Who is the manufacturer of Multi-LinkTM X2 ECG Adapter and Leadwires?

Vyaire Medical, Inc. filed the 510(k) submission for Multi-LinkTM X2 ECG Adapter and Leadwires (K200510).

What is the FDA product code for Multi-LinkTM X2 ECG Adapter and Leadwires?

DSA. It is classified under 21 CFR 870.2900 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Multi-LinkTM X2 ECG Adapter and Leadwires?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Multi-LinkTM X2 ECG Adapter and Leadwires?

Multi-Link X2 ECG Cable and Lead Wire System (K162432).

Who can help prepare an FDA 510(k) submission like Multi-LinkTM X2 ECG Adapter and Leadwires?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Multi-LinkTM X2 ECG Adapter and Leadwires

K200510 · Vyaire Medical, Inc. · DSA · Oct 9, 2020 · Cardiovascular

Device Facts

Record ID	K200510
Device Name	Multi-LinkTM X2 ECG Adapter and Leadwires
Applicant	Vyaire Medical, Inc.
Product Code	DSA · Cardiovascular
Decision Date	Oct 9, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2900
Device Class	Class 2
Attributes	Pediatric

Indications for Use

The Multi-LinkTM X2 ECG Adapter and Leadwires are intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes.

Device Story

Device consists of reusable adapters and single-patient-use leadwires; functions as passive conductors transmitting electrical ECG signals from patient electrodes to host ECG monitoring equipment. Adapters feature thermoplastic insulating jackets; leadwires utilize conductive material with metal shielding to mitigate environmental noise (Faraday cage principle). Used in hospital environments; operated by clinical staff. Design modifications enable compatibility with Dräger Infinity monitoring platforms. Device facilitates continuous patient ECG monitoring; allows patient mobility within facility without disconnecting leads. Benefits include seamless integration with existing monitoring infrastructure and reliable signal transmission.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (AAMI ANSI ES 60601-1), performance (AAMI ANSI EC53), and biocompatibility (ISO 10993-1, -5, -10) for patient-contacting leadwires.

Technological Characteristics

Passive cable conductors; TPU/PVC insulating jackets; metal shielding for noise reduction. 3, 5, or 6-lead configurations. Standards: AAMI ANSI ES 60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53, IEC 60601-1-6. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for any patient population requiring ECG monitoring. Used to transmit ECG signals from electrodes to ECG monitors. Adapters are reusable/reprocessable; leadwires are single-patient-use.

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 X2 ECG Cable and Lead Wire System (K162432)

