k) summary for the Deltex Medical KDP72 Doppler Probe, asserting its substantial equivalence to previously cleared devices. It describes the device, its intended use, and performance data related to its design and safety standards, but does not contain information about a study proving the device meets specific acceptance criteria related to its clinical performance as a diagnostic tool for cardiac output and fluid status.
The "Performance Data" section briefly mentions:
- "The performance data recommended in 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,' issued on September 9, 2008, has been included." This suggests that general requirements for diagnostic ultrasound devices were addressed, likely related to acoustic output and image quality, not the accuracy of cardiac output measurements.
- "Additionally a flexibility test has been conducted on the subject and predicate devices which demonstrates the comparative flexibility." This is a mechanical performance test, not a clinical diagnostic performance study.
Therefore, many of the requested categories for acceptance criteria and a study to prove they are met cannot be extracted from this document, as the document focuses on demonstrating substantial equivalence based on design, materials, sterilization, biocompatibility, and electrical safety standards rather than clinical diagnostic accuracy.
However, based on the provided text, here’s what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (KDP72 Doppler Probe) |
|---|---|---|
| Sterilization | Sterilized in accordance with ISO 11135-1 (version of standard current at time of submission). | Meets ISO 11135-1 (version current at submission). |
| Shelf Life | Meets ISO 11607-1 (version of standard current at time of submission). | Meets ISO 11607-1 (version current at submission). |
| Biocompatibility | Tested in accordance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization), ISO 10993-7 (Ethylene Oxide Sterilization Residuals) (version of standard current at time of submission). Note: ISO 10993-7 is about ETO residuals, not a direct biocompatibility test type, but often included for ETO sterilized devices. | Meets ISO 10993-5, ISO 10993-10, ISO 10993-7 (versions current at submission). |
| EMC and Electrical Safety | Meets IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests), IEC 60601-2-37 (Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) (version of standard current at time of submission). | Meets IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37 (versions current at submission). |
| Packaging | Meets ISO 11607-1 (Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems), ISO 11607-2 (Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes) (version of standard current at time of submission). | Meets ISO 11607-1, ISO 11607-2 (versions current at submission). |
| Flexibility | Demonstrates comparative flexibility to predicate devices. (No specific quantitative acceptance criterion stated). | Flexibility test conducted; demonstrates comparative flexibility. |
| Diagnostic Ultrasound Performance Data | Based on "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", issued on September 9, 2008. (Likely relates to acoustic output, measurement accuracy of general ultrasound parameters, not necessarily cardiac output accuracy specifically). | "Included" (no specific results provided). |
2. Sample size used for the test set and the data provenance:
Not specified in the document for any clinical performance or diagnostic accuracy study. The document mentions a flexibility test, but details on sample size or provenance are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/not specified. The document does not describe a study involving expert-established ground truth for clinical diagnostic performance.
4. Adjudication method for the test set:
Not applicable/not specified.
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. This device is a probe for a cardiac output monitor, not an AI-assisted diagnostic imaging system that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not specified. The document refers to "performance data recommended in 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'" but does not detail what kind of study was performed or if it was standalone. The device is a probe to be used with a monitoring system, implying a system performance, not a standalone algorithm.
7. The type of ground truth used:
Not specified for diagnostic accuracy. For the engineering criteria (sterilization, biocompatibility, etc.), the ground truth is established by adherence to the respective international standards (e.g., ISO, IEC).
8. The sample size for the training set:
Not applicable/not specified. No information on an algorithm training set is provided; this is a medical device (probe) for measurement, not an AI/ML diagnostic algorithm.
9. How the ground truth for the training set was established:
Not applicable/not specified.
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