(90 days)
The LIFEPAK ECG cables are reusable electrode cable systems intended to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes. LIFEPAK ECG cables are intended for use in outdoor and indoor emerqency care settings.
LIFEPAK ECG Cables:
- LIFEPAK 3-wire ECG Cable -
- LIFEPAK 5-wire ECG Cable i
- -LIFEPAK 4-wire ECG cable
- LIFEPAK 3-wire extended precordial ECG Cable l
- -LIFEPAK 6-wire expandable precordial ECG cable
The LIFEPAK ECG cables are an accessory designed to be used with Physio-Control LIFEPAK 35 monitor/defibrillator. The LIFEPAK ECG cables are intended for use by Advanced Life Support (ALS) and Basic Life Support (BLS) providers to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes.
The LIFEPAK ECG Cables are reusable ECG trunk cables and lead wires that connect to the LIFEPAK 35 monitor/defibrillator for ECG monitoring. There are several types or configurations of ECG cables: 3-wire, a 4-wire cable assembly to be used with the LIFEPAK 6-wire precordial cable and/or the LIFEPAK 3-wire precordial cable to perform a 12 or 15-lead ECG Cable assembly. When the LIFEPAK 4-wire ECG cable is configured with a 6-wire expandable precordial cable, a 12-lead ECG is constructed. Likewise, when the LIFEPAK 4-wire ECG cable is configured with a 6-wire expandable precordial cable and a 3-wire extended precordial ECG cable a 15-lead ECG is constructed.
The 4- wire ECG cable is available in two lengths, 5 feet or 8 feet. Additionally, the 3-, 4-, and 5-wire ECG Cables and the 6-wire precordial ECG cable are available with color coding according to the American Heart Association (AHA) or International Electrotechnical Commission (IEC) standards.
The LIFEPAK ECG cables are a reusable electrode cable system intended to transmit signals from patient electrodes to the LIFEPAK 35 monitor/defibrillator for both diagnostic and monitoring purposes. These accessories consist of conductor wires that are shielded and insulated by a polyurethane jacket material. The lead wires are color coded according to which electrode location they are attached to on the patient.
The LIFEPAK ECG cables are not intended for use with other manufacturers' defibrillators. The LIFEPAK ECG cables are intended only for use with LIFEPAK 35 monitor/defibrillator.
The provided text describes the 510(k) premarket notification for LIFEPAK® ECG Cables. This is a device for transmitting ECG signals, not an AI/ML-based medical device. Therefore, many of the requested criteria (such as MRMC studies, AI/ML-specific ground truth, training set information, etc.) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (Multi-Link™ X2 ECG Cable and Leadwire System) primarily through performance testing of the hardware components and comparison of technical characteristics.
Here's an attempt to answer the questions based only on the provided document, acknowledging that much of it is not relevant for an AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted against applicable standards:
| Test Performed | Applicable Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Connector mating/unmating, Retention force | 60601-2-25:2011, 60601-2-27:2011, ANSI AAMI EC53:2013/(R)2020 | Meet standard requirements | Met |
| Inspection of Air Clearance | 60601-2-25:2011, 60601-2-27:2011 | Meet standard requirements | Met |
| Cable Noise Testing | ANSI AAMI EC53:2013/(R)2020 | Meet standard requirements | Met |
| Flex/Twist Life Testing | ANSI AAMI EC53:2013/(R)2020 | Meet standard requirements | Met |
| Tensile Strength Testing | ANSI AAMI EC53:2013/(R)2020 | Meet standard requirements | Met |
| Defibrillation Protection and Energy Reduction | IEC 60601-1:2005/AMD2:2020, IEC 60601-2-25:2011, IEC 60601-2-27:2011 | Meet standard requirements | Met |
| Dielectric Withstand Testing | IEC 60601-1:2005/AMD2:2020, ANSI AAMI EC53:2013/(R)2020 | Meet standard requirements | Met |
| Leakage Current Testing | IEC 60601-1:2005/AMD2:2020 | Meet standard requirements | Met |
| Storage Conditioning and Drop Test | IEC 60601-1:2005/AMD2:2020, IEC 60601-2-27:2011 | Meet standard requirements | Met |
| Material Resistance for Cleaning and Disinfection Stress | IEC 60601-1:2005/AMD2:2020 | Meet standard requirements | Met |
| Electromagnetic Compatibility | IEC 60601-1-2:2014 | Meet standard requirements | Met |
| Shock, Vibration and IP Classification | IEC 60601-1:2005/AMD2:2020, IEC 60601-2-27:2011, IEC 60529: 2013 | Meet standard requirements | Met |
| Biocompatibility Assessment | ISO 10993-1 | Meet standard requirements | Yes - Assessed |
| ASCA Test Reports | N/A (General term) | Meet standard requirements | Yes |
| Design Verification Testing | N/A (General term) | Meet standard requirements | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each physical test. It confirms that "Performance testing has been completed to demonstrate that the proposed LIFEPAK ECG Cables meet the safety and performance requirements established in the design specifications." These are typically laboratory-based engineering tests on device samples, not studies on patient data. The provenance for these tests is the manufacturer (Physio-Control Inc.). The tests are "non-clinical performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a hardware device undergoing engineering and safety performance testing, not an AI/ML algorithm requiring expert interpretation of medical images or data for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for human-read or AI-generated interpretations of medical data, not for physical performance tests of a cable.
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 is not an AI/ML-based device. No human clinical studies were submitted as part of this 510(k) Premarket Notification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is typically adherence to established engineering, electrical, and biocompatibility standards (e.g., IEC 60601, ANSI AAMI EC53, ISO 10993-1). Compliance with these standards confirms the device's technical specifications and safety profile, rather than a clinical ground truth like a pathology report.
8. The sample size for the training set
Not applicable. This is not an AI/ML-based device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML-based device.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).