(211 days)
No
The device description and performance studies focus on the physical properties and signal transmission capabilities of adapters and lead wires, with no mention of AI or ML.
No
The device is used for transmitting ECG signals for monitoring purposes, and is described as an accessory to host monitoring devices, not as a device that delivers therapy.
No
This device is an accessory (adapter and lead wires) used to transmit ECG signals to monitoring devices. It does not perform diagnostic functions itself but rather facilitates the transmission of data for monitoring purposes. The product description clarifies that it "are not stand alone devices, but are accessories to the host monitoring devices."
No
The device description explicitly states it is a "combination of reusable adapters, already cleared lead wires... and direct connect disposable single patient use lead wires" and that these are "conductors carrying the signal from the patient to the monitor." This indicates the device is primarily hardware components (adapters and lead wires) used for signal transmission, not software.
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 electrodes to transmitters for monitoring purposes on ambulatory patients. This is a physiological measurement, not an in vitro test performed on samples taken from the body.
- Device Description: The device is described as an accessory to host monitoring devices, acting as conductors for the signal. This aligns with a device used for physiological monitoring, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile 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.
Product codes
DSA
Device Description
The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a combination of reusable adapters, already cleared lead wires (reusable K980582 and disposable single patient use K101660) and direct connect disposable single patient use lead wires, used to transmit signals from patient electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are not stand alone devices, but are accessories to the host monitoring devices. The adapters and lead wires are conductors carrying the signal from the patient to the monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
Any patient population requiring ambulatory ECG
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 Direct Connect Lead Wire System was tested to ensure compliance to the following standards:
- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (AAMI ANSI ES60601-1:2005/(R):2012 and A1:200012)
- Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (AAMI ANSI IEC 60601-2-27:2011)
- ECG trunk cables and patient leadwires (AAMI ANSI EC53: 2013)
- Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6 Edition 3.1 2013-10)
Non-clinical Performance Test Summary: All tests passed.
- Compatibility Testing with 60601-2-27:2011, section 201.12.1.101.15
- Lifecycle and Contact Resistance According to EC53 Section 5.3.5 and 5.3.7 for host Connectors of Multi-Link X2 Adapters and Direct Connect Leadwires and Grabber and Snap Lifecycle According EC53 Section 5.3.5 and 5.3.7 for Direct Connect Lead wires
- EC53 Section 5.3.5, 5.3.6 and 5.3.7 for Multi-Link Yoke of adapter and Lead wires
- Inspection of Air Clearance for Multi-Link X2 Telemetry Adapters and Direct Connect's
- Defibrillation Protection and Energy Reduction
- Dielectric Withstand Testing for Direct Connect's and Telemetry Adapters
- Storage Conditioning and Drop Test
- Cable and Lead wire Noise for Multi-Link X2
- Flex Life Test
- Tensile Strength
- Connector mating/unmating
- Retention force test
- Contact Resistance Test
- Lead wire Resistance According EC53 section 5.3.8 for Long SPUL and Direct Connect Lead wires
- Material Resistance for Cleaning and Disinfection Stress for Multi-Link X2
- Wiping Durability Test for Long SPUL, Direct Connect Lead wires and Predicate SPUL
Biocompatibility tests for skin contact, with a prolonged duration (greater than 24 hours but less than 30 days): Cytotoxicity, Sensitization and Irritation. These tests followed:
- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (AAMI ANSI ISO 10993-1:2009/ (R)2013)
- Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity (AAMI ANSI ISO 10993-5:2009/(R2014))
- Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization. (AAMI ANSI ISO 10993-10:2010/(R2014))
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The background is plain white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2017
Carefusion/Vyaire Medical, Inc. Colleen O'Keeffe Acting Director, Regulatory Affairs 26125 Riverwoods Blvd Mettawa, Illinois 60045
Re: K163316
Trade/Device Name: Multi-link X2 ECG Adapter and Direct Connect Lead Wire System Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: May 23, 2017 Received: Mav 24, 2017
Dear Colleen O'Keeffe:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
M.A. Wilhelm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163316
Device Name Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System
Indications for Use (Describe)
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, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile 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.
| 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.
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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:
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"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
K163316
510(k) Summary
1. SUBMITTER
Carefusion/Vyaire Medical, Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 Phone: (224) 706-6818
Contact Person: Colleen O'Keeffe Acting Director, Regulatory Affairs
Date Prepared: May 22, 2017
2. Device
| Product Name: | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System |
|---|---|
| Trade or proprietary name | Multi-Link™ |
| Device Name: | Patient transducer and electrode cable (including connector) |
| Common Name: | Patient transducer and electrode cable (including connector) |
| Classification Name: | Patient transducer and electrode cable (including connector) |
| 21 CFR 870.2900 | |
| Regulatory Class: | II |
| Product Code: | DSA |
3. Predicate Device
Multi-Link Cable and Lead Wire Systems cleared under K980582 on March 16, 1998, and secondary predicate device, ECG Single Patient Use Lead Wire Set, cleared under K101660 on August 11, 2010. These predicate devices have not been subject to a design-related recall.
