(81 days)
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
The Omni S analyzer represents a combined pH, blood gas, electrolyte, glucose, lactate, urea/BUN, total hemoglobin, hemoglobin derivatives, hematocrit and oxygen saturation test system classified as a Class II device based on the individual test parameters measured.
The provided text is a 510(k) summary for the Roche Diagnostics Omni S Analyzer. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than detailing a specific study with acceptance criteria and performance metrics in the way a clinical trial report would.
Therefore, the information required to fully answer your request regarding acceptance criteria and the study that proves the device meets the acceptance criteria is not explicitly present in the provided document.
Here's what can be extracted and what is missing, based on the standard structure of your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The 510(k) summary states that the Omni S Analyzer has "incorporated the same blood gas modules as utilized in the Omni Modular and Omni C analyzers," and "the same ISE modules," "the same tHb (total hemoglobin ) and SO2 (oxygen saturation) sensor," and "similar types of MSS sensors." This implies that the performance of the Omni S is expected to be substantially equivalent to the predicate devices, but specific numerical acceptance criteria or performance results for the Omni S are not presented.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. While it mentions "samples of whole blood, serum, plasma and aqueous solutions," it does not specify the sample size used in any testing or the provenance (country, retrospective/prospective) of such data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The device is a diagnostic analyzer for measuring various physiological parameters, and its ground truth would typically be established by reference methods or validated laboratory instruments, not necessarily through human expert consensus in the same way an imaging AI might.
4. Adjudication Method for the Test Set:
This information is not provided in the document. As mentioned above, the nature of the device's measurements would typically rely on instrument-based validation rather than human adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This type of study is relevant for devices like imaging AI that assist human readers in interpretation. The Omni S Analyzer is a laboratory instrument that provides direct measurements, not an assistive AI for human interpretation.
6. If a Standalone Study Was Done:
The document implies that the device (Omni S Analyzer) was tested for its performance, as it leverages components from previous cleared devices. However, a detailed "standalone study" report with specific performance metrics (e.g., accuracy, precision, linearity) for the Omni S itself is not included in this 510(k) summary. The summary focuses on demonstrating substantial equivalence by comparing its components and intended use to existing, legally marketed devices.
7. The Type of Ground Truth Used:
While not explicitly stated for the Omni S, for such laboratory analyzers, the ground truth would typically be established by reference methods or by measurements obtained from validated predicate devices or established laboratory techniques known to be accurate.
8. The Sample Size for the Training Set:
This information is not applicable as the Omni S Analyzer is not an AI/ML device that requires a "training set" in the conventional sense. It's an automated analyzer based on established sensor technologies.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
In summary:
This 510(k) summary is designed to demonstrate substantial equivalence to predicate devices, mainly by comparing the intended use, measured parameters, and the nature of the incorporated modules (e.g., "same blood gas modules," "similar types of MSS sensors"). It does not contain the detailed study results with acceptance criteria and performance metrics that would be part of a full validation report for the device.
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K032-311
OCT 17 2003
510(k) Summary
:
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250Contact Person: Jennifer TribbettDate Prepared: July 25, 2003 |
| 2) Device name | Proprietary name: Omni S AnalyzerCommon name or Classification Name: Automated analyzer for themeasurement of pH, blood gases, electrolytes, hematocrit, glucose, lactate,urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin,deoxyhemoglobin, carboxyhemoglobin and methemoglobin. |
| 3) Predicatedevice | We claim substantial equivalence to the current legally marketed OmniModular Analyzer (K990092) and the Omni C Analyzer (K013373). |
| 4) DeviceDescription | The Omni S analyzer represents a combined pH, blood gas, electrolyte,glucose, lactate, urea/BUN, total hemoglobin, hemoglobin derivatives,hematocrit and oxygen saturation test system classified as a Class II devicebased on the individual test parameters measured. |
| 5) Intended use | The Roche Diagnostics Omni S Analyzer is a fully automated critical careanalyzer intended to be used for the measurement of pH, PO2, PCO2, sodium,potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN,total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin,carboxyhemoglobin and methemoglobin in samples of whole blood, serum,plasma and aqueous solutions as appropriate. |
Continued on next page
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Comparison to Predicate Device
- Intended Use As shown in the following comparison table the intended use of the OMNI S covers the measurements of the parameters currently available on the OMNI Modular system with the addition of the oxygen saturation parameter of the OMNI C.
