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510(k) Data Aggregation

    K Number
    K093280
    Device Name
    OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
    Manufacturer
    OPTI MEDICAL SYSTEMS INC.
    Date Cleared
    2011-01-07

    (444 days)

    Product Code
    CHL,GKR,GLY,KHP
    Regulation Number
    862.1120
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K061974
    Why did this record match?
    Device Name :

    OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OPTI CCA-TS B-Lac cassette is intended to be used for in vitro measurements of pH, PCO2, PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point-of-care locations.

    Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Lactate (lactic acid) measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). Total hemoglobin measurement is used to determine the hemoglobin content of human blood. Oxygen saturation measurement is used to determine the oxygen capacity of the hemoglobin.

    The OPTI CCA-TS B-Lac cassette is for prescription use only.

    Device Description

    The OPTI CCA-TS system is a portable [4.7 x 14.2 x 9.1 inches, 12 pounds], microprocessor-based instrument using optical fluorescence for the measurement blood gases, electrolytes and enzymes and utilizes a graphical touch screen interface. There is an additional laser based measurement of total hemoglobin (tHb) and SO2 capability available with any cassette that contains a pO₂ sensor.

    The OPTI CCA-TS system is currently cleared [K993837, K984299, and K974784] for the measurement of pH, PO2, PCO2, Na, K, Ca, Cl, Glucose, BUN (Urea), tHb and SO2, Measurements made on the OPTI CCA-TS system require the use of the OPTI CCA-TS analyzer, a disposable cassette containing fluorescent sensors for the measurement of the analytes (except tHb and SO2) and presentation of the blood sample for measurement of tHb and SO2 by lasers on board the CCA-TS analyzer, and software to calculate measurements from the optical data provided by the analyzer for a blood sample and perform on-board QC tests to safeguard results using known standards.

    OPTI Medical has designed a lactic acid (lactate) sensor to provide lactate results when a cassette containing the lactate sensor is used with the OPTI CCA-TS analyzer. The B-Lac cassette is a disposable, single use cassette that contains four (4) sensors for in vitro measurements of pH, PCO2, PO2, and Lactate. The B-Lac cassette is sealed in a foil pouch along with a desiccant and is marked with a barcode label that includes a lot identification number, calibration information, and expiration date.

    The OPTI Critical Care Analyzer (CCA-TS model) hardware is unchanged from the design described in the most recent clearance [K993837] of the device. The capacity to add analytes was part of the design since product inception and electromagnetic compatibility is unaffected. Software changes were made to add the lactate measurement algorithms and operational features for the B-Lac cassette addition.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the OPTI CCA-TS B-Lac cassette, based on the provided 510(k) summary:

    Acceptance Criteria and Device Performance

    The document doesn't explicitly state "acceptance criteria" for each parameter in a quantifiable manner (e.g., "accuracy must be within X%"). Instead, it states that the device's performance was equivalent to marketed devices. The "Reportable ranges" for each analyte serve as a de facto target range for accuracy and linearity.

    ParameterAcceptance Criteria (Implied)Reported Device Performance (Implied)
    pHAccurately measure within the range of 6.6 to 7.8, equivalent to predicate device.Performance shown to be equivalent to predicate device. Reportable range: 6.6 to 7.8
    PO2Accurately measure within the range of 10-700 mmHg, equivalent to predicate device.Performance shown to be equivalent to predicate device. Reportable range: 10-700 mmHg
    PCO2Accurately measure within the range of 10-200 mmHg, equivalent to predicate device.Performance shown to be equivalent to predicate device. Reportable range: 10-200 mmHg
    LactateAccurately measure within the range of 0.3 to 17.5 mmol/l, equivalent to predicate device.Performance shown to be equivalent to predicate device. Reportable range: 0.3 to 17.5 mmol/l
    tHbAccurately measure within the range of 5.0 - 25 g/dL, equivalent to predicate device.Performance shown to be equivalent to predicate device. Reportable range: 5.0 - 25 g/dL
    SO2Accurately measure, equivalent to predicate device.Performance shown to be equivalent to predicate device.
    PrecisionAcceptable, demonstrated through in-house studies and clinical site studies.Demonstrated through in-house studies and clinical site studies.
    AccuracyAcceptable, demonstrated through in-house studies and clinical site studies, equivalent to predicate.Demonstrated through in-house studies and clinical site studies, equivalent to predicate.
    ReproducibilityAcceptable, demonstrated through in-house studies.Demonstrated through in-house studies.
    LinearityAcross claimed measurement ranges, demonstrated through in-house studies.Demonstrated through in-house studies.
    Limit of DetectionEstablished using CLSI standard methods.Established using CLSI standard methods.
    InterferenceEstablished using CLSI standard methods.Established using CLSI standard methods.

