Multi-Link X2 ECG Cable and Lead Wire System

K162432 · Carefusion 2200, Inc. · DSA · Jan 18, 2017 · Cardiovascular

Device Facts

• Record ID: K162432
• Device Name: Multi-Link X2 ECG Cable and Lead Wire System
• Applicant: Carefusion 2200, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Jan 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

The Multi-Link Cable and Lead Wire 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 (care cables) are reusable, nonsterile and can be reprocessed. The Multi-Link lead wires are available reusable and disposable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.

Device Story

System consists of reusable ECG trunk cables and reusable/disposable lead wires; transmits electrical ECG signals from patient electrodes to host electrocardiograph monitors. Conductive signal wires are shielded by metal to form a Faraday cage; insulated by thermoplastic jackets. Used in hospital environments by healthcare professionals. Device is an accessory to host monitors; does not perform independent analysis. Output is raw ECG signal for display/processing by host monitor; facilitates clinical monitoring of cardiac activity.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via compatibility testing with bedside monitors, lifecycle/contact resistance testing (EC53:2013), air clearance inspection (60601-1:2012, 60601-2-27:2011), defibrillation protection, and leakage current testing.

Technological Characteristics

Trunk cables (TPU 75-80A) and lead wires (POM, PVC, TPU) utilize conductive signal wires with metal shielding (Faraday cage) and thermoplastic insulation. Compatible with GE, Philips, Mindray, Spacelabs, and Nihon Kohden monitors. Complies with AAMI ANSI ISO 10993-1, 5, 10 for biocompatibility; EC53:2013 for lifecycle/resistance; 60601-1 and 60601-2-27 for electrical safety/compatibility. Non-sterile.

Indications for Use

Indicated for transmission of ECG signals from patient electrodes to patient monitors for monitoring purposes. Patient population is defined by the 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 Cable and Lead Wire System (K980582)
• ECG Single Patient Use Lead Wire Set (K101660)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

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

January 18, 2017

CareFusion 2200 Inc. Erika Fernandez Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, Illinois 60061

Re: K162432

Trade/Device Name: Multi-link X2 ECG Cable and 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: December 9, 2016 Received: December 12, 2016

Dear Erika Fernandez:

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 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.

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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.

Sincerely.

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

510(k) Number (if known) K162432

Device Name

Multi-Link X2 ECG Cable and Lead Wire System

#### Indications for Use (Describe)

The Multi-Link Cable and Lead Wire System is intended to transmit ECG signals from 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. The Multi-Link lead wires are available reusable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in a dark gray sans-serif font. Below the text, in a smaller font, it says "has joined BD".

5 N Fairway Dr

# Summary of Safety and Effectiveness

510k summary complying with 21 CFR 807.92.

#### 1. SUBMITTER

CareFusion 2200, Inc. 75 N Fairway Drive, Vernon Hills, IL 60061 Phone: [phone] Fax: [phone]

Contact Person: Erika Fernandez Date Prepared: December 9th, 2016

#### 2. Device

| Product Name: | Multi-Link X2 ECG Cable and Lead Wire System |
|----------------------|----------------------------------------------------------------------------------|
| Device Name: | Cable and Lead Wire System |
| Common Name: | Cable, Transducer and Electrode, Patient, (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

This submission demonstrates substantial equivalence to the Multi-Link Cable and Lead Wire System, K980582 was cleared on March 16, 1998. The secondary predicate device, ECG Single Patient Use Lead Wire Set, K101660 was cleared on August 11, 2010. This predicate device has not been subject to a design-related recall.

#### 4. Device Description

The Multi-Link X2 ECG Cable and Lead Wire Systems are a combination of reusable ECG trunk cables and single-patient use lead wires (SPUL) used to transmit signals from patient electrodes to various electrocardiograph monitors for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Cable and Lead Wire Systems are not stand alone devices but are accessories to the host monitoring devices.

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Image /page/4/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the word "CareFusion" in gray text. Below the word "CareFusion" are the words "has joined BD" in a smaller font.

75 N Fairway Or

## 5. Indication for use

The Multi-Link Cable and Lead Wire 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 (care cables) are reusable, nonsterile and can be reprocessed. The Multi-Link lead wires are available reusable and disposable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.

