The STA Compact Max® is a fully automatic clinical analyzer designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Device Description

Diagnostica Stago's STA Compact Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA Compact® analyzer (K093167). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment. The device consists of a cuvette, a metal ball, three needles, oscillation amplitude detection, a light source and sensor, and software.

AI/ML Overview

The STA Compact Max® is a modified version of the legally marketed device, STA Compact® (K093167). The modifications primarily involve updates to the onboard computer, operating system, and user interface, as well as minor external design changes. The company claims that these modifications do not alter the fundamental technological characteristics, principles of operation, or performance of the device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for the STA Compact Max®. Instead, the acceptance criteria are implicitly stated through the claim of "comparable performances" to the predicate device and the assertion that "no new questions were raised regarding the Safety, Effectiveness, Performance, Indication for Use, Technology and the Principles of Operation."

The device performance is described as:

Characteristic/Attribute	STA Compact Max® (Subject Device)	STA Compact® (Predicate Device K093167)
Indications for Use/Intended Use	The STA Compact Max® is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.	The STA Compact® is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Target Population	To aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy in patients.	To aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy in patients.
Anatomical Sites	In vitro testing of human plasma	In vitro testing of human plasma
Point of Use	Hospital Laboratory or other Health Care Laboratory.	Hospital Laboratory or other Health Care Laboratory.
Fundamental Scientific Technology	There is no change in the Fundamental Scientific technology used. No new question generated.	No new questions demonstrated in K093167.
Chronometric Method of Coagulation Detection	Mechanical measurement of the oscillation of the metal ball in the cuvette.	Mechanical measurement of the oscillation of the metal ball in the cuvette.
Photometric method of Coagulation Detection	Light absorption technique provided by a filtered light source.	Light absorption technique provided by a filtered light source.
Firmware Versions	(Identical to STA Compact®)	(Identical to STA Compact®)
Performance	Same as Predicate Device	See K093167

The essential acceptance criterion is that the STA Compact Max® demonstrates "comparable performances" to the predicate device (STA Compact® K093167) despite the internal and external modifications. The study performed aims to demonstrate this equivalence. The specific performance metrics (e.g., precision, accuracy, linearity) that were likely evaluated to establish "comparable performances" are not detailed in the provided summary, but would have been part of the Verification and Validation utilized as part of the Design Controls.

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

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "Validation Studies" and "Risk Assessment" but does not provide details of these studies. Given that this is a Special 510(k) for modifications to an existing device, the focus is on demonstrating that the changes do not adversely affect performance. The validation studies would have focused on verifying that the new hardware and software components perform as expected and do not introduce new risks or alter the previously established performance characteristics of the predicate device.

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. For a coagulation analyzer, "ground truth" would typically be established by comparing results to reference methods, other established analyzers, or clinical outcomes, perhaps interpreted by medical professionals. However, the details of expert involvement are not mentioned in this summary.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable to the STA Compact Max® device. This device is an automated clinical analyzer for in vitro coagulation studies and does not involve human readers interpreting images or data with AI assistance. It performs measurements directly on plasma samples.

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

The STA Compact Max® is an automated device, meaning it operates in a standalone manner without human-in-the-loop performance influencing its measurement results. The results are generated by the instrument's mechanical, optical, and software components. Human interaction is primarily for loading samples, reagents, and interpreting the output. So, in essence, its core function is "algorithm only" in terms of its diagnostic output. However, the document doesn't explicitly describe a separate "standalone study" in the context often associated with AI diagnostic algorithms. Rather, its inherent operation is standalone.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for the validation studies. However, for coagulation analyzers, ground truth often involves:

Reference methods: Comparing results to established, highly accurate laboratory reference methods.
Certified reference materials/standards: Using materials with known analyte concentrations.
Comparison to predicate device: A primary method in a 510(k) where modifications are made to an existing device. The performance of the modified device would be compared against the predicate device using patient samples and quality control materials.

The study's goal was to demonstrate "comparable performances" to the predicate device, implying that the predicate's performance served as a de-facto 'ground truth' or benchmark for the new device.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the same way it would be for machine learning or AI-based devices. The "training" for this type of device involves engineering design, calibration, and verification/validation processes rather than a data-driven training set for an algorithm to learn from. The software migration and new graphical user interface were likely developed and tested against defined functional requirements rather than a "training set."

