(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.
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Vyaire Medical, Inc. Suzanne Moreno Regulatory Affairs Associate 26125 N. Riverwoods Blvd. Mettawa, Illinois 60630
Re: K191273
Trade/Device Name: Multi-Link X2 ECG and SpO2 Adapter Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA, DQA Dated: August 16, 2019 Received: August 20, 2019
Dear Suzanne Moreno:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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542 of the Act); 21 CFR 1000-1050.
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole Goodsell Acting Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
MULTI-LINK X2 ECG AND SpO2 ADAPTER
Indications for Use (Describe)
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 and are compatible with the Philips MX40 electrocardiograph monitor.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- |
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510(k) Summary MULTI-LINK™ X2 ECG AND SpO₂ ADAPTER
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
1.0 Submitter Information
| Submitter: | VYAIRE MEDICAL, INC. |
|---|---|
| Address: | 26125 N. Riverwoods Blvd.Mettawa, IL 60045USA |
| Establishment Registration Number: | 3013421741 |
| Contact: | Suzanne Moreno |
|---|---|
| Title: | Regulatory Affairs Associate |
| Telephone: | (872) 757-0147 |
| Suzanne.Moreno@Vyaire.com |
Date Summary Prepared:
2.0 Device Information
| Device Name:Trade Name: | Multi-LinkTM X2 ECG AND SpO2 ADAPTERSMulti-LinkTM |
|---|---|
| Primary Product Code:Device Classification:Regulation Name: | DSAClass II per 21 CFR 870.2900870.2900 Patient transducer and electrode cable(including connector) |
| Common Name: | Patient transducer and electrode cable (includingconnector) |
| Subsequent | |
| Product Code: | DQA |
| Device Classification: | Class II per 21 CFR 870.2700 |
| Regulation Name: | 870.2700 Oximeter |
| Common Name: | Oximeter |
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3.0 Purpose of Submission
The purpose of this submission is to gain clearance for the new device, The Multi-LinkTM X2 ECG AND SpO2 ADAPTERS.
4.0 Predicate and Reference Device Information
The Multi-Link™ X2 ECG AND SpO2 ADAPTERS described in this submission is substantially equivalent to the following predicate:
| Predicate Device | 510(k) No. | Decision Date |
|---|---|---|
| Multi-Link X2 ECG Adapterand Direct Connect Lead WireSystem | K163316 | 06/22/2017 |
| Reference Device | 510(k) No. | Decision Date |
| MX40 Release B.07 | K172226 | 11/09/2017 |
5.0 Device Description
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.
5.1 Intended Use
The Multi-Link X2 ECG Adapter and Lead Wire System is intended to transmit signals from patient electrodes to various electrocardiograph recorders /monitors for monitoring purposes.
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5.2 Indications for Use
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.
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6.0 Summary of Substantial Equivalence
| Element ofcomparison | Subject Device | Primary Predicate DeviceMulti-Link™ X2 ECGAdapter and Direct ConnectLead Wire System(K163316) | Reference DeviceK172226 |
|---|---|---|---|
| Intended Use | The Multi-Link X2 ECGAdapter and Lead WireSystem is intended totransmit signals from patientelectrodes to variouselectrocardiograph recorders/monitors for monitoringpurposes. | The Multi-Link X2 ECGAdapter and Direct ConnectLead Wire System is intendedto transmit signals frompatient electrodes to variouselectrocardiograph recorders/monitors for monitoringpurposes. | The device is intendedfor monitoring andrecording of and togenerate alarms for,multiple physiologicalparameters of adults andpediatrics in a hospitalenvironment and duringpatient transport insidehospitals. Not intendedfor home use. Intendedfor use by health careprofessionals. |
| Indications forUse | The Multi-Link™ X2 ECGAdapter and Lead WireSystem are used in telemetryto transmit ECG and/or SpO2-signals from the electrodesand sensors to thetransmitters on ambulatorypatients within a definedcoverage area for monitoringpurposes. The Multi-Link™Adapters are reusable,nonsterile and can bereprocessed. The Multi-Link™ X2 ECG Adapter andLead Wire System are usedwith any patient populationrequiring ambulatorymonitoring and arecompatible with the PhilipsMX40 electrocardiographmonitor. | The Multi-Link™ X2 ECGAdapter and Direct ConnectLead Wire System are usedin telemetry totransmit ECG signals fromthe electrodes to thetransmitters on ambulatorypatients within adefined coverage area formonitoring purposes. TheMulti-Link Direct-ConnectLead wires aresingle-patient-use, nonsterileand cannot be reprocessed.The Multi-Link Adapters arereusable,nonsterile and can bereprocessed. The Multi-LinkX2 ECG Adapter and DirectConnect LeadWire System are used withany patient populationrequiring ambulatory ECG,and arecompatible with Philips,Mindray and Nihon Kohdenelectrocardiograph monitors. | Indicated for use ofhealthcare professional swhenever there is a needfor monitoring thephysiological parametersof patients. Intended formonitoring and recordingof, and to generatealarms for, multiplephysiological parametersof adults and pediatricsin hospital environmentsand during transportinside hospitals. |
