(238 days)
No
The description details a rule-based algorithm using specific ECG features (RR irregularity, PR interval variability, P wave variability) to detect AF, without mentioning AI or ML techniques.
No.
The device is a diagnostic tool that detects atrial fibrillation based on ECG data; it does not provide any treatment or therapy.
Yes
The device is intended to detect the presence of atrial fibrillation (AF) by processing ECG data, which is a diagnostic function.
Yes
The device is described as "QP-039P software" and its function is to process ECG data to detect AF. It is explicitly stated to be "Modular" and used as an "accessory to Patient Monitoring Devices (Host Devices)", indicating it is a software component that integrates with existing hardware, not a standalone hardware device itself. The description focuses solely on the software's algorithms and data processing capabilities.
Based on the provided information, the QP-039P software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- QP-039P Function: The QP-039P software analyzes ECG signals directly from the patient. ECG is a measurement of electrical activity of the heart, not a specimen derived from the body.
- Intended Use: The intended use is to detect atrial fibrillation based on ECG data, which is a physiological measurement, not an analysis of a biological specimen.
Therefore, the QP-039P software falls under the category of a medical device that processes physiological signals, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Afib detection program (QP-039P software) is used for processing adult patient if atrial fibrillation (AF) is present continuously for more than 2.5 minutes. QP-039P software is intended to be used by qualified health care professionals in hospital or clinical environment.
Product codes
DSI
Device Description
QP-039P is the atrial fibrillation (AF) processing software is intended to detect AF using patient's ECG. The Software is "Modular" and is to be used as an accessory to Patient Monitoring Devices (Host Devices). The software has a specific function to detect AF using RR interval and P wave and provides the result of atrial fibrillation detection to other software modules (See Figure1-1).
AF detection is performed using both the RR intervals and the P waves of input ECG. More precisely, the algorithm uses three features of input ECG to output AF detection result; RR irregularity, PR interval variability, and P wave variability.
The software detects if atrial fibrillation (AF) is present or not by 2 minutes of analysis at the earliest, and notifies AF presence every time it is detected.
Functionality shall include:
- QP-039P receives RR intervals and ECG wave from other software modules.
- QP-039P detects AF using three features for AF detection which are derived from input data, including RR irregularity, PR interval variability, and P wave variability.
- QP-039P provides that AF is present or not to other software modules.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ECG
Anatomical Site
Not Found
Indicated Patient Age Range
adult patient
Intended User / Care Setting
qualified health care professionals in hospital or clinical environment.
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
Performance testing for the QP-039P includes software verification tests, system validation testing, and testing to compliance standards. Traceability has been documented between all system specifications to validation test protocols.
Standards testing includes:
- AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms
- IEC 62304 First Edition 2006-05, Medical Device Software Software Life Cycle Processes
Verification and validation testing includes: - Code inspections
- Unit level testing
- Integration level testing
- System level testing
- ECG waveform database testing
Summary of key tests:
- Code inspections: The review that checking whether the program was implemented as it was designed. Results: Pass
- Unit level testing: Unit level testing tests that all software units perform those intended function. It is checked that software unit outputs intended value depending on input value. And it is checked that software unit performs according to design with executing step by step. Results: Pass
- Integration level testing: Integration level testing tests that transfer of data and control among software units and software items. It is checked that integrated software outputs intended value depending on input value. Results: Pass
- System level testing: Comprehensive testing of the functional requirements in the required hardware platforms described in SRS, version 01-01. Results: Pass
- ECG waveform database testing: Comprehensive testing of the performance requirements described in SRS, version 01-01. Results: Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Nihon Kohden Corporation % Thomas Bento Senior Vice President of OA/RA Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618
Re: K152305
Trade/Device Name: Nihon Kohden Afib Detection Program QP-039P Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: March 9, 2016 Received: March 11, 2016
Dear Thomas Bento:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152305
Device Name
Nihon Kohden Afib Detection Program QP-039P
Indications for Use (Describe)
The intended use of Afib detection program (QP-039P software) is used for processing adult patient if atrial fibrillation (AF) is present continuously for more than 2.5 minutes. QP-039P software is intended to be used by qualified health care professionals in hospital or clinical environment.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary for Nihon Kohden QP-039P Afib Detection Program
| Submitter:
Address: | Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-ku
Tokyo, JAPAN 161-8560 |
|------------------------|--------------------------------------------------------------------------------------|
| Phone number: | (949) 268-7708 |
| Fax number: | (949) 580-1550 |
| Contact person: | Tom Bento |
| Phone number: | (949) 268-7708 |
| Fax number: | (949) 580-1550 |
| Date prepared: | August 05, 2015 |
| Device name: | Afib Detection Program QP-039P |
| Common name: | Arrhythmia detector |
| Product Code: | DSI |
| Regulation: | 21 CFR 870.1025 |
Substantial equivalence claimed to: K964122 HP STAR ST and Arryhythmia Software which is the sponsor and primary predicate device and K080461 Philips Star ST and Arrhythmia Software as the reference predicate device which includes the Atrial Fibrillation detection that our device is claiming substantial equivalence to.
