(21 days)
None
No
The summary describes standard ECG processing and reporting functionalities without mentioning AI or ML. The "auto recording" and "automatically measure" features are likely based on pre-programmed algorithms, not learning models.
No
The device is described as an exercise test option for an electrocardiograph, which processes electrical signals to display and record heart activity, indicating a diagnostic rather than therapeutic purpose.
Yes
The device processes electrical signals from the heart to produce a visual display and record, and it develops a report based on acquired data and calculations, which are used to manage and evaluate exercise testing for medical purposes. This falls under the definition of a diagnostic device as it aids in identifying or monitoring medical conditions.
No
The device description explicitly states that the QP-156E is an "optional accessory" for the ECG-1500A Series or Cardiofax V Electrocardiograph, and the software is "installed into" these hardware devices. The performance studies also include environmental and safety testing typically associated with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart." This describes a device that measures and records physiological signals directly from the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The device description reinforces that it's an accessory for an electrocardiograph, which is a device used for measuring electrical activity of the heart in vivo (within the living body).
- Lack of Mention of Samples: There is no mention of the device analyzing any samples taken from the patient.
Therefore, the QP-156E Exercise Test Option with its parent device is a medical device used for in vivo measurement of cardiac electrical activity, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The QP-156E Exercise Test Option with its parent device, the Nihon Kohden ECG-1500A Series/Cardiofax V Electrocardiograph, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-156E will develop a report based upon acquired data and subsequent calculations.
Product codes
DPS
Device Description
The QP-156E Exercise Test Option is an optional accessory for the Nihon Kohden ECG-1500A Series or Cardiofax V Electrocardiograph. The QP-156E exercise test software is installed into an ECG-1500A Series or Cardiofax V Electrocardiograph, it can manage exercise testing, perform auto recording and automatically measure heart rate and ST level. After exercise testing, QP-156E can also print a final report and save the examination data in the memory, or in an optional memory card or diskette, or transfer it to other external instruments. The product is similar to Nihon Kohden predicate device QP-932E Exercise Test Option and it provides setting items and protocol settings that can be changed in the system setting screen. You can use an ergometer and treadmill for exercise stress testing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The ECG-1500A Series/Cardiofax V Electrocardiograph with QP-156E Exercise Test Option will be available for use by a physician within a hospital, laboratory, clinic or in a remote environment under the supervision of a physician.
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)
Performance Testing
- The device is not sterile.
- The device was subject to environmental testing including vibration, impact and drop test. EMC testing, including EMI, electrostatic, emission immunity, burst, conductive immunity, voltage dip, commercial frequency magnetic field and attachment document. Safety testing, including labeling, temperature rise, power input, protection against defibrillation discharge, electrical separation, ground resistance, humidity, withstanding voltage, leakage current, deflection, sharp edge, power interruption, creepage distance and air clearance were conducted. See Attachment 8.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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, INC.
510(k) NOTIFICATION OP-156E Exercise Test Software
SECTION 2- 510(K) SUMMARY
Name and Address of Applicant
Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610
AUG 1 7 2007 Contact: Jack Coggan Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550
The QP-156E Exercise Test Option is an optional accessory for the Nihon Kohden ECG-1500A Series or Cardiofax V Electrocardiograph, per 510(k) K052511, commercial distribution certification dated May 24, 2006. 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.
- Common or usual Name: Electrocardiograph/ECG .
- Legally Marketed Predicate: Nihon Kohden OP-932E ECG Exercise Test . Option, 510(k): K972310 commercial distribution certification dated August 20, 1997 for ECG-9320A Cardiofax Electrocardiograph per 510(k) K961272 commercial distribution certification dated November 1, 1996.
Description and Intended Use: The QP-156E Exercise Test Option with its parent device, the Nihon Kohden ECG-1500A Series or Cardiofax V Electrocardiograph, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-156E will develop a report based upon acquired data and subsequent calculations. The ECG-1500A Series or Cardiofax V with OP-156E Exercise Test Option will be available for use by a physician within a hospital, laboratory, and clinic or in a remote environment under the supervision of a physician.
A summary of the technological characteristics of the device compared to the predicate device: The QP-156E exercise test software is installed into an ECG-1500A Series or Cardiofax V Electrocardiograph, it can manage exercise testing, perform auto recording and automatically measure heart rate and ST level. After exercise testing, QP-156E can also print a final report and save the examination data in the memory, or in an optional memory card or diskette, or transfer it to other external instruments. The product is similar to Nihon Kohden predicate device QP-932E Exercise Test Option and it provides setting items and protocol settings that can be changed in the system setting screen. You can use an ergometer and treadmill for exercise stress testing. See attachment # 5 for comparison of the QP-156E and QP-932E Exercise Test Options.
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772660 p2/2
Performance Testing
- The device is not sterile. .
- The device was subject to environmental testing including vibration, impact and . drop test. EMC testing, including EMI, electrostatic, emission immunity, burst, conductive immunity, voltage dip, commercial frequency magnetic field and attachment document. Safety testing, including labeling, temperature rise, power input, protection against defibrillation discharge, electrical separation, ground resistance, humidity, withstanding voltage, leakage current, deflection, sharp edge, power interruption, creepage distance and air clearance were conducted. See Attachment 8.
There are no significant changes in function, performance or manufacturability compared to the predicate device that would affect the safety and effectiveness of the device as intended for use. Therefore, Nihon Kohden believes that the device is substantially equivalent to the predicate device.
2
Public Health Service
Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2007
Nihon Kohden America, Inc. c/o Mr. Jack Coggan Regulatory Affairs Director 90 Icon Street Foothill Ranch, CA 92610
Re: K072060
QP-156E Exercise Test Software Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: Undated Received: July 27, 2007
Dear Mr. Coggan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Jack Coggan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 comply 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter 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 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), please contact the Office of Compliance at (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bfimmmer for
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NIHON KOHDEN AMERICA, INC.
510(k) NOTIFICATION QP-156E Exercise Test Software
Indications for Use Statement: G.
K072060 510(K) Number (if known):
Device Name: 1 QP-156E Exercise Test Software
Indications for Use:
The QP-156E Exercise Test Option with its parent device, the Nihon Kohden ECG-1500A Series/Cardiofax V Electrocardiograph, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-156E will develop a report based upon acquired data and subsequent calculations.
The ECG-1500A Series/Cardiofax V Electrocardiograph with QP-156E Exercise Test Option will be available for use by a physician within a hospital, laboratory, clinic or in a remote environment under the supervision of a physician.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELQW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Blumeno
Division of Cardiove 510(k) Number
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
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