CPR BAND
Device Facts
| Record ID | K201581 |
|---|---|
| Device Name | CPR BAND |
| Applicant | Credo |
| Product Code | LIX · Cardiovascular |
| Decision Date | Mar 6, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5210 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Wrist-worn CPR aid for trained first aid personnel; monitors chest compressions during CPR on suspected SCA victims. Input: chest compression depth measured via built-in accelerometer and force sensor. Operation: device provides real-time visual feedback on LED (compression depth) and auditory rhythm guidance; data stored locally and transmitted via Bluetooth to a mobile application. Output: real-time compression feedback; post-event data (compression depth, rhythm, pressure axis angle, average values, chest compression graph) displayed on mobile app. Additional non-CPR functions include time, step count, distance, and calorie tracking. Healthcare providers use output to assess CPR quality and improve training/skill. Benefits: assists in maintaining consistent, effective manual CPR according to current guidelines.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-5, -10), electrical safety/EMC (IEC 60601-1, -1-2, -1-11), performance testing (compression depth, rate, count, time targets), usability validation (IEC 62366), and software verification (IEC 62304).
Technological Characteristics
Wrist-worn device; PC module enclosure, Urethan band. Sensing: accelerometer and force sensor. Energy: rechargeable lithium battery. Connectivity: Bluetooth for mobile app data transfer. Software: PEMS (IEC 62304). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1, ISO 10993-5, ISO 10993-10.
Indications for Use
Indicated for suspected sudden cardiac arrest (SCA) victims at least 8 years old. Intended for use by first aid personnel trained in CPR and device operation.
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
- CPRmeter 2 CPR Feedback Device (K173886)
Submission Summary (Full Text)
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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
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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
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# 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)
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# 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
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## 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.
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# 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.
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# 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<br>(CPR) Aid | Cardiopulmonary Resuscitation<br>(CPR) Aid | |
| Classification | Class II | Class II | |
| Product Code | LIX | LIX | |
| Indications for Use | The CPR BAND is used as a<br>guide in administering<br>cardiopulmonary resuscitation<br>(CPR) to a suspected sudden<br>cardiac arrest (SCA) victim at<br>least 8 years old. | The CPRmeter 2 CPR Feedback<br>Device is used as a guide in<br>administering cardiopulmonary<br>resuscitation (CPR) to a suspected<br>sudden cardiac arrest (SCA)<br>victim at least 8 years old. | |
| Mechanism | When placed on the bare chest of<br>a suspected SCA victim, the CPR<br>BAND provides real-time<br>feedback on CPR compressions in<br>accordance with current CPR<br>guidelines.<br>The device measures the chest<br>compression depth during CPR<br>via the built-in accelerometer and<br>displays it on the LED.<br>The measured data is temporarily<br>stored in the device and<br>transmitted to the application via<br>the Bluetooth interface. In the<br>application, detailed data<br>information such as compression<br>depth and compression rhythm<br>can be checked | When placed on the bare chest of<br>a suspected SCA victim, the<br>CPRmeter 2 provides real-time<br>feedback on CPR compressions in<br>accordance with current CPR<br>guidelines.<br>The device measures the chest<br>compression depth during CPR<br>via the built-in accelerometer and<br>displays it on the LED.<br>The measured data is temporarily<br>stored in the device and<br>transmitted to the application via<br>the Bluetooth interface. In the<br>application, detailed data<br>information such as compression<br>depth and compression rhythm<br>can be checked | |
| | Dimension | 47.1mm x 21.1mm x 12mm | 153mm x 64mm x 25mm |
| | Weight | 11.0g | 163g |
| | Measuring<br>Methods | Accelerometer and force sensor | Accelerometer and force sensor |
| | Visual<br>Output | Light emitting diodes | Light emitting diodes |
| Design | Auditory<br>Output | Rhythm Guide | None |
| | Expected<br>Service<br>Life | 3 years | 2 years |
| | Battery | Lithium Battery | AA Battery |
| | Data<br>Transfer | Bluetooth | Bluetooth |
| Real Time<br>Compression<br>Feedback | Depth<br>Target | >50mm and <60mm | >50mm and <60mm |
| | Rate<br>Target | 100-120 per minute | 100-120 per minute |
| Material | | PC (Module Enclosure)<br>URETHAN (BAND Part) | PC (Enclosure) |
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Image /page/7/Picture/0 description: The image shows the word "CREDO" in a bold, sans-serif font. To the left of the word, there are four circles arranged in a square pattern. The circles are black, and the word "CREDO" is also black. The background is white.
