EKG-PLUS II SOFTWARE

K090895 · Bionet Co., Ltd. · LOS · Aug 26, 2009 · CV

Device Facts

• Record ID: K090895
• Device Name: EKG-PLUS II SOFTWARE
• Applicant: Bionet Co., Ltd.
• Product Code: LOS · CV
• Decision Date: Aug 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Attributes: Software as a Medical Device

Intended 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.

Device Story

EKG-PLUS II is a Windows-based software application designed for network environments. It functions as a data management tool for ECG data generated by Bionet's CardioCare-2000 or CardioTouch-3000 devices. The software receives, displays, stores, and prints ECG data; it also supports storage of ECG data in JPEG format. It is intended for use by healthcare professionals in clinical settings to facilitate the review and documentation of ECG records. By enabling network-based access and storage, the device assists clinicians in managing patient cardiac data, supporting clinical decision-making through organized data presentation.

Clinical Evidence

Bench testing only. The performance of the EKG-PLUS II Software was verified and validated against defined specifications using the CardioCare-2000 and CardioTouch-3000 devices. No clinical data was required or provided.

Technological Characteristics

Windows-based software application; operates in a network environment; compatible with Bionet CardioCare-2000 and CardioTouch-3000 ECG devices; supports JPEG file storage; adheres to FDA CDRH guidance for software contained in medical devices (May 11, 2005).

Indications for Use

Indicated for use as a Windows-based software program to manage (receive, display, store, print) ECG data previously monitored, recorded, and analyzed by specific Bionet ECG devices (CardioCare-2000 or CardioTouch-3000).

Predicate Devices

• CARDIOVIEW ECG Interpretive Software (K974352)

Submission Summary (Full Text)

{0}------------------------------------------------

K090895

# 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: [phone] Fax: [phone]

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: [phone] Fax: [phone]

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 [phone] or [phone] 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):

K090895

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