Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

K163316 · Carefusion 303, Inc. · DSA · Jun 22, 2017 · Cardiovascular

Device Facts

• Record ID: K163316
• Device Name: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
• Applicant: Carefusion 303, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Jun 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

The Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System are used in telemetry to transmit ECG signals from the electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Direct Connect Lead Wires are single-patient-use, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used with any patient population requiring ambulatory ECG, and are compatible with Philips, Mindray and Nihon Kohden electrocardiograph monitors.

Device Story

Device consists of reusable adapters and disposable single-patient-use lead wires; functions as accessory to host ECG monitoring equipment. Inputs: electrical ECG signals from patient electrodes. Operation: conductive signal wires transmit ECG data from electrodes to telemetry transmitters; metal shielding acts as Faraday cage to reduce environmental noise; thermoplastic insulating jacket provides electrical insulation. Output: transmitted ECG signal for display on compatible Philips, Mindray, or Nihon Kohden monitors. Used in hospital telemetry settings; operated by healthcare professionals. Benefits: enables continuous ambulatory ECG monitoring by providing reliable signal conduction between patient and monitoring system.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included electrical safety (AAMI ANSI ES60601-1), ECG monitoring equipment safety (AAMI ANSI IEC 60601-2-27), and cable/lead wire performance (AAMI ANSI EC53:2013). Biocompatibility testing (ISO 10993-1, -5, -10) confirmed safety for prolonged skin contact.

Technological Characteristics

Materials: TPU C78A Grey (Munsell N7) thermoplastic jacket. Sensing: Conductive signal wires with metal shielding (Faraday cage). Connectivity: Wired connection to patient electrodes and host telemetry transmitters. Sterilization: Non-sterile. Standards: AAMI ANSI ES60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53:2013, ISO 10993. Form factor: 3, 5, or 6 lead wire configurations.

Indications for Use

Indicated for any patient population requiring ambulatory ECG monitoring in a hospital environment.

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 Cable and Lead Wire Systems (K980582)
• ECG Single Patient Use Lead Wire Set (K101660)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The background is plain white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 22, 2017

Carefusion/Vyaire Medical, Inc. Colleen O'Keeffe Acting Director, Regulatory Affairs 26125 Riverwoods Blvd Mettawa, Illinois 60045

Re: K163316

Trade/Device Name: Multi-link X2 ECG Adapter and Direct Connect Lead Wire System Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: May 23, 2017 Received: Mav 24, 2017

Dear Colleen O'Keeffe:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

M.A. Wilhelm

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163316

Device Name Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System

Indications for Use (Describe)

The Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System are used in telemetry to transmit ECG signals from the electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Direct Connect Lead Wires are single-patient-use, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used with any patient population requiring ambulatory ECG, and are compatible with Philips, Mindray and Nihon Kohden electrocardiograph monitors.

| 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# K163316

## 510(k) Summary

## 1. SUBMITTER

Carefusion/Vyaire Medical, Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 Phone: [phone]

Contact Person: Colleen O'Keeffe Acting Director, Regulatory Affairs

Date Prepared: May 22, 2017

## 2. Device

| Product Name: | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System |
|---------------------------|---------------------------------------------------------------------------------|
| Trade or proprietary name | Multi-Link™ |
| Device Name: | Patient transducer and electrode cable (including connector) |
| Common Name: | Patient transducer and electrode cable (including connector) |
| Classification Name: | Patient transducer and electrode cable (including connector)<br>21 CFR 870.2900 |
| Regulatory Class: | II |
| Product Code: | DSA |

## 3. Predicate Device

Multi-Link Cable and Lead Wire Systems cleared under K980582 on March 16, 1998, and secondary predicate device, ECG Single Patient Use Lead Wire Set, cleared under K101660 on August 11, 2010. These predicate devices have not been subject to a design-related recall.

