(21 days)
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.
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 provided text describes a 510(k) notification for the NIHON KOHDEN AMERICA, INC. QP-156E Exercise Test Software. However, it does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or most of the requested fields.
The document states that 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," and therefore, "Nihon Kohden believes that the device is substantially equivalent to the predicate device." This suggests that the performance expectations for the QP-156E are aligned with its predicate, the Nihon Kohden OP-932E ECG Exercise Test Option.
Here's a breakdown based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or corresponding reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) are explicitly stated in the provided text. The document focuses on performance testing related to environmental, EMC, and safety standards, rather than clinical performance or diagnostic accuracy.
The relevant section states: "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."
This implies that the device is expected to perform at a level comparable to its predicate device, but no quantitative performance data is provided to demonstrate this.
2. Sample Size Used for the Test Set and Data Provenance
Not mentioned in the provided text. The document describes environmental, EMC, and safety testing but does not detail any clinical test set, sample size, or data provenance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not mentioned in the provided text. No information is given about experts or ground truth establishment for any clinical performance evaluation.
4. Adjudication Method for the Test Set
Not mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned in the provided text. There is no indication of an MRMC study or any assessment of human reader improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Not mentioned in the provided text. The document does not describe a standalone performance study for the algorithm's clinical capabilities. The "performance testing" mentioned refers to non-clinical aspects like environmental, EMC, and safety testing.
7. Type of Ground Truth Used
Not mentioned in the provided text. Due to the lack of clinical performance study details, the type of ground truth is not specified.
8. Sample Size for the Training Set
Not mentioned in the provided text. This device is an "Exercise Test Software" and likely relies on established algorithms for ECG analysis rather than recent machine learning models that require large training datasets in the conventional sense. The document does not provide details of any such training set.
9. How Ground Truth for the Training Set Was Established
Not mentioned in the provided text.
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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.
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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.
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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
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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)
Page 8 of 20
§ 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).