(531 days)
No
The summary describes standard ECG analysis algorithms and signal processing techniques, without mentioning AI, ML, or related concepts like neural networks or deep learning.
No.
The device is described as software that analyzes ECG data and detects arrhythmias but explicitly states it is not intended to offer independent diagnosis or provide medical alarms, and is not for use in life-supporting or sustaining systems. It aids in data interpretation, but does not directly treat or prevent a medical condition.
Yes
The device analyzes ECG data, classifies arrhythmias, and provides measurements and textual interpretations, all of which are diagnostic functions, even though it states it is "not intended to offer independent diagnosis." Clinical judgment and experience are used to check and interpret the data as part of a diagnosis.
Yes
The device description explicitly states "The Guava II is a medical device software". It describes an API for integration into other systems and focuses on software functionalities like capturing, storing, retrieving, viewing, editing, and analyzing ECGs. There is no mention of accompanying hardware developed or included by the manufacturer of Guava II.
Based on the provided text, the Guava II device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The Guava II analyzes ECG data, which is an electrical signal measured on the body's surface.
- The intended use and device description clearly state it processes and analyzes ECG data. There is no mention of analyzing biological samples.
- The device description focuses on software for capturing, storing, retrieving, viewing, editing, and analyzing ECGs and other Biosignals. This aligns with a device that processes physiological signals, not biological samples.
Therefore, the Guava II falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Guava II is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. Guava II is intended to be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems. Guava II includes an algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. The product also includes an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat by beat basis. QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to twelve (12) leads of historic ambulatory ECG data. The Guava II algorithm analysis can detect and classify arrhythmias and may be used to triage data, however, Guava II is not intended to offer independent diagnosis or provide medical alarms. Clinical judgment and experience are used to check and interpret the data as part of a diagnosis. Guava II is not for use in lifesupporting or sustaining systems or EGG monitoring devices. Guava II is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate.
Product codes
DPS, DSH
Device Description
The Guava II is a medical device software with a formal Application Programming Interface (API). The API can be invoked from Host Applications to provide services for capturing, storing, retrieving, viewing, editing, and analyzing ECGs (1-, 2-, 3-Channel and 12-Lead) and other Biosignals. Guava II may also be licensed to 3rd party organizations interested in embedding the capabilities within their own products. When the Guava II is used in other medical products, manufacturers will identify the indications for use depending on the application of their device.
The Guava II is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
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
Not Found
Intended User / Care Setting
Intended User: cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers
Care Setting: clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate.
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
The device complies with AAMI EC11 and AAMI EC38 standards. Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases. The activities included scenario validations, algorithm confirmation testing, and device functional testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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Pg. 1 of 3
510(k) SUMMARY (as required by 807.92(c))
FEB 1 1 2014
| Regulatory Correspondent: | AJW Technology Consultants, Inc.
445 Apollo Beach Blvd.
Apollo Beach, FL 33572
Jon Ward
wardjp@ajwtech.com
Phone: 813-645-2855
Fax: 813-677-4787 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | CardioComm Solutions, Inc.
919 Fort St. Suite 203
Victoria, BC V8V 3K3
Mona Palfreyman
mona@cardiocomm.com
Phone: 250-744-1122
Fax: 250-744-1866 |
| Date of Summary: | January 31, 2014 |
| Trade/Proprietary Name: | Guava II |
| Classification Name: | Class II |
| Product Code: | DPS and DSH |
| Regulation: | 870.2340 |
Intended Use:
Guava II is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. Guava II is intended to be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems. Guava II includes an algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. The product also includes an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat by beat basis. QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to twelve (12) leads of historic ambulatory ECG data. The Guava II algorithm analysis can detect and classify arrhythmias and may be used to triage data, however, Guava II is not intended to offer independent diagnosis or provide medical alarms. Clinical judgment and experience are
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Pg. 2 of 3
used to check and interpret the data as part of a diagnosis. Guava II is not for use in lifesupporting or sustaining systems or EGG monitoring devices. Guava II is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate.
