(29 days)
The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). 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.
The provided text is a 510(k) summary for the STA R Max® device. This document focuses on demonstrating substantial equivalence to a predicate device (STA-R Evolution® Expert Series) for regulatory approval, rather than detailing a study that proves the device meets specific acceptance criteria based on performance metrics.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance studies, and ground truth establishment cannot be found in this document.
The document does describe the device's intended use, principle of operation, and how it is substantially equivalent to its predicate.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing characteristics, not on presenting specific performance data against predefined acceptance criteria for the subject device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document does not describe a clinical or performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document does not describe the establishment of a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The document does not describe the use of a test set or an adjudication method.
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
This information is not provided in the document. The STA R Max® is an automated clinical instrument for coagulation studies, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers assisting AI is not relevant to this device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the STA R Max® as a "fully automatic clinical instrument" which performs tests and reports results. This implies a standalone (algorithm only) performance, however, specific performance metrics or a dedicated standalone study are not detailed. The document relies on similarity to the predicate device, not on new standalone performance studies of the subject device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The document does not detail how specific ground truth was established for performance evaluation of the subject device. The clearance is based on substantial equivalence.
8. The sample size for the training set
This information is not provided in the document. The document does not describe a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not provided in the document. The document does not describe a training set or its ground truth.
Summary of available information related to the device and its regulatory submission:
- Device Name: STA R Max®
- Regulation Number: 21 CFR 864.5425
- Regulation Name: Multipurpose system for in vitro coagulation studies
- Regulatory Class: Class II
- Product Code: JPA
- Indications for Use: The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
- Predicate Device: STA-R Evolution® Expert Series (K093001)
Key points from the "Substantial Equivalence Comparison" (Table 1):
The document argues for substantial equivalence based on the following:
- Identical Indications for Use/Intended Use.
- Identical Target Population (to aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy in patients).
- Identical Anatomical Sites (in vitro testing of human plasma).
- Identical Point of use (Hospital Laboratory or other Health Care Laboratory).
- Identical Chronometric Method of Coagulation Detection (Mechanical measurement of the oscillation of the metal ball in the cuvette).
- Identical Photometric Method of Coagulation Detection (Light absorption technique provided by a filtered light source (405μm, 540μm)).
- Identical Electrical Safety standards.
- Identical Disposables.
Differences highlighted in the table, but deemed not to affect substantial equivalence:
- Dimensions, Integrated PC specifications (processor, memory, hard disk), Weight, Connections, Disk drive, Computer table, Touch Screen: These are considered minor differences stemming from obsolescence of computer peripherals, ergonomic enhancements, and new graphical interface/communication protocol, with "no impact on performance, principle of operation, or fundamental technology."
Conclusion drawn from the document: The STA R Max® is substantially equivalent to the STA-R Evolution® Expert Series (K093001) predicate device because they share the same intended use, fundamental technology, principles of operation, and comparable performance characteristics. The modifications are primarily software (GUI, communication protocol), new peripherals, and external design changes for ergonomics. The document states that "no new questions of safety and effectiveness were raised" through risk assessment and verification/validation activities.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
Diagnostica Stago, Inc. James Monroe Regulatory Project Manager 5 Century Drive Parsippany, NJ 07054
Re: K151867
Trade/Device Name: STA R Max® Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: June 29, 2015 Received: July 10, 2015
Dear Mr. Monroe:
This letter corrects our substantially equivalent letter of August 7, 2015.
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
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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 ); medical device reporting (reporting of medical 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 Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) 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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Indications for Use
510(k) Number (if known)
Device Name STA R Max®
Indications for Use (Describe)
The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/14 description: The image features the logo for Stago, a company specializing in in-vitro diagnostics. The logo consists of the word "Stago" in a serif font, with the "S" capitalized and the rest of the letters in lowercase. Above the word "Stago" is an abstract graphic element, featuring a red shape resembling a stylized flame or leaf, positioned next to a gray teardrop shape. The overall design is clean and professional, reflecting the company's focus on healthcare and diagnostics.
