(193 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any AI/ML components in the device description or performance studies.
No.
Explanation: The device is intended for monitoring and detection of cardiac conditions, not for treating or preventing them.
Yes.
The device records ECG rhythms and heart sounds, displays ECG rhythms, and detects the presence of normal sinus rhythm and atrial fibrillation, which are all diagnostic functions for heart conditions.
No
The device description explicitly states it is a "medical device system" and mentions recording ECG rhythms and heart sounds, implying the use of hardware sensors for data acquisition. The predicate devices also include hardware components (ECG monitors and stethoscopes).
Based on the provided information, the Coala Heart Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically involves blood, urine, tissue, or other bodily fluids.
- The Coala Heart Monitor directly measures physiological signals from the body. It records ECG rhythms and heart sounds through contact with the skin (chest and thumb).
The device is a medical device that performs non-invasive measurements of the body's electrical and acoustic activity. It is used to aid in the diagnosis and monitoring of heart conditions, but it does not analyze samples taken from the body in the way an IVD does.
N/A
Intended Use / Indications for Use
The Coala Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms and heart sound. The Coala Heart Monitor also displays ECG rhythms and detects the presence of normal sinus rhythm and atrial fibrillation (when prescribed or used under the care of a physician). The Coala Heart Monitor is intended for use by healthcare professionals and adults with known or suspected heart conditions. Rx ONLY.
Product codes
DXH, DPS, DOD, DOC
Device Description
The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.
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
Adults
Intended User / Care Setting
healthcare professionals and adults with known or suspected heart conditions.
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
ECG performance of the Coala Heart Monitor was demonstrated in a real-world study in which 1,000 ECG recordings taken from a diverse patient demographics of 150 patients (men, women, age 20-90, BMI30) were analyzed by the device and assigned a category (0: Unreadable, 1: Normal Sinus Rhythm, 2: Atrial Fibrillation, 99: Unclassified). The ECG recordings were derived from actual Coala users in Sweden, without any exclusions, training, control or influence, under a defined time period. The prevalence of cardiac conditions in the user population was unknown. The same recordings were analyzed manually by a cardiologist as the gold standard.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ECG performance of the Coala Heart Monitor was demonstrated in a real-world study in which 1,000 ECG recordings taken from a diverse patient demographics of 150 patients (men, women, age 20-90, BMI30) were analyzed by the device and assigned a category (0: Unreadable, 1: Normal Sinus Rhythm, 2: Atrial Fibrillation, 99: Unclassified). Signal quality and accuracy for Atrial Fibrillation detection by the Coala Heart Monitor were found to be high, with 97.2% sensitivity and 94.6% specificity as compared to a trained cardiologist. Similarly, signal quality and accuracy for Normal Sinus Rhythm detection by the Coala Heart Monitor were also found to be high, with 96.5% sensitivity and 88.7% specificity as compared to a trained cardiologist.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Signal quality and accuracy for Atrial Fibrillation detection by the Coala Heart Monitor: 97.2% sensitivity and 94.6% specificity.
Signal quality and accuracy for Normal Sinus Rhythm detection by the Coala Heart Monitor: 96.5% sensitivity and 88.7% specificity.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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.
February 8, 2019
Coala Life AB % Pierre Bounaud Senior Regulatory Specialist Acknowledge Regulatory Strategies 2251 San Diego Ave, Suite B-257 San Diego, California 92110
Re: K182040
Trade/Device Name: Coala Heart Monitor Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DPS, DOD, DOC Dated: February 1, 2019 Received: February 4, 2019
Dear Pierre Bounaud:
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.
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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Arielle Drummond -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182040
Device Name Coala Heart Monitor
Indications for Use (Describe)
The Coala Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms and heart sound. The Coala Heart Monitor also displays ECG rhythms and detects the presence of normal sinus rhythm and atrial fibrillation (when prescribed or used under the care of a physician). The Coala Heart Monitor is intended for use by healthcare professionals and adults with known or suspected heart conditions. Rx ONLY.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the word "COALA" in a light gray color. To the left of the word is a heart-shaped design made up of many small circles. To the right of the word is a circled "R", which is a registered trademark symbol.
