(149 days)
Not Found
No
The summary describes software for receiving, displaying, storing, and printing ECG data, with no mention of AI or ML terms or functionalities.
No
The software is intended to receive, display, store, and print ECG data, which is for diagnostic purposes, not therapeutic intervention.
Yes
The software receives, displays, stores, and prints out ECG data that is analyzed by a Bionet's ECG device, specifically the CardioCare-2000 or CardioTouch-3000. These ECG devices are typically used for diagnostic purposes by recording and interpreting the electrical activity of the heart. The software facilitates the handling of this diagnostic data, and its predicate device is "CARDIOVIEW ECG Interpretive Software", which further supports its diagnostic role.
Yes
The device is described as a "Window-based program" and "software" that receives, displays, stores, and prints ECG data from separate hardware devices (CardioCare-2000 or CardioTouch-3000). The description focuses solely on the software's functions and its interaction with existing hardware, without indicating any hardware components are part of the EKG-PLUS II device itself.
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.
- Device function: The EKG-PLUS II Software processes and manages ECG data, which is electrical activity measured from the surface of the body. It does not analyze biological samples.
- Intended Use: The intended use clearly states it receives, displays, stores, and prints ECG data from external ECG devices. This is related to physiological monitoring, not in vitro analysis.
Therefore, the EKG-PLUS II Software falls under the category of medical device software that processes physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EKG-PLUS II Software is a Window-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device-CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.
Product codes (comma separated list FDA assigned to the subject device)
LOS
Device Description
The EKG-PLUS II Software is a program which receives, displays, stores and prints out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device.
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
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)
The performance of the EKG-PLUS If Software was comprehensively tested with the CardioCare-2000 and CardioTouch-3000. All functions as defined in the specifications were completely verified and validated.
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
N/A
0
Section 5
AUG 2 6 2009
510(k) Summary
[As Required by 21 CFR 807.92]
Date Prepared:
Mar. 27, 2009
Submitter:
Bionet Co., Ltd. #1101 E&C Venture Dream Tower 3rd 197-33, Guro-3dong, Guro-gu, Seoul, 152-719, Republic of Korea Tel: 82-2-6300-6410 Fax: 82-2-6300-6425
Contact Person:
MI Consulting Co., Ltd. (Mr. HL Jung) RM 431, Life Officetel, 61-3, Yoido-dong, Youngdeungpo-gu, Seoul, 150-731, Republic of Korea Tel: 82-2-6264-9001 Fax: 82-2-6269-9001
Trade Name: Common Name: Classification Name: Predicate Device:
EKG-PLUS II Software ECG Analysis System ECG Analysis System, product code LOS CARDIOVIEW ECG Interpretive Software (K974352)
Device Description:
The EKG-PLUS II Software is a program which receives, displays, stores and prints out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device.
Intended use:
EKG-PLUS II Software is a Windows-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device-CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.
Bionet Co., Ltd.
EKG-PLUS II
Section 5: Page 1 of 2
1
Non-clinical tests:
The performance of the EKG-PLUS If Software was comprehensively tested with the CardioCare-2000 and CardioTouch-3000. All functions as defined in the specifications were completely verified and validated.
The EKG-PLUS II Software adheres to the following FDA CDRH guidance: CDRH Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, ODE, May 11, 2005
Conclusions:
The EKG-PLUS II Software is safe, as effective, and performs as well as the CARDIOVIEW ECG Interpretive Software. Accordingly, the EKG-PLUS If Software is substantially equivalent to the CARDIOVIES ECG Interpretive Software.
EKG-PLUS II
Section 5: Page 2 of 2
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines extending upwards from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 2 6 2009
Bionet Co., Ltd. c/o Mr. H.L. Jung MI Consulting Co., Ltd. RM 431 Life Officetel, 61-3 Yoido-dong, Youngdeungpo-gu Seoul, 150-731, Republic of Korea
Re: K090895
Trade/Device Name: EKG-PLUS II Software Regulation Number: Unclassified Regulation Name: ECG Analysis System Regulatory Class: Unclassified Product Code: LOS Dated: August 4, 2009 Received: August 10, 2009
Dear Mr. Jung:
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 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. H.L. Jung
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/CDRH0ffices/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.htm for 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.
Environmental Devices/Resource Center/Pollution Prevention.html
Sincerely yours,
una R. Vahner
A 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):
EKG-PLUS II Software Device Name:
Indications For Use:
EKG-PLUS II Software is a Window-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device-CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.
Prescription Use
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IN NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
una R. Vc. Ines
Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K090895
Bionet Co., Ltd.
Section 4: Page 1 of 1