    Study Details

    The provided document describes both non-clinical (in-house) and clinical site testing to demonstrate the device's performance.

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

    • Test Set (Clinical Site Studies): The document states "Specimens analyzed were remnant from patient samples of whole blood collected from routine analysis on existing instrumentation." It also mentions "whole blood sample discards were used by multiple clinicians". The exact number of samples is not specified in the provided text.
    • Data Provenance (Clinical Site Studies): The studies were conducted at "multiple user sites" in a "clinical setting or point-of-care locations." The country of origin is not explicitly stated, but the FDA 510(k) submission is for the USA, implying studies likely took place within the US or under US regulatory standards. The data is retrospective as it utilized "remnant from patient samples" and "whole blood sample discards."
    • Test Set (Non-Clinical/In-house Studies): "In-house studies were conducted using CLSI guidelines on both aqueous controls and whole blood samples." The sample size for these studies is not specified.
    • Data Provenance (Non-Clinical/In-house Studies): Likely performed at the manufacturer's facility.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

    • The document mentions that clinical site studies were performed "by several personnel trained to perform and report these analyses." It also states "multiple clinicians" introduced samples.
    • The ground truth for comparison was established by "legally marketed devices in a clinical setting," specifically the Instrument Laboratory Co. GEM Premier 4000 (K061974).
    • The "experts" establishing the ground truth were the legally marketed predicate device itself, and the "several personnel trained to perform and report these analyses" would be the clinical laboratory professionals operating both the test device and the predicate device for comparison. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

    4. Adjudication Method for the Test Set:

    • The document describes a method comparison study where the OPTI CCA-TS B-Lac cassette's results were compared against the predicate device (GEM Premier 4000). There is no mention of an adjudication method in the context of expert consensus for resolving discrepancies. The comparison relies on the results generated by the predicate device as the reference.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

    • No, an MRMC comparative effectiveness study as typically understood in diagnostic imaging (human readers with/without AI assistance) was not done. This device is a diagnostic instrument, not an AI-assisted diagnostic imaging system. The comparison involved the device reading samples and comparing those results to a predicate device.

    6. If a Standalone (Algorithm Only) Performance Study was Done:

    • Yes, the performance studies described (both non-clinical and clinical site studies) assess the standalone performance of the OPTI CCA-TS system with the B-Lac cassette. The algorithm (software) for calculating measurements is integrated into the device, and its output is directly compared to a reference standard (gravimetric tonometry for blood gases) or a predicate device. The performance data presented in the 510(k) is intrinsic to the device operating independently.

    7. The Type of Ground Truth Used:

    • For Blood Gases (PO2, PCO2): Gravimetric tonometry standards were used in non-clinical studies.
    • For all analytes (Lactate, pH, PCO2, PO2, tHb, SO2): The legally marketed predicate device (Instrument Laboratory Co. GEM Premier 4000) served as the primary ground truth/reference method in the clinical site studies for method comparison. It also likely served as the ground truth for some in-house studies.

    8. The Sample Size for the Training Set:

    • The document does not specify a training set sample size. This device is an analyzer that uses optical fluorescence and enzymatic oxidation principles, not a machine learning model that requires explicit "training data" in the conventional sense. While the software algorithms for calculation were developed and "modified," this is more akin to traditional software engineering verification and validation, rather than a deep learning model's training phase with labeled data.

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

    • As noted above, a distinct "training set" in the context of machine learning is not described. The device's operational parameters and algorithms (lactate sensor calculations and calculation parameters for dry storage pH, PCO2, and PO2 sensors) would have been developed and validated against known laboratory standards, reference methods (like gravimetric tonometry), and possibly internal reference samples. The principles of measurement are based on established chemical and physical reactions/optics, not on learning from a large, labeled dataset in a way that necessitates a "ground truth for a training set" in the AI/ML sense.
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