The LIFEPAK ECG cables are reusable electrode cable systems intended to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes. LIFEPAK ECG cables are intended for use in outdoor and indoor emerqency care settings.

LIFEPAK ECG Cables:

LIFEPAK 3-wire ECG Cable -
LIFEPAK 5-wire ECG Cable i
-LIFEPAK 4-wire ECG cable
LIFEPAK 3-wire extended precordial ECG Cable l
-LIFEPAK 6-wire expandable precordial ECG cable

Device Description

The LIFEPAK ECG cables are an accessory designed to be used with Physio-Control LIFEPAK 35 monitor/defibrillator. The LIFEPAK ECG cables are intended for use by Advanced Life Support (ALS) and Basic Life Support (BLS) providers to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes.

The LIFEPAK ECG Cables are reusable ECG trunk cables and lead wires that connect to the LIFEPAK 35 monitor/defibrillator for ECG monitoring. There are several types or configurations of ECG cables: 3-wire, a 4-wire cable assembly to be used with the LIFEPAK 6-wire precordial cable and/or the LIFEPAK 3-wire precordial cable to perform a 12 or 15-lead ECG Cable assembly. When the LIFEPAK 4-wire ECG cable is configured with a 6-wire expandable precordial cable, a 12-lead ECG is constructed. Likewise, when the LIFEPAK 4-wire ECG cable is configured with a 6-wire expandable precordial cable and a 3-wire extended precordial ECG cable a 15-lead ECG is constructed.

The 4- wire ECG cable is available in two lengths, 5 feet or 8 feet. Additionally, the 3-, 4-, and 5-wire ECG Cables and the 6-wire precordial ECG cable are available with color coding according to the American Heart Association (AHA) or International Electrotechnical Commission (IEC) standards.

The LIFEPAK ECG cables are a reusable electrode cable system intended to transmit signals from patient electrodes to the LIFEPAK 35 monitor/defibrillator for both diagnostic and monitoring purposes. These accessories consist of conductor wires that are shielded and insulated by a polyurethane jacket material. The lead wires are color coded according to which electrode location they are attached to on the patient.

The LIFEPAK ECG cables are not intended for use with other manufacturers' defibrillators. The LIFEPAK ECG cables are intended only for use with LIFEPAK 35 monitor/defibrillator.

AI/ML Overview

The provided text describes the 510(k) premarket notification for LIFEPAK® ECG Cables. This is a device for transmitting ECG signals, not an AI/ML-based medical device. Therefore, many of the requested criteria (such as MRMC studies, AI/ML-specific ground truth, training set information, etc.) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (Multi-Link™ X2 ECG Cable and Leadwire System) primarily through performance testing of the hardware components and comparison of technical characteristics.

Here's an attempt to answer the questions based only on the provided document, acknowledging that much of it is not relevant for an AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted against applicable standards:

Test Performed	Applicable Standard	Acceptance Criteria (Implied)	Reported Device Performance
Connector mating/unmating, Retention force	60601-2-25:2011, 60601-2-27:2011, ANSI AAMI EC53:2013/(R)2020	Meet standard requirements	Met
Inspection of Air Clearance	60601-2-25:2011, 60601-2-27:2011	Meet standard requirements	Met
Cable Noise Testing	ANSI AAMI EC53:2013/(R)2020	Meet standard requirements	Met
Flex/Twist Life Testing	ANSI AAMI EC53:2013/(R)2020	Meet standard requirements	Met
Tensile Strength Testing	ANSI AAMI EC53:2013/(R)2020	Meet standard requirements	Met
Defibrillation Protection and Energy Reduction	IEC 60601-1:2005/AMD2:2020, IEC 60601-2-25:2011, IEC 60601-2-27:2011	Meet standard requirements	Met
Dielectric Withstand Testing	IEC 60601-1:2005/AMD2:2020, ANSI AAMI EC53:2013/(R)2020	Meet standard requirements	Met
Leakage Current Testing	IEC 60601-1:2005/AMD2:2020	Meet standard requirements	Met
Storage Conditioning and Drop Test	IEC 60601-1:2005/AMD2:2020, IEC 60601-2-27:2011	Meet standard requirements	Met
Material Resistance for Cleaning and Disinfection Stress	IEC 60601-1:2005/AMD2:2020	Meet standard requirements	Met
Electromagnetic Compatibility	IEC 60601-1-2:2014	Meet standard requirements	Met
Shock, Vibration and IP Classification	IEC 60601-1:2005/AMD2:2020, IEC 60601-2-27:2011, IEC 60529: 2013	Meet standard requirements	Met
Biocompatibility Assessment	ISO 10993-1	Meet standard requirements	Yes - Assessed
ASCA Test Reports	N/A (General term)	Meet standard requirements	Yes
Design Verification Testing	N/A (General term)	Meet standard requirements	Yes

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

The document does not specify exact sample sizes for each physical test. It confirms that "Performance testing has been completed to demonstrate that the proposed LIFEPAK ECG Cables meet the safety and performance requirements established in the design specifications." These are typically laboratory-based engineering tests on device samples, not studies on patient data. The provenance for these tests is the manufacturer (Physio-Control Inc.). The tests are "non-clinical performance testing."

