(125 days)
Not Found
ZOLL AEDPLUS®, ZOLL AEDPRO®
No
The description focuses on real-time feedback based on accelerometer data and pre-programmed logic (voice prompts, visual indicators, metronome). There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
No.
The device assists in the performance of CPR, which is a life-sustaining measure, but it does not directly treat a disease or condition itself. It provides feedback and guidance, rather than delivering a therapeutic intervention.
No
Explanation: The device assists in the performance of CPR by providing real-time feedback and instructions; it does not diagnose a medical condition.
No
The device description explicitly states that PocketCPR uses an "integrated accelerometer" to directly measure acceleration, indicating the presence of a hardware component.
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.
- PocketCPR Function: The PocketCPR device assists in the performance of CPR by providing real-time feedback on chest compression depth and rate. It does this by measuring acceleration directly from the chest.
- No Biological Samples: The device does not analyze any biological samples from the patient. Its function is entirely external to the body and focused on the mechanical action of CPR.
Therefore, the PocketCPR falls under the category of a medical device that assists in a medical procedure (CPR), but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To assist users in the performance of effective CPR on a victim 8 years or older.
Product codes
LIX
Device Description
PocketCPR™ is a device that uses voice prompts and visual indicators to assist rescuers in the performance of cardiopulmonary resuscitation (CPR). PocketCPR is designed to be used by a rescuer to perform CPR. PocketCPR provides rescuers with real-time feedback during the administration of CPR.
PocketCPR has two operating modes: Normal and Silent Operating Mode which allows the rescuer to perform CPR in any type of environmental condition. In Normal Operating Mode, PocketCPR operates with all sounds, including voice prompts and metronome beeping. In Silent Operating Mode, PocketCPR operates with visual flashing metronome and chest compression lights "only".
The PocketCPR directly measures acceleration through the use of an integrated accelerometer and The Fookers' It allocaly model is not compressing the chest at least 1.5 inches Instantal. Books are will instruct them to increase compression depth. The rate of compression is (comm), the Fooketer ( will morable non signal, encouraging the rescuer to keep pace with the prompled by the ace of a fiten 30 compressions or about 18 seconds of chest compressions, PocketCPR will instruct the rescuer to give breaths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
8 years or older
Intended User / Care Setting
rescuer; Not Found
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)
Extensive performance testing ensures that the PocketCPR meets all of its functional requirements and performance specifications.
Testing of the PocketCPR demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CPR EZY
Reference Device(s)
ZOLL AEDPLUS®, ZOLL AEDPRO®
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
K07/321
Image /page/0/Picture/1 description: The image shows the logo for BIO-DETEK INCORPORATED. The logo consists of two parts: a symbol on the left and the company name on the right. The symbol is made up of four mirrored "B" shapes arranged in a square. The company name is written in bold, uppercase letters, with "BIO-DETEK" on the top line and "INCORPORATED" on the bottom line.
SEP 1 2 2007
510(k) Summary:
Submitter's Name and Address:
Bio-Detek Incorporated
A Division of ZOLL Medical Corporation
525 Narragansett Park Drive
Pawtucket, RI 02861-4323 (401) 729-1400
Contact Person:
Robert Morse
(401) 729-1400 ext. 224
Date Summary Prepared:
July 31, 2007
Device:
PocketCPR™
Classification: Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)
Description:
PocketCPR™ is a device that uses voice prompts and visual indicators to assist rescuers in the performance of cardiopulmonary resuscitation (CPR). PocketCPR is designed to be used by a rescuer to perform CPR. PocketCPR provides rescuers with real-time feedback during the administration of CPR.
PocketCPR has two operating modes: Normal and Silent Operating Mode which allows the rescuer to perform CPR in any type of environmental condition. In Normal Operating Mode, PocketCPR operates with all sounds, including voice prompts and metronome beeping. In Silent Operating Mode, PocketCPR operates with visual flashing metronome and chest compression lights "only".
525 Narragansett Park Drive, Pawtucket, Rhode Island 02861-4323, Tel. (401) 729-1400 or (800) 729-1408
1
The PocketCPR directly measures acceleration through the use of an integrated accelerometer and The Fookers' It allocaly model is not compressing the chest at least 1.5 inches Instantal. Books are will instruct them to increase compression depth. The rate of compression is (comm), the Fooketer ( will morable non signal, encouraging the rescuer to keep pace with the prompled by the ace of a fiten 30 compressions or about 18 seconds of chest compressions, PocketCPR will instruct the rescuer to give breaths.
Indications for Use:
To assist users in the performance of effective CPR on a victim 8 years or older.
Substantial Equivalence:
PocketCPR is substantially equivalent to CPR EZY and uses the technology substantially equivalent to CPR feedback in the ZOLL AEDPLUS® and ZOLL AEDPRO®. The features and equivalent to OF N Toubable in the same technology as that found in the ZOLL AEDPLUS® and ZOLL AEDPRO®.
Performance Testing:
Extensive performance testing ensures that the PocketCPR meets all of its functional requirements and performance specifications.
Conclusion
Testing of the PocketCPR demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around a stylized eagle-like symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2007
Bio-Detek Incorporated c/o Mr. Robert Morse QA/QC Manager 525 Narragansett Park Drive Pawtucket, Rhode Island 02861
Re: K071321
Pocket CPR™ Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III (three) Product Code: LIX Dated: August 8, 2007 Received: August 24, 2007
Dear Mr. Morse:
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 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.
3
Page 2 - Mr. Robert Morse
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
Bram/D./Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use
.
:
510(k) Number (if known): K071321_________________________________________________________________________________________________________________________________________
PocketCPR™ Device Name:
:
PocketCPR Function:
、
:
1
. .
To assist users in the performance of effective CPR on a victim 8 years or older.
and the country of the county of
Rev 6
:
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use | X
(21 CFR 807 Subpart C) |
|------------------------------------------------------------------|--------|----------------------|-----------------------------|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF | | | |
| NEEDED) | | | |
| Concurrence of Office of Device Evaluation (ODE) | | | |
| 4071321 | | | |