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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.

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.

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The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use.

As an electrocardiograph with 12-channel, CARDIOTOUCH-3000 does not only provide parameters and diagnose a patient automatically for patient's electrocardiogram, but also it improves chart management by printing information on an operator as well as on the patient. Furthermore, for the convenience of operators, it is designed so that an operator needs to press a button once to let the machine measure and record patient's electrocardiogram, apply a filter, extract parameters, diagnose a patient automatically then print out a result on an A-4- size report. In addition, the built-in battery helps an operator carry and use CARDIOTOUCH-3000 easily and conveniently for a hospital on wheel and an emergency.

Acceptance Criteria and Device Performance for CARDIOTOUCH-3000

This submission for the CARDIOTOUCH-3000 is a "SPECIAL type" 510(k), claiming substantial equivalence to the predicate device, Bionet's EKG-2000 Cardio Care (K011328). The submission focuses on comparing technological characteristics rather than presenting new clinical study data with specific acceptance criteria. Therefore, the "acceptance criteria" are implicitly met by demonstrating identical or similar performance to the legally marketed predicate device.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, it relies on demonstrating technological equivalence to the predicate device. The "acceptance criteria" are therefore qualitative statements of similarity or identicality to the predicate device across various features and performance aspects.

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

The document does not describe a specific test set, sample size, or data provenance for evaluating the CARDIOTOUCH-3000's performance against clinical acceptance criteria. The submission relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and shared intended use. This type of 510(k) (Special 510(k)) often focuses on design control changes and verification/validation activities to ensure the new device meets its own specifications, which are aligned with the predicate. There is no mention of a clinical performance study using patient data to prove diagnostic accuracy.

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

As no specific test set or clinical performance study for diagnostic accuracy is described, there is no information regarding experts, ground truth establishment, or their qualifications.

4. Adjudication Method for the Test Set

Since no specific test set or clinical performance study is described, there is no information regarding an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or at least not described in the provided summary. The submission focuses purely on demonstrating technological equivalence to a predicate device, not on comparing human reader performance with or without AI assistance. The device is a standalone ECG analysis system, not an AI-assisted interpretation tool for human readers in the context of this submission.

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

The device itself includes "automatic diagnosis" as a feature ("Twenty-five diagnoses are available through auto diagnosis"). However, the document does not describe a standalone performance study for this automatic diagnosis algorithm with explicit metrics (e.g., sensitivity, specificity, accuracy against a reference standard). The performance claims are limited to the technical specifications of ECG signal acquisition and analysis, stating they are "Identical" to the predicate.

7. The Type of Ground Truth Used

As no specific clinical performance study for diagnostic accuracy is described, there is no mention of the type of ground truth used. The "ground truth" for the submission is effectively the established performance and safety profile of the predicate device.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. ECG analysis algorithms can be developed using large datasets, but this information is not part of this 510(k) summary, which focuses on hardware and basic functionality equivalence.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

Ask a specific question about this device

Ask a specific question about this device