(138 days)
The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.
The ABL700 Series Analyzer with the AutoCheck module is an ABL700 Analyzer with the added capability of performing automated analysis of quality control fluids. The AutoCheck module is designed to work with a quality control fluid system named AutoCheck 5+. The AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids in AutoCheck 5+ correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135).
The AutoCheck 5+ ampoules comprise a cap on the top of the ampoules designed to break the top of an ampoule when it is to be used. Furthermore, each ampoule has a bar code containing information on the specific level and lot of the quality control fluid.
Installing an AutoCheck module into an existing ABL700 Series Analyzer includes physically installing the module and loading upgraded software which controls the function of the AutoCheck module. The AutoCheck module comprises an ampoule carrousel carrying 20 ampoules of quality control fluid and further comprises a bar code reader for reading the bar code located on each ampoule. When installed into the ABL700 Series Analyzer, the AutoCheck module automatically performs the quality control of the analyzer. Thus, when a quality control is due, the analyzer warns the user and if the user accepts, the quality control is performed. The software selects the appropriate ampoule, the AutoCheck module opens the ampoule by pressing the cap through the top of the ampoule, the quality control fluid is automatically introduced into the analyzer inlet and the measurements are performed. The upgraded software controls all steps. If required, a manual quality control may be performed as well.
The provided text describes a medical device, the ABL700 with AutoCheck Module, and its 510(k) submission for market clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the statistical metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in such a study report.
The document focuses on:
- Product Description: How the AutoCheck module adds automated quality control functionality to the ABL700 analyzer.
- Intended Use: The parameters measured (pH, pCO2, pO2, etc.) and the types of samples (human arterial/venous and capillary whole blood).
- Technological Characteristics vs. Predicate Device: Stating it's "Similar to the ABL700 Series."
- Substantial Equivalence: Claiming it's substantially equivalent to the existing ABL700 Series (K980130).
The mention of "automated analysis of quality control fluids" is the closest it comes to a performance claim, but no specific performance targets or results are presented.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's an attempt to answer based on the available information, noting where data is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | The device performs automated analysis of quality control fluids. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "automated analysis of quality control fluids" but does not detail a specific test study with a defined sample size of these fluids.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. Ground truth for automated quality control measurements on a device would typically be established by comparing against known reference values of the quality control fluids, not expert consensus.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified.
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
- MRMC Study: No, this is not an MRMC study. The device is an automated blood gas analyzer with an automated quality control module. It does not involve human readers interpreting medical images or data that would be assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly this device operates in a standalone manner for its quality control function. The AutoCheck module "automatically performs the quality control of the analyzer." However, specific performance metrics for this standalone function are not provided.
7. The type of ground truth used
- Type of Ground Truth: For quality control fluids, the ground truth would typically be the known, certified values of the analytes (pH, pCO2, pO2, etc.) within the quality control solutions themselves. The document mentions "AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids...correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135)," indicating the use of commercial quality control materials with established values.
8. The sample size for the training set
- Sample Size (Training Set): Not specified. The device is an analyzer for blood gases and electrolytes, not an AI/ML algorithm that would typically have a "training set" in the conventional sense of machine learning. The "upgraded software" mentioned controls the automated quality control process, but the document does not describe its development in terms of a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable/Not specified, as this is not a traditional AI/ML training context for which a ground truth for a training set would be established. The "ground truth" for the device's functionality would be the accuracy and precision of its measurements against known standards, including those provided by the quality control fluids.
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RADIOMETER AMERICA INC.