#### 4. Device Description

The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a combination of reusable adapters, already cleared lead wires (reusable K980582 and disposable single patient use K101660) and direct connect disposable single patient use lead wires, used to transmit signals from patient electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are not stand alone devices, but are accessories to the host monitoring devices. The adapters and lead wires are conductors carrying the signal

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from the patient to the monitor.

## 5. Principle of Operation

Adapters and lead wires are cable conductors to conduct ECG signal from patient ECG electrodes to monitoring equipment. Signal is conducted from ECG electrode through insulated signal wires made of conductive material. Signal wires are protected from environmental noise factors with metal shielding around it, acting as Faraday's cage. The adapters and lead wires have an insulating jacket made of thermoplastics providing electrical insulation.

#### 6. Indication for use

The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used in telemetry to transmit ECG signals from the electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Direct Connect Lead Wires are single-patient-use, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used with any patient population requiring ambulatory ECG, and are compatible with Philips, Mindray and Nihon Kohden electrocardiograph monitors.

| Element of comparison | Proposed Device | Primary Predicate Device<br>Multi-Link Cable and Lead<br>Wire Systems K980582 | Secondary Predicate<br>Device<br>ECG Single Patient Use<br>Lead Wire Set K101660 |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Multi-Link X2 ECG<br>Adapter and Direct Connect<br>Lead Wire System are used<br>in telemetry to transmit<br>ECG signals from the<br>electrodes to the<br>transmitters on ambulatory<br>patients within a defined<br>coverage area for<br>monitoring purposes. The<br>Multi-Link Direct-Connect<br>Leadwires are single-<br>patient-use, nonsterile and<br>cannot be reprocessed. The<br>Multi-Link Adapters are<br>reusable, nonsterile and<br>can be reprocessed. The<br>Multi-Link X2 ECG Adapter<br>and Direct Connect Lead<br>Wire System are used with<br>any patient population<br>requiring ambulatory ECG,<br>and are compatible with<br>Philips, Mindray and Nihon<br>Kohden electrocardiograph | Multi-Link Cable and Lead<br>Wire Systems are reusable<br>electrode cable system used<br>to transmit signals from<br>patient electrodes to various<br>electrocardiograph<br>recorders/monitors from<br>both diagnostic and<br>monitoring purposes. Multi-<br>Link Cable and Lead Wire<br>Systems are limited to<br>indications for use of the<br>connected monitoring or<br>diagnostic equipment. Such<br>equipment is commonly<br>located in hospitals, doctor's<br>offices, and emergency<br>vehicles, as well as in home<br>use | The Single Patient Use ECG<br>Lead Wire is an electrode<br>cable systems used to<br>transmit signals from<br>patient electrodes to<br>various electrocardiograph<br>recorders / monitors for<br>both diagnostic and<br>monitoring purposes. Use<br>is limited by the<br>indications for use of the<br>connected monitoring or<br>diagnostic equipment. The<br>Single Patient Use ECG<br>Lead Wire set is intended<br>to be used by trained<br>operators in a medical<br>professional's<br>environment |