| Topic | OMNI S Analyzer | OMNI Modular Analyzer(K990092) | OMNI C Analyzer(K013373) |
|---|---|---|---|
| Intended Use | Omni S Analyzer is intended tobe used for the measurement ofpH, PO2, PCO2, sodium,potassium, ionized calcium,chloride, hematocrit, glucose,lactate, urea/BUN, totalhemoglobin, oxygen saturation,oxyhemoglobin,deoxyhemoglobin,carboxyhemoglobin andmethemoglobin in samples ofwhole blood, serum, plasma andaqueous solutions as appropriate. | Omni Modular Analyzer isintended to be used for themeasurement of pH, PCO2, PO2,total hemoglobin,deoxyhemoglobin,oxyhemoglobin,carboxyhemoglobin,methemoglobin, sulfhemoglobin,sodium, potassium, chloride,ionized calcium, hematocrit,glucose, lactate and ureanitrogen, in samples of wholeblood, serum, plasma andaqueous solutions as appropriate. | Omni C Analyzer is intendedto be used for themeasurement of pH, PO2,PCO2, sodium, potassium,ionized calcium, chloride,hematocrit, total hemoglobin,and oxygen saturation insamples of whole blood,serum, plasma and aqueoussolutions as appropriate. |
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Comparison to Predicate Device, Continued
| Similarities anddifferences frompredicate devices | The information listed below describes the similarities and differencesbetween the Omni S analyzer and the predicate Omni Modular and Omni Canalyzers. |
|---|---|
| ----------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Topic | Description |
|---|---|
| Parameters Measured | pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose,lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin,deoxyhemoglobin, carboxyhemoglobin and methemoglobin |
| Same as the combination of Omni Modular and Omni C parameters. | |
| Omni Modular: pH, PCO2, PO2, total hemoglobin, deoxyhemoglobin,oxyhemoglobin, carboxyhemoglobin, methemoglobin, sulfhemoglobin sodium,potassium, chloride, ionized calcium, hematocrit, glucose, lactate and urea nitrogen | |
| Omni C: pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit,total hemoglobin, and oxygen saturation | |
| Sample Types | Same as Omni Modular and Omni C:Whole blood, serum, plasma and aqueous (QC material and dialysis) solutions |
| Blood Gases (pO2,pCO2, pH) | The Omni S has incorporated the same blood gas modules as utilized in the OmniModular and Omni C analyzers. |
| ISE (sodium,potassium, calcium,chloride) | The Omni S has incorporated the same ISE modules as utilized in the Omni Modularand Omni C analyzers. |
| tHB and SO2 | The Omni S has incorporated the same tHb (total hemoglobin ) and SO2 (oxygensaturation) sensor as utilized in the Omni C analyzer. |
| MSS (glucose,lactate, urea/BUN)chamber | The Omni S has incorporated similar types of MSS sensors as utilized in the OmniModular analyzer; however, the Omni S uses Braunstein instead of PACE technologyfor the glucose and lactate parameters. |
| The Omni S MSS chamber also incorporates some enhancements. The sampledetection feature has been improved and the MSS chamber contains an additionaljunction in the front to allow for direct aspiration of standby solution. | |
| Reagent Supply | The Omni S will provide enhanced customer convenience by utilizing two reagentpacks (7 incorporated pouches) plus two bottles instead of the fourteen bottlescurrently used on the Omni Modular system. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 17 2003
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K032311 Trade/Device Name: Omni S. Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (Pco2, Po2) and blood pH test system Regulatory Class: Class II Product Code: CEM: JFP; JGS; CGZ; CHL;KHP; CGA; CDS;GKR; GGZ; GKF; GHS; KHG Dated: July 25, 2003 Received: July 28, 2003
Dear Ms. Tribbett:
Re:
We have reviewed vour 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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).
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Page 2 -
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.
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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Indications for Use Statement
510(k) Number (if known): Device Name: Omni S Analyzer
Indications for Use:
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K032311
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.