MEDICAL DIVISION
810 SHARON DRIVE, WESTLAKE, OHIO 44145
810 SHARON DRIVE, 800-736-0600, 440-871-8900
JAN 1 0 2000
| SUBJECT: | 510(K) SUMMARY NUMBER: K992859 |
|---|---|
| FROM: | Vince SigmundManager of Customer Relations & Technical SupportRadiometer America Inc.810 Sharon DriveWestlake, Ohio 44145(440)871-8900, Ext. 209 or 1-800-736-0600Fax (440)871-2633 871- 2510 |
| DATE: | November 22, 1999 |
| PRODUCT: | Trade Name: ABL700 with AutoCheck ModuleCommon Name: pH/Blood Gas/Co-oximetry/Electrolyte/MetabolyteAnalyzerClassification Name: Blood Gas and Blood pH Test System |
| PREDICATE DEVICE: | RADIOMETER ABL700 Series (K980130, RADIOMETER Qualicheck 5+(K980135) and AVL9181 Electrolyte Analyzer (K972673). |
| PRODUCT DESCRIPTION: | The ABL700 Series Analyzer with the AutoCheck module is an ABL700Analyzer with the added capability of performing automated analysis ofquality control fluids. The AutoCheck module is designed to work with aquality control fluid system named AutoCheck 5+. The AutoCheck 5+ isan ampouled four level quality control fluid system. The composition of thevarious levels of Quality control fluids in AutoCheck 5+ correspond to thecomposition of the corresponding levels of Qualicheck 5+ system (K980135).The AutoCheck 5+ ampoules comprise a cap on the top of the ampoulesdesigned to break the top of an ampoule when it is to be used. Furthermore,each ampoule has a bar code containing information on the specific level andlot of the quality control fluid.Installing an AutoCheck module into an existing ABL700 Series Analyzerincludes physically installing the module and loading upgraded softwarewhich controls the function of the AutoCheck module. The AutoCheckmodule comprises an ampoule carrousel carrying 20 ampoules of qualitycontrol fluid and further comprises a bar code reader for reading the barcode located on each ampoule. When installed into the ABL700 SeriesAnalyzer, the AutoCheck module automatically performs the quality controlof the analyzer. Thus, when a quality control is due, the analyzer warns theuser and if the user accepts, the quality control is performed. The softwareselects the appropriate ampoule, the AutoCheck module opens the ampouleby pressing the cap through the top of the ampoule, the quality control fluidis automatically introduced into the analyzer inlet and the measurements areperformed. The upgraded software controls all steps. If required, a manualquality control may be performed as well. |
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RADIOMETER AMERICA INC.
| MEDICAL DIVISION | 810 SHARON DRIVE, WESTLAKE, OHIO 44145800-736-0600, 440-871-8900FAX 440-835-2633 |
|---|---|
| The automatic inlet of sample loaded into a carrousel is a principle, whichis well known from various types of analyzers. Thus, it is well known incoagulation and/or urine analyzers that the samples to be measured areloaded with a sample carrousel. Also, the AVL9181 Electrolyte Analyzer(K972673) for measuring electrolytes in i. a. whole blood, serum, or plasmacomprises a built-in autosampler. For further details of performing theautomatic quality control in the ABL700 Series Analyzer with theAutoCheck module I refer to the enclosed sections of the Operator'sManual. | |
| INTENDED USE: | The ABL700 Series Analyzer with the AutoCheck module is a stand-aloneblood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-,Glucose, Lactate, and Co-oximetry parameters on human arterial/venousand capillary whole blood. The AutoCheck Module is an addedfunctionality to perform automated analysis of quality control fluids. |
| TECHNOLOGICALCHARACTERISTICSVERSUS PREDICATEDEVICE: | Similar to the ABL700 Series |
| SUBSTANTIALEQUIVALENCE: | The ABL700 Series Analyzer with the AutoCheck module is substantiallyequivalent in features and characteristics to the current ABL700 Series(K980130) marketed by Radiometer America Inc. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 0 2000
Mr. Vincent M. Sigmund Product Manager, Quality Services Radiometer America Inc. 810 Sharon Drive Westlake, Ohio 44145
K992859 Re:
Trade Name: ABL700 with AutoCheck Module Regulatory Class: II Product Code: CHL, JFP, CGZ, CGA, KHP, CEM, JGS, GKF Regulatory Class: I Product Code: JJS, KHP Dated: December 22, 1999 Received: December 23, 1999
Dear Mr. Sigmund:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT III
510(k) NUMBER (IF KNOWN): K992859
DEVICE NAME: ABL700 with AutoCheck Module
INDICATIONS FOR USE:
The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa*, cK+, cCa2+, cCL; Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.
Dan Cooper
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use Use (Per 21 CFR 801-109) Over-The-Counter-
(Optional Format 1-2-96)
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.