(92 days)
Not Found
No
The description focuses on real-time feedback based on current CPR guidelines, not on adaptive or learning algorithms. There is no mention of AI, ML, or related concepts.
No
The device is a feedback tool that guides the user in administering CPR; it does not directly treat or cure a medical condition.
No
Explanation: The device provides real-time feedback on CPR compressions (depth, rate, and release), counts compressions, and indicates lack of CPR activity. It does not diagnose medical conditions. Its purpose is to guide CPR administration.
No
The device description explicitly details physical components (housing, battery, size, weight, self-adhesive foam pad) and mentions hardware testing (biocompatibility, electrical safety, electromagnetic compatibility). This indicates it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CPRmeter™ 2 is a device that provides real-time feedback on the mechanical action of CPR (chest compressions). It measures physical parameters like depth, rate, and release.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It interacts directly with the patient's chest during the physical act of CPR.
Therefore, the CPRmeter™ 2 falls under the category of a medical device used for direct patient care and intervention, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes
LIX
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"× 2 ½"× 1") and weighs approximately 163 g (5.7 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 by means of a self-adhesive foam pad. The CPRmeter™ 2 is intended to be used by responders who have been trained in CPR and use of the CPRmeter™ 2. If the responder is in doubt about its appropriateness for use or the ability to use it. CPR is to be performed without using the CPRmeter™ 2 device.
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 CPRmeter™ 2 may be reused, provided proper cleaning procedures are performed after each patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest
Indicated Patient Age Range
at least 8 years old.
Intended User / Care Setting
responders who have been trained in CPR and use of the CPRmeter™ 2.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation testing demonstrates that the CPRmeter™ 2 device meets its functional requirements and supports a determination of substantial equivalence. In particular,
- Biocompatibility testing in accordance with FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", (June 16, 2016). Testing of the patientcontacting parts of the CPRmeter™ 2 demonstrates an appropriate biocompatibility profile for the device;
- Testing in accordance with AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; and AAMI/ANSI/IEC 60601-1-2:2007/(R)2012, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests (Edition 3), demonstrates appropriate electrical safety and electromagnetic compatibility of the device;
- Nonclinical performance testing under simulated use conditions demonstrates acceptable performance of the device and adequate ability to withstand changes in ambient pressure, temperature and humidity, and other factors;
- Shelf life testing demonstrates that the device can perform acceptably at the end of its labeled shelf life; and
- Human factors testing validates that the device design and labeling are sufficient for effective use by the intended user.
The results of these tests support the conclusion that the CPRmeter™ 2 performs acceptably and does not raise any different questions regarding the safety or effectiveness compared to the predicate device, thus supporting a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 23, 2018
Laerdal Medical AS % Dan Dillon Senior Regulatory Scientist MED Institute Inc. 1330 Win Hentschel Blvd West Lafayette, Indiana 47906
Re: K173886
Trade/Device Name: CPRmeter 2 CPR Feedback Device Regulation Number: 21 CFR 870.5210 Regulation Name: Cardiopulmonary Resuscitation (CPR) Aid Regulatory Class: Class II Product Code: LIX Dated: December 20, 2017 Received: December 21, 2017
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. 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
1
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.
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.
For comprehensive regulatory information about mediation-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,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173886
Device Name CPRmeter™ 2 CPR Feedback Device
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
CPRmeter™ 2 CPR Feedback Device 21 CFR 870.5210(b) Date Prepared: March 22, 2018
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.com
l
Device Information
| Trade Name: | CPRmeter™ 2 CPR Feedback Device |
|---|---|
| Common/Usual Name: | CPR feedback device |
| Classification Name: | CPR aid with feedback |
| Regulation: | 21 CFR 870.5210(b) |
| Product Code: | LIX |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
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.
Predicate Device:
The CPRmeter™ 2 CPR Feedback Device is substantially equivalent to the predicate device, the CPRmeter™ CPR Feedback Device (Laerdal Medical AS) as described in K151702, cleared on August 13, 2015.
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
COMPANY CONFIDENTIAL
4
approximately 153 mm × 64 mm × 25 mm (6"× 2 ½"× 1") and weighs approximately 163 g (5.7 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 by means of a self-adhesive foam pad. The CPRmeter™ 2 is intended to be used by responders who have been trained in CPR and use of the CPRmeter™ 2. If the responder is in doubt about its appropriateness for use or the ability to use it. CPR is to be performed without using the CPRmeter™ 2 device.
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 CPRmeter™ 2 may be reused, provided proper cleaning procedures are performed after each patient use.
Substantial Equivalence:
The CPRmeter™ 2 is substantially equivalent to the predicate device, the CPRmeter™ CPR Feedback Device (510(k) No. K151702, cleared August 13, 2015). The table below presents the similarities and differences between the two products for substantial equivalence purposes. The differences between the subject device and the predicate do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence and were developed using acceptable scientific methods for evaluation.
| | CPRmeter™ 2
(subject of this submission) | CPRmeterTM
(K151702) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Indications for Use | Used as a guide in administering
cardiopulmonary resuscitation (CPR) to
a suspected sudden cardiac arrest (SCA)
victim at least 8 years old. | Identical |
| Housing Material | Polycarbonate | Polycarbonate/Siloxane |
| Measuring Methods | Accelerometer and force sensor | Identical |
| Depth Target | > 50 mm and 50 mm and