Reference Devices

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (K163316)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 9, 2020 Vyaire Medical, Inc. Suzanne Moreno Regulatory Affairs Associate 26125 N. Riverwoods Blvd. Mettawa, Illinois 60045 Re: K200510 Trade/Device Name: Multi-Link X2 ECG Adapter and Leadwires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: September 4, 2020 Received: September 8, 2020 Dear Suzanne Moreno: 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 control's 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing 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, for Jennifer Shih Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200510 Device Name Multi-LinkTM X2 ECG ADAPTERS AND LEAD WIRES #### Indications for Use (Describe) The Multi-Link™ X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is written in a stylized, sans-serif font in a dark blue color. The letters are connected, giving the logo a modern and fluid appearance. Below "Vyaire", the word "MEDICAL" is written in a smaller, lighter blue font. ## 510(k) Summary MULTI-LINK™ X2 ECG ADAPTER AND LEADWIRES This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92. ## 1.0 Submitter Information | Submitter: | VYAIRE MEDICAL, INC. | |------------------------------------|-------------------------------------------------------| | Address: | 26125 N. Riverwoods Blvd. Mettawa, IL 60045 USA | | Establishment Registration Number: | 3013421741 | Contact: Suzanne Moreno Title: Regulatory Affairs Associate Telephone: (872) 757-0147 e-mail Suzanne.Moreno@Vyaire.com Date Summary February 28, 2020 Prepared: ## 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 (including connector) | | Classification Panel: | 74-Cardiovascular | | Proprietary Name: | Multi-Link ™ X2 ECG ADAPTER AND LEADWIRES | | Common Name: | Cable, Transducer and Electrode, Patient, (Including Connector) | Vvaire Medical Inc 22745 Savi Ranch Pkwv Yorba Linda, CA 92887 USA Vvaire Medical Ox Kuortaneenkatu 2 FI-00510 Helsinki Finland Vyaire Medical GmbH Leibnizstrasse 7 97204 Hoechberg Germany {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Vyaire Medical. The logo is in blue and consists of the word "Vyaire" in a stylized font, with the letters connected. The word "MEDICAL" is written in a smaller, light blue font below the word "Vyaire". The letters in "MEDICAL" are spaced out. ## 3.0 Predicate and Reference Device Information | Predicate Device | 510(k) No. | Decision Date | |------------------------------------------------------------------|------------|---------------| | Multi-Link X2 ECG Cable and Lead Wire System | K162432 | 01/18/2017 | | Reference Device | 510(k) No. | Decision Date | | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | K163316 | 06/22/2017 | ## 4.0 Device Description [21 CFR 807.92(a) (4)] The Multi-Link™ X2 ECG Cable, Adapter and Direct Connect Leadwires is an FDA cleared accessory portfolio. The cleared device portfolio consists of adapters & leadwires (reusable adapters and direct connect disposable single patient use leadwires, K163316), and (leadwires reusable, and disposable single patient use, K162432). The cleared portfolio is compatible multiple FDA cleared ECG monitoring platforms, such as Philips, Mindray, Nihon Kohden, GE and Spacelabs. This pre-market notification is to expand the portfolio to be used with additional FDA cleared ECG monitoring platforms. The Subject device, Multi-Link ™ X2 ECG ADAPTER AND LEADWIRES consists of reusable adapters and direct connect single patient use leadwires that connect to FDA cleared Dräger Infinity (R) monitoring platforms. Design modifications are made to allow for connections with specific additional platforms to allow patients to move throughout the facility without the hassle of disconnecting and reconnecting leadwires. The system is used to transmit signals from patient ECG electrodes to monitoring equipment, providing patients with continuous ECG (electrocardiogram) monitorina. This device is common to both industry and medical establishments. The Multi-Link™ X2 ECG ADAPTER AND LEADWIRES is not a stand-alone device but is used with the host monitoring device and functions as conductors on the system to carry the electrical signals. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Vyaire Medical. The logo is in blue and consists of the word "Vyaire" in a stylized font, with the letters connected. The word "MEDICAL" is written in a smaller, lighter blue font below the word "Vyaire". There is a trademark symbol to the right of the word "Vyaire". #### 5.0 Intended Use of device and Indications for Use [21 CFR 807.92(a) (5)] ### Intended Use The Multi-LinkTM X2 ECG Adapter and Leadwires are intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. ### Indications for Use The Multi-Link™ X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is written in a stylized, sans-serif font in blue. Below "Vyaire" is the word "MEDICAL" in a smaller, lighter blue font. The letters in "MEDICAL" are spaced out. # 6.0 Summary of Substantial Equivalence [21 CFR 807.92 (a) (6)] | Element of comparison | Subject Device Multi-Link™ X2 ECG ADAPTER AND LEADWIRES | Predicate Device Multi-link X2 ECG Cable and Lead Wire System (K162432) | Reference Device Multi- link X2 ECG Adapter and Direct Connect Lead Wire System (K163316) | |--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Multi-Link™ X2 ECG Adapter and Leadwires are intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. | The Multi-Link Cable and Lead Wire System is intended to transmit signals from patient electrodes to various electrocardiograph recorders /monitors for monitoring purposes. | The Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire 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 Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi- Link Direct-Connect Leadwires are single-patient- use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring. | 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. | 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, nonsterile and cannot be reprocessed. The Multi- Link Adapters are reusable, nonsterile 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. | | Principal of Operation | The adapters and leadwires are cable conductors that conduct the ECG signal from patient ECG electrodes to the monitoring equipment. The signal is conducted through insulated signal wires made | The trunk cables and leadwires are cable conductors that conduct the ECG signal from patient ECG electrodes to the monitoring equipment. The signal is conducted from the ECG | The adapters and leadwires are cable conductors that conduct the ECG signal from patient ECG electrodes to the monitoring equipment. The signal is | | | of conductive material. The signal wires are protected from environmental noise factors with metal shielding around it, acting as Faraday's cage. The adapters have an insulating jacket made of thermoplastics providing