NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES

• K Number: K961272
• Device Name: NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
• Manufacturer: NIHON KOHDEN AMERICA, INC.
• Date Cleared: 1996-11-01 ( 213 days)
• Product Code: LOS
• Regulation Number: N/A
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: K865032 , K895520
• Predicate For: N/A

Intended Use

intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart.

Device Description

model number ECG-9320A, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart.

AI/ML Overview

This 510(k) summary for the NIHON KOHDEN ECG-9320A Cardiofax does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria, particularly concerning AI/algorithm performance.

Here's why and what information is provided:

Summary of Provided Information:

• Device Name: NIHON KOHDEN ECG-9320A Cardiofax (Electrocardiograph/Cardiograph)
• Intended Use: To process electrical signals from ECG electrodes, produce a visual display, and record electrical signals from the heart.
• Classification: Class II device, under 21 CFR Part 870.2340 "Electrocardiograph."
• Predicate Devices:
  • Nihon Kohden Cardiofax, ECG-8340A Electrocardiograph (K865032)
  • Hewlett-Packard M1700A PageWriter XLi Cardiograph (K895520)
• Testing: Subject to electromagnetic, environmental, safety, and performance testing. Software validation tested acquisition, processing, displaying, and recording functions.
• Conclusion: Nihon Kohden believes the ECG-9320A Cardiofax is substantially equivalent to its predicate devices based on the testing.

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Answer to Your Specific Questions (Based on the provided document):

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

   • Acceptance Criteria: The document states that the device was subject to "electromagnetic, environmental, safety and performance testing procedures" and "Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of all functions of the device." However, the specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy, error rates, measurement tolerances for ECG parameters) are not detailed in this summary.
   • Reported Device Performance: The document only states, "The results confirmed that the device performed within specifications." No specific performance metrics or results are reported within this summary.

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

   • Not provided. The document does not describe a clinical test set or any patient data used for evaluation. The testing described appears to be technical/engineering validation of device functionality, not a clinical performance study using patient ECG data.

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 provided. Since no specific clinical test set or ground truth establishment process is mentioned, there's no information about experts.

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

   • Not applicable/Not provided. No clinical test set or adjudication process is mentioned.

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:

   • Not applicable/Not provided. This document describes an Electrocardiograph (ECG) device, which acquires and displays ECG waveforms. It does not mention any Artificial Intelligence (AI) components, interpretation algorithms, or human-in-the-loop performance evaluation. The device's function is presented as a signal acquisition and display tool.

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

   • Not applicable/Not provided. As stated above, no AI or automated interpretation algorithm performance is mentioned or evaluated in this summary. The "software validation" referred to is about the basic operational functions of acquiring, processing, displaying, and recording, not clinical interpretation.

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

   • Not applicable/Not provided. No clinical ground truth is described, as the testing mentioned is more aligned with engineering and software functionality validation.

8. The sample size for the training set:

   • Not applicable/Not provided. There is no mention of a training set, as there is no AI or interpretation algorithm discussed.

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

   • Not applicable/Not provided. No training set or associated ground truth establishment is mentioned.

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Conclusion:

This 510(k) summary is for a traditional electrocardiograph device, focusing on its functional equivalence to existing devices. It does not provide information related to the performance of any diagnostic algorithms, AI capabilities, or detailed clinical study results typical for devices with interpretive functions. The "performance testing" referenced is likely related to electrical safety, signal integrity, and basic device operation, rather than clinical diagnostic accuracy against a defined ground truth.

Summary

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NIHON KOHDEN AMERICA, INC. April 1, 1996

510(k) NOTIFICATION ECG-9320A CARDIOFAX

NOV - 1 1996

SECTION 2 - 510(K) SUMMARY

K9612722

Name and Address of Applicant Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92715-1601

Contact Person and Telephone Mr. Gary Reasoner Director of Technical Operations [phone] ext. 3387

The device has been classified as Class II by the Division of Cardiovascular. Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per part 74 DPS, 21 CFR.

Common names for the ECG-9320A Cardiofax device include electrocardiograph and Cardiograph.

The predicate devices are the Nihon Kohden Cardiofax, ECG-8340A Electrocardiograph per 510(k) #K865032, commercial distribution certification dated March 10, 1987 and the Hewlett-Packard M1700A PageWriter XLi Cardiograph per 510(k) #K895520, commercial distribution certification dated July 17, 1990

Nihon Kohden's Cardiofax, model number ECG-9320A, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart. This product will be available for use by a physician within the hospital, laboratory, clinic or in a remote environment under the direct supervision of a physician.

To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861.

The ECG-9320A Cardiofax 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 functions of acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.

Therefore based on the above, Nihon Kohden believes that the ECG-9320A Cardiofax is substantially equivalent to the Nihon Kohden ECG-8340A Cardiofax and the Hewlett-Packard M1700A PageWriter XLi cardiograph.

Regulation Number and Section

N/A