(221 days)
The Multi-Link™ X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring.
The Multi-Link™ X2 ECG Cable, Adapter and Direct Connect Leadwires is an FDA cleared accessory portfolio. The cleared device portfolio consists of adapters & leadwires (reusable adapters and direct connect disposable single patient use leadwires, K163316), and (leadwires reusable, and disposable single patient use, K162432). The cleared portfolio is compatible multiple FDA cleared ECG monitoring platforms, such as Philips, Mindray, Nihon Kohden, GE and Spacelabs. This pre-market notification is to expand the portfolio to be used with additional FDA cleared ECG monitoring platforms.
The Subject device, Multi-Link ™ X2 ECG ADAPTER AND LEADWIRES consists of reusable adapters and direct connect single patient use leadwires that connect to FDA cleared Dräger Infinity (R) monitoring platforms. Design modifications are made to allow for connections with specific additional platforms to allow patients to move throughout the facility without the hassle of disconnecting and reconnecting leadwires.
The system is used to transmit signals from patient ECG electrodes to monitoring equipment, providing patients with continuous ECG (electrocardiogram) monitorina.
This device is common to both industry and medical establishments. The Multi-Link™ X2 ECG ADAPTER AND LEADWIRES 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.
The provided document is a 510(k) summary for Vyaire Medical's Multi-Link X2 ECG Adapter and Leadwires. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets a set of acceptance criteria through a clinical study.
Therefore, this document does not contain the information requested about acceptance criteria and a study proving the device meets them. It details non-clinical performance testing against established standards for medical electrical equipment and ECG cables, but it does not describe a study to establish performance metrics against acceptance criteria as typically defined for an AI/ML-driven device or a diagnostic accuracy study.
Specifically, the document states:
- "No clinical studies were deemed needed to support this submission." This explicitly indicates that a study demonstrating device performance against clinical acceptance criteria was not conducted or required for this 510(k) clearance.
- The performance data section (Section 7.0, 7.1, 7.3) lists compliance with various safety and electrical standards (e.g., AAMI ANSI ES 60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53). These are general safety and performance requirements for the device type, not specific diagnostic performance metrics (like accuracy, sensitivity, specificity) for a particular medical condition.
- The device's function is to transmit ECG signals, not to interpret them or provide a diagnosis. This means the performance metrics would revolve around signal integrity and electrical safety, which are covered by the listed standards, rather than diagnostic accuracy.
Given this, I cannot extract the requested information as it is not present in the provided text.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 9, 2020
Vyaire Medical, Inc. Suzanne Moreno Regulatory Affairs Associate 26125 N. Riverwoods Blvd. Mettawa, Illinois 60045
Re: K200510
Trade/Device Name: Multi-Link X2 ECG Adapter and Leadwires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: September 4, 2020 Received: September 8, 2020
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 control's 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 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing 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 531-542 of the Act); 21 CFR 1000-1050.
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 mediation-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,
for
Jennifer Shih Kozen 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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Indications for Use
510(k) Number (if known) K200510
Device Name Multi-LinkTM X2 ECG ADAPTERS AND LEAD WIRES
Indications for Use (Describe)
The Multi-Link™ X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring.
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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Image /page/3/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is written in a stylized, sans-serif font in a dark blue color. The letters are connected, giving the logo a modern and fluid appearance. Below "Vyaire", the word "MEDICAL" is written in a smaller, lighter blue font.
510(k) Summary MULTI-LINK™ X2 ECG ADAPTER AND LEADWIRES
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 e-mail Suzanne.Moreno@Vyaire.com
Date Summary February 28, 2020 Prepared:
2.0 Device Information [21 CFR 807.92 (a) (2)]
| Device Classification: | Class II |
|---|---|
| Product Code: | DSA |
| Regulation: | 21 CFR 870.2900 |
| Regulation Name: | Patient transducer and electrode cable (includingconnector) |
| Classification Panel: | 74-Cardiovascular |
| Proprietary Name: | Multi-Link ™ X2 ECG ADAPTER AND LEADWIRES |
| Common Name: | Cable, Transducer and Electrode, Patient, (IncludingConnector) |
Vvaire Medical Inc 22745 Savi Ranch Pkwv Yorba Linda, CA 92887 USA
Vvaire Medical Ox Kuortaneenkatu 2 FI-00510 Helsinki Finland
Vyaire Medical GmbH Leibnizstrasse 7 97204 Hoechberg Germany
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Image /page/4/Picture/1 description: The image shows the logo for Vyaire Medical. The logo is in blue and consists of the word "Vyaire" in a stylized font, with the letters connected. The word "MEDICAL" is written in a smaller, light blue font below the word "Vyaire". The letters in "MEDICAL" are spaced out.
