AIACT KIT by SIENCO, INC. | FDA 510(k) Summary

The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.

The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥ 400 seconds on Sonoclot Analyzer) as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment.

Device Description

The aiACT Kit is a yellow plastic lidded cuvette containing contact activator and magnetic stir bar.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the aiACT Kit.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the aiACT Kit as specific thresholds for regulatory approval. However, it presents "Normal Ranges" for the aiACT test. While this isn't framed as a pass/fail criteria, it serves as a performance benchmark against healthy individuals without heparin.

Result	Acceptance Criteria (Normal Range, No Heparin)	Reported Device Performance (Native Whole Blood - Normal Population, No Heparin)
ACT/Onset	62-93 seconds	62-93 seconds
Clot RATE	22-41 Clot Signal Units / minute	22-41 Clot Signal Units / minute

Note: The document only provides the normal range itself as the "reported device performance." It doesn't present a separate study cohort demonstrating the aiACT kit's performance relative to these ranges from an external dataset. It's implied that the observed normal range is the performance of the device in a normal, unheparinized population.

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

The document does not explicitly state the sample size used to establish the "Normal Range" for the aiACT Kit. It only refers to a "Normal Population, No Heparin" for "Native Whole Blood."

Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated (e.g., country of origin). It can be inferred that it is retrospective or prospective data collected to establish the normal range, but the methodology is not detailed.

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

This section is not applicable as the document does not describe the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy. The ground truth, in this case, is simply the observed range of ACT/Onset and Clot Rate results from a presumably healthy, unheparinized population. There's no mention of a diagnostic task requiring expert interpretation.

4. Adjudication Method for the Test Set

This section is not applicable as the document does not describe a scenario requiring adjudication, such as conflicting expert interpretations or complex diagnostic judgments. The "ground truth" is based on direct measurement of clotting parameters in a normal population.

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

This section is not applicable. The document describes a comparison of the aiACT Kit with the SonACT Kit, but it is a comparison of technological characteristics and expected performance, not an MRMC study assessing human reader improvement with or without AI assistance. The aiACT Kit is an in vitro diagnostic test, not an AI-assisted diagnostic tool for Human Readers.

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

Yes, implicit in the document, a standalone performance of the device (aiACT Kit with Sonoclot Analyzer) was assessed. The "Normal Range" values (ACT/Onset and Clot RATE) are the direct output of the device itself without human interpretation in a diagnostic loop.

7. The Type of Ground Truth Used

The ground truth used for establishing the normal ranges is based on direct physiological measurement of Activated Clotting Time (ACT/Onset) and Clot Rate from a "Normal Population" with "Native Whole Blood" (i.e., not heparanized). It's an empirical observation of typical values in a healthy state.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. This is common for in vitro diagnostic devices where "training" in the machine learning sense is not typically applicable for establishing performance characteristics like normal ranges. The normal ranges are typically derived from a studied population.

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

As no explicit "training set" is mentioned in the context of machine learning, this question doesn't entirely apply. However, if we consider the data used to define the "Normal Range" as the equivalent of data used to establish expected performance, the ground truth (the observed ACT/Onset and Clot RATE values) was established by direct measurement using the aiACT Kit on native whole blood samples from a "Normal Population" without heparin. The methodology of this measurement (e.g., number of subjects, how "normal" was defined, protocol for measurement) is not detailed in this summary.

Summary

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Sienco. Inc. 11485-A West 48th Avenue Wheat Ridge, CO 80033 USA 800/432-1624 303/420-1148 303/420-2204(Fax) http://www.sienco.com email:sienco@sienco.com

510(k) SUMMARY

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: K032952

(1) Contact Person: Barbara DeBiase, Director, Sienco Inc. Summary Preparation Date: 26 November, 2003
(2) Device Trade Name: aiACT Kit Common Name: Activated Clotting Time (ACT) Test Classification Name: Activated Whole Blood Clotting Time Test Classification: Class II, 21 CFR 864.7174
(3)Identification of predicate device to which substantial equivalence is being claimed: SonACT Kit, included in 510(k) # K952560

(4) and (5) Device Description and Intended Use:

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(6) Technological Characteristic Comparison of the aiACT+ Kit to the standard

