IMMEDIA PROTHROMBIN TIME SYSTEM by FARALLON MEDIAL INC

The Immedia System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood. It is intended for use by health care professional at the point of care to monitor patients who are on warfarin-type (coumarin) anticoagulation therapy. The device is not intended to be used for screening purposes.

Device Description

The Immedia™ Prothrombin Time System measures the Prothrombin Time (PT) of fresh capillary whole blood. The test is performed by inserting a test strip into the meter and applying a drop of blood to the sample receptacle of the test strip. The meter automatically performs the PT test and the result is displayed as International Normalized Ratio (INR) and seconds (PT). The meter automatically stores all test results in memory. The device is powered by batteries and/or AC adapter. The disposable strip contains a rotating, spoked wheel that draws the sample into the reaction well after it is applied to the sample receptacle. The spokes rotate across the path of an infrared light beam and mix the liquid sample with the thromboplastin which is dried in the reaction well. When the sample clots, the clot is picked up by the spokes, interrupting the path of the infrared light beam that is detected by the meter. A separate Calibration Strip is used for inputting the calibration data. High Control and Low Control Strips are also provided for quality control purposes.

AI/ML Overview

The provided text describes the Immedia Prothrombin Time System, a device for measuring Prothrombin Time (PT) and International Normalized Ratio (INR) in fresh capillary whole blood, intended for monitoring patients on warfarin-type anticoagulation therapy.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states the device was compared to the predicate device (Roche CoaguChek S) and a reference method, with the accuracy found to be "equivalent (r>0.90)." It also mentions that "Precision and linearity evaluations were performed on the Immedia device and the results were found to be acceptable." Specific numerical acceptance criteria for precision and linearity are not provided.

Metric	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Accuracy (r)	r > 0.90 (vs. predicate and reference)	r > 0.90 (found to be equivalent)
Precision	Acceptable (implied)	Acceptable
Linearity	Acceptable (implied)	Acceptable

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

Sample Size: Not explicitly stated in the provided text for the accuracy studies. The document only mentions "field studies."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The term "field studies" suggests prospective data collection in a real-world setting.

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

Not applicable. This device is an in-vitro diagnostic system that measures a physiological parameter (PT/INR) which typically has a gold standard measurement technique or a reference method. It does not rely on expert interpretation of images or other subjective data for ground truth establishment.

4. Adjudication Method:

Not applicable, as expert ground truth establishment is not relevant for this device.

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

Not applicable. This is an in-vitro diagnostic device that provides quantitative results, not an imaging device requiring human reader interpretation with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was done for the algorithm (device). The "Summary of performance data" section indicates that the accuracy, precision, and linearity of the Immedia device were evaluated independently. While the accuracy was compared to a predicate and reference method, the precision and linearity evaluations were performed on the Immedia device itself, implying standalone testing.

7. Type of Ground Truth Used:

The ground truth for the accuracy study was established by comparison to a reference method and the predicate device (Roche CoaguChek S). For precision and linearity, the ground truth would be statistical measures inherent to the device's ability to consistently and accurately measure across a range.

8. Sample Size for the Training Set:

Not applicable. This device is a measurement system and not described as using machine learning or AI that would require a "training set" in the conventional sense. Its performance is based on its mechanical, chemical, and optical design, not on a learned algorithm.

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

Not applicable, as no training set (in the AI/ML context) is mentioned or implied for this device.

Summary

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

K050293

JUN 6 - 2005

PREMARKET NOTIFICATION 510(k) Summary

According to the requirements of 21 CFR 807.92 the following information provides sufficient detail to understand the basis for determination of substantial equivalence

Farallon Medical Inc. 3521 Investment Blvd., Suite 1 Hayward, CA 94545 Phone: 510-785-0800 FAX: 510-785-0888

Contact person: Mr. James McKinley

Date Prepared: January 31, 2005

1. Device name:
1. Predicate device:
1. Device description:

Device Name: Immedia Prothrombin Time System Proprietary/Trade Name: Immedia Prothrombin Time System Common Name: Prothrombin Time Test

The Roche CoaguChek® system: Device for testing Prothrombin Time and INR in whole blood.

Introduction

Submitter's name,

address, contact:

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

The Immedia system is an in vitro diagnostics system that 5. Intended use: provides a quantitative ProthrombinTime test result for fresh capillary whole blood expressed in seconds and an international normalized ratio (INR). It is intended for use by health care professionals in monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy. This device is not intended to be used for screening purposes. The Immedia system is substantially equivalent in design, 6. Comparison to materials and intended use to other products that measure Predicate device Prothrombin Time in human blood. Most notably, it is substantially equivalent to the CoaguChek S®, manufactured by Roche Diagnostics. The accuracy of the Immedia device was compared to the 7. Summary of CoaguChek S and a reference method in field studies and performance data found to be equivalent (r>0.90). Precision and linearity evaluations were performed on the Immedia device and the results were found to be acceptable. Additional testing on
interfering substances, and hematocrit were performed and

the results are reflected in the product labeling

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

JUN 6 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James McKinley President and CEO Farallon Medical, Inc. 3521 Investement Boulevard Suite 1 Hayward, California 94545

Re: K050243 Trade/Device Name: Immedia Prothrombin Time System Regulation Number: 21 CFR § 864.5425 Regulation Name: System, multipurpose for in vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: May 2, 2005 Received: May 3, 2005

Dear Mr. McKinley:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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

Page 2 –

If you desire specific information about the application of labeling requirements to your device, IT you desire specific information as advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the Vitto Diagnostic Doved Drailand in reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may obtain of Schorar monitational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckeyh

Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K050243

Immedia Prothrombin Time System Device Name: _________________________________________________________________________________________________________________________________________________________________

The Immedia System is an in vitro diagnostic device that provides Indications For Use: quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood. It is intended for use by health care professional at the point of care to monitor patients who are on warfarin-type (coumarin) anticoagulation therapy. The device is not intended to be used for screening purposes.

Stephanic Bautista

Division/Sign Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) -

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.