Medline Patient Cables and Lead Wires
Device Facts
| Record ID | K181726 |
|---|---|
| Device Name | Medline Patient Cables and Lead Wires |
| Applicant | Medline Industries, Inc. |
| Product Code | DSA · Cardiovascular |
| Decision Date | Sep 20, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2900 |
| Device Class | Class 2 |
Indications for Use
Medline Patient Cables and Lead Wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. Additionally, the use of Medline Patient Cables and Lead Wires is limited by the indications for use of the ECG monitoring or diagnostic equipment it is connected to. Medline Patient Cables and Lead Wires are intended for Prescription Use only.
Device Story
Medline Patient Cables and Lead Wires act as a passive conduit for transmitting electrical signals from skin-mounted ECG electrodes to ECG monitoring/diagnostic equipment. The system comprises reusable trunk cables and disposable lead wires. Trunk cables feature a monitor connector at one end and a yoke connector at the other; lead wires connect to the yoke at one end and to patient electrodes at the other. Used in healthcare settings by professionals, the device facilitates signal conduction to enable clinical monitoring or diagnostic evaluation. It does not process signals; it serves as a physical interface between the patient and the monitor. Benefits include reliable signal transmission for patient monitoring.
Clinical Evidence
No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10. Performance testing conducted per IEC 60601-1, IEC 60601-2-27, and ANSI/AAMI EC53.
Technological Characteristics
Passive cabling system consisting of shielded copper lead wires with polyurethane jackets and reusable trunk cables. Connectors include monitor, yoke, pinch, and snap types. Non-sterile. Complies with IEC 60601-1, IEC 60601-2-27, and ANSI/AAMI EC53:2013.
Indications for Use
Indicated for patients requiring ECG monitoring or diagnostic evaluation. Used to connect surface electrodes to ECG recorders/monitors. Prescription use only.
Regulatory Classification
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.
Predicate Devices
- Curbell Patient Monitoring Cables and Lead Wires (K081762)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized image of a human figure. The FDA acronym is in a blue box, and the full name, "U.S. Food & Drug Administration," is in blue text.
September 20, 2018
Medline Industries, Inc. Dinah Rincones Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093
Re: K181726
Trade/Device Name: Medline Patient Cables and Lead Wires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: July 20, 2018 Received: July 23, 2018
Dear Dinah Rincones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for 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) K181726
Device Name Medline Patient Cables and Lead Wires
#### Indications for Use (Describe)
Medline Patient Cables and Lead Wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. Additionally, the use of Medline Patient Cables and Lead Wires is limited by the indications for use of the ECG monitoring or diagnostic equipment it is connected to. Medline Patient Cables and Lead Wires are intended for Prescription Use only.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### 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/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with a stylized white starburst symbol positioned to the right of the text. The starburst is composed of four elongated triangles converging at a central point. A gray bar is located on the right side of the image.
ledline Industries, Inc. Three Lakes Drive Northfield. IL 60093
# 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
#### Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
#### Contact Person
Dinah Rincones Regulatory Affairs Specialist Phone: 847-949-2687 Fax: 224-931-1271 Email: DRincones@medline.com
Summary Preparation Date June 28, 2018
Type of 510(k) Submission Traditional
#### Device Name / Classification
- Device Common Name Patient transducer and cable .
- Proprietary Name - Medline Patient Cables and Lead Wires
- Device Class - II
- Panel Cardiovascular .
- Product Code - DSA
- . Regulation Number - 21 CFR §870.2900
#### Predicate Device
The legally-marketed predicate device that is most suitable for comparison with Medline Patient Cables and Lead Wires is: Curbell Patient Monitoring Cables and Lead Wires. This device was cleared under 510(k) number K081762 on August 18th, 2008 to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo consists of the word "MEDLINE" in white, set against a dark blue square background. A stylized white starburst or cross-like symbol is positioned behind and slightly above the text, adding a visual element to the logo. A gray bar is on the right side of the logo.
ledline Industries. Inc Three Lakes Drive Northfield. IL 60093
#### Subject Device Description
Medline Patient Cables and Lead Wires are used to transmit signals from patient surface electrodes to various electrocardiograph (ECG) recorders/monitors for diagnostic and/or monitoring purposes. Medline Patient Cables and Lead Wires are not stand-alone devices, but are accessories to legallymarketed ECG monitors and patient electrodes, ultimately acting as a conduit between the two to transmit signals from the patient to the monitor.
