The CPRmeter™ is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

Device Description

The Modified Cover is an optional accessory to the CPRmeter™ that is designed to cover the patient contacting side of the CPRmeter™ and provide a larger patient-contact area during use and does not require a patient adhesive. The CPRmeter™ is small, lightweight, and powered by a replaceable battery. The device is approximately 154 mm × 28 mm (6" × 2½" × 1″) and weighs approximately 227 grams (8 ounces) - approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR. The CPRmeter™ is intended for use by responders who have been trained in CPR and use of the CPRmeter™. The CPRmeter™ is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. When placed on the bare chest of a suspected SCA victim, the CPRmeter™ provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity.

AI/ML Overview

This document describes the FDA 510(k) summary for the CPRmeter™ CPR Feedback Device with a Modified Cover. It primarily focuses on demonstrating substantial equivalence to a previously marketed device (CPRmeter™ with Predicate Cover) by showing that the new Modified Cover does not raise new questions of safety or effectiveness.

Here’s a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct performance table for each criterion. Instead, it states that "The following tests demonstrate that the Modified Cover met applicable design and performance requirements and support a determination of substantial equivalence." and mentions general outcomes.

Implied Acceptance Criteria & Reported Performance (Based on the text):

Acceptance Criterion (Implied)	Reported Device Performance
Acceptable performance of the device (general)	Demonstrated acceptable performance.
Adequate ability to withstand changes in ambient pressure, temperature, and humidity, and other factors	Demonstrated adequate ability to withstand these changes.
Acceptable performance at the end of its labeled shelf life	Performed acceptably at the end of its labeled shelf life.
Biocompatibility of the material	Demonstrated biocompatibility of the material.
No new questions of safety or effectiveness compared to predicate	No new questions regarding safety or effectiveness raised.

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

The document does not specify a sample size for any test set in terms of patient data or a specific number of units tested.
The "Data Used in Determination of Substantial Equivalence" section refers to "Bench testing," "Shelf life testing," and "Biocompatibility analysis." These are likely laboratory or in-vitro tests, not clinical studies with patient data.

Sample Size: Not specified (refers to bench testing, not human subjects).
Data Provenance: Not explicitly stated as retrospective or prospective human data. The tests described (bench, shelf life, biocompatibility) are typically performed in a laboratory setting. The device manufacturer, Laerdal Medical AS, is based in Norway.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document as the tests described are bench tests and material analyses, not studies requiring expert clinical judgment for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the tests described are bench tests and material analyses, not studies involving human interpretation or adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. The submission focuses on substantial equivalence of a modified accessory (the cover) through bench testing, not clinical effectiveness studies comparing human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The CPRmeter™ is a physical device that provides real-time feedback during CPR. Its function relies on sensors (accelerometer and force sensor) and internal processing to provide visual feedback to a human rescuer. Therefore, the concept of a "standalone algorithm" acting without human-in-the-loop performance is not directly applicable in the typical sense of AI-driven diagnostic tools.

However, the "bench testing" and "shelf life testing" could be considered as evaluating the device's intrinsic performance (its 'algorithm' for sensing and displaying data) independent of a human rescuer, under controlled, simulated conditions. The document states these tests demonstrated "acceptable performance," implying the device's sensing and feedback mechanism functions correctly.

7. The Type of Ground Truth Used

For the bench testing, the ground truth would likely be known physical parameters (e.g., precisely controlled compression depths, rates, and release) against which the device's reported measurements are compared. For biocompatibility, the ground truth is established by biocompatibility standards and test protocols.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The document describes a 510(k) submission for a physical device with a modified cover, not an AI/ML device that typically requires a training set. The device's functionality is based on established biomechanical principles and sensor technology, not machine learning trained on large datasets.

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

This information is not applicable/not provided as there is no mention of a training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 13, 2015

Laerdal Medical AS % Dan Dillon Regulatory Scientist MED Institute 1330 Win Hentschel Boulevard, Ste 100 West Lafayette, Indiana 47906

Re: K151702

Trade/Device Name: CPRmeter CPR Feedback Device Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III Product Code: LIX Dated: July 14, 2015 Received: July 16, 2015

Dear Mr. Dillon:

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 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 (reporting of medical device

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M. A. Hillebrand

for.

for 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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Indications for Use

510(k) Number (if known): K151702

Device Name: CPRmeter™ CPR Feedback Device

Indications for Use:

The CPRmeter™ is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

Prescription Use	XX
(Part 21 CFR 801 Subpart D)
OR
Over-the-Counter Use	__________
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) SUMMARY

Submitted By:	Mari Kaada
	Corporate Regulatory Affairs Manager
	Laerdal Medical AS
	Tanke Svilandsgate 30
	P.O. Box 377
	4002 Stavanger
	Norway
	(011) 47-51-51-16-30
	Mari.Kaada@laerdal.no

Device:

Trade Name:	CPRmeter™ CPR Feedback Device
Common Name:	CPR Feedback Device Accessory
Classification Name:	Cardiopulmonary Resuscitation Aid

