(118 days)
The ECG-9110K and ECG-9130K Cardiofax Q electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart.
For non-interpretive applications, the ECG-9110K and ECG-9130K are 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 solo basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
The ECG-9110K and ECG-9130K have been classified as Class III by the Division of Cardiovascular, Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per 74 LOS.
Common names for the ECG-9110K and ECG-9130K include ECG and electrocardiograph.
Nihon Kohden's model ECG-9130K are intended for medical purposes to process the electrical signals transmitted through two or more electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart.
The ECG-9110K and ECG-9130K devices comply with the IEC 601-1 standard including subclause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for these devices. The devices are also in compliance with the following voluntary industrial standards: IEC 601-2-25 and CSA 601-1. Defibrillator Discharge Protection: Class I, Type CF.
The ECG-9110K and ECG-9130K are not intended to be sterile.
The devices were determined to be non-contacting. Therefore, good laboratory practice studies were not required per 21 CFR part 58.
The ECG-9110K and ECG-9130K were subjected 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.
The provided document describes the Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q electrocardiographs and their submission for 510(k) clearance. However, the document does not contain the detailed acceptance criteria or a study proving the device meets specific performance metrics in the way modern AI/ML device submissions do.
This submission is from 1998/1999, which predates the widespread use of sophisticated AI/ML algorithms in medical devices and the associated rigorous performance study requirements now common. The information provided heavily focuses on regulatory compliance, safety standards, and substantial equivalence to a predicate device, rather than detailed performance metrics.
Therefore, I will extract what is available and note the gaps according to your requested format.
Acceptance Criteria and Device Performance Study for Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 601-1 standard (including subclause 56.3(c)) | "The ECG-9110K and ECG-9130K devices comply with the IEC 601-1 standard..." |
| Compliance with 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables | "...including subclause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables." |
| Compliance with voluntary industrial standards: IEC 601-2-25 and CSA 601-1 | "The devices are also in compliance with the following voluntary industrial standards: IEC 601-2-25 and CSA 601-1." |
| Defibrillator Discharge Protection: Class I, Type CF | Stated as Class I, Type CF. (Implies compliance with this classification) |
| Electromagnetic compatibility | "The ECG-9110K and ECG-9130K were subjected to electromagnetic... testing procedures." Results: "These tests verified the operation of the device." |
| Environmental compatibility | "The ECG-9110K and ECG-9130K were subjected to... environmental... testing procedures." Results: "These tests verified the operation of the device." |
| Safety performance | "The ECG-9110K and ECG-9130K were subjected to... safety... testing procedures." Results: "These tests verified the operation of the device." |
| General performance (within specifications) | "The ECG-9110K and ECG-9130K were subjected to... performance testing procedures." Results: "These tests verified the operation of the device." "The results confirmed that the device performed within specifications." |
| Software validation | "Software validation tested the operation of the software of the device." Results: "The results confirmed that the device performed within specifications." |
| Substantial Equivalence to ECG-9320A | "Therefore based on the above, Nihon Kohden believes that the ECG-9110K and ECG-9130K are substantially equivalent to the ECG-9320A." (FDA concurred with this finding) |
Regarding the interpretive ECG program:
The document explicitly states: "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 solo basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography."
This framing suggests that the "interpretation program" is an assistive tool, and the focus of the submission is on the electrical and functional performance of the electrocardiograph hardware and basic software, rather than a standalone diagnostic performance of the interpretive algorithm against specific clinical endpoints. Therefore, a detailed study proving performance of the interpretive algorithm in a clinical context, beyond verifying it "performed within specifications," is not described in this document.
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance. The testing described (electromagnetic, environmental, safety, performance, software validation) would typically use hardware units or simulated conditions, not a dataset of patient ECGs in the way an AI/ML algorithm is evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This information is not provided as there is no described test set of clinical data for an algorithm.
4. Adjudication method for the test set
N/A - Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided document. The focus is on the device's adherence to technical standards and functional specifications, and its substantial equivalence to a predicate device. The interpretive program is explicitly stated as an "assistive" tool requiring physician review.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone performance study of the interpretive algorithm. The "software validation" mentioned would likely pertain to its functional accuracy against internal specifications rather than clinical diagnostic performance. The indications for use emphasize the assistive nature of the interpretive program, requiring review by qualified physicians.
7. The type of ground truth used
For the general device performance and software validation, the "ground truth" would be the engineering specifications and expected behavior of the device as designed. For the interpretive program, the document does not specify how its "assessments" were validated or against what type of ground truth (e.g., expert consensus, pathology, outcomes data). Given the era and nature of the submission, it's likely it was validated against internal logic and a reference ECG database typical for interpretive algorithms of that time, but this is not detailed.
8. The sample size for the training set
N/A - The document does not describe the development or training of a specific clinical algorithm, nor does it refer to a "training set."
9. How the ground truth for the training set was established
N/A - Not applicable, as no training set is described.
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APR 15
NIHON KOHDEN AMERICA, INC. December 17, 1998
510(k) NOTIFICATION ECG-9110K and ECG-9130K Cardiofax Q
SECTION 2 - 510(K) SUMMARY
Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 2601 Campus Drive Irvine, California 92612-1601 (949) 250-3959
The ECG-9110K and ECG-9130K have been classified as Class III by the Division of Cardiovascular, Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per 74 LOS.
Common names for the ECG-9110K and ECG-9130K include ECG and electrocardiograph.
Nihon Kohden's model ECG-9130K are intended for medical purposes to process the electrical signals transmitted through two or more electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart.
The ECG-9110K and ECG-9130K devices comply with the IEC 601-1 standard including subclause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for these devices. The devices are also in compliance with the following voluntary industrial standards: IEC 601-2-25 and CSA 601-1. Defibrillator Discharge Protection: Class I, Type CF.
The ECG-9110K and ECG-9130K are not intended to be sterile.
The devices were determined to be non-contacting. Therefore, good laboratory practice studies were not required per 21 CFR part 58.
The ECG-9110K and ECG-9130K were subjected 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 ECG-9110K and ECG-9130K are substantially equivalent to the ECG-9320A.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1999
Mr. Gary Reasoner Nihon Kohden America, Inc. 2601 Campus Drive Irvine, CA 92612
Re: K984504 Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q Requlatory Class: III (three) Product Code: 74 LOS Dated: April 6, 1999 Received: April 7, 1999
Dear Mr. Reasoner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Gary Reasoner
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NIHON KOHDEN AMERICA, INC. December 17, 1998
510(k) NOTIFICATION ECG-9110K and ECG-9130K Cardiofax Q
G. Indications for Use Statement
K984504 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ECG-9110K and ECG-9130K Cardiofax Q
Indications for Use:
The ECG-9110K and ECG-9130K Cardiofax Q electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart.
For non-interpretive applications, the ECG-9110K and ECG-9130K are 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 solo basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atl. R. Ciarkowsl.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K984504
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use -------
(Optional Formal 1-2-96)
N/A