Multi-Link X2 ECG Cable and Leadwire System

K211294 · Vyaire Medical, Inc. · DSA · Aug 16, 2021 · Cardiovascular

Device Facts

• Record ID: K211294
• Device Name: Multi-Link X2 ECG Cable and Leadwire System
• Applicant: Vyaire Medical, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Aug 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

The Multi-Link™ X2 ECG Cable and Leadwire System is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes.

Device Story

Multi-Link X2 ECG Cable and Leadwire System transmits ECG signals from patient electrodes to cardiac monitors/defibrillators. System consists of reusable trunk cables and leadwires; acts as passive conductor using insulated signal wires with metal shielding (Faraday cage) to minimize environmental noise; thermoplastic insulating jacket. Used in hospital and pre-hospital environments (emergency scenes, transport) by clinicians. Device does not interpret signals or deliver shocks; provides continuous ECG monitoring connectivity. Benefits include expanded compatibility with Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (ANSI AAMI ES60601-1), performance (ANSI AAMI EC53), and environmental/mechanical testing (shock, vibration, IP classification).

Technological Characteristics

Reusable, non-sterile trunk cables and leadwires. Materials: TPU C78A Grey (Munsell N7) coating. Sensing: Passive electrical signal conduction. Shielding: Metal shielding (Faraday cage). Connectivity: Wired interface to patient electrodes and ECG monitors. Standards: ANSI AAMI ES60601-1, ANSI AAMI EC53, IEC 60601-2-27, IEC 60601-1-12, IEC 60529, IEC 60068.

Indications for Use

Indicated for any patient requiring ECG monitoring, according to the connected monitor's intended patient population. Limited to indications for use of the connected monitoring equipment.

Regulatory Classification

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.

Predicate Devices

• Multi-Link™ X2 ECG Cable and Leadwire System (K162432)

Reference Devices

• K980582
• K101660

Submission Summary (Full Text)

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August 16, 2021

Vyaire Medical. Inc. Joshua Davis Regulatory Affairs Advisor 26125 North Riverwoods Blvd. Mettawa, Illinois 60045

Re: K211294

Trade/Device Name: Multi-Link X2 ECG Cable and Leadwire System Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: July 11, 2021 Received: July 15, 2021

Dear Joshua Davis:

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.

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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

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 531-542 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality 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) K211294

### Device Name

Multi-Link X2 ECG Cable and Leadwire System

Indications for Use (Describe)

The Multi-Link X2 ECG Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (6/20)

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# 510(k) Summary Multi-Link™ X2 ECG Cable and Leadwire System

# This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.

# 1.0 Submitter Information [21 CFR 807.92(a) (1)]

| Submitter: | Vyaire Medical, Inc. |
|-----------------------------------------------|-------------------------------------------------------|
| Address: | 26125 N. Riverwoods Blvd.<br>Mettawa, IL 60045<br>USA |
| Establishment Registration Number: 3013421741 | |

| Official Correspondent: | Joshua Davis |
|-------------------------|----------------------------|
| Title | Regulatory Affairs Advisor |
| Phone: | [phone] |
| Email: | [e-mail] |

| Alternate Contact: | Rekha Anand |
|--------------------|--------------------------------|
| Title | Sr. Manager Regulatory Affairs |
| Phone: | [phone] |
| Email: | [e-mail] |

Date Summary Prepared:

April 27, 2021

## 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 (including<br>connector) |
| Classification Panel: | 74-Cardiovascular |
| Device Name: | Multi-Link™ X2 ECG Cable and |
| | Leadwire System |
| Proprietary Name: | Multi-Link™ |
| Common Name: | Cable, Transducer and Electrode, Patient, (Including<br>Connector) |

# 3.0 Predicate Device Information [21 CFR 807.92(a) (3)]

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The Multi-Link™ X2 ECG Cable and Leadwire System described in this submission is substantially equivalent to the following predicate:

| Predicate Device | 510(k) No. | 510(k) Owner | Decision<br>Date |
|-------------------------------------------------|------------|----------------------|------------------|
| Multi-Link™ X2 ECG Cable<br>and Leadwire System | K162432 | Vyaire Medical, Inc. | 18-Jan-<br>2017 |

# 4.0 Purpose and Device Description [21 CFR 807.92(a) (4)]

The purpose of this subject pre-market notification is to introduce a modified set of Reusable Trunk Cables within the Multi-Link™ X2 ECG Cable and Leadwire System in order to expand the system compatibility with additional FDA-cleared ECG (electrocardiogram) monitoring platforms. There are no changes to the other components within the system, such as Leadwires, and therefore they are not part of this submission.

The Multi-Link™ X2 ECG Cable and Leadwire System is a product portfolio that is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. The system consists of Reusable Trunk Cables (K980582, K101660, K162432), Reusable Leadwires (K980582) and Disposable Single Patient Use Leadwires (K101660, K162432). The existing portfolio is compatible with the following ECG monitoring platforms: Philips, Mindray, Nihon Kohden, GE, and Spacelabs.