# 6. Comparison of technological characteristics with the predicate device

The fundamental scientific technology is the same for both proposed and predicate device. The trunk cables and lead wires transmit signals from patient electrodes to various electrocardiograph recorders/ monitoring purposes. The Multi-Link X2 Cable and Lead Wire System is substantially equivalent to the predicate devices Multi-Link Cable and Lead Wire Systems and ECG Single Patient Use Lead Wire Set regarding safety, effectiveness, intended use and performance. The proposed Multi-Link X2 Cable and Lead Wire System is designed to work with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors. Successful verification test results ensured that the proposed device does not raise any different question of safety and effectiveness.

| Element of<br>comparison | Proposed Device | Primary<br>Predicate Device<br>K980582 Multi-Link Cable and<br>Lead Wire System | Secondary<br>Predicate Device<br>K101660: ECG Single<br>Patient Use Lead Wire Set |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Multi-Link Cable and Lead<br>Wire System is intended to<br>transmit ECG signals from<br>patient electrodes to patient<br>monitors for monitoring<br>purposes. The Multi-Link Cable<br>and Lead Wire System is<br>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<br>be reprocessed. The Multi-Link<br>lead wires are available<br>reusable and disposable (single<br>patient use).<br>The Multi-Link Cable and Lead<br>Wire System is compatible<br>with GE Healthcare, Philips,<br>Mindray, Spacelabs and Nihon<br>Kohden electrocardiograph<br>monitors. | Multi-Link Cable and Lead Wire<br>Systems are reusable electrode<br>cable system used to transmit<br>signals from patient electrodes to<br>various electrocardiograph<br>recorders/monitors from both<br>diagnostic and monitoring<br>purposes. Multi-Link Cable and<br>Lead Wire Systems are limited to<br>indications for use of the<br>connected monitoring or<br>diagnostic equipment. Such<br>equipment is commonly located<br>in hospitals, doctor's offices, and<br>emergency vehicles, as well as in<br>home 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 is<br>limited by the indications<br>for use of the connected<br>monitoring or diagnostic<br>equipment. The Single<br>Patient Use ECG Lead Wire<br>set is intended to be used<br>by trained operators in a<br>medical professional's<br>environment |
| Element of<br>comparison | Proposed Device | Primary<br>Predicate Device<br>K980582 Multi-Link Cable and<br>Lead Wire System | Secondary<br>Predicate Device<br>K101660: ECG Single<br>Patient Use Lead Wire Set |
| Principal of<br>Operation | 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 it,<br>acting as Faraday's cage. The<br>trunk cables and lead wires<br>have an insulating jacket made<br>of thermoplastics providing<br>electrical insulation. | Trunk cables and lead-wires are<br>cable conductors to conduct ECG<br>signal from patient ECG<br>electrodes to monitoring<br>equipment. Signal is conducted<br>from ECG electrode through<br>insulated signal wires made of<br>conductive material. Signal wires<br>are protected from<br>environmental noise factors with<br>metal shielding around it, acting<br>as Faraday's cage. The trunk<br>cables and lead wires have an<br>insulating jacket made of<br>thermoplastics providing<br>electrical insulation. | Trunk cables and lead-wires<br>are cable conductors to<br>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 made<br>of conductive material.<br>Signal wires are protected<br>from environmental noise<br>factors with metal shielding<br>around it, acting as<br>Faraday's cage. The trunk<br>cables and lead wires have<br>an insulating jacket made of<br>thermoplastics providing<br>electrical insulation. |
| Patient<br>Population | Limited to indications for use<br>of the connected monitoring<br>equipment | Limited to indications for use of<br>the connected monitoring<br>equipment | Limited to indications for<br>use of the connected<br>monitoring equipment |
| Anatomical Sites | Chest and Leg | Chest and Leg | Chest and Leg |
| Environment of<br>Use | Hospital Environment | Hospitals, doctor's offices, and<br>emergency vehicles, as well as in<br>home use | Medical professional's<br>environment |
| Compatibility<br>with environment<br>and other devices | GE Healthcare, Philips,<br>Mindray, Spacelabs and Nihon<br>Kohden electrocardiograph<br>monitors | GE Healthcare electrocardiograph<br>monitors | GE Healthcare<br>electrocardiograph<br>monitors |
| Characteristics | | | |
| Number of lead<br>wires | 3, 5, 6 or 12 lead version | 3,5 or 12 | 3,5 or 12 |
| Sterility | Multi-Link trunk cables are<br>reusable, nonsterile<br>Multi-Link leadwire is single- | Multi-Link trunk cables are<br>reusable, nonsterile<br>Multi-Link leadwire is reusable, | Multi-Link trunk cables are<br>reusable, nonsterile<br>Multi-Link leadwire is single- |
| Lead wire colors | patient-use, nonsterile<br>According 60601-2-27 | nonsterile<br>According 60601-2-27 | patient-use, nonsterile<br>According 60601-2-27 |
| Element of<br>comparison | Proposed Device | Primary<br>Predicate Device<br>K980582 Multi-Link Cable and<br>Lead Wire System | Secondary<br>Predicate Device<br>K101660: ECG Single<br>Patient Use Lead Wire Set |
| Cable coating<br>materials: trunk<br>cables | TPU 75-80A Grey (Munsell N7) | POLYURETHANE,ELASTOLIAN118<br>5A10<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 |
| Cable coating<br>materials: Single<br>Patient Use lead<br>wires | POM BASF N2320 003 UNC<br>Grey (Munsell N7)<br>POM BASF N2320 003 UNC<br>White (Pantone Bright White)<br>POM BASF N2320 003 UNC<br>Brown (Pantone 161C)<br>Medical PVC Green (RAL6019)<br>TPU C78A Grey (Munsell N7)<br>TPU C78A Brown (Pantone<br>161C)<br>TPU C78A White (Pantone<br>Bright White) | SANTOPRENE 271-87<br>PP Hival<br>2420NA(Body)+SANTOPRENE<br>271-73(color band<br>TPU4675 N7 Gray<br>DOW TPU 2102-75A | POM BASF N2320 003 UNC<br>Grey (Munsell N7)<br>POM BASF N2320 003 UNC<br>White (Pantone Bright<br>White)<br>POM BASF N2320 003 UNC<br>Brown (Pantone 161C)<br>Medical PVC Green<br>(RAL6019)<br>TPU C78A Grey (Munsell<br>N7)<br>TPU C78A Brown (Pantone<br>161C)<br>TPU C78A White (Pantone<br>Bright White) |
| Cable coating<br>materials:<br>Reusable lead<br>wires | SANTOPRENE 271-87<br>PP Hival<br>2420NA(Body)+SANTOPRENE<br>271-73(color band<br>TPU4675 N7 Gray<br>DOW TPU 2102-75A | SANTOPRENE 271-87<br>PP Hival<br>2420NA(Body)+SANTOPRENE<br>271-73(color band<br>TPU4675 N7 Gray<br>DOW TPU 2102-75A | POM BASF N2320 003 UNC<br>Grey (Munsell N7)<br>POM BASF N2320 003 UNC<br>White (Pantone Bright<br>White)<br>POM BASF N2320 003 UNC<br>Brown (Pantone 161C)<br>Medical PVC Green<br>(RAL6019)<br>TPU C78A Grey (Munsell<br>N7)<br>TPU C78A Brown (Pantone<br>161C)<br>TPU C78A White (Pantone<br>Bright White) |

