(46 days)
The Dimension ® clinical chemistry system is an in vitro diagnostic device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
The Dimension system chemical and immunochemical applications utilize photometric, turbidimetric, and integrated ion selective multisensor technology for clinical use.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used for diagnosis in diseases with high and low Potassium levels.
Chloride measurements are primarily use to detect and treatment of metabolic disorders.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Thyroid stimulating hormone measurements are used in diagnosis of thyroid or pituitary disorders.
Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
The Siemens Healthcare Diagnostics Dimension® clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex® reagent test cartridges to measure a variety of analytes in human body fluids. The systems can process samples in random access, batch and stat modes. The systems are multi-functional analytical tools that process chemical and immunochenical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension systems include the ability to communicate and connect with laboratory information system (LIS) networks.
With revision 10.0 software, the Operating System of the Dimension clinical chemistry analyzers, RxL/ RxLMax (K963498), Xpand Plus (K010061), will change from QNX to Linux.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Dimension® RxL/RxL Max clinical chemistry analyzer (with Linux Operating System)
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantified, pass/fail manner. Instead, the acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device. The key performance metrics evaluated were Method Comparison and Precision (within run, within lab) for specific representative assays. The performance is reported as meeting this equivalency.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence in Principle | Determined based on similarity of system design (floor model, microprocessor-controlled, integrated instrument systems using prepackaged Siemens Flex® reagent cartridges and integrated ion selective multisensor technology). The primary change is the OS from QNX to Linux. |
| Substantial Equivalence in Performance for Representative Methods (Method Comparison) | "Comparative data for Method Comparison...demonstrate equivalent performance in evaluations of the representative methods." |
| Substantial Equivalence in Performance for Representative Methods (Precision - within run, within lab) | "...and Precision (with in run, within lab) demonstrate equivalent performance in evaluations of the representative methods." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that "representative methods were tested" and compares "the same samples and methods" on predicate and test instruments. However, the specific number of samples (sample size) used for the test set for Method Comparison and Precision studies is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be prospective in the sense that samples were deliberately run on both the predicate and test devices for comparison purposes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is an in vitro diagnostic chemistry analyzer, and its performance is evaluated against itself (predicate device performance) using quantitative measurements, not against expert human interpretations or diagnoses. The ground truth would be the actual concentration of analytes in the samples.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is a quantitative analytical device comparison, not a diagnostic interpretation where adjudication of expert opinions would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This type of study (MRMC) is typically performed for diagnostic imaging or similar devices where multiple human readers interpret cases. This submission is for a clinical chemistry analyzer, which does not involve human interpretation of outputs in the same way. The evaluation is purely based on instrument performance.
6. Standalone (Algorithm Only) Performance:
Yes, an equivalent of a "standalone" performance was done. The study directly compared the analytical results obtained from the Dimension® clinical chemistry system with the Linux operating system (test device) against the analytical results obtained from the Dimension® clinical chemistry system with the QNX operating system (predicate device). The evaluation focuses solely on the output of the instrument itself, without human intervention in the result generation.
7. Type of Ground Truth Used:
The ground truth implicitly used for the performance comparison is the analytical result produced by the predicate device. The goal was to show that the new device (with Linux OS) produces equivalent results to the established predicate device (with QNX OS) when processing the same samples. The underlying ground truth for the analytes themselves would be the true concentration in the human body fluids, likely measured by a highly accurate validated method, but the comparison here is between two versions of the same product.
8. Sample Size for the Training Set:
Not applicable. This device is a measurement instrument, not an AI or machine learning model that requires a training set in the conventional sense. The "training" of such a system would involve instrument calibration and quality control procedures, but not a data-driven training set like an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reasons as point 8.
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Summary of Safety and Effectiveness Information
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.
| Submitter's Name: | Lorraine H PiestrakSiemens Healthcare DiagnosticsP.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Contact Information: | Siemens Healthcare DiagnosticsP.O. Box 6101Newark, DE 19714Attn: LH PiestrakTelephone: 302.631.6279 |
Date of Preparation: November 15, 2011
Name of Product:
Dimension® RxL/RxL Max clinical chemistry analyzer (with Linux Operating System)
FDA Classification Name:
Discrete photometric chemistry analyzer for clinical use (Class I)
Predicate Device:
The following table describes the predicate device, device classification, regulation and product code associated with this pre-market notification:
| NewProduct | PredicateDevice | Predicate510(k) | DeviceClass | Regulation | ProductCode |
|---|---|---|---|---|---|
| Dimension® RxL/RxLMax clinical chemistryanalyzer(with Linux Operating System) | Dimension® RxL/RxL Maxclinical chemistry analyzer(with QNX Operating System) | K963498 | I | 862.2160 | JJE |
Device Description:
The Siemens Healthcare Diagnostics Dimension® clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex® reagent test cartridges to measure a variety of analytes in human body fluids. The systems can process samples in random access, batch and stat modes. The systems are multi-functional analytical tools that process chemical and immunochenical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension systems include the ability to communicate and connect with laboratory information system (LIS) networks.
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With revision 10.0 software, the Operating System of the Dimension clinical chemistry analyzers, RxL/ RxLMax (K963498), Xpand Plus (K010061), will change from QNX to Linux.
Intended Use:
The Dimension ® clinical chemistry system is an in vitro diagnostic device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
The Dimension system chemical and immunochemical applications utilize photometric, turbidimetric, and integrated ion selective multisensor technology for clinical use.
