RHYTHM OF LIFE, MODEL R0901-05

K092408 · Rapid Response Solutions, LLC · LIX · Oct 14, 2009 · Cardiovascular

Device Facts

• Record ID: K092408
• Device Name: RHYTHM OF LIFE, MODEL R0901-05
• Applicant: Rapid Response Solutions, LLC
• Product Code: LIX · Cardiovascular
• Decision Date: Oct 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5210
• Device Class: Class 2

Intended Use

The Rhythm of Life is a visual and audio timing device assisting individuals trained in CPR to provide effective resuscitation by conforming to the guidelines promoted by the American Heart Association in the field, clinical, and hospital settings. The Rhythm of Life is also intended for use by those in an educational setting who are in the process of learning CPR.

Device Story

Pocket-sized metronome; assists professional and lay rescuers in performing CPR. User inputs patient type/data; device provides audio/visual prompts for chest compressions, ventilation, and 2-minute reassessment intervals. Operates based on American Heart Association (AHA) guidelines. Used in field, clinical, hospital, and educational settings. Benefits patient by promoting adherence to AHA resuscitation rates and ratios, improving quality of care. Device is neither life-supporting nor life-sustaining.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing confirmed the device meets design specifications and complies with electrical safety and electromagnetic compatibility standards (ANSI C63.4, 47 CFR Part 15, EN60601-1-2, CISPR 11, IEC61000-4-2, IEC61000-4-3, IEC61000-4-8).

Technological Characteristics

Pocket-sized electronic metronome. Provides audio/visual feedback. Powered by internal battery. Complies with standards: ANSI C63.4, 47 CFR Part 15 Subpart B, EN60601-1-2:2001+A1:2006, CISPR 11:2003, IEC61000-4-2, IEC61000-4-3, and IEC61000-4-8. Operates via user-selected patient parameters to output specific resuscitation rates/ratios.

Indications for Use

Indicated for individuals trained in CPR or those learning CPR in educational settings to assist in providing effective resuscitation in field, clinical, and hospital environments.

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

• CPR Ezy-Pad by Medteq Innovations Pty LTD (K003937)
• Pocket-CPR by Bio-Detek Incorporated (K071321)
• CPR Prompt by County Line LTD (K954692)

Reference Devices

• LyfeTymer

Submission Summary (Full Text)

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# 510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K092408

# Submitter / Distributor:

OCT 1 4 2009

Rapid Response Solutions, LLC N 10623 County Road A Athelstane, WI 54104

#### Contact Person:

Jorge Millan, PhD Email: [e-mail]

#### Manufacturer:

MiniMax Manufacturing Co.,LTD 1F No.144,Lane 101,Sec.3,Jiayuan Rd. Shulin City, Taiwan(R.O.C.) TEL:[phone] FAX:[phone]

Date Prepared:

July 29, 2009

Name of the device:

- . Trade/Proprietary Name: Rhythm of Life
- Common Name: CPR Aid (Metronome) - CPR Timer .
- . Classification: 21 CFR 870.5200 CPR Aid (Metronome) Class III

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510(k) Summary Rhythm of Life

# Legally Marketed Predicate Device:

CPR Ezy-Pad by Medteq Innovations Pty LTD K003937

Pocket-CPR by Bio-Detek Incorporated K071321

K954692 CPR Prompt by County Line LTD

N/A LyfeTymer

#### Device Description:

The Rhythm of Life by Rapid Response Solutions, LLC, is a pocket-sized metronome designed to assist both professional rescuers and trained lay rescuers in providing high quality cardiopulmonary resuscitation. This device is designed in accordance with the latest American Heart Association guidelines for CPR. The Rhythm of Life provides three distinctly different tones and visual feedback to prompt the rescuer to compress the patient's chest, ventilate the patient, and reassess the patient's condition every two minutes. The metronome will allow the rescuer to enter the type of patient that is being resuscitated along with other pertinent information, and then outputs proper resuscitation rates and ratios for that specific patient. Both professional and lay rescuers will benefit from additional guidance provided by the Rhythm of Life as it promotes adherence to the American Heart Association's guidelines and therefore improves the quality of patient care. The device is neither life supporting nor life sustaining.

# Statement of Intended Use:

The Rhýthm of Life is a visual and audio timing device assisting individuals trained in CPR to provide effective resuscitation by conforming to the guidelines promoted by the American Heart Association in the field, clinical, and hospital settings. The Rhythm of Life is also intended for use by those in an educational setting who are in the process of learning CPR.

# Testing:

Testing was conducted to validate and verify that the Rhythm of Life met all design specifications and was substantially equivalent to the predicate devices. Testing was performed to demonstrate compliance with the following applicable standards:

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ANSI C63.4 & 47 CFR Part 15, Subpart B; EN60601-1-2 : 2001+A1:2006 CISPR 11 : 2003; IEC61000-4-2 : 1995+A1:1998+A2:2000; IEC61000-4-3 : 2006 and IEC61000-4-8 : 1993+A1:2000.

# Conclusion:

The Rhythm of Life Metronome is as safe, as effective, and performs as well to legally marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling a stylized eagle or bird in flight, composed of curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

OCT 1 4 2009

Rapid Response Solutions, LLC c/o Jorge Millan, Ph.D. Official Correspondent 601 West 20 Street Hialeah, FL 33010

Re: K092408

Rhythm of Life Regulation Number: 21 CFR 870.5200 Regulation Name: Aid, Cardiopulmonary Resuscitation Regulatory Class: Class III Product Code: LIX Dated: July 31, 2009 Received: August 6, 2009

Dear Dr. Millan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or sations 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.

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Page 2 -- Jorge Millan, Ph.D.

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-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/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,

Duna R. Vahner

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):

Device Name:

Rhythm of Life

K092408

Indications for Use:

The Rhythm of Life is a visual and audio timing device assisting individuals trained in CPR to provide effective resuscitation by conforming to the guidelines promoted by the American Heart Association in the field, clinical, and hospital settings. The Rhythm of Life is also intended for use by those in an educational setting who are in the process of learning CPR.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/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)

Duna R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices Page 1 of

510(k) Number Kory 2408