(101 days)
The ECG-9010K and ECG-9020K Cardiofax GEM 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-9010K and ECG-9020K 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 sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
The ECG-9010K and ECG-9020K 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-9010K and ECG-9020K include ECG and electrocardiograph.
Nihon Kohden's model ECG-9010K and ECG-9020K are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart.
The ECG-9010K and ECG-9020K 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-9010K and ECG-9020K 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-9010K and ECG-9020K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation is performed to test the operation of the device software. The results confirm that the device performs within specifications.
The provided text describes the 510(k) notification for the Nihon Kohden ECG-9010K and ECG-9020K Cardiofax GEM electrocardiographs. However, this document does not contain the detailed information needed to completely fill out all sections of your request regarding acceptance criteria and the study proving device performance.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "The ECG-9010K and ECG-9020K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation is performed to test the operation of the device software. The results confirm that the device performs within specifications."
However, specific acceptance criteria values and the reported performance values are not provided in this document. It only confirms that tests were done and the device met its specifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the document. The document mentions "performance testing procedures" but doesn't specify the details of the test set for these procedures, especially for the interpretive ECG program.
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)
This information is not provided. For the "interpretive ECG program," it states that "All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography," but it doesn't describe how ground truth was established for the device's validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The document describes a standalone device that provides an interpretive program but does not detail comparative studies with human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the document implies standalone performance testing for the device's "interpretive ECG program" as it is designed to provide an assessment. It states, "The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis." It also clarifies: "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." This suggests an algorithm-only assessment component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. While the device provides an interpretation, how the "ground truth" was established for validating this interpretation is not described.
8. The sample size for the training set
The document is a 510(k) summary for a medical device and does not delve into the specifics of the training data used for the interpretive algorithm. This information is not provided.
9. How the ground truth for the training set was established
Similar to point 8, this information is not provided in the 510(k) summary.
Summary of available information vs. missing information:
| Category | Information from Document | Missing Information |
|---|---|---|
| Acceptance Criteria & Performance | Device "performs within specifications." | Specific numerical acceptance criteria and reported performance values. |
| Test Set Sample Size & Provenance | Implied testing was done. | Specific sample size, country of origin, retrospective/prospective nature. |
| Ground Truth Experts (Test Set) | "Qualified physicians trained in electrocardiography" review output. | Number of experts, specific qualifications of experts establishing ground truth. |
| Adjudication Method (Test Set) | Not mentioned. | Adjudication method (e.g., 2+1, 3+1). |
| MRMC Comparative Study | Not mentioned. | Whether an MRMC study was done, effect size of human improvement with AI. |
| Standalone Performance | Yes, the interpretive program provides assessments. | Detailed standalone performance metrics (e.g., sensitivity, specificity, accuracy). |
| Type of Ground Truth | Not mentioned. | Whether it was expert consensus, pathology, outcomes, etc. |
| Training Set Sample Size | Not mentioned. | Specific sample size for training data. |
| Training Set Ground Truth Establishment | Not mentioned. | How ground truth was established for training data. |
In conclusion, this 510(k) document confirms that the device underwent various tests and met its specifications, and it has an interpretive ECG program. However, it lacks the detailed study methodology, sample sizes, and specific performance metrics that would typically be found in a detailed validation study report.
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4/16/99
K G G 6031
NIHON KOHDEN AMERICA, INC. January 4, 1999
510(k) NOTIFICATION ECG-9010K and ECG-9020K Cardiofax GEM
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-9010K and ECG-9020K 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-9010K and ECG-9020K include ECG and electrocardiograph.
Nihon Kohden's model ECG-9010K and ECG-9020K are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart.
The ECG-9010K and ECG-9020K 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-9010K and ECG-9020K 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-9010K and ECG-9020K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation is performed to test the operation of the device software. The results confirm that the device performs within specifications.
Therefore based on the above, Nihon Kohden believes that the ECG-9010K and ECG-9020K are substantially equivalent to the ECG-9320A.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1999
Mr. Gary Reasoner Nihon Kohden America, Inc. 2601 Campus Drive Irvine, CA 92612
Re: к990031 Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and Accessories Regulatory 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory 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 regulation (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,
Thomas J. Callahon
allahan, Ph.D. Thomas J. 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. January 4, 1999
510(k) NOTIFICATION ECG-9010K and ECG-9020K Cardiofax GEM
G. Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ECG-9010K and ECG-9020K Cardiofax GEM
Indications for Use:
The ECG-9010K and ECG-9020K Cardiofax GEM 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-9010K and ECG-9020K 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 sole 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)
Ar. A. Ca. U.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
K990031 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
N/A