The HEMOCHRON® Signature Elite™ is a battery operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. The system is intended Incilitiation point coughtton toots of mare coagulation testing. Whole blood test results are displayed as clotting times (in seconds). The HEMOCHRON® Signature Elite™ also displays ulsplayed as clouing times (in socondo). The Hame equivalent values, and the PT INR value.

For in vitro Diagnostic Use Only

Device Description

The HEMOCHRON® Signature Elite™ Whole Blood Microcoagulation System is a batteryr ne real over to re in the nement that performs individual point-of-care coagulation tests on fresh or operated, norial morantents include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from ITC.

Data management capabilities are included with the instrument. These capabilities include Storage of up to 600 patient results and 600 quality control results, designation of quality control levels, tagging of test results with date and time, entry of Patient ID and/or Operator ID or levers, tagging of toot room and bate HEMOCHRON® Configuration Manager software is included with the instrument. This software allows the user to connect a personal computer to the included with the instrument. This octtivation functions using a Microsoft Windows® user interface. HEMOCHRON® ReportMaker" and idms " software which are provided separately, allow the user to connect a personal computer to the instrument and perform various data management and data reporting functions.

For in vitro Diagnostic Use

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative acceptance criteria for a new device. However, the core implication is that the HEMOCHRON® Signature Elite™ must perform equivalently to the HEMOCHRON® Jr. Signature+ in terms of coagulation test results.

Table 1: Implied Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Coagulation test results are substantially equivalent to the predicate device.	"All clinical and laboratory data demonstrate the substantial equivalence of the HEMOCHRON® Signature Elite™ instrument system to the predicate HEMOCHRON® Jr. Signature+ instrument system." This implies that the measurements (Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate)) taken by the new device were comparable to those taken by the predicate device.
User interface, data storage, and data manipulation functions are updated and improved.	The document explicitly states: "The submitted instrument design upgrades the user interface, data storage and data manipulation functions. The instrument provides a secondary information input pathway using a barcode/scanner in addition to manual keypad entry, and offers a larger capacity to store data."
User utility and ease of use are acceptable compared to the predicate device.	A "user-based evaluation of the clinical utility and ease of use of the instructional format displayed on the HEMOCHRON® Signature Elite™ instrument system when compared to the predicate HEMOCHRON® Jr. Signature+ instrument system was performed." The overall conclusion of substantial equivalence suggests this evaluation was favorable.
Technological aspects (reagent system, clot detection algorithms) are the same as predicate.	"It utilizes the same reagent system, the same closed end method and clot detection algorithms as the predicate device." This is a foundational aspect of claiming substantial equivalence.

Study Details for Substantial Equivalence:

The provided text describes studies conducted to demonstrate substantial equivalence, rather than a single study designed to meet specific new performance acceptance criteria.

Sample sizes used for the test set and the data provenance:
- Laboratory Comparison: "ITC whole blood control products for each currently 510(k) cleared assay for the HEMOCHRON® Jr. Signature+ instrument (predicate)." The exact number of samples or runs is not specified.
- Clinical Comparison: "split patient blood samples on the two instrument systems using each currently 510(k) cleared assay for the HEMOCHRON® Jr. Signature+ instrument system." The exact number of patient samples is not specified.
- Data Provenance: The studies appear to be internal laboratory and clinical comparisons to the predicate device, implying a retrospective (or at minimum, comparative) structure based on existing assays and clinical samples, likely conducted within the United States where ITC is based. No specific country of origin for the data is mentioned outside of the company's US location.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies are comparisons to a predicate device, and the "ground truth" for the predicate device's measurements would have been established during its own validation. For this submission, the predicate device itself serves as the reference point for "truth."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document. Given it's a comparative study of a diagnostic instrument rather than interpretation of images or complex clinical scenarios, a formal adjudication method by experts is unlikely to have been part of the primary data comparison. The comparison would involve statistical analysis of the numerical results from both devices.
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:
- No, an MRMC comparative effectiveness study was not done. This document describes a medical device (a microcoagulation system) that performs automated tests. It is not an AI-assisted diagnostic tool for human interpretation, thus, MRMC studies and "human readers" are not applicable in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device, the HEMOCHRON® Signature Elite™, is an automated diagnostic instrument. Its performance is inherently standalone in terms of generating coagulation test results. The studies compared its results directly to the predicate device's results. There isn't a separate "algorithm only" performance reported as distinct from the device's operational performance, as the device is the implementation of the algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the laboratory comparison, "whole blood control products" were used. These controls have known or expected values, serving as a form of reference standard.
- For the clinical comparison, "split patient blood samples" were used. In this case, the "ground truth" for each sample was implicitly the result obtained from the predicate device (HEMOCHRON® Jr. Signature+), as the study aimed to demonstrate equivalence to it.
The sample size for the training set:
- This information is not provided. The device utilizes "the same reagent system, the same closed end method and clot detection algorithms as the predicate device." This suggests the core algorithms were already established and validated with the predicate device. This submission focuses on hardware and software interface upgrades, therefore, a new "training set" for the coagulation algorithms is unlikely to have been part of this 510(k) submission.
How the ground truth for the training set was established:
- This information is not provided. As mentioned above, the underlying coagulation algorithms are stated to be the same as the predicate device. The ground truth for those original algorithms would have been established during the development and validation of the HEMOCHRON® Jr. Signature+ system, likely through comparison with reference laboratory methods and clinical correlation, but details are not in this document.

