The portable, battery operated HEMOCHRON® Jr. Generation II and Signature are microcoagulation instruments designed to perform whole blood coagulation tests using fresh whole blood at the point-of-care. The system is intended to be used in numerous clinical settings requiring point-of-care testing. Test results are displayed as whole blood test results and plasma equivalent values, in seconds. For the ACT, the instrument also displays correlated celite equivalent values. The APTT and PT correlated values are based on regression analyses of comparative whole blood/plasma studies.

Device Description

The Generation II system performs the same tests as the predicate Jr. system, APTT, PT, ACT+, and ACT-LR with the same end point detection system. All assays are intended to be performed at point of care (POC). Blood is placed in a collection reservoir of the test cuvette and automatically sampled into a test channel which contains reagents required to perform the respective assay. Excess blood is drawn into a waste cuvette. The clot detection mechanism is a combination mechanical-optical system. As blood is actively pumped back and forth in the test channel, two LED detectors measure the position of the blood. As clotting occurs, the movement of the blood decreases below a pre-determined rate and an endpoint is recorded. Test results for the APTT and PT are displayed as whole blood clotting times and plasma equivalent times. Test results for the ACT+ and ACT-LR are displayed as traditional HEMOCHRON® celite ACT values.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the HEMOCHRON® Jr. Generation II Microcoagulation System. It focuses on the device's technological characteristics, intended use, and its substantial equivalence to a predicate device, rather than presenting a detailed study report with acceptance criteria and comprehensive performance data. Therefore, many of the requested items cannot be fully extracted from this specific document.

However, based on the available information, here's what can be inferred and stated:

1. A table of acceptance criteria and the reported device performance:

This document does not explicitly state specific acceptance criteria (e.g., a required accuracy, precision, or correlation coefficient) for the device's performance. It describes the device's function and claims the new system "performs the same tests as the predicate Jr. system, APTT, PT, ACT+, and ACT-LR with the same end point detection system."

The main "performance" described is the display of:

Whole blood clotting times and plasma equivalent times for APTT and PT.
Traditional HEMOCHRON® celite ACT values for ACT+ and ACT-LR.
Correlated values based on regression analyses of comparative whole blood/plasma studies.

Without specific performance metrics or acceptance thresholds in the provided text, a table like the one requested cannot be fully populated.

2. Sample size used for the test set and the data provenance:

The document mentions "regression analyses of comparative whole blood/plasma studies" as the basis for correlated values, but does not provide details on the sample size used for these studies or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not available in the provided 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not available in the provided 510(k) summary.

5. 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:

This device is a microcoagulation system, not an imaging or diagnostic AI device that involves "human readers" in the sense of interpreting images or complex data with AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and is not mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone instrument that performs coagulation tests. The "performance" in this context refers to the accuracy and reliability of its measurements compared to established laboratory methods. While its operation is automated once blood is loaded, the summary does not detail specific "standalone" performance studies or their results beyond stating it performs the same tests as the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document implies that the ground truth for establishing correlated values was based on comparative studies with established laboratory plasma coagulation tests. For the ACT, it mentions "correlated celite equivalent values," suggesting a comparison against traditional celite-based Activated Clotting Time methods as a ground truth.

8. The sample size for the training set:

The document does not provide information on a "training set" sample size. This terminology is more common for machine learning or AI algorithm development which is not the primary focus of this 510(k) (which is an upgrade for advanced program and interface capability, not a new measurement algorithm). The "regression analyses" for correlated values would have used a dataset, but its size is not specified.

9. How the ground truth for the training set was established:

Similar to question 8, the document does not speak in terms of "training sets." It states that "The APTT and PT correlated values are based on regression analyses of comparative whole blood/plasma studies." This implies that the ground truth for these correlations was established by comparing the device's whole blood results to simultaneously obtained plasma results from a reference laboratory method. For ACT, traditional HEMOCHRON® celite ACT values served as a basis for correlation.

Summary

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197479999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999

INTERNATIONAL

TECHNIDYNE

JUL 7 1998

8 Olsen Avenue ▼ Edison, NJ 08820 Toll Free Phone: (800) 631-5945 CORPORATION Phone: (732) 548-5700 FAX: (732) 632-9299

510 (k) SUMMARY

Prepared: 1/19/98

Submitted by: Robert Matland International Technidyne Corp. 23 Nevsky St. Edison, N.J. 08820 Office: (732) 548-5700 X-248 Fax: (732)548-2419

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K974799.

Device Name

Common/Usual Name:	HEMOCHRON® Jr. Generation IIMicrocoagulation System
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Product Name: HEMOCHRON® Jr. Generation II HEMOCHRON® Jr. Signature

Predicate Device

International Technidyne Corp. HEMOCHRON® Jr. Microcoagulation System which was approved under 510 (k) K923761/A (APTT only, January 21, 1993) and K940401 (multiple assay use May 11, 1994) ,

Device Description

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Statement of Intended Use

Summary of Technological Characteristics

The upgrade for which this 510(k) is intended is the incorporation into the Generation II system of advanced program capability and interface capability with a PC(personal computer). These features allow the user to execute a number of software functions which specifically:

Allow users to screen the test operators and provide or 1. limit system access. This is provided in response to clinical user's desire to monitor quality assurance and execute specific operator lockout.
Allow users to input specific performance ranges into the 2. device for specific assays. With this feature users are able to utilize institution-specific correlations of the HEMOCHRON® Jr. POC test (i.e., APTT or PT) to the local laboratory.
1. Allow users to download data from the individual systems to a computer system.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

7 1998 . IUL

Robert Matland . Compliance Officer International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820

K974799 Re : HEMOCHRON® Jr. Generation II, HEMOCHRON® Jr. Signature Requlatory Class: II Product Code: JPA Dated: April 23, 1998 Received: May 12, 1998

Dear Mr. Matland:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 requlation (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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".

Sincerely yours,

Steven Autman

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) : K974799

HEMOCHRON® JR. GENERATION II Device Name : HEMOCHRON® JR. SIGNATURE

Indications For Use:

The portable, battery operated HEMOCHRON® JR. SIGNATURE is a microcoagulation instrument designed to perform whole blood coagulation tests using fresh whole blood at the patient bedside. The system is intended to be used in many clinical settings requiring point-of-care testing. Whole blood test results are displayed as clotting times, in seconds. The instrument also displays correlated celite equivalent values. The correlated values are based on regression analyses of comparative whole blood/plasma studies.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 974799

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.