The intended use of the Sysmex® CA-500 Series is as a compact, fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.

The instrument uses citrated human plasma to perform the following parameters and calculated parameters:

Clotting Analysis Parameters

Prothrombin Time (PT) .
Activated Partial Thromboplastin Time (APTT) .
Fibrinogen (Clauss) .
Thrombin Time .

Chromogenic Analysis Parameters

Antithrombin III ●
Calculated Parameters
PT Ratio .
PT INR .
Derived Fibrinogen .

Device Description

The CA-500 is substantially equivalent in intended use and technological characteristics to its predecessor, the CA-6000 analyzer. Both instruments are manufactured by TOA Medical Electronics, CO, Ltd., Kobe, Japan. The CA-6000 analyzer was described in details under Document Control No. K964139. The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Sysmex® Automated Coagulation Analyzer CA-500, based on the provided text:

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

The document does not explicitly state pre-defined acceptance criteria (e.g., target ranges for coefficient of correlation or regression coefficients). Instead, it presents the results of a correlation study between the proposed device (CA-500) and its predicate device (CA-6000) as evidence of substantial equivalence. The reported device performance is indicated by the Coefficient of Correlation (r) and the Regression Equation (Y = mX + c) for various coagulation tests. High correlation coefficients and regression equations close to Y=X (slope near 1, intercept near 0) indicate good agreement.

Test	Sample Number (n)	Coefficient of Correlation (r)	Regression Equation
Prothrombin Time (Dade® Innovin®, seconds)	111	0.991	Y = 0.98X + 0.3
Prothrombin Time (Dade® Innovin®, INR)	111	0.991	Y = 0.99X + 0.03
Derived Fibrinogen (Dade® Innovin®)	104	0.983	Y = 0.78X + 31.2
Prothrombin Time (Dade® Thromboplastin C Plus, seconds)	131	0.997	Y = 1.00X + 0.02
Prothrombin Time (Dade® Thromboplastin C Plus, INR)	131	0.997	Y = 1.00X + 0.01
Derived Fibrinogen (Dade® Thromboplastin C Plus)	131	0.979	Y = 0.92X + 20.2
Prothrombin Time (Thromborel® S, seconds)	119	0.990	Y = 0.99X + 0.2
Prothrombin Time (Thromborel® S, INR)	119	0.989	Y = 1.00X + 0.01
Derived Fibrinogen (Thromborel® S)	115	0.985	Y = 0.86X + 29.2
Activated Partial Thromboplastin Time (Dade® Actin®)	114	0.997	Y = 1.00X - 0.3
Activated Partial Thromboplastin Time (Dade® Actin® FSL)	116	0.997	Y = 1.01 X - 0.01
Activated Partial Thromboplastin Time (Pathromtin® SL)	114	0.996	Y = 0.98X + 1.0
Fibrinogen (Clauss)	119	0.989	Y = 0.95X + 20.3
Thrombin Time	128	0.806	Y = 0.54X + 9.8
Antithrombin III	109	0.927	Y = 0.91X + 10.8

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

Sample Size for Test Set: Varies by assay, ranging from 104 to 131 samples (as shown in the table above under "Sample Number (n)").
Data Provenance: The studies were performed "in house" by Dade Behring Inc. The samples included "apparently healthy individuals and from patients with different pathological conditions." The country of origin for the data is not explicitly stated, but Dade Behring Inc. is located in Miami, FL, USA. The study is retrospective in the sense that the data was collected and then analyzed to compare the two devices.

3. 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 study compares the performance of a new automated analyzer (CA-500) against a predicate automated analyzer (CA-6000), rather than against a human expert or gold standard like pathology in the context of image analysis. Therefore, the concept of "experts establishing ground truth" as it would apply to diagnostic imaging, for instance, isn't directly relevant here. The predicate device's results are considered the "truth" for comparison.

4. Adjudication method for the test set

This information is not provided and is not applicable in this type of device comparison study. Adjudication methods are typically used when human interpretation is involved and discrepancies need to be resolved. Here, the comparison is between two automated instruments.

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

There was no MRMC comparative effectiveness study and no human readers or AI assistance are mentioned. This study is focused on the analytical performance of an automated coagulation analyzer compared to another automated analyzer, not the impact on human clinicians' diagnostic abilities.

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

Yes, the study is essentially a standalone performance study of the Sysmex® Automated Coagulation Analyzer CA-500. It measures the device's output against the predicate device's output, without human intervention in the result generation or interpretation process of the devices themselves.

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

The "ground truth" in this context is the results obtained from the predicate device, the Sysmex® CA-6000 analyzer. The study aims to demonstrate substantial equivalence by showing a strong correlation between the measurements of the proposed device and the predicate device.

8. The sample size for the training set

This information is not provided and is not applicable for this type of medical device submission. The CA-500 is an automated analyzer, and the results presented are from a validation study comparing its performance to a predicate device, not from an AI model that requires a training set.