1) Same points between the subject device and the predicate device
| Same Items | Description |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | The proposed regulation number is “21CFR870.5210”. The<br>Regulation is related to the Cardiopulmonary Resuscitation<br>(CPR) Aid Device.<br>It is the same point between the subject device (CPR BAND)<br>and the predicate device (CPRmeter 2). |
| Regulation Name | The proposed regulation name is Cardiopulmonary<br>Resuscitation (CPR) Aid in accordance with<br>21CFR870.5210.<br>The subject device and predicate device are A CPR Aid<br>device with feedback that provides real-time feedback to the<br>rescuer regarding the quality of CPR being delivered to the<br>victim, and provides either audio and/or visual information<br>to encourage the rescuer to continue the consistent<br>application of effective manual CPR in accordance with<br>current accepted CPR guidelines.<br>It is the same point between the subject device (CPR BAND)<br>and the predicate device (CPRmeter 2). |
| Classification | In accordance with same regulation number<br>(21CFR870.5210), FDA provide the regulatory<br>classification. It is Class II and same point between the<br>subject device (CPR BAND) and the predicate device<br>(CPRmeter 2). |
| Product Code | The proposed product code of the subject device is “LIX”.<br>It is the same product code with the predicate device. |
| Indication for use | In case of the indication for use, there is same overall with<br>the subject device (CPR BAND) and the predicate device<br>(CPRmeter 2). Both devices are used as a guide in<br>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 both devices provide real-time feedback on CPR compressions in accordance with current CPR guidelines. Especially, both devices measure the chest compression depth during CPR via the built-in accelerometer and displays it on the LED.<br>In addition, the measured data is temporarily stored in the device and transmitted to the application via the Bluetooth interface as the additionally function. In the application, detailed data information such as compression depth and compression rhythm can be checked.<br>Its mechanism is same with subject device and predicate device. |
| Measuring Methods | Both devices measure the real-time compression feedback by using accelerometer and force sensor.<br>Its point is same with subject device and predicate device. |
| Visual Output | Both devices have the LED Function as a visual output.<br>Its point is same with subject device and predicate device. |
| Data Transfer | After compression, the measured data is temporarily stored in the device and transmitted to the application via the Bluetooth interface as the additionally function.<br>Its point is same with subject device and predicate device. |
| Depth Target | In accordance with CPR guideline, CPR involves chest compressions between 5 cm (2.0 in) and 6 cm (2.4 in) deep.<br>Its point is same with subject device and predicate device. |
| Rate Target | In accordance with CPR guideline, CPR involves chest compressions at a rate of at least 100 to 120 per minute. |
| Same Items | Description |
| 510(k) Number | K number does not influence the safety and the performance<br>of the subject device as well as does not influence substantial<br>equivalence between the subject device the predicate device. |
| Dimension | Although the dimension of device is different between the<br>subject device (CPR BAND) and the predicate device<br>(CPRmeter 2), the subject device is verified by performance<br>test. As a result, there are not any problems, which influence<br>safety and performance of the subject device as well as<br>critical fact to decision of the substantial equivalence<br>between the subject device and the predicate device. |
| Weight | Although the weight of device is different between the<br>subject device (CPR BAND) and the predicate device<br>(CPRmeter 2), the subject device is verified by performance<br>test. As a result, there are not any problems, which influence<br>safety and performance of the subject device as well as<br>critical fact to decision of the substantial equivalence<br>between the subject device and the predicate device. |
| Auditory Output | Although the auditory output of device is different between<br>the subject device (CPR BAND) and the predicate device<br>(CPRmeter 2), the subject device is verified by performance<br>test. As a result, there are not any problems, which influence<br>safety and performance of the subject device as well as<br>critical fact to decision of the substantial equivalence<br>between the subject device and the predicate device. |
| Expected Service Life | Although the expected service life of device is different<br>between the subject device (CPR BAND) and the predicate<br>device (CPRmeter 2), the service life of subject device is<br>decided to 3 years in accordance with the certified battery<br>service life because the battery service life is critical<br>component of CPR BNAD.<br>As a result, there are not any problems, which influence<br>safety and performance of the subject device as well as |