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

Not applicable. This is a hardware device undergoing engineering and safety performance testing, not an AI/ML algorithm requiring expert interpretation of medical images or data for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for human-read or AI-generated interpretations of medical data, not for physical performance tests of a cable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML-based device. No human clinical studies were submitted as part of this 510(k) Premarket Notification.

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

Not applicable. This is not an AI/ML-based device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is typically adherence to established engineering, electrical, and biocompatibility standards (e.g., IEC 60601, ANSI AAMI EC53, ISO 10993-1). Compliance with these standards confirms the device's technical specifications and safety profile, rather than a clinical ground truth like a pathology report.

8. The sample size for the training set

Not applicable. This is not an AI/ML-based device.

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

Not applicable. This is not an AI/ML-based device.

Summary

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May 7, 2024

Stryker Physio-Control Craig Schultz Senior Staff Regulatory Affairs Specialist 11811 Willows Road NE Redmond, Washington 98052

Re: K240377

Trade/Device Name: LIFEPAK® ECG Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: February 7, 2024 Received: February 7, 2024

Dear Craig Schultz:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240377

Device Name

LIFEPAK ECG Cables

Indications for Use (Describe)

LIFEPAK 5-wire ECG Cable
LIFEPAK 4-wire ECG cable
LIFEPAK 3-wire extended precordial ECG Cable
LIFEPAK 6-wire expandable precordial ECG cable

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)

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:

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510(k) SUMMARY

1.0 Submitter Information [21 CFR 807.92(a) (1)]

Physio-Control, Inc. 11811 Willows Road Northeast Redmond, Washington 98073-9706 Registration Number: 3015876, 3006703820

Contact:

Craig Schultz Sr. Staff Regulatory Affairs Specialist +1 (425) 442-3268 (P) Craig.schultz@stryker.com

Date of Preparation: April 29, 2024

2.0 Device Information [21 CFR 807.92 (a) (2)]

Device Trade/Proprietary Name:

LIFEPAK® ECG Cables

Device Common Name:

LIFEPAK ECG Cables

Table 1 Device Classification

Device Classification and CFR Reference	Classification Panel	Product Code
Cable, Transducer and Electrode, Patient,(Including Connector), Class II (870.2900)	Cardiovascular Devices	DSA

3.0 Predicate Device [21 CFR 807.92(a) (3)]

The features and functions of the proposed subject accessory are equivalent to the following previously cleared device:

Table 2 Predicate Device

Predicate Device	510(k) Number(s) / Clearance Date
Multi-Link™ X2 ECG Cable and LeadwireSystem	K211294/August 16, 2021

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4.0 Purpose and Device Description [21 CFR 807.92(a) (4)]

The LIFEPAK ECG cables are not intended for use with other manufacturers' defibrillators. The LIFEPAK ECG cables are intended only for use with LIFEPAK 35 monitor/defibrillator.

5.0 Intended Use of device and Indications for Use [21 CFR 807.92(a) (5)]

LIFEPAK ECG Cables:

LIFEPAK 3-wire ECG Cable -
LIFEPAK 5-wire ECG Cable i
-LIFEPAK 4-wire ECG cable
LIFEPAK 3-wire extended precordial ECG Cable l
-LIFEPAK 6-wire expandable precordial ECG cable

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6.0 Summary of Substantial Equivalence [21 CFR 807.92 (a)(6)]:

The fundamental scientific technology is the same for the proposed and the predicate devices. The ECG cables transmit signals from patient electrocardiograph monitor for monitoring purposes. The LIFEPAK ECG cables are substantially equivalent to the Multi-Link X2 Cable and Lead Wire System regarding safety, effectiveness, intended use and performance. The proposed LIFEPAK ECG Cables are designed to work with the LIFEPAK 35 monitor/defibrillator.

No new questions regarding the safety and effectiveness of the device have been raised with the proposed LIFEPAK ECG Cables.

