(211 days)
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.
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 from the patient to the monitor.
This document is a 510(k) Premarket Notification from the FDA for a device called "Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System" (K163316). It primarily focuses on demonstrating substantial equivalence to predicate devices through performance and biocompatibility testing against international standards.
Given the nature of the device (ECG adapters and lead wires), the acceptance criteria are based on meeting specified performance standards rather than measures like accuracy, sensitivity, or specificity often associated with diagnostic AI tools. Therefore, information related to AI-specific elements such as training/test sets, ground truth establishment, expert adjudication, or MRMC studies for improved human reader performance will not be relevant.
Here's the breakdown of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic (Acceptance Criteria - Standard/Section) | Reported Device Performance |
|---|---|
| Non-clinical Performance Testing | |
| Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (AAMI ANSI ES60601-1:2005/(R):2012 and A1:200012) | Pass |
| Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (AAMI ANSI IEC 60601-2-27:2011) | Pass |
| ECG trunk cables and patient leadwires (AAMI ANSI EC53: 2013) | Pass |
| Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6 Edition 3.1 2013-10) | Not explicitly detailed but implied by "Pass" for all relevant tests. |
| Specific Performance Tests (derived from the above standards): | |
| Compatibility Testing | Pass |
| Lifecycle and Contact Resistance | Pass |
| Inspection of Air Clearance | Pass |
| Defibrillation Protection and Energy Reduction | Pass |
| Dielectric Withstand Testing | Pass |
| Storage Conditioning and Drop Test | Pass |
| Cable and Lead wire Noise | Pass |
| Flex Life Test | Pass |
| Tensile Strength | Pass |
| Connector mating/unmating | Pass |
| Retention force test | Pass |
| Contact Resistance Test | Pass |
| Lead wire Resistance | Pass |
| Material Resistance for Cleaning and Disinfection Stress | Pass |
| Wiping Durability Test | Pass |
| Biocompatibility Testing | |
| Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (AAMI ANSI ISO 10993-1:2009/(R)2013) | Implied "Pass" by completing the subsequent tests. |
| Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity (AAMI ANSI ISO 10993-5:2009/(R2014)) | Pass |
| Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization (AAMI ANSI ISO 10993-10:2010/(R2014)) | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes performance testing of physical components (adaptors and lead wires) against established engineering and safety standards. It does not refer to a "test set" in the context of clinical data or patient records. Therefore, information about sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided. The testing is likely conducted in a laboratory setting on a sample of manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable. The device is a medical accessory, and its performance is evaluated against engineering and safety standards, not against "ground truth" established by clinical experts for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable, as the testing involves meeting pre-defined objective engineering standards, not subjective clinical evaluations requiring adjudication.
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
An MRMC study is not relevant to this device. This device is an ECG adapter and lead wire system, which transmits ECG signals. It is not an AI-powered diagnostic tool, and therefore, there is no human reader "improvement with AI vs without AI assistance" to measure.
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 physical accessory and does not contain an "algorithm" for standalone performance evaluation in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is defined by the objective pass/fail criteria outlined in the referenced international engineering and safety standards (e.g., AAMI ANSI ES60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53, ISO 10993 series). There is no clinical "ground truth" like expert consensus or pathology involved in evaluating these performance characteristics.
8. The sample size for the training set
This information is not applicable. The device is a physical accessory and does not involve training data or algorithms in the way an AI-driven diagnostic device would.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
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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 (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.
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)
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K163316
510(k) Summary
1. SUBMITTER
Carefusion/Vyaire Medical, Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 Phone: (224) 706-6818
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)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 DeviceMulti-Link Cable and LeadWire Systems K980582 | Secondary PredicateDeviceECG Single Patient UseLead Wire Set K101660 |
|---|---|---|---|
| Indications for Use | The Multi-Link X2 ECGAdapter and Direct ConnectLead Wire System are usedin telemetry to transmitECG signals from theelectrodes to thetransmitters on ambulatorypatients within a definedcoverage area formonitoring purposes. TheMulti-Link Direct-ConnectLeadwires are single-patient-use, nonsterile andcannot be reprocessed. TheMulti-Link Adapters arereusable, nonsterile andcan be reprocessed. TheMulti-Link X2 ECG Adapterand Direct Connect LeadWire System are used withany patient populationrequiring ambulatory ECG,and are compatible withPhilips, Mindray and NihonKohden electrocardiograph | Multi-Link Cable and LeadWire Systems are reusableelectrode cable system usedto transmit signals frompatient electrodes to variouselectrocardiographrecorders/monitors fromboth diagnostic andmonitoring purposes. Multi-Link Cable and Lead WireSystems are limited toindications for use of theconnected monitoring ordiagnostic equipment. Suchequipment is commonlylocated in hospitals, doctor'soffices, and emergencyvehicles, as well as in homeuse | The Single Patient Use ECGLead Wire is an electrodecable systems used totransmit signals frompatient electrodes tovarious electrocardiographrecorders / monitors forboth diagnostic andmonitoring purposes. Useis limited by theindications for use of theconnected monitoring ordiagnostic equipment. TheSingle Patient Use ECGLead Wire set is intendedto be used by trainedoperators in a medicalprofessional'senvironment |