4. Device Description
The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a combination of reusable adapters, already cleared lead wires (reusable K980582 and disposable single patient use K101660) and direct connect disposable single patient use lead wires, used to transmit signals from patient electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are not stand alone devices, but are accessories to the host monitoring devices. The adapters and lead wires are conductors carrying the signal
4
from the patient to the monitor.
5. Principle of Operation
Adapters and lead wires are cable conductors to conduct ECG signal from patient ECG electrodes to monitoring equipment. Signal is conducted from ECG electrode through insulated signal wires made of conductive material. Signal wires are protected from environmental noise factors with metal shielding around it, acting as Faraday's cage. The adapters and lead wires have an insulating jacket made of thermoplastics providing electrical insulation.
6. Indication for use
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, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile 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.
| Element of comparison | Proposed Device | Primary Predicate Device
Multi-Link Cable and Lead
Wire Systems K980582 | Secondary Predicate
Device
ECG Single Patient Use
Lead Wire Set K101660 |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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
Leadwires 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 | Multi-Link Cable and Lead
Wire Systems are reusable
electrode cable system used
to transmit signals from
patient electrodes to various
electrocardiograph
recorders/monitors from
both diagnostic and
monitoring purposes. Multi-
Link Cable and Lead Wire
Systems are limited to
indications for use of the
connected monitoring or
diagnostic equipment. Such
equipment is commonly
located in hospitals, doctor's
offices, and emergency
vehicles, as well as in home
use | The Single Patient Use ECG
Lead Wire is an electrode
cable systems used to
transmit signals from
patient electrodes to
various electrocardiograph
recorders / monitors for
both diagnostic and
monitoring purposes. Use
is limited by the
indications for use of the
connected monitoring or
diagnostic equipment. The
Single Patient Use ECG
Lead Wire set is intended
to be used by trained
operators in a medical
professional's
environment |
| Element of comparison | Proposed Device | Primary Predicate Device
Multi-Link Cable and Lead
Wire Systems K980582 | Secondary Predicate
Device
ECG Single Patient Use
Lead Wire Set K101660 |
| | monitors. | | |
| Principle of Operation | Adapters and lead wires are
cable conductors to conduct
ECG signal from patient ECG
electrodes to monitoring
equipment. Signal is
conducted from ECG
electrode through insulated
signal wires made of
conductive material. Signal
wires are protected from
environmental noise factors
with metal shielding around
it, acting as Faraday's cage.
The adapters and lead wires
have an insulating jacket
made of thermoplastics
providing electrical
insulation. | Trunk cables and lead wires
are cable conductors to
conduct ECG signal from
patient ECG electrodes to
monitoring equipment. Signal
is conducted from ECG
electrode through insulated
signal wires made of
conductive material. 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. | Trunk cables and lead
wires are cable conductors
to conduct ECG signal from
patient ECG electrodes to
monitoring equipment.
Signal is conducted from
ECG electrode through
insulated signal wires
made of conductive
material. 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. |
| Patient Population | Any patient population
requiring ECG monitoring | Any patient population
requiring ECG monitoring | Any patient population
requiring ECG monitoring |
| Anatomical Sites | Chest | Chest | Chest |
| Environment of Use | Hospital Environment | Hospitals, doctor's offices,
and emergency vehicles, as
well as in home use | Medical professional's
environment |
| Compatibility with
environment and other
devices | Philips, Mindray and Nihon
Kohden electrocardiograph
monitors | GE Healthcare
electrocardiograph monitors | GE Healthcare
electrocardiograph
monitors |
| Characteristics | | | |
| Number of lead wires | 3, 5 or 6 lead version | 3,5 or 12 lead version | 3,5 or 12 lead version |
| Sterility | Multi-Link adapters are
reusable, nonsterile
Multi-Link direct connect
lead wire is single-patient-
use, nonsterile | Multi-Link trunk cables are