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Image /page/5/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in gray. Below the text, in smaller gray font, it says "has joined BD".

75 N. Fairway Dr.
Vernon Hills, IL 60061
Phone: [phone]
Fax: carefusion.com

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Image /page/6/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, in smaller font, it says "has joined BD".

75 N. Fairway Dr.
Vernon Hills, IL 60061
Phone: [phone]
Fax: carefusion.com

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Image /page/7/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in a dark gray sans-serif font. Below the text, in a smaller font, it says "has joined BD".

75 N Fairway

## 7. Performance Data

The proposed device was tested to ensure compliance to the following standards:

## Biocompatibility

The lead wire is considered to be a skin contact, with a prolonged duration (greater than 24 hours to 30 days): Cytotoxicity, Sensitization, and Irritation. The trunk cable has no patient contact.

#### Standards

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

#### Performance

The following tests were performed for the proposed device to support the substantial equivalence decision.

| Test | Relevant Standard |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Compatibility Testing with Bedside Monitors | 60601-2-27:2011 |
| Lifecycle and Contact Resistance According to EC53 Section<br>5.3.5 and 5.3.7 for Instrument Connectors of X2-Cables and<br>Grabber and Snap Lifecycle According EC53 Section 5.3.5<br>and 5.3.7 for Long SPUL and Direct Connect Lead wires | EC53:2013 |
| EC53 Section 5.3.5, 5.3.6 and 5.3.7 for Multi-Link Yoke and<br>Long Lead wires | EC53:2013 |
| Inspection of Air Clearance for Multi-Link X2 | 60601-1:2012 and 60601-<br>2-27:2011 |
| Defibrillation Protection and Energy Reduction | 60601-1 |
| Leakage Current Test for Multi-Link X2 Cables, Long SPUL's<br>and Predicates | 60601-1:2012 |