Who is the manufacturer of Multi-Link X2 ECG and SpO2 Adapter?

Vyaire Medical, Inc. filed the 510(k) submission for Multi-Link X2 ECG and SpO2 Adapter (K191273).

What is the FDA product code for Multi-Link X2 ECG and SpO2 Adapter?

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-Link X2 ECG and SpO2 Adapter?

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

What are the predicate devices for Multi-Link X2 ECG and SpO2 Adapter?

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

Who can help prepare an FDA 510(k) submission like Multi-Link X2 ECG and SpO2 Adapter?

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-Link X2 ECG and SpO2 Adapter

K191273 · Vyaire Medical, Inc. · DSA · Sep 13, 2019 · Cardiovascular

Device Facts

Record ID	K191273
Device Name	Multi-Link X2 ECG and SpO2 Adapter
Applicant	Vyaire Medical, Inc.
Product Code	DSA · Cardiovascular
Decision Date	Sep 13, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2900
Device Class	Class 2

Indications for Use

The Multi-Link X2 ECG Adapter and Lead Wire System is intended to transmit signals from patient electrodes to various electrocardiograph recorders /monitors for monitoring purposes.

Device Story

Reusable, nonsterile telemetry adapter; connects Philips IntelliVue MX40 monitor to patient ECG electrodes and SpO2 sensors. Functions as passive cable conductor; transmits electrical signals from patient sensors to ambulatory monitoring equipment. Features insulated signal wires with metal shielding (Faraday cage) and thermoplastic (TPU) jacket. Used in hospital environments by healthcare professionals. Does not have patient contact. Output is raw physiological signal transmitted to host monitor for display and alarm generation; enables continuous patient monitoring.

Clinical Evidence

Bench testing only. No clinical data. Testing included electrical safety (AAMI ANSI ES60601-1), performance of ECG monitoring equipment (AAMI ANSI IEC 60601-2-27), ECG trunk cable/lead wire standards (AAMI ANSI EC53), and pulse oximeter equipment standards (ISO 80601-2-61). Tests included compatibility, contact resistance, dielectric withstand, defibrillation protection, and mechanical stress (drop/storage/mating).

Technological Characteristics

Reusable, nonsterile cable adapter. Materials: TPU jacket, metal shielding. Sensing principle: Passive electrical signal conduction. Connectivity: Wired interface between patient sensors and Philips MX40 monitor. Standards: AAMI ANSI ES60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53, ISO 80601-2-61.

Indications for Use

Indicated for use in telemetry to transmit ECG and/or SpO2-signals from electrodes and sensors to transmitters on ambulatory patients within a defined coverage area for monitoring purposes. Used with any patient population requiring ambulatory monitoring and compatible with the Philips MX40 electrocardiograph monitor.

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 Adapter and Direct Connect Lead Wire System (K163316)

Reference Devices

MX40 Release B.07 (K172226)

Submission Summary (Full Text)

