The Harmony INR Monitoring System is indicated for the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.

Device Description

The Harmony System consists of a meter and test strip. When a drop of blood is placed on the test strip, the blood is drawn into the reaction cells and mixed with reagents that cause blood clotting to begin. The meter monitors the blood clotting process by passing a light beam through the blood sample being tested. The meter detects blood clot formation and, at the conclusion of the test, the prothrombin time is displayed in International Normalized Ratio (INR) units.

AI/ML Overview

Here's an analysis of the provided text regarding the Harmony™ INR Monitoring System, focusing on acceptance criteria and the supporting study:

The provided text contains very limited information regarding detailed acceptance criteria and the specifics of the performance study. It states that "The study conducted to compare equivalency of the Rubicon 510(k) cleared device to the modified Harmony System met the performance requirements for accuracy and precision relative to the reference laboratory system." However, it does not explicitly list those performance requirements (acceptance criteria) or provide the detailed results that would allow for a table comparing them to the device's reported performance.

Therefore, many sections of your request cannot be fully answered based only on the provided text.

Here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy	Met performance requirements relative to the reference laboratory system (specific criterion not provided)
Precision	Met performance requirements relative to the reference laboratory system (specific criterion not provided)
Equivalency to Predicate	Determined to be equivalent in meeting user requirements

Note: The specific numerical or qualitative acceptance criteria for accuracy and precision are not detailed in the provided document.

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

Sample Size: Not specified. The document only mentions "The study conducted to compare equivalency..." without detailing the number of participants or samples.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

Not specified. The document refers to a "reference laboratory system" for comparison, implying expert-derived ground truth, but gives no details about the number or qualifications of experts.

4. Adjudication Method for the Test Set

Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, this was not an MRMC comparative effectiveness study in the context of human readers improving with AI. This is a point-of-care device for measuring INR, not an AI or imaging diagnostic tool that would typically involve human reader improvement. The study was a comparison of the Harmony system to a predicate device and a reference laboratory system.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Yes, implicitly. The "Performance Testing" section states, "The study conducted to compare equivalency... met the performance requirements for accuracy and precision relative to the reference laboratory system." This refers to the device (meter and test strip) performing the measurement and generating the INR result, which is a standalone performance by the device's inherent mechanisms. There isn't a separate "algorithm" in the sense of a machine learning model, but rather the device's electrochemical and optical detection system.

7. The Type of Ground Truth Used

Reference Laboratory System: The performance of the Harmony device was compared to a "reference laboratory system." This typically implies a highly accurate and precise laboratory method for measuring INR, often considered the gold standard for clinical ground truth in this context.

8. The Sample Size for the Training Set

Not applicable/Not specified. This device is not an AI/machine learning system that requires a separate "training set" in the conventional sense. Its "training" would be its design, calibration during manufacturing, and internal parameters, which are not learned from data in the same way an AI model is.

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

Not applicable/Not specified as there is no "training set" in the context of an AI model for this device. Its inherent performance is based on its physical/chemical design and calibration.

Summary of Limitations Based on Provided Text:

The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device and broadly states that performance requirements for accuracy and precision were met. It does not delve into the detailed methodology, specific acceptance criteria values, sample sizes, or expert involvement in the way a scientific publication or a more detailed technical report would. This level of detail is often contained within the full 510(k) submission, which is not fully provided here.

Summary

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

Convenience. Confidence. Control.

Johnson+Johnson company

SEP 3 0 2002

510(k) Summary

LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

Tel 408 263.9789 Fax 408 946.6070 www.LifeScan.com

Submitted By:	LifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035(408) 942-5903(408) 942-5606 (fax)
Contact:	John E. Hughes
Date of Preparation:	September 3, 2002
Establishment RegistrationNo:	2939301
Device Name:	Harmony™ INR Monitoring System
Common/ClassificationName:	Prothrombin Time Test
Device Classification:	Class II
Regulation Number:	CFR 864.7750
Classification Panel:	Hematology
Product Code:	GJS
Predicate Device:	Rubicon™ Prothrombin Time Monitoring SystemK001699

Device Description:

Intended Use:

For the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.

LifeScan, Inc. Harmony ™ INR Monitoring System 510(k) Summary

{1}------------------------------------------------

Comparison to Predicate Device:

The Harmony INR Monitoring System and the Rubicon Prothrombin Time Monitoring System both consist of a meter and disposable test strip. Both systems employ whole blood as a test sample and can be used by laypersons in the home environment to monitor oral anti-coagulation therapy. Both employ thromboplastin to cause blood coagulation.

The systems differ in that the Harmony System has been enhanced by reducing the number of calibration codes required which makes the product simpler to use. In addition, an active use confirmation was added to ensure the integrity of the LCD display prior to each use.

Environmental and Non-Clinical Testing:

Applicable environmental and non-clinical testing was performed per IEC 60601 and other applicable standards and procedures. The Harmony INR Monitoring System passed all tests.

Performance Testing:

The study conducted to compare equivalency of the Rubicon 510(k) cleared device to the modified Harmony System met the performance requirements for accuracy and precision relative to the reference laboratory system. Equivalent performance in meeting user requirements was determined.

Conclusion:

The test results demonstrate the Harmony INR Monitoring System is substantially equivalent to the Rubicon Prothrombin Time Monitoring System.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

SEP 3 0 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John E. Hughes Senior Manager, Regulatory Submissions LifeScan. Inc. 1000 Gibraltar Drive Milpitas, California 95035

Re: K022922

Trade/Device Name: Harmony™ INR Monitoring System Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: September 3, 2002 Received: September 4, 2002

Dear Mr. Hughes:

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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number:

K022923

Name:

Harmony™ INR Monitoring System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

Josephine Bautcher

(Division Sign-Off) (Division of Clinical Laboratory Devices 222922

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).