CARDIO XP

K102767 · Bionet Co., Ltd. · DPS · Jun 3, 2011 · Cardiovascular

Device Facts

• Record ID: K102767
• Device Name: CARDIO XP
• Applicant: Bionet Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

CardioXP is intended for use as a diagnostic tool by trained operators in health facilities. It provides the following functions: Acquire ECG waveform data from up to twelve (12) leads through surface electrodes adhered to the patient's body. Input patient data. View, store and print captured data. Analyze captured data; display and print analysis results. Retain captured data and analysis results for up to 120 patients. Transfer retained data to a PC (via server IP) or directly to insertable SD RAM.

Device Story

CardioXP is a 12-lead electrocardiograph system used by trained operators in health facilities. It acquires ECG signals via surface electrodes connected to a Patient Signal Module, which transmits data to the main unit via direct cable or Bluetooth. The system features a touch screen and rotary knob for user input, a thermal printer for output, and internal storage for up to 120 patient records. It performs automated ECG analysis, providing computer-generated interpretations of cardiac abnormalities. Clinicians review these results on the device display or printouts to assist in cardiac diagnosis and monitoring. The device benefits patients by providing rapid, standardized ECG data acquisition and preliminary analysis to support clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence is supported by compliance with recognized standards, including AAMI/ANSI EC11 for electrocardiographs, and bench testing.

Technological Characteristics

12-lead ECG system; 500 samples/sec/channel; touch screen and rotary knob interface; Bluetooth and hardwired Ethernet connectivity; thermal printer; battery or AC powered (95-240 VAC). Complies with IEC 60601-1, IEC 60601-2-25, ISO 10993-1, and ISO 14971. Filters: AC (50/60 Hz), Muscle (25-35 Hz), Baseline drift (0.1 Hz), and Low pass (40/100/150 Hz).

Indications for Use

Indicated for use by clinicians to evaluate and diagnose cardiac function in adult and pediatric patients. Includes 12-lead ECG interpretive algorithm for computer-generated analysis of potential cardiac abnormalities, requiring physician confirmation.

Regulatory Classification

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.

Predicate Devices

• Welch Allyn CP 200™ Electrocardiograph with Optional Spirometry (K072449)

Submission Summary (Full Text)

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K102767
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### 1. 510(k) Summary - Basic Information

| 1.1 Submitter | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter:<br>Address: | Bionet Co., LTD<br>#1101, 11F E&C Dream Tower III, 197-33<br>Guro-dong, Guro-gu, Seoul, South Korea (ZIP 152-050) | JUN - 3 2011 |
| Contact: | Marc Goodman | |
| Company: | Noblitt & Rueland<br>5405 Alton Parkway, Suite A530<br>Irvine, CA 92604 | |
| Voice: | [phone] | |
| FAX: | [phone] | |
| Cell: | [phone] | |
| Email: | [e-mail] | |
| Date Prepared: | April 13, 2011 | |

#### 1.2 Device Name

| Device Name: | CardioXP |
|----------------------|-----------------------------------------|
| Common Name: | Electrocardiograph |
| Classification Name: | Electrocardiograph (870.2340, Class II) |

## 1.3 Identification of Legally Marketed Device

Substantial equivalence is claimed to the Welch Allyn CP 200™ Electrocardiograph with Optional Spirometry (K072449).

#### 1.4 Device Description

CardioXP is an EKG monitoring system that provides standard EKG diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG monitoring, data analysis and data management functions.

# Figure 1: CardioXP Block Diagram Depiction

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### 1.5 Intended Use

CardioXP is intended for use as a diagnostic tool by trained operators in health facilities. It provides the following functions:

- Acquire ECG waveform data from up to twelve (12) leads through surface electrodes . adhered to the patient's body. .
- . Input patient data.
- View, store and print captured data. .
- Analyze captured data; display and print analysis results. .
- Retain captured data and analysis results for up to 120 patients. ●
- . Transfer retained data to a PC (via server IP) or directly to insertable SD RAM.

#### 1.6 Comparison to Cleared Device

Table 1 compares the relevant features of CardioXP to the Welch Allyn CP 200™ Electrocardiograph with Optional Spirometry.

