The MAX-ACT Activated Clotting Time test tubes are intended for use in the measurement of the activated clotting time test (ACT) on Actalyke Models A1, A1P, A2, A2P, and Hemochron® Models 400, 401, 800, 801 and 8000.

Device Description

The MAX-ACT Activated Clotting Time test tubes utilize a "cocktail" of particulate activators (including celite, kaolin, and glass particles) and is intended for use in the measurement of the activated clotting time test (ACT) on Actalyke Models A1, A1P, A2, A2P, and Hemochron® Models 400, 401, 800, 801 and 8000.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MAX-ACT Activated Clotting Time Test Tube, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined performance acceptance criteria. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (Array Medical Actalyke C-ACT test tube, K964609) through correlation studies. The reported performance is presented as correlation coefficients.

Study Type / Group	Performance Metric	Reported Device Performance	Acceptance Criteria (Implicit)
In-Vitro (Normal Donors)	Correlation with C-ACT/FTCA510	r = 0.97, p = 0.0001 (n=72)	Strong positive correlation (demonstrating substantial equivalence)
Clinical - Bypass Patients	Correlation with C-ACT/FTCA510	r² = 0.82 (all samples), r² = 0.87 (after omitting samples outside linear range)	Strong positive correlation (demonstrating substantial equivalence)
Clinical - Aprotinin Bypass Patients	Correlation with ACTII/K-ACT/FTKACT	r² = 0.89	Strong positive correlation (demonstrating substantial equivalence)
Clinical - Pediatric Bypass	Correlation with FTCA510	r² = 0.86	Strong positive correlation (demonstrating substantial equivalence)
Clinical - Catheterization Patients	Correlation with FTCA510	r² = 0.88	Strong positive correlation (demonstrating substantial equivalence)

2. Sample Size Used for the Test Set and Data Provenance

In-vitro study:
- Sample Size: 72 samples (derived from 3 normal, healthy volunteers by adding increasing amounts of heparin).
- Data Provenance: In-house study, in-vitro heparinization of normal donor blood. The country of origin is not explicitly stated but can be inferred as the US given the submission to the FDA. Retrospective/Prospective: Not explicitly stated, but the description of generating samples suggests a controlled, prospective approach.
Clinical studies:
- Total Sample Size: 330 paired blood samples.
- Breakdown by Study Group:
  - Bypass Patients: 239 patient samples (from n=30 patients)
  - Aprotinin Bypass Patients: 28 patient samples (from n=6 patients)
  - Pediatric Bypass: 41 patient samples (from n=5 patients)
  - Catheterization Patients: 22 patient samples (from n=10 patients)
- Data Provenance: Clinically collected samples from patients (adult bypass, pediatric bypass, cardiac catheterization) at "numerous institutions." The country of origin is not explicitly stated, but given FDA submission, it's likely primarily US data. Retrospective/Prospective: The description "collected... before, during, and following heparinization" suggests these were prospectively collected as part of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not provided in the given document. The "ground truth" in this context is the measurement provided by the legally marketed predicate devices (C-ACT, FTCA510, ACTII/K-ACT/FTKACT). These are established laboratory tests, and their results are considered the standard for comparison rather than requiring expert consensus on individual results.

4. Adjudication Method for the Test Set

This type of information is not applicable to this study. The study compares a new device's readings to those of a predicate device. There is no mention of human interpretation or a need for adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of a diagnostic device (activated clotting time measurement), not on the diagnostic accuracy of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented is that of the device (MAX-ACT Activated Clotting Time Test Tube) in a standalone capacity, i.e., without a human-in-the-loop evaluating its output in a diagnostic context. It compares the MAX-ACT's readings directly to those of established ACT tests.

7. The Type of Ground Truth Used

The ground truth used for comparison was the readings obtained from legally marketed predicate Activated Clotting Time (ACT) tests. Specifically, these included:

Array Medical Actalyke C-ACT
HEMOCHRON CA510
HEMOCHRON FTKACT
ACTII/K-ACT

These predicate devices serve as the established standard for measuring ACT.

8. The Sample Size for the Training Set

This document does not mention a 'training set.' The MAX-ACT device is a physical test tube containing "a cocktail of particulate activators." It’s not an AI/ML algorithm that requires a training set in the conventional sense. The studies described are for validation and demonstration of equivalence, not for training an algorithm.

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

As there is no training set for this device, this question is not applicable.