Comparison to Predicate Device:
The Dimension® clinical chemistry systems with the Linux operating system (revision 10.0 software) and the predicate Dimension systems employ prepackaged reagents in flexible plastic, Siemens Flex® reagent cartridges. Both systems automatically process and analyze clinical samples using a variety of in vitro diagnostic test methods. Both systems utilize integrated, ion selective multisensor detection technology for analysis of sodium, potassium and chloride electrolytes. A comparison of the important similarities and differences is provided in the following table:
| Similar Features | Test Devices(with Linux) | Predicate Devices(with QNX) |
|---|---|---|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| System Control | Fully automatic,microprocessor controlled | Fully automatic,microprocessor controlled |
| User Interface | Keyboard controlStationary barcode scannersGraphical user interface | Keyboard controlStationary barcode scannersGraphical user interface |
| DetectionTechnologies | photometricturbidimetricmultisensor electrodes, ionselective | photometricturbidimetricmultisensor electrodes, ion selective |
| Reagents | Prepackaged, 6 & 8 well plastic,Siemens Flex® reagent cartridgesstored on board | Prepackaged, 6 & 8 well plastic,Siemens Flex® reagent cartridgesstored on board |
| System fluids andSupplies | Stored on board | Stored on board |
| Reaction Vessels | soft, plastic cuvettes &plastic reaction vessels | soft, plastic cuvettes &plastic reaction vessels |
| Temperature control | Reactions are controlled at 37°CReagents are stored at 2 to 8 °C | Reactions are controlled at 37°CReagents are stored at 2 to 8 °C |
| Spectral Selection | Interference filters -quartz/halogen lamp source | Interference filters -quartz/halogen lamp source |
| Test Throughput(typical) | Up to 500 tests/hr | Up to 500 tests/hr |
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| LIS externalconnectivitycapability | Yes | Yes |
|---|---|---|
| SystemPerformanceMonitoring | Traditional preventativemaintenance (time-based) | Traditional preventative maintenance(time-based) |
| Sample LevelDetection Capability | Automatic | Automatic |
| Calibration/QC | Manual calibration/QC | Manual calibration/QC |
| Sample Integrity(hemolysis, icterus,lipemia) Monitoring | Yes - spectral interferencemonitoring (optional) | Yes- spectral interferencemonitoring (optional) |
| Different Features | Test Devices | Predicate Devices |
|---|---|---|
| Operating System | Linux | QNX |
| Data storage device | USB | Floppy disk |
| Designated PrintedCircuit Boards | RoHS compliant. | Not RoHS compliant |
Comments on Substantial Equivalence:
Models of the Dimension® clinical chemistry systems are designed similarly for the same purpose. They are floor model units that are microprocessor-controlled, integrated instrument systems that use prepackaged. Siemens Healthcare Diagnostics Flex® reagent cartridges and integrated ion selective multisensor technology to analyze a variety of analytes in human body fluids. The instruments spectrally analyze processed clinical samples using chemical and immunochemical methodologies. To ensure substantial equivalence with the Operating System change, representative methods were tested on instruments with ONX based software and compared to results of the same samples and methods on instruments updated with the Linux Operating System (revision 10.0 software). The representative methods, Na. K. Cl. GLUC, TSH and AST, were chosen to exercise different detection technologies on the instruments.
Comparative data for Method Comparison and Precision (with in run, within lab) demonstrate equivalent performance in evaluations of the representative methods.
Conclusion:
The Dimension® clinical chemistry systems with the Linux Operating System (revision 10.0 software), are substantially equivalent in principle and performance to Dimension® clinical chemistry systems with QNX operating systems, based on the similarity of system design and comparative data from representative methods.
Lorraine H Piestrak Regulatory Affairs & Compliance Manager November 15, 2011
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 an abstract symbol of a human figure with outstretched arms, resembling a bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV 22 2011
Siemens Healthcare Diagnostics c/o Lorraine H. Piestrak P.O. Box 6101 Mailstop 514 Newark, DE 19714-6101
Re: K112999
Trade Name: Dimension Clinical Chemistry System Regulation Number: 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: CFR, JJE, CEM, JGS, CGZ, CIT, CEW Dated: October 6, 2011 Received: October 24, 2011
Dear Lorraine H. Piestrak:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to pareny a notification" (21 CFR 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 tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: Wiss
Enclosure
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Indications for Use
K112999 510(k) Number (if known):
Device Name:
Dimension® clinical chemistry systems with Linux Operating System (revision 10.0 software) with:
- Dimension® QuikLYTE® Integrated Multisensor (NA* / K* / Ct ) .
- Dimension® Glucose Flex® Reagent Cartridge (GLUC) .
- Dimension® Thyroid Stimulating Hormone Flex® Reagent Cartridge (TSH) . ●
- Dimension® Aspartate Aminotransferase Flex® Reagent Cartridge (AST) .
Indications For Use:
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used for diagnosis in diseases with high and low Potassium levels.
Chloride measurements are primarily use to detect and treatment of metabolic disorders.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Thyroid stimulating hormone measurements are used in diagnosis of thyroid or pituitary disorders.
Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Prescription Use ✔ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CRS
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112994
Page 1 of 2 ___
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Indications for Use
510(k) Number (if known):
Device Name: Dimension® clinical chemistry systems with Linux Operating System (revision 10.0 software)
Indications For Use:
The Dimension ® clinical chemistry system is an in vitro diagnostic device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
The Dimension system chemical and immunochemical applications utilize photometric, turbidimetric, and integrated ion selective multisensor technology for clinical use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112999
Page of 2
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.