(149 days)
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.
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.
The provided text describes a 510(k) submission for the EKG-PLUS II Software. However, it does not include detailed information regarding discrete acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or ground truth methodologies that would typically be found in a performance study section.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "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."
This indicates that internal specifications for the software's functions served as the acceptance criteria. However, the document does not provide specific quantitative acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) or the reported performance metrics against those criteria. It only states that the functions were "completely verified and validated."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text. The device is an ECG analysis system, implying it processes data from ECG devices. While it might perform some interpretive functions (like its predicate), the text does not detail a study where human experts independently establish a ground truth to evaluate the device's diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is described as "EKG-PLUS II Software ECG Analysis System," an "algorithm only" product for displaying, storing, and printing ECG data, and performing analysis. It's not presented as an AI-powered assistive tool for human interpretation in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the described "EKG-PLUS II Software" is a standalone algorithm as it is an "ECG Analysis System" intended to "receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device." The "Non-clinical tests" section focuses on the performance of the software itself in conjunction with the specified ECG devices. The conclusion states it is "as effective, and performs as well as the CARDIOVIEW ECG Interpretive Software" (predicate device), implying a standalone, algorithmic comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document states "All functions as defined in the specifications were completely verified and validated." This implies an engineering-centric verification and validation against internal functional and technical specifications, rather than a clinical ground truth like expert consensus on diagnostic interpretations, pathology, or outcomes data. If there were interpretive capabilities, the ground truth methodology for those specific functions is not detailed.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given text. As a pre-2009 submission, it's less likely to extensively detail machine learning training sets in the way more recent AI/ML device submissions would. The "analysis" capabilities are likely based on established ECG interpretation algorithms rather than a trained machine learning model in the contemporary sense.
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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
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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
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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.
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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
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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
N/A