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Table 3 Comparison of Predicate Device and Subject Device

Characteristic	Predicate DeviceMulti-Link X2 ECG Cable and LeadwireSystem (K211294)	Subject DeviceLIFEPAK ECG Cables
Trade Name	Multi-Link X2 ECG Cable and LeadwireSystem	LIFEPAK ECG Cables
Manufacturer	Vyaire Medical Inc.	Physio-Control Inc.
FDA Product Code	DSA	DSA
Prescription/Over-the-Counter Use	Prescription	Same
Indications forUse/Intended Use	The Multi-LinkTM X2 ECG Cable andLeadwire System is intended to transmitsignals from patient electrodes to variouselectrocardiograph recorders / monitors formonitoring purposes.	The LIFEPAK ECG cables are reusable electrode cablesystems intended to transmit signals from patientelectrodes to the LIFEPAK monitor/defibrillator formonitoring purposes.
Contraindications	None known	Same
Intended Environment	Hospital Environment and Pre-HospitalEnvironment (i.e., scene of emergency,transport, including airborne).	Indoor and outdoor emergency care settings.
Patient Population	Any patient requiring ECG monitoring,according to the monitor's intended use.	Same
Anatomical sites	The anatomical site of the compatiblepreviously cleared ECG Leadwires is Chest	Attached to electrodes placed at standard specifiedlocations on chest or extremities.

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Characteristic	Predicate DeviceMulti-Link X2 ECG Cable and LeadwireSystem (K211294)	Subject DeviceLIFEPAK ECG Cables
Usage	Reusable	Same
Sterile	Nonsterile	Same
ECG Monitoring	3 or 5 lead	3, 5, 6, 12 or 15-lead
Cable Materials	TPU	PU, PVC, TPU
Cable Length	Variable	5 ft, 8 ft
Compatibility withEnvironment and otherdevices	Philips, Mindray, Nihon Kohden, GE,Spacelabs,	LIFEPAK 35 monitor/defibrillator
Biocompatibility	ISO 10993-1	ISO 10993-1

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The subject and predicate devices are based on the following same technological principles:

Conducting electrical signals passively from ECG lead wires to the monitoring ● equipment.
Device contains interfaces to allow the ECG wires and the ECG monitoring to connect.
. Device composed of a plug face, contact pins, pre-mold, over-mold, and cable.
Cable coating materials are the same.

The following technological differences exist between the subject and predicate devices:

. The predicate device is compatible with Leadwires containing 3-Wire and 5-Wire ECG cables, while the subject device is compatible with 3, 5, 6, 12 and 15-leads.
The trunk cable monitor interfaces are different as the predicate and subject devices . are compatible with different monitors.

7.0 Performance Data [21 CFR 807.92(b)(1)]:

Performance testing has been completed to demonstrate that the proposed LIFEPAK ECG Cables meet the safety and performance requirements established in the design specifications. Comprehensive testing included the following:

ASCA Test Reports ●
Design Verification Testing ●
Biocompatibility Assessment ●

No human clinical studies were submitted as part of this 510(k) Premarket Notification.

Test Performed	Applicable Standard	Result
Connector mating/unmating, Retentionforce	60601-2-25:201160601-2-27:2011ANSI AAMI EC53:2013/(R)2020	Met
Inspection of Air Clearance	60601-2-25:201160601-2-27:2011	Met
Cable Noise Testing	ANSI AAMI EC53:2013/(R)2020	Met
Flex/Twist Life Testing	ANSI AAMI EC53:2013/(R)2020	Met
Tensile Strength Testing	ANSI AAMI EC53:2013/(R)2020	Met

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Test Performed	Applicable Standard	Result
Defibrillation Protection and EnergyReduction	IEC 60601-1:2005/AMD2:2020IEC 60601-2-25:2011IEC 60601-2-27:2011	Met
Dielectric Withstand Testing	IEC 60601-1:2005/AMD2:2020ANSI AAMI EC53:2013/(R)2020	Met
Leakage Current Testing	IEC 60601-1:2005/AMD2:2020	Met
Storage Conditioning and Drop Test	IEC 60601-1:2005/AMD2:2020IEC 60601-2-27:2011	Met
Material Resistance for Cleaningand Disinfection Stress	IEC 60601-1:2005/AMD2:2020	Met
Electromagnetic Compatibility	IEC 60601-1-2:2014	Met
Shock, Vibration and IP Classification	IEC 60601-1:2005/AMD2:2020IEC 60601-2-27:2011 2011IEC 60529: 2013	Met

8.0 Conclusion [21 CFR 807.92(b)(3)]:

The subject device and the predicate device have the same intended use, similar indications for use, same technological characteristics, and the subject device does not raise any new issues affecting safety or effectiveness of the device. A risk benefit assessment concluded that the benefits associated with the subject device do outweigh any potential risks. The subject device has passed all acceptance criteria for the non-clinical performance testing. Therefore, it was determined that the subject device is substantially equivalent to the predicate devices identified in this submission.

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).