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

As explained above, the concept of a "training set" with established ground truth is not directly applicable to this type of automated medical device in the same way it is for AI algorithms. The "ground truth" for the development and testing of the device's components (hardware, firmware, and software) would be based on engineering specifications, physical laws, chemical reactions, and established principles of coagulation measurement, rather than a dataset with labeled medical conditions. The previous STA Compact® (predicate device) and its proven performance would serve as the benchmark for how the new device should function and deliver results.

Summary

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Attachment_10

K130090

510(k) Summary

STA Compact Max®

FEB 1 2 2013

A.	510(k) Submitter information	1
B.	Device Information	2
C.	Predicate Device Information	2
D.	Indication/Intended Use	3
E.	Purpose of the Special 510(k) Notice	3
F.	Description of the device	3
	1) Principles of Operation	4
	2) Fundamental technologies	4
G.	Substantial Equivalence	5

A. 510(k) Submitter information

Submitter's name	Diagnostica STAGO Inc.
Address	5 Century DriveParsippany, New Jersey 07054
Phone Number	973.631.1200
Fax Number	973.867.6030
Date of Preparation	01/11/2013

Application Correspondent and Contact Person information

Name	Carlo d'AlessandroDirector, IVD Quality and RegulatoryDonawa Lifescience Consulting
Address	Piazza Albania, 10 - 00153 Rome, Italy
Phone Number	+39 06 578 2665
Fax Number	+39 06 574 3786

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B. Device Information

Device Trade Name	STA Compact Max®.
Device Common Name	IVD Coagulation Device/InstrumentAutomated and Semi-Automated Hematology deviceMulti-Parametric Analyzer
Device Classification Name	System, Multipurpose for In Vitro Coagulation Studies
Regulatory Class	Class II
Panel	Part 864 - Hematology and Pathology Devices
Product Code	JPA
Regulation Number	864.5425

Image /page/1/Picture/5 description: The image shows the text "Picture 1: STA Compact Max®". The text is written in a serif font and is left-aligned. The word "Picture" is underlined. The "®" symbol is a registered trademark symbol.

Image /page/1/Picture/6 description: The image shows a large piece of medical machinery. The machine is white and gray, and it has a large opening in the front. The inside of the machine is dark, and there are some objects visible inside. The machine appears to be a CT scanner or MRI machine.

C. Predicate Device Information

510(k) Number	K093167
Device Trade Name	STA Compact®.Automated Multi-Parametric Analyzer
Device Common Name	STA Compact®
	IVD Coagulation Device/Instrument
	Automated and Semi-Automated Hematology device
	Multi-Parametric Analyzer
Device Classification Name	System, Multipurpose for In Vitro Coagulation Studies
Regulatory Class	Class II
Panel	Part 864 - Hematology and Pathology Devices
Product Code	JPA
Regulation Number	864.5425

Image /page/1/Picture/12 description: The image shows the text "Picture 2: STA Compact® (K093167)". The text is written in a serif font and is left-aligned. The words "STA Compact" are in bold, and the "®" symbol is a registered trademark symbol. The number in parentheses is likely a product or model number.

Image /page/1/Picture/10 description: The image shows a large, box-shaped machine with a light gray exterior. The machine has a section with horizontal ventilation slats on the left side. To the right of the ventilation section, there is a curved design element that frames a dark, enclosed area, possibly a viewing window or operational space.

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D. Indication/Intended Use

The STA Compact Max is a fully automatic clinical analyzer designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

E. Purpose of the Special 510(k) Notice

The STA Compact Max® is a modification to the company's own legally marketed device, STA Compact® (K093167).

The modifications of the device involve:

Change of the on-board computer to allow the use of current technologies - 1 for data transfer (USB, DVD), without any change in the technology or mechanical operation by which samples are processed.
-2-Change of the operating system: from DOS for the predicate device to Windows for the STA Compact Max .
Migration of the user/application software to accommodate the new -3operating system, the use of new peripherals (USB, DVD, touch screen) and update the graphical user interface without modification of specifications and functionalities.
Change of the external design (colors and shape) of the analyzer to -4refresh external aspect.

