(140 days)
Not Found
No
The document describes a system of cables and lead wires for transmitting ECG signals, which are passive components. There is no mention of AI, ML, image processing, or any computational analysis of the signals within the device itself. The device is an accessory to monitoring equipment, and any potential AI/ML would reside in the monitor, not the cable system.
No
The device is described as transmitting ECG signals for "monitoring purposes" and is an accessory to "host monitoring devices," indicating it is for diagnostic or monitoring use rather than direct treatment.
No
The device is described as an accessory that transmits ECG signals for monitoring purposes to patient monitors. It does not perform diagnostic functions itself but facilitates data transfer for other diagnostic equipment.
No
The device description explicitly states it is a "combination of reusable ECG trunk cables and single-patient use lead wires," which are physical 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 monitors for monitoring purposes." This involves collecting electrical signals from the patient's body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces that it's an accessory to transmit signals from electrodes on the patient to a monitor.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the collection and transmission of physiological signals from the body, which falls under the category of a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Multi-Link Cable and Lead Wire System is intended to transmit ECG signals from 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. The Multi-Link lead wires are available reusable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.
Product codes
DSA
Device Description
The Multi-Link X2 ECG Cable and Lead Wire Systems are a combination of reusable ECG trunk cables and single-patient use lead wires (SPUL) used to transmit signals from patient electrodes to various electrocardiograph monitors for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Cable and Lead Wire Systems are not stand alone devices but are accessories to the host monitoring devices.
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
Not Found
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 proposed device was tested to ensure compliance to the following standards:
Biocompatibility: The lead wire is considered to be a skin contact, with a prolonged duration (greater than 24 hours to 30 days): Cytotoxicity, Sensitization, and Irritation. The trunk cable has no patient contact.
Standards:
- 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))
Performance Tests:
- Compatibility Testing with Bedside Monitors (60601-2-27:2011)
- Lifecycle and Contact Resistance According to EC53 Section 5.3.5 and 5.3.7 for Instrument Connectors of X2-Cables and Grabber and Snap Lifecycle According EC53 Section 5.3.5 and 5.3.7 for Long SPUL and Direct Connect Lead wires (EC53:2013)
- EC53 Section 5.3.5, 5.3.6 and 5.3.7 for Multi-Link Yoke and Long Lead wires (EC53:2013)
- Inspection of Air Clearance for Multi-Link X2 (60601-1:2012 and 60601-2-27:2011)
- Defibrillation Protection and Energy Reduction (60601-1)
- Leakage Current Test for Multi-Link X2 Cables, Long SPUL’s and Predicates (60601-1:2012)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
CareFusion 2200 Inc. Erika Fernandez Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K162432
Trade/Device Name: Multi-link X2 ECG Cable and 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: December 9, 2016 Received: December 12, 2016
Dear Erika Fernandez:
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 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.
1
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.
Sincerely.
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
510(k) Number (if known) K162432
Device Name
Multi-Link X2 ECG Cable and Lead Wire System
Indications for Use (Describe)
The Multi-Link Cable and Lead Wire System is intended to transmit ECG signals from 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. The Multi-Link lead wires are available reusable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs 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) |
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Image /page/3/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in a dark gray sans-serif font. Below the text, in a smaller font, it says "has joined BD".
5 N Fairway Dr
Summary of Safety and Effectiveness
510k summary complying with 21 CFR 807.92.
1. SUBMITTER
CareFusion 2200, Inc. 75 N Fairway Drive, Vernon Hills, IL 60061 Phone: 847-362-8097 Fax: 312 949-0731
Contact Person: Erika Fernandez Date Prepared: December 9th, 2016
2. Device
| Product Name: | Multi-Link X2 ECG Cable and Lead Wire System |
|---|---|
| Device Name: | Cable and Lead Wire System |
| Common Name: | Cable, Transducer and Electrode, Patient, (Including Connector) |
| Classification Name: | Patient transducer and electrode cable(including connector) |
| (21 CFR 870.2900) | |
| Regulatory Class: | II |
| Product Code: | DSA |
3. Predicate Device
This submission demonstrates substantial equivalence to the Multi-Link Cable and Lead Wire System, K980582 was cleared on March 16, 1998. The secondary predicate device, ECG Single Patient Use Lead Wire Set, K101660 was cleared on August 11, 2010. This predicate device has not been subject to a design-related recall.
4. Device Description
The Multi-Link X2 ECG Cable and Lead Wire Systems are a combination of reusable ECG trunk cables and single-patient use lead wires (SPUL) used to transmit signals from patient electrodes to various electrocardiograph monitors for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Cable and Lead Wire Systems are not stand alone devices but are accessories to the host monitoring devices.
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Image /page/4/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the word "CareFusion" in gray text. Below the word "CareFusion" are the words "has joined BD" in a smaller font.
75 N Fairway Or
5. Indication for use
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.
