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510(k) Data Aggregation
(151 days)
These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.
Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.
Here's a summary of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use (Measure fetal heart rate and uterine contractions in the gravid patient.) | Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended to measure fetal heart rate and uterine contractions. |
| Anatomical Sites (Ultrasound transducer on maternal abdomen aimed at fetal heart; toco transducer on maternal abdomen over fundal area of uterus.) | Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended for the same anatomical placement. |
| Target Patient Population (Gravid patients, especially during labor.) | Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended for the same patient population. |
| FHR Range (Dependent upon monitor specifications.) | Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are dependent on the connected monitor for FHR range. |
| Uterine Activity Range (Dependent upon monitor specifications.) | Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are dependent on the connected monitor for uterine activity range. |
| Patient Use/Reuse (Reusable.) | Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are reusable. |
| Sterility (Non-Sterile.) | Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are non-sterile. |
| Description of Patient Attachment (Attach to patient with elastic straps around the mother.) | Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and attach with elastic straps. |
| Cable Length (8 feet.) | Same as predicate devices (8 feet). |
| Acoustic Output | < 20mW/cm² ave. |
| Operational Characteristics (Ultrasound Transducers) | EFU100-20 = Pulsed DopplerEFU200-20 = Pulsed DopplerEFU300-25 = ContinuousEFU400-25 = Pulsed Doppler Comparing to predicate devices: Coro 5600 = Continuous, Coro 5700 = Pulsed Doppler; HP 8040 = Pulsed Doppler, HP 1356 = Pulsed Doppler. While specific types vary, the devices offer both pulsed and continuous Doppler options, similar to the predicates. |
| Specifications (Ultrasound Center Frequency) | Epic EFU100-20 = 1.0 MHzEpic EFU200-20 = 1.0 MHzEpic EFU300-25 = 2.3 MHzEpic EFU400-25 = 1.151 MHz Comparing to predicate devices: Corometrics 5600 = 2.3 MHz, Corometrics 5700 = 1.151 MHz; HP 8040 = 1.024 MHz, HP 1356 = 0.9984 MHz. The frequencies are in a similar range to the predicate devices. |
| Bench Testing Performance | Bench testing demonstrates that the devices perform as intended. |
| Conformity to Consensus Standards | The company has declared conformity to consensus standards relating to Electrical/Mechanical/Thermal Safety and Biocompatibility. |
The document states that the Epic Medical Equipment Services transducers are "equivalent to the following legally-marketed devices" (predicate devices). The performance data primarily focuses on demonstrating that the Epic transducers meet the same general functional requirements, specifications, and safety standards as the predicate devices.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Acoustic output testing" and "Bench testing" but does not provide details on the number of units or test cases used for these tests.
- Data Provenance: Not explicitly stated (e.g., country of origin). Since it's bench testing and acoustic output testing, it would likely be laboratory-based rather than from clinical patient data. The context implies it's retrospective device testing performed by the manufacturer, Epic Medical Equipment Services, Inc., located in Plano, TX, USA.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for Test Set
- Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence through specifications, acoustic output, and bench testing, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No. This device is a transducer, a hardware accessory for a medical monitor, not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "Performance Data & Conclusions," the "ground truth" is implied to be:
- Measurements: Actual acoustic output measurements for the acoustic output testing.
- Engineering Specifications/Functional Requirements: For bench testing, the "ground truth" would be whether the device meets its design specifications and functional requirements as intended when connected to the monitors.
- Consensus Standards: Declaration of conformity to relevant Electrical/Mechanical/Thermal Safety and Biocompatibility standards.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware accessory (transducer), not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as this is not an AI/machine learning device.
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