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 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.

AI/ML Overview

The document provided is a 510(k) summary for the Medline Patient Cables and Lead Wires, stating its substantial equivalence to a predicate device (Curbell Patient Monitoring Cables and Lead Wires, K081762). As such, it focuses on demonstrating that the new device is as safe and effective as the predicate, rather than establishing novel acceptance criteria or conducting a study to prove new performance claims typical of an AI/ML device.

Therefore, the requested information regarding acceptance criteria and a study to prove device performance as typically understood for an AI/ML device (e.g., diagnostic accuracy, reader studies, etc.) is not applicable to this submission. The document primarily describes non-clinical performance and biocompatibility testing to ensure the device meets established standards for patient cables and lead wires. Here's a breakdown of the relevant information provided:

1. Table of acceptance criteria and reported device performance:

The document lists performance testing against standards, rather than specific acceptance criteria with numerical targets and reported performance values. The summary states that functional performance testing was conducted to demonstrate the device meets the "standard specifications" of the listed standards. It does not provide a table of measured performance against specific pre-defined acceptance values.

Standard / Test Category	Description of Performance Test / Standard Met	Device Performance (as reported)
Biocompatibility	Conducted per FDA guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" and ISO 10993-1. For direct skin contact (> 24 hours to 30 days): - Cytotoxicity MEM Elution (ISO 10993-5:2009) - Buehler Dermal Sensitization - Repeated Patch (GLP-2 Extracts) (ISO 10993-10:2010) - Irritation - Primary Skin Irritation (ISO 10993-10:2010)	Tests performed and concluded favorably (implied by 510(k) clearance, specific results not provided in summary).
Performance Testing	Functional performance testing conducted to demonstrate that the device meets "standard specifications" according to: - 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"	Tests performed and concluded favorably (implied by 510(k) clearance, specific results not provided in summary).

2. Sample size used for the test set and the data provenance:

This type of information is not provided because the submission describes the testing of physical medical devices (cables and lead wires) against safety and performance standards for their construction and electrical properties, not clinical or algorithmic performance on patient data.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable, as this is not an AI/ML device submission evaluating diagnostic or interpretative performance.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used:

For the performance testing, the "ground truth" would be the established requirements and thresholds within the cited international and national standards (IEC 60601-1, IEC 60601-2-27, ANSI/AAMI EC53) for electrical safety, signal integrity, mechanical durability, and biocompatibility.

8. The sample size for the training set:

Not applicable; this is not an AI/ML or software algorithm device that undergoes a "training set."

9. How the ground truth for the training set was established:

Not applicable.

In summary: The provided document is a 510(k) submission for patient cables and lead wires, a type of electro-mechanical medical device. The "study" proving device performance involved non-clinical laboratory testing to ensure the device met established industry-standard specifications for safety and performance, as required for its classification and comparability to a predicate device. It does not involve a clinical study, AI/ML algorithm evaluation, or human-in-the-loop performance assessment.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K181726

Device Name Medline Patient Cables and Lead Wires

Indications for Use (Describe)

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 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.

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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

Indications for Use

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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(K081762)	ComparisonAnalysis
PRODUCT NAME	Medline Patient Cables andLead Wires	Curbell Patient Monitoring Cablesand Lead Wires	DIFFERENT
PRODUCT CODE	DSA	DSA	SAME
CLASSIFICATION NAME	Patient Transducer andElectrode Cable (IncludingConnector)	Patient Transducer and ElectrodeCable (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 atspecified locations as requiredby the patient monitor.Examples include Left arm,Right arm, Chest, Left leg &Right leg.	Attached to sensors placed atspecified locations as required bythe patient monitor. Examplesinclude Left arm,Right arm, Chest, Left leg & RightRight leg.	SAME
INTENDED USE	Used to connect electrodesand/or sensors placed at theappropriate sites on the patientto a monitoring device forgeneral monitoring and/ordiagnostic evaluation by ahealthcare professional.	Used to connect electrodes and/orsensors placed at the appropriatesites on the patient to a monitoringdevice for general monitoringand/or diagnostic evaluation by ahealthcare professional.	SAME
PRINCIPLE OF OPERATION	Includes trunk cables and leadwires that form a conductionchannel for transmitting signalsfrom electrodes affixed topatient skin to an ECGmonitoring device. Lead wiresattach to patient electrodes atone end and to a correspondingtrunk cable at the other end.Trunk cables then span fromlead wire connection point atthis end, to their opposite endthat plugs into a respective ECGmonitor, facilitating signalconduction from patient tomonitor.Use and function of this deviceis limited to the area spanningfrom the patient electrodes to the	Includes trunk cables and leadwires that form a conductionchannel for transmitting signalsfrom electrodes affixed to patientskin to an ECG monitoring device.Lead wires attach to patientelectrodes at one end and to acorresponding trunk cable at theother end. Trunk cables then spanfrom lead wire connection point atthis end, to their opposite end thatplugs into a respective ECGmonitor, facilitating signalconduction from patient to monitor.Use and function of this device islimited to the area spanning fromthe patient electrodes to the ECGmonitoring device, where itprovides a means of cable	SAME
Device Characteristic	Proposed Device	Predicate Device(K081762)	ComparisonAnalysis
	ECG monitoring device, whereit provides a means of cableconnection for the transmissionof signals.	connection for the transmission ofsignals.
APPEARANCE	Designed as replacements forsimilar cables manufactured bythe Original EquipmentManufacturers (OEM) and otherthird party manufacturers fortheir respective ECG monitors.Include Trunk Cables and LeadWires with various type ofconnectors at each end (monitor,trunk/lead wire, electrode pinchor snap)	Designed as replacements forsimilar cables manufactured by theOriginal Equipment Manufacturers(OEM) and other third partymanufacturers for their respectiveECG monitors.Include Trunk Cables and LeadWires with various type ofconnectors at each end (monitor,trunk/lead wire, electrode pinch,snap or Sure Lock)	SIMILAR
LEAD WIRECONSTRUCTION	Shielded Copper withpolyurethane jacket	Shielded and Unshielded Copperwith 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(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

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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:

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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).

Regulation Number and Section

§ 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).