510(k) Summary K182040
DATE PREPARED
February 1, 2019
MANUFACTURER AND 510(k) OWNER
Coala Life AB Riddargatan 18 Telephone: Official Contact: Philip Siberg, CEO
REPRESENTATIVE/CONSULTANT
Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: pbounaud@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
Coala Heart Monitor
COMMON NAME
ECG Monitor
DEVICE CLASSIFICATION
| Telephone electrocardiograph transmitter and receiver | 21 CFR 870.2920 | Class II | DXH |
|---|---|---|---|
| Electrocardiograph | 21 CFR 870.2340 | Class II | DPS |
| Stethoscope | 21 CFR 870.1875 | Class II | DQD |
| Phonocardiograph | 21 CFR 870.2390 | Class I | DQC |
PREMARKET REVIEW
ODE/Division of Cardiovascular Devices (DCD)/Cardiac Diagnostics Devices Branch (CDDB) Cardiovascular review panel
PREDICATE DEVICE IDENTIFICATION
The Coala Heart Monitor is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K142743 | AliveCor Heart Monitor / AliveCor, Inc. | ✓ |
| K170874 | Eko Model E5 / Eko Devices, Inc. | |
| K083903 | 3M Littmann Electronic Stethoscope, Model 3200 / | |
| 3M Company |
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Image /page/4/Picture/1 description: The image shows the logo for COALA. The logo consists of a heart-shaped cluster of dots on the left, followed by the word "COALA" in large, bold letters. A registered trademark symbol is located to the upper right of the letter A.
DEVICE DESCRIPTION
The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.
INDICATIONS FOR USE
The Coala Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms and heart sound. The Coala Heart Monitor also displays ECG rhythms and detects the presence of normal sinus rhythm and atrial fibrillation (when prescribed or used under the care of a physician). The Coala Heart Monitor is intended for use by healthcare professionals and adults with known or suspected heart conditions. Rx ONLY.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject device has a similar design and dimensions, and uses similar materials (stainless steel electrodes, plastic body) as the devices cleared in K142743 and K170874. The subject device has equivalent general intended use and similar technological characteristics (ECG recordings) as the device cleared in K142743. The subject device has similar technological characteristics (ECG recordings or heart sound recordings) as the devices cleared in K170874 and K083903.
Unlike the predicate device cleared in K142743, the Coala Heart Monitor is prescription use only and uses a combination of chest and thumb recordings for ECG rhythms detection, with an additional electrode for noise suppression. It features a wider ECG sampling frequency, higher sample rate, higher ECG resolution, and the ECG recording length is fixed to 30 seconds. It also allows simultaneous heart sound recordings. The Coala Heart Monitor functions on a rechargeable battery and recordings are transferred via Bluetooth technology. The accompanying mobile app includes a messaging system for communication with a physician.
Unlike the predicate device cleared in K170874, the Coala Heart Monitor is intended for adults only and uses a combination of chest and thumb recordings for ECG rhythms detection, with an additional electrode for noise suppression. It features a wider ECG sampling frequency, the ECG recording length is fixed to 30 seconds, and the stethoscope frequency range is narrower. The accompanying mobile app communicates with a cloud server for recording analysis and storage, and it includes a messaging system for communication with a physician.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Coala Heart Monitor. The following non-clinical tests were performed in order to demonstrate safety based on current industry standards:
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Image /page/5/Picture/1 description: The image shows the word "COALA" in a light gray color. To the left of the word is a heart shape made up of many small circles. To the right of the word is a circled R symbol, indicating that the word is a registered trademark.
- . Shelf life
- Biocompatibility Risk Assessment per ISO 10993-1
- Cytotoxicity testing per ISO 10993-5
- Irritation and sensitization testing per ISO 10993-10
- Chemical characterization per ISO 10993-18
- Software per AAMI/ANSI/IEC 62304
- Cybersecurity
- . Electrical safety per IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 62133
- . Wireless coexistence testing
- . Bench performance testing
- Stethoscope bench performance testing (frequency response, impulse response, amplification and maximum output sound level)
- . Sound sensor validation in a blind A/B type study with 20 patients
- . Usability testing per IEC 62366
The results of these tests indicate that the Coala Heart Monitor is substantially equivalent to the predicate devices.
ECG performance of the Coala Heart Monitor was demonstrated in a real-world study in which 1,000 ECG recordings taken from a diverse patient demographics of 150 patients (men, women, age 20-90, BMI30) were analyzed by the device and assigned a category (0: Unreadable, 1: Normal Sinus Rhythm, 2: Atrial Fibrillation, 99: Unclassified). The ECG recordings were derived from actual Coala users in Sweden, without any exclusions, training, control or influence, under a defined time period. The prevalence of cardiac conditions in the user population was unknown. The same recordings were analyzed manually by a cardiologist as the gold standard. Signal quality and accuracy for Atrial Fibrillation detection by the Coala Heart Monitor were found to be high, with 97.2% sensitivity and 94.6% specificity as compared to a trained cardiologist. Similarly, signal quality and accuracy for Normal Sinus Rhythm detection by the Coala Heart Monitor were also found to be high, with 96.5% sensitivity and 88.7% specificity as compared to a trained cardiologist.
CONCLUSION
Based on the testing performed, including biocompatibility, shelf life validation, software validation, cybersecurity, electrical safety, wireless coexistence validation, non-clinical performance testing (bench testing, stethoscope performance testing, sound sensor validation), and usability testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Coala Heart Monitor are assessed to be substantially equivalent to the predicate devices.