The HEMOCHRON® Signature+ is a portable, battery-operated point of care microcoagulation instrument designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. Whole blood test results are displayed as clotting times (in seconds). The Signature+ also displays correlated Celite® equivalent ACT values, APTT and PT plasma equivalent values, and the PT INR value. For In Vitro Diagnostic Use Only

Device Description

The Hemochron Jr. Signature + instrument is an upgrade to the current Hemochron Jr. Signature instrument cleared under K974799 (July 1998). The HEMOCHRON® Signature+ is a portable, battery-operated point of care microcoagulation instrument designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. The Signature Plus instrument performs the same assays as the predicate instrument. There are no modifications to the clot detection algorithm. The Signature Plus instrument employs the same clot detection mechanism as the predicate Signature. The clot detection mechanism is a combination mechanical-optical system. Blood is placed in a collection reservoir of a test cuvette and subsequently drawn into the test channel of the cuvette, which contains the reagent required to perform the respective coagulation assay. As blood is actively pumped back and forth in the test channel, LED detectors measure the position of the blood. As clotting begins to occur, the movement of the blood decreases below a pre-determined rate where the endpoint is recorded. The HEMOCHRON® Signature+ provides data management capabilities including the following: Patient and quality control result storage, Input of operator and patient identification, Designation of quality control level, Date and time stamp for all test results, Printer access, Tests performed are tracked by test type and quality control failures. The HEMOCHRON® Signature+ Configuration Manager (HCM) is a Windows-based software application. With this software, the Point-of-Care Coordinator (POCC) or Supervisor, may configure the HEMOCHRON® Signature+ to meet the needs of the clinical setting. The functionality addressed with the Configuration Manager allows the POCC to set mandatory requirements for the input of operator and patient identifications, set limitations for liquid and electronic quality control, can prohibit operators from erasing database information or changing time/date settings. The POCC may also use the HCM to load predetermined notes (up to nine notes) into the Signature+ instrument that may be appended to the patient or quality control test. The HCM may be used to synchronize several HEMOCHRON® Signature+ instruments to the same requirements via the PC connection. The modifications to the Hemochron Jr. Signature+ system include a software revision to the instrument, which allows for enhanced programming capability and flexibility for the user through the use of the Hemochron Configuration Manager (HCM Application Software), which is provided to the user for use in a Personal Computer (PC). Accessing the PC interface is accomplished through the use of special hot keys on the instrument, which enables the user to interact with the instrument database and the HCM. The Signature + software modifications allow the user many additional programmable features. The user interface for the clinician remains consistent with the previously cleared system with the exception of the enhanced features described in the revised operators manual including the features associated with the (HCM).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Hemochron® Jr. Signature +, based on the provided 510(k) summary:

The provided document is a 510(k) summary for a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with specific acceptance criteria and performance data in the format requested. Therefore, some requested categories (like statistical significance, multi-reader multi-case studies, and detailed ground truth establishment for a training set) are not applicable or not provided in this type of document.

Acceptance Criteria and Device Performance (Not explicitly stated as criteria in this document, but implied by the comparison to the predicate device)

The 510(k) summary focuses on demonstrating substantial equivalence by stating that the Hemochron® Jr. Signature + performs the same assays with the same clot detection algorithm as its predicate device (Hemochron Jr. Signature, K974799). The "acceptance criteria" are implicitly met if the new device functions identically in its core measurement capabilities to the previously cleared predicate.

Acceptance Criteria Category (Implied)	Reported Device Performance
Maintenance of Core Functionality	Performs the same assays as the predicate instrument (ACT-LR, ACT+, APTT, PT).
Clot Detection Algorithm Equivalence	No modifications to the clot detection algorithm. Employs the same clot detection mechanism (combination mechanical-optical system).
Test Result Units	Displays clotting times (seconds), correlated Celite® equivalent ACT, APTT and PT plasma equivalent values, and PT INR value. (Same as predicate, implied).
Intended Use	Portable, battery-operated point of care microcoagulation instrument for whole blood coagulation tests using fresh or citrated whole blood. (Same as predicate, implied).

Additional Study Information:

Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document focuses on the technological changes (software upgrade and improved PC interface) and states that the core coagulation measurement algorithms and mechanisms are unchanged from the predicate device. Therefore, new clinical performance data for coagulation measurements would likely not have been generated for this 510(k). The focus is on demonstrating that the modifications do not adversely affect safety or effectiveness.
- Data Provenance: Not provided, as detailed clinical efficacy data is not the primary subject of this 510(k) for a software upgrade.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as detailed clinical test set data with expert-established ground truth is not presented in this 510(k) summary for a software upgrade. The device measures coagulation times, which are typically compared against established laboratory methods or reference values, not expert interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The device measures objective clotting times, not subjective interpretations requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a point-of-care coagulation instrument, not an AI-assisted diagnostic imaging or interpretation system. "Human readers" in the context of diagnostic interpretation are not involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device inherently operates as a standalone instrument for measuring coagulation times. Its "algorithm only" performance is its primary function. The 510(k) states that there are "no modifications to the clot detection algorithm" and it "employs the same clot detection mechanism" as the predicate. This implies that the standalone performance is considered equivalent to the predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For coagulation tests, the "ground truth" would typically be established through comparison with established laboratory reference methods (e.g., standard plasma APTT or PT assays performed in a central lab), or potentially through the use of calibrated control materials. This 510(k) does not provide specific data on how the original ground truth for the predicate device's accuracy was established, and for the upgraded device, it relies on the predicate's established performance.
The sample size for the training set
- Not applicable. This is a 510(k) for a physical instrument with a software upgrade, not a machine learning or AI algorithm development that typically involves a distinct training set. The "software revision" is for "enhanced programming capability and flexibility for the user," and "data management capabilities."
How the ground truth for the training set was established
- Not applicable, for the same reasons as #7.