3.0 Predicate and Reference Device Information
| Predicate Device | 510(k) No. | Decision Date |
|---|---|---|
| Multi-Link X2 ECG Cable and LeadWire System | K162432 | 01/18/2017 |
| Reference Device | 510(k) No. | Decision Date |
| Multi-Link X2 ECG Adapter andDirect Connect Lead Wire System | K163316 | 06/22/2017 |
4.0 Device Description [21 CFR 807.92(a) (4)]
The Multi-Link™ X2 ECG Cable, Adapter and Direct Connect Leadwires is an FDA cleared accessory portfolio. The cleared device portfolio consists of adapters & leadwires (reusable adapters and direct connect disposable single patient use leadwires, K163316), and (leadwires reusable, and disposable single patient use, K162432). The cleared portfolio is compatible multiple FDA cleared ECG monitoring platforms, such as Philips, Mindray, Nihon Kohden, GE and Spacelabs. This pre-market notification is to expand the portfolio to be used with additional FDA cleared ECG monitoring platforms.
The Subject device, Multi-Link ™ X2 ECG ADAPTER AND LEADWIRES consists of reusable adapters and direct connect single patient use leadwires that connect to FDA cleared Dräger Infinity (R) monitoring platforms. Design modifications are made to allow for connections with specific additional platforms to allow patients to move throughout the facility without the hassle of disconnecting and reconnecting leadwires.
The system is used to transmit signals from patient ECG electrodes to monitoring equipment, providing patients with continuous ECG (electrocardiogram) monitorina.
This device is common to both industry and medical establishments. The Multi-Link™ X2 ECG ADAPTER AND LEADWIRES 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.
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Image /page/5/Picture/1 description: The image shows the logo for Vyaire Medical. The logo is in blue and consists of the word "Vyaire" in a stylized font, with the letters connected. The word "MEDICAL" is written in a smaller, lighter blue font below the word "Vyaire". There is a trademark symbol to the right of the word "Vyaire".
5.0 Intended Use of device and Indications for Use [21 CFR 807.92(a) (5)]
Intended Use
The Multi-LinkTM X2 ECG Adapter and Leadwires are intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes.
Indications for Use
The Multi-Link™ X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring.
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Image /page/6/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is written in a stylized, sans-serif font in blue. Below "Vyaire" is the word "MEDICAL" in a smaller, lighter blue font. The letters in "MEDICAL" are spaced out.
6.0 Summary of Substantial Equivalence [21 CFR 807.92 (a) (6)]
| Element ofcomparison | Subject DeviceMulti-Link™ X2 ECGADAPTER ANDLEADWIRES | Predicate DeviceMulti-link X2 ECG Cableand Lead Wire System(K162432) | Reference Device Multi-link X2 ECG Adapterand Direct ConnectLead Wire System(K163316) |
|---|---|---|---|
| Intended Use | The Multi-Link™ X2 ECGAdapter and Leadwires areintended to transmit signalsfrom patient electrodes tovarious electrocardiographrecorders / monitors formonitoring purposes. | The Multi-Link Cable andLeadWire System is intended totransmit signals from patientelectrodes to variouselectrocardiograph recorders/monitors for monitoringpurposes. | The Multi-Link™ X2 ECGAdapter and DirectConnect Lead WireSystem is intended totransmit signals frompatient electrodes tovariouselectrocardiographrecorders /monitors formonitoring purposes. |
| Indications forUse | The Multi-Link™ X2 ECGAdapters and Leadwires areused to transmit ECG signalsfrom the electrodes to ECGmonitors for monitoringpurposes. The Adapters arereusable, nonsterile and canbe reprocessed. The Multi-Link Direct-ConnectLeadwires are single-patient-use, nonsterile and cannot bereprocessed. The Multi-LinkX2 ECG Adapters and DirectConnect Leadwire Systemare used with any patientpopulation requiring ECGmonitoring. | The Multi-Link Cable andLead Wire System is intendedto transmit ECG signals frompatient electrodes to patientmonitors for monitoringpurposes. The Multi-LinkCable and Lead Wire Systemis limited