| Principal ofOperation | Adapters are cableconductors to conduct ECGsignal from patient ECGelectrodes and SpO2-signalfrom sensors to monitoringequipment. Signal isconducted through insulatedsignal wires made ofconductive material. Signalwires are protected from | Adapters are cableconductors to conduct ECGsignal from patient ECGelectrodes to monitoringequipment. Signal isconducted through insulatedsignal wires made ofconductive material. Signalwires are protected fromenvironmental noise factors | Detects and processECG the signalconducted by sensorsand lead wires |
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K191273
| environmental noise factorswith metal shielding around it,acting as Faraday's cage.The adapters have aninsulating jacket made ofthermoplastics providingelectrical insulation. | with metal shielding around it,acting as Faraday's cage.The adapters have aninsulating jacket made ofthermoplastics providingelectrical insulation. | ||
|---|---|---|---|
| PatientPopulation | Any patient populationrequiring ambulatorymonitoring | Any patient populationrequiring ambulatory ECG | Any patient populationrequiring monitoring |
| AnatomicalSites | Adapters do not have patientcontact | Adapters do not have patientcontact | SpO2-sensors areconnected to finger ortoe. Monitor does nothave patient contact. |
| Environment ofUse | Hospital Environment | Hospital Environment | Hospital Environment |
| Compatibilitywithenvironmentand otherdevices | Philips MX40electrocardiograph monitors | Philips, Mindray and NihonKohden electrocardiographmonitors | N/A |
| Characteristics | |||
| Number of leadwires | 5 or 6 lead version | 3, 5 or 6 lead version | 3, 5 or 6 lead version |
| Sterility | Adapters are reusable,nonsterile | Adapters are reusable,nonsterile | SpO2-sensors are non-sterile, disposable,monitor is reusable |
| Cable coatingmaterials:Adapters | TPU | TPU | N/A |
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7.0 Performance Data
The Multi-LinkTM X2 ECG AND SpO2 ADAPTERS was tested to ensure compliance to the following standards:
7.1 Performance Testing
| Standard Number | Performance Characteristic |
|---|---|
| AAMI ANSI ES60601-1:2005/(R):2012 andA1:2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance |
| AAMI ANSI IEC60601-2-27:2011(R)2016 | Medical electrical equipment - Part 2-27: Particularrequirements for the basic safety and essentialperformance of electrocardiographic monitoringequipment |
| AAMI ANSI EC53:2013 | ECG trunk cables and patient lead wires |
| IEC 60601-1-6 Edition3.1 2013-10 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance- Collateral standard: Usability |
The following standard has been used as a guidance for compatibility testing of adapter with Philips IntelliVue MX40-system and SpO₂-sensors:
| Standard Number | Performance Characteristic |
|---|---|
| ISO 80601-2-61 :2017-12 (CorrectedVersion 2018-02) | Medical electrical equipment - Part 2-61: Particularrequirements for basic safety and essential performanceof pulse oximeter equipment |
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| Test | Standard | Standard Section | Result |
|---|---|---|---|
| Compatibility Testing withPhilips IntelliVue MX40System, ECG Lead wiresand SpO2-sensors | 60601-2-27:2011(R)201680601-2-61 | 201.12.1.101.15 | Pass |
| Lifecycle and ContactResistance According toEC53 Section 5.3.5 and5.3.7 for SpO2-connector | EC53:2013 | 5.3.5 and 5.3.7 | Pass |
| EC53 section 5.3.5, 5.3.6and 5.3.7 for SubjectDevice Multi-Link™ X2ECG and SpO2 AdapterYoke and InstrumentConnector | EC53:2013 | 5.3.5, 5.3.6 and5.3.7 | Pass |
| Inspection of Air Clearancefor Subject Device Multi-Link™ X2 ECG and SpO2Adapter | 60601-1:2012 and60601-2-27:2011 | 8.5.2.3 and201.8.5.2.3 | Pass |
| Defibrillation Protection andEnergy Reduction | 60601-1:2012 | 8.5.5.1 and 8.5.5.2 | Pass |
| Dielectric WithstandTesting according EC53section 5.3.9 for Multi-Link™ X2 ECG and SpO2Adapter | EC53:2013 | 5.3.9 | Pass |
| Dielectric WithstandTesting according 60601-1section 8.8.3 for Multi-Link™ X2 ECG and SpO2Adapter | 60601-1:2012 | 8.8.3 | Pass |
| Storage Conditioning andDrop Test | 60601-1:2012 | 15.3.1, 15.3.6 and15.3.7 | Pass |
| Connector mating/unmating | EC53:2013 | 5.3.5 | Pass |
| Retention force test | EC53:2013 | 5.3.6 | Pass |
| Contact Resistance Test | EC53:2013 | 5.3.7 | Pass |
| Material Resistance forCleaning and DisinfectionStress | 60601-1:2012EC53:2013 | 11.6.68.8.35.3.9 | Pass |
7.2 Non-Clinical Performance Test Summary
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8.0 Biocompatibility
The Multi-LinkTM X2 ECG and SpO2 Adapters do not have patient contact. Per the requirements outlined in ISO 10993-1 biocompatibility testing is not applicable for the subject device.
| Standard Number | Performance Characteristic |
|---|---|
| AAMI ANSI ISO10993-1:2009/ (R)2013 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| ISO 10993-1 Fifthedition 2018-08 |
9.0 Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate, the Multi-Link™ X2 ECG AND SpO2 ADAPTERS has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any different issues of safety or effectiveness.
§ 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).