The subject device of this pre-market notification consists of a modified set of Reusable Trunk Cables that are designed to be compatible with the following cardiac defibrillation systems: Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms. The subject device is used to transmit signals from patient electrodes and sensors to support continuous ECG monitoring only. The subject device does not interpret or deliver the shock applied when the defibrillators are in use. The subject device was evaluated in accordance with ANSI AAMI ES60601-1 and determined to be defibrillation-proof.

#### 5.0 Intended Use of device and Indications for Use [21 CFR 807.92(a) (5)]

## Intended Use

The Multi-Link™ X2 ECG Cable and Leadwire System is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes.

## Indications for Use

The Multi-Link™ X2 ECG Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The

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Multi-Link™ ECG Cable and Leadwire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables (care cables) are reusable, nonsterile and can be reprocessed.

#### Summary of Substantial Equivalence [21 CFR 807.92 (a)(6)] 6.0

The rationale for substantial equivalence is based on consideration of the following characteristics:

- Intended use: Same as the predicate ●
- Indications for use: Similar to the predicate .
- . Materials: Similar to the predicate
- Technology: Same as the predicate .
- Design Features: Same as the predicate .
- . Performance: Same as the predicate

| Element of<br>comparison | Subject Device<br>Multi-Link X2 ECG Cable and<br>Leadwire System | Predicate Device<br>Multi-Link X2 ECG Cable and<br>Leadwire System<br>(K162432) |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Multi-Link X2 ECG Cable and<br>Leadwire System is intended to<br>transmit signals from patient<br>electrodes to various<br>electrocardiograph recorders /<br>monitors for monitoring purposes. | The Multi-Link Cable and Leadwire<br>System is intended to transmit<br>signals from patient electrodes to<br>various electrocardiograph<br>recorders / monitors for monitoring<br>purposes. |
| Indications for<br>Use | The Multi-Link X2 ECG Cable and<br>Leadwire System is intended to<br>transmit ECG signals from patient<br>electrodes to patient monitors for<br>monitoring purposes. The Multi-Link<br>ECG Cable and Leadwire System is<br>limited to indications for use of the<br>connected monitoring equipment.<br>The Multi-Link trunk cables (care<br>cables) are reusable, nonsterile and<br>can be reprocessed. | The Multi-Link Cable and Leadwire<br>System is intended to transmit<br>ECG signals from patient<br>electrodes to patient monitors for<br>monitoring purposes. The Multi-<br>Link Cable and Leadwire System<br>is limited to indications for use of<br>the connected monitoring<br>equipment. The Multi-Link<br>trunk cables (care cables) are<br>reusable, nonsterile and can be<br>reprocessed. The Multi-Link Cable<br>and Leadwire System is<br>compatible with GE Healthcare,<br>Philips, Mindray, Spacelabs and<br>Nihon Kohden electrocardiograph<br>monitors. |
| Principal of<br>Operation | Trunk Cables and Leadwires are<br>cable conductors to conduct ECG<br>signal from patient ECG electrodes to<br>monitoring equipment. Signal is<br>conducted from ECG electrode<br>through insulated signal wires made<br>of conductive material. Signal wires<br>are protected from environmental<br>noise factors with metal shielding<br>around it, acting as a Faraday's<br>cage. The trunk cables have an<br>insulating jacket made of<br>thermoplastics providing electrical<br>insulation. | Trunk cables and leadwires are<br>cable conductors to<br>conduct ECG signal from patient<br>ECG electrodes to<br>monitoring equipment. Signal is<br>conducted from ECG electrode<br>through insulated signal wires<br>made of conductive material.<br>Signal wires are protected from<br>environmental noise factors with<br>metal shielding around it, acting as<br>a Faraday's cage. The<br>trunk cables and leadwires have<br>an insulating jacket made of<br>thermoplastics providing electrical<br>insulation. |
| Patient<br>Population | Any patient requiring ECG<br>monitoring, according to the<br>monitor's intended patient<br>population. | Any patient population requiring<br>ECG monitoring, according to the<br>monitor's intended patient<br>population. |
| Anatomical<br>Sites | Proposed device does not have<br>anatomical sites itself. The<br>anatomical site of the compatible<br>previously-cleared ECG Leadwires is<br>Chest. | Predicate device cable does not<br>have anatomical sites itself. The<br>anatomical site of the compatible<br>previously-cleared ECG Leadwires<br>is Chest. |
| Environment of<br>Use | Hospital Environment and Pre-<br>Hospital Environment (i.e.,<br>scene of emergency, transport<br>including airborne transport). | Hospital Environment. |
| Compatibility<br>with<br>environment<br>and other<br>devices | Physio Control Lifepak, Zoll R and<br>Zoll X electrocardiograph<br>monitors. | Philips, GE, Mindray, Spacelabs<br>and Nihon Kohden<br>electrocardiograph monitors. |
| Characteristics | | |
| Number of lead<br>wires | 3 or 5 lead | 3, 5, 6 or 12 lead version |
| Sterility | Multi-Link cables are reusable,<br>nonsterile | Multi-Link cables are reusable,<br>nonsterile |
| Cable coating<br>materials: | TPU C78A Grey (Munsell N7) | TPU C78A Grey (Munsell N7) |

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Transmitting signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes is the technological principle for both the subject and predicate devices.