| Element of comparison | Proposed Device | Primary Predicate Device<br>Multi-Link Cable and Lead<br>Wire Systems K980582 | Secondary Predicate<br>Device<br>ECG Single Patient Use<br>Lead Wire Set K101660 |
| | monitors. | | |
| Principle of Operation | Adapters and lead wires are<br>cable conductors to conduct<br>ECG signal from patient ECG<br>electrodes to monitoring<br>equipment. Signal is<br>conducted from ECG<br>electrode through insulated<br>signal wires made of<br>conductive material. Signal<br>wires are protected from<br>environmental noise factors<br>with metal shielding around<br>it, acting as Faraday's cage.<br>The adapters and lead wires<br>have an insulating jacket<br>made of thermoplastics<br>providing electrical<br>insulation. | Trunk cables and lead wires<br>are cable conductors to<br>conduct ECG signal from<br>patient ECG electrodes to<br>monitoring equipment. Signal<br>is conducted from ECG<br>electrode through insulated<br>signal wires made of<br>conductive material. Signal<br>wires are protected from<br>environmental noise factors<br>with metal shielding around<br>it, acting as Faraday's cage.<br>The trunk cables and lead<br>wires have an insulating<br>jacket made of<br>thermoplastics providing<br>electrical insulation. | Trunk cables and lead<br>wires are cable conductors<br>to conduct ECG signal from<br>patient ECG electrodes to<br>monitoring equipment.<br>Signal is conducted from<br>ECG electrode through<br>insulated signal wires<br>made of conductive<br>material. Signal wires are<br>protected from<br>environmental noise<br>factors with metal<br>shielding around it, acting<br>as Faraday's cage. The<br>trunk cables and lead<br>wires have an insulating<br>jacket made of<br>thermoplastics providing<br>electrical insulation. |
| Patient Population | Any patient population<br>requiring ECG monitoring | Any patient population<br>requiring ECG monitoring | Any patient population<br>requiring ECG monitoring |
| Anatomical Sites | Chest | Chest | Chest |
| Environment of Use | Hospital Environment | Hospitals, doctor's offices,<br>and emergency vehicles, as<br>well as in home use | Medical professional's<br>environment |
| Compatibility with<br>environment and other<br>devices | Philips, Mindray and Nihon<br>Kohden electrocardiograph<br>monitors | GE Healthcare<br>electrocardiograph monitors | GE Healthcare<br>electrocardiograph<br>monitors |
| Characteristics | | | |
| Number of lead wires | 3, 5 or 6 lead version | 3,5 or 12 lead version | 3,5 or 12 lead version |
| Sterility | Multi-Link adapters are<br>reusable, nonsterile<br>Multi-Link direct connect<br>lead wire is single-patient-<br>use, nonsterile | Multi-Link trunk cables are<br>reusable, nonsterile<br>Lead wire is<br>reusable, nonsterile | Trunk cables are reusable,<br>nonsterile<br>Lead wire is single-patient-<br>use, nonsterile |
| Element of comparison | Proposed Device | Primary Predicate Device<br>Multi-Link Cable and Lead<br>Wire Systems K980582 | Secondary Predicate<br>Device<br>ECG Single Patient Use<br>Lead Wire Set K101660 |
| Lead wire colors | According 60601-2-27 | According 60601-2-27 | According 60601-2-27 |
| Cable coating materials:<br>Adapters | TPU C78A Grey (Munsell<br>N7) | Polyurethane, Elastolia<br>N1185A10<br>Durometer 85A<br>Color-Munsell N7 (GREY)<br>Colorant: TSE RV73442435<br>Load at 3%<br>TPU 1185A10<br>Polyurethane: Resin PUR<br>Natural 75D Durometer<br>Color Munsell N7 Grey | N/A |

