(123 days)
No
The device description and performance studies focus on the electrical and mechanical properties of an adapter and lead wire system for transmitting signals, with no mention of data processing or analysis that would typically involve AI/ML.
No.
The device is described as an adapter and lead wire system used to transmit ECG and/or SpO2 signals for monitoring purposes, not for providing therapy or treatment.
No
The device transmits ECG and SpO2 signals for monitoring purposes, but it does not analyze or interpret these signals to diagnose a disease or condition. It acts as a conductor within a system for continuous monitoring.
No
The device is described as a reusable telemetry adapter that connects physical components (Philips IntelliVue MX40, lead wires, SpO2 sensors) and functions as a conductor to carry electrical signals. The performance studies focus on hardware standards and physical testing, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transmit physiological signals (ECG and SpO2) from the patient to a monitoring device. This is for monitoring purposes on ambulatory patients.
- Device Description: The device is described as an adapter that functions as a conductor to carry electrical signals. It connects electrodes and sensors to a monitoring device.
- Nature of IVDs: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The Multi-Link™ X2 ECG Adapter and Lead Wire System is a medical device used for patient monitoring, but it falls under the category of devices that directly interact with the patient to acquire physiological data, rather than analyzing samples taken from the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DSA, DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Adapters do not have patient contact
Indicated Patient Age Range
Any patient population requiring ambulatory monitoring
Intended User / Care Setting
Hospital Environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Multi-LinkTM X2 ECG AND SpO2 ADAPTERS was tested to ensure compliance to the following standards:
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:
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
Tests performed and their results:
Compatibility Testing with Philips IntelliVue MX40 System, ECG Lead wires and SpO2-sensors - Pass
Lifecycle and Contact Resistance According to EC53 Section 5.3.5 and 5.3.7 for SpO2-connector - 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 - Pass
Inspection of Air Clearance for Subject Device Multi-Link™ X2 ECG and SpO2 Adapter - Pass
Defibrillation Protection and Energy Reduction - Pass
Dielectric Withstand Testing according EC53 section 5.3.9 for Multi-Link™ X2 ECG and SpO2 Adapter - Pass
Dielectric Withstand Testing according 60601-1 section 8.8.3 for Multi-Link™ X2 ECG and SpO2 Adapter - Pass
Storage Conditioning and Drop Test - Pass
Connector mating/unmating - Pass
Retention force test - Pass
Contact Resistance Test - Pass
Material Resistance for Cleaning and Disinfection Stress - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- |
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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 |
| 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.