(110 days)
No
The device description and performance studies focus on the electrical and mechanical properties of the cables and leadwires for transmitting ECG signals. There is no mention of any data processing, interpretation, or algorithmic functions that would suggest the use of AI or ML.
No
The device is intended for transmission of ECG signals for monitoring purposes, not for providing therapy. It explicitly states that it does not interpret or deliver shock.
No
The device is intended to transmit ECG signals for monitoring purposes, not to provide a diagnosis. It supports continuous ECG monitoring but does not interpret signals or deliver therapy.
No
The device description explicitly states it consists of "Reusable Trunk Cables" and "Reusable Leadwires," which are physical hardware components used to transmit electrical signals. The performance studies also focus on physical characteristics and testing of these hardware components.
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 ECG signals from patient electrodes to patient monitors for monitoring purposes." This describes a device that facilitates the collection and transmission of physiological signals from a living patient, not a device used to examine specimens derived from the human body in vitro.
- Device Description: The description reinforces the intended use, stating it "is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes." It also explicitly states the device "does not interpret or deliver the shock applied when the defibrillators are in use," further indicating it's a signal transmission device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
The device is clearly intended for use in a clinical setting to support in vivo monitoring of a patient's electrical heart activity.
N/A
Intended Use / Indications for Use
The Multi-Link X2 ECG Cable and Leadwire 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) are reusable, nonsterile and can be reprocessed.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The Multi-Link™ X2 ECG Cable and Leadwire System is a product portfolio that is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. The system consists of Reusable Trunk Cables (K980582, K101660, K162432), Reusable Leadwires (K980582) and Disposable Single Patient Use Leadwires (K101660, K162432). The existing portfolio is compatible with the following ECG monitoring platforms: Philips, Mindray, Nihon Kohden, GE, and Spacelabs.
The subject device of this pre-market notification consists of a modified set of Reusable Trunk Cables that are designed to be compatible with the following cardiac defibrillation systems: Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms. The subject device is used to transmit signals from patient electrodes and sensors to support continuous ECG monitoring only. The subject device does not interpret or deliver the shock applied when the defibrillators are in use. The subject device was evaluated in accordance with ANSI AAMI ES60601-1 and determined to be defibrillation-proof.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proposed device does not have anatomical sites itself. The anatomical site of the compatible previously-cleared ECG Leadwires is Chest.
Indicated Patient Age Range
Any patient requiring ECG monitoring, according to the monitor's intended patient population.
Intended User / Care Setting
Hospital Environment and Pre-Hospital Environment (i.e., scene of emergency, transport including airborne transport).
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 subject device was tested and analyzed to demonstrate substantial equivalence to the predicate device. The test reports are listed below:
- Compatibility Testing with Zoll R, Zoll X and Physio Control Systems: Applicable Standard ANSI AAMI IEC 60601-2-27:2011(R)2016, Result: Pass
- Connector mating/unmating, Retention force and Contact Resistance for Instrument Connectors: Applicable Standard ANSI AAMI EC53:2013, Result: Pass
- Connector mating/unmating, Retention force and Contact Resistance for Multilink Cable Yokes: Applicable Standard ANSI AAMI EC53:2013, Result: Pass
- Inspection of Air Clearance: Applicable Standard ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) ANSI AAMI IEC 60601-2-27:2011(R)2016, Result: Pass
- Cable Noise Testing: Applicable Standard ANSI AAMI EC53:2013, Result: Pass
- Flex Life Testing: Applicable Standard ANSI AAMI EC53:2013, Result: Pass
- Tensile Strength Testing: Applicable Standard ANSI AAMI EC53:2013, Result: Pass
- Defibrillation Protection and Energy Reduction: Applicable Standard ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) ANSI AAMI IEC 60601-2-27:2011(R)2016, Result: Pass
- Dielectric Withstand Testing: Applicable Standard ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Result: Pass
- Leakage Current Testing: Applicable Standard ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Result: Pass
- Storage Conditioning and Drop Test: Applicable Standard ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Result: Pass
- Material Resistance for Cleaning and Disinfection Stress: Applicable Standard ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) ANSI AAMI EC53:2013, Result: Pass
- Resistance from electrosurgery interference: Applicable Standard ANSI AAMI IEC 60601-2-27:2011(R)2016, Result: Pass
- Shock, Vibration and IP Classification: Applicable Standard IEC 60601-1-12:2014+AMD1:2020 IEC 60529:1989+A1:1999+A2:2013 IEC 60068-2-27:2008 IEC 60068-2-64:2008+AMD1:2019, Result: 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2021
Vyaire Medical. Inc. Joshua Davis Regulatory Affairs Advisor 26125 North Riverwoods Blvd. Mettawa, Illinois 60045
Re: K211294
Trade/Device Name: Multi-Link X2 ECG Cable and Leadwire System Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: July 11, 2021 Received: July 15, 2021
Dear Joshua Davis:
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.
