(110 days)
The Multi-Link X2 ECG Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed.
The Multi-Link™ X2 ECG Cable and Leadwire System is a product portfolio that is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. The system consists of Reusable Trunk Cables (K980582, K101660, K162432), Reusable Leadwires (K980582) and Disposable Single Patient Use Leadwires (K101660, K162432). The existing portfolio is compatible with the following ECG monitoring platforms: Philips, Mindray, Nihon Kohden, GE, and Spacelabs. The subject device of this pre-market notification consists of a modified set of Reusable Trunk Cables that are designed to be compatible with the following cardiac defibrillation systems: Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms. The subject device is used to transmit signals from patient electrodes and sensors to support continuous ECG monitoring only. The subject device does not interpret or deliver the shock applied when the defibrillators are in use.
The provided text describes a 510(k) premarket notification for the "Multi-Link X2 ECG Cable and Leadwire System." This submission is to introduce a modified set of reusable trunk cables to expand system compatibility with additional FDA-cleared ECG monitoring platforms. The document outlines the device's intended use, indications for use, and a comparison to a predicate device (K162432).
Crucially, this document is for a medical device that transmits ECG signals from electrodes to monitors, i.e., it's a cable system. It is not an AI/algorithm-based diagnostic device. Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies) are not applicable to this submission.
Instead, the acceptance criteria for this device are related to its electrical and mechanical performance, and its ability to properly and safely transmit signals without interference or degradation. The "study" proving it meets these criteria is a series of non-clinical performance tests against established industry standards.
Here's how to interpret the information provided in the context of the requested questions, noting where the requested information is not applicable:
1. A table of acceptance criteria and the reported device performance
For a cable system, acceptance criteria are typically defined by performance standards. The reported performance is "Pass" for all tests, indicating it met the criteria defined by the applicable standards.
| Acceptance Criterion (Test Performed) | Applicable Standard | Reported Device Performance |
|---|---|---|
| Compatibility Testing with Zoll R, Zoll X and Physio Control Systems | ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Connector mating/unmating, Retention force and Contact Resistance for Instrument Connectors | ANSI AAMI EC53:2013 | Pass |
| Connector mating/unmating, Retention force and Contact Resistance for Multilink Cable Yokes | ANSI AAMI EC53:2013 | Pass |
| Inspection of Air Clearance | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text); ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Cable Noise Testing | ANSI AAMI EC53:2013 | Pass |
| Flex Life Testing | ANSI AAMI EC53:2013 | Pass |
| Tensile Strength Testing | ANSI AAMI EC53:2013 | Pass |
| Defibrillation Protection and Energy Reduction | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text); ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Dielectric Withstand Testing | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | Pass |
| Leakage Current Testing | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | Pass |
| Storage Conditioning and Drop Test | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | Pass |
| Material Resistance for Cleaning and Disinfection Stress | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text); ANSI AAMI EC53:2013 | Pass |
| Resistance from electrosurgery interference | ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Shock, Vibration and IP Classification | IEC 60601-1-12:2014+AMD1:2020; IEC 60529:1989+A1:1999+A2:2013; IEC 60068-2-27:2008; IEC 60068-2-64:2008+AMD1:2019 | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated in terms of number of cables tested, but the tests were performed on representative samples to demonstrate compliance with standards. For physical devices, sample sizes are typically determined by statistical methods or engineering judgment to ensure sufficient confidence in product safety and performance.
- Data Provenance: The testing is non-clinical performance testing of the device itself (a cable system), not data from patient studies. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply. The tests were performed in a lab setting to relevant international and national standards.
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)
- Not Applicable. This is a hardware device (cable system) for signal transmission, not an AI/algorithm. "Ground truth" in the context of expert review of images or data is not relevant here. The ground truth for cable performance is defined by the technical specifications and standards (e.g., voltage, resistance, signal integrity, mechanical strength).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As explained above, this device does not involve human interpretation or subjective assessment of data for "ground truth" adjudication. The tests involve objective quantitative measurements against defined thresholds in relevant 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
- Not Applicable. This is not an AI-assisted diagnostic device. MRMC studies are used to evaluate diagnostic accuracy and reader performance of AI systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical cable system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by international and national engineering and medical device standards (e.g., ANSI AAMI IEC 60601 series, ANSI AAMI EC53, IEC 60068 series, IEC 60529). These standards define the acceptable performance characteristics for ECG cables, including electrical properties, mechanical durability, and safety features like defibrillation protection. The device's performance is measured against the thresholds and methodologies specified in these standards.