## 7. Comparison of technological characteristics with the predicate device

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# K163316

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# K163316

# 8. Performance Data

The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System was tested to ensure compliance to the following standards:

# 8.1 Performance Testing

| Performance Characteristic | Standard |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Medical electrical equipment – Part 1: General requirements<br>for basic safety and essential performance | AAMI ANSI ES60601-<br>1:2005/(R):2012 and<br>A1:200012 |
| Medical electrical equipment – Part 2-27: Particular<br>requirements for the basic safety and essential performance of<br>electrocardiographic monitoring equipment | AAMI ANSI IEC 60601-2-<br>27:2011 |
| ECG trunk cables and patient leadwires | AAMI ANSI EC53: 2013 |
| Medical electrical equipment – Part 1-6: General requirements<br>for basic safety and essential performance - Collateral<br>standard: Usability | IEC 60601-1-6 Edition 3.1<br>2013-10 |

## Non-clinical Performance Test Summary:

| Test | Relevant<br>Standard | Standard Section | Result |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|------------------------------|--------|
| Compatibility Testing with | 60601-2-27:2011 | 201.12.1.101.15 | Pass |
| Test | Relevant<br>Standard | Standard Section | Result |
| Lifecycle and Contact Resistance<br>According to EC53 Section 5.3.5<br>and 5.3.7 for host Connectors of<br>Multi-Link X2 Adapters and Direct<br>Connect Leadwires and Grabber<br>and Snap Lifecycle According EC53<br>Section 5.3.5 and 5.3.7 for Direct<br>Connect Lead wires | EC53:2013 | 5.3.5 and 5.3.7 | Pass |
| EC53 Section 5.3.5, 5.3.6 and 5.3.7<br>for Multi-Link Yoke of adapter and<br>Lead wires | EC53:2013 | 5.3.5, 5.3.6 and<br>5.3.7 | Pass |
| Inspection of Air Clearance for<br>Multi-Link X2 Telemetry Adapters<br>and Direct Connect's | 60601-1:2012 and<br>60601-2-27:2011 | 8.5.2.3 and<br>201.8.5.2.3 | Pass |
| Defibrillation Protection and<br>Energy Reduction | 60601-1:2012 | 8.5.5.1 and 8.5.5.2 | Pass |
| Dielectric Withstand Testing for<br>Direct Connect's and Telemetry<br>Adapters | 60601-1:2012<br>EC53:2013 | 8.8.3<br>5.3.9 | Pass |
| Storage Conditioning and Drop<br>Test<br>(Results in tables 19.2 B C F and I ) | 60601-1:2012 | 15.3.1, 15.3.6 and<br>15.3.7 | Pass |
| Cable and Lead wire Noise for<br>Multi-Link X2 | EC53:2013 | 5.3.2 | Pass |
| Flex Life Test | EC53:2013 | 5.3.3 | Pass |
| Tensile Strength | EC53:2013 | 5.3.4 | Pass |
| Connector mating/unmating<br>(Results in tables 19.2 B and<br>19.2C) | EC53:2013 | 5.3.5 | Pass |
| Retention force test<br>(Results in table 19.2.C)<br>Clinician validation test | EC53:2013 | 5.3.6 | Pass |
| Contact Resistance Test<br>(Results in tables 19.2.B and<br>19.2.C) | EC53:2013 | 5.3.7 | Pass |
| Lead wire Resistance According<br>EC53 section 5.3.8 for Long SPUL<br>and Direct Connect Lead wires | EC53:2013 | 5.3.8 | Pass |
| Material Resistance for Cleaning<br>and Disinfection Stress for Multi-<br>Link X2 | 60601-1:2012<br>EC53:2013 | 11.6.6<br>8.8.3<br>5.3.9 | Pass |
| Test | Relevant<br>Standard | Standard Section | Result |
| Wiping Durability Test for Long<br>SPUL, Direct Connect Lead wires<br>and Predicate SPUL | 60601-1:2012<br>EC53:2013 | 11.6.6<br>8.8.3<br>5.3.9 | Pass |

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## 8.2 Biocompatibility

Test for skin contact, with a prolonged duration (greater than 24 hours but less than 30 days): Cytotoxicity, Sensitization and Irritation.

| Performance Characteristic | Standard |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Biological evaluation of medical devices - Part 1: Evaluation<br>and testing within a risk management process | AAMI ANSI ISO 10993-1:2009/ (R)<br>2013 |
| Biological Evaluation of Medical Devices-Part 5: Tests for In<br>Vitro Cytotoxicity | AAMI ANSI ISO 10993-5:2009/<br>(R2014) |
| Biological Evaluation of Medical Devices-Part 10: Tests for<br>Irritation and Skin Sensitization. | AAMI ANSI ISO 10993-10:2010/<br>(R2014) |

## 9. Conclusion

The non-clinical data demonstrates that the Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is as safe and as effective as the predicate and therefore substantially equivalent to the predicate device.