Philips ECG leadsets are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Device Description

The Philips ECG Leadwire Set is a single patient electrode cable system used to transfer signals from patient electrodes to various electrocardiograph recorders and monitors. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

AI/ML Overview

This document describes the 510(k) premarket notification for the Philips ECG Leadwire Set (K110287). This submission is for a medical device (leadwire set) and not an AI/ML powered device, therefore much of the requested information (sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies) is not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with established electrical and biocompatibility standards, and the "reported device performance" is the claim of substantial equivalence to the predicate device based on meeting these standards and having similar technological characteristics.

Acceptance Criteria	Reported Device Performance
Compliance with recognized standards:	Philips ECG Leadwire Set is designed and tested to conform to the following FDA-recognized standards:
- IEC 60601-1:1998 (Medical electrical equipment)	Achieved through verification testing.
- UL 60601-1:2003 (National deviations for IEC 60601-1)	Achieved through verification testing.
- ANSI/AAMI ES 60601-1:2005 (National deviations for IEC 60601-1)	Achieved through verification testing.
- AAMI/ANSI EC 13:2002/(R)2007 (Cardiac monitors, heart rate meters and alarms)	Achieved through verification testing.
- AAMI/ANSI EC53:1995/(R) 2008 (ECG cables and leadwires, including Amendment 1)	Achieved through verification testing.
- AAMI/ANSI/ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)	Achieved through verification testing.
- ISO 10993-10:2002 (Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity)	Achieved through verification testing.
- Product Inspection for non-measurable characteristics	Compliance achieved for characteristics such as color and intrinsic design.
- Substantial Equivalence to Predicate Device (K102430)	The new device has equivalent technological characteristics related to safety and effectiveness as the predicate device. The primary difference (grabber vs. snap connector) is considered substantially equivalent. Indications for use are identical.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as this is a traditional medical device submission (ECG leadwire set) and not an AI/ML device that would involve a "test set" of data in the sense of patient data for model evaluation. The "testing" referred to is engineering verification testing against recognized standards, not performance evaluation on a patient dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the context of AI/ML, refers to reference labels for a dataset. For this device, the "ground truth" is defined by compliance with established engineering and biocompatibility standards. Expert review would be part of the internal design and testing process, but not in the format of "ground truth" for a dataset.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the AI/ML context described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-powered diagnostic or screening devices to assess how the AI impacts human reader performance, which is not applicable to a passive leadwire set.

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

No, a standalone performance study was not done. This is also relevant for AI/ML algorithms and not for an ECG leadwire set, which is a physical component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is compliance with recognized international and national standards for medical electrical equipment, cardiac monitors, ECG cables and leadwires, and biological evaluation of medical devices. This involves objective measurements and assessments against predefined criteria specified in these standards.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML algorithm requiring a "training set" for this device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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K110287

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 100

Philips ECG Leadwire Set

FEB 1 5 2011

Submitter's Name and Address

Submitter's Name:	Philips Medical Systems
Division:	Medical Consumers and Sensors
Address:	3000 Minuteman Road
City, State, and Zip:	Andover, MA 01810

Contact Person / Submission Correspondent

Name:	Peter Schipelliti
Title:	Regulatory Program Manager
Telephone:	( 978 ) 659-4744
Facsimile:	( 978 ) 659-7712
E-mail:	peter.schipelliti@philips.com

Manufacturers' Information; Establishment Registration Number.

Establishment name:	Philips Medical Systems
Address:	3000 Minuteman Road
	Andover, MA 01810
Establishment Registration No.	1218950

New Device Details

Proprietary or Trade Name:	Philips ECG Leadwire Set
Common Name:	ECG Leadwire Set
Device Class:	Class II
Device Procode:	DSA
Device CFR:	21 CFR 870.2900
Classification Panel:	Cardiovascular
Classification Name:	Patient transducer and electrode cable (includingconnector).

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K110287

Predicate Device Details

510(k) Number	K102430 (cleared on September 10, 2010)
Proprietary or Trade Name:	Tyco Electronics Electrocardiograph (ECG)Leadwire Set
Common Name:	ECG Leadwire Set
Device Class:	Class II
Device Procode:	DSA
Device CFR:	21 CFR 870.2900
Classification Panel:	Cardiovascular
Classification Name:	Patient transducer and electrode cable (includingconnector)

Device Description

Intended Use

Philips Single-Patient-Use Disposable ECG Leadsets are intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These Philips leadsets are intended for short-term use only (an average patient stay of 5 days).

Product Comparison

The new device has equivalent technological characteristics related to safety and effectiveness as the predicate device.

The primary difference between the new device and the predicate is that Philips ECG Leadwire Set utilizes a grabber connector and the predicate utilizes a snap connector to fasten to the electrode.

The indications for use for the new device is identical to the predicate. Though the leadsets are used to transfer signals from patient electrodes, actual use is limited by the indications for use of the connected monitoring or diagnostic equipment.