reusable, nonsterile
Lead wire is
reusable, nonsterile | Trunk cables are reusable,
nonsterile
Lead wire is single-patient-
use, nonsterile |
| Element of comparison | Proposed Device | Primary Predicate Device
Multi-Link Cable and Lead
Wire Systems K980582 | Secondary Predicate
Device
ECG Single Patient Use
Lead Wire Set K101660 |
| Lead wire colors | According 60601-2-27 | According 60601-2-27 | According 60601-2-27 |
| Cable coating materials:
Adapters | TPU C78A Grey (Munsell
N7) | Polyurethane, Elastolia
N1185A10
Durometer 85A
Color-Munsell N7 (GREY)
Colorant: TSE RV73442435
Load at 3%
TPU 1185A10
Polyurethane: Resin PUR
Natural 75D Durometer
Color Munsell N7 Grey | N/A |
7. Comparison of technological characteristics with the predicate device
5
K163316
6
K163316
8. Performance Data
The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System was tested to ensure compliance to the following standards:
8.1 Performance Testing
| Performance Characteristic | Standard |
|---|---|
| Medical electrical equipment – Part 1: General requirements | |
| for basic safety and essential performance | AAMI ANSI ES60601- |
| 1:2005/(R):2012 and | |
| A1:200012 | |
| Medical electrical equipment – Part 2-27: Particular | |
| requirements for the basic safety and essential performance of | |
| electrocardiographic monitoring equipment | AAMI ANSI IEC 60601-2- |
| 27:2011 | |
| ECG trunk cables and patient leadwires | AAMI ANSI EC53: 2013 |
| Medical electrical equipment – Part 1-6: General requirements | |
| for basic safety and essential performance - Collateral | |
| standard: Usability | IEC 60601-1-6 Edition 3.1 |
| 2013-10 |
Non-clinical Performance Test Summary:
| Test | Relevant
Standard | Standard Section | Result |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|------------------------------|--------|
| Compatibility Testing with | 60601-2-27:2011 | 201.12.1.101.15 | Pass |
| Test | Relevant
Standard | Standard Section | Result |
| Lifecycle and Contact Resistance
According to EC53 Section 5.3.5
and 5.3.7 for host Connectors of
Multi-Link X2 Adapters and Direct
Connect Leadwires and Grabber
and Snap Lifecycle According EC53
Section 5.3.5 and 5.3.7 for Direct
Connect Lead wires | EC53:2013 | 5.3.5 and 5.3.7 | Pass |
| EC53 Section 5.3.5, 5.3.6 and 5.3.7
for Multi-Link Yoke of adapter and
Lead wires | EC53:2013 | 5.3.5, 5.3.6 and
5.3.7 | Pass |
| Inspection of Air Clearance for
Multi-Link X2 Telemetry Adapters
and Direct Connect's | 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 for
Direct Connect's and Telemetry
Adapters | 60601-1:2012
EC53:2013 | 8.8.3
5.3.9 | Pass |
| Storage Conditioning and Drop
Test
(Results in tables 19.2 B C F and I ) | 60601-1:2012 | 15.3.1, 15.3.6 and
15.3.7 | Pass |
| Cable and Lead wire Noise for
Multi-Link X2 | EC53:2013 | 5.3.2 | Pass |
| Flex Life Test | EC53:2013 | 5.3.3 | Pass |
| Tensile Strength | EC53:2013 | 5.3.4 | Pass |
| Connector mating/unmating
(Results in tables 19.2 B and
19.2C) | EC53:2013 | 5.3.5 | Pass |
| Retention force test
(Results in table 19.2.C)
Clinician validation test | EC53:2013 | 5.3.6 | Pass |
| Contact Resistance Test
(Results in tables 19.2.B and
19.2.C) | EC53:2013 | 5.3.7 | Pass |
| Lead wire Resistance According
EC53 section 5.3.8 for Long SPUL
and Direct Connect Lead wires | EC53:2013 | 5.3.8 | Pass |
| Material Resistance for Cleaning
and Disinfection Stress for Multi-
Link X2 | 60601-1:2012
EC53:2013 | 11.6.6
8.8.3
5.3.9 | Pass |
| Test | Relevant
Standard | Standard Section | Result |
| Wiping Durability Test for Long
SPUL, Direct Connect Lead wires
and Predicate SPUL | 60601-1:2012
EC53:2013 | 11.6.6
8.8.3
5.3.9 | Pass |
7
8
8.2 Biocompatibility
Test for skin contact, with a prolonged duration (greater than 24 hours but less than 30 days): Cytotoxicity, Sensitization and Irritation.
| Performance Characteristic | Standard |
|---|---|
| Biological evaluation of medical devices - Part 1: Evaluation | |
| and testing within a risk management process | AAMI ANSI ISO 10993-1:2009/ (R) |
| 2013 | |
| Biological Evaluation of Medical Devices-Part 5: Tests for In | |
| Vitro Cytotoxicity | AAMI ANSI ISO 10993-5:2009/ |
| (R2014) | |
| Biological Evaluation of Medical Devices-Part 10: Tests for | |
| Irritation and Skin Sensitization. | AAMI ANSI ISO 10993-10:2010/ |
| (R2014) |
9. Conclusion
The non-clinical data demonstrates that the Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is as safe and as effective as the predicate and therefore substantially equivalent to the predicate device.