1
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 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 531-542 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.
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211294
Device Name
Multi-Link X2 ECG Cable and Leadwire System
Indications for Use (Describe)
The Multi-Link X2 ECG Cable and Leadwire 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) are reusable, nonsterile and can be reprocessed.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
3
510(k) Summary Multi-Link™ X2 ECG Cable and Leadwire System
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
1.0 Submitter Information [21 CFR 807.92(a) (1)]
| Submitter: | Vyaire Medical, Inc. |
|---|---|
| Address: | 26125 N. Riverwoods Blvd. |
| Mettawa, IL 60045 | |
| USA | |
| Establishment Registration Number: 3013421741 |
| Official Correspondent: | Joshua Davis |
|---|---|
| Title | Regulatory Affairs Advisor |
| Phone: | (508) 294-0749 |
| Email: | Joshua.Davis@vyaire.com |
| Alternate Contact: | Rekha Anand |
|---|---|
| Title | Sr. Manager Regulatory Affairs |
| Phone: | (872) 757-0224 |
| Email: | Rekha.Anand@vyaire.com |
Date Summary Prepared:
April 27, 2021
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 |
| Device Name: | Multi-Link™ X2 ECG Cable and |
| Leadwire System | |
| Proprietary Name: | Multi-Link™ |
| Common Name: | Cable, Transducer and Electrode, Patient, (Including |
| Connector) |
3.0 Predicate Device Information [21 CFR 807.92(a) (3)]
4
The Multi-Link™ X2 ECG Cable and Leadwire System described in this submission is substantially equivalent to the following predicate:
| Predicate Device | 510(k) No. | 510(k) Owner | Decision
Date |
|-------------------------------------------------|------------|----------------------|------------------|
| Multi-Link™ X2 ECG Cable
and Leadwire System | K162432 | Vyaire Medical, Inc. | 18-Jan-
2017 |
4.0 Purpose and Device Description [21 CFR 807.92(a) (4)]
The purpose of this subject pre-market notification is to introduce a modified set of Reusable Trunk Cables within the Multi-Link™ X2 ECG Cable and Leadwire System in order to expand the system compatibility with additional FDA-cleared ECG (electrocardiogram) monitoring platforms. There are no changes to the other components within the system, such as Leadwires, and therefore they are not part of this submission.
The Multi-Link™ X2 ECG Cable and Leadwire System is a product portfolio that is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. The system consists of Reusable Trunk Cables (K980582, K101660, K162432), Reusable Leadwires (K980582) and Disposable Single Patient Use Leadwires (K101660, K162432). The existing portfolio is compatible with the following ECG monitoring platforms: Philips, Mindray, Nihon Kohden, GE, and Spacelabs.
The subject device of this pre-market notification consists of a modified set of Reusable Trunk Cables that are designed to be compatible with the following cardiac defibrillation systems: Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms. The subject device is used to transmit signals from patient electrodes and sensors to support continuous ECG monitoring only. The subject device does not interpret or deliver the shock applied when the defibrillators are in use. The subject device was evaluated in accordance with ANSI AAMI ES60601-1 and determined to be defibrillation-proof.