to indications foruse of the connectedmonitoring equipment. TheMulti-Link trunk cables (carecables) are reusable,nonsterile and canbe reprocessed. The Multi-Link lead wires are availablereusable and disposable(single patient use). TheMulti-Link Cable and LeadWire System is compatiblewith GE Healthcare, Philips,Mindray, Spacelabs andNihon Kohdenelectrocardiographmonitors. | The Multi-Link™ X2 ECGAdapter and DirectConnect Lead WireSystem are used intelemetry to transmitECG signals from theelectrodes to thetransmitters onambulatory patientswithin a definedcoverage area formonitoring purposes.The Multi-Link Direct-Connect Lead wires aresingle-patient-use,nonsterile and cannot bereprocessed. The Multi-Link Adapters arereusable, nonsterile andcan be reprocessed. TheMulti-Link X2 ECGAdapter and DirectConnect Lead WireSystem are used withany patient populationrequiring ambulatoryECG, and are compatiblewith Philips, Mindray andNihon Kohdenelectrocardiographmonitors. |
| Principal ofOperation | The adapters and leadwiresare cable conductors thatconduct the ECG signal frompatient ECG electrodes to themonitoring equipment. Thesignal is conducted throughinsulated signal wires made | The trunk cables andleadwires are cableconductors that conduct theECG signal from patient ECGelectrodes to the monitoringequipment. The signal isconducted from the ECG | The adapters andleadwires are cableconductors that conductthe ECG signal frompatient ECG electrodesto the monitoringequipment. The signal is |
| of conductive material. Thesignal wires are protectedfrom environmental noisefactors with metal shieldingaround it, acting as Faraday'scage. The adapters have aninsulating jacket made ofthermoplastics providingelectrical insulation. | electrode through insulatedsignal wires made ofconductive material. Thesignal wires are protectedfrom environmental noisefactors with metal shieldingaround it, acting as Faraday'scage. The trunk cables andlead wires have an insulatingjacket made of thermoplasticsproviding electrical insulation. | conducted throughinsulated signal wiresmade of conductivematerial. The signalwires are protected fromenvironmental noisefactors with metalshielding around it,acting as Faraday'scage. The adapters havean insulating jacket madeof thermoplasticsproviding electricalinsulation. | |
| PatientPopulation | Limited to indications for useof the connected monitoringequipment | Limited to indications for useof the connected monitoringequipment | Any patient populationrequiring ambulatoryECG |
| AnatomicalSites | Chest and Leg | Chest and Leg | Chest and Leg |
| Environment ofUse | Hospital Environment | Hospital Environment | Hospital Environment |
| Compatibilitywithenvironmentand otherdevices | Dräger electrocardiographmonitors | Philips, GE, Mindray,Spacelabs and Nihon Kohdenelectrocardiograph monitors | Philips, Mindray andNihon Kohdenelectrocardiographmonitors |
| Characteristics | |||
| Number of leadwires | 3, 5 or 6 lead version | 3, 5, 6 or 12-lead lead version | 3, 5 or 6 lead version |
| Sterility | The Multi-Link adapters arereusable, and nonsterileThe Multi-Link direct connectleadwires are single patient-use, and nonsterile | The Multi-Link trunk cablesare reusable, and nonsterileThe Multi-Link leadwires areavailable as reusable anddisposable (single patientuse) and are nonsterile | The Multi-Link adaptersare reusable, andnonsterileThe Multi-Link directconnect leadwires aresingle patient-use, andnonsterile |
| Cable coatingmaterials:Adapters | Thermoplastic polyurethane(TPU), and Polyvinyl chloride(PVC) | TPU, PVC | TPU, PVC |
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Image /page/7/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a dark blue sans-serif font, with the "V" and "y" connected. Below "Vyaire" is the word "MEDICAL" in a light blue sans-serif font.
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Image /page/8/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is written in a blue sans-serif font, with the letters connected. Above the "re" in Vyaire is the trademark symbol. Below the word "Vyaire" is the word "MEDICAL" in a smaller, light blue sans-serif font.
