The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.

Device Description

The LIFEPAK Invasive Pressure Adapter Cable is a reusable, insulated, shielded, electrical cord (trunk cable) with a proximal connector (to connect with the LIFEPAK 35 device) and a main yoke that houses three distal leans with connectors (to connect with invasive pressure transducers). The LIFEPAK Invasive Pressure Adapter Cable is designed to transmit an electrical signal (data) between devices (i.e., to connect invasive pressure transducers from the patient to the LIFEPAK 35 monitor/defibrillator). The invasive pressure cable is designed to connect up to three pressure transducers to the front panel of the LIFEPAK 35 monitor/defibrillator for invasive pressure monitoring. Three channels are available for invasive pressure (IP) monitoring, with labels P1, P2, and P3. Each channel also has a user-selectable label for the line type through the LIFEPAK 35 monitor/defibrillator.

Invasive Pressure monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer (i.e., IP Probe). The invasive pressure cable passes the electrical signal from the transducers to the LIFEPAK 35 monitor/defibrillator.

The LIFEPAK Invasive Pressure Adapter Cable is available in two different models that are compatible with either ICU Medical Transpac® IV Disposable Pressure Transducers or Edwards Lifesciences TruWave® Disposable Pressure Transducers. These pressure transducers provide industry standard sensitivity and defibrillation protection of at least 360 joules.

The LIFEPAK Invasive Pressure Adapter Cable is not intended for use with other manufacturers' defibrillators and/or monitors. The LIFEPAK Invasive Pressure Adapter Cable is intended only for use with LIFEPAK 35 monitor/defibrillator.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "LIFEPAK® Invasive Pressure Adapter Cable." It does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through general performance testing.

Therefore, most of the requested information cannot be extracted from this document. However, I can provide the available details:

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

This information is not provided in the document. The document states "Performance testing has been completed to demonstrate that the proposed LIFEPAK Invasive Pressure Adapter Cable meets the safety and performance requirements established in the design specifications." However, the specific acceptance criteria and the numerical results of these tests are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document only mentions "Biocompatibility Evaluation" and "Design Verification Testing" were completed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. The document does not describe a study involving expert-established ground truth.

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

Not applicable. The document does not describe a study with adjudication.

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. The device is an adapter cable, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. The device is a physical cable, not an algorithm.

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

Not applicable. The document does not describe a study that uses ground truth in this context. The "performance data" refers to engineering and biocompatibility testing.

8. The sample size for the training set:

Not applicable. The device is a physical cable, not a machine learning algorithm that requires a training set.

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

Not applicable. The device is a physical cable, not a machine learning algorithm.

Summary

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April 30, 2024

Physio-Control, Inc. Elisha McGaff Staff Regulatory Affairs Specialist 11811 Willows Road NE Redmond, Washington 98052

Re: K240156

Trade/Device Name: LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: January 19, 2024 Received: January 19, 2024

Dear Elisha McGaff:

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.

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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).

Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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,

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Enclosure

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Indications for Use

Submission Number (if known)

K240156

Device Name

LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021);

LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

Submitter:

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

Contact:

Elisha McGaff Senior Staff Regulatory Affairs Specialist 425-605-3483 (office) Elisha.McGaff@stryker.com

Date of Preparation: January 19, 2024

Device Trade/Proprietary Name: LIFEPAK® Invasive Pressure Adapter Cable

Device Common Name: Invasive Pressure (IP) Cable

Device Classification:

Device Classification and CFR Reference	Classification Panel	Product Code
Patient transducer and electrode cable(21 CFR 870.2900)	Cardiovascular Devices	DSA

Predicate Device(s):

The features and functions of the proposed LIFEPAK Invasive Pressure Adapter Cable accessory are equivalent to the following previously cleared device(s):

Predicate Device	510(k) Number(s) / Clearance Date
JKH USA, LLC Patient Monitoring Cables	K203635 /Cleared on 02/05/2021

LIFEPAK Invasive Pressure Adapter Cable Traditional 510(k)

Stryker Emergency Care

11811 Willows Road NE, Redmond, WA 98052

Page 1 of 4

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Device Description:

Indications for Use:

The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or to aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.