Attachment_09
510(k) Summary
STA R Max®
| A. 510(k) Submitter information | ||
|---|---|---|
| B. Device Information | ||
| C. Predicate Device Information | ||
| D. Indication/Intended Use | ||
| E. Purpose of the Special 510(k) Notice | ||
| F. Description of the device | ||
| 1) | Principles of Operation | |
| 2) | Fundamental technologies | |
| G. Substantial Equivalence |
A. 510(k) Submitter information
| Submitter's name | Diagnostica STAGO S.A.S |
|---|---|
| 125 Avenue Louis Roche | |
| Address | 92230 Gennevilliers |
| France | |
| Phone Number | +33 1 46 85 48 80 |
| Fax Number | +33 1 41 47 57 50 |
| Date of Preparation | 06/29/2015 |
Application Correspondent and Contact Person information
| Name | James Monroe |
|---|---|
| Address | 5 Century DriveParsippany, New Jersey 07054 |
| Phone Number | +1-973-631-1200 x 4306 |
| Fax Number | +1-973-775-8063 |
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
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B. Device Information
| Device Trade Name | STA R 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 |
| Picture 1: STA R Max® | |
|---|---|
| ----------------------- | -- |
Image /page/4/Picture/6 description: The image shows a large, automated laboratory analyzer and a computer workstation. The analyzer is white and gray with a blue-tinted window, and it has a sample loading area on the left side. The computer workstation includes a monitor, keyboard, mouse, and barcode scanner, all mounted on a rolling stand. The analyzer is likely used for high-throughput clinical chemistry or immunoassay testing.
C. Predicate Device Information
| 510(k) Number | K093001 |
|---|---|
| Device Trade Name | STA-R Evolution® Expert Series |
| Device Common Name | STA-R Evolution® Expert SeriesIVD Coagulation Device/Instrument Automated andSemi-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 |
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
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Image /page/5/Picture/3 description: The image shows a STA-R Evolution Expert Series machine, identified by the code (K093001). It features a monitor at the top, displaying a graphical user interface with various icons and data points. The machine has a modular design with different sections, including a sample loading area and a processing unit, all mounted on wheels for mobility.
Picture 2: STA-R Evolution® Expert Series
D. Indication/Intended Use
The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
E. Purnose of the Snecial 510(k) Notice
The STA R Max® is a modification to the company's own legally marketed device, STA-R Evolution® Expert Series (K093001).
The modifications of the device involve:
- Implementation of a new graphical user interface (GUI) to use the graphical chart -1of Max line of STA Analyzers.
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- -2-Changes to the external design (colors and shape) of the analyzer which include modifications of the openings and the addition of a new computer table for improved ergonomics.
- -3-Improvement of the communication protocol with a LIS or a middleware so more information can be exchanged.
F. Description of the device
Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment.
The device consists of the following components:
- -1a 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;
- three needles that will aspirate and dispense the patient's sample and reagents into -3the cuvette:
- -4oscillation amplitude detection of a metal ball in a cuvette to measure sample coagulation by the chronometric method;
- -2a 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-
Principles of Operation 1)
The principles of operation are the same as described for STA -R Evolution® Expert Series (predicate device) in submission, K093001. A brief summary follows:
-
The STA R Max® is designed as a fully automatic system. 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, system supervision, support for instrument maintenance, and workload optimization.
-
The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators and controls
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facilitate their use on the system and facilitates reagent management. Manual entry of reagent information enables the use of non-barcoded-reagents.
-
There are two methods used by the instrument to measure coagulation: the chronometric (clotting time or clot-based measurements) and photometric assays (at specific wave lengths) on plasma samples.