Summary

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DEC 1 1 1998

K983649

510(k) Summary of Safety and Effectiveness Information MAX-ACT Activated Clotting Time Test Tube

Array Medical, Inc. One Harvard Way, Suite 5 Hillsborough Campus Somerville, NJ 08876 908-707-8872

Michael F. Corsello, 908-707-8872 Contact:

October 12, 1998 Date:

Device Names:

Trade Names: MAX-ACT

Activated clotting time test Common Name:

Classification Name: Activated whole blood clotting time tests

Legally Marketed Device:

Array Medical Actalyke C-ACT test tube, K964609.

Device Description:

Intended Use:

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Performance Data:

Substantial equivalence of the MAX-ACT ACT test tubes to the Array Medical Actalyke C-ACT is supported by an in-house study.

Whole blood was obtained from normal donors and heparinized in vitro up to 10.0 units of heparin/ml. Currently, the most common method for heparin monitoring in these heparinization ranges are the celite and kaolin based ACT tests (C-ACT (celite) and K-ACT (kaolin) (0.0-5.0 units/ml - 600 seconds) and HEMOCHRON CA510 (celite) (up to 600 seconds). Hemochron FTKACT (kaolin) (up to 600 seconds). The correlation of the MAX-ACT Activated Clotting Time test tube and various combinations of Actalyke and Hemochron instruments and ACT tubes were determined.

In-vitro heparin sensitivity curves were generated from three normal, healthy volunteers. Samples (n=72) were generated by adding increasing amounts of heparin to aliquots of normal donor blood. MAX-ACT Activated Clotting Time Tests were performed.

A positive correlation between the MAX-ACT and the C-ACT/FTCA510 was demonstrated when paired testing was performed. The MAX-ACT demonstrated a positive correlation with the C-ACT tubes (r=0.97, p=.0001, n=72) (Figure E1). The data is shown in Table E1.

Studies were also conducted clinically at numerous institutions. A total of 330 paired blood samples were collected from patients (including adult bypass, pediatric bypass, and cardiac catheterization) before, during, and following heparinization. The patients were divided into four discrete groups. These groups consisted of:

Study Group 1. Bypass Patients: Results obtained using a reference celite-based ACT test (C-ACT/FTCA510) were compared to those obtained using MAX-ACT test tubes. A total of 239 patient samples were collected from bypass patients (n=30) before, during, and following heparinization during cardiopulmonary bypass. The data vielded a correlation coefficient of r2 =0.82 (Figure E2) and r2 = 0.87 (Figure E3) when samples from the reference group were omitted which were outside the published linear range for the reference tube. The data is shown in Table E2.

Study Group 2. Aprotinin Bypass Patients: Results obtained using a reference kaolin-based ACT test (ACTII/K-ACT/FTKACT) were compared to those obtained using MAX-ACT test tubes. A total of 28 patient samples were collected from bypass patients receiving antifibrinolytic therapy (aprotinin) (n=6) before, during, and following heparinization during cardiopulmonary bypass. The data yielded a correlation coefficient of r2 =0.89 (Figure E4). The data is shown in Table E3.

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Study Group 3. Pediatric Bypass: Results obtained using a reference celitebased ACT test (FTCA510) were compared to those obtained using MAX-ACT test tubes. A total of 41 patient samples were collected from pediatric bypass patients (n=5) before, during, and following heparinization during cardiopulmonary bypass. The data yielded a correlation coefficient of r2=0.86 (Figure E5). The data is shown in Table E4.

Study Group 4. Catheterization Patients: Results obtained using a reference celite-based ACT test (FTCA510) were compared to those obtained using MAX-ACT test tubes. A total of 22 patient samples were collected from cardiac catheterization patients (n=10) before, during, and following heparinization during the procedure (diagnostic and interventional). The data vielded a correlation coefficient of 2 =0.88 (Figure E6). The data is shown in Table E5.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

DEC 1 1 1998

Mr. Michael F. Corsello Array Medical, Inc. One Harvard Way, Suite 5 Hillsborough Campus Somerville, New Jersey 08876

Re : K983649 Trade Name: MAX-ACT Regulatory Class: II Product Code: JBP Dated: October 14, 1998 Received: October 16, 1998

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. Existinq major requlations affectinq your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

This letter will allow you to beqin 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 diaqnostic 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, "Misbrandinq by reference to premarket notification"(21 CFR 807.97). Other qeneral 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 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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Statement of Indications For Use

510(k) Number:

K983649

Device Namo:

MAX-ACT™ Activated Clotting Time Tubes

"Indications For Use" -

The MAX-ACT Activated Clotting Time test tubes are I lie MAX-AOT - Floridae - Frences of the activated clotting time Intended for the measure Models A1, A1P, A2, A2P, and on (ACT) test on Piels 400,401,800,801, and 8000.

Peter R. Mafini

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﮯ Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 864.7140 Activated whole blood clotting time tests.

(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).