(239 days)
Not Found
No
The document describes a standard ECG device for recording and displaying electrical heart activity, with no mention of AI or ML capabilities for analysis or interpretation.
No.
The device is a portable recording device used to acquire, display, record, and export 12-lead ECG signals. It is a diagnostic device, not a therapeutic one as it does not actively treat a condition.
Yes
The device acquires, displays, records, and exports 12-lead ECG signals and data, which are used to assess the electrical activity of the heart. This information is then used by a physician to evaluate a patient's health.
No
The device description explicitly states that the CARDIPIA800H and CARDIPIA400H "consist of main body, power cable" and are "freely operated by main AC power without additional adjustment, or by the built-in rechargeable battery," indicating the presence of physical hardware components beyond just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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.
- Device Function: The CARDIPIA800H and CARDIPIA400H acquire, display, record, and export 12-lead ECG signals. This involves measuring electrical activity on the patient's skin using electrodes.
- Lack of Sample Analysis: The device does not analyze biological samples taken from the patient's body. It directly measures electrical signals on the body.
Therefore, the function of this device falls under the category of a medical device that measures physiological signals directly from the patient, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatic which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician. CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. NOTE: ECG should not be used as the patient monitoring system for long term patient monitor.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The CARDIPIA800H and CARDIPIA400H consist of main body, power cable. Both devices are intended to be used with 3rd party lead electrodes supplied to a patient by a physician or a monitoring center. High quality FDA cleared lead electrodes should be used.
TRISMED's CARDIPIA ECG (model: CARDIPIA800H, CARDIPIA400H) feature the resting ECG, 12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. CARDIPIA ECG is able to record the standard 12-lead resting ECG with 12, 6 or 3 channel format and any lead combinations of the 12 leads in automatic or manual mode. The preview mode allows to verify the content of the report on the display before printing it. This is useful to avoid printing reports with artifacts or unusable signal. CARDIPIA ECG is freely operated by main AC power without additional adjustment, or by the built-in rechargeable battery which can be used for a limited time in place of AC power. CARDIPIA ECG can save internal memory and export all patient data from USB memory stick or import from USB memory stick to on data management mode.
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 which is defined between 0 and 15 years old
Intended User / Care Setting
by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician.
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)
Non-Clinical Performance Data:
Non-clinical performance testing has been performed on CARDIPIA ECG, the subject device, and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA quidance document.
- IEC 60601-1: 2005+A1:2012 +A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- IEC 62366-1:2015, AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices
- IEC 62304:2006 +AMD1:2015 Medical device software - Software life-cycle processes
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014.
The subject device was tested in accordance with the internal Verification and Validation processes of TRISMED CO., LTD. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications, and the risk management results.
The test results in this 510(k), demonstrate those CARDIPIA ECG:
- comply with the aforementioned international and FDA-recognized consensus standards and
- FDA quidance document, and
- meets the acceptance criteria and is adequate for its intended use.
Clinical Testing:
CARDIPIA ECG does not require clinical studies to demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 21, 2023
Trismed Co., Ltd. Sul Ki Lee Senior Researcher 409 SMECA, 65 Techno 3-ro, Yuseong-gu Daejeon, 34016 South Korea
Re: K230834
Trade/Device Name: CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: October 18, 2023 Received: October 19, 2023
Dear Sul Ki Lee:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices
2
Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230834
Device Name
CARDIPIA ECG (Model: CARDIPIA400H, CARDIPIA800H)
Indications for Use (Describe)
CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatic which is defined between () and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician. CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system.
NOTE: ECG should not be used as the patient monitoring system for long term patient monitor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of as required by section 807.92(c).
SUBMITTER l.
TRISMED CO., LTD. 409 SMECA, 65 Techno 3-ro, Yuseong-gu, Daejeon 34016, REPUBLIC OF KOREA Tel: +82-42-936-7201 Fax: +82-42-936-7202 Contact person: Sul Ki Lee Date Prepared: March 23, 2023
II. DEVICE
Device Name: CARDIPIA400H, CARDIPIA800H Trade Name: CARDIPIA ECG Common Name: Electrocardiograph Regulatory Class: II Product Code: DPS Regulatory Description: Electrocardiograph (21 CFR 870.2340)
III. PREDICATE DEVICE
The CARDIPIA ECG (CARDIPIA400H, CARDIPIA800H) addressed in this premarket notification, is substantially equivalent to the following commercially available electrocardiograph device:
Predicate device (Legally Marketed Device)
· K133622 - MAC2000 ECG Analysis System, WIPRO GE Healthcare
IV. DEVICE DESCRIPTION
The CARDIPIA800H and CARDIPIA400H consist of main body, power cable. Both devices are intended to be used with 3rd party lead electrodes supplied to a patient by a physician or a monitoring center. High quality FDA cleared lead electrodes should be used.
TRISMED's CARDIPIA ECG (model: CARDIPIA800H, CARDIPIA400H) feature the resting ECG, 12/6recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. CARDIPIA ECG is able to record the standard 12-lead resting ECG with 12, 6 or 3 channel format and any lead combinations of the 12 leads in automatic or manual mode. The preview mode allows to verify the content of the report on the display before printing it. This is useful to avoid printing reports with artifacts or unusable signal. CARDIPIA ECG is freely operated by main AC power without additional adjustment, or by the built-in rechargeable battery which can be used for a limited time in place of AC power. CARDIPIA ECG can save internal memory and export all patient data from USB memory stick or import from USB memory stick to on data management mode.
5
V. INDICATIONS FOR USE
CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display. record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatric which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical use facilities or a prescribed environment under the direction of a physician. CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. NOTE: ECG should not be used as the patient monitoring system for long term patient monitor.
