(69 days)
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.
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.
The provided text is a 510(k) summary for the "Rhythm of Life" device, a CPR aid (metronome). It describes the device, its intended use, and indicates that testing was performed to demonstrate substantial equivalence to predicate devices and compliance with applicable standards. However, it does not include specific acceptance criteria or a detailed study report that proves the device meets those criteria in the way typically expected for a medical device's diagnostic or predictive performance.
The document focuses on regulatory compliance for device safety and effectiveness, primarily through demonstrating substantial equivalence to pre-existing devices and adherence to electrical safety and electromagnetic compatibility standards. It does not describe a study to assess the device's clinical performance in terms of improving CPR outcomes, diagnostic accuracy, or similar metrics.
Therefore, for many of your requested items, the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ANSI C63.4 & 47 CFR Part 15, Subpart B (Electromagnetic Compatibility - Emissions) | Performed Testing |
| Compliance with EN60601-1-2 : 2001+A1:2006 (Medical Electrical Equipment - EMC Requirements) | Performed Testing |
| Compliance with CISPR 11 : 2003 (Industrial, Scientific and Medical RF Equipment - EMC Requirements) | Performed Testing |
| Compliance with IEC61000-4-2 : 1995+A1:1998+A2:2000 (Electrostatic Discharge Immunity) | Performed Testing |
| Compliance with IEC61000-4-3 : 2006 (Radiated RF Electromagnetic Field Immunity) | Performed Testing |
| Compliance with IEC61000-4-8 : 1993+A1:2000 (Power Frequency Magnetic Field Immunity) | Performed Testing |
| Substantial equivalence to predicate devices (CPR Ezy-Pad, Pocket-CPR, CPR Prompt, LyfeTymer) | Determined substantially equivalent by FDA |
| Meets all design specifications | Performed Testing (details not provided) |
Note: The document states that testing was "performed to demonstrate compliance" and that the device "is as safe, as effective, and performs as well to legally marketed predicate devices." However, it does not provide specific numerical results or performance metrics from these tests beyond the general statement of compliance. The focus is on regulatory and electrical standards, not clinical performance metrics like accuracy, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described appears to be engineering/regulatory compliance testing, not a clinical trial with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The device is a metronome, not a diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no indication that an MRMC or comparative effectiveness study of this nature was conducted. The device is a "CPR Aid (Metronome)" which provides visual and audio timing, not an AI-assisted diagnostic or interpretive tool where "human readers" would be involved in the sense of image or data interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" metronome; it doesn't involve an algorithm in the sense of AI or complex data processing that would typically be evaluated for standalone performance versus human-in-the-loop. Its primary function is timing and guidance, which is inherently "standalone" in its operation once activated. However, this is not "standalone performance" in the context of diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (a metronome for CPR), the concept of "ground truth" for clinical performance in the typical diagnostic sense (e.g., against pathology) is not applicable or described. The "ground truth" for this device would relate to the accuracy of its timing signals against established AHA guidelines. The document does not detail how the accuracy of these timing signals was verified beyond stating that it "met all design specifications."
8. The sample size for the training set
This information is not provided and is not applicable for this type of device. The Rhythm of Life is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for this type of device.
{0}------------------------------------------------
ﻟﻌ
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: jmillan@hiatec.org
Manufacturer:
MiniMax Manufacturing Co.,LTD 1F No.144,Lane 101,Sec.3,Jiayuan Rd. Shulin City, Taiwan(R.O.C.) TEL:(886)-2-2680-5276 FAX:(886)-2-2680-5275
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
{1}------------------------------------------------
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:
{2}------------------------------------------------
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.
{3}------------------------------------------------
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.
{4}------------------------------------------------
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 (800) 638-2041 or (240) 276-3150 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
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
Rhythm of Life
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
§ 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.