# Table 1: Comparison of CardioXP to Welch Allyn CP 200

| | Welch Allyn CP200 | Bionet CardioXP |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating<br>Principle | electrocardiographs | same |
| Target<br>Population | Adult and pediatric patients | same |
| ECG<br>Acquisition | Simultaneous 12 leads resting ECG data<br>cables plug into front end harness which<br>then connects directly to CP200 unit. | Simultaneous 12 leads resting ECG<br>connects to Patient Signal Module.<br>CardioXP System Unit receives data from<br>Patient Signal Module using either<br>(1) direct cable connection or (2) Bluetooth<br>communication. |
| Sampling<br>Rate | 1000 samples/sec/channel | 500 samples/sec/channel |
| Filters | 0.5 Hz high-performance baseline filter 35Hz muscle-tremor filter AC interference filter | AC (50/60 Hz, -20dB or better) Muscle (25~35Hz, -3dB or better) Base line drift (0.1Hz, -3dB or better) Low pass filter(off, 40Hz, 100Hz, 150Hz) |
| Display<br>Functions | View and adjust ECG waveforms. Spirometry option provides for view<br>patients' information. | View and adjust ECG waveforms. Does not have spirometry option. |
| Display Type | built in color LCD | same |
| User Input | Integrated alphanumeric keyboard dedicated function keys | touch screen and rotary push-knob |
| data Storage | Storage for up to 50 ECG and 50<br>Spirometry records Additional storage available using built<br>in SD RAM slot | Storage for up to 120 ECG Does not have spirometry option. Additional storage available using built<br>in SD RAM slot |
| Weight | 11.6 lb | Approx. 4 kg (8.8 lb) |
| Dimensions | 16.2 x 15.6 x 6.2 in | 300 x 299 x 123mm<br>(11.8 x 11.8 x 4.8 in) |
| Power Source | AC power supply (100 ~ 240 VAC, 50/60Hz, 65 VA max) or battery power. | AC power supply (95 ~ 240 VAC, 50/60Hz, 60 VA max) or battery power. |
| Battery | 4 hours of normal use or print 100<br>ECG pages. Battery recharge to full capacity in 12<br>hours. | 3 hours of normal use or print 300<br>ECG pages. Battery recharge to full capacity in 8<br>hours. |
| Printer | Thermal printer (internal) | same |

510(k) Summary (per 21 CFR Bionet CardioXP 807.92)

02767

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| | Welch Allyn CP200 | Bionet CardioXP |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | Wipe exterior of patient cable and<br>electrocardiograph with damp cloth using<br>mild detergent diluted in water.<br>Disinfect patient cable using damp cloth of<br>chemical disinfectants containing one of<br>the following:<br>ethanol (70% - 80%) propanol (70% - 80%) aldehydes (2% - 4%) | same |
| Safety | Recognized and applicable standards:<br>EC11 (AAMI/ANSI) UL60601-1 IEC 60601-1-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-2-25 IEC 60601-2-51 | Recognized and applicable standards:<br>EC11 (AAMI/ANSI) IEC 60601-1-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-1-6 IEC 60601-1-8 IEC 60601-2-25 ISO 10993-1:2003 ISO 14971:2007 ETSI EN 301 489 ETSI EN 300 328 EN 60950-1 |
| Network<br>Connection | Wireless | Hardwired Ethernet |
| Indication for<br>Use | The electrocardiograph is one of the tools<br>that clinicians use to evaluate, diagnose,<br>and monitor patient cardiac function. The<br>12-lead ECG interpretive algorithm<br>provides a computer-generated analysis of<br>potential patient cardiac abnormalities,<br>which must be confirmed by a physician<br>with other relevant clinical information. The<br>optional spirometry module is indicated for<br>use in clinical situations to assess a<br>patient's pulmonary health status and<br>evaluated symptoms, signs, or abnormal<br>laboratory test results. | The CardioXP electrocardiograph is one of<br>the tools that clinicians can use to evaluate<br>and diagnose patient cardiac function. The<br>12-lead ECG interpretive algorithm<br>provides a computer-generated analysis of<br>potential patient cardiac abnormalities,<br>which must be confirmed by a physician<br>with other relevant clinical information. |

#### 1.6.1 Differences between CardioXP and CP200

The meaningful difference between CardioXP and CP200 is the method of ECG data acquisition.

- . In the case of CP200, patient leads plug into a front end harness, which then connects to a COM port on the CP200 system unit.
- In the case of CardioXP, patient leads plug into a front end harness, which plugs . into a special adapter on the Patient Signal Module. The Patient Signal Module passes the raw ECG data to the CardioXP system unit as if the data had come directly from the patient leads. The data transfer to the system unit can be accomplished by direct cable connection or wireless (Bluetooth) data transfer.
- . While CP200 includes an optional spirometry option, the current CardioXP offering does not provide a spirometry option

.

The Patient Signal Module also provides basic single signal display functions.

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# 2. Performance Information

Because CardioXP complies with the EC11 standard, assessment of performance data is not necessary to determine of Substantial Equivalence for this type of device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 3 2011

Bionet Co., Ltd. c/o Mr. Marc Goodman Senior Associate Noblitt & Reuland 5405 Alton Parkway, Suite #A530 Irvine, CA 92604

K102767 Re:

> Trade/Device Name: CardioXP Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: May 12, 2011 Received: May 16, 2011

Dear Mr. Goodman:

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 10 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

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Page 2 - Mr. Marc Goodman

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.

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.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.

Sincerely yours,

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 Statement

510 (k) Number (if known) K102767

Device Name CardioXP

Indications The CardioXP electrocardiograph is one of the tools that clinicians can use for Use to evaluate and diagnose patient cardiac function. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

Prescription Use X (Part 21 CFR 801 Subpart D)

.

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

cular Devices

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510(k) Number K102767