(140 days)
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.
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.
The provided text is a 510(k) premarket notification for a medical device called the "Multi-Link X2 ECG Cable and Lead Wire System." This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. It covers the device's indications for use, technological characteristics, and performance data, primarily focusing on compliance with established medical device standards.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the device performance is demonstrated through adherence to recognized medical device standards. The "Performance Data" section lists the standards the device was tested against and states that the tests were performed to support substantial equivalence.
| Performance Characteristic | Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | AAMI ANSI ISO 10993-5:2009/ (R2014) | The lead wire is considered to be a skin contact with prolonged duration. Tests for Cytotoxicity, Sensitization, and Irritation were performed (implied successful by submission). |
| Sensitization | AAMI ANSI ISO 10993-10:2010/ (R2014) | The lead wire is considered to be a skin contact with prolonged duration. Tests for Cytotoxicity, Sensitization, and Irritation were performed (implied successful by submission). |
| Irritation | AAMI ANSI ISO 10993-10:2010/ (R2014) | The lead wire is considered to be a skin contact with prolonged duration. Tests for Cytotoxicity, Sensitization, and Irritation were performed (implied successful by submission). |
| General Biocompatibility | AAMI ANSI ISO 10993-1:2009/ (R) 2013 | Biological evaluation performed within a risk management process (implied successful by submission). |
| Electrical Performance | ||
| Compatibility Testing with Bedside Monitors | 60601-2-27:2011 | Tests performed to ensure compatibility (implied successful by submission). |
| Lifecycle and Contact Resistance (Instrument Connectors) | EC53:2013 (Section 5.3.5 and 5.3.7) | Tests performed (implied successful by submission). |
| Grabber and Snap Lifecycle (Long SPUL and Direct Connect Lead wires) | EC53:2013 (Section 5.3.5 and 5.3.7) | Tests performed (implied successful by submission). |
| Multi-Link Yoke and Long Lead wires | EC53:2013 (Section 5.3.5, 5.3.6 and 5.3.7) | Tests performed (implied successful by submission). |
| Inspection of Air Clearance | 60601-1:2012 and 60601-2-27:2011 | Tests performed (implied successful by submission). |
| Defibrillation Protection and Energy Reduction | 60601-1 | Tests performed (implied successful by submission). |
| Leakage Current Test | 60601-1:2012 | Tests performed (implied successful by submission). |
The document states, "Successful verification test results ensured that the proposed device does not raise any different question of safety and effectiveness." This indicates that the device met the requirements of the listed standards, and this compliance serves as the "acceptance criteria" for demonstrating substantial equivalence for this type of device (ECG cables and lead wires).
For a device like an ECG cable and lead wire system, performance is primarily assessed through its ability to safely and effectively transmit ECG signals, which is verified through compliance with electrical safety, biocompatibility, and functional standards, rather than diagnostic accuracy metrics typically associated with AI-driven diagnostic devices.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data, as it describes a hardware device that transmits signals rather than a diagnostic algorithm. The testing described refers to engineering verification and validation of the device's physical and electrical characteristics against recognized safety and performance standards. Therefore, information about "sample size" for a clinical test set or "data provenance" (country of origin, retrospective/prospective) is not applicable here. The testing would involve a sufficient number of device units or components to demonstrate compliance with the specified standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to the presented device and study. The "ground truth" for an ECG cable and lead wire system is its adherence to electrical and material safety standards, which is assessed through laboratory testing and engineering analysis, not through expert clinical consensus on diagnostic findings.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often with AI systems. The studies here involve objective measurements against technical standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is an ECG cable and lead wire system, which are hardware accessories for patient monitoring. It does not incorporate AI technology, nor is it a diagnostic tool that assists human readers in interpreting results. Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a hardware component; it is not an algorithm and does not operate in a standalone algorithmic capacity.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is compliance with established international and national medical device standards for electrical safety, biocompatibility, and functional performance (e.g., "60601-2-27:2011," "EC53:2013," "AAMI ANSI ISO 10993"). This is determined through objective engineering tests and material analyses.
