(111 days)
Diagnostic ECG for 12 Channel Resting ECG Patient Population: Male/Female, Pediatric to Adult Environment of Use: Hospital, Clinic and Home Use Prescription Device by a Physician
The EKGCard™ System is a diagnostic electrocardiograph (ECG or EKG) for 12 channel resting ECG's. The patient population is for both male and female, pediatric and adult. The System requires a Type II PC Card Slot and Windows CE Pocket PC 2002 and is a Prescription Device.
The provided K030535 filing describes the EKGCard™ System, a diagnostic electrocardiograph. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a dedicated study with defined acceptance criteria and statistical analysis.
Based on the provided document, there is no detailed information describing acceptance criteria and a study dedicated to proving the device meets those criteria. Instead, the submission relies on a comparison to legally marketed predicate devices (Biolog 3000 and ECG Interface) to establish substantial equivalence.
Here's a breakdown of the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated or presented in a table format within the provided document. The submission details the features and specifications of the EKGCard™ System and compares them to the predicate devices. The "performance" assessment is implicitly based on matching or being similar to the predicate devices' capabilities.
| Acceptance Criteria (Inferred from comparison) | Reported Device Performance (EKGCard™ System) |
|---|---|
| Indications for Use (Match Predicate) | ECG and Connection to Pocket PC |
| Patient Population (Match Predicate) | Male/Female, Pediatric to Adult |
| Environment (Match Predicate) | Hospital, Clinic, Home Use |
| Number of Electrodes (Match Predicate) | 12 Lead ECG |
| Batteries (Match Predicate) | No |
| Internal Isolation (Match Predicate) | Yes |
| Defibrillator Protection (Match Predicate) | Yes |
| Banana Plugs (Match Predicate) | Yes |
| Types of Electrodes (Match Predicate) | Snap or Tab |
| CMRR (Match Predicate) | Yes |
| Heart Rate (Match Predicate) | Yes |
| Standards AAMI, EC11 (Compliance) | Yes |
| Standards 60601-2-25 (Compliance) | Yes |
| Interpretation (Not applicable, explicitly different) | No |
| Transtelephonic (Not applicable, explicitly different) | No |
| Cable Length (Match Predicate) | Yes |
| Type BF (Match Predicate) | Yes |
| Filters (Match Predicate) | 50 or 60 Hz |
| Connection Status (Match Predicate) | Yes |
| Electrode Labeling (Match Predicate) | IEC or AAMI |
| Print EKG's (Not applicable, explicitly different) | No |
| Supplied Non-Sterile (Match Predicate) | Yes |
| Prescription Device (Match Predicate) | Yes |
| Safety Standards (Compliance) | Yes |
| EMC Standards (Compliance) | Yes |
| Operating Conditions (Match Predicate) | Yes |
Note: The "acceptance criteria" here are inferred to be "being substantially equivalent to the predicate device" in each listed characteristic or demonstrating compliance with relevant industry standards. The reported performance is the EKGCard™ System's stated feature/capability.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" of patient data for evaluating the EKGCard™ System's performance in a clinical or analytical study. The comparison is feature-based against predicate devices and compliance with standards. Therefore, information on sample size and data provenance is not available in this filing related to performance validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no specific test set or clinical study to establish performance is described, there is no information on experts used to establish ground truth.
4. Adjudication Method for the Test Set
Since no specific test set or clinical study for performance evaluation is detailed, there is no information on 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 reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical comparisons and compliance with standards, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The EKGCard™ System is a diagnostic electrocardiograph, which is a device for acquiring ECG signals. It does not appear to incorporate an AI algorithm for interpretation, as explicitly stated under "Differences" that "The EKGCard does not have interpretation, whereas the Biolog 3000 does or can." Therefore, a standalone algorithm performance study is not applicable and not reported.
7. The Type of Ground Truth Used
Given the nature of the device (an ECG acquisition system) and the type of submission (substantial equivalence based on technical features and standards compliance), the "ground truth" implicitly refers to the established technical specifications and validated performance of the predicate devices and/or compliance with recognized industry standards (e.g., IEC 601-1, ANSI/AAMI EC11). There's no mention of expert consensus on specific cases, pathology, or outcomes data being used as ground truth for performance validation of the EKGCard™ System itself.
8. The Sample Size for the Training Set
The document does not mention any training set as there is no indication of an AI or machine learning component being developed or trained for this device. The device is for ECG acquisition.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned, this question is not applicable.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).