8. The sample size for the training set
- Not Applicable. This device does not use a "training set" as it is not an AI/machine learning algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set is used.
In summary, the document details the non-clinical performance testing of an ECG cable and leadwire system to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are embodied by the various ANSI, AAMI, and IEC standards listed, and the "study" proving compliance is a series of laboratory tests where the device passed all criteria. The questions related to AI/algorithm development, such as "expert ground truth," "MRMC studies," and "training/test sets," are not relevant to this specific medical device submission.
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August 16, 2021
Vyaire Medical. Inc. Joshua Davis Regulatory Affairs Advisor 26125 North Riverwoods Blvd. Mettawa, Illinois 60045
Re: K211294
Trade/Device Name: Multi-Link X2 ECG Cable and Leadwire System Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: July 11, 2021 Received: July 15, 2021
Dear Joshua Davis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211294
Device Name
Multi-Link X2 ECG Cable and Leadwire System
Indications for Use (Describe)
The Multi-Link X2 ECG Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
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510(k) Summary Multi-Link™ X2 ECG Cable and Leadwire System
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
1.0 Submitter Information [21 CFR 807.92(a) (1)]
| Submitter: | Vyaire Medical, Inc. |
|---|---|
| Address: | 26125 N. Riverwoods Blvd.Mettawa, IL 60045USA |
| Establishment Registration Number: 3013421741 |
| Official Correspondent: | Joshua Davis |
|---|---|
| Title | Regulatory Affairs Advisor |
| Phone: | (508) 294-0749 |
| Email: | Joshua.Davis@vyaire.com |
| Alternate Contact: | Rekha Anand |
|---|---|
| Title | Sr. Manager Regulatory Affairs |
| Phone: | (872) 757-0224 |
| Email: | Rekha.Anand@vyaire.com |
Date Summary Prepared:
April 27, 2021
2.0 Device Information [21 CFR 807.92 (a) (2)]
| Device Classification: | Class II |
|---|---|
| Product Code: | DSA |
| Regulation: | 21 CFR 870.2900 |
| Regulation Name: | Patient transducer and electrode cable (includingconnector) |
| Classification Panel: | 74-Cardiovascular |
| Device Name: | Multi-Link™ X2 ECG Cable and |
| Leadwire System | |
| Proprietary Name: | Multi-Link™ |
| Common Name: | Cable, Transducer and Electrode, Patient, (IncludingConnector) |
3.0 Predicate Device Information [21 CFR 807.92(a) (3)]
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The Multi-Link™ X2 ECG Cable and Leadwire System described in this submission is substantially equivalent to the following predicate:
| Predicate Device | 510(k) No. | 510(k) Owner | DecisionDate |
|---|---|---|---|
| Multi-Link™ X2 ECG Cableand Leadwire System | K162432 | Vyaire Medical, Inc. | 18-Jan-2017 |
4.0 Purpose and Device Description [21 CFR 807.92(a) (4)]
The purpose of this subject pre-market notification is to introduce a modified set of Reusable Trunk Cables within the Multi-Link™ X2 ECG Cable and Leadwire System in order to expand the system compatibility with additional FDA-cleared ECG (electrocardiogram) monitoring platforms. There are no changes to the other components within the system, such as Leadwires, and therefore they are not part of this submission.
The Multi-Link™ X2 ECG Cable and Leadwire System is a product portfolio that is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. The system consists of Reusable Trunk Cables (K980582, K101660, K162432), Reusable Leadwires (K980582) and Disposable Single Patient Use Leadwires (K101660, K162432). The existing portfolio is compatible with the following ECG monitoring platforms: Philips, Mindray, Nihon Kohden, GE, and Spacelabs.