6. Comparison of technological characteristics with the predicate device
The fundamental scientific technology is the same for both proposed and predicate device. The trunk cables and lead wires transmit signals from patient electrodes to various electrocardiograph recorders/ monitoring purposes. The Multi-Link X2 Cable and Lead Wire System is substantially equivalent to the predicate devices Multi-Link Cable and Lead Wire Systems and ECG Single Patient Use Lead Wire Set regarding safety, effectiveness, intended use and performance. The proposed Multi-Link X2 Cable and Lead Wire System is designed to work with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors. Successful verification test results ensured that the proposed device does not raise any different question of safety and effectiveness.
| Element of
comparison | Proposed Device | Primary
Predicate Device
K980582 Multi-Link Cable and
Lead Wire System | Secondary
Predicate Device
K101660: ECG Single
Patient Use Lead Wire Set |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | 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. | 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
K980582 Multi-Link Cable and
Lead Wire System | Secondary
Predicate Device
K101660: ECG Single
Patient Use Lead Wire Set |
| Principal of
Operation | 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. | 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 | Limited to indications for use
of the connected monitoring
equipment | Limited to indications for use of
the connected monitoring
equipment | Limited to indications for
use of the connected
monitoring equipment |
| Anatomical Sites | Chest and Leg | Chest and Leg | Chest and Leg |
| 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 | GE Healthcare, Philips,
Mindray, Spacelabs and Nihon
Kohden electrocardiograph
monitors | GE Healthcare electrocardiograph
monitors | GE Healthcare
electrocardiograph
monitors |
| Characteristics | | | |
| Number of lead
wires | 3, 5, 6 or 12 lead version | 3,5 or 12 | 3,5 or 12 |
| Sterility | Multi-Link trunk cables are
reusable, nonsterile
Multi-Link leadwire is single- | Multi-Link trunk cables are
reusable, nonsterile
Multi-Link leadwire is reusable, | Multi-Link trunk cables are
reusable, nonsterile
Multi-Link leadwire is single- |
| Lead wire colors | patient-use, nonsterile
According 60601-2-27 | nonsterile
According 60601-2-27 | patient-use, nonsterile
According 60601-2-27 |
| Element of
comparison | Proposed Device | Primary
Predicate Device
K980582 Multi-Link Cable and
Lead Wire System | Secondary
Predicate Device
K101660: ECG Single
Patient Use Lead Wire Set |
| Cable coating
materials: trunk
cables | TPU 75-80A Grey (Munsell N7) | POLYURETHANE,ELASTOLIAN118
5A10
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 |
| Cable coating
materials: Single
Patient Use lead
wires | POM BASF N2320 003 UNC
Grey (Munsell N7)
POM BASF N2320 003 UNC
White (Pantone Bright White)
POM BASF N2320 003 UNC
Brown (Pantone 161C)
Medical PVC Green (RAL6019)
TPU C78A Grey (Munsell N7)
TPU C78A Brown (Pantone
161C)
TPU C78A White (Pantone
Bright White) | SANTOPRENE 271-87
PP Hival
2420NA(Body)+SANTOPRENE
271-73(color band
TPU4675 N7 Gray
DOW TPU 2102-75A | POM BASF N2320 003 UNC
Grey (Munsell N7)
POM BASF N2320 003 UNC
White (Pantone Bright
White)
POM BASF N2320 003 UNC
Brown (Pantone 161C)
Medical PVC Green
(RAL6019)
TPU C78A Grey (Munsell
N7)
TPU C78A Brown (Pantone
161C)
TPU C78A White (Pantone
Bright White) |
| Cable coating
materials:
Reusable lead
wires | SANTOPRENE 271-87
PP Hival
2420NA(Body)+SANTOPRENE
271-73(color band
TPU4675 N7 Gray
DOW TPU 2102-75A | SANTOPRENE 271-87
PP Hival
2420NA(Body)+SANTOPRENE
271-73(color band
TPU4675 N7 Gray
DOW TPU 2102-75A | POM BASF N2320 003 UNC
Grey (Munsell N7)
POM BASF N2320 003 UNC
White (Pantone Bright
White)
POM BASF N2320 003 UNC
Brown (Pantone 161C)
Medical PVC Green
(RAL6019)
TPU C78A Grey (Munsell
N7)
TPU C78A Brown (Pantone
161C)
TPU C78A White (Pantone
Bright White) |
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Image /page/5/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in gray. Below the text, in smaller gray font, it says "has joined BD".
75 N. Fairway Dr.
Vernon Hills, IL 60061
Phone: 847 362-8097
Fax: carefusion.com
6
Image /page/6/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, in smaller font, it says "has joined BD".
75 N. Fairway Dr.
Vernon Hills, IL 60061
Phone: 847 362-8097
Fax: carefusion.com
7
Image /page/7/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in a dark gray sans-serif font. Below the text, in a smaller font, it says "has joined BD".
75 N Fairway
7. Performance Data
The proposed device was tested to ensure compliance to the following standards:
Biocompatibility
The lead wire is considered to be a skin contact, with a prolonged duration (greater than 24 hours to 30 days): Cytotoxicity, Sensitization, and Irritation. The trunk cable has no patient contact.
Standards
| 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) |
Performance
The following tests were performed for the proposed device to support the substantial equivalence decision.
| Test | Relevant Standard |
|---|---|
| Compatibility Testing with Bedside Monitors | 60601-2-27:2011 |
| Lifecycle and Contact Resistance According to EC53 Section | |
| 5.3.5 and 5.3.7 for Instrument Connectors of X2-Cables and | |
| Grabber and Snap Lifecycle According EC53 Section 5.3.5 | |
| and 5.3.7 for Long SPUL and Direct Connect Lead wires | EC53:2013 |
| EC53 Section 5.3.5, 5.3.6 and 5.3.7 for Multi-Link Yoke and | |
| Long Lead wires | EC53:2013 |
| Inspection of Air Clearance for Multi-Link X2 | 60601-1:2012 and 60601- |
| 2-27:2011 | |
| Defibrillation Protection and Energy Reduction | 60601-1 |
| Leakage Current Test for Multi-Link X2 Cables, Long SPUL's | |
| and Predicates | 60601-1:2012 |