Reusable Full Silicone Cover

K151702 · Laerdal Medical AS · LIX · Aug 13, 2015 · Cardiovascular

Device Facts

• Record ID: K151702
• Device Name: Reusable Full Silicone Cover
• Applicant: Laerdal Medical AS
• Product Code: LIX · Cardiovascular
• Decision Date: Aug 13, 2015
• Decision: SESE
• Submission Type: Special
• 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, lightweight, battery-powered device used by trained responders to provide real-time feedback during CPR. Placed between the responder's hands and the patient's bare chest, it uses an accelerometer and force sensor to monitor chest compressions. The device processes these inputs to provide visual feedback via LEDs regarding compression depth, rate, and release; it also counts compressions and notifies the user of inactivity. The device is intended for use in clinical or emergency settings. The Modified Cover accessory provides a textured silicone surface to stabilize the device on the patient's chest, eliminating the need for patient adhesive. By providing objective, real-time guidance, the device assists responders in adhering to current CPR guidelines, potentially improving the quality of resuscitation efforts.

Clinical Evidence

Bench testing only. Testing included performance verification under varying ambient pressure, temperature, and humidity; shelf-life testing; and biocompatibility analysis of the silicone material.

Technological Characteristics

Dimensions: 154 mm x 28 mm; Weight: 227g. Materials: Silicone (Elastosil R 4000/70). Sensing: Accelerometer and force sensor. Output: Visual LED indicators for depth, rate, and release. Power: Replaceable battery. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for suspected sudden cardiac arrest (SCA) victims at least 8 years old requiring cardiopulmonary resuscitation (CPR).

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

• CPRmeter™ with Predicate Cover (K122050)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 | <u>XX</u> |
|-----------------------------|------------|
| (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 |
| | [phone]-16-30 |
| | [e-mail] |

#### 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:

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.

#### 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<br>(this 510(k)) | CPRmeter™<br>with Predicate Cover<br>(K122050) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indications for Use | Used as a guide in administering<br>cardiopulmonary resuscitation (CPR) to<br>a suspected sudden cardiac arrest (SCA)<br>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 all<br>internal components. | Identical |
| Status LED | Indicates operating status of the device:<br>• Green blinking light: Device in<br>standby mode.<br>• Orange steady light: Device has<br>failed internal self-test and must be<br>taken out of service.<br>• No light: Battery needs<br>replacement. | Identical |
| Display panel | Provides feedback to the user when<br>performing chest compressions,<br>approximately 25 mm × 25 mm. | Identical |
| Compression area | Provides area for the responder to<br>perform compressions. | Identical |
| Placement guide | Indicates correct placement of the device<br>on the patient's chest. | Identical |
| | CPRmeter™ with Modified Cover<br>(this 510(k)) | CPRmeter™<br>with Predicate Cover<br>(K122050) |
| On/Off button | Turns the device on or off. Device turns<br>off automatically after 10 minutes of<br>inactivity. | Identical |
| Rear cover | A hydrophobic membrane prevents<br>ingress of water and dust while<br>equalizing atmospheric pressure changes<br>within CPRmeter™ | Identical. |
| Rear cover screws | Two (2) screws allow for opening the<br>rear 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 silicone<br>cover 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.