The subject device of this pre-market notification consists of a modified set of Reusable Trunk Cables that are designed to be compatible with the following cardiac defibrillation systems: Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms. The subject device is used to transmit signals from patient electrodes and sensors to support continuous ECG monitoring only. The subject device does not interpret or deliver the shock applied when the defibrillators are in use. The subject device was evaluated in accordance with ANSI AAMI ES60601-1 and determined to be defibrillation-proof.
5.0 Intended Use of device and Indications for Use [21 CFR 807.92(a) (5)]
Intended Use
The Multi-Link™ X2 ECG Cable and Leadwire System is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes.
Indications for Use
The Multi-Link™ X2 ECG Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The
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Multi-Link™ ECG Cable and Leadwire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables (care cables) are reusable, nonsterile and can be reprocessed.
Summary of Substantial Equivalence [21 CFR 807.92 (a)(6)] 6.0
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended use: Same as the predicate ●
- Indications for use: Similar to the predicate .
- . Materials: Similar to the predicate
- Technology: Same as the predicate .
- Design Features: Same as the predicate .
- . Performance: Same as the predicate
| Element ofcomparison | Subject DeviceMulti-Link X2 ECG Cable andLeadwire System | Predicate DeviceMulti-Link X2 ECG Cable andLeadwire System(K162432) |
|---|---|---|
| Intended Use | The Multi-Link X2 ECG Cable andLeadwire System is intended totransmit signals from patientelectrodes to variouselectrocardiograph recorders /monitors for monitoring purposes. | The Multi-Link Cable and LeadwireSystem is intended to transmitsignals from patient electrodes tovarious electrocardiographrecorders / monitors for monitoringpurposes. |
| Indications forUse | The Multi-Link X2 ECG Cable andLeadwire System is intended totransmit ECG signals from patientelectrodes to patient monitors formonitoring purposes. The Multi-LinkECG Cable and Leadwire System islimited to indications for use of theconnected monitoring equipment.The Multi-Link trunk cables (carecables) are reusable, nonsterile andcan be reprocessed. | The Multi-Link Cable and LeadwireSystem is intended to transmitECG signals from patientelectrodes to patient monitors formonitoring purposes. The Multi-Link Cable and Leadwire Systemis limited to indications for use ofthe connected monitoringequipment. The Multi-Linktrunk cables (care cables) arereusable, nonsterile and can bereprocessed. The Multi-Link Cableand Leadwire System iscompatible with GE Healthcare,Philips, Mindray, Spacelabs andNihon Kohden electrocardiographmonitors. |
| Principal ofOperation | Trunk Cables and Leadwires arecable conductors to conduct ECGsignal from patient ECG electrodes tomonitoring equipment. Signal isconducted from ECG electrodethrough insulated signal wires madeof conductive material. Signal wiresare protected from environmentalnoise factors with metal shieldingaround it, acting as a Faraday'scage. The trunk cables have aninsulating jacket made ofthermoplastics providing electricalinsulation. | Trunk cables and leadwires arecable conductors toconduct ECG signal from patientECG electrodes tomonitoring equipment. Signal isconducted from ECG electrodethrough insulated signal wiresmade of conductive material.Signal wires are protected fromenvironmental noise factors withmetal shielding around it, acting asa Faraday's cage. Thetrunk cables and leadwires havean insulating jacket made ofthermoplastics providing electricalinsulation. |
| PatientPopulation | Any patient requiring ECGmonitoring, according to themonitor's intended patientpopulation. | Any patient population requiringECG monitoring, according to themonitor's intended patientpopulation. |
| AnatomicalSites | Proposed device does not haveanatomical sites itself. Theanatomical site of the compatiblepreviously-cleared ECG Leadwires isChest. | Predicate device cable does nothave anatomical sites itself. Theanatomical site of the compatiblepreviously-cleared ECG Leadwiresis Chest. |
| Environment ofUse | Hospital Environment and Pre-Hospital Environment (i.e.,scene of emergency, transportincluding airborne transport). | Hospital Environment. |
| Compatibilitywithenvironmentand otherdevices | Physio Control Lifepak, Zoll R andZoll X electrocardiographmonitors. | Philips, GE, Mindray, Spacelabsand Nihon Kohdenelectrocardiograph monitors. |
| Characteristics | ||
| Number of leadwires | 3 or 5 lead | 3, 5, 6 or 12 lead version |
| Sterility | Multi-Link cables are reusable,nonsterile | Multi-Link cables are reusable,nonsterile |
| Cable coatingmaterials: | TPU C78A Grey (Munsell N7) | TPU C78A Grey (Munsell N7) |
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Transmitting signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes is the technological principle for both the subject and predicate devices.