| Battery | critical fact to decision of the substantial equivalence between the subject device and the predicate device.<br>The subject device (CPR BAND) should be used with lithium battery, but equivalent device (CPRmeter 2) should be sued with AA battery.<br>Although the battery is different between the subject device and the equivalent device, the subject device battery shall be used with CE Marking in accordance with 2004/108/EC.<br>As a result, there are not any problems, which influence safety and performance of the subject device as well as critical fact to decision of the substantial equivalence between the subject device and the predicate device. |
| Material | Material of device is different because there is no band on the equivalent device.<br>Although the material is different between the subject device and the equivalent device, the subject device is verified with biocompatibility test in accordance with EN ISO 10993-1 for material safety.<br>As a result, there are not any problems, which influence safety and performance of the subject device as well as critical fact to decision of the substantial equivalence between the subject device and the predicate device. |
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2) Different points between the subject device and the predicate device
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# %CREDO
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## 8. NON-CLINICAL DATA
## 8.1 Safety Test
## 1) Biocompatibility
The biocompatibility tests were performed to protect patients from undue risks arise from biological hazards associated with materials of manufacture and final device. The tests were performed in accordance with the following standards and FDA Guidance - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
| No. | Test Items | Standards |
|-----|--------------------------------|-------------------|
| 1 | Cytotoxicity | ISO 10993-5:2009 |
| 2 | Sensitization | ISO 10993-10:2010 |
| 3 | Intracutaneous Reactivity Test | ISO 10993-10:2010 |
## 2) Electrical Safety and EMC
The electrical safety tests were performed to protect patients from undue risks arise from any hazards associated with final device. The tests were performed in accordance with the following standards.
| No. | Test Items | Standards |
|-----|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| 1 | General requirement for basic safety and<br>essential performance | • IEC 60601-1:2005+A1:2012 |
| 2 | General requirement for safety – Electromagnetic<br>disturbances | • IEC 60601-1-2:2014 |
| 3 | General requirement for safety – Medical<br>electrical equipment used in the home healthcare<br>environment | • IEC 60601-1-11:2015<br>• FDA Guidance (“Design<br>Considerations for Devices Intended<br>for Home Use”) |
| 4 | RoHS Test | • Directive 2011/65/EU<br>• IEC 62321 Series |
| 5 | FCC | • FCC Part15 Subpart C 15.247<br>• Radio Frequency Wireless<br>Technology in Medical Devices<br>Guidance |
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## 8.2 Performance Test
The following tests were performed to assess effectiveness of the product performance. The tests were performed in accordance with following standards.
| No. | Test Items | Standards |
|-----|-----------------------------|------------------|
| 1 | Compression Depth Indicator | Manufacturer SOP |
| 2 | Compression Rate Target | Manufacturer SOP |
| 3 | Compression Depth Target | Manufacturer SOP |
| 4 | Compression Count Target | Manufacturer SOP |
| 5 | Compression Time Target | Manufacturer SOP |
| 6 | Dimension Test | Manufacturer SOP |
## 8.3 Usability V&V
The following tests were performed to assess effectiveness of usability of the device. The test was performed in accordance with following standards
| No. | Test Items | Standards |
|-----|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 1 | General requirement for safety - Usability | IEC 60601-1-6:2010+A1:2013IEC 62366:2007+A1:2014FDA Guidance ("Applying Human Factors and Usability Engineering to Medical Devices") |
## 8.4 Software
The following tests were performed to assess effectiveness of software of the device. The test was performed in accordance with following standards.
| No. | Test Items | Standards |
|-----|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | General requirement for safety – Programmable<br>electrical medical systems (PEMS) | IEC 62304:2006/A1:2015 FDA Guidance (“Guidance for the<br>Content of Premarket Submissions<br>for Software Contained in Medical<br>Devices”) |
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# 9. CONCLUSION
Under the comparing substantial equivalence between the subject device and the predicate device, there are the same points such as general information, some technical and material information. Although there are some differences, the safety and performance test reports support that the subject device is substantially equivalent to the predicate device.
In this regard, we conclude that the subject device is substantially equivalent to the predicate device.