{0}------------------------------------------------ Vyaire Medical, Inc. Suzanne Moreno Regulatory Affairs Associate 26125 N. Riverwoods Blvd. Mettawa, Illinois 60630 Re: K191273 Trade/Device Name: Multi-Link X2 ECG and SpO2 Adapter Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA, DQA Dated: August 16, 2019 Received: August 20, 2019 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 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. 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 {1}------------------------------------------------ 542 of the Act); 21 CFR 1000-1050. 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- 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 medical devices and radiation-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, Nicole Goodsell Acting 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K191273 Device Name MULTI-LINK X2 ECG AND SpO2 ADAPTER #### Indications for Use (Describe) The Multi-Link™ X2 ECG Adapter and Lead Wire System are used in telemetry to transmit ECG and/or SpO2-signals from the electrodes and sensors to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Lead Wire System are used with any patient population requiring and are compatible with the Philips MX40 electrocardiograph monitor. Type of Use (Select one or both, as applicable) | <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.2222 2.77783L2.77778 13.2223" stroke="black" stroke-linecap="round" stroke-linejoin="round" stroke-width="2"></path> <path d="M2.77778 2.77783L13.2222 13.2223" stroke="black" stroke-linecap="round" stroke-linejoin="round" stroke-width="2"></path> </svg> 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}------------------------------------------------ #### 510(k) Summary MULTI-LINK™ X2 ECG AND SpO₂ ADAPTER 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 Prepared: #### 2.0 Device Information | Device Name: Trade Name: | Multi-LinkTM X2 ECG AND SpO2 ADAPTERS Multi-LinkTM | |---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Primary Product Code: Device Classification: Regulation Name: | DSA Class II per 21 CFR 870.2900 870.2900 Patient transducer and electrode cable (including connector) | | Common Name: | Patient transducer and electrode cable (including connector) | | Subsequent | | | Product Code: | DQA | | Device Classification: | Class II per 21 CFR 870.2700 | | Regulation Name: | 870.2700 Oximeter | | Common Name: | Oximeter | {4}------------------------------------------------ #### 3.0 Purpose of Submission The purpose of this submission is to gain clearance for the new device, The Multi-LinkTM X2 ECG AND SpO2 ADAPTERS. ### 4.0 Predicate and Reference Device Information The Multi-Link™ X2 ECG AND SpO2 ADAPTERS described in this submission is substantially equivalent to the following predicate: | Predicate Device | 510(k) No. | Decision Date | |---------------------------------------------------------------------|------------|---------------| | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | K163316 | 06/22/2017 | | Reference Device | 510(k) No. | Decision Date | | MX40 Release B.07 | K172226 | 11/09/2017 | ## 5.0 Device Description The Multi-Link™ X2 ECG AND SpO2 ADAPTERS is a reusable telemetry Adapter that connects the Philips IntelliVue MX40 (cleared under telemetry transmitter K172226), on one end to Vyaire-owned lead wires (cleared under K980582 and K101660) and market available SpO2 sensors (cleared under K172226 and K111888) on the other end. The Adapter functions to transmit signals from patient ECG electrodes and SpO2 sensors to ambulatory monitoring equipment, providing ambulatory patients with continuous ECG (electrocardiogram) and SpO2 (blood oxygen saturation) monitoring. This device is common to both industry and medical establishments. The Multi-Link X2 ECG and SpO2 Adapter 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. #### 5.1 Intended Use The Multi-Link X2 ECG Adapter and Lead Wire System is intended to transmit signals from patient electrodes to various electrocardiograph recorders /monitors for monitoring purposes. {5}------------------------------------------------ #### 5.2 Indications for Use The Multi-Link™ X2 ECG Adapter and Lead Wire System are used in telemetry to transmit ECG and/or SpO2-signals from the electrodes and sensors to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Lead Wire System are used with any patient population requiring ambulatory monitoring, and are compatible with the Philips MX40 electrocardiograph monitor. {6}------------------------------------------------ # 6.0 Summary of Substantial Equivalence | Element of comparison | Subject Device | Primary Predicate Device Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System (K163316) | Reference Device K172226 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Multi-Link X2 ECG Adapter 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. | The device is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals. | | Indications for Use | The Multi-Link™ X2 ECG Adapter and Lead Wire System are used in telemetry to transmit ECG and/or SpO2- signals from the electrodes and sensors to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link™ Adapters are reusable, nonsterile and can be reprocessed. The Multi- Link™ X2 ECG Adapter and Lead Wire System are used with any patient population requiring ambulatory monitoring and are compatible with the Philips MX40 electrocardiograph monitor. | 