CPRMETER CPR FEEDBACK DEVICE

K122050 · Laerdal Medical A/S · LIX · Oct 22, 2012 · Cardiovascular

Device Facts

• Record ID: K122050
• Device Name: CPRMETER CPR FEEDBACK DEVICE
• Applicant: Laerdal Medical A/S
• Product Code: LIX · Cardiovascular
• Decision Date: Oct 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5210
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 Story

CPRmeter is a small, battery-powered, portable device for use by trained responders. Attached to the bare chest of a suspected SCA victim, it monitors chest compressions. It provides real-time feedback on compression depth, rate, and release; counts compressions; and notifies users of inactivity. The device is intended to guide CPR performance in accordance with current guidelines. It is used in clinical or field settings by trained personnel. Output is displayed to the provider to adjust compression technique, potentially improving CPR quality and patient outcomes.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing of patient-contacting materials, electrical safety and electromagnetic compatibility testing per IEC 60601 standards, and software verification. Compression depth detection and accuracy were verified under various stress conditions, including drop testing, temperature/humidity cycling, and repeated cleaning, confirming durability and performance consistency.

Technological Characteristics

Battery-powered, portable device. Patient-contacting materials verified for biocompatibility. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-1-4 (programmable electrical medical systems). Sensing principle involves compression depth, rate, and release detection. Software-based feedback system.

Indications for Use

Indicated for use as a guide in administering CPR to suspected sudden cardiac arrest (SCA) victims at least 8 years old.

Regulatory Classification

Identification

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.

Special Controls

*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.

Predicate Devices

• Compression sensor of the HeartStart MRx Monitor/Defibrillator with Q-CPR® Option (Philips Medical Systems), K051134
• PocketCPRTM CPR feedback device (Bio-Detek, Incorporated), K071321

Submission Summary (Full Text)

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#### 510(k) Summary 5

### Submitter's Name and Address

Mari Kaada Regulatory Affairs Manager Laerdal Medical AS Tanke Svilandsgate 30 P.O. Box 377 4002 Stavanger Norway [phone]-16-30 [e-mail]

**Device Name**

Proprietary Name: Common Name: Classification Name: CPRmeter™ CPR feedback device Cardiopulmonary Resuscitation Aid

#### Device Description

The CPRmeter™ device is small, lightweight (approximately the size and weight of a cell phone), and powered by a replaceable battery. The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. If in doubt about the appropriateness for use or ability to use. CPR is to be performed without using the CPRmeter device.

When attached to the bare chest of a suspected SCA victim, the CPRmeter device 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.

#### 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.

#### Predicate Devices

The legally marketed devices to which Laerdal Medical AS claims equivalence for the CPRmeter device are:

OCT 22 2012

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- Compression sensor of the HeartStart MRx Monitor/Defibrillator with Q-CPR® . Option (Philips Medical Systems), K051134
- PocketCPRTM CPR feedback device (Bio-Detek, Incorporated), K071321 .

# Data Used in Determination of Substantial Equivalence

Design verification and design validation testing demonstrates that the CPRmeter device meets its functional requirements and performance specifications. In particular,

- . Biocompatibility testing on the patient-contacting materials of the CPRmeter device demonstrates an acceptable biocompatibility profile for the device,
- Testing in accordance with IEC60601-1:1988, Medical electrical equipment, Part . 1: General requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995), IEC 60601-1-2:2001, General requirements for safety -Collateral standard: Electromagnetic compatibility - requirements and tests, with Amendment 1:2004, and IEC 60601-1-4:2000, Consolidated Edition 1.1, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, demonstrates acceptable electromagnetic compatibility and electrical safety.
- Software testing demonstrates acceptable performance of the software. .
- . Compression depth detection and accuracy have been verified under a wide variety of use or pre-use conditions (e.g., drop testing, temperature and humidity stress, after repeated cleaning). That testing provides substantial evidence of the . device's durability and its ability to perform acceptably under a wide variety of stresses, under the labeled shelf-life and operating conditions specified in the labeling.

# Conclusion

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

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

OCT 22 2012

Laerdal Medical AS c/o Ms. Mari Kaada Regulatory Affairs Manager Laerdal Medical AS Tanke Svilandsgate 30 P.O. Box 377 4002 Stavanger Norway

Re: K122050

CPRmeter™ CPR Feedback Device Regulation Number: 21 CFR 870.5200 Regulation Name: Cardiopulmonary Resuscitation Aid Regulatory Class: Class III Product Code: LIX Dated: July 6, 2012 Received: July 12, 2012

Dear Ms. Kaada:

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

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Page 2 - Ms. Mari Kaada

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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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): K122050

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 X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

(Division, Sign-Off) Division of Cardiovascular De Aces 510(k) Number 12205 U