The HEMOCHRON® Electronic System Verification Tube is intended for in vitro diagnostic use in performing a quantitative electronic detection system verification of HEMOCHRON® Coagulation Instruments. The Electronic System Verification Tube electronically simulates test initiation and clot detection in the same manner as patient assay end points are recorded.

Device Description

The device is a plastic tube with battery operated electronic circuitry that electronically simulate test initiation and clot detection using the same principles employed in a clotting time assay. Once started and placed in the Hemochron test well, the ESVT electronically simulates the operation of a 100, 300 and 500 second clotting time.

The comparison of the displayed Hemochron clotting time with the ESVT clotting time is a quality control test of the functionality of the test well and test detector.

AI/ML Overview

The HEMOCHRON® Electronic System Verification Tube (ESVT) is an in vitro diagnostic device used for quantitative electronic detection system verification of HEMOCHRON® Coagulation Instruments. It electronically simulates test initiation and clot detection to check the timing capability and well rotation of HEMOCHRON instruments.

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria:

1. Acceptance Criteria and Reported Device Performance

Control	Acceptable Range	Reported Mean	Reported Standard Deviation (SD)	Reported Coefficient of Variation (CV%)
Normal level	90-110 seconds	97.56 seconds	2.67	2.74%
Abnormal level I	290-310 seconds	297.3 seconds	3.03	1.02%
Abnormal Level II	490-510 seconds	497.6 seconds	3.11	0.63%

Analysis:
The reported mean values for all three control levels (Normal, Abnormal I, and Abnormal II) fall within their respective acceptable ranges. The low Standard Deviation and Coefficient of Variation percentages indicate high precision and reproducibility of the device's performance across different operators and days.

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: For each of the three control levels (Normal, Abnormal I, Abnormal II), the sample size (N) was 120. This means 120 measurements were taken for each level.
Data Provenance: The study was conducted by International Technidyne Corp., located in Edison, NJ, USA. The data is prospective, as it was generated specifically for the purpose of demonstrating the device's performance and supporting its 510(k) submission. There is no indication of retrospective data use.

3. Number of Experts and Qualifications for Ground Truth

The provided document describes a precision study for the HEMOCHRON® ESVT, not a study involving interpretation by human experts to establish ground truth for clinical outcomes or diagnoses. The "ground truth" in this context is the pre-defined ideal timing ranges for the electronic simulations, which are a characteristic of the device itself and its internal electronic circuitry.

Therefore:

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Since this is a precision study of an electronic device's timing accuracy against pre-defined electronic simulation ranges, there was no need for human adjudication of results in the traditional sense (e.g., for diagnostic discrepancies). The device's output (clotting time) was compared directly to the electronically simulated time.

Therefore:

Adjudication method: Not applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant for this device. The HEMOCHRON® ESVT is an electronic quality control device, not a diagnostic aid requiring human interpretation of clinical cases. Its purpose is to verify the functionality of a coagulation instrument, not to assist humans in making clinical diagnoses.

6. Standalone (Algorithm Only) Performance Study

Yes, the study described is a standalone performance study (algorithm only, though "algorithm" here refers to the electronic circuitry and its programmed timing). The device operates independently to simulate clotting times, and its outputs were measured and analyzed directly for accuracy and precision against preset electronic values. There is no human-in-the-loop component in the primary function being tested (electronic simulation and output).

7. Type of Ground Truth Used

The ground truth used is pre-defined electronic simulation timing values. These values were established based on the previous predicate device submission (K940957/S1) and represent the expected outputs for a properly functioning HEMOCHRON® instrument. The device is designed to simulate these specific clotting times.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The HEMOCHRON® ESVT simulates fixed, predefined timing values. These timings are inherent to the device's design and function, rather than being "trained" on a dataset in the way a machine learning algorithm would be. The precision study assesses the device's consistent execution of these predefined timings.

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

As mentioned above, there isn't a traditional "training set" in the context of this device. The "ground truth" for the simulated times (90-110s, 290-310s, 490-510s) was established and previously approved in the predicate device submission (K940957/S1). These are intrinsic design specifications for the electronic quality control system, not data derived from training.

Summary

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4/13/99

510 (k) Summary

HEMOCHRON® Electronic System Verification Tube

Prepared: February 10, 1999

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

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

Device Name

Common / Usual Name:	HEMOCHRON® Electronic Quality Control (EQC)
Product Name:	HEMOCHRON® Electronic System Verification Tube (ESVT)

Predicate Device

HEMOCHRON® Verify System / Factor VI Qualify System (K940957/S1)

Device Description

The Electronic System Verification Tube (ESVT) performs Electronic Quality Control on all marketed HEMOCHRON® tube instruments HEMOCHRON® models 8000, 401, 801 and the new HEMOCHRON® RESPONSE (K983475) currently under FDA review.

The comparison of the displayed Hemochron clotting time with the ESVT clotting time is a quality control test of the functionality of the test well and test detector.

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Statement of Intended Use

Summary of Technological Characteristics and Performance Data

The HEMOCHRON® ESVT is an improvement to the Electronic Quality Control designed to perform the same three (3) testing time ranges as the predicate three (3) separate electronic verification tubes. The upgrade provides the end user with additional quality features to assure the HEMOCHRON® instrument is operating properly. The ESVT is designed to check the timing capability of the HEMOCHRON instrument, as well as, verifying well rotation.

The previously approved test ranges are established in (K940957/S1).

Specifications

Control	Acceptable range
Normal level	90-110 seconds
Abnormal level I	290-310 seconds
Abnormal Level II	490-510 seconds

Precision was validated using three different operators on all HEMOCHRON® models (401, 801, 8000, Response) over a minimum of three days. The precision study data are summarized below.

Normal		Abnormal 1		Abnormal 2
Mean	97.56	Mean	297.3	Mean	497.6
SD	2.67	SD	3.03	SD	3.11
CV%	2.74	CV%	1.02	CV%	0.63
N	120	N	120	N	120

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Image /page/2/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. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.

Public Health Service

APR 1 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Clay Regulatory Compliance Officer International Technidyne Corporation 6 Olsen Avenue Edison, New Jersey 08820

Re: K990449 Trade Name: HEMOCHRON® Electronic System Verification Tube (ESVT) Regulatory Class: II Product Code: JPA Dated: February 10, 1999 Received: February 12, 1999

Dear Mr. Clay:

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 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). 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 Regulations, 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 action. In addition, FDA may publish further announcements 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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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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"(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 "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): K99044 9

Device name: HEMOCHRON ® Electronic System Verification Tube

Indications for Use:

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)

Peter E. Makim

Prescription Use_V 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.