F. Description of the device

The device consists of the following components:

1 a cuvette, which holds the patient sample and any needed reagent;
-2a metal ball located in the cuvette, that is induced to oscillate to measure coagulation;
-3three needles that will aspirate and dispense the patient's sample and reagents into the cuvette;
-4oscillation amplitude detection of a metal ball in a cuvette to measure sample coagulation by the chronometric method;

-5a light source and sensor to transmit light through the cuvette containing the sample and reagents that subsequently measures the light absorbed as a reaction takes place;

Software which conducts the measurement and test determination; -6-

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1) Principles of Operation

STA Compact Max® is a fully automatic clinical laboratory analyzer. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, support for instrument maintenance, and work load optimization.

The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wave lengths) on plasma samples.

Fundamental technologies 2)

The proposed device has same fundamental technological characteristics as the predicate device based on the following:

. . Chronometry Measurement Principle

The principle consists in measuring the variations of the ball oscillation amplitude through inductive sensors. The ball has a pendular movement obtained:

thanks to the two curved rail tracks of the cuvettes
and an alternate electro-magnetic field created by two independent . coils.
The oscillation amplitude is constant when the environment has a constant viscosity. The oscillation amplitude decreases when the environment viscosity increases as shown in Schema 1.

Image /page/3/Figure/13 description: The image shows a diagram of the amplitude of a ball oscillation during clotting. The diagram shows a U-shaped container with three balls inside, oscillating back and forth. Below the container is a graph showing the amplitude of the ball oscillation over time, with the amplitude decreasing as clotting occurs. The graph is labeled with "Amplitude of the ball oscillation" and "Clotting".

Schema 1: Amplitude of the ball oscillation during clotting

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Photometry Measurement Principle ●

The detection of chromogenic assays is based on the absorbance (optical density: O.D) of monochromatic light passing through the cuvette as a chromogenic reaction takes place.

Incident light entering the cuvette is partially absorbed by the reaction mixture as it passes through. The transmitted light is measured, and converted to absorbance. The Beer-lambert law is applied to convert absorbance to concentration of the substance being measured. The principle of absorbance measurement is depicted by the Schema 2.

Schema 2: Measurement principle of absorbance

Image /page/4/Picture/7 description: The image shows a diagram of light passing through a liquid in a container. There are three light intensities labeled in the image: I0, Ip, and Ih. The light intensity Ih is equal to the sum of I and Ip. There is also a small square in the upper right corner of the image with some numbers in it.

G. Substantial Equivalence

The STA Compact Max® and its Predicate Device, STA Compact® (K093167) have the same Indications for Use, Technology, Principles of Operation and comparable Performances as described in Table 1.

Characteristics orAttributes	Diagnostica Stago, STACompact Max®	Diagnostica Stago, STACompact®
510(k) number	510(k) subject device	K093167
Indications forUse/Intended Use	The STA Compact Max® is afully automatic clinicalinstrument indicated andintended for the performanceof tests on human plasmas,the results of which aid in thediagnosis of coagulationabnormalities or inmonitoring anticoagulanttherapy.	The STA Compact® is a fullyautomatic clinical instrumentindicated and intended for theperformance of tests onhuman plasmas, the results ofwhich aid in the diagnosis ofcoagulation abnormalities orin monitoring anticoagulanttherapy.
Target Population	To aid in the diagnosis ofcoagulation abnormalities orin monitoring anticoagulanttherapy in patients	To aid in the diagnosis ofcoagulation abnormalities orin monitoring anticoagulanttherapy in patients.

Table 1: Substantial Equivalence Comparison
---------------------------------------------	--	--	--	--	--

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Diagnostica Stago, Inc STA Compact Max®

Anatomical Sites	In vitro testing of humanplasma	In vitro testing of humanplasma
Point of use	Hospital Laboratory or otherHealth Care Laboratory.	Hospital Laboratory or otherHealth Care Laboratory.
Fundamental ScientificTechnology	There is no change in theFundamental Scientifictechnology used. No newquestion generated.	No new questionsdemonstrated in K093167.
Chronometric Method ofCoagulation Detection	Mechanical measurement ofthe oscillation of the metalball in the cuvette.	Mechanical measurement ofthe oscillation of the metalball in the cuvette.
Photometric method ofCoagulation Detection	Light absorption techniqueprovided by a filtered lightsource.	Light absorption techniqueprovided by a filtered lightsource.
Design Control	Design Controls: Verificationand Validation utilized.	Design Controls: Verificationand Validation utilized.
Electrical Safety	UL Listed.	UL Listed.
Performance	Same as Predicate Device	See K093167

The specific differences between the instruments are the on-board computer, to allow the use of Windows operating system, new peripherals (USB, CD/DVD), and the migration of the application software with a new graphical user interface. The purposes are to improve the ease of use, to include operator/user use enhancements and to manage obsolescence (See Table 2). These modifications don't change, delete or add functionalities.