| Element of comparison | Proposed Device | Primary Predicate DeviceMulti-Link Cable and LeadWire Systems K980582 | Secondary PredicateDeviceECG Single Patient UseLead Wire Set K101660 |
| monitors. | |||
| Principle of Operation | Adapters and lead wires arecable conductors to conductECG signal from patient ECGelectrodes to monitoringequipment. Signal isconducted from ECGelectrode through insulatedsignal wires made ofconductive material. Signalwires are protected fromenvironmental noise factorswith metal shielding aroundit, acting as Faraday's cage.The adapters and lead wireshave an insulating jacketmade of thermoplasticsproviding electricalinsulation. | 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 aroundit, acting as Faraday's cage.The trunk cables and leadwires have an insulatingjacket made ofthermoplastics providingelectrical insulation. | Trunk cables and leadwires are cable conductorsto conduct ECG signal frompatient ECG electrodes tomonitoring equipment.Signal is conducted fromECG electrode throughinsulated signal wiresmade of conductivematerial. Signal wires areprotected fromenvironmental noisefactors with metalshielding around it, actingas Faraday's cage. Thetrunk cables and leadwires have an insulatingjacket made ofthermoplastics providingelectrical insulation. |
| Patient Population | Any patient populationrequiring ECG monitoring | Any patient populationrequiring ECG monitoring | Any patient populationrequiring ECG monitoring |
| Anatomical Sites | Chest | Chest | Chest |
| Environment of Use | Hospital Environment | Hospitals, doctor's offices,and emergency vehicles, aswell as in home use | Medical professional'senvironment |
| Compatibility withenvironment and otherdevices | Philips, Mindray and NihonKohden electrocardiographmonitors | GE Healthcareelectrocardiograph monitors | GE Healthcareelectrocardiographmonitors |
| 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 arereusable, nonsterileMulti-Link direct connectlead wire is single-patient-use, nonsterile | Multi-Link trunk cables arereusable, nonsterileLead wire isreusable, nonsterile | Trunk cables are reusable,nonsterileLead wire is single-patient-use, nonsterile |
| Element of comparison | Proposed Device | Primary Predicate DeviceMulti-Link Cable and LeadWire Systems K980582 | Secondary PredicateDeviceECG Single Patient UseLead Wire Set K101660 |
| Lead wire colors | According 60601-2-27 | According 60601-2-27 | According 60601-2-27 |
| Cable coating materials:Adapters | TPU C78A Grey (MunsellN7) | Polyurethane, ElastoliaN1185A10Durometer 85AColor-Munsell N7 (GREY)Colorant: TSE RV73442435Load at 3%TPU 1185A10Polyurethane: Resin PURNatural 75D DurometerColor 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 requirementsfor basic safety and essential performance | AAMI ANSI ES60601-1:2005/(R):2012 andA1:200012 |
| Medical electrical equipment – Part 2-27: Particularrequirements for the basic safety and essential performance ofelectrocardiographic monitoring equipment | AAMI ANSI IEC 60601-2-27:2011 |
| ECG trunk cables and patient leadwires | AAMI ANSI EC53: 2013 |
| Medical electrical equipment – Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability | IEC 60601-1-6 Edition 3.12013-10 |
Non-clinical Performance Test Summary:
| Test | RelevantStandard | Standard Section | Result |
|---|---|---|---|
| Compatibility Testing with | 60601-2-27:2011 | 201.12.1.101.15 | Pass |
| Test | RelevantStandard | Standard Section | Result |
| Lifecycle and Contact ResistanceAccording to EC53 Section 5.3.5and 5.3.7 for host Connectors ofMulti-Link X2 Adapters and DirectConnect Leadwires and Grabberand Snap Lifecycle According EC53Section 5.3.5 and 5.3.7 for DirectConnect Lead wires | EC53:2013 | 5.3.5 and 5.3.7 | Pass |
| EC53 Section 5.3.5, 5.3.6 and 5.3.7for Multi-Link Yoke of adapter andLead wires | EC53:2013 | 5.3.5, 5.3.6 and5.3.7 | Pass |
| Inspection of Air Clearance forMulti-Link X2 Telemetry Adaptersand Direct Connect's | 60601-1:2012 and60601-2-27:2011 | 8.5.2.3 and201.8.5.2.3 | Pass |
| Defibrillation Protection andEnergy Reduction | 60601-1:2012 | 8.5.5.1 and 8.5.5.2 | Pass |
| Dielectric Withstand Testing forDirect Connect's and TelemetryAdapters | 60601-1:2012EC53:2013 | 8.8.35.3.9 | Pass |
| Storage Conditioning and DropTest(Results in tables 19.2 B C F and I ) | 60601-1:2012 | 15.3.1, 15.3.6 and15.3.7 | Pass |
| Cable and Lead wire Noise forMulti-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(Results in tables 19.2 B and19.2C) | EC53:2013 | 5.3.5 | Pass |
| Retention force test(Results in table 19.2.C)Clinician validation test | EC53:2013 | 5.3.6 | Pass |
| Contact Resistance Test(Results in tables 19.2.B and19.2.C) | EC53:2013 | 5.3.7 | Pass |
| Lead wire Resistance AccordingEC53 section 5.3.8 for Long SPULand Direct Connect Lead wires | EC53:2013 | 5.3.8 | Pass |
| Material Resistance for Cleaningand Disinfection Stress for Multi-Link X2 | 60601-1:2012EC53:2013 | 11.6.68.8.35.3.9 | Pass |
| Test | RelevantStandard | Standard Section | Result |
| Wiping Durability Test for LongSPUL, Direct Connect Lead wiresand Predicate SPUL | 60601-1:2012EC53:2013 | 11.6.68.8.35.3.9 | 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: 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) |
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.
§ 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).