The subject and predicate devices are based on the following same technological elements:
- Conducting electrical signals passively from ECG lead wires to the ECG . monitoring equipment
- Device contains interfaces to allow connection to ECG lead wires and ECG ● monitoring equipment
- Device composed of a plug face, contact pins, pre-mold, over-mold, and cable
- Cable coating materials are the same
- . Signal wires are protected from environmental noise factors with metal shielding around it, acting as Faraday's cage
- The cables have an insulating jacket made of thermoplastics providing electrical . insulation
The following technological differences exist between the subject and predicate devices:
- . The predicate device is compatible with leadwires containing 3, 5, 6 or 12 leads whereas the subject device is only compatible with leadwires containing 3 or 5 leads
- . The trunk cable monitor interfaces are different, as the subject and predicate devices are compatible for connection with different monitors
7.0 Performance Data [21 CFR 807.92(b)(1)]
The subject device was tested and analyzed to demonstrate substantial equivalence to the predicate device. The test reports are listed below:
7.1 Non-Clinical Performance Testing
| Test Performed | Applicable Standard | Result |
|---|---|---|
| Compatibility Testing with Zoll R,Zoll X and Physio ControlSystems | ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Connector mating/unmating,Retention force and ContactResistance for InstrumentConnectors | ANSI AAMI EC53:2013 | Pass |
| Test Performed | Applicable Standard | Result |
| Connector mating/unmating,Retention force and ContactResistance for Multilink CableYokes | ANSI AAMI EC53:2013 | Pass |
| Inspection of Air Clearance | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText)ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Cable Noise Testing | ANSI AAMI EC53:2013 | Pass |
| Flex Life Testing | ANSI AAMI EC53:2013 | Pass |
| Tensile Strength Testing | ANSI AAMI EC53:2013 | Pass |
| Defibrillation Protection andEnergy Reduction | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText)ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Dielectric Withstand Testing | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) | Pass |
| Leakage Current Testing | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) | Pass |
| Storage Conditioning and DropTest | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) | Pass |
| Material Resistance for Cleaningand Disinfection Stress | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) | Pass |
| Test Performed | Applicable Standard | Result |
| A2:2010/(R)2012 (Consolidated Text) | ||
| ANSI AAMI EC53:2013 | ||
| Resistance from electrosurgery interference | ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Shock, Vibration and IP Classification | IEC 60601-1-12:2014+AMD1:2020 | Pass |
| IEC 60529:1989+A1:1999+A2:2013 | ||
| IEC 60068-2-27:2008 | ||
| IEC 60068-2-64:2008+AMD1:2019 |
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7.2 Biocompatibility
The Multi-Link™ X2 ECG Cables do not have any direct or indirect patient contact. The cables have transitory contact with intact skin of the clinician. Per the requirements outlined in ISO 10993-1, biocompatibility testing is not applicable for the subject device.
| Analysis Performed | Applicable Standard |
|---|---|
| BiocompatibilityEvaluation Plan | ISO 10993-1 Fifth edition 2018-08 Biological evaluationof medical devices - Part 1: Evaluation and testingwithin a risk management process |
7.3 Clinical Data [21 CFR 807.92(b)(2)]
Based on the similarities in the safety and effectiveness profiles of the subject and predicate devices, no clinical studies were deemed necessary to support this submission.
8.0 Conclusions [21 CFR 807.92(b)(3)]
The subject device and predicate device have the same intended use, similar indications for use, same technological characteristics, and the same principle of
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operation. A benefit-risk assessment has concluded that the benefits associated with the subject device outweigh the potential risks. The subject device has successfully passed all acceptance criteria for non-clinical performance testing, demonstrating that the subject device is as safe, as effective, and performs as well as or better than the predicate device for its intended use. Therefore, it can be concluded that the subject device has been shown to be substantially equivalent to the predicate device identified in this submission.
§ 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).