The modifications of external design: color and shape, are only a marketing purpose, and has no impact on performances, principles of operation or fundamental technologies.

Features	STA Compact Max®	STA Compact®Predicate Device K093167
Dimensions	Height	705 mm (27.75 in)	640mm (26.5 in)
	Width	970 mm (38.18 in)	975mm (38.4 in)
	Depth	730 mm (28.73 in)lower part 685 mm (26.97in)	720mm (28.3 in)lower part 657 mm (25.9 in)
Weight		140 kg (331 lbm)	140 kg (331 lbm)
Barcode ID of samples and reagents		Yes	Yes
Integrated PC		Yes	Yes
Connections		USB, RJ45, Port parallel	Port parallel
Disk		CD/DVD disk	floppy disk
Touch Screen		Yes	No
Optical Wavelengths		405μm, 540μm	405μm, 540μm
Mechanical clotting		Yes	Yes
Disposables		identical	identical

Table 2: Minor Modifications comparison

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Firmware versions of STA Compact Max® and its predicate device, STA Compact® are strictly identical as described below.

Name	Version	Description
MSTB	V1.00	Measurement
GSTB	V4.72	Management of the measurement and itsenvironment
ISTB	V3.10	Identification of the products and sample(controlling barre code reader)
CSTB	V10.42	Needles control (z axis).
	V1.81	Needles control (z axis) with cap piercing
MPP	V2.81	Arms and pipetting control

Table 3: Firmware versions shared by STA Compact Max® and STA Compact®

Conclusion

The STA Compact Max and its Predicate Device, STA Compact® (K093167), have the same Intended Use/Indications for Use, same fundamental technological characteristics, principles of operation and comparable performances characteristics. The modifications consist in a new PC on-board computer, with new operating system, new peripherals, a new graphical user interface to include operator/user use enhancements and to improve easy to use.

As evidenced by Risk Assessment and Validation Studies, no new questions were raised regarding the Safety, Effectiveness, Performance, Indication for Use, Technology and the Principles of Operation. Therefore, The STA Compact Max® is substantially equivalent to the STA Compact® Predicate Device.

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: ·

, .

Attachment_05

Proposed Labeling

Symbol	Meaning
Image: Alternating current symbol	Alternating current
Image: Direct current symbol	Direct Current
Image: Protective conductor terminal symbol	Protective conductor terminal
Image: Off (Power) symbol	Off (Power)
Image: On (Power) symbol	On (Power)
Image: Caution, risk of electric shock symbol	Caution, risk of electric shock
Image: Caution, hot surface symbol	Caution, hot surface
Image: Caution, consult documentation symbol	Caution, consult the provided documentation for important cautionaryinformation such as warnings and precautions
Image: Caution, biological risks symbol	Caution, biological risks
Image: In vitro diagnostic medical device symbol	In vitro diagnostic medical device
Image: Medical device manufacturer symbol	Medical device manufacturer
Image: Separate collection symbol	Separate collection: do not discard with other waste.
Image: Hourglass symbol	For additional information about the disposal procedure, see chapter1.8.

This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized design featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being.

Public Health Service

February 12, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Diagnostica Stago, Inc. c/o Mr. Carlo d'Alessandro. Director, IVD Quality and Regulatory Donawa Lifescience Consulting Piazza Albania, 10 Rome, Italy 00153

Re: K130090

Trade/Device Name: STA Compact Max® Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: January 11, 2013 Received: January 18, 2013

Dear Mr. d'Alessandro:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Carlo d'Alessandro

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Maria Mix Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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Attachment 01

Indications for Use

K130090 510(k) Number (if known):

STA Compact Max®

Indications for Use:

Device Name:

Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Sereh

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K130090

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.