(250 days)
Not Found
No
The document mentions a "computer-generated analysis" and an "interpretive algorithm," but does not use terms like AI, ML, or deep learning, nor does it describe characteristics typically associated with AI/ML development (training/test sets, performance metrics like AUC).
Yes
The device is used to "evaluate and diagnose patient cardiac function," which is a therapeutic purpose.
Yes
Explanation: The device is described as an "electrocardiograph" and an "EKG monitoring system" that provides an "interpretive algorithm" for "potential patient cardiac abnormalities." It is explicitly stated that clinicians can use it to "evaluate and diagnose patient cardiac function."
No
The device description explicitly states it "consists of the several components depicted in Figure 1 that perform EKG and pulmonary monitoring, data analysis and data management functions," implying hardware components beyond just software. It also mentions "surface electrodes" as the anatomical site, which are hardware.
Based on the provided information, the Cardio7 electrocardiograph 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.
- Cardio7 Function: The description clearly states that the Cardio7 is an electrocardiograph that uses surface electrodes placed on the patient's body to measure electrical activity of the heart. This is a non-invasive, in vivo measurement, not an in vitro test on a sample.
- Intended Use: The intended use is to evaluate and diagnose patient cardiac function by analyzing the electrical signals from the heart, not by analyzing a biological sample.
Therefore, the Cardio7 falls under the category of a medical device that performs physiological measurements directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cardio7 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 USB Memory.
The Cardio7 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.
Product codes
DPS
Device Description
Cardio7 is an EKG monitoring system that provides standard EKG and (optional) pulmonary diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG and pulmonary monitoring, data analysis and data management functions.
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
Adult and pediatric patients
Intended User / Care Setting
trained operators in health facilities
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)
Because Cardio7 complies with the EC11 standard, assessment of performance data is not necessary to determine of Substantial Equivalence for this type of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K11330le
16 2012
1. 510(k) Summary - Basic Information
| 1.1 Submitter | |
|---|---|
| Submitter: | Bionet Co., LTD |
| Address: | #1101, 11F E&C Dream Tower III, 197-33 |
| Guro-dong, Guro-gu, Seoul, South Korea (ZIP 152-050) | |
| Contact: | Marc Goodman |
| Company: | Noblitt & Rueland |
| 5405 Alton Parkway, Suite A530 | |
| Irvine, CA 92604 | |
| Voice: | (714) 258-4646 |
| FAX: | (714) 258-3990 |
| Cell: | (949) 872-1011 |
| Email: | marcgood@ca.rr.com |
| Date Prepared: | October 7, 2011 |
1.2 Device Name
| Device Name: | Cardio7 |
|---|---|
| Common Name: | Electrocardiograph |
| Classification Name: | Electrocardiograph (870.2340, Class II) |
1.3 Identification of Legally Marketed Device
Substantial equivalence is claimed to the Bionet CardioXP (K102767).
1.4 Device Description
Cardio7 is an EKG monitoring system that provides standard EKG and (optional) pulmonary diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG and pulmonary monitoring, data analysis and data management functions.
Figure 1: Cardio7 Block Diagram Depiction
Image /page/0/Figure/10 description: The image shows a diagram of the Cardio7 System Unit and its connections to other devices. The Cardio7 System Unit is connected to a Remote PC via a network connector, a Local PC via RS232, and an SD Memory via a built-in SD Slot. The Cardio7 System Unit is also connected to Patient Leads via a Patient Cable.
1
1.5 Intended Use
Cardio7 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 USB Memory.
1.6 Comparison to Cleared Device
Table 1 compares the relevant features of Cardio7 to the Bionet CardioXP (K102767).
Table 1: Comparison of Cardio7 to Predicate Device (CardioXP)
| CardioXP | Cardio7 | |
|---|---|---|
| Operating | ||
| Principle | electrocardiographs | same |
| Target | ||
| Population | Adult and pediatric patients | same |
| ECG | ||
| Acquisition | Simultaneous 12 leads resting ECG connects to Patient | |
| Signal Module. CardioXP System Unit receives data from | ||
| Patient Signal Module using either (1) direct cable | ||
| connection or (2) Bluetooth communication. | Simultaneous 12 leads | |
| resting ECG connect | ||
| directly to Cardio7 System | ||
| Unit. | ||
| Basic | ||
| measurement | Heart rate, PR int, QRS dur, QT/OTc, P-R-T axis | same |
| Sampling | ||
| Rate | 500 samples/sec/channel | same |
| Filters | • 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) | same | |
| Display Type | built in color LCD | same |
| Display | ||
| Functions | View and adjust ECG waveforms. | same |
| Monitor | ||
| display | ID, HR, Sensitivity, Speed, Date, Power status | HR, ID, date, AC or Battery |
| state, sensitivity, speed, | ||
| number of saved data, | ||
| printing form, rhythm lead | ||
| Patient Data | ID, name, age, birth, gender, height, weight, smoke, | |
| department, room number, race | ID, name, age, sex, height, | |
| weight, smoke, race | ||
| User Input | touch screen and rotary push-knob | same |
| Signal quality | ||
| control | Disconnected lead detection. | |
| Pacemaker pulse detection | same | |
| Data Storage | • Internal storage for up to 120 ECG | |
| • Additional storage available using built in SD RAM slot | same | |
| Weight | Approx. 4 kg (8.8 lb) | Approx. 3.5 kg (7.7 lb) |
| Dimensions | 300 x 299 x 123mm | |
| (11.8 x 11.8 x 4.8 in) | 296 x 305 x 92 mm | |
| (11.7 x 12 x 3.6 in) | ||
| Power Source | AC power supply (95 ~ 240 VAC, 50/60Hz, 60 VA max) | |
| or battery power | same |
2
| CardioXP | Cardio7 | |
|---|---|---|
| Battery | 3 hours of normal use or print 300 ECG pages. Battery recharge to full capacity in 8 hours. | 1 hours of normal use or print 100 ECG pages. Battery recharge to full capacity in 4 hours. |
| Sterility | Wipe exterior of patient cable and electrocardiograph with | |
| damp cloth using mild detergent diluted in water. | ||
| Disinfect patient cable using damp cloth of chemical | ||
| disinfectants containing one of the following: | ||
| ethanol (70% - 80%) | ||
| propanol (70% - 80%) | ||
| aldehydes (2% - 4%) | same | |
| Safety | 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 | 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 | ||
| Printer | Thermal printer (internal) | same |
| Network | ||
| Connection | Hardwired Ethernet | same |
| Indication for | ||
| Use | 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. | same |
1.6.1 Differences between Cardio7 and CP200
The meaningful differences between Cardio7 and CardioXP are the method of ECG data acquisition and the availability of an external monitor.
- . Whereas CardioXP acquires ECG data from its Patient Signal Module, Cardio7 acquires ECG data directly from the Patient Cable. (CardioXP's Patient Signal Module is capable of transmitting ECG data to its system unit from a distance via wireless Bluetooth communication).
- CardioXP provides for an external monitor and Cardio7 does not. .
2. Performance Information
Because Cardio7 complies with the EC11 standard, assessment of performance data is not necessary to determine of Substantial Equivalence for this type of device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 16 2012
Bionet Co., Ltd. c/o Marc Goodman Regulatory Consultant 5405 Alton Parkway 5A, #530 Irvine, CA 92604-3718
Re: K113306
Trade/Device Name: Cardio7 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: July 5, 2012 Received: July 9, 2012
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. Marc Goodman
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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Bram Zuckerman, MD
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510 (k) Number (if known)
Device Name Cardio7
Indications for Use
The Cardio7 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.
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)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K113306
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