Device Description:
The Guava II is a medical device software with a formal Application Programming Interface (API). The API can be invoked from Host Applications to provide services for capturing, storing, retrieving, viewing, editing, and analyzing ECGs (1-, 2-, 3-Channel and 12-Lead) and other Biosignals. Guava II may also be licensed to 3rd party organizations interested in embedding the capabilities within their own products. When the Guava II is used in other medical products, manufacturers will identify the indications for use depending on the application of their device.
The Guava II is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
| Predicate Device(s): | GlobalCardio (K111320)
Monebo Automated ECG Analysis and
Interpretation Software Library (K062282) |
| ---------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
Guava II has the same classification information, the same performance safety, the same design principle, similar intended use and technological characteristics, similar product design and specifications. similar effectiveness. and similar function as compared to the predicate devices.
Guava II represents, specifically, the subset of the functionality embedded within the predicate GlobalCardio (K111320) - Guava, the predecessor of Guava II, which is the subject of this 510(k) application.
GlobalCardio makes full use of the Guava functionality to capture and manage ECG's the same functionality found in Guava II. Beyond that, GlobalCardio contains additional functionality outside the scope of ECG processing such as Patient Management, System Administration, Device Inventory Control, Cardiac Rehabilitation Data Management, etc. These are capabilities of the predicate device that are not contained in Guava II.
Guava II extends its predecessor, Guava, through the inclusion of features such as;
- . The integration of the Monebo Automated ECG Analysis and Interpretation Software Library (K062282) for use in analysis and triage.
- Technological enhancements such as a "globalization" capability to simplify . the translation of the software user interface into other languages.
- . The ability to run on current software platforms.
- . Incremental features such as the storage of the raw input data (e.g. audio waveform) into the ECG representation.
- And support for additional annotation types. .
2
The Guava II also contains a version of the QRS Louvain Algorithm; which is also embedded within the GlobalCardio predicate. The Guava II Louvain Data Processor performs automated ECG analysis and interpretation in the same manner as GlobalCardio. The two products use the identical machine code library (DLL) to perform the analysis, and testing demonstrates the ORS Algorithm embedded in the Guaya II Louvain Data Processor is identical in function to the QRS Algorithm embedded in GlobalCardio.
All other features of Guava II are present in at least one of the predicate devices. Therefore, the proposed Guava II device is substantially equivalent to GlobalCardio (K111320) and Monebo Automated ECG Analysis and Interpretation Software Library (K062282).
Performance Testing:
The device complies with AAMI EC11 and AAMI EC38 standards. Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases. The activities included scenario validations, algorithm confirmation testing, and device functional testing.
Conclusion:
The proposed device is substantial equivalent to the GlobalCardio (K111320) Monebo Automated ECG Analysis and Interpretation Software Library (K062282) devices. The proposed device has a similar intended use, technological, and design characteristics as the predicate device. Any minor differences do not introduce new issues of safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or being embraced, represented by three curved lines.
February 11, 2014
Cardiocomm Solutions, Inc. Jonathan Ward 962 Allegro Lane Apollo Beach, FL 33572 US
Re: K122632
Trade/Device Name: Guava II Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DSH Dated: October 25, 2013 Received: August 29, 2012
Dear Jonathan Ward:
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 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.
4
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.htmfor 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen-Paris-S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
. . . . ......
510(k) Number (if known): K122632
Device Name: Guava II
Guava II is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. Guava II is intended to be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems. Guava II includes an algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. The product also includes an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to twelve (12) leads of historic ambulatory ECG data. The Guava II algorithm analysis can detect and classify arrhythmias and may be used to triage data, however, Guava II is not intended to offer independent diagnosis or provide medical alarms. Clinical judgment and experience are used to check and interpret the data as part of a diagnosis. Guava II is not for use in lifesupporting or sustaining systems or EGG monitoring devices. Guava II is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate.
Prescription Use X Prescription Ose A
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| Digitally signed by |
| Owen P. Faris -S |
Digitally signed By
Owen P. Faris -S
Date: 2014.02.11
16:23:45'-05'00'
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