The CardioXP electrocardiograph is one of the tools that clinicians can 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.

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.

AI/ML Overview

This document describes the Bionet CardioXP, an electrocardiograph. The acceptance criteria and supporting study information are derived directly from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "CardioXP complies with the EC11 standard". EC11 (now ANSI/AAMI EC11:2007/(R)2017) is a standard for diagnostic electrocardiographic devices, specifying general safety and performance requirements. The document does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular condition) for an interpretive algorithm, nor does it present explicit performance metrics against such criteria. Instead, compliance with the EC11 standard is presented as the primary "performance information."

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Compliance with EC11 standard	Complies with EC11 standard

2. Sample Size Used for the Test Set and Data Provenance

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

Therefore, there is no specific test set sample size reported for evaluating the interpretive algorithm's performance, as a comparative clinical effectiveness study was deemed unnecessary for substantial equivalence based on standard compliance. The data provenance (country of origin, retrospective/prospective) is not applicable/not reported for an absent test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no specific test set data was provided or analyzed for the interpretive algorithm's performance against ground truth, the number and qualifications of experts involved in establishing such ground truth are not applicable/not reported.

4. Adjudication Method for the Test Set

As there was no specific test set and no performance data presented for the interpretive algorithm, an adjudication method for the test set is not applicable/not reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this submission. The device's substantial equivalence was based on compliance with the EC11 standard rather than such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study of the algorithm's diagnostic accuracy was not presented in the provided document. The claim is based on compliance with a standard, not on a direct performance evaluation of the interpretive algorithm's diagnostic capabilities.

7. The Type of Ground Truth Used

Given that no performance data for the interpretive algorithm was presented beyond compliance with a technical standard, the type of ground truth (expert consensus, pathology, outcomes data, etc.) used for such an evaluation is not applicable/not reported. The submission indicates that the interpretive algorithm provides "computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information," implying that the algorithm's output is not the definitive ground truth.

8. The Sample Size for the Training Set

The document does not report any information regarding a training set sample size for the interpretive algorithm.

9. How the Ground Truth for the Training Set Was Established

The document does not report how the ground truth for any training set, if one was used for the interpretive algorithm, was established.

Summary

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1. 510(k) Summary - Basic Information

1.1 Submitter
Submitter:Address:	Bionet Co., LTD#1101, 11F E&C Dream Tower III, 197-33Guro-dong, Guro-gu, Seoul, South Korea (ZIP 152-050)	JUN - 3 2011
Contact:	Marc Goodman
Company:	Noblitt & Rueland5405 Alton Parkway, Suite A530Irvine, CA 92604
Voice:	(714) 258-4646
FAX:	(714) 258-3990
Cell:	(949) 872-1011
Email:	marcgood@ca.rr.com
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

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
OperatingPrinciple	electrocardiographs	same
TargetPopulation	Adult and pediatric patients	same
ECGAcquisition	Simultaneous 12 leads resting ECG datacables plug into front end harness whichthen connects directly to CP200 unit.	Simultaneous 12 leads resting ECGconnects to Patient Signal Module.CardioXP System Unit receives data fromPatient Signal Module using either(1) direct cable connection or (2) Bluetoothcommunication.
SamplingRate	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)
DisplayFunctions	View and adjust ECG waveforms. Spirometry option provides for viewpatients' 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 50Spirometry records Additional storage available using builtin SD RAM slot	Storage for up to 120 ECG Does not have spirometry option. Additional storage available using builtin 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(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 100ECG pages. Battery recharge to full capacity in 12hours.	3 hours of normal use or print 300ECG pages. Battery recharge to full capacity in 8hours.
Printer	Thermal printer (internal)	same

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

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	Welch Allyn CP200	Bionet CardioXP
Sterility	Wipe exterior of patient cable andelectrocardiograph with damp cloth usingmild detergent diluted in water.Disinfect patient cable using damp cloth ofchemical disinfectants containing one ofthe following:ethanol (70% - 80%) propanol (70% - 80%) aldehydes (2% - 4%)	same
Safety	Recognized and applicable standards: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: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
NetworkConnection	Wireless	Hardwired Ethernet
Indication forUse	The electrocardiograph is one of the toolsthat clinicians use to evaluate, diagnose,and monitor patient cardiac function. The12-lead ECG interpretive algorithmprovides a computer-generated analysis ofpotential patient cardiac abnormalities,which must be confirmed by a physicianwith other relevant clinical information. Theoptional spirometry module is indicated foruse in clinical situations to assess apatient's pulmonary health status andevaluated symptoms, signs, or abnormallaboratory test results.	The CardioXP electrocardiograph is one ofthe tools that clinicians can use to evaluateand diagnose patient cardiac function. The12-lead ECG interpretive algorithmprovides a computer-generated analysis ofpotential patient cardiac abnormalities,which must be confirmed by a physicianwith 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 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).