5.0 Intended Use of device and Indications for Use [21 CFR 807.92(a) (5)]
Intended Use
The Multi-Link™ X2 ECG Cable and Leadwire 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 Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The
5
Multi-Link™ ECG Cable and Leadwire 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.
Summary of Substantial Equivalence [21 CFR 807.92 (a)(6)] 6.0
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended use: Same as the predicate ●
- Indications for use: Similar to the predicate .
- . Materials: Similar to the predicate
- Technology: Same as the predicate .
- Design Features: Same as the predicate .
- . Performance: Same as the predicate
| Element of
comparison | Subject Device
Multi-Link X2 ECG Cable and
Leadwire System | Predicate Device
Multi-Link X2 ECG Cable and
Leadwire System
(K162432) |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Multi-Link X2 ECG Cable and
Leadwire System is intended to
transmit signals from patient
electrodes to various
electrocardiograph recorders /
monitors for monitoring purposes. | The Multi-Link Cable and Leadwire
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 Cable and
Leadwire System is intended to
transmit ECG signals from patient
electrodes to patient monitors for
monitoring purposes. The Multi-Link
ECG Cable and Leadwire 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 Cable and Leadwire
System is intended to transmit
ECG signals from patient
electrodes to patient monitors for
monitoring purposes. The Multi-
Link Cable and Leadwire 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 Cable
and Leadwire System is
compatible with GE Healthcare,
Philips, Mindray, Spacelabs and
Nihon Kohden electrocardiograph
monitors. |
| Principal of
Operation | Trunk Cables and Leadwires 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 a Faraday's
cage. The trunk cables have an
insulating jacket made of
thermoplastics providing electrical
insulation. | Trunk cables and leadwires 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
a Faraday's cage. The
trunk cables and leadwires have
an insulating jacket made of
thermoplastics providing electrical
insulation. |
| Patient
Population | Any patient requiring ECG
monitoring, according to the
monitor's intended patient
population. | Any patient population requiring
ECG monitoring, according to the
monitor's intended patient
population. |
| Anatomical
Sites | Proposed device does not have
anatomical sites itself. The
anatomical site of the compatible
previously-cleared ECG Leadwires is
Chest. | Predicate device cable does not
have anatomical sites itself. The
anatomical site of the compatible
previously-cleared ECG Leadwires
is Chest. |
| Environment of
Use | Hospital Environment and Pre-
Hospital Environment (i.e.,
scene of emergency, transport
including airborne transport). | Hospital Environment. |
| Compatibility
with
environment
and other
devices | Physio Control Lifepak, Zoll R and
Zoll X electrocardiograph
monitors. | Philips, GE, Mindray, Spacelabs
and Nihon Kohden
electrocardiograph monitors. |
| Characteristics | | |
| Number of lead
wires | 3 or 5 lead | 3, 5, 6 or 12 lead version |
| Sterility | Multi-Link cables are reusable,
nonsterile | Multi-Link cables are reusable,
nonsterile |
| Cable coating
materials: | TPU C78A Grey (Munsell N7) | TPU C78A Grey (Munsell N7) |
6
7
Transmitting signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes is the technological principle for both the subject and predicate devices.