Summary

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INTERNATIONAL

MAR 2 8 2002

CORPORATION

510 (k) Summary

Hemochron® Jr. Signature +

This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K020798

Prepared: March 6, 2002

John Clay Submitted by: International Technidyne Corp. 6 Olsen Ave. Edison, NJ 08820 (732-548-5700) Ext. 265 (732-548-2325) Fax

Device Name

Common / Usual Name:	Whole Blood Microcoagulation Test System
Product Name:	HEMOCHRON® Jr. Signature +

Predicate Device

The Signature+ is substantially equivalent to the previously cleared Hemochron Jr. Signature instrument K974799.

Device Description and Technological Characteristics

The Hemochron Jr. Signature + instrument is an upgrade to the current Hemochron Jr. Signature instrument cleared under K974799 (July 1998).

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The Signature Plus instrument performs the same assays as the predicate instrument. There are no modifications to the clot detection algorithm. The tests performed are the following:

Test Assay	Application	Display Units	Result	Equivalent UnitsConverted*
ACT-LR	Low Dose Heparin	ClottingSeconds	Time	Hemochron CeliteACT
ACT+	High Dose Heparin	ClottingSeconds	Time	Hemochron CeliteACT
APTT(fresh or citratedblood)	Low Dose HeparinCoagulationScreening	ClottingSeconds	Time	Plasma APTT
PT(fresh or citratedblood)	WarfarinMonitoriingCoagulationScreening	ClottingSecondsINR	Time	Plasma PT

Converted equivalent units represent standard clinical terms.

The Signature Plus instrument employs the same clot detection mechanism as the predicate Signature. The clot detection mechanism is a combination mechanical-optical system. Blood is placed in a collection reservoir of a test cuvette and subsequently drawn into the test channel of the cuvette, which contains the reagent required to perform the respective coagulation assay. As blood is actively pumped back and forth in the test channel, LED detectors measure the position of the blood. As clotting begins to occur, the movement of the blood decreases below a pre-determined rate where the endpoint is recorded.

The HEMOCHRON® Signature+ provides data management capabilities including the following:

Patient and quality control result storage .
Input of operator and patient identification
Designation of quality control level .
Date and time stamp for all test results .
Printer access .
Tests performed are tracked by test type and quality control failures

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The HEMOCHRON® Signature+ Configuration Manager (HCM) is a Windows-based software application. With this software, the Point-of-Care Coordinator (POCC) or Supervisor, may configure the HEMOCHRON® Signature+ to meet the needs of the clinical setting. The functionality addressed with the Configuration Manager allows the POCC to set mandatory requirements for the input of operator and patient identifications, set limitations for liquid and electronic quality control, can prohibit operators from erasing database information or changing time/date settings. The POCC may also use the HCM to load predetermined notes (up to nine notes) into the Signature+ instrument that may be appended to the patient or quality control test. The HCM may be used to synchronize several HEMOCHRON® Signature+ instruments to the same requirements via the PC connection.

New Features of the Hemochron Jr. Signature + Instrument

The modifications to the Hemochron Jr. Signature+ system include a software revision to the instrument, which allows for enhanced programming capability and flexibility for the user through the use of the Hemochron Configuration Manager (HCM Application Software), which is provided to the user for use in a Personal Computer (PC). These features have been described in the predicate device submission (K974799).

As described in that previous 510K, the interface between the Hemochron Jr. Signature and the PC required the use of a special cuvette, called the Commander Cuvette. The new Signature + software enables the activation of the PC interface software without using the Commander Cuvette. Accessing the PC interface is accomplished through the use of special hot keys on the instrument, which enables the user to interact with the instrument database and the HCM. The Signature + software modifications allow the user many additional programmable features.

The user interface for the clinician remains consistent with the previously cleared system with the exception of the enhanced features described in the revised operators manual including the features associated with the (HCM).

Statement of Intended Use

For In Vitro Diagnostic Use Only

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle are three stylized human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white.

MAR 2 8 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John Clay Director, Regulatory Affairs International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820

Re: K020798

Trade/Device Name: HEMOCHRON® Jr. Signature + Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Instruments Regulatory Class: II Product Code: JPA Dated: March 11, 2002 Received: March 12, 2002

Dear Mr. Clay:

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.

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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/cdrh/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

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510(k) Number (If Known):

Device Name: HEMOCHRON® Jr. Signature + Indications for Use:

The HEMOCHRON® Signature+ is a portable, battery-operated point of care microcoagulation I he HEMOCHKON "Signature" is a perform whole blood coagulation tests using fresh or whole blood.
Instrument designed to perform whole blood coagulation tests using fresh or instrument designed to perform whole onlou ocusetings requiring point-of-care testing. Whole The system is intended for use in many of times (in seconds). The Signaturet also displays blood test results are usplayed as cloting thires (in escollasma equivalent values, and the PT INR value.

K020798

For In Vitro Diagnostic Use Only

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K020798

Prescription Use Per 21 CFR 801.109 Over- the- Counter Use _______________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.