VI. SUBSTANTIAL EQUIVALENCE TABLE
The submission provides a comparison between the new device, the CARDIPIA ECG (Type: CARDIPIA800H , CARDIPIA400H), compared to the MAC2000 ECG Analysis System by WIPRO GE Healthcare cleared under K133622. The following is a comparison table which includes a comparison of the indications for use, technological characteristics, principles of operation, and performance specifications. There are no fundamental technological differences between CARDIPIA ECG and predicate MAC2000 regarding the basis for the determination of substantial equivalence. It has no effect on the safety or efficacy of the subject device and does not raise any potential safety risks, and the subject device is identical in performance to the legally marketed device.
| Characteristics | Subject Device – CARDIPIA ECG
(CARDIPIA400H, CARDIPIA800H) | Predicate Device - MAC2000 ECG
Analysis System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatric which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician. CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. NOTE: ECG should not be used as the patient monitoring system for long term patient monitor. | The MACTM2000 ECG Analysis System is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional's facility, clinics, physician's office or outreach centers. NOTE: Pediatric populations are defined as patients between the ages of 0 and 15 years. The MACTM2000 ECG Analysis System provides the following modes of operation: • Resting ECG mode • Arrhythmia mode • Exercise mode for exercise stress testing (optional) • RR analysis mode for RR interval analysis (optional) |
| | | The basic system prints 6 or 12 leads
of ECG and is upgradeable to provide
software
options such as 12-lead ECG
measurement and interpretive analysis.
Arrhythmia detection is provided for the
convenience of automatic
documentation.
Transmission and reception of ECG
data to and from a central ECG
cardiovascular
information system is optional. |
| Product Code | DPS | DPS, DQK, DXH |
| Operating
Principle | Electrocardiographs | Electrocardiographs (DPS) |
| Target
Population | Pediatric patient (0 ~ 15 years) and
adult | Pediatric patients (0~15 years) and
adult |
| ECG
Acquisition | 12-lead ECG with simultaneous 10-
lead | 12-lead simultaneous acquisition |
| Lead | 12 Standard Leads : I, II, III, aVR, aVL,
aVF, V1, V2, V3, V4, V5, V6 | 12-lead analysis |
| Safety | EN 60601-1 (IEC 60601-1) Medical
electrical equipment –
Part 1: General Requirements for
Safety
Class I (Degree of protection against
electrical shock)
Defibrillation proof (5000VDC) based
on type CF applied part
Complied IEC60601-1 | EN 60601-1 (IEC 60601-1) Medical
electrical equipment –
Part 1: General Requirements for
Safety
IEC60601-1 protection class I
Type CF defibrillation-proof applied part |
| EMC | IEC 60601-1-2 General Requirements
for Safety
Electromagnetic Compatibility
CISPR 11, Class A / IEC60601-1-2 | CISPR11, Group 1, Class B |
| Performance | IEC 60601-2-25 Safety of
Electrocardiographs | IEC 60601-2-25 Safety of
Electrocardiographs |
| Sensitivity | 1.25, 2.5, 5, 10, 20, 40mm/mV, Auto | 2.5, 5, 10, 20, 40 mm/mV with ±5%
accuracy |
| Recording
Speed | 5, 10, 12.5, 25, 50, 100 mm/s | 5, 12.5, 25, and 50 mm/s |
| QRS Beat
Display &
Sound | 30 ~ 240 bpm on real time. | Heart Rate meter: 30 to 300 BPM
QRS Detection: available |
| Sampling
Rate | 1000 samples/sec/channel | 500 or 1000 samples/second/channel |
| Filters | Muscle Filter: 25 / 35 Hz
Drift filter(baseline): 0.1/0.15 /0.25/
0.32 / 0.5 Hz
AC filter : 50 / 60 Hz
High frequency filter: 75 / 100 / 150 /
200 Hz | Muscle: 20 Hz, 40 Hz, 100 Hz, 150 Hz
Automatic Baseline correction: User-selectable
Hight cutoff Frequency: configurable at
20 Hz, 40 Hz, 100 Hz, 150 Hz |
| Display Type | Color TFT 7" LCD (Viewing area:
154.08mm x 85.92mm), Dots: 800 x
480 | 7-inch (177.8 mm) color TFT graphics
display with support of minimum 32K
colors
Resolution WVGA – 800 x 480 pixels |
| Patient Data | Patient Name, ID, Code(barcode), Sex,
Ethnic, Birthday, Age, Weight, Height,
Drugs, Smoker, Systolic, Diastolic,
Physician, hospital name | Patient information entry: Patient ID,
Secondary Patient ID,
Height, Weight, Gender, Race,
Pacemaker Patient, Systolic BP,
Diastolic BP, Location#, Room, Order
Number, Phone Number,
Medication, Ordering Physician,
Referring Physician, Attending
Physician, Technician, Test indication,
four user-definable fields. |
| Key
Operation | Alphanumeric key by membrane and
LCD touch screen | Membrane keyboard with tactile
feedback –
Soft function keys, alphanumeric keys
(Qwerty key set), |
| Weight | CARDIPIA 400H : 2.8 Kg with battery
CARDIPIA 800H : 3.5 Kg with battery | approx. 5 kg (11.0 lb)
(including battery, without paper) |
| Dimensions | CARDIPIA400H : 313 (L) x 252 (W) x
107 (H)
CARDIPIA800H : 332 (L) x 308 (W) x
107 (H) | 390 x 330 x 200 mm
Width x Depth x Height |
| Operation
Power | 100 - 240VAC ±10 % 50/60 Hz free
voltage | 100 to 240 VAC ±10% |
| Input
Impedance | Greater than 100 MΩ per 10 Hz | >10MΩ @ 10 Hz |
| Leakage
Current | Less than 10μΑ |