Search Results

The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor. It is intended to acquire, store and display ambulatory ECG signals from adult and pediatric patient. It is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are displayed and stored in the recorder. It is intended to be used by trained personnel under the direction of doctors.

Holter ECG and ABP System (Model: SA-20, SA-19, SA-18, SA-15, SA-16) is composed of the recorder, NIBP cuff, lead wire. The ambulatory blood pressure adopts the principle of the oscillometric method for non-invasive blood pressure measurement. ECG signals are obtained by placing electrodes on the patient's surface to record the potential change signal of the human heart and then processing the data to form an ECG waveform and store it in the Recorder to monitor the ECG signal.

The provided text describes the Holter ECG and ABP System and its performance data to establish substantial equivalence to predicate devices. However, the document does not contain an acceptance criteria table or specific details of a study directly proving the device meets acceptance criteria in the format often associated with AI/ML algorithm validation (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on non-clinical performance testing to demonstrate the device's adherence to relevant industry standards and functional specifications, ensuring its safety and effectiveness are comparable to the predicate devices.

Here's a breakdown of the information that can be extracted or inferred based on common medical device submission practices, acknowledging that explicit details on some points are missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal "acceptance criteria" table in terms of diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). Instead, the performance evaluations are based on compliance with established medical device standards. The "reported device performance" is the successful compliance with these standards.

2. Sample size used for the test set and the data provenance

The document states, "Clinical data: Not applicable," implying that the assessment for this 510(k) submission did not involve a clinical trial or a test set derived from patient data in the typical sense of evaluating diagnostic accuracy. The testing was primarily bench-based and software verification. Therefore, there's no "sample size for a test set" or "data provenance" related to patient data for diagnostic performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set for diagnostic performance was used. The "ground truth" for the non-clinical testing was defined by the specifications and requirements of the referenced industry standards.

4. Adjudication method for the test set

Not applicable, as no clinical test set for diagnostic performance was used.

5. 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

Not applicable. This device is a Holter ECG and ABP system (hardware for acquisition, storage, and display of physiological signals), not an AI/ML diagnostic algorithm designed to assist human readers or perform automated interpretations beyond basic parameter measurements.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm in the context of diagnostic interpretation. It is a device for signal acquisition and measurement. The "algorithm" for NIBP (oscillometric method) and ECG signal processing is inherent to the device's function, but it's not described as a standalone diagnostic algorithm requiring performance evaluation against a specific ground truth like an AI model would be.

7. The type of ground truth used

For the performance testing, the "ground truth" was the specifications and requirements defined by the referenced international and national consensus standards (e.g., IEC 60601 series, ANSI AAMI standards). The device's measurements (ECG signals, blood pressure) are verified against the expected outputs and accuracy tolerances dictated by these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set of patient data.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML algorithm that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the document):

The "study" proving the device meets its "acceptance criteria" is a series of non-clinical performance tests and software verification and validation activities designed to demonstrate compliance with recognized medical device standards.

1. Electrical Safety and EMC Testing: The device was tested against ANSI AAMI ES 60601-1 and IEC 60601-1-2 to ensure it is electrically safe and does not cause or succumb to electromagnetic interference.
2. Performance Testing (Bench): Functional and system-level bench testing was conducted to validate the device's performance against the accuracy specifications and requirements outlined in:
   • IEC 60601-2-47: For ambulatory electrocardiographic systems (ECG Holter functionality).
   • IEC 80601-2-30: For automated non-invasive sphygmomanometers (ABP functionality).
   • ANSI AAMI EC53: For ECG trunk cables and patient leadwires.
   • IEC 60601-1-11: For devices used in the home healthcare environment.
     These tests would involve simulating physiological signals or using calibrated equipment to ensure the device accurately acquires, processes, and displays ECG and ABP data within acceptable error margins defined by these standards.
3. Software Verification and Validation: This involved rigorous testing of the device's embedded software to ensure it functions as intended, is free from critical bugs, and meets specified requirements, following FDA guidance for software in medical devices.

The conclusion drawn from these "non-clinical data" is that the "subject devices are as safe and as effective as the predicate device," thus establishing substantial equivalence for market clearance.

