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.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
pH	Accurately 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
PO2	Accurately 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
PCO2	Accurately 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
Lactate	Accurately 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
tHb	Accurately 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
SO2	Accurately measure, equivalent to predicate device.	Performance shown to be equivalent to predicate device.
Precision	Acceptable, demonstrated through in-house studies and clinical site studies.	Demonstrated through in-house studies and clinical site studies.
Accuracy	Acceptable, demonstrated through in-house studies and clinical site studies, equivalent to predicate.	Demonstrated through in-house studies and clinical site studies, equivalent to predicate.
Reproducibility	Acceptable, demonstrated through in-house studies.	Demonstrated through in-house studies.
Linearity	Across claimed measurement ranges, demonstrated through in-house studies.	Demonstrated through in-house studies.
Limit of Detection	Established using CLSI standard methods.	Established using CLSI standard methods.
Interference	Established 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.

Summary

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Traditional 510(k) Summary

liminary

2024

K093280
Date of Preparation: 20 December 2010
1. Applicant Name & Address OPTI Medical Systems, Inc. 235 Hembree Park Drive Roswell, GA 30076
  JAN - 7 2011

2) Purpose for Submission:

Addition of Lactic Acid (lactate) test (Class I) to cleared OPTI CCA-TS analyzer system Modify pH, PO2, and PCO2 sensors to dry-stored type on cleared OPTI CCA-TS analyzer system

3) Applicant Contact

Primary Contact Person Len Owens VP Quality and Regulatory Affairs Email: len.owens@optimedical.com Office: (770) 688-1658 Fax: (770) 510-4445

Secondary Contact Person

Paul Travers Director Research and Development Email: Paul.Travers@optimedical.com Office: (770) 688-1682 Fax: (770) 510-4445

4) Establishment Registration Number The establishment registration number is: 3004102403

1. User Fee Payment ID: MD6045790-956733
ର୍ତ । Device Trade/Proprietary Name B-Lac cassette for OPTI CCA-TS Critical Care Analyzer system

7) Device Common Name

Blood analysis system - gases, pH, Lactic Acid, Hemoglobin, and Oxygen saturation

8) Device Classification

Product Nomenclature	Regulation	ProductCode	Class	Panel
ACID, LACTIC, ENZYMATIC METHOD	862.1450	KHP	I	CHEMISTRY (75)
ELECTRODE, BLOOD GASES (PCO₂, PO₂) ANDBLOOD PH	862.1120	CHL	II	CHEMISTRY (75)
SYSTEM, HEMOGLOBIN, AUTOMATED	864.5620	GKR	II	HEMATOLOGY (81)
OXIMETER, WHOLE BLOOD	864.7500	GLY	II	HEMATOLOGY (81)

9) Description of Device

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10) Intended Use / Indications for Use

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

11) Substantial Equivalence

The CCA-TS B-Lac cassette is substantially equivalent in safety, function, and efficacy to several currently marketed devices already on the market known as 'Combi Analyzers' and 'Point of Care' analyzers. Specifically, the sensors in the B-Lac cassette are shown to be equivalent to the Instrument Laboratory Co. GEM Premier 4000 |K061974| for the measurement of blood gases and ph, total hemoglobin, oxygen saturation, and lactic acid. Non-clinical studies were performed to demonstrate equivalence when compared to the predicate device and to gravimetric tonometry standards for the Blood Gases (PO2, PCO2). Clinical site studies demonstrated substantial equivalence when compared to legally marketed devices in a clinical setting at multiple sites by several personnel trained to perform and report these analyses. Specimens analyzed were remnant from patient samples of whole blood collected from routine

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analysis on existing instrumentation. Samples were aspirated into the OPTI CCA-TS B-Lac cassette from both heparinized syringes and heparinized capillary tubes.

