(123 days)
The Multi-Link™ X2 ECG Adapter and Lead Wire System are used in telemetry to transmit ECG and/or SpO2-signals from the electrodes and sensors to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Lead Wire System are used with any patient population requiring ambulatory monitoring, and are compatible with the Philips MX40 electrocardiograph monitor.
The Multi-Link™ X2 ECG AND SpO2 ADAPTERS is a reusable telemetry Adapter that connects the Philips IntelliVue MX40 (cleared under telemetry transmitter K172226), on one end to Vyaire-owned lead wires (cleared under K980582 and K101660) and market available SpO2 sensors (cleared under K172226 and K111888) on the other end. The Adapter functions to transmit signals from patient ECG electrodes and SpO2 sensors to ambulatory monitoring equipment, providing ambulatory patients with continuous ECG (electrocardiogram) and SpO2 (blood oxygen saturation) monitoring.
This device is common to both industry and medical establishments. The Multi-Link X2 ECG and SpO2 Adapter is not a stand-alone device but is used with the host monitoring device and functions as conductors on the system to carry the electrical signals.
This looks like a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria for aspects like diagnostic accuracy.
Based on the provided document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance characteristics and standards to which the device was tested, with all tests reported as "Pass." This indicates that the device met the requirements of these standards, which serve as the acceptance criteria for the safety and essential performance of such medical electrical equipment.
| Performance Characteristic | Standard Number | Standard Section | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|---|
| Compatibility Testing with Philips IntelliVue MX40 System, ECG Lead wires and SpO2-sensors | 60601-2-27:2011(R)2016, 80601-2-61 | 201.12.1, 101.15 | The device must function correctly and safely when integrated with the Philips IntelliVue MX40 system, ECG lead wires, and SpO2 sensors as specified in the referenced standards for electrocardiographic monitoring equipment and pulse oximeter equipment. | Pass |
| Lifecycle and Contact Resistance According to EC53 Section 5.3.5 and 5.3.7 for SpO2-connector | EC53:2013 | 5.3.5 and 5.3.7 | The SpO2 connector must withstand specified lifecycle stress and maintain contact resistance within acceptable limits as defined by AAMI ANSI EC53. | Pass |
| EC53 section 5.3.5, 5.3.6 and 5.3.7 for Subject Device Multi-Link™ X2 ECG and SpO2 Adapter Yoke and Instrument Connector | EC53:2013 | 5.3.5, 5.3.6 and 5.3.7 | The ECG and SpO2 Adapter's yoke and instrument connector must comply with the lifecycle, retention force, and contact resistance requirements of AAMI ANSI EC53. | Pass |
| Inspection of Air Clearance for Subject Device Multi-Link™ X2 ECG and SpO2 Adapter | 60601-1:2012 and 60601-2-27:2011 | 8.5.2.3 and 201.8.5.2.3 | The device must meet the specified air clearance requirements for patient electrical safety as defined in the general requirements for basic safety and essential performance of medical electrical equipment and particular requirements for electrocardiographic monitoring equipment. | Pass |
| Defibrillation Protection and Energy Reduction | 60601-1:2012 | 8.5.5.1 and 8.5.5.2 | The device must provide adequate protection against defibrillation and reduce energy transmission to the patient as specified in the general requirements for basic safety and essential performance of medical electrical equipment. | Pass |
| Dielectric Withstand Testing according EC53 section 5.3.9 for Multi-Link™ X2 ECG and SpO2 Adapter | EC53:2013 | 5.3.9 | The device must withstand specified dielectric voltage without breakdown, demonstrating adequate electrical insulation as defined in AAMI ANSI EC53. | Pass |
| Dielectric Withstand Testing according 60601-1 section 8.8.3 for Multi-Link™ X2 ECG and SpO2 Adapter | 60601-1:2012 | 8.8.3 | The device must withstand specified dielectric voltage without breakdown, demonstrating adequate electrical insulation as defined in the general requirements for basic safety and essential performance of medical electrical equipment. | Pass |
| Storage Conditioning and Drop Test | 60601-1:2012 | 15.3.1, 15.3.6 and 15.3.7 | The device must withstand storage conditions and physical impact (drop test) without compromising its safety or performance characteristics as specified in the general requirements for basic safety and essential performance of medical electrical equipment. | Pass |
| Connector mating/unmating | EC53:2013 | 5.3.5 | Connectors must be able to be mated and unmated for a specified number of cycles without damage or degradation of performance as defined in AAMI ANSI EC53. | Pass |
| Retention force test | EC53:2013 | 5.3.6 | Connectors must maintain a specified retention force to ensure secure connection during use as defined in AAMI ANSI EC53. | Pass |
| Contact Resistance Test | EC53:2013 | 5.3.7 | Electrical contacts must exhibit resistance within specified limits to ensure proper signal transmission as defined in AAMI ANSI EC53. | Pass |
| Material Resistance for Cleaning and Disinfection Stress | 60601-1:2012, EC53:2013 | 11.6.6, 8.8.3, 5.3.9 | The materials of the device must withstand cleaning and disinfection procedures without degradation that could affect its safety or performance, as per the requirements of medical electrical equipment and ECG trunk cables/patient lead wires standards. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size (number of units or test cycles) used for each test. The tests are general performance and safety tests for a medical device adapter, not clinical studies involving patient data. Therefore, concepts like data provenance (country of origin, retrospective/prospective) are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a cable/adapter for transmitting ECG and SpO2 signals. The "ground truth" for the test set is established by recognized engineering and medical standards (e.g., AAMI, IEC, ISO) for electrical safety, performance durability, and compatibility. It does not involve expert interpretation of medical images or data that would require a panel of clinical experts for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are technical compliance tests against engineering standards, not diagnostic assessments requiring human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study assesses the impact of AI on diagnostic accuracy or reader performance in clinical scenarios, often involving interpretation of medical images. The Multi-Link X2 ECG and SpO2 Adapter is a signal transmission device, not an AI-powered diagnostic tool, so an MRMC study is not relevant or included in this submission.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The device is a hardware component (adapter/cable), not an algorithm or AI system. Its function is to transmit signals, which is assessed through technical performance tests.
7. Type of Ground Truth Used
The "ground truth" for the performance tests in this submission is the established technical specifications and performance requirements outlined in the referenced international and national standards (AAMI, ANSI, IEC, ISO). Compliance with these standards indicates the device meets the accepted safety and performance criteria for its intended function.
8. Sample Size for the Training Set
Not applicable. This device is a hardware accessory and does not involve AI or machine learning, therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this 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).