Ask a specific question about this device

Vasomedical-Biox Model 2302 Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder is a Non-Invasive device intended to acquire Ambulatory 12 Channel ECG signals and non- invasive oscillometric Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via ECG signals.

Vasomedical-Biox Model 1804 Ambulatory BP Recorder is a non- invasive device intended to acquire ambulatory non-invasive oscillometric Blood Pressure signals from the upper body surfaces.

The Recorders are intended for adults and children who are over the age of six years.

The Models 2302 and 1804 work with the CB Series ECG and ABP Analysis Software which has been previously cleared under (k)092785

“The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications”.

The system is only for measurement, recording and display. It makes no diagnosis.

Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302 is intended to be used as a combined Holter Ambulatory Electrocardiograph device and a non-invasive Ambulatory Blood Pressure Monitor for the purpose of screening ECG rhythms and blood pressure measurements for periods to 24 hours. Blood Pressure measurements are obtained using oscillometric signals at intervals set by the physician or on demand. Cardiac rhythm is acquired by 12 Channel ECG signals. The Recorders are intended for adults and children over the age of six years old.

The Model 2302 Recorder is a modified version of Model 2301 which FDA granted clearance on April 2, 2010 (K092785), with 3-Channel ECG replaced by 12-Channel ECG.

Vasomedical-Biox Ambulatory Blood Pressure Recorder Model 1804 is intended to be used as a non-invasive ABP Monitor for the purpose of recording blood pressure measurements also for a period of 24 hours. The Recorders are intended for adults and children over the age of six years old.

The Model 1804 Ambulatory Blood Pressure Recorder is a modified version of Model 2301. Model 2301 records both ECG and BP signals and Model 1804 is a Blood Pressure only Recorder.

The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.

The provided text is a 510(k) summary for the Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302 and Ambulatory Blood Pressure Monitor (ABPM) Model 1804.

Based on the information provided, this submission primarily focuses on technical modifications (specifically increasing ECG channels from 3 to 12) and establishing substantial equivalence to a previously cleared predicate device (Vasomedical - Biox, 3 Channel Ambulatory ECG and Blood Pressure Recorder 2301, K092785).

The document does NOT contain a study or acceptance criteria in the typical sense of a clinical performance evaluation against specific metrics like sensitivity, specificity, or accuracy for diagnostic capability. This is because the device, as stated, "makes no diagnosis" and its intended use is for "measurement, recording and display" of ECG and blood pressure signals.

Therefore, the requested information elements cannot be fully populated as they pertain to clinical performance studies, which are not detailed in this 510(k) summary for this device. The summary emphasizes technological equivalence rather than new clinical performance data.

However, I can extract the relevant information that is present and indicate where information is not available based on the provided text.

Acceptance Criteria and Device Performance Study

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., accuracy, sensitivity, specificity) for diagnostic capabilities, nor does it report specific clinical performance results against such criteria. The focus is on demonstrating that the modified devices (Model 2302 and 1804) are substantially equivalent to the predicate device (Model 2301) in their technological and functional characteristics, and that "The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications."

The "performance" documented here is primarily related to the device's technical specifications and intended function as a recorder, rather than a diagnostic tool.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document does not describe a specific "test set" for performance evaluation in a clinical study. Substantial equivalence is asserted based on technological and functional characteristics, not new clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. No ground truth establishment by experts is described as part of this submission, as it focuses on technological equivalence rather than clinical diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 510(k) summary. No adjudication method is described.

5. 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

This information is not applicable / not provided. The device is an ECG and Blood Pressure recorder, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable / not provided. The device is a hardware recorder. While it works with "CB Series ECG and ABP Analysis Software," the submission explicitly states the system "makes no diagnosis" and the software was previously cleared (K092785). The current submission does not describe a standalone algorithm performance study for diagnostic purposes beyond the recording functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. As no clinical performance study against a diagnostic ground truth is described, no ground truth type is mentioned. The ground truth for technical specifications would be engineering measurements and standards.

8. The sample size for the training set

This information is not applicable / not provided. The device is a recorder, not a machine learning algorithm that requires a training set in the typical sense.

9. How the ground truth for the training set was established

This information is not applicable / not provided. (See #8)

Ask a specific question about this device