12) Identification of Predicate Device

Manufacturer	Device Name	510k Number
Instrument Laboratory Co. (IL)	GEM Premier 4000	K061974

13) Comparison with Predicate Device

OPTI CCA-TS B-Lac cassette is the device being introduced to enable the OPTI CCA-TS system to report lactate measurements and report pH, PO2, and PCO2 measurements using modified dry sensors. This table shows how the device compares to the predicate device:

	OPTI CCA - TS B-LactateCassette	GEM Premier 4000
510(k) #	To be determined	K061974	Comparison
Item	Device	Predicate
Intended use	The OPTI CCA-TS B-Lac cassette isintended to be used for in vitromeasurements of pH, pO2, pCO2,lactate (lactic acid), totalhemoglobin (tHb), and oxygensaturation (SO₂), in heparinizedwhole blood samples (eitherarterial or venous) on the OPTICCA-TS system, in either a clinicalsetting or point-of-care locations.	The GEM Premier 4000 is aportable system for use by healthcare professionals to rapidlyanalyze whole blood samples atthe point of health care delivery ina clinical setting and in a centrallaboratory. The instrumentprovides quantitativemeasurements of pH, PCO2, PO2,Na+, K+, Cl-, Ca++, Glucose, Lactatehematocrit, and CO-Oximetry(tHb, O2Hb, COHb, MetHb, HHb)parameters.	Similar
Where use	Hospital	Hospital	Same
MeasuredParameter	Lactate, pH, PCO2, PO2, tHb andSO₂	Lactate, pH, pCO2, PO2, Na, K,Ca, Cl, Glu, Hct, tHb, O2Hb,COHb, MetHb, HHb, TotalBilirubin	Similar
CalculatedParameters	BEHCO3-BEactst HCO3-cH+st.pHSO₂(c)	ctO₂PCO₂tBBBEecfHct(c)P50	TCO2, P/F Ratio, BE(B), pAO2,BE(ecf), CaO2, tHb(c), CvO2, Ca++(7.4), p50, Anion gap O2cap,sO2, RI, sO2(c), CcO2, HCO3-std,a-vDO2, HCO3-(c), Qsp/Qt (est),A-aDO2, Qsp/Qt, paO2/pAO2,Hct(c)	Similar
Sample Type	Whole blood (heparinized,venous or arterial)	Whole blood samples	Same
Reportableranges	pH: 6.6 to 7.8PO2: 10-700 mmHgPCO2: 10-200 mmHgLactate: 0.3 to 17.5 mmol/ltHb: 5.0 - 25 g/dL	pH: 6.8 to 8.0PO2: 0-800 mmHgPCO2: 0-150 mmHgLactate: 0.1 to 20.0 mmol/ltHb: 5.0 - 23.0 g/dL	Similar
Sample	125 µL	65 -150 µL	Similar

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	OPTI CCA - TS B-LactateCassette	GEM Premier 4000
Volume	Testconsumable	One use cassette with opticalfluorescence multi-sensor arrayPort for sample introductionFluid waste chamber	One use cartridge withElectrochemical multi-sensor arrayPort for sample introductionFluid waste chamber	Similar
Testconsumablestorage	Refrigerated storage until expirydate including max 14 days atroom temperature.	15-25 °C until expiry date	Similar
Measurementsequence	Calibrate cassette - introducesample - measure	Calibrate test cartridge - introducesample - measure	Similar
Measurementtime	180 sec from sample introduction	70-95 sec	Similar
MeasurementTemperature	37°C	37°C	Same
Error detection	QC system to detect user errorsQC system for reader self checkQC system to detect cassettenon-conformance	QC system to detect user errorsQC system for reader self checkQC system to detect test cartridgenon-conformance	Similar
MeasurementPrinciple	pH: fluorescencePO2: fluorescencePC02: fluorescenceLactic acid - Lactate oxidasebased fluorescent oxygendetectiontHb and SO2 – Optical reflectancemeasurement.	pH: electrochemicalPO2: electrochemicalPCO2: electrochemicalLactic acid - Lactate oxidase basedamperometric peroxide detectionHematocrit and CO-Oximetry -Optical measurement ofhemoglobin and fractionalderivatives of hemoglobin in lysedblood	Similar

14) Technological Characteristics

Principle of Measurement

The single use B-Lac cassette contains a port that allows the introduction of a sample to an array of sensors sealed inside the cassette. The OPTI CCA-TS analyzer aspirates the sample from a capillary tube or syringe. The sensors use fluorescence optodes to measure the intensity of light emitted from fluorescent dyes exposed to specific analytes. The concentration of the analyte is determined by the calculation of the difference in fluorescence measured at a defined calibration point and that measured with the unknown concentration of analyte. The principles of measurement of pO2, pCO2 and pH for the B-Lac cassette are similar to those used with existing cassette styles that are used on the OPTI CCA platform [K993837, K984299, and K974784].

