(474 days)
The OPTI® B-Lac cassette is intended to be used for the in vitro measurement of pH, PO2, total hemoglobin (tHb), and % Saturated O2 in sodium heparinized venous blood samples on the OPTI CCA-TS and OPTI CCA-TS2 platform in a clinical laboratory location.
· Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
- · Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood.
· Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin.
The OPTI CCA-TS/TS2 are portable devices, microprocessor-based instrument using optical fluorescence for the measurement blood gases, electrolytes and enzymes. The OPTI CCA-TS/TS2 utilize a color, graphical touch screen user interface. A disposable, single-use cassette contains all of the elements needed for calibration, sample measurement, and waste containment. Specific calibration from the cassette is scanned into the analyzer by holding the cassette package in front of the bar code scanner. The cassette is then placed into the measurement chamber. The analyzer warms the cassette to 37.0±0.1°C and performs a calibration verification. When calibration is verified, the analyzer aspirates the blood sample into the cassette and across the optode sensors. Fluorescence emission is then measured after equilibrating with the blood sample. After a single measurement, the cassette containing the blood sample is removed from the analyzer and discarded. The analyzer contains no reagents, blood, or waste. The B-Lac cassette is a disposable, single use cassette that contains four (4) sensors for in vitro quantitative measurements of PO2, PCO2, pH. There is an additional laser based measurement of total hemoglobin (tHb) and SO2. 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 provided document describes the OPTI® B-Lac Cassette for in vitro measurement of blood gases and related parameters. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the performance of the redesigned B-Lac cassette was determined to meet the performance claims made in the original B-Lac cassette submission (K093280) for all analytes. However, the specific quantitative acceptance criteria from K093280 are not detailed in this document. The reported device performance is indicated by the statement that the device "meets the performance claims" or "was demonstrated to meet the performance claims."
Here's a table based on the information provided, noting where specific numerical criteria are not available in this document:
| Parameter | Acceptance Criteria (from K093280 - not detailed in this document) | Reported Device Performance |
|---|---|---|
| pH Precision | (Not detailed, but based on CLIA 1988 specifications) | Meets performance claims from K093280 |
| PCO2 Precision | (Not detailed, but based on CLIA 1988 specifications) | Meets performance claims from K093280 |
| PO2 Precision | (Not detailed, but based on CLIA 1988 specifications) | Meets performance claims from K093280 |
| tHb Precision | (Not detailed, but based on CLIA 1988 specifications) | Meets performance claims from K093280 |
| SO2 Precision | (Not detailed, but based on CLIA 1988 specifications) | Meets performance claims from K093280 |
| pH Method Comparison | (Not detailed, but comparison with ABL90 Flex) | Meets performance claims from K093280 |
| PCO2 Method Comparison | (Not detailed, but comparison with gravimetric target/ABL90 Flex) | Meets performance claims from K093280 |
| PO2 Method Comparison | (Not detailed, but comparison with gravimetric target/ABL90 Flex) | Meets performance claims from K093280 |
| tHb Method Comparison | (Not detailed, but comparison with ABL90 Flex) | Meets performance claims from K093280 |
| SO2 Method Comparison | (Not detailed, but comparison with E series cassettes) | Meets performance claims from K093280 |
| Interferents (PCO2) | (Not detailed) | No interferents found |
| Interferents (PO2) | (Not detailed) | Only one interferent found |
| Interferents (pH) | (Not detailed) | Only one interferent found |
| Interferents (tHb) | (Not detailed) | Several interferents found |
| Interferents (SO2) | (Not detailed) | Several interferents found |
| Altitude Performance | (Not detailed, but assessed for linearity and bias at critical levels) | Demonstrated to meet performance claims from K093280 |
| Shelf Life (B-Lac cassette) | (Not detailed, but expected to be 12 months) | Demonstrated to meet performance claims for up to 6 months (with real-time testing continuing for 13 months) |
2. Sample Size Used for the Test Set and Data Provenance
-
20-Day Precision:
- Sample Size: Paired samples run twice daily over 20 days. Three lots of B-Lac cassettes were used, and three levels of aqueous quality control solution.
- Data Provenance: In-house (presumably US-based, as the company is in Georgia, USA). Retrospective data analysis of prospective testing.
