HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Device Description

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

AI/ML Overview

This document describes the performance data for the HemosIL SynthASil device after optimization of its APTT parameter settings on the ACL Futura and ACL Advance systems. The stated purpose of this submission is to demonstrate substantial equivalence to the predicate device (K953981 HemosIL SynthASil) and to the HemosIL SynthASil reagent run on the ACL TOP system (K033414).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly uses the performance of the predicate device (K953981 HemosIL SynthASil) and the HemosIL SynthASil on the ACL TOP (K033414) as the acceptance criteria for achieving "improved correlation" and "substantial equivalence." While explicit numerical acceptance criteria are not presented in a table format, the performance data provided aims to demonstrate this correlation.

Performance Metric	Acceptance Criteria (Implicit - from predicate/ACL TOP)	Reported Device Performance (ACL Futura/Advance with optimized settings)
Within Run Precision	Similar or equivalent precision to predicate device and/or HemosIL SynthASil on ACL TOP.	Normal: Mean 28.5 seconds, CV% (Within run) 0.6, CV% (Total) 0.6Low Abnormal: Mean 49.0 seconds, CV% (Within run) 0.8, CV% (Total) 0.9High Abnormal: Mean 62.5 seconds, CV% (Within run) 0.7, CV% (Total) 0.8
Method Comparison	Strong correlation with the predicate device/ACL TOP system, indicated by slope close to 1, intercept close to 0, and high correlation coefficient (r close to 1).	Slope: 1.011, 0.984, 0.994, 0.973 (across 4 lots)Intercept: -0.664, 0.293, 0.159, 1.260 (across 4 lots)r: 0.9979, 0.9987, 0.9976, 0.9973 (across 4 lots)

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

Precision Test Set: The sample size for the precision study is not explicitly stated as a number of individual samples. It mentions "three levels of control plasma" and "assessed over multiple runs." This implies multiple measurements were taken for each of these three control levels.
Method Comparison Test Set: For each of the four SynthASil lots, n=93 or n=92 citrated plasma samples were used.
Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective in nature, performed to optimize and validate the device settings for regulatory submission. The samples are referred to as "human citrated plasma."

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

This type of in-vitro diagnostic device (reagent for APTT determination) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" for the method comparison is the measurement obtained from the predicate device or the ACL TOP system, which are themselves validated instruments. Therefore, there were no human experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is an objective measurement study comparing an optimized device's performance to established methods, not subjective human interpretation requiring adjudication.

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

No MRMC study was done. This study concerns the performance of an in-vitro diagnostic reagent and instrument settings, not a device that involves human interpretation of results requiring a comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this is effectively a standalone performance study. The document describes the performance of the HemosIL SynthASil reagent and its optimized settings on the ACL Futura and ACL Advance instruments. The results reported (precision, slope, intercept, r) are direct measurements from the device system without requiring human-in-the-loop analysis. The "algorithm" here refers to the optimized parameter settings and the reagent's performance characteristics.

7. Type of Ground Truth Used

The ground truth used for the method comparison study was the measurements obtained from a legally marketed predicate device (K953981 HemosIL SynthASil) or an equivalent, legally marketed device (HemosIL SynthASil on the ACL TOP system - K033414). This is a form of "reference standard" or "comparative standard" established by existing, validated medical devices.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. Instead, it refers to the "optimization" of APTT parameter settings. While this optimization process would have involved testing and refining these settings on various samples, the specific sample size, type, and method used for this optimization are not detailed in this summary. It's implied that the "optimization" process served a similar purpose to training, but no specific dataset is identified as a training set.

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

Since there is no explicitly defined "training set" in the context of an AI/ML model, the concept of establishing ground truth for it is not directly applicable here. The "optimization" likely involved iterative adjustments of the parameter settings and testing them against known reference values or comparative measurements (similar to the method comparison's ground truth, but likely a larger or different set of samples used during development) to achieve the desired performance, particularly for correlation with the ACL TOP and predicate devices.

Summary

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APR 1 3 2006

K060688

510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

Contact Person:

Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 Fax No .: 781-861-4207

Prepared:

March 14, 2006

Device Name:

HemosIL SynthASil

Regulatory Information:

Regulation No.:	864.7925
Classification Name:	Partial Thromboplastin Time Tests
Product Code:	GFO
Panel:	Hematology

Predicate Device:

K953981 HemosIL SynthASil

Device Description:

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Reason for Submission:

The APTT parameter settings for HemosIL SynthASil on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

The performance of HemosIL SynthASil with optimized APTT parameter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially equivalent to the performance of the current legally marketed device on the ACL TOP (K033414).

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510(k) Summary (Cont.) (Summary of Safety and Effectiveness)

Summary of Performance Data:

Within Run Precision

Within run and total precision assessed over multiple runs using three levels of control plasma for APTT gave the following results:

	Mean (Seconds)	CV% (Within run)	CV% (Total)
Normal	28.5	0.6	0.6
Low Abnormal	49.0	0.8	0.9
High Abnormal	62.5	0.7	0.8

Method Comparison

In a method comparison study evaluating citrated plasma samples, the slopes and correlations coefficient (r) are shown below for four different lots of the legally marketed HemosLL SynthASil tested on an ACL Advance with optimized APTT parameters versus on the ACL TOP:

SynthASil Lot	n	Slope	Intercept	r	Sample Range (Sec.)
Lot No. A	93	1.011	-0.664	0.9979	25.6 - 188.6
Lot No. B	93	0.984	0.293	0.9987	27.0 - 220.1
Lot No. C	93	0.994	0.159	0.9976	25.7 - 228.1
Lot No. D	92	0.973	1.260	0.9973	27.4 - 204.8

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the text "U.S. Department of Health & Human Services USA" in a circular pattern.

Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421-3125

K060688 Trade/Device Name: HemosIL SynthASil Regulation Number: 21 CFR § 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: II Product Code: GFO Dated: March 14, 2006 Received: March 15, 2006

Dear Ms. Marble:

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.

APR 1 3 2006

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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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 (240) 276-0484. 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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HemosIL SynthASil -- Optimized Parameter Settings on the ACL Futura/ACL Advance

Indications for Use:

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bruntidin
Director of Staff

Office of In Vitro Diagnostic Device Evaluation and Safety

K060688

Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).