CARDIOFAX CE, MODEL PEA-1110K by NIHON KOHDEN AMERICA, INC.

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.

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.

AI/ML Overview

The provided 510(k) submission for the NIHON KOHDEN AMERICA PEA-1110K Series (Cardiofax CE) is a summary document for a substantial equivalence determination, not a detailed study report. Therefore, it does not contain the specific information requested in many of the categories, such as detailed acceptance criteria with performance metrics, sample sizes for test sets (beyond general statements about compliance), specifics on expert involvement, or details on ground truth establishment for a diagnostic algorithm.

The submission focuses on establishing substantial equivalence to a predicate device (ECG-9130K) by demonstrating that the new device has similar indications for use, fundamental technology, and meets relevant safety and performance standards. The "study" referenced is primarily a battery of engineering and software validation tests to confirm the device operates within specifications and meets regulatory standards, rather than a clinical performance study with specific diagnostic accuracy endpoints.

Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
General Operation	Device operation within specifications	"The results confirmed that the device performed within specifications."
Safety	Compliance with IEC 60601-1	"The device complies with the IEC 60601-1 standard..."
Performance (Lead Wires/Cables)	Compliance with 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables (sub-clause 56.3(c))	"...and sub-clause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables."
Electromagnetic Compatibility	Test procedures for electromagnetic compatibility	"The device was subject to electromagnetic... testing procedures. These tests verified the operation of the device."
Environmental	Test procedures for environmental conditions	"The device was subject to... environmental... testing procedures. These tests verified the operation of the device."
Software Validation	Software validation confirmed operation	"Software validation tested the operation of the software of the device. The results confirmed that the device performed within specifications."
Equivalence to Predicate	Substantially equivalent to ECG-9130K	"Nihon Kohden believes that the PEA-1110K series is substantially equivalent to our predicated ECG-9130K."
Interpretive ECG Program	Provide assessment of ECG waveform rhythm and morphology to assist physician in diagnosis.	Device provides "an interpretive ECG program intended for use with patients age 3 years to adult." and "The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis." (This is stated as its intended function, implying it meets this functional requirement, but no specific performance metrics are given on its diagnostic accuracy).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "testing procedures" and "software validation" but does not give a number of cases, patients, or data points used for these tests.
Data Provenance: Not specified. It's likely these were internal engineering validation tests, potentially using synthetic data or a limited set of internal human data, but no details are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Specified. The document describes a Class II device (Electrocardiograph) that has an "interpretive ECG program" (an algorithm). However, the primary focus of this submission is on the device's technical specifications and substantial equivalence, not on the clinical performance validation of the interpretive algorithm itself. There is no mention of experts establishing a ground truth for a diagnostic test set in this summary. The ECG interpretation is stated to be "on an advisory basis" and requires review by "qualified physicians trained in electrocardiography."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Specified. As no diagnostic performance study of the interpretive algorithm (with a test set and ground truth determination by experts) is described, there's no mention of an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This type of study was not conducted or reported in this 510(k) summary. The submission focuses on the standalone device's compliance and equivalence, not on its assistive capabilities for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly, for the interpretive program's internal validation. The text states, "Software validation tested the operation of the software of the device. The results confirmed that the device performed within specifications." This suggests the algorithm within the device was tested to ensure it generated interpretations as designed. However, the clinical diagnostic accuracy of this standalone algorithm (e.g., sensitivity, specificity for specific conditions) is not reported or mentioned as part of the "acceptance criteria" presented in this document for the 510(k) submission. The interpretation is explicitly "advisory" and requires physician review.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified for the interpretive algorithm's diagnostic performance. For the non-diagnostic aspects (safety, electrical performance, software function), the ground truth was presumably defined by engineering specifications, regulatory standards (like IEC 60601-1), and internal performance benchmarks.

8. The sample size for the training set

Not specified. The document does not describe the development or training of the interpretive ECG algorithm.

9. How the ground truth for the training set was established

Not specified. The document does not describe the development or training of the interpretive ECG algorithm.

Summary

{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.

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.

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

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).