SonACT Kit:

ITEM	aiACT	STANDARD SONACT
Classification Name	Activated Whole Blood ClottingTime Test	Activated Whole Blood ClottingTime Test
IVD Reagent forUse With	Sonoclot Coagulation & PlateletFunction Analyzer	Sonoclot Coagulation & PlateletFunction Analyzer
Intended Use	High dose heparin anticoagulationmanagement , especially in thepresence of aprotinin	General purpose global hemostasismonitoring, hypercoagulable andhyperfibrinolysis screening,platelet function assessment,anticoagulation management (lowto high heparin levels)
Results Provided	Quantitative results for ActivatedClotting Time (Sonoclot OnsetTime) and rate of fibrinpolymerization (Sonoclot ClotRate).	Quantitative results for ActivatedClotting Time (Sonoclot OnsetTime) and rate of fibrinpolymerization (Sonoclot ClotRate). Qualitative and quantitativeplatelet function information (timeto peak, clot retraction).
Test Design	Yellow plastic lidded cuvettecontaining contact activator andmagnetic stir bar	Colorless plastic lidded cuvettecontaining contact activator andmagnetic stir bar
Kit Contents	Cuvettes, probes and instructionsfor use	Cuvettes, probes and instructionsfor use
Quality Control	Reference plasma quality control	Reference plasma quality control

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(7) Performance Comparison of the aiACT Kit to the standard SonACT Kits Expected Performance Comparison of the arrow of the arrow to the provided in the tables below.

aiACT Test (#800-0442, #800-0441)Native Whole Blood - Normal Population, No Heparin
Result	Normal Range
ACT/Onset	62-93 seconds
Clot RATE	22-41 Clot Signal Units / minute

Standard SonACT Test (#800-0435, #800-0434)Native Whole Blood - Normal Population, No
Result	Normal Range
ACT/Onset	85-145 seconds
Clot RATE	15-45 Clot Signal Units / minute
Time to Peak	< 30 minutes

Normal, aiACT Test, Native Whole

Image /page/2/Figure/4 description: This image shows a graph of clot signal versus time in minutes. The graph shows an upward sloping curve, indicating that the clot signal increases over time. The onset L/ACT is 82, and the clot rate is 2.4. The x-axis represents time in minutes, ranging from 0 to 20, while the y-axis represents the clot signal, ranging from 0 to 120.

Normal, SonACT Test, Native Whole Blood

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	if1	:	ੂੰ	4				:. .:=	5200 ICC.ﻟﻬﺎ ﻓﻬﻮ ﺍ-	*****

Onset/ACT: 89
22 Clot RATE: Time to Peak; 17.5

Jon H. Hardman, President Nov 29, 2003

Jon Henderson, President

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEC 1 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Barbara DeBiase Director Sienco. Inc. 11485-A West 48th Avenue Wheat Ridge, Colorado 80033

Re: K032952

Trade/Device Name: aiACT Kit Regulation Number: 21 CFR § 864.7140 Regulation Name: Activated Whole Blood Clotting Time Test Regulatory Class: II Product Code: JBP Dated: September 16, 2003 Received: September 22, 2003

Dear Ms. DeBiase:

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.

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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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K032952 510(k) Number (if known):

aiACT Kit Device Name:_

Indications For Use:

The aiACT Kit is an in vitro diagnostic test for use with the Sonocloff Coagulation & Platelet The aiACT Kit is an in Vito diagnostic test is an activated whole blood closing time test which Function Analyzer System. The alACT test is an activation while been of the birds.
uses a blend of celite and clay for contact activation. It may also be used with citrated blood.

The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥ 400 The aiACT Kit is intended only in the mesantered during cardiopulmonary bypass surgery.
Seconds on Sonoclot Analyzer) as typically encountered by announin when used seconds on Sonoclot Analyzes as lyncation of extentially unaffected by protition. When used The aiACT test provides ACT test provides quantitative Oneet/ACT and Clot Rate
with the Sonoclot Analyzes System, the siACT test provides quantitative OneerACT and Clot Rate with the Sonociol Analyzel System, the arrest for platelet function assessment.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Division/Sign/Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032952

Prescription Use $\checkmark$

(Optional Format 3-10-98)

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).