The subject and predicate devices are based on the following same technological elements:
- Conducting electrical signals passively from ECG lead wires to the ECG . monitoring equipment
- Device contains interfaces to allow connection to ECG lead wires and ECG ● monitoring equipment
- Device composed of a plug face, contact pins, pre-mold, over-mold, and cable
- Cable coating materials are the same
- . Signal wires are protected from environmental noise factors with metal shielding around it, acting as Faraday's cage
- The cables have an insulating jacket made of thermoplastics providing electrical . insulation
The following technological differences exist between the subject and predicate devices:
- . The predicate device is compatible with leadwires containing 3, 5, 6 or 12 leads whereas the subject device is only compatible with leadwires containing 3 or 5 leads
- . The trunk cable monitor interfaces are different, as the subject and predicate devices are compatible for connection with different monitors
7.0 Performance Data [21 CFR 807.92(b)(1)]
The subject device was tested and analyzed to demonstrate substantial equivalence to the predicate device. The test reports are listed below:
7.1 Non-Clinical Performance Testing
| Test Performed | Applicable Standard | Result |
|---|---|---|
| Compatibility Testing with Zoll R, | ||
| Zoll X and Physio Control | ||
| Systems | ANSI AAMI IEC 60601-2- | |
| 27:2011(R)2016 | Pass | |
| Connector mating/unmating, | ||
| Retention force and Contact | ||
| Resistance for Instrument | ||
| Connectors | ANSI AAMI EC53:2013 | Pass |
| Test Performed | Applicable Standard | Result |
| Connector mating/unmating, | ||
| Retention force and Contact | ||
| Resistance for Multilink Cable | ||
| Yokes | ANSI AAMI EC53:2013 | Pass |
| Inspection of Air Clearance | ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012, | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 (Consolidated | ||
| Text) | ||
| ANSI AAMI IEC 60601-2- | ||
| 27:2011(R)2016 | Pass | |
| Cable Noise Testing | ANSI AAMI EC53:2013 | Pass |
| Flex Life Testing | ANSI AAMI EC53:2013 | Pass |
| Tensile Strength Testing | ANSI AAMI EC53:2013 | Pass |
| Defibrillation Protection and | ||
| Energy Reduction | ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012, | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 (Consolidated | ||
| Text) | ||
| ANSI AAMI IEC 60601-2- | ||
| 27:2011(R)2016 | Pass | |
| Dielectric Withstand Testing | ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012, | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 (Consolidated | ||
| Text) | Pass | |
| Leakage Current Testing | ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012, | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 (Consolidated | ||
| Text) | Pass | |
| Storage Conditioning and Drop | ||
| Test | ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012, | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 (Consolidated | ||
| Text) | Pass | |
| Material Resistance for Cleaning | ||
| and Disinfection Stress | ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012, | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 (Consolidated | ||
| Text) | Pass | |
| Test Performed | Applicable Standard | Result |
| A2:2010/(R)2012 (Consolidated Text) | ||
| ANSI AAMI EC53:2013 | ||
| Resistance from electrosurgery interference | ANSI AAMI IEC 60601-2-27:2011(R)2016 | Pass |
| Shock, Vibration and IP Classification | IEC 60601-1-12:2014+AMD1:2020 | Pass |
| IEC 60529:1989+A1:1999+A2:2013 | ||
| IEC 60068-2-27:2008 | ||
| IEC 60068-2-64:2008+AMD1:2019 |
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7.2 Biocompatibility
The Multi-Link™ X2 ECG Cables do not have any direct or indirect patient contact. The cables have transitory contact with intact skin of the clinician. Per the requirements outlined in ISO 10993-1, biocompatibility testing is not applicable for the subject device.
| Analysis Performed | Applicable Standard |
|---|---|
| Biocompatibility | |
| Evaluation Plan | ISO 10993-1 Fifth edition 2018-08 Biological evaluation |
| of medical devices - Part 1: Evaluation and testing | |
| within a risk management process |
7.3 Clinical Data [21 CFR 807.92(b)(2)]
Based on the similarities in the safety and effectiveness profiles of the subject and predicate devices, no clinical studies were deemed necessary to support this submission.
8.0 Conclusions [21 CFR 807.92(b)(3)]
The subject device and predicate device have the same intended use, similar indications for use, same technological characteristics, and the same principle of
10
operation. A benefit-risk assessment has concluded that the benefits associated with the subject device outweigh the potential risks. The subject device has successfully passed all acceptance criteria for non-clinical performance testing, demonstrating that the subject device is as safe, as effective, and performs as well as or better than the predicate device for its intended use. Therefore, it can be concluded that the subject device has been shown to be substantially equivalent to the predicate device identified in this submission.