Indications for Use:

The CPRmeter™ is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

Device Description:

Comparison to Predicate Device:

The CPRmeter™ with the Modified Cover is substantially equivalent to the currently-marketed device (hereinafter referred to as the CPRmeter™ with the Predicate Cover). The Predicate Cover and the Modified Cover have the same intended use, which is to provide a larger patient contact area during use, and are similar in terms of design. Materials, fundamental scientific technology, and principle of operation are the same. When the CPRmeter™ is used with the

COMPANY CONFIDENTIAL

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Predicate Cover, the patient adhesive is required to be placed between the CPRmeter™ and the patient's skin. When the CPRmeter™ is used with the Modified Cover, the patient adhesive is not required. Instead, the patient contacting surface is soft silicone with a textured surface. The textured surface serves to stabilize the CPRmeter™ on the patient's chest during use.

Substantial Equivalence Comparison Table

	CPRmeter™ with Modified Cover(this 510(k))	CPRmeter™with Predicate Cover(K122050)
Indications for Use	Used as a guide in administeringcardiopulmonary resuscitation (CPR) toa suspected sudden cardiac arrest (SCA)victim at least 8 years old	Identical
Prescription status	Prescription only	Identical
Design
Measuring methods	Accelerometer and force sensor	Identical
Visual output	Light emitting diodes	Identical
Auditory output	None	Identical
Compression Feedback
Depth	Visual	Identical
Rate	Visual	Identical
Release	Visual	Identical
Shelf Life	5 years	Identical
External Components
Housing (top and bottom)	Basic structure of device, encasing allinternal components.	Identical
Status LED	Indicates operating status of the device:• Green blinking light: Device instandby mode.• Orange steady light: Device hasfailed internal self-test and must betaken out of service.• No light: Battery needsreplacement.	Identical
Display panel	Provides feedback to the user whenperforming chest compressions,approximately 25 mm × 25 mm.	Identical
Compression area	Provides area for the responder toperform compressions.	Identical
Placement guide	Indicates correct placement of the deviceon the patient's chest.	Identical
	CPRmeter™ with Modified Cover(this 510(k))	CPRmeter™with Predicate Cover(K122050)
On/Off button	Turns the device on or off. Device turnsoff automatically after 10 minutes ofinactivity.	Identical
Rear cover	A hydrophobic membrane preventsingress of water and dust whileequalizing atmospheric pressure changeswithin CPRmeter™	Identical.
Rear cover screws	Two (2) screws allow for opening therear cover.	Identical
Optional Silicone Cover
Prescription status	Prescription only	Identical
Device type	Optional accessory	Identical
Material	Silicone (Elastosil R 4000/70)	Identical
Length	157 mm	156 mm
Height	31 mm	24 mm
Width	66 mm	Identical
Skin contacting surface	Silicone with an etched textured pattern	Patient adhesive and siliconecover with smooth surface
Requires patient adhesive	No	Yes
Shelf life	5 years	Identical

COMPANY CONFIDENTIAL

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Data Used in Determination of Substantial Equivalence

The following tests demonstrate that the Modified Cover met applicable design and performance requirements and support a determination of substantial equivalence.

Bench testing demonstrated acceptable performance of the device and adequate ability to ● withstand changes in ambient pressure, temperature and humidity, and other factors.
Shelf life testing showed that the device could perform acceptably at the end of its labeled shelf life.
Biocompatibility analysis was performed and demonstrated the biocompatibility of the material.

Conclusion

Based on the results of the testing and other information submitted in the 510(k) application, the Modified Cover does not raise any different questions regarding the safety or effectiveness compared to the Predicate Cover. Further, the device was tested based on accepted scientific

COMPANY CONFIDENTIAL

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methods and the performance data demonstrate substantial equivalence; therefore, the CPRmeter™ with the Modified Cover is considered to be substantially equivalent to the CPRmeter™ with the Predicate Cover.

Regulation Number and Section

§ 870.5210 Cardiopulmonary resuscitation (CPR) aid.

(a)
CPR aid without feedback —(1)Identification. A CPR aid without feedback is a device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
CPR aid with feedback —(1)Identification. A CPR Aid device with feedback is a device that provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines (to include, but not be limited to, parameters such as compression rate, compression depth, ventilation, recoil, instruction for one or multiple rescuers, etc.). These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform effective CPR on a victim.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Nonclinical performance testing under simulated physiological or use conditions must demonstrate the accuracy and reliability of the feedback to the user on specific compression rate, depth and/or respiration over the intended duration, and environment of use.
(ii) Labeling must include the clinical training, if needed, for the safe use of this device and information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant).(iii) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iv) For devices containing software, software verification, validation, and hazard analysis must be performed.
(v) Components of the device that come into human contact must be demonstrated to be biocompatible.
(vi) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user.
(3)
Premarket notification. The CPR Aid with feedback device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter if it does not contain software (e.g., is mechanical or electro-mechanical) and is in compliance with the special controls under paragraph (b)(2) of this section, subject to the limitations of exemptions in § 870.9.