8. The Sample Size for the Training Set:
This information is not applicable. The device is an ECG cable and lead wire system, which undergoes engineering verification and validation. It is not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable, as there is no "training set" for this hardware device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 847-362-8097 Fax: 312 949-0731
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)(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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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 ofcomparison | Proposed Device | PrimaryPredicate DeviceK980582 Multi-Link Cable andLead Wire System | SecondaryPredicate DeviceK101660: ECG SinglePatient Use Lead Wire Set |
|---|---|---|---|
| Indications forUse | The Multi-Link Cable and LeadWire System is intended totransmit ECG signals frompatient electrodes to patientmonitors for monitoringpurposes. The Multi-Link Cableand Lead Wire System islimited to indications for use ofthe connected monitoringequipment. The Multi-Linktrunk cables (care cables) arereusable, nonsterile and canbe reprocessed. The Multi-Linklead wires are availablereusable and disposable (singlepatient use).The Multi-Link Cable and LeadWire System is compatiblewith GE Healthcare, Philips,Mindray, Spacelabs and NihonKohden electrocardiographmonitors. | Multi-Link Cable and Lead WireSystems are reusable electrodecable system used to transmitsignals from patient electrodes tovarious electrocardiographrecorders/monitors from bothdiagnostic and monitoringpurposes. Multi-Link Cable andLead Wire Systems are limited toindications for use of theconnected monitoring ordiagnostic equipment. Suchequipment is commonly locatedin hospitals, doctor's offices, andemergency vehicles, as well as inhome use | The Single Patient Use ECGLead Wire is an electrodecable systems used totransmit signals frompatient electrodes tovarious electrocardiographrecorders / monitors forboth diagnostic andmonitoring purposes. Use islimited by the indicationsfor use of the connectedmonitoring or diagnosticequipment. The SinglePatient Use ECG Lead Wireset is intended to be usedby trained operators in amedical professional'senvironment |
| Element ofcomparison | Proposed Device | PrimaryPredicate DeviceK980582 Multi-Link Cable andLead Wire System | SecondaryPredicate DeviceK101660: ECG SinglePatient Use Lead Wire Set |
| Principal ofOperation | Trunk cables and lead-wiresare cable conductors toconduct ECG signal frompatient ECG electrodes tomonitoring equipment. Signalis conducted from ECGelectrode through insulatedsignal wires made ofconductive material. Signalwires are protected fromenvironmental noise factorswith metal shielding around it,acting as Faraday's cage. Thetrunk cables and lead wireshave an insulating jacket madeof thermoplastics providingelectrical insulation. | Trunk cables and lead-wires arecable conductors to conduct ECGsignal from patient ECGelectrodes to monitoringequipment. Signal is conductedfrom ECG electrode throughinsulated signal wires made ofconductive material. Signal wiresare protected fromenvironmental noise factors withmetal shielding around it, actingas Faraday's cage. The trunkcables and lead wires have aninsulating jacket made ofthermoplastics providingelectrical insulation. | Trunk cables and lead-wiresare cable conductors toconduct ECG signal frompatient ECG electrodes tomonitoring equipment.Signal is conducted fromECG electrode throughinsulated signal wires madeof conductive material.Signal wires are protectedfrom environmental noisefactors with metal shieldingaround it, acting asFaraday's cage. The trunkcables and lead wires havean insulating jacket made ofthermoplastics providingelectrical insulation. |
