(87 days)
The 12-Lead option (#C90) adds 12-Lead ECG functionality to the CodeMaster 100 monitor/defibrillator, M2475B. This feature will be used by emergency medical personnel who have been trained and authorized for its use.
The primary patient population for which this feature is intended is defined as persons with symptoms associated with acute myocardial infarction or cardiac annythmias. The 12-Lead feature can also be applied to patients for routine.medical examinations or anytime a baseline ECG is ordered by a physician. Note that a physician must review the preliminary report. Like any computer assisted ECG interpretation program, the predictive instrument evaluation is not a substitute for the physician's decision process.
This product is not intended for home use.
The #C90 12 Lead ECG option to the M2475B provides 12-Lead acquisition and high fidelity printing for on-site manual interpretation. The preview display allows the user to scroll through all 12 leads and computerized ECG analysis for fast ECG interpretation. The integrated modem (U.S. version only) provides combined cellular / land line for ECG transmission to a physician to over-read and diagnose ECGs. It offers an industry standard RS232 port for hardwire connection with an external (not provided) modem. In addition, it features the ACI-TIPI, Acute Cardiac Ischemia - Time Insensitive Predictive Instrument that aids in patient diagnosis. The complete system is compatible with the Hewlett-Packard cardiology network, which includes the TraceMaster ECG Management System, M1730B and the EGC Manager, M1765A.
This 510(k) summary (K982025) describes the Hewlett-Packard 12-Lead Option (#C90) for the M2475B CodeMaster 100 defibrillator/monitor. The submission claims substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for the device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity for detecting AMI). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical testing.
Reported Device Performance: The document states that "The results summarized in Appendix D show that non-clinical tests were successfully used to determine the substantial equivalence of the 12-Lead (#C90) option to the M2475B." However, Appendix D is not provided in the input text, so specific performance metrics from those non-clinical tests cannot be extracted. The text emphasizes that the device employs "the same technologies" and "re-use of... hardware, hardware design, application software, and algorithm software" as predicate devices, implying that its performance is expected to be equivalent.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Substantial Equivalence to Predicate Devices (LifePak 11/11R, M1770A) in terms of safety and effectiveness, and compliance with mandatory and voluntary standards, software baselines, and hardware functionality. | Summary: "Non-clinical tests were successfully used to determine the substantial equivalence of the 12-Lead (#C90) option to the M2475B." The device uses "the same technologies" and "identical" hardware and software components (including the ECG interpretation algorithm) as the predicate devices. Specific quantitative performance data is not provided in this summary, but referenced in Appendix D (not included). |
2. Sample Size for the Test Set and Data Provenance
The provided document does not describe a clinical study with a "test set" or patient data. The claim of substantial equivalence is based on non-clinical tests, as stated: "The use of non-clinical tests as defined in the 'Verification and Validation' section contained in Appendix D demonstrates that the 12-Lead option #C90 is substantially equivalent..."
Therefore, information on sample size for a test set, data provenance (e.g., country of origin, retrospective/prospective) related to patient data, is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided. The device's substantial equivalence was established through non-clinical testing, not a clinical study involving experts establishing ground truth for a diagnostic test set. The use of computerized ECG analysis by the device for interpretation is "not a substitute for the physician's decision process."
4. Adjudication Method for the Test Set
This information is not applicable or provided. As there was no clinical test set described in the provided text, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed or described in this 510(k) summary. The submission focuses on non-clinical substantial equivalence.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for the algorithm per se is not explicitly described as a separate study with specific metrics. However, the document states: "The M2475B CodeMaster 100 Defibrillator/Monitor option #C90 employs the same technologies as the predicate devices...Re-use of PageWriter 200i Cardiograph hardware, hardware design, application software, and algorithm software to make the #C90 option for CodeMaster 100 demonstrate the technology is not just similar, but identical."
This implies that the "computerized ECG analysis" algorithm is the same as that in the predicate Hewlett-Packard PageWriter 200i Cardiograph (M1770A). Therefore, the standalone performance of the algorithm would be based on prior evaluations of that predicate device's algorithm, rather than a new standalone study for this specific 12-Lead option. The provided text doesn't offer details of such prior evaluations.
7. Type of Ground Truth Used
For the non-clinical tests, the ground truth would typically be established based on engineering specifications, recognized standards, and functional requirements rather than clinical outcomes or pathology. The goal was to prove the device met these engineering and performance standards, showing it functions equivalently to predicate devices.
8. Sample Size for the Training Set
The document does not provide information on a training set sample size. The submission focuses on the new device's substantial equivalence to existing devices, relying on the 'identical' software and algorithms already proven in the predicate devices. Therefore, any training of the algorithm would have occurred prior to the predicate device's original submission, and is not detailed here.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As with the training set size, the method for establishing ground truth for the algorithm's training would have been part of the development process for the predicate device's ECG interpretation algorithm, not this specific 510(k) submission.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.