The lactate measurement is based on the enzymatic oxidation of lactate.

Pyruvate + H2O2 L-Lactate + O2 -4 Lactate Oxidase

The sensor is constructed of an enzyme layer over an oxygen sensor. As a sample containing lactate contacts the sensor this enzymatic oxidation of the lactate consumes the oxygen locally

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present in the sensor. This decrease in oxygen is detected by the oxygen sensor. The amount of lactate is determined to be proportional to the rate at which the oxygen is consumed.

15) Summary of Non-Clinical Testing

Electrical Standards:

The cleared OPTI CCA-TS analyzer system [K993837, K984299, K974784] has been tested and found to comply with EN61010-1 Safety Requirements for Electrical Equipment, FCC Class A Radiated and Conducted Emissions, EN55022 Radiated and Conducted Emissions, EN61000-3-2 Quasi-Stationary Current Harmonics, EN61000-3-3 Voltage Fluctuation and Flicker Test, and EN61326-1 Electrical Equipment Electromagnetic Compatibility standards. No changes were made to the cleared analyzer system to add the B-Lac cassette so the studies cited above remain valid.

Performance:

In-house studies were conducted using CLSI guidelines on both aqueous controls and whole blood samples to demonstrate acceptable precision, accuracy, reproducibility, and linearity across the claimed measurement ranges with both syringe and capillary tube sampling methods. Limit of detection and interference studies were completed using CLSI standard methods and are summarized in device labeling.

The OPTI CCA-TS system is calibrated with methods traceable to NIST standards.

Stability studies were performed on the B-Lac cassette design and Instructions for use are included with the B-Lac cassette style to instruct the user of the storage and use limitations.

CCA-TS software required modification to add the lactate sensor calculations and modify the calculation parameters in algorithms for the dry storage pH, PCO2, and PO2 sensors used in the B-Lac cassette. The CCA-TS software level of concern is moderate based on an assessment of the software in its intended use using tables 1 and 2 in "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005. Software modifications were made, verified, and validated as outlined in the guidance document cited above.

16) Summary of Clinical Site Testing

Precision and accuracy of the OPTI CCA-TS system with the B-Lac cassette was verified at multiple user sites and data provided in the 510(k) demonstrates performance equivalent to marketed devices used for method comparisons. Whole blood sample discards were used by multiple clinicians and introduced to the analyzer system in both heparinized syringes and heparinized capillary tubes to demonstrate equivalence between the two sampling modes and to marketed reference analyzers.

17) Conclusion

Analysis of the method comparison data collected during clinical site studies for this device presented in this 510(k), together with the linearity and precision data collected during nonclinical and clinical studies demonstrates that the OPTI CCA-TS system with B-Lac cassette is safe, effective, and substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES-USA

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

OPTI Medical Systems, Inc. c/o Mr. Len Owens Vice President of Quality & Regulatory Affairs 235 Hembree Park Drive Roswell, Georgia 30076

JAN 0 7 2011

Re: K093280 Trade Name: OPTI CCA-TS B-Lac cassette

Regulation Number: 21 CFR §862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system.
Regulatory Class: Close U Regulatory Class: Class II Product Codes: CHL, KHP, GKR, GLY Dated: December 21, 2010 Received: December 27, 2010

Dear Mr. Owens:

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 levice is substantially equivalent (for the 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 provisions of
approval application (PMA) - Yourse of (Act) that do not require approval of a 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 publich furth 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) (2) CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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 (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 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 toll-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.

C.C.

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

Enclosure

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Indications for Use Form

510(k) Number (if known): K093280

Device Name: OPTI CCA-TS B-Lac Cassette

JAN - 7 2011

Indications for 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 (SO3), 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093280

Regulation Number and Section

§ 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.