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

This information is not provided and is not applicable, as there is no mention of a "training set" for an AI model.

Summary

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SEP 3 0 1998

Premarket Notification 510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-500

510K

Summo

Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125

Contact Person: Radames Riesgo at 305.636.7727 or by facsimile at 305.637.6887.

Trade or Proprietary Name: Sysmex® Automated Coagulation Analyzer CA-500

Common or Usual Name: Automated Coagulation Instruments

Classification Name:

Coagulation instrument (21 CFR §864.5400)

Registration Number:

Manufacturing Site TOA Medical Electronics Co. Kobe. Japan

7010360

1981711

Importer Sysmex™ Corporation of America Gilmer Road 6699 RFD Long Grove, IL 60047-9596

1422681

Distributor Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125

1017272

Data to support substantial equivalence to the predicate device were generated during correlation studies performed in house. In these studies, comparative performance evaluations were conducted using the proposed device and the predicate device to evaluate specimens from apparently healthy individuals and from patients with different pathological conditions which are

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510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-500 Page 2

100 100

expected to affect the results for a particular assay. The following summary shows the results of the comparison between the proposed and the predicate devices.

్ నిర్మా ఇతర ప్ర

Test	SampleNumber(n)	Coefficient ofCorrelation(r)	RegressionEquation
Prothrombin Time(Dade® Innovin®, seconds)	111	0.991	Y = 0.98X + 0.3
Prothrombin Time(Dade® Innovin®, INR)	111	0.991	Y = 0.99X + 0.03
Derived Fibrinogen(Dade® Innovin®)	104	0.983	Y = 0.78X + 31.2
Prothrombin Time(Dade® Thromboplastin C Plus, seconds)	131	0.997	Y = 1.00X + 0.02
Prothrombin Time(Dade® Thromboplastin C Plus, INR)	131	0.997	Y = 1.00X + 0.01
Derived Fibrinogen(Dade® Thromboplastin C Plus)	131	0.979	Y = 0.92X + 20.2
Prothrombin Time(Thromborel® S, seconds)	119	0.990	Y = 0.99X + 0.2
Prothrombin Time(Thromborel® S, INR)	119	0.989	Y = 1.00X + 0.01
Derived Fibrinogen(Thromborel® S)	115	0.985	Y = 0.86X + 29.2
Activated Partial Thromboplastin Time(Dade® Actin®)	114	0.997	Y = 1.00X - 0.3
Activated Partial Thromboplastin Time(Dade® Actin® FSL)	116	0.997	Y = 1.01 X - 0.01
Activated Partial Thromboplastin Time(Pathromtin® SL)	114	0.996	Y = 0.98X + 1.0
Fibrinogen (Clauss)	119	0.989	Y = 0.95X + 20.3
Thrombin Time	128	0.806	Y = 0.54X + 9.8
Antithrombin III	109	0.927	Y = 0.91X + 10.8

Summary of Method Comparison Studies between CA-500 and CA-6000

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Image /page/2/Picture/0 description: The image shows a black ink blot on a white background. The ink blot is irregular in shape, with a rounded body and some smaller extensions. The ink blot is solid black, with no internal details visible. The white background is plain and uniform.

PREMARKET NOTIFICATION THFUL AND ACCURATE STATEMEN [As Required by 21 CFR 807.87(j)]

I certify that, in my capacity as manager of Hemostasis Systems Integration of Dade Behring Inc., I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

William M. Hoover

Manager, Systems Integration

15 May 1998
Date

K981711 Premarket Notification Number

*Must be signed by a responsible person of the firm required to submit the premarket notification (e.g., not a consultant for the 510(k) submitter).

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2098 Gaither Road Rockville MD 20850

Food and Drug Administration

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

SEP 3 0 1998

Mr. Radames Riesgo Manager Regulatory Affairs DADE Behring, Inc. P.O. Box 520672 Miami, Florida 33152-0672

Re : K981711/S1

Trade Name: Sysmex® Automated Coaqulation Analyzer CA-500 Requlatory Class: II Product Code: JPA Dated: September 4, 1998 Received: September 8, 1998

Dear Mr. Riesgo:

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, Druq, 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 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

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 Butman

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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K981711 510(k) Number (if known):

Revis.
Find to
Use

Device Name: Sysmex® Automated Coagulation Analyzer CA-500

Indications For Use:

The intended use of the Sysmex® CA-500 Series is as a compact, fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. I a

The instrument uses citrated human plasma to perform the following parameters and calculated parameters:

Clotting Analysis Parameters

Prothrombin Time (PT) .
Activated Partial Thromboplastin Time (APTT) .
Fibrinogen (Clauss) .
Thrombin Time .

Chromogenic Analysis Parameters

Antithrombin III ●
Calculated Parameters
PT Ratio .
PT INR .
Derived Fibrinogen .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rur E. Mahon

nru Dannou

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

00108

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.