electrical insulation. | electrode through insulated signal wires made of conductive material. The signal wires are protected from environmental noise factors with metal shielding around it, acting as Faraday's cage. The trunk cables and lead wires have an insulating jacket made of thermoplastics providing electrical insulation. | conducted through insulated signal wires made of conductive material. The signal wires are protected from environmental noise factors with metal shielding around it, acting as Faraday's cage. The adapters have an insulating jacket made of thermoplastics providing electrical insulation. | | Patient Population | Limited to indications for use of the connected monitoring equipment | Limited to indications for use of the connected monitoring equipment | Any patient population requiring ambulatory ECG | | Anatomical Sites | Chest and Leg | Chest and Leg | Chest and Leg | | Environment of Use | Hospital Environment | Hospital Environment | Hospital Environment | | Compatibility with environment and other devices | Dräger electrocardiograph monitors | Philips, GE, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors | Philips, Mindray and Nihon Kohden electrocardiograph monitors | | Characteristics | | | | | Number of lead wires | 3, 5 or 6 lead version | 3, 5, 6 or 12-lead lead version | 3, 5 or 6 lead version | | Sterility | The Multi-Link adapters are reusable, and nonsterile The Multi-Link direct connect leadwires are single patient- use, and nonsterile | The Multi-Link trunk cables are reusable, and nonsterile The Multi-Link leadwires are available as reusable and disposable (single patient use) and are nonsterile | The Multi-Link adapters are reusable, and nonsterile The Multi-Link direct connect leadwires are single patient-use, and nonsterile | | Cable coating materials: Adapters | Thermoplastic polyurethane (TPU), and Polyvinyl chloride (PVC) | TPU, PVC | TPU, PVC | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a dark blue sans-serif font, with the "V" and "y" connected. Below "Vyaire" is the word "MEDICAL" in a light blue sans-serif font. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is written in a blue sans-serif font, with the letters connected. Above the "re" in Vyaire is the trademark symbol. Below the word "Vyaire" is the word "MEDICAL" in a smaller, light blue sans-serif font. #### 7.0 Performance Data The MULTI-LINK™ X2 ECG ADAPTER AND LEADWIRES were tested to ensure compliance to the following standards: ## 7.1 Performance Testing | Standard Number | Performance Characteristic | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AAMI ANSI ES 60601- 1:2005/(R):2012 and A1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | | AAMI ANSI IEC 60601-2- 27:2011(R)2016 | Medical electrical equipment — Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment | | AAMI ANSI EC53: 2013 | ECG trunk cables and patient lead wires | | IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the "Vyaire Medical" logo. The word "Vyaire" is in a dark blue font, and the word "Medical" is in a light blue font. The logo is simple and modern. ## 7.2 Biocompatibility The Multi-Link™ X2 adapters do not have patient contact. Per the requirements outlined in ISO 10993-1 biocompatibility testing is not applicable for the adapters for the subject device. The direct connect single-patient-use lead wires are considered to have surface contact, intact skin with prolonged exposure greater than 24 hours to 30 days. Based on the contact type and duration the following testing was conducted on the leadwires; Cytotoxicity, Sensitization, and Irritation according to the standards listed below. | Standard Number | Performance Characteristic | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------| | ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | | AAMI ANSI ISO 10993-5:2009/(R) 2014 | Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity | | AAMI ANSI ISO 10993-10:2010/(R) 2014 | Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization | ## Clinical Data [21 CFR 807.92(b)(2)] Based on the similarities in the safety and effectiveness profiles of the subject, predicate and reference devices, no clinical studies were deemed needed to support this submission. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for Vyaire Medical. The logo is in blue and features the word "Vyaire" in a stylized font, with the letters connected. Above the "e" is the trademark symbol. Below the word "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font in a lighter shade of blue. # 7.3 Non-Clinical Performance Test Summary | Test | Standard | Standard Section | Result | |-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------|--------| | Compatibility Testing with Dräger Infinity (R) System | AAMI ANSI IEC 60601-2- 27:2011(R)2016 | 201.12.1, and 101.15 | Pass | | EC53 section 5.3.5, 5.3.6 and 5.3.7 for Subject Device Multi-Link™ X2 ECG Adapter Yoke and Instrument Connector | AAMI ANSI EC53:2013 | 5.3.5, 5.3.6, and 5.3.7 | Pass | | Inspection of Air Clearance for Subject Device | AAMI ANSI ES60601- 1: 2005/(R):2012 and A1:2012 | 8.5.2.3 | Pass | | | ANSI IEC 60601-2-27:2011 (R)2016 | 201.8.5.2.3 | | | Defibrillation Protection and Energy Reduction | AAMI ANSI ES 60601- 1: 2005/(R):2012 and A1:2012 | 8.5.5.1, and 8.5.5.2 | Pass | | Dielectric Withstand Testing according 60601-1 section 8.8.3 and EC53 section 5.3.9 | AAMI ANSI EC53:2013 | 5.3.9 | Pass | | Storage Conditioning and Drop Test | AAMI ANSI ES 60601- 1: 2005/(R):2012 and A1:2012 | 15.3.1, 15.3.6, and 15.3.7 | Pass | | Material Resistance for Cleaning and Disinfection Stress | AAMI ANSI ES 60601- 1: 2005/(R):2012 and A1:2012 AAMI ANSI EC53:2013 | 11.6.6 8.8.3 | Pass | | EC53 section 5.3.2 for Cable Noise | AAMI ANSI EC53:2013 | 5.3.2 | Pass | | EC53 section 5.3.3 for Flex Life | AAMI ANSI EC53:2013 | 5.3.3 | Pass | | EC53 section 5.3.4 for Tensile Strength | AAMI ANSI EC53:2013 | 5.3.4 | Pass | | EC53 section 5.3.8 for Leadwire Resistance | AAMI ANSI EC53:2013 | 5.3.8 | Pass | {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a stylized font, with the "V" and "y" connected. The word "MEDICAL" is in smaller letters below "Vyaire". The logo is in a blue color. ## 8.0 Conclusions Safety and Effectiveness SW [21 CFR 807.92(b) (3)] Based on the same intended use, similar indications for use, same technological characteristics and same principle of operation the subject device, Multi-Link™ X2 ECG ADAPTER AND LEADWIRES are substantially equivalent to the predicate identified in this submission and do not present any different issues of safety or effectiveness.

Multi-LinkTM X2 ECG Adapter and Leadwires

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Multi-LinkTM X2 ECG Adapter and Leadwires

Device Facts

Indications for Use

Device Story

Clinical Evidence

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Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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