(221 days)
No
The device is described as an accessory (adapters and leadwires) for transmitting ECG signals. There is no mention of any analytical or interpretive functions, nor any terms related to AI or ML.
No.
The device is an accessory (adapters and leadwires) used to transmit ECG signals to a monitor, not to provide therapy.
No
The device transmits ECG signals for monitoring purposes, but the interpretation and diagnosis are performed by a separate ECG monitoring platform.
No
The device description explicitly states it consists of "reusable adapters and direct connect single patient use leadwires" and functions as "conductors on the system to carry the electrical signals." This indicates a physical hardware component, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transmit ECG signals from the electrodes to ECG monitors for monitoring purposes." This describes a device that works in vivo (on the living body) to acquire physiological signals, not a device that examines specimens in vitro (outside the body).
- Device Description: The description reinforces this by stating the system is used to "transmit signals from patient ECG electrodes to monitoring equipment, providing patients with continuous ECG (electrocardiogram) monitoring." It also explicitly states it "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."
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the Multi-Link™ X2 ECG Adapters and Leadwires are considered medical devices used for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
DSA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest and Leg
Indicated Patient Age Range
any patient population
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-LINK™ X2 ECG ADAPTER AND LEADWIRES were tested to ensure compliance to the following standards:
AAMI ANSI ES 60601-1:2005/(R):2012 and A1:2012 for Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
AAMI ANSI IEC 60601-2-27:2011(R)2016 for Medical electrical equipment — Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
AAMI ANSI EC53:2013 for ECG trunk cables and patient lead wires
IEC 60601-1-6 Edition 3.1 2013-10 for Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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.
ISO 10993-1 Fifth edition 2018-08 for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
AAMI ANSI ISO 10993-5:2009/(R)2014 for Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity
AAMI ANSI ISO 10993-10:2010/(R)2014 for Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
Non-Clinical Performance Test Summary:
- Compatibility Testing with Dräger Infinity (R) System (Standard: AAMI ANSI IEC 60601-2-27:2011(R)2016, Section: 201.12.1, and 101.15) - Result: 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 (Standard: AAMI ANSI EC53:2013, Section: 5.3.5, 5.3.6, and 5.3.7) - Result: Pass
- Inspection of Air Clearance for Subject Device (Standard: AAMI ANSI ES60601-1: 2005/(R):2012 and A1:2012, Section: 8.5.2.3; ANSI IEC 60601-2-27:2011(R)2016, Section: 201.8.5.2.3) - Result: Pass
- Defibrillation Protection and Energy Reduction (Standard: AAMI ANSI ES 60601-1: 2005/(R):2012 and A1:2012, Section: 8.5.5.1, and 8.5.5.2) - Result: Pass
- Dielectric Withstand Testing according 60601-1 section 8.8.3 and EC53 section 5.3.9 (Standard: AAMI ANSI EC53:2013, Section: 5.3.9) - Result: Pass
- Storage Conditioning and Drop Test (Standard: AAMI ANSI ES 60601-1: 2005/(R):2012 and A1:2012, Section: 15.3.1, 15.3.6, and 15.3.7) - Result: Pass
- Material Resistance for Cleaning and Disinfection Stress (Standard: AAMI ANSI ES 60601-1: 2005/(R):2012 and A1:2012, AAMI ANSI EC53:2013, Section: 11.6.6; 8.8.3) - Result: Pass
- EC53 section 5.3.2 for Cable Noise (Standard: AAMI ANSI EC53:2013, Section: 5.3.2) - Result: Pass
- EC53 section 5.3.3 for Flex Life (Standard: AAMI ANSI EC53:2013, Section: 5.3.3) - Result: Pass
- EC53 section 5.3.4 for Tensile Strength (Standard: AAMI ANSI EC53:2013, Section: 5.3.4) - Result: Pass
- EC53 section 5.3.8 for Leadwire Resistance (Standard: AAMI ANSI EC53:2013, Section: 5.3.8) - Result: Pass
Clinical Data: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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.