(147 days)
The TrueCPR device is intended to provide feedback to assist rescuers to perform cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device. The TrueCPR device is intended for use on patients eight years of age and older.
The TrueCPR coaching device provides rescuers with real-time feedback on chest compressions during cardiopulmonary resuscitations (CPR) in accordance with current guidelines.
This device is a CPR coaching device, meaning it provides real-time feedback on chest compressions. The provided text, however, focuses on administrative information related to the 510(k) submission and does not contain detailed information about the specific acceptance criteria or the study that demonstrates the device meets these criteria.
Therefore, for aspects related to precise performance metrics, sample sizes for test/training sets, expert qualifications, or comparative effectiveness studies, the information is not available in the provided text. The text states that the 510(k) includes documentation related to verification and validation activities but does not elaborate on their specifics.
Based on the provided snippets, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given text. The submission mentions "Performance Standards" and "verification and validation activities supporting the safe and effective use of TrueCPR," but it does not detail specific quantitative acceptance criteria or the device's reported performance against them (e.g., accuracy of depth measurement, rate measurement, etc.).
2. Sample size used for the test set and the data provenance
This information is not available in the provided text. The document refers to "Bench Testing (Comprehensive verification testing)" and "Simulated Use Testing" but does not specify the sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text.
4. Adjudication method for the test set
This information is not available in the provided text.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device is a "coaching device" to assist rescuers, not an AI-assisted diagnostic tool that would typically involve "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply here in the typical sense of interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is explicitly a "coaching device" intended to "provide feedback to assist rescuers," which inherently implies a human-in-the-loop scenario. The text does not describe any standalone algorithm-only performance testing in the context of interpretation or diagnosis. However, "bench testing" and "simulated use testing" would likely involve evaluating the device's ability to accurately measure and provide feedback on CPR parameters independently, but these are not referred to as a "standalone algorithm performance" in the context of diagnosis.
7. The type of ground truth used
The text does not explicitly state the type of ground truth used for specific performance evaluations. For a CPR coaching device, ground truth would typically refer to accurate measurements of compression depth, rate, recoil, etc., obtained through high-precision sensors or standardized testing apparatus in a laboratory or simulated environment, rather than expert consensus, pathology, or outcomes data, which are more common for diagnostic devices.
8. The sample size for the training set
This information is not available in the provided text.
9. How the ground truth for the training set was established
This information is not available in the provided text.
{0}------------------------------------------------
.
.
.
.
:
SECTION E: 510(K) SUMMARY
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted inaccordance with the requirements of 21 C.F.R. § 807.92. |
|---|---|
| Submitter | Physio-Control, Inc.11811 Willow Road NortheastP.O. Box 97006Redmond, Washington 98073-9706Registration Number: 3015876 |
| Contact Person | Teresa DavidsonTelephone: (425) 867-4733Fax: (425) 867-4154email: teresa.davidson@physio-control.com |
| Date SummaryPrepared | November 20, 2012 |
| Device Name | TrueCPR™ COACHING DEVICE |
| Device CommonName | Aid, Cardiopulmonary Resuscitation |
| RegulationDescription | External Cardiac Compressor |
| DeviceClassification | Device Class: IIIProduct Code: LIXClassification Panel: Cardiovascular DeviceRegulation Number: 21 CFR 870.5200 |
| Identification ofthe LegallyMarketed Device | PocketCPR(K112660, K071321) and HeartStart MRx with Optional Q-CPR(K051134) |
| (PredicateDevice) | Device class: IIIProduct Code: LIXClassification Panel: Cardiovascular DeviceRegulation Number: 21 CFR 870.5200 |
| PerformanceStandards | This 510(k) includes documentation related to the verification and validation activitiessupporting the safe and effective use of TrueCPR. |
| Description | The TrueCPR coaching device provides rescuers with real-time feedback on chestcompressions during cardiopulmonary resuscitations (CPR) in accordance withcurrent guidelines. |
E-1
{1}------------------------------------------------
SECTION E: 510(K) SUMMARY (continued)
The TrueCPR device is intended to provide feedback to assist rescuers to perform Intended Use cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device. The TrueCPR device is intended for use on patients eight years of ac e and older.
Testing Types
Bench Testing (Comprehensive verification testing):
- Requirements Testing .
- Electromagnetic Compatibility .
- . Software Performance
- . Environmental
- Simulated Use Testing
- . Biocompatibility
Technological Characteristics of subject and predicate device
Device intended use, feature and functional characteristics for predicate devices identified are substantially equivalent when compared to the proposed TrueCPR device. Importantly, no new issues of safety and effectiveness have been raised with the proposed device.
Conclusion of The information in this 510(k) demonstrates that the TrueCPR сомсничь ремсе is testing substantially equivalent to the identified predicate devices with respect to safety, effectiveness, and performance.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
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
April 17, 2013
Physio-Control, Inc. c/o Teresa Davidson 11811 Willows Rd. NE PO Box 97006 Redmond, Washington 98073-9706
Re: K123597
Trade/Device Name: TrueCPR Coaching Device Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor/CPR Aide Device Regulatory Class: Class III (three) Product Code: LIX Dated: April 3, 2013 Received: April 4, 2013
Dear Ms. Davidson:
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
{3}------------------------------------------------
Page 2 - Ms. Teresa Davidson
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-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Matthew G. Hillebrenner
tor
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Physio-Control, Inc TrueCPR Coaching Device 510(k) Pre-Market Notification
SECTION D: STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K123597
Device Name: TrueCPR™ coaching device
Indications for Use:
The TrueCPR device is intended to provide feedback to assist rescuers to perform cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device.
The TrueCPR device is intended for use on patients eight years of age and older.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ イ (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)
Matthew G. Hillebrenner
§ 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.