The new device and the predicate cannot be sterilized or otherwise reprocessed for reuse; they are intended to be used only with one patient then discarded.

The following table provides a comparison between the Philips ECG Leadwire Set cables and the predicate Tyco Electronics ECG Leadwire Set cables.

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1410287

Specification	PhilipsECG Leadwire Set(New Device)	Tyco ElectronicsECG Leadwire Set(Predicate)K102430	Comparison
	Indications for Use	Philips ECG leadsets areindicated for use in themonitoring of cardiacsignals for bothdiagnostic andmonitoring purposes.Use is limited by theindications for use of theconnected monitoring ordiagnostic equipment.
Sterility	Supplied non-sterile;cannot be sterilized orotherwise reprocessed	Supplied non-sterile:cannot be sterilized orotherwise reprocessed	Same
Reusability	Not reusable	Not reusable	Same
Anatomical Sites	Attached to electrodesplaced at standardspecified locations onchest wall andextremities	Attached to electrodesplaced at standardspecified locations onchest wall andextremities	Same
Design / Appearance	Cables with "grabber"configuration of ECGelectrode connector(distal connector) andcommon "header"connection (proximalconnector)	Cables with "snap"configuration of ECGelectrode connector(distal connector) andcommon "header"connection (proximalconnector)	Substantially Equivalent
Type of Construction	Flexible shielded multiconductor electricalcable	Flexible shielded multiconductor electricalcable	Same
Distal Connector Design	"Grabber" electrodeconnectors are colorcoded (red, white, green,black, brown)	"Snap" electrodeconnectors are colorcoded (red, white, green,black, brown)	Substantially Equivalent
	Connector designations(LL,RL etc.) moldedinto plastic	Connector designations(LL,RL etc.) moldedinto plastic	Same
Cable Length	1.0 m and 0.85 m	1.0 m	Substantially Equivalent
Wire Colors	White	White	Same
Leadwire Construction	Ribbonized leads withindividual coax shields	Shielded copper leadwire with polymerjacket	Substantially Equivalent
Proximal ConnectorDesign	All-in-one commonconnector, fits onlyPhilips ECGmonitor/recorders; colorcoded for use with ECG	All-in-one commonconnector, fits onlyPhilips ECGmonitor/recorders; colorcoded for use with ECG	Same

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Performance Data

Testing includes but is not necessarily limited to the recognized standards identified below:

. Medical electrical equipment IEC 60601-1:1998, including Amendments 1 (1991) and 2 (1995) and the national deviations described within UL 60601-1:2003 and ANSI/AAMI ES 60601-1:2005.
AAMI / ANSI EC 13:2002/(R)2007, Cardiac monitors, heart rate meters and . alarms
. AAMI/ANSI EC53:1995/(R) 2008, ECG cables and leadwires, including Amendment l
AAMI / ANSI / ISO 10993-5:2009, Biological evaluation of medical devices -. Part 5: Tests for in vitro cytotoxicity
. ISO 10993-10:2002, Biological evaluation of medical devices - Part 10 and Amendment 1: Tests for irritation and delayed-type hypersensitivity (including sensitization)

Compliance with the requirements of these standards will be achieved through verification testing, except in cases such as color and intrinsic design, where compliance will be achieved through product inspection. Testing will be conducted and will meet specified acceptance criteria prior to market release of the associated medical device.

Additional preference testing of product characteristics not related to safety and effectiveness and as specified by Philips Medical Systems will also be performed.

Conclusions

The Philips ECG Leadwire Sets (the new device) serve as a conductor of electrical energy. The new devices are substantially equivalent to predicate.

Product design and testing will be in conformance with FDA-recognized standards. Conformance with recognized standards ensures product design and function will raise no new issues related to safety and effectiveness.

Based on similarity in technology, characteristics and indications for use as the predicate, the Philips ECG Leadwire Sets are substantially equivalent.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three flowing lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Philips Medical Systems C/O Dawn Tibodeau TUV SUD America 1775 Old Highway 8 New Brighton. MN 55112-1891

FEB 1 5 2011

Re: K110287

Trade/Device Name: Philips ECG Leadwire Set Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: January 28, 2011 Received: January 31, 2011

Dear Ms. Tibodeau:

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 rr your as heet to additional controls. Existing major regulations affecting your device can be may be subject to additions, 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 I Teast of advised that I Drivedance or our device complies with other requirements of the Act that I Dr Has intess and regulations administered by other Federal agencies. You must or any I oded butters and requirements, including, but not limited to: registration and listing (21

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Page 2 – Ms. Dawn Timbodeau

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

[signature]

S Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pg 1 of 1

4.0 Indications for Use Statement

PHILIPS

11023 510(k) Number:

Device Name: Philips ECG Leadwire Set

Indications for Use:

Prescription Use	X
(21 CFR 801 Subpart D)	AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.P

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K110028

Philips Medical Systems Philips ECG Leadwire Set 510(k) CONFIDENTIAL

December 14, 2010 And Products of the States

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).