7.0 Performance Data
The MULTI-LINK™ X2 ECG ADAPTER AND LEADWIRES were tested to ensure compliance to the following standards:
7.1 Performance Testing
| Standard Number | Performance Characteristic |
|---|---|
| AAMI ANSI ES 60601-1:2005/(R):2012 andA1:2012 | Medical electrical equipment – Part 1: Generalrequirements for basic safety and essentialperformance |
| 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 essentialperformance - Collateral standard: Usability |
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Image /page/9/Picture/1 description: The image shows the "Vyaire Medical" logo. The word "Vyaire" is in a dark blue font, and the word "Medical" is in a light blue font. The logo is simple and modern.
7.2 Biocompatibility
The Multi-Link™ X2 adapters do not have patient contact. Per the requirements outlined in ISO 10993-1 biocompatibility testing is not applicable for the adapters for the subject device.
The direct connect single-patient-use lead wires are considered to have surface contact, intact skin with prolonged exposure greater than 24 hours to 30 days. Based on the contact type and duration the following testing was conducted on the leadwires; Cytotoxicity, Sensitization, and Irritation according to the standards listed below.
| Standard Number | Performance Characteristic |
|---|---|
| ISO 10993-1 Fifthedition 2018-08 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| AAMI ANSI ISO10993-5:2009/(R)2014 | Biological Evaluation of Medical Devices-Part 5: Testsfor In Vitro Cytotoxicity |
| AAMI ANSI ISO10993-10:2010/(R)2014 | Biological Evaluation of Medical Devices-Part 10: Testsfor Irritation and Skin Sensitization |
Clinical Data [21 CFR 807.92(b)(2)]
Based on the similarities in the safety and effectiveness profiles of the subject, predicate and reference devices, no clinical studies were deemed needed to support this submission.
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Image /page/10/Picture/1 description: The image shows the logo for Vyaire Medical. The logo is in blue and features the word "Vyaire" in a stylized font, with the letters connected. Above the "e" is the trademark symbol. Below the word "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font in a lighter shade of blue.
7.3 Non-Clinical Performance Test Summary
| Test | Standard | Standard Section | Result |
|---|---|---|---|
| Compatibility Testing withDräger Infinity (R) System | AAMI ANSI IEC60601-2-27:2011(R)2016 | 201.12.1, and101.15 | Pass |
| EC53 section 5.3.5, 5.3.6and 5.3.7 for SubjectDevice Multi-Link™ X2ECG Adapter Yoke andInstrument Connector | AAMI ANSIEC53:2013 | 5.3.5, 5.3.6, and5.3.7 | Pass |
| Inspection of Air Clearancefor Subject Device | AAMI ANSI ES60601-1: 2005/(R):2012 andA1:2012 | 8.5.2.3 | Pass |
| ANSI IEC60601-2-27:2011(R)2016 | 201.8.5.2.3 | ||
| Defibrillation Protection andEnergy Reduction | AAMI ANSI ES 60601-1: 2005/(R):2012 andA1:2012 | 8.5.5.1, and8.5.5.2 | Pass |
| Dielectric WithstandTesting according 60601-1section 8.8.3 and EC53section 5.3.9 | AAMI ANSIEC53:2013 | 5.3.9 | Pass |
| Storage Conditioning andDrop Test | AAMI ANSI ES 60601-1: 2005/(R):2012 andA1:2012 | 15.3.1, 15.3.6, and15.3.7 | Pass |
| Material Resistance forCleaning and DisinfectionStress | AAMI ANSI ES 60601-1: 2005/(R):2012 andA1:2012AAMI ANSIEC53:2013 | 11.6.68.8.3 | Pass |
| EC53 section 5.3.2 forCable Noise | AAMI ANSIEC53:2013 | 5.3.2 | Pass |
| EC53 section 5.3.3 for FlexLife | AAMI ANSIEC53:2013 | 5.3.3 | Pass |
| EC53 section 5.3.4 forTensile Strength | AAMI ANSIEC53:2013 | 5.3.4 | Pass |
| EC53 section 5.3.8 forLeadwire Resistance | AAMI ANSIEC53:2013 | 5.3.8 | Pass |
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Image /page/11/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a stylized font, with the "V" and "y" connected. The word "MEDICAL" is in smaller letters below "Vyaire". The logo is in a blue color.
8.0 Conclusions Safety and Effectiveness SW [21 CFR 807.92(b) (3)]
Based on the same intended use, similar indications for use, same technological characteristics and same principle of operation the subject device, Multi-Link™ X2 ECG ADAPTER AND LEADWIRES are substantially equivalent to the predicate identified in this submission and do 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).