2) Fundamental technologies
The Technological characteristics are the same for the STA R Max® and the STA-R Evolution® Expert Series
● 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:
- due to the two curved rail tracks in the bottom of the cuvettes
- and an alternating electromagnetic field generated by two independent drive coils.
The oscillation amplitude is constant when the viscosity of the medium through which the ball moves remains constant.
The oscillation amplitude decreases when the viscosity of this medium increases as shown in Schema 1.
Image /page/7/Figure/13 description: The image shows a diagram of a ball oscillating in a container, along with a graph of the amplitude of the ball's oscillation over time. The graph shows that the amplitude of the ball's oscillation decreases over time, eventually leading to clotting. The x-axis of the graph is labeled "Amplitude of the ball oscillation", and the y-axis is labeled "T".
Schema 1: Amplitude of the ball oscillation during clotting
- Photometry Measurement Principle
The detection principle for chromogenic or immunological analyses on the STA R Max® is based on the absorbance (optical density, O.D.) of monochromatic (405 nm or 540 nm) light passing through a cuvette as an enzymatic or immunological reaction takes place.
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The principle underlying the measurement of absorbance is depicted in the Schema 2 below:
Image /page/8/Figure/4 description: The image contains the text "Schema 2: Measurement principle of absorbance". The text appears to be a title or heading, possibly indicating the subject matter of a diagram or explanation related to the measurement principle of absorbance. The text is written in a formal font.
Image /page/8/Picture/5 description: The image shows a diagram of a container with liquid and arrows indicating light intensity. The arrows are labeled I0, Ip, and I1=I+Ip, representing different light intensities. In the upper right corner, there is a table showing DO values with corresponding numbers 0, 1, and 2, and values of 1, 1.0, and 100.
Incident light (lo) entering the cuvette is partially absorbed by the reaction medium as it passes through.
The transmitted light (I1 = I + Ip) is measured.
The effect of stray light (lo) is eliminated by taking two measurements of transmitted light within a brief interval:
I1 = I + In (first measurement which includes incident light and stray light)
I2 = Io (second measurement, while blocking incident light, corresponds to the stray light)
l2 is subtracted from 11 to obtain I, which corresponds to light resulting only from incident light. Stray light (In) is assumed to remain constant between the two measurements.
The absorbance is calculated using the following equation: A = -log(I/Io) note: log decimal
Monochromatic incident light (lo) is produced by passing light from a tungstenhalogen lamp through a 405 nm or 540 nm monochromatic filter, placed in a mobile filter holder.
These parts are located inside the optical module. The monochromatic light is directed from the optical module to the measurement heads by optical fibers, then another set of optical fibers carries the light from the measurement heads to the photometry measurement board.
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
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G. Substantial Equivalence
The STA R Max® and its Predicate Device, STA-R Evolution® Expert Series (K093001) have the same Indications for Use, Technology, Principles of Operation and comparable Performances as described in Table 1.