| PatientPopulation | Limited to indications for useof the connected monitoringequipment | Limited to indications for use ofthe connected monitoringequipment | Limited to indications foruse of the connectedmonitoring equipment |
| Anatomical Sites | Chest and Leg | Chest and Leg | Chest and Leg |
| Environment ofUse | Hospital Environment | Hospitals, doctor's offices, andemergency vehicles, as well as inhome use | Medical professional'senvironment |
| Compatibilitywith environmentand other devices | GE Healthcare, Philips,Mindray, Spacelabs and NihonKohden electrocardiographmonitors | GE Healthcare electrocardiographmonitors | GE Healthcareelectrocardiographmonitors |
| Characteristics | |||
| Number of leadwires | 3, 5, 6 or 12 lead version | 3,5 or 12 | 3,5 or 12 |
| Sterility | Multi-Link trunk cables arereusable, nonsterileMulti-Link leadwire is single- | Multi-Link trunk cables arereusable, nonsterileMulti-Link leadwire is reusable, | Multi-Link trunk cables arereusable, nonsterileMulti-Link leadwire is single- |
| Lead wire colors | patient-use, nonsterileAccording 60601-2-27 | nonsterileAccording 60601-2-27 | patient-use, nonsterileAccording 60601-2-27 |
| Element ofcomparison | Proposed Device | PrimaryPredicate DeviceK980582 Multi-Link Cable andLead Wire System | SecondaryPredicate DeviceK101660: ECG SinglePatient Use Lead Wire Set |
| Cable coatingmaterials: trunkcables | TPU 75-80A Grey (Munsell N7) | POLYURETHANE,ELASTOLIAN1185A10DUROMETER 85ACOLOR-MUNSELL N7 (GREY)COLORANT: TSE RV73442435Load at 3%TPU 1185A10POLYURETHANE: RESIN PURNATURAL 75D DUROMETERCOLOR MUNSELL N7 GREY | N/A |
| Cable coatingmaterials: SinglePatient Use leadwires | POM BASF N2320 003 UNCGrey (Munsell N7)POM BASF N2320 003 UNCWhite (Pantone Bright White)POM BASF N2320 003 UNCBrown (Pantone 161C)Medical PVC Green (RAL6019)TPU C78A Grey (Munsell N7)TPU C78A Brown (Pantone161C)TPU C78A White (PantoneBright White) | SANTOPRENE 271-87PP Hival2420NA(Body)+SANTOPRENE271-73(color bandTPU4675 N7 GrayDOW TPU 2102-75A | POM BASF N2320 003 UNCGrey (Munsell N7)POM BASF N2320 003 UNCWhite (Pantone BrightWhite)POM BASF N2320 003 UNCBrown (Pantone 161C)Medical PVC Green(RAL6019)TPU C78A Grey (MunsellN7)TPU C78A Brown (Pantone161C)TPU C78A White (PantoneBright White) |
| Cable coatingmaterials:Reusable leadwires | SANTOPRENE 271-87PP Hival2420NA(Body)+SANTOPRENE271-73(color bandTPU4675 N7 GrayDOW TPU 2102-75A | SANTOPRENE 271-87PP Hival2420NA(Body)+SANTOPRENE271-73(color bandTPU4675 N7 GrayDOW TPU 2102-75A | POM BASF N2320 003 UNCGrey (Munsell N7)POM BASF N2320 003 UNCWhite (Pantone BrightWhite)POM BASF N2320 003 UNCBrown (Pantone 161C)Medical PVC Green(RAL6019)TPU C78A Grey (MunsellN7)TPU C78A Brown (Pantone161C)TPU C78A White (PantoneBright 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: 847 362-8097
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: 847 362-8097
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: Evaluationand testing within a risk management process | AAMI ANSI ISO 10993-1:2009/ (R) 2013 |
| Biological Evaluation of Medical Devices-Part 5: Tests for InVitro Cytotoxicity | AAMI ANSI ISO 10993-5:2009/ (R2014) |
| Biological Evaluation of Medical Devices-Part 10: Tests forIrritation and Skin Sensitization. | AAMI ANSI ISO 10993-10:2010/ (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 Section5.3.5 and 5.3.7 for Instrument Connectors of X2-Cables andGrabber and Snap Lifecycle According EC53 Section 5.3.5and 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 andLong Lead wires | EC53:2013 |
| Inspection of Air Clearance for Multi-Link X2 | 60601-1:2012 and 60601-2-27:2011 |
| Defibrillation Protection and Energy Reduction | 60601-1 |
| Leakage Current Test for Multi-Link X2 Cables, Long SPUL'sand Predicates | 60601-1:2012 |
§ 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).