-
Within-Run Precision:
- Sample Size: Multiple repeats using three lots of B-Lac cassettes, three levels of aqueous quality controls, and whole blood manipulated to 3 different levels.
- Data Provenance: In-house. Retrospective data analysis of prospective testing.
-
Method Comparison (in-house):
- Sample Size: Whole blood samples tonometered to different levels using different O2/CO2 gas mixtures to generate test levels for pH, PCO2, PO2, and SO2. Samples manipulated for tHb. The exact numerical count of samples or measurements is not specified.
- Data Provenance: In-house. Retrospective data analysis of prospective testing.
-
Method Comparison (Altitude):
- Sample Size: Whole blood samples were tonometered to obtain samples that span the range for PCO2, PO2, and pH, and spiked or diluted for tHb. Aqueous solutions were measured. Number of samples/measurements not specified, but done at 4 distinct altitude sites (75 ft, 1080 ft, 5560 ft, 10151 ft).
- Data Provenance: Conducted in the USA (Maine, Georgia, North Carolina, Colorado). Retrospective data analysis of prospective testing.
-
Interference Testing:
- Sample Size: 16 interferents tested for each analyte (PCO2, PO2, pH, tHb, SO2). The number of samples per interferent is not specified.
- Data Provenance: In-house. Retrospective data analysis of prospective testing.
-
Stability Testing:
- Sample Size: Three lots of B-Lac cassettes were tested. One lot was subjected to two cycles of elevated and frozen temperatures.
- Data Provenance: In-house. Retrospective data analysis of prospective testing for the initial 6 months, with real-time testing ongoing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a medical device for in vitro diagnostic measurements. The "ground truth" for the test set is established by:
-
Reference Methods/Predicate Devices:
- Gravimetric target for PCO2 and PO2 (based on gas concentration).
- Predicate device ABL90 Flex for pH, PCO2, PO2, and tHb.
- E series cassettes on the OPTI CCA-TS/TS2 for SO2.
-
No human "experts" (e.g., radiologists) were involved in establishing the ground truth in the way
this question implies for imaging or subjective interpretation devices. The ground truth is
based on established analytical methods and reference instruments.
4. Adjudication Method for the Test Set
Not applicable. This device provides quantitative measurements, and ground truth is established by reference methods/instruments, not through expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies described are of standalone performance of the device (OPTI® B-Lac Cassette on OPTI CCA-TS/TS2 platforms). The measurements are performed automatically by the instrument and its embedded algorithms. There is no human-in-the-loop performance described or implied for the measurement process itself, although clinical interpretation of the results by healthcare professionals would follow.
7. Type of Ground Truth Used
The ground truth used for performance evaluation includes:
- Gravimetric targets: For PCO2 and PO2 (based on gas concentration for tonometered samples).
- Predicate device measurements: Measurements from the Radiometer ABL90 Flex for pH, PCO2, PO2, tHb, and from the OPTI CCA TS2 E-Series Cassettes for SO2.
- Aqueous quality control solutions and manipulated whole blood samples: Used for precision and linearity studies, where the expected values are known or derived from previous characterization.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. The device utilizes "new algorithms utilized to calculate concentrations for these sensors" (specifically for PCO2) and has updated software. However, the data sets described are for performance verification and validation, not for training a new algorithm from scratch in the classical AI sense. If there was an internal dataset used for algorithm development or "training" (e.g., to derive calibration curves or correction factors), that information is not provided. The described studies are primarily for demonstrating post-development performance.
9. How the Ground Truth for the Training Set was Established
As no specific "training set" is described for algorithm development, the method of establishing ground truth for such a set is not provided. The document focuses on the verification and validation of the device's performance against established clinical and analytical standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
August 2, 2021
OPTI Medical Systems, Inc. Theron Gober Director, Quality and Regulatory 235 Hembree Park Drive Roswell, Georgia 30114
Re: K200986
Trade/Device Name: OPTI® B-Lac Cassette Regulation Number: 21 CFR 862.1120 Regulation Name: Blood Gases (pCO2, pO2) And Blood pH Test System Regulatory Class: Class II Product Code: CHL, GKR, GLY Dated: March 3, 2021 Received: March 4, 2021
Dear Theron Gober:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200986
Device Name OPTI® B-Lac Cassette
Indications for Use (Describe)
The OPTI® B-Lac cassette is intended to be used for the in vitro measurement of pH, PO2, total hemoglobin (tHb), and % Saturated O2 in sodium heparinized venous blood samples on the OPTI CCA-TS and OPTI CCA-TS2 platform in a clinical laboratory location.
· Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
- · Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood.
· Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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OPTI® Medical Systems B-Lac Cassette 510(k) Summary
| Submitted by: | OPTI Medical Systems, Inc.Phone Number: (770) 510-4444Fax Number: (770) 510-4447 |
|---|---|
| Contact: | Theron Gober |
| Date of Preparation: | April 6, 2020 |
| Current 510(k): | K200986 |
| Device Trade Name: | OPTI® B-Lac Cassette |
| Common Name: | Blood gas Analyzer |
| Type of Test: | Measurement of pH, PO2, PCO2, total hemoglobin (tHb) and SO2 |
| Classification Names: | Blood gas and pH test systemAutomated hemoglobin test systemWhole blood hemoglobin test system |
| Regulations: | 862.1120864.5620864.7500862.1450 |
| Product codes: | CHLGKRGLY |
| Panel: | Cliinical Chemistry, Hematology |
| Predicate Devices: | Instrumentation Laboratory GEM Premier 4000 |
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1. REASON FOR SUBMISSION
The purpose of this submission is to provide data to demonstrate that the new B-Lac cassette design meets the performance claims included in the previous submission referenced above and that it is substantially equivalent to the referenced predicate device. This submission includes changes to the PCO2 sensor as well as the new algorithms utilized to calculate concentrations for these sensors. No changes have been made to the pH or PQ2 sensors or the measurement of tHb or SO2(Saturated Oxygen). In addition, changes to the software that were made to the OPTI CCA-TS (K984299) and CCA-TS2 (K131126), referred to as OPTI CCA-TS/TS2, to implement the algorithms for the PCO2, sensors are documented.
2. DEVICE DESCRIPTION
2.1. OPTI CCA-TS and OPTI CCA-TS2 Instruments
The OPTI CCA-TS/TS2 are portable devices, microprocessor-based instrument using optical fluorescence for the measurement blood gases, electrolytes and enzymes. The OPTI CCA-TS/TS2utilize a color, graphical touch screen user interface.
A disposable, single-use cassette contains all of the elements needed for calibration, sample measurement, and waste containment. Specific calibration from the cassette is scanned into the analyzer by holding the cassette package in front of the bar code scanner. The cassette is then placed into the measurement chamber.
The analyzer warms the cassette to 37.0±0.1°C and performs a calibration verification. When calibration is verified, the analyzer aspirates the blood sample into the cassette and across the optode sensors. Fluorescence emission is then measured after equilibrating with the blood sample. After a single measurement, the cassette containing the blood sample is removed from the analyzer and discarded. The analyzer contains no reagents, blood, or waste.
No changes to the OPTI CCA-TS/TS2analyzer's hardware have been made to accommodate the addition of the parameters associated with the B-Lac cassette, thus the electromagnetic compatibility remains unchanged from prior claims of the OPTI CCA-TS. The software driving the analyzer has been updated according to internal design control and verification procedures
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of the Quality System at OPTI Medical Systems, Inc. to accommodate the addition of the B-Lac cassette.
2.2. OPTI B-LAC Cassette
The B-Lac cassette is a disposable, single use cassette that contains four (4) sensors for in vitro quantitative measurements of PO2, PCO2, pH. There is an additional laser based measurement of total hemoglobin (tHb) and SO2. 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.
2.2.1. Principle of Measurement
The B-Lac cassette uses 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-TS/TS2.
2.2.2. Calibration
Each lot of B-Lac cassettes is calibrated during the manufacturing process. The process utilizes multi-levels of high precision standard solutions spanning the operating range for pH_. For O2 and CO2 the calibration parameters are determined using specially targeted calibration standards focusing on the clinically critical ranges. Every cassette package has a bar code label containing this calibration information as well as its lot number and expiration date. A onepoint calibration is performed each time a cassette is used. The B-Lac cassette uses a proprietary dry-calibration for the pH sensor. For the Blood Gas sensors PO2 and PCO2, a precision gas mixture similar to that used by conventional blood analyzers is used. The calibration for the tHb and SO2 measurements is factory set for each analyzer.