Description:
The following section provides an overview of QP-039P features that are controlled by software, and the intended operational environment.
QP-039P is the atrial fibrillation (AF) processing software is intended to detect AF using patient's ECG. The Software is "Modular" and is to be used as an accessory to Patient Monitoring Devices (Host Devices). The software has a specific function to detect AF using RR interval and P wave and provides the result of atrial fibrillation detection to other software modules (See Figure1-1).
AF detection is performed using both the RR intervals and the P waves of input ECG. More precisely, the algorithm uses three features of input ECG to output AF detection result; RR irregularity, PR interval variability, and P wave variability.
The software detects if atrial fibrillation (AF) is present or not by 2 minutes of analysis at the earliest, and notifies AF presence every time it is detected.
Functionality shall include:
-
- QP-039P receives RR intervals and ECG wave from other software modules.
-
- QP-039P detects AF using three features for AF detection which are derived from input data, including RR irregularity, PR interval variability, and P wave variability.
-
- QP-039P provides that AF is present or not to other software modules.
4
Figure 1-1 Relations of QP-039P and other software modules and hardware devices in the host device
Indications for Use:
The intended use of Afib detection program (QP-039P software) is used for processing adult patient ECG and detecting if atrial fibrillation (AF) is present continuously for more than 2.5 minutes. QP-039P software is intended to be used by qualified health care professionals in hospital or clinical environment.
Technological Characteristics - Substantial Equivalence Discussion
The Afib Detection Program QP-039P is substantially equivalent to the predicate device, Philips STAR (K080461). Differences between the devices are minor and do not raise questions regarding safety or efficacy. Minor differences in the performance between the two devices are explained below.
-
- Indications for Use: The QP-039P does not have all the features of the predicate device and only references the features relating to detecting atrial fibrillation.
Test Summary
Performance testing for the QP-039P includes software verification tests, system validation testing, and testing to compliance standards. Traceability has been documented between all system specifications to validation test protocols.
Standards testing includes:
-
- AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms
5
-
- IEC 62304 First Edition 2006-05, Medical Device Software Software Life Cycle Processes
Verification and validation testing includes:
- IEC 62304 First Edition 2006-05, Medical Device Software Software Life Cycle Processes
-
- Code inspections
-
- Unit level testing
-
- Integration level testing
-
- System level testing
-
- ECG waveform database testing
6
1.1. Test Summaries for Selective Tests
The following table provides a summary of the key tests performed to demonstrate proper functional operation, correct implementation of risk control measures, and support substantial equivalence of the Afib detection program QP-039P.
| Protocol | Summary | Results | Protocol/
Report No. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------------|
| Code inspections | The review that checking whether the
program was implemented as it was
designed. | Pass | See V&V Report
A701-033701
A701-033753
A701-033977 |
| Unit level testing | Unit level testing tests that all software
units perform those intended function. It is
checked that software unit outputs
intended value depending on input value.
And it is checked that software unit
performs according to design with
executing step by step. | Pass | See V&V Report |
| Integration level
testing | Integration level testing tests that transfer
of data and control among software units
and software items. It is checked that
integrated software outputs intended
value depending on input value. | Pass | See V&V Report
A276-006524 |
| System level testing | Comprehensive testing of the functional
requirements in the required hardware
platforms described in SRS, version 01-
01 | Pass | See V&V Report
A277-004317 |
| ECG waveform
database testing | Comprehensive testing of the
performance requirements described in
SRS, version 01-01 | Pass | See V&V Report
A152-009761 |
Conclusion:
The performance of the Afib Detection Program QP-039P is substantially equivalent to the sponsor and primary predicate device, HP STAR ST and Arryhythmia Software (K964122) and the reference predicate device the Philips Star ST and Arrhythmia Software (K080461). The QP-039P raises no safety or effectiveness issues and performs as well or better than the predicate devices.