The subject and predicate devices are based on the following same technological elements:

- Conducting electrical signals passively from ECG lead wires to the ECG . monitoring equipment
- Device contains interfaces to allow connection to ECG lead wires and ECG ● monitoring equipment
- Device composed of a plug face, contact pins, pre-mold, over-mold, and cable
- Cable coating materials are the same
- . Signal wires are protected from environmental noise factors with metal shielding around it, acting as Faraday's cage
- The cables have an insulating jacket made of thermoplastics providing electrical . insulation

The following technological differences exist between the subject and predicate devices:

- . The predicate device is compatible with leadwires containing 3, 5, 6 or 12 leads whereas the subject device is only compatible with leadwires containing 3 or 5 leads
- . The trunk cable monitor interfaces are different, as the subject and predicate devices are compatible for connection with different monitors

# 7.0 Performance Data [21 CFR 807.92(b)(1)]

The subject device was tested and analyzed to demonstrate substantial equivalence to the predicate device. The test reports are listed below:

# 7.1 Non-Clinical Performance Testing

| Test Performed | Applicable Standard | Result |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Compatibility Testing with Zoll R,<br>Zoll X and Physio Control<br>Systems | ANSI AAMI IEC 60601-2-<br>27:2011(R)2016 | Pass |
| Connector mating/unmating,<br>Retention force and Contact<br>Resistance for Instrument<br>Connectors | ANSI AAMI EC53:2013 | Pass |
| Test Performed | Applicable Standard | Result |
| Connector mating/unmating,<br>Retention force and Contact<br>Resistance for Multilink Cable<br>Yokes | ANSI AAMI EC53:2013 | Pass |
| Inspection of Air Clearance | ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text)<br>ANSI AAMI IEC 60601-2-<br>27:2011(R)2016 | Pass |
| Cable Noise Testing | ANSI AAMI EC53:2013 | Pass |
| Flex Life Testing | ANSI AAMI EC53:2013 | Pass |
| Tensile Strength Testing | ANSI AAMI EC53:2013 | Pass |
| Defibrillation Protection and<br>Energy Reduction | ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text)<br>ANSI AAMI IEC 60601-2-<br>27:2011(R)2016 | Pass |
| Dielectric Withstand Testing | ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text) | Pass |
| Leakage Current Testing | ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text) | Pass |
| Storage Conditioning and Drop<br>Test | ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text) | Pass |
| Material Resistance for Cleaning<br>and Disinfection Stress | ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text) | Pass |
| Test Performed | Applicable Standard | Result |
| | A2:2010/(R)2012 (Consolidated Text) | |
| | ANSI AAMI EC53:2013 | |
| Resistance from electrosurgery interference | ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Shock, Vibration and IP Classification | IEC 60601-1-12:2014+AMD1:2020 | Pass |
| | IEC 60529:1989+A1:1999+A2:2013 | |
| | IEC 60068-2-27:2008 | |
| | IEC 60068-2-64:2008+AMD1:2019 | |

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#### 7.2 Biocompatibility

The Multi-Link™ X2 ECG Cables do not have any direct or indirect patient contact. The cables have transitory contact with intact skin of the clinician. Per the requirements outlined in ISO 10993-1, biocompatibility testing is not applicable for the subject device.

| Analysis Performed | Applicable Standard |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility<br>Evaluation Plan | ISO 10993-1 Fifth edition 2018-08 Biological evaluation<br>of medical devices - Part 1: Evaluation and testing<br>within a risk management process |

#### 7.3 Clinical Data [21 CFR 807.92(b)(2)]

Based on the similarities in the safety and effectiveness profiles of the subject and predicate devices, no clinical studies were deemed necessary to support this submission.

# 8.0 Conclusions [21 CFR 807.92(b)(3)]

The subject device and predicate device have the same intended use, similar indications for use, same technological characteristics, and the same principle of

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operation. A benefit-risk assessment has concluded that the benefits associated with the subject device outweigh the potential risks. The subject device has successfully passed all acceptance criteria for non-clinical performance testing, demonstrating that the subject device is as safe, as effective, and performs as well as or better than the predicate device for its intended use. Therefore, it can be concluded that the subject device has been shown to be substantially equivalent to the predicate device identified in this submission.