(86 days)
ECG-9130K
ECG-9130K
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use in the device description or performance studies. The "interpretation program" is mentioned, but the description does not suggest it uses AI/ML, and the lack of training/test set information further supports this.
No
The device is used to process electrical signals to produce a visual display and/or wireless transmission of data, and to provide an interpretive ECG program to assist in diagnosis, which are diagnostic rather than therapeutic functions.
Yes
The "Intended Use / Indications for Use" section states: "The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis." This clearly indicates its role in diagnosis.
No
The device description explicitly states it is a "portable ECG acquisition terminal" that "measures 12 lead ECG waveforms" and has a "built-in battery," indicating it is a hardware device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Cardiofax CE function: The Cardiofax CE electrocardiograph measures electrical signals directly from the patient's body through electrodes placed on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it processes electrical signals transmitted through electrodes to produce a visual display and/or wireless transmission of data. This is a direct measurement of physiological activity, not an analysis of a biological specimen.
Therefore, based on the provided information, the Cardiofax CE is a medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cardiofax CE electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or wireless transmission of data to a remote printer and/or computer.
For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended for use with patients age 3 years to adult.
The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
Product codes
DPS
Device Description
Cardiofax CE, PEA-1110K series, is a portable ECG acquisition terminal, which measures 12 lead ECG waveforms. The measured ECG waveforms are analyzed and transferred to an ECG data filing system thru a wireless LAN. The device features a built-in battery.
The new device offers a full page file with 1 to 12 channel selectable formats, keyboard data entry, battery and AC power operation with internal battery recharging circuit and waveform analyses with measurements, all of which are features of the predicate device. The new device provides a waveform display and PC memory card option, all comparable to the predicate ECG-9130K.
While the device is equivalent, there are a few changes in the new device as compared to the predicate. The new device is smaller, lighter and more compact than the predicate device. In addition, the new device does not include a printer and uses a different type of battery. These changes have been made to address user preferences and do not affect the indication for use or safety and efficacy of the new device.
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
The device is intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended for use with patients age 3 years to adult.
Intended User / Care Setting
Not Found
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)
The device complies with the IEC 60601-1 standard and sub-clause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. .
The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software of the device. The results confirmed that the device performed within specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ECG-9130K
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
NIHON KOHDEN AMERICA
510K SUBMISSION FOR PEA-1110K Series
1042827
SECTION 2 - 510(K) SUMMARY September 23, 2004
JAN - 6 2005
Name and Address of Applicant
Nihon Kohden America, Inc. Attn: Regulatory Affairs Serrah Namini 90 Icon St. Foothill Ranch, Ca 92610 (949) 580-1555 Ext 4401 Fax: (949) 580-1550
Trade Name: Cardiofax CE Common Name: Electrocardiograph and ECG Classification Name: The device has been classified as Class II by the Division of Cardiovascular, Respiratory, and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" per 74 LOS.
Cardiofax CE, PEA-1110K series, is a portable ECG acquisition terminal, which measures 12 lead ECG waveforms. The measured ECG waveforms are analyzed and transferred to an ECG data filing system thru a wireless LAN. The device features a built-in battery.
Nihon Kohden's PEA-1110K series is intended for medical purposes to process the electrical signals transmitted through electrocardiograph electrodes and to produce a visual display and/or transmit data to a remote printer and/or a computer of the electrical signals produced by the heart. Measurements and waveforms and diagnostic information are offered to physicians on an advisory basis.
The new device offers a full page file with 1 to 12 channel selectable formats, keyboard data entry, battery and AC power operation with internal battery recharging circuit and waveform analyses with measurements, all of which are features of the predicate device. The new device provides a waveform display and PC memory card option, all comparable to the predicate ECG-9130K.
While the device is equivalent, there are a few changes in the new device as compared to the predicate. The new device is smaller, lighter and more compact than the predicate device. In addition, the new device does not include a printer and uses a different type of battery. These changes have been made to address user preferences and do not affect the indication for use or safety and efficacy of the new device.
The device complies with the IEC 60601-1 standard and sub-clause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. .
The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software of the device. The results confirmed that the device performed within specifications.
Therefore based on the above, Nihon Kohden believes that the PEA-1110K series is substantially equivalent to our predicated ECG-9130K.
1
Image /page/1/Picture/11 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2005
Nihon Kohden America, Inc. c/o Ms. Serrah Namini Regulatory Affairs 90 Icon St. Foothill Ranch, CA 92610
Re: K042827
Trade Name: Cardiofax CE, PEA-1110K series Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: September 23, 2004 Received: October 12, 2004
Dear Ms. Namini:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Americans, or to conninered proc to May 20, 1978, in easily accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (110c) that ac novice, subject to the general controls provisions of the Act. The r ou may, morelors, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (see accroy as . Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 – Ms. Serrah Namini
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r roube over love 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It Fat 6077; adomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. production will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dosire specific arrant an (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Blummer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
NIHON KOHDEN AMERICA
G. Indications for Use Statement
510(k) Number (if known):
Device Name: Cardiofax CE; PEA-1110K Series
Indications for Use: The Cardiofax CE electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or wireless transmission of data to a remote printer and/or computer.
For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended for use with patients age 3 years to adult.
The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
042827
Cardiovascular Devices