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510(k) Data Aggregation
(210 days)
These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.
AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate.
AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions.
AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.
AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors.
The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.
Here's an analysis of the provided text regarding the acceptance criteria and study for the fetal monitoring transducers, formatted as requested:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acoustic Output < 20mW/cm² average | Acoustic output testing shows power is less than 20mW/cm² average. |
| Assembly design equivalent to predicate device | AIV assembly design is equivalent to predicate device assembly design. |
| Performance as intended and equivalent to predicate device assemblies | Bench Testing demonstrates that the AIV devices perform as intended and are equivalent to predicate device assemblies. |
| Biocompatibility | AIV plastics have conformed to consensus standards relating to Biocompatibility. |
| Does not raise new issues of safety and effectiveness | "These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices." |
| Does not alter fundamental technology of predicate devices | "These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices." |
| Intended Use: Measure fetal heart rate and uterine contractions in the gravid patient (same as predicate) | The AIV devices are intended to be used as replacement transducer accessories for Corometrics and Hewlett Packard monitors, for use in measuring fetal heart rates and uterine contractions, which is "Same" as the predicate devices. |
| Anatomical Sites (same as predicate) | The ultrasound transducer is placed on the maternal abdomen aimed at the fetal heart; the TOCO transducer is placed on the maternal abdomen over the fundal area of the uterus (Same as predicate). |
| Target Patient Population (same as predicate) | Gravid patients, especially during labor (Same as predicate). |
| FHR Range (same as predicate: dependent upon monitor specifications) | Dependent upon monitor specifications (Same as predicate). |
| Uterine Activity Range (same as predicate: dependent upon monitor specifications) | Dependent upon monitor specifications (Same as predicate). |
| Patient Use/Reuse: Reusable (same as predicate) | Reusable (Same as predicate). |
| Sterility: Non-sterile (same as predicate) | Non-sterile (Same as predicate). |
| Description of Patient Attachment (same as predicate) | These devices attach to the gravid patient with elastic straps around the waist (Same as predicate). |
| Cable Length: 10 feet (predicate varied) | 10 feet (predicate varied, e.g., Epic had 8 feet). This is a point of minor difference but not flagged as non-equivalent. |
| Accessories (same as predicate) | Transducer belts and ultrasonic gel (Same as predicate). |
| Connector Design (same as predicate) | Transducer cable connectors are color-coded and keyed to fit the appropriate fetal monitors (Same as predicate). |
| Operational Characteristics (Pulsed Doppler) | AIV FM10835 = Pulsed Doppler; AIV FM10836 = Pulsed Doppler (Same as predicate). |
| Ultrasound Center Frequency (approx. 1.0 MHz) | AIV FM10835 = 1.0 MHz; AIV FM10836 = 1.0 MHz (predicate 5700LAX = 1.151 MHz, EFU200-20 = 1.0 MHz). The AIV devices match one predicate directly and are close to the other. |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set. This was a 510(k) premarket notification for a replacement accessory, focusing on equivalence to predicate devices rather than a new clinical study with a test set of patients.
- Data Provenance: Not applicable in the context of a clinical test set. The data presented is from bench testing and conformity to standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with ground truth established by experts. The determination of substantial equivalence relies on comparison to existing, legally marketed devices and specified technical performance.
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Adjudication method for the test set:
- Not applicable. No test set requiring adjudication is described.
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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:
- No. This is a medical device (transducer) for measuring physiological signals, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant or mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is an accessory transducer, not a standalone algorithm. The "performance" assessment is based on physical and technical characteristics and its ability to function as a direct replacement for predicate transducers.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the performance and specifications of the predicate devices (Corometrics, Epic, Hewlett Packard transducers) and established consensus standards (e.g., for biocompatibility, acoustic output limits). The AIV transducers aim to meet or be equivalent to these.
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The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, this device is not an AI algorithm.
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(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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