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. | Indicated for use of healthcare professional s whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. | | Principal of Operation | Adapters are cable conductors to conduct ECG signal from patient ECG electrodes and SpO2-signal from sensors to monitoring equipment. Signal is conducted through insulated signal wires made of conductive material. Signal wires are protected from | Adapters are cable conductors to conduct ECG signal from patient ECG electrodes to monitoring equipment. Signal is conducted through insulated signal wires made of conductive material. Signal wires are protected from environmental noise factors | Detects and process ECG the signal conducted by sensors and lead wires | {7}------------------------------------------------ #### K191273 | | 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. | with metal shielding around it, acting as Faraday's cage. The adapters have an insulating jacket made of thermoplastics providing electrical insulation. | | |--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Patient Population | Any patient population requiring ambulatory monitoring | Any patient population requiring ambulatory ECG | Any patient population requiring monitoring | | Anatomical Sites | Adapters do not have patient contact | Adapters do not have patient contact | SpO2-sensors are connected to finger or toe. Monitor does not have patient contact. | | Environment of Use | Hospital Environment | Hospital Environment | Hospital Environment | | Compatibility with environment and other devices | Philips MX40 electrocardiograph monitors | Philips, Mindray and Nihon Kohden electrocardiograph monitors | N/A | | Characteristics | | | | | Number of lead wires | 5 or 6 lead version | 3, 5 or 6 lead version | 3, 5 or 6 lead version | | Sterility | Adapters are reusable, nonsterile | Adapters are reusable, nonsterile | SpO2-sensors are non- sterile, disposable, monitor is reusable | | Cable coating materials: Adapters | TPU | TPU | N/A | {8}------------------------------------------------ ## 7.0 Performance Data The Multi-LinkTM X2 ECG AND SpO2 ADAPTERS was tested to ensure compliance to the following standards: ### 7.1 Performance Testing | Standard Number | Performance Characteristic | |------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AAMI ANSI ES60601- 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 | The following standard has been used as a guidance for compatibility testing of adapter with Philips IntelliVue MX40-system and SpO₂-sensors: | Standard Number | Performance Characteristic | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 80601-2-61 : 2017-12 (Corrected Version 2018-02) | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | {9}------------------------------------------------ | Test | Standard | Standard Section | Result | |-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------|--------| | Compatibility Testing with Philips IntelliVue MX40 System, ECG Lead wires and SpO2-sensors | 60601-2- 27:2011(R)2016 80601-2-61 | 201.12.1. 101.15 | Pass | | Lifecycle and Contact Resistance According to EC53 Section 5.3.5 and 5.3.7 for SpO2-connector | EC53:2013 | 5.3.5 and 5.3.7 | Pass | | EC53 section 5.3.5, 5.3.6 and 5.3.7 for Subject Device Multi-Link™ X2 ECG and SpO2 Adapter Yoke and Instrument Connector | EC53:2013 | 5.3.5, 5.3.6 and 5.3.7 | Pass | | Inspection of Air Clearance for Subject Device Multi- Link™ X2 ECG and SpO2 Adapter | 60601-1:2012 and 60601-2-27:2011 | 8.5.2.3 and 201.8.5.2.3 | Pass | | Defibrillation Protection and Energy Reduction | 60601-1:2012 | 8.5.5.1 and 8.5.5.2 | Pass | | Dielectric Withstand Testing according EC53 section 5.3.9 for Multi- Link™ X2 ECG and SpO2 Adapter | EC53:2013 | 5.3.9 | Pass | | Dielectric Withstand Testing according 60601-1 section 8.8.3 for Multi- Link™ X2 ECG and SpO2 Adapter | 60601-1:2012 | 8.8.3 | Pass | | Storage Conditioning and Drop Test | 60601-1:2012 | 15.3.1, 15.3.6 and 15.3.7 | Pass | | Connector mating/unmating | EC53:2013 | 5.3.5 | Pass | | Retention force test | EC53:2013 | 5.3.6 | Pass | | Contact Resistance Test | EC53:2013 | 5.3.7 | Pass | | Material Resistance for Cleaning and Disinfection Stress | 60601-1:2012 EC53:2013 | 11.6.6 8.8.3 5.3.9 | Pass | # 7.2 Non-Clinical Performance Test Summary {10}------------------------------------------------ #### 8.0 Biocompatibility The Multi-LinkTM X2 ECG and SpO2 Adapters do not have patient contact. Per the requirements outlined in ISO 10993-1 biocompatibility testing is not applicable for the subject device. | Standard Number | Performance Characteristic | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------| | AAMI ANSI ISO 10993-1:2009/ (R) 2013 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | | ISO 10993-1 Fifth edition 2018-08 | | ## 9.0 Conclusion Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate, the Multi-Link™ X2 ECG AND SpO2 ADAPTERS has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any different issues of safety or effectiveness.

Multi-Link X2 ECG and SpO2 Adapter

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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-Link X2 ECG and SpO2 Adapter

Device Facts

Indications for Use

Device Story

Clinical Evidence

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Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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