(100 days)
The Ambulatory ECG Recorder described in this 510(k) Premarket Notification is a non-invasive device intended to acquire, record and store ambulatory three (3) channel ECG signals from the upper body surface of adults and children over the age of six years old for a minimum of 24 hours. It works in concert with the CB Series Analysis Software to playback, review, analyze, edit and print ECG data. The software does not perform diagnostics. These data are used by physicians for diagnostic evaluations.
Vasomedical's Ambulatory ECG Recorder Model 1305 is intended to be used as a Holter ambulatory electrocardiograph monitor for the purpose of screening ECG rhythms for periods up to 72 hours. Cardiac rhythm is acquired by 3 channel ECG signals. The recorders are intended for adults and children over the age of six years old. The recorders are portable, microprocessor based devices that are worn by a patient with the use of a carrying case and strap. Vasomedical's Ambulatory ECG CB Series Analysis System Software allows transfer of data from the recorder to a Windows based PC via a removable storage card for the purpose of creating printouts and reports. These data are used by physicians for diagnostic evaluations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vasomedical Ambulatory ECG Recorder and Analysis Software:
Acceptance Criteria and Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. Therefore, a direct table of acceptance criteria and reported device performance, in the way one might expect for a de novo device or a more rigorous performance study, is not explicitly provided.
However, the document does list the technical specifications and features of the device, which implicitly serve as performance characteristics that are intended to meet the standards of the predicate device.
Implicit "Acceptance Criteria" (Technical Specifications) and Reported Device Characteristics:
| Feature/Characteristic | Implicit "Acceptance Criteria" (as per predicate equivalence) | Vasomedical Biox 1305 / CB Series Software Performance |
|---|---|---|
| Recorder (1305 Biox Holter) | Substantially equivalent to Huntleight Healthcare Cardiology Products Division Recorders (Medilog AR4 and AR12) | |
| Leads | 3 | 3 |
| Electrodes | 5 or 7 | 5 or 7 |
| Lead wire type | Lead-7C/5C | Lead-7C/5C |
| Display | LED | LED |
| Batteries | 1 "AA" alkaline | 1 "AA" alkaline |
| Dimensions | 3.3" x 2.3" x 0.8" | 3.3" x 2.3" x 0.8" |
| Storage Medium | SD Card | SD Card |
| Memory | 1 GB or more | 1 GB or more |
| Sample Rate | 256 Hz/channel; 10,000 Hz/channel for pacemaker; 1,000 Hz/channel with SAECG option | 256 Hz/channel; 10,000 Hz/channel for pacemaker; 1,000 Hz/channel with SAECG option |
| Resolution | 10 bit, 12 bit for SAECG option | 10 bit, 12 bit for SAECG option |
| Analysis Software (CB Series Software) | Substantially equivalent to Huntleight Healthcare Cardiology Products Division (Medilog Darwin) | |
| QRS Classification | Ventricular, Supra-Ventricular, Normal, Artifact | Ventricular, Supra-Ventricular, Normal, Artifact |
| Comprehensive Event Reports | VE, VE pair, VE bigeminy, V-run, R on T, SVE, SVE pair, SVE-run, pause, long RR, tachycardia, bradycardia, and atrial fibrillation | VE, VE pair, VE bigeminy, V-run, R on T, SVE, SVE-run, pause, long RR, tachycardia, bradycardia, and atrial fibrillation |
| ST-segment reports | Deviation, Slope, Duration, Heart rate | Deviation, Slope, Duration, Heart rate |
| Analysis capability | Arrhythmia, ST-segment, HRV, pacemaker, atrial fibrillation, SAECG, HRT | Arrhythmia, ST-segment, HRV, pacemaker, atrial fibrillation, SAECG, HRT |
| Viewing modes | Standard ECG, ECG thumbnail, Page scanning | Standard ECG, ECG thumbnail, Page scanning |
| Data reporting | Trend charts, statistical tables, category specific histograms | Trend charts, statistical tables, category specific histograms |
| Intended Use | Acquire, record, and store 3-channel ECG signals for 24+ hours from adults/adolescents (6+ years old) for playback, review, analysis, editing, and printing. | Acquire, record, and store 3-channel ECG signals for 24+ hours from adults/adolescents (6+ years old) for playback, review, analysis, editing, and printing. |
The study presented here is a substantial equivalence determination rather than a performance study with defined acceptance criteria and statistical analysis of device performance. The evidence for meeting criteria is primarily asserted through the direct comparison of technological and functional characteristics to known predicate devices that are already cleared.
Study Information:
Based on the provided K083820 510(k) summary, the following information is either not explicitly stated or not applicable because the submission method relies on substantial equivalence rather than independent performance evaluation against predefined criteria.
-
Sample size used for the test set and the data provenance: Not explicitly stated. The submission relies on demonstrating similarity to predicate devices. It doesn't describe a new test set with specific data provenance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. There is no information about an independent ground truth establishment process for the device's performance data.
-
Adjudication method for the test set: Not applicable, as there's no described independent test set or adjudication process for this 510(k) submission.
-
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 document does not describe an AI-driven device or a MRMC study. The software functions as an analysis system for human review, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" performance. The device is explicitly designed to work "in concert with the CB Series Analysis Software to playback, review, analyze, edit and print ECG data. These data are used by physicians for diagnostic evaluations." The software itself "does not perform diagnostics," indicating it's a tool for human interpretation rather than a standalone diagnostic algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated or outlined within this 510(k) summary. The submission focuses on substantial equivalence based on technical specifications and intended use matching predicate devices.
-
The sample size for the training set: Not applicable. This submission doesn't describe a machine-learning algorithm that would require a "training set."
-
How the ground truth for the training set was established: Not applicable, as there is no training set described.
Summary of this 510(k) Submission Approach:
The provided document is a 510(k) summary for a Class II medical device (Medical Magnetic Tape Recorder and Computer, Diagnostic, Programmable). The primary method for demonstrating safety and effectiveness relied on proving substantial equivalence to existing predicate devices (Huntleight Healthcare Cardiology Products Division Recorder Models MedilogAR4 and MedilogAR12; and Medilog Darwin software).
This means the submission's "study" wasn't a de novo clinical trial or performance study against specific acceptance criteria, but rather an engineering and functional comparison to prove that the new device's technical specifications and features are "essentially the same as those of the predicate devices" and "therefore substantially equivalent." There is no detailed information provided on the specific performance validation data (e.g., accuracy, sensitivity, specificity) against a ground truth dataset, which would typically be included in a de novo submission or a more complex device requiring specific performance metrics beyond equivalence.
§ 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).