(268 days)
Not Found
No
The description focuses on real-time feedback based on pre-defined CPR guidelines and sensor data (depth, rhythm, time, count). There is no mention of adaptive algorithms, learning from data, or complex pattern recognition that would typically indicate AI/ML. The mobile app functionality appears to be for data display and training, not for AI/ML processing.
No
The device provides real-time feedback and guidance for CPR administration; it does not directly treat or cure a disease or condition.
No
The device provides real-time feedback during CPR to guide compression performance; it does not diagnose a medical condition.
No
The device description explicitly states it is a "small, lightweight device that uses rechargeable batteries and is worn on the wrist," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the CPR BAND is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CPR BAND Function: The CPR BAND's function is to provide real-time feedback and guidance during cardiopulmonary resuscitation (CPR) performed on a patient. It measures physical parameters like chest compression depth, rate, and time.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. It interacts directly with the patient's body during the CPR procedure.
Therefore, the CPR BAND falls under the category of a medical device used for treatment and monitoring during an emergency procedure, not an IVD device used for laboratory analysis of specimens.
N/A
Intended Use / Indications for Use
The CPR BAND 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 (comma separated list FDA assigned to the subject device)
LIX
Device Description
The CPR BAND is a small, lightweight device that uses rechargeable batteries and is worn on the wrist. This device is designed for first aid personnel trained in CPR and use of the CPR BAND. The CPR BAND (Model: CREDO-CB) provides real-time information about chest compression according to the latest CPR guideline when CPR is performed on patient who is estimated a sudden cardiac arrest (SCA). This device displays CPR feedback indicator for the chest compression depth. It guides chest compression rhythm through sound and indicates the total chest compression time and number of chest compression.
The CPR BAND is a device that provides Bluetooth function. It can transmit CPR record and confirm information on the mobile application of the smart device in order to training CPR Skill for user via checking data. In the smart device that provides the wireless communication function by receiving information provided by the CPR BAND, it can display the pressure axis angle, pressure axis average value, compression depth average value, compression rhythm average value, and chest compression graph which are not displayed on the CPR BAND.
The device provides other functions on the user's wrist while waiting without CPR. The time, step count, movement distance and calorie consumption function are displayed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest (for CPR compression measurement)
Indicated Patient Age Range
at least 8 years old
Intended User / Care Setting
first aid personnel trained in CPR and use of the CPR BAND.
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)
The following tests were performed to assess effectiveness of the product performance:
- Compression Depth Indicator (Manufacturer SOP)
- Compression Rate Target (Manufacturer SOP)
- Compression Depth Target (Manufacturer SOP)
- Compression Count Target (Manufacturer SOP)
- Compression Time Target (Manufacturer SOP)
- Dimension Test (Manufacturer SOP)
The performance test results were used to support that the subject device is substantially equivalent to the predicate device despite differences in dimension, weight, auditory output, expected service life, battery, and material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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 6, 2021
Credo % Dongha Lee Regulatory Affairs Consultant KMC, Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, 08375 Republic of Korea
Re: K201581
Trade/Device Name: CPR Band Regulation Number: 21 CFR 870.5210 Regulation Name: Cardiopulmonary Resuscitation (CPR) Aid Regulatory Class: Class II Product Code: LIX Dated: June 8, 2020 Received: June 11, 2020
Dear Dongha Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201581
Device Name CPR BAND (Model: CREDO-CB, CREDO-CB-MO)
Indications for Use (Describe)
The CPR BAND is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
| Type of Use (Select one or both, as applicable) | |
|---|---|
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
This summary of 510(k) -safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: June 08, 2020
1. INFORMATION
1.1 Submitter Information
- Submitter Name: CREDO Ltd.
- . Address
- : #302, 86, Baeul-ro, Wonju-si, Gangwon-do, 26465, Republic of Korea
- . . Telephone Number: +82-33-766-8901 Fax: +82-33-766-8902
1.2 First Contact Person
- . Name: DongHa Lee (Consultant / KMC, Inc.)
- . Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea
- . Telephone Number: +82-70-8965-5554 . Fax: +82-2-2672-0579
- . E-mail: dhlee@kmcerti.com
1.3 Secondary Contact Person
- I Name: Milly (Consultant / KMC, Inc.)
- . Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea
- . . Telephone Number: +82-70-8965-5554 Fax: +82-2-2672-0579
- . E-mail: milly@kmcerti.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: CPR BNAD (Model: CREDO-CB, CREDO-CB-MO)
- 2.2 Common Name: Cardiopulmonary resuscitation (CPR) aid
- 2.3 Classification Name: Aid, Cardiopulmonary Resuscitation
- 2.4 Product Code: LIX
- 2.5 Classification Regulation: 21CFR 870.5210
- 2.6 Device Class: Class II (Special Control)
- 2.7 Classification Panel: Cardiovascular
4
3. PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Manufacturer | Laerdal Medical AS |
| Device Name (Trade Name) | CPRmeter 2 CPR Feedback Device |
| 510(k) Number | K173886 |
4. SUBJECT DEVICE DESCRIPTION
The CPR BAND is a small, lightweight device that uses rechargeable batteries and is worn on the wrist. This device is designed for first aid personnel trained in CPR and use of the CPR BAND. The CPR BAND (Model: CREDO-CB) provides real-time information about chest compression according to the latest CPR guideline when CPR is performed on patient who is estimated a sudden cardiac arrest (SCA). This device displays CPR feedback indicator for the chest compression depth. It guides chest compression rhythm through sound and indicates the total chest compression time and number of chest compression.
The CPR BAND is a device that provides Bluetooth function. It can transmit CPR record and confirm information on the mobile application of the smart device in order to training CPR Skill for user via checking data. In the smart device that provides the wireless communication function by receiving information provided by the CPR BAND, it can display the pressure axis angle, pressure axis average value, compression depth average value, compression rhythm average value, and chest compression graph which are not displayed on the CPR BAND.
The device provides other functions on the user's wrist while waiting without CPR. The time, step count, movement distance and calorie consumption function are displayed.
5. Principle Operation
It is intended to wear it on the responder's wrist during CPR. The CPR BAND is intended for use by responders who have been trained in CPR and use of the CPR BAND. When placed on the bare chest of a suspected SCA victim, the CPR BAND provides real-time feedback on CPR compressions in accordance with current CPR guidelines. The CPR BAND measures the chest compression depth during CPR via the built-in accelerometer and displays it on the LED. After CPR, the measured data is temporarily stored in the CPRBAND and transmitted to the application via the Bluetooth interface in order to training CPR Skill for user via checking data. In the application, detailed data information such as compression depth and compression rhythm can be checked.
5
6. INTENDED USE
The CPR BAND is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
6
7. SUBSTANTIAL EQUIVALENCE
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Manufacturer | CREDO Ltd. | Laerdal Medical AS | |
| Device Name | CPR BAND | CPRmeter 2 | |
| 510(k) Number | K201581 | K173886 | |
| Regulation Number | 21CFR 870.5210 | 21CFR 870.5210 | |
| Regulation Name | Cardiopulmonary Resuscitation | ||
| (CPR) Aid | Cardiopulmonary Resuscitation | ||
| (CPR) Aid | |||
| Classification | Class II | Class II | |
| Product Code | LIX | LIX | |
| Indications for Use | The CPR BAND is used as a | ||
| guide in administering | |||
| cardiopulmonary resuscitation | |||
| (CPR) to a suspected sudden | |||
| cardiac arrest (SCA) victim at | |||
| least 8 years old. | 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. | |||
| Mechanism | When placed on the bare chest of | ||
| a suspected SCA victim, the CPR | |||
| BAND provides real-time | |||
| feedback on CPR compressions in | |||
| accordance with current CPR | |||
| guidelines. | |||
| The device measures the chest | |||
| compression depth during CPR | |||
| via the built-in accelerometer and | |||
| displays it on the LED. | |||
| The measured data is temporarily | |||
| stored in the device and | |||
| transmitted to the application via | |||
| the Bluetooth interface. In the | |||
| application, detailed data | |||
| information such as compression | |||
| depth and compression rhythm | |||
| can be checked | 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. | |||
| The device measures the chest | |||
| compression depth during CPR | |||
| via the built-in accelerometer and | |||
| displays it on the LED. | |||
| The measured data is temporarily | |||
| stored in the device and | |||
| transmitted to the application via | |||
| the Bluetooth interface. In the | |||
| application, detailed data | |||
| information such as compression | |||
| depth and compression rhythm | |||
| can be checked | |||
| Dimension | 47.1mm x 21.1mm x 12mm | 153mm x 64mm x 25mm | |
| Weight | 11.0g | 163g | |
| Measuring | |||
| Methods | Accelerometer and force sensor | Accelerometer and force sensor | |
| Visual | |||
| Output | Light emitting diodes | Light emitting diodes | |
| Design | Auditory | ||
| Output | Rhythm Guide | None | |
| Expected | |||
| Service | |||
| Life | 3 years | 2 years | |
| Battery | Lithium Battery | AA Battery | |
| Data | |||
| Transfer | Bluetooth | Bluetooth | |
| Real Time | |||
| Compression | |||
| Feedback | Depth | ||
| Target | >50mm and 50mm and |