The proposed device consists of two distinct parts – reusable trunk cables and disposable lead wires – which are used as a system to transfer signals originating from skin-mounted EGG electrodes (distal end) to an ECG monitoring device (proximal end). All designs of Medline Trunk Cables feature a monitor connector at one end, which mates with a designated OEM monitor, and a yoke connector at the other end, which provides the connection point from the trunk cable to the lead wires. Similarly, all designs of Medline Lead Wires feature a lead connector at one end, which mates with the yoke end of the trunk cable, and an electrode connector at the other end, which attaches to patient electrodes. It is this system's cabling that facilitates the conduction of signals from the electrodes to the ECG monitoring device.
#### Indications for Use
Medline Patient Cables and Lead Wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. Additionally, the use of Medline Patient Cables and Lead Wires is limited by the indications for use of the ECG monitoring or diagnostic equipment it is connected to. Medline Patient Cables and Lead Wires are intended for Prescription Use only.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, placed on a blue square. A white, stylized starburst shape is behind the text, with the center of the starburst aligned with the center of the word "MEDLINE". The starburst shape has four points, each pointing towards a corner of the blue square.
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
## Summary of Technological Characteristics
# TABLE 1: COMPARISON OF SUBJECT AND PREDICATE DEVICES
| Device Characteristic | Proposed Device | Predicate Device<br>(K081762) | Comparison<br>Analysis |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| PRODUCT NAME | Medline Patient Cables and<br>Lead Wires | Curbell Patient Monitoring Cables<br>and Lead Wires | DIFFERENT |
| PRODUCT CODE | DSA | DSA | SAME |
| CLASSIFICATION NAME | Patient Transducer and<br>Electrode Cable (Including<br>Connector) | Patient Transducer and Electrode<br>Cable (Including Connector) | SAME |
| REGULATION NUMBER | 21 CFR §870.2900 | 21 CFR §870.2900 | SAME |
| DEVICE CLASS | Class II | Class II | SAME |
| COMMON NAME | ECG Cable and Lead Wire | ECG Cable and Lead Wire | SAME |
| ANATOMICAL SITES | Attached to sensors placed at<br>specified locations as required<br>by the patient monitor.<br>Examples include Left arm,<br>Right arm, Chest, Left leg &<br>Right leg. | Attached to sensors placed at<br>specified locations as required by<br>the patient monitor. Examples<br>include Left arm,<br>Right arm, Chest, Left leg & Right<br>Right leg. | SAME |
| INTENDED USE | Used to connect electrodes<br>and/or sensors placed at the<br>appropriate sites on the patient<br>to a monitoring device for<br>general monitoring and/or<br>diagnostic evaluation by a<br>healthcare professional. | Used to connect electrodes and/or<br>sensors placed at the appropriate<br>sites on the patient to a monitoring<br>device for general monitoring<br>and/or diagnostic evaluation by a<br>healthcare professional. | SAME |
| PRINCIPLE OF OPERATION | Includes trunk cables and lead<br>wires that form a conduction<br>channel for transmitting signals<br>from electrodes affixed to<br>patient skin to an ECG<br>monitoring device. Lead wires<br>attach to patient electrodes at<br>one end and to a corresponding<br>trunk cable at the other end.<br>Trunk cables then span from<br>lead wire connection point at<br>this end, to their opposite end<br>that plugs into a respective ECG<br>monitor, facilitating signal<br>conduction from patient to<br>monitor.<br>Use and function of this device<br>is limited to the area spanning<br>from the patient electrodes to the | Includes trunk cables and lead<br>wires that form a conduction<br>channel for transmitting signals<br>from electrodes affixed to patient<br>skin to an ECG monitoring device.<br>Lead wires attach to patient<br>electrodes at one end and to a<br>corresponding trunk cable at the<br>other end. Trunk cables then span<br>from lead wire connection point at<br>this end, to their opposite end that<br>plugs into a respective ECG<br>monitor, facilitating signal<br>conduction from patient to monitor.<br>Use and function of this device is<br>limited to the area spanning from<br>the patient electrodes to the ECG<br>monitoring device, where it<br>provides a means of cable | SAME |