During the calibration and measurement processes, diagnostic tests are automatically performed to assure correct operation of the instrument and measurement of the cassette. These tests include automatic checks of the cassette for packaging integrity, proper cassette
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temperature control, and proper equilibration behavior of the sensors during calibration and measurement, automatic detection of bubbles and short sample during aspiration, and automatic detection of dirty optics.
Three levels of standard control solutions (OPTI Check Level 1, 2 and 3) are supplied by Bionostics Inc., of Acton Massachusetts. Each level of control solution contains a different concentration of PO2, PCO2, pH, K, Na, Ca, Cl.
3. INDICATIONS FOR USE
The OPTI® B-Lac cassette is intended to be used for the in vitro measurement of pH, PO2, PCO2, , total hemoglobin (tHb), and % Saturated O2 in sodium heparinized venous blood samples on the OPTI CCA-TS and OPTI CCA-TS2 platform in a clinical laboratory location.
- Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and ● treatment of life-threatening acid-base disturbances.
- Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood.
- Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin.
4. TECHNOLOGICAL CHARACTERISTICS
The primary technological characteristics and intended use of the OPTI® B-Lac Cassette used with the OPTI CCA-TS/TS2 Analyzers are substantially equivalent to other legally marketed devices used for the quantitative measurement of blood gases, pH, and metabolites (lactate).
As indicated in Table 1 the OPTI B-Lac Cassette is substantially equivalent to significant characteristics of the identified predicate device, the Radiometer ABL90 Flex (K092686) and the OPTI CCA TS2 E-Series Cassettes (K131126).
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Table 1: Comparison of the OPTI® B-Lac Cassette with the predicate device
| B-Lac on OPTI CCA TS & TS2 | ABL90 FLEX | ||
|---|---|---|---|
| 510(k) # | K200986 | K092686 | Comparison |
| Item | Subject of this submission | Predicate | |
| Intended use | The OPTI Medical B-Lac cassette is intended to be usedfor the in vitro measurement of pH, PO2, PCO2, totalhemoglobin (tHb), and % Saturated O2 in sodiumheparinized venous blood samples on the OPTI CCA-TSand OPTI CCA-TS2 platform in a clinical laboratorylocation.• Measurements of blood gases (pCO2, pO2) and bloodpH are used in the diagnosis and treatment of life-threatening acid-base disturbances.• Total hemoglobin (tHb) measurement is used todetermine the hemoglobin content of human blood.• Oxygen saturation (SO2) measurement is used todetermine the oxygen capacity of the hemoglobin. | The ABL90 FLEX analyzer is a portable,automated analyzer that measures pH, bloodgases, electrolytes, glucose, lactate, bilirubinand oximetry in whole blood. It is intendedfor use in a laboratory environment, nearpatient or point-of-care setting. | ABL90 FLEX: Similar |
| Where used | Hospital (Laboratory Environment) | Laboratory environment | ABL90 FLEX: Similar |
| MeasuredParameter | pH, PCO2, PO2, tHb (total hemoglobin) and SO2 (oxygensaturation). | pH, PCO2, PO2, tHb (total hemoglobin) andSO2 (oxygen saturation). | ABL90 FLEX: Similar |
| Sample Type | Whole blood (sodium heparinized, venous) | Whole blood samples | ABL90 FLEX: Same |
| Reportableranges | pH: 6.818 to 7.8PO2: 10 to 700 mmHgPCO2: 10 to 200 mmHgtHb: 5.0 to 24 g/dL | pH: 6.818 to 7.797PO2: 30.1 to 488 mmHgPCO2: 15.4 to 98.3 mmHgtHb: 0.1 to 24 g/dL | ABL90 FLEX: Similar |
| B-Lac on OPTI CCA TS & TS2 | ABL90 FLEX | ||
| 510(k) # | K200986 | K092686 | Comparison |
| Item | Subject of this submission | Predicate | |
