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.

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:

1. QP-039P receives RR intervals and ECG wave from other software modules.
1. 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.
1. QP-039P provides that AF is present or not to other software modules.

AI/ML Overview

The Nihon Kohden Afib Detection Program QP-039P is software intended to detect atrial fibrillation (AF) continuously for more than 2.5 minutes in adult patients using their ECG.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity or specificity targets) for AF detection. However, it indicates comprehensive testing was performed to demonstrate "proper functional operation, correct implementation of risk control measures, and support substantial equivalence." The overall conclusion is that the device "performs as well or better than the predicate devices."

The document focuses on the type of tests conducted rather than specific quantitative performance metrics against predefined thresholds.

Acceptance Criteria (Inferred/General)	Reported Device Performance (General)
Proper functional operation	Pass (Code inspections, Unit level testing, Integration level testing, System level testing)
Correct implementation of risk control measures	Pass (Implied by overall V&V process)
Substantial equivalence to predicate devices	Pass (Conclusion based on all testing)
Performance as good as or better than predicate devices	Pass (Explicitly stated in conclusion)

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "ECG waveform database testing" but does not specify the sample size (number of patients or ECG recordings) used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth regarding AF presence in the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or detailed in the provided information. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The "ECG waveform database testing" would fall under standalone performance, as it tests the algorithm's detection capabilities against existing ECG waveforms with known conditions. The indications for use and description of the software as "detecting AF using patient's ECG" and "notifies AF presence every time it is detected" also confirm its standalone functionality.

7. Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the "ECG waveform database testing." Given the context of arrhythmia detection, it is highly likely that the ground truth within the ECG waveform database would have been established by expert review of the ECGs, but this is not explicitly confirmed.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It primarily focuses on the verification and validation of the device, implying that the algorithm development (training) phase occurred prior to these tests.

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary for Nihon Kohden QP-039P Afib Detection Program

Submitter:Address:	Nihon Kohden Corporation1-31-4 Nishiochiai, Shinjuku-kuTokyo, 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.

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:

1. QP-039P receives RR intervals and ECG wave from other software modules.
1. 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.
1. 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.

1. 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:

1. AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms

{5}------------------------------------------------

1. IEC 62304 First Edition 2006-05, Medical Device Software Software Life Cycle Processes
  Verification and validation testing includes:
1. Code inspections
1. Unit level testing
1. Integration level testing
1. System level testing
1. 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 theprogram was implemented as it wasdesigned.	Pass	See V&V ReportA701-033701A701-033753A701-033977
Unit level testing	Unit level testing tests that all softwareunits perform those intended function. It ischecked that software unit outputsintended value depending on input value.And it is checked that software unitperforms according to design withexecuting step by step.	Pass	See V&V Report
Integration leveltesting	Integration level testing tests that transferof data and control among software unitsand software items. It is checked thatintegrated software outputs intendedvalue depending on input value.	Pass	See V&V ReportA276-006524
System level testing	Comprehensive testing of the functionalrequirements in the required hardwareplatforms described in SRS, version 01-01	Pass	See V&V ReportA277-004317
ECG waveformdatabase testing	Comprehensive testing of theperformance requirements described inSRS, version 01-01	Pass	See V&V ReportA152-009761

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.

Regulation Number and Section

§ 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.