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510(k) Data Aggregation
(229 days)
CardioScope™ is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and pediatric patients. CardioScope also provides non-invasive central (aortic) systolic, mean and diastolic blood pressure, and pulse waveform intended for use in adult patients.
CardioScope performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm.
The device is intended to be used under supervision by qualified healthcare personnel.
Caution: Federal (USA) law restricts this device to sale by or on order of a physician.
The CardioScope™ is a compact standalone measurement device that incorporates a SP10 compliant conventional oscillometric blood pressure module using a brachial cuff on the upper arm.
The CardioScope first measures brachial systolic and diastolic blood pressures and pulse rate using the Oscillometric method. It then inflates the cuff to a pressure about 30 mmHg higher than systolic (Suprasystolic) pressure to acquire a further oscillometric pulse waveform. The suprasystolic pulse waveform is used in combination with the conventional upper-arm blood pressures to derive central systolic, diastolic and mean blood pressures.
Here's a breakdown of the requested information regarding the acceptance criteria and the study proving the CardioScope™ device meets them, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Target) | Reported Device Performance |
|---|---|---|
| Agreement with Tonometric Estimation (Central Systolic, Diastolic, Mean BP) | Mean differences |
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(16 days)
This device is a patented combination device that includes Electrocardiograph and manual Stethoscope with an integrated graphics display of ECG signal, heart rate, presence of a pacemaker, as well as a standard acoustic stethoscope that reduces interference ("Anti-Interference System")
This device is intended for use as a diagnostic aid as part of physical assessment of patient by healthcare professionals or other individuals trained to administer emergency first aid or otherwise care for a patient.
It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying, measuring, storing and transmitting to a database the cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.
SONOPLUS 3000 is not intended for use in intensive care. Simultaneous use with defibrillators is prohibited.
This device SONOPLUS 3000 is a combination product that includes Electrocardiograph and manual Stethoscope.
It displays ECG and heart rate data with automatic pacemaker detection, auto scaling of ECG amplitudes and filtering.
A Windows-based software installed on an external computer allows for:
- creating patient database
- downloading, storing, graphically displaying as well as printing required data from device
- setting date on device
- communicating with PULSONIC website for software updates
The provided text "K051126" does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the SONOPLUS 3000 device, an electrocardiograph and manual stethoscope combination.
It focuses on establishing substantial equivalence to a predicate device (CADITEC's CADISCOPE, 510k #K990809) based on technological characteristics like indications for use, target population, design, materials, and performance.
Therefore, I cannot provide the requested information in the table or the subsequent points as the input does not contain a description of acceptance criteria or a study.
The document only states "13-Safety and Effectiveness of the device: This device is safe and effective as the other predicate devices cited above." and "14-Summary comparing technological characteristics with other predicate device: ...Performance | Similar". This indicates a comparison to a predicate device, but no specific performance study or acceptance criteria are detailed.
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