Search Results
Found 1 results
510(k) Data Aggregation
(167 days)
BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy.
BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy.
BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
Being operated with battery, it allows babies to be checked anywhere, at any time. Using high sensitive and harmless ultrasound sensor, it detects and displays the accurate FHR on the LCD. BABYCARE is especially suitable for routine use in OB/GYN.
Features:
- Accurate FHR detection & display -
- Clear sound offered from separate speaker -
- Cap-shaped speaker for probe protection -
- -Compact size and battery operated
- Harmless ultrasound sensor "
- Easy to use -
Technical Specifications:
- Display: 3-digit segment ー
- FHR Measuring Range: 50-240 bpm -
- Measurement Resolution: ± 3bpm -
- Speaker output power: 1 W -
- Ultrasound frequency: 2.0 Mhz -
- Power: 9V batterv -
- Sensitivity: 12 Weeks Fetus -
- Weight: 290g (without battery) ~
- Standard Accessory: Gel, 9V battery --
The provided 510(k) summary for the BABYCARE fetal ultrasonic monitor does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance thresholds in a clinical or standalone setting. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (IMEX's Pocket, 510k #K910462) based on technological characteristics and performance parameters.
Here's an analysis of the information provided in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" for a study are not listed, the table below presents the performance characteristics of the BABYCARE device as described, and how they are compared to the predicate device. The claim is "identical" or "similar" rather than meeting pre-defined acceptance thresholds from a study.
| Acceptance Criteria (Inferred/Claimed from Predicate Equivalence) | Reported Device Performance (BABYCARE) |
|---|---|
| Ability to measure fetal heart rate after 12 weeks of pregnancy | Possible to measure fetal heart rate after 12 weeks of pregnancy (Identical to predicate) |
| Output power (sound/ultrasound) | ≤ 100mW/cm² (Identical to predicate) |
| FHR Measuring Range | 50bpm ~ 240bpm (Identical to predicate) |
| Resolution | ± 3bpm (Listed in technical specifications) |
| Ultrasound frequency | 2.0 Mhz (Listed in technical specifications) |
| Sensitivity | 12 Weeks Fetus (Listed in technical specifications) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not report any specific sample size for a test set or study data. The entire submission is based on a "technological characteristics" comparison to a predicate device, not on new clinical performance data from a specific test set. Therefore, there is no information on data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided as there is no mention of a study involving ground truth establishment by experts for the BABYCARE device. The claims are based on substantial equivalence to an already approved predicate device.
4. Adjudication Method
Not applicable. No study requiring adjudication is described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not conducted/reported. The submission does not describe any MRMC study or any comparison of human readers with or without AI assistance. The device is a standalone fetal heart rate monitor, not an AI-assisted diagnostic tool for interpretation by human readers.
6. Standalone Performance Study
A formal standalone performance study with detailed results is not explicitly described in the provided 510(k) summary. The "Performance" claim in the table is "Identical" to the predicate, meaning it is expected to perform comparably based on its technical specifications. The technical specifications listed (FHR Measuring Range, Resolution, Sensitivity) are inherent to the device's design and operation, rather than derived from a performance study.
7. Type of Ground Truth Used
Not explicitly stated/used for the BABYCARE device's performance demonstration. The entire premise is substantial equivalence to a predicate device, implying that the predicate's established performance serves as the reference.
8. Sample Size for the Training Set
Not applicable. The BABYCARE device described is a hardware-based fetal heart rate monitor using continuous wave Doppler echoscopy. There is no mention of a "training set" as it is not a machine learning or AI-driven device.
9. How Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of device, ground truth establishment for a training set is not relevant.
Ask a specific question about this device
Page 1 of 1