| Table 1. Substantial Equivalence Comparison | ||
|---|---|---|
| Characteristicsor Attributes | Diagnostica Stago,STA R Max® | Diagnostica Stago,STA-R Evolution®Expert Series | Identical/Different | |
|---|---|---|---|---|
| 510(k) number | 510(k) subject device | K093001 | N/A | |
| Indications forUse/IntendedUse | The STA R Max® 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. | The STA-R Evolution®Expert Series is a fullyautomatic clinicalinstrument indicatedand intended for theperformance of tests onhuman plasmas, theresults of which aid inthe diagnosis ofcoagulationabnormalities or inmonitoringanticoagulant therapy. | Identical | |
| TargetPopulation | To aid in the diagnosis ofcoagulation abnormalities orin monitoring anticoagulanttherapy in patients. | To aid in the diagnosisof coagulationabnormalities or inmonitoringanticoagulant therapyin patients. | Identical | |
| AnatomicalSites | In vitro testing of humanplasma | In vitro testing ofhuman plasma | Identical | |
| Point of use | Hospital Laboratory or otherHealth Care Laboratory. | Hospital Laboratory orother Health CareLaboratory. | Identical | |
| ChronometricMethod ofCoagulationDetection | Mechanical measurement ofthe oscillation of the metalball in the cuvette. | Mechanicalmeasurement of theoscillation of the metalball in the cuvette. | Identical | |
| Photometricmethod ofCoagulationDetection | Light absorption techniqueprovided by a filtered lightsource (405μm, 540μm). | Light absorptiontechnique provided bya filtered light source(405μm, 540μm). | Identical | |
| Characteristicsor Attributes | DiagnosticaStago, STA RMax® | Diagnostica Stago,STA-R Evolution®Expert Series | Identical/Different | |
| Electrical Safety | UL Listed.+ IEC 61010-2-101:2003 - Safetyrequirements forelectrical equipment formeasurement, controland laboratory use –Part 2-101: Particularrequirements for invitro diagnostic (IVD)medical equipment. | UL Listed.+ IEC 61010-2-101:2003 - Safetyrequirements forelectrical equipment formeasurement, controland laboratory use –Part 2-101: Particularrequirements for in vitrodiagnostic (IVD)medical equipment. | Identical | |
| Dimensions | Height | 1265 mm | 1250 mm | Different |
| Width | 1220 mm | 1280 mm | Different | |
| Depth | 805 mm | 820 mm | Different | |
| IntegratedPC | µprocessor | Intel Celeron M4231.06 GHz | Pentium MMX(200MHz Min) | Different |
| Memory | 1 GB | 64Mb (Min) | Different | |
| Harddisk | 80 GB | 2.4 GB (Min) | Different | |
| Weight | 238 kg | 226 kg | Different | |
| Barcode ID of samples andreagents | Yes | Yes | Identical | |
| Connections | RS232, USB, RJ45 | RS232 | Different | |
| Disk | None (external USBCD/DVD optional) | CD/DVD recorder,floppy disk | Different | |
| Computer table | Yes (with 6 x 2.0USB ports to connectthe following USBperipheral devices:keyboard, mouse,touchscreen, printer,USB flash drive) | Yes (unconnected) | Different | |
| Touch Screen | Yes | Yes (optional) | Different | |
| Disposables | identical | identical | Identical |
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
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Image /page/10/Picture/1 description: The image shows the logo for Stago, a company that specializes in in-vitro diagnostics. The logo features the company name "Stago" in a serif font, with the "S" slightly larger than the other letters. Above the name is an abstract graphic element in two colors: red and gray. The red portion is shaped like a curved triangle, while the gray portion resembles a crescent shape.
Comparison between the predicate and subject devices have minor differences. The differences are a result of the obsolescence of computer peripherals such as floppy discs, computer processors, and the addition of the new graphic interface and evolution of the communication protocol have no impact on performance, principle of operation, or
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Image /page/11/Picture/1 description: The image shows the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word is a stylized graphic element that resembles two overlapping shapes, one red and one gray. The red shape is positioned slightly above and to the left of the gray shape, creating a sense of depth.
fundamental technology. The modifications of external design (e.g. color, weight, dimension, and shape) are ergonomic and cosmetic enhancements, which neither affect the fundamental technology, nor raise any new questions of safety and effectiveness. Thus the two devices are substantially equivalent with respect to their key attributes.
Conclusion
The STA R Max® and its Predicate Device, STA-R Evolution® Expert Series (K093001), have the same Intended Use/Indications for Use, same fundamental technology, same principles of operation, and comparable performance characteristics. The modifications consist of changes to the software (to integrate a new graphical user interface and a new communication protocol), new peripherals, and new external shape (for ergonomic improvements).
As evidenced by risk assessment and verification and validation activities, no new questions of safety and effectiveness were raised. Therefore we believe, the STA R Max® is substantially equivalent to the STA-R Evolution® Expert Series (K093001) predicate device.
§ 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.