The CPRmeter 2 CPR Feedback Device 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 CPRmeter 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter 2 is composed of polycarbonate. It is small, lightweight, and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6.0" × 2.5" × 1.0") and weighs approximately 191 g (6.7 oz) excluding batteries. The device is 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 2 is intended for use by responders who have been trained in CPR and use of the CPRmeter 2. When placed on the bare chest of a suspected SCA victim, the CPRmeter 2 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.

The Silicone Cover is an optional accessory to the CPRmeter 2 that is designed to cover the patient contacting side of the CPRmeter 2 and provide a larger patient-contact area during use. The Silicone Cover does not require a patient adhesive.

AI/ML Overview

The CPRmeter 2 CPR Feedback Device does not appear to be an AI/ML device per the provided text. Therefore, an analysis of the acceptance criteria and study that proves the device meets the acceptance criteria in the context of AI/ML is not applicable. The document describes a traditional medical device (CPR feedback device) and its accessory (a silicone cover) with comparisons primarily based on physical characteristics, materials, and existing functionalities, rather than algorithmic performance.

However, based on the provided text, I can extract the following information regarding the device and its testing:

Device Name: CPRmeter 2 CPR Feedback Device (with Silicone Cover accessory)
Indications for Use: To be used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for the CPRmeter 2 with the Silicone Cover based on its functional indications (e.g., accuracy of depth, rate, or release feedback). Instead, it focuses on verifying that the addition of the Silicone Cover does not negatively impact the existing performance and safety of the CPRmeter 2 device. The acceptance criteria are implied by the nature of the tests performed to demonstrate substantial equivalence, ensuring the accessory does not introduce new safety or effectiveness concerns.

Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical/Physical	- Withstand changes in ambient pressure - Adequate physical fit - Minimal water ingress - Silicone Cover provides larger patient-contact area - Textured surface stabilizes the device - No new safety concerns compared to predicate	- Bench testing demonstrated acceptable performance for: - Withstanding changes in ambient pressure - Adequate physical fit - Minimal water ingress - The Silicone Cover functions as intended to provide a larger patient contact area and its textured surface stabilizes the device. - The Silicone Cover does not raise any different questions regarding the safety or effectiveness of the CPRmeter 2.
Biocompatibility	- Materials of the device (specifically the new Silicone Cover) are biocompatible with patient contact.	- Biocompatibility analysis was performed and demonstrated biocompatibility of the materials of the device.
Shelf Life	- Device (with Silicone Cover) performs acceptably at the end of its labeled shelf life.	- Shelf life testing showed that the device could perform acceptably at the end of its labeled shelf life.
Functional Equivalence	- The addition of the Silicone Cover does not change the indications for use. - Fundamental scientific technology and principle of operation are unchanged.	- The Silicone Cover does not change the indications for use of the CPRmeter 2. - The materials, fundamental scientific technology, and principle of operation of the CPRmeter 2 are unchanged with the addition of the Silicone Cover.
Adhesive Requirement	- When used with the Silicone Cover, a patient adhesive is not required.	- When the CPRmeter 2 is used with the Silicone Cover, the patient adhesive is not required.

2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes in terms of patient data or specific CPR measurements. Instead, it refers to different types of engineering and materials testing:

Bench testing: Performed to assess physical and mechanical aspects (pressure changes, fit, water ingress). No sample size or data provenance is provided.
Shelf life testing: Conducted to evaluate performance over time. No specific sample size or provenance is provided.
Biocompatibility analysis: Performed on the materials. No specific sample size or provenance is provided.

The testing seems to be laboratory-based (bench testing, shelf life, biocompatibility) rather than involving human subjects for performance evaluation in a clinical setting. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the context of these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described are engineering and material science evaluations, which typically rely on established standards and laboratory procedures rather than expert consensus on clinical ground truth.