Summary of Technological Characteristics:

The intended use, features, and functional characteristics of the proposed LIFEPAK Invasive Pressure Adapter Cable are equivalent to the predicate device. A minor difference related to limiting the connection to one type (i.e., patient IP transducers to the monitoring device) was noted. Overall, this difference does not alter the effect or raise new issues for the safety and effectiveness of the invasive pressure adapter cable as compared to the predicate.

LIFEPAK Invasive Pressure Adapter Cable Traditional 510(k)

11811 Willows Road NE, Redmond, WA 98052 | P +1 425 867 4000 | stryker.com

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The proposed changes have not raised any new issues of safety and effectiveness when compared to the existing predicate device.

Characteristic	Predicate Device:Patient Monitoring CablesK203635	Subject Device:LIFEPAK Invasive PressureAdapter Cable
Manufacturer	JKH USA, LLC	Physio-Control Inc.
Trade Name	Patient Monitoring Cables	LIFEPAK Invasive PressureAdapter Cable
510(k) Number	K203635	K240156
DeviceClassification	II	II
Product Code	DSA	DSA
Regulation Number	21 CFR 870.2900	21 CFR 870.2900
Prescription/ Over-the-Counter Use	Prescription	Prescription
Indications for Use/Intended Use	The Patient Monitoring Cablesare intended to be used withECG, EKG, SpO2 and BPmonitoring devices. The PatientMonitoring Cables are used toconnect electrodes, catheters,and/or sensors placed atappropriate site on the patient toa monitoring device for generalmonitoring and/or diagnosticevaluation by health careprofessional.	The LIFEPAK Invasive PressureAdapter Cable is intended toconnect invasive pressuretransducers from the patient tothe LIFEPAK monitor/defibrillatorfor invasive pressure monitoringpurposes and/or to aid indiagnostic evaluation by a healthcare professional. The LIFEPAKInvasive Pressure Adapter Cableis intended for use in outdoor andindoor emergency care settings.
Contraindications	None known	Same
Usage	Reusable	Same
Sterile	Non-sterile	Same
Design /Appearance	Connectors on each cable endand a shielded bulk cable	Same
Characteristic	Predicate Device:Patient Monitoring CablesK203635	Subject Device:LIFEPAK Invasive PressureAdapter Cable
Material	Shielded and unshielded Copperwith PVC or TPU jacket	Same
Cable Length	Various specified standardlengths	96 inches (2.44 meters)
Patient Connection	Electrodes, catheters, and/orsensors placed at appropriate siteon the patient.	Invasive Pressure transducersplaced at appropriate site on thepatient.
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-1
Electrical Safety andPerformance	IEC 60601-1AAMI/ANSI EC53	IEC 60601-1IEC 60601-2IEC 60601-2-34

LIFEPAK Invasive Pressure Adapter Cable Traditional 510(k)

Stryker Emergency Care

11811 Willows Road NE, Redmond, WA 98052

P +1 425 867 4000 -stryker.com

Page 3 of 4

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Performance Data:

Performance testing has been completed to demonstrate that the proposed LIFEPAK Invasive Pressure Adapter Cable meets the safety and performance requirements established in the design specifications. Comprehensive testing included the following:

Biocompatibility Evaluation ●
. Design Verification Testing

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

Conclusion:

The information in this 510(k) notification demonstrates that the Physio-Control LIFEPAK Invasive Pressure Adapter Cable is substantially equivalent to the predicate JKH USA, LLC Patient Monitoring Cables with respect to safety, effectiveness, and performance.

LIFEPAK Invasive Pressure Adapter Cable Traditional 510(k)

Stryker Emergency Care

11811 Willows Road NE, Redmond, WA 98052

| stryker.com
Page 4 of 4

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).