(65 days)
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.
| Acceptance Criteria (Implied from Substantial Equiv.) | Reported Device Performance (from specifications) |
|---|---|
| Function as a 12-Channel Ambulatory ECG recorder | 12-Lead ECG acquisition |
| Function as a Non-invasive Ambulatory Blood Pressure Monitor | Oscillometric BP measurement |
| Acquisition of ECG and BP signals from upper body surfaces | Device intended for upper body measurements |
| Intended for adults and children over six years old | Recorders intended for adults and children over six years old |
| Measurement, recording, and display only | System is only for measurement, recording and display. It makes no diagnosis. |
| Compliance with predicate device's measurement and recording function for BP signals | Model 1804 (BP only) functions exactly the same as Model 2301/2302 for measurement and recording of Blood Pressure signals. |
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)
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).