4. Adjudication method for the test set
Not applicable, as the tests performed are not clinical evaluations requiring 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, as this is not an AI/ML device, and no MRMC study or human reader improvement data is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device. The CPRmeter 2 provides real-time feedback; it's a device for human-in-the-loop performance, not an algorithm performing autonomously.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in a clinical diagnostic or predictive sense is not directly applicable here. The "truth" for the tests performed (bench, shelf life, biocompatibility) would be defined by engineering specifications, material standards, and regulatory requirements.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.

Summary

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December 17, 2018

Laerdal Medical AS % Dan Dillon Senior Regulatory Scientist MED Institute Inc. 1330 Win Hentschel Blvd. West Lafayette, Indiana 47906

Re: K183348

Trade/Device Name: Reusable Silicone Cover CPRmeter 2 Regulation Number: 21 CFR 870.5210 Regulation Name: Cardiopulmonary resuscitation (CPR) aid Regulatory Class: Class II Product Code: LIX Dated: November 30, 2018 Received: December 3, 2018

Dear Dan 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. 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 Actinclude 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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,

Fernande Aguel Fernando Aguel -S

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): K183348

Device Name: CPRmeter 2 CPR Feedback Device

Indications for Use:

The CPRmeter 2 CPR Feedback Device 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)

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 KaadaCorporate Regulatory Affairs ManagerLaerdal Medical ASTanke Svilandsgate 30P.O. Box 3774002 StavangerNorway(011) 47-51-51-16-30Mari.Kaada@laerdal.com
Device:
Trade Name:	CPRmeter 2 CPR Feedback Device
Common Name:	CPR Feedback Device Accessory
Classification Name:	Cardiopulmonary Resuscitation Aid

Indications for Use:

The CPRmeter 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

De vice Description:

Comparison to Predicate Device:

The CPRmeter 2 with Silicone Cover is substantially equivalent to the CPRmeter 2. See Table 2-1. The addition of the Silicone Cover does not change the indications for use of the CPRmeter 2. The purpose of the Silicone Cover is to provide a larger patient contact area

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during use. The materials, fundamental scientific technology, and principle of operation of the CPRmeter 2 are unchanged with the addition of the Silicone Cover. When the CPRmeter 2 is used without the Silicone Cover, a patient adhesive is required between the CPRmeter 2 and the patient's skin. When the CPRmeter 2 is used with the Silicone 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 2 on the patient's chest during use.

	CPRmeter 2 with Silicone Cover(this 510(k))	CPRmeter 2(K173886)
Indications for Use	The CPRmeter 2 CPR Feedback Deviceis 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 needs replacement.	Identical
Display panel	Provides feedback to the user whenperforming chestcompressions,approximately 30 mm × 37 mm.	Identical
Compression area	Provides area for the responder toperform compressions.	Identical
Placement guide	Indicates correct placement of thedevice on the patient's chest.	Identical

Table 2-1: Substantial Equivalence Comparison Table

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	CPRmeter 2 with Silicone Cover(this 510(k))	CPRmeter 2(K173886)
On/Off button	Turns the device on or off. Deviceturns off automatically after 10 minutesof inactivity.	Identical
A hydrophobic membrane thatprevents ingress of water and dustwhile equalizing atmosphericpressure changes within the device	Located on the side of the device	Identical
Rear cover screws	No rear cover or rear cover screws	Identical
Optional Silicone Cover
Material	Silicone	Not Applicable
Dimensions (length × height ×width)	$156 mm × 31 mm × 67 mm$	Not Applicable
Skin contacting surface	Silicone with an etched textured pattern	Not Applicable
Requires patient adhesive	No	Not Applicable
Shelf life	5 years	Not Applicable

Data Used in Determination of Substantial Equivalence

The following tests demonstrate that the Silicone 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, adequate physical fit, minimal water ingress, 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 biocompatibility of the materials of the device.

Conclusion

Based on the results of the testing and other information submitted in the 510(k) application, the Silicone Cover does not raise any different questions regarding the safety or effectiveness of the CPRmeter 2. Further, the device was tested based on accepted scientific methods and the performance data demonstrate substantial equivalence; the CPRmeter 2 with Silicone Cover is considered to be substantially equivalent to the CPRmeter 2.

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.