| Device Characteristic | Proposed Device | Predicate Device<br>(K081762) | Comparison<br>Analysis |
| | ECG monitoring device, where<br>it provides a means of cable<br>connection for the transmission<br>of signals. | connection for the transmission of<br>signals. | |
| APPEARANCE | Designed as replacements for<br>similar cables manufactured by<br>the Original Equipment<br>Manufacturers (OEM) and other<br>third party manufacturers for<br>their respective ECG monitors.<br>Include Trunk Cables and Lead<br>Wires with various type of<br>connectors at each end (monitor,<br>trunk/lead wire, electrode pinch<br>or snap) | Designed as replacements for<br>similar cables manufactured by the<br>Original Equipment Manufacturers<br>(OEM) and other third party<br>manufacturers for their respective<br>ECG monitors.<br>Include Trunk Cables and Lead<br>Wires with various type of<br>connectors at each end (monitor,<br>trunk/lead wire, electrode pinch,<br>snap or Sure Lock) | SIMILAR |
| LEAD WIRE<br>CONSTRUCTION | Shielded Copper with<br>polyurethane jacket | Shielded and Unshielded Copper<br>with polyurethane jacket | SIMILAR |
| TRUNK CABLES LENGTH | 2500mm | 3848mm | SIMILAR |
| LEAD WIRES LENGTH | 965mm | 457mm to 1311mm | SIMILAR |
| NUMBER OF LEADS | 3 and 5 lead versions | 3, 5 and 6 lead versions | SIMILAR |
| TYPE OF USE<br>(RX VS OTC) | Prescription Use | Prescription Use | SAME |
| USE ENVIRONMENT | Health Care Settings | Health Care Settings | SAME |
| STERILITY | Non-Sterile | Non-Sterile | SAME |
| TRUNK CABLES USAGE | Reusable | Reusable | SAME |
| LEAD WIRES USAGE | Disposable (Single Use) | Reusable | DIFFERENT |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image features the Medline logo set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with a stylized starburst symbol positioned to the right of the text. The starburst is white and appears to be composed of four elongated triangles converging at a central point. A small gray square is visible in the upper right corner of the image.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
## Summary of Non-Clinical Testing
#### Biocompatibility Testing
The biological evaluation for the Medline Patient Cables and Lead Wires was conducted in accordance with FDA guidance document, "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process. The proposed device (Medline Lead Wire Models only) is in direct contact with the skin for a prolonged duration of contact (> 24 hours to 30 days); therefore, the following biocompatibility tests were performed:
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. A white star-like shape is in the center, with the word "MEDLINE" in white, bold letters to the left of the star.
**Medline Industries, Inc.**
Three Lakes Drive
Northfield, IL 60093
- Cytotoxicity MEM Elution per ISO 10993-5: 2009 "Biological Evaluation of Medical Devices-● Part 5: Tests for in vitro cytotoxicity."
- Buehler Dermal Sensitization - Repeated Patch (GLP-2 Extracts) per ISO 10993-10: 2010 "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
- . Irritation - Primary Skin Irritation per ISO 10993-10: 2010 "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
#### Performance Testing
Functional performance testing was conducted to demonstrate that the proposed device meets the standard specifications for a Patient Transducer and Electrode cable (including connector). To assure this, the Medline Patient Cables and Lead Wires were tested in accordance with the following standards applicable to this device type:
- IEC 60601-1:2005 (Third Edition) + CORR, 1:2006 + CORR. 2:2007 + A1:2012 = "Medical ● electrical equipment - Part 1: General requirements for basic safety and essential performance".
- IEC 60601-2-27:2011 "Medical electrical equipment Part 2-27: Particular requirements for the ● basic safety and essential performance of electrocardiographic monitoring equipment.
- ANSI/AAMI EC53:2013 - "ECG trunk cables and patient lead wires"
## Summary of Clinical Testing
Not applicable.
#### Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Patients Cables and Lead Wires are as safe and as effective for their intended use as the predicate device Curbell Patient Monitoring Cables and Lead Wires (K081762).