Summary

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

FEB 1 0 2005

510(k) Summary

K05 0016

Submitter Information

International Technidyne Corporation 8 Olsen Avenue Edison, NJ 08820 (800) 631-5945

Establishment Registration Number: 2248721

Contact: Leslie Young Date Prepared: 1/3/05

Device Information

HEMOCHRON® Signature Elite™ Whole Blood Microcoagulation System Proprietary Name: Microcoagulation Analyzer Common Name: Multipurpose system for In-Vitro Coagulation (21 CFR 864.5425) Classification Name: Device Class: 11 Hematology & Pathology Panel: 81JPA Product Code:

Predicate Device

Substantial equivalence is claimed to the currently marketed International Technidyne Corporation's HEMOCHRON® Jr. Signature+ Whole Blood Microcoagulation System (K 020798).

Description of Device

For in vitro Diagnostic Use

Microsoft and Windows are registered trademarks of Microsoft Corporation.

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

Intended Use:

The HEMOCHRON® Signature Elite™ Whole Blood Microcoagulation System is a battery-The Hillioon Nort One Ognatan operated, nand-field increment mindude: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboolastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from ITC.

For in vitro Diagnostic Use.

Technological Comparison to Predicate

The HEMOCHRON® Signature Elite™ performs the same assays as the predicate instrument. It rine heation system of the closed in method and clot detection algorithms as the predicate device. The submitted instrument design upgrades the user interface, data storage and data. manipulation functions. The instrument provides a secondary information input pathway using a manipulation farrenoner in addition to manual keypad entry, and offers a larger capacity to store data.

HEMOCHRON® Configuration Manager, which was cleared in the same 510(k) as the predicate device, is a Microsoft Windows® based software application. This software allows the user to configure the instrument to meet specific user needs in the clinical setting. The functionality of configure the instrument to meet specific user nocus in the cannounce of the rature filled in the laterially as the predicate device.

Substantial Equivalence Data Summary

Laboratory Comparison to Predicate

Laboratory Companson to Fredicate
The HEMOCHRON® Signature Elite " and predicate HEMOCHRON® Jr. Signature+ instruments were compared in the laboratory using ITC whole blood control products for each currently Were compared in the HEMOCHRON® Jr. Signature+ instrument (predicate).

Clinical Comparison to Predicate

Olinical ochipanison to Production to the HEMOCHRON® Signature Elite™ clinical comparison to the predicate HEMOCHRON® Jr. Signature+ instrument system. The evaluation compared results obtained using split patient blood samples on the two instrument systems using each currently 510(k) cleared assay for the HEMOCHRON® Jr. Signature+ instrument system.

Clinical User Interface Evaluation

A user-based evaluation of the clinical utility and ease of use of the instructional format displayed on the HEMOCHRON® Signature Elite™ instrument system when compared to the predicate HEMOCHRON® Jr. Signature+ instrument system was performed.

All clinical and laboratory data demonstrate the substantial equivalence of the HEMOCHRON® Signature Elite™ instrument system to the predicate HEMOCHRON® Jr. Signature+ instrument system.

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

Substantial Equivalence Conclusion Summary

The modifications described herein for the HEMOCHRON® Signature Elite™ Whole Blood Microcoagulation System do not alter the intended use, the indications for use, nor the microooaganation tific technology used in the previously cleared predicate device. The HEMOCHRON® Signature Elite " is substantially equivalent to the previously cleared
HEMOCHRON® Signature+" Whole Blood Microcoagulation System (K020798).

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

FEB 1 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Leslie Young Regulatory Affairs Associate International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820

Re: K050016

Trade/Device Name: HEMOCHRON® Signature Elite™ Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for In Vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: January 3, 2005 Received: January 4, 2005

Dear Ms. Young:

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.

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

Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

Robert Beckerh

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

Enclosure

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

February 3, 2005

International Technidyne Corporation 510(k) Submission International Technidyne Gorporation of othy Crocoagulation System

Indications for Use

510(k) Number (if known): K050016____

Device Name: ________HEMOCHRON® Signature Elite™

Indications for Use:

For in vitro Diagnostic Use Only

Prescription Use XX
(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 OF NEEDED)

Concurrence of CDRA, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of 1

Division Sign-Off

O'fice of In Vitro Diagnostic Device
Evaluation ana Salety
Page 4

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.