| SampleVolume | 125 μL | 65 -150 μL | ABL90 FLEX: Similar |
| Testconsumable | Single use cassette with optical fluorescence multi-sensor arrayPort for sample introductionFluid waste chamber | Sensor cassette and solution pack | ABL90 FLEX: Similar |
| Testconsumablestorage | Refrigerated storage (2 - 8°C) until expiry dateincluding max 28 days at room temperature. | Sensor Pack: 2 - 8°C storage until expirydate.Fluid Pack: 2 - 25°C storage until expiry date | ABL90 FLEX: Similar |
| Measurement sequence | Calibrate cassetteIntroduce sample - MeasureDisplay Results | Introduce sampleMeasureDisplay results | ABL90 FLEX: similar |
| Measurement time | 180 sec from sample introduction | 35 sec | ABL90 FLEX: Similar |
| MeasurementTemperature | 37°C | 37°C | ABL90 FLEX: Same |
| Errordetection | QC system to detect user errorsQC system for reader self-checkQC system to detect cassette non-conformance | QC system to detect user errorsQC system for reader self-checkQC system to detect test cartridge non-conformance | ABL90 FLEX: similar |
| Measurement Principle | pH: fluorescencePO2: fluorescencePCO2: fluorescencetHb- Optical reflectance measurement. | pH, pCO2, K+, Na+, Ca2+, Cl-, Glu:electrochemistryPO2: opticalctHb, sO2, FO2Hb, FCOHb, FHHb, FMetHb,FHbF and ctBil: Spectrophotometry | ABL90 FLEX: Similar |
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| B-Lac on OPTI CCA TS & TS2 | OPTI CCA TS2 E-Series Cassettes | ||
|---|---|---|---|
| 510(k) # | K200986 | K131126 (TS2) | Comparison |
| Item | Subject of this submission | Predicate | |
| Intended use | The OPTI Medical B-Lac cassette is intended to be usedfor the in vitro measurement of pH, PO2, PCO2, -totalhemoglobin (tHb), and % Saturated O2 in sodiumheparinized venous blood samples on the OPTI CCA-TSand OPTI CCA-TS2 platform in a clinical laboratorylocation.• Measurements of blood gases (pCO2, pO2) and bloodpH are used in the diagnosis and treatment of life-threatening acid-base disturbances.• Total hemoglobin (tHb) measurement is used todetermine the hemoglobin content of human blood.• Oxygen saturation (SO2) measurement is used todetermine the oxygen capacity of the hemoglobin. | The OPTI CCA-TS & TS2 cassette is intended to beused for in vitro measurements of pH, PO2, PCO2,total hemoglobin (tHb), Na+, K+ Ca++ and oxygensaturation (SO2), in heparinized whole blood,plasma, and serum samples (either arterial orvenous) on the OPTI CCA-TS & TS2 system, in eithera clinical laboratory setting or point-of-carelocations. | OPTI-CCA: Similar |
| Where used | Hospital (Laboratory Environment) | Hospital (Laboratory or near patient) | OPTI-CCA: Similar |
| MeasuredParameter | SO2 (oxygen saturation). | SO2. | OPTI-CCA: Similar |
| Sample Type | Whole blood (sodium heparinized, venous) | Whole blood, serum, and plasma (heparinized,venous or arterial) | OPTI-CCA: Similar |
| Reportableranges | SO2: 60% to 100% | SO2: 60% to 100% | OPTI-CCA: Similar |
| SampleVolume | 125 μL | 125 μL | OPTI-CCA: Same |
| Testconsumable | Single use cassette with optical fluorescence multi-sensor arrayPort for sample introductionFluid waste chamber | Single use cassette with optical fluorescence multi-sensor arrayPort for sample introductionFluid waste chamber | OPTI-CCA: Same |
| Testconsumablestorage | Refrigerated storage (2 - 8°C) until expiry dateincluding max 28 days at room temperature. | Room temperature storage (4 - 30°C) until expirydate | OPTI-CCAE-Ca: Similar |
| B-Lac on OPTI CCA TS & TS2 | OPTI CCA TS2 E-Series Cassettes | ||
| 510(k) # | K200986 | K131126 (TS2) | Comparison |
| Item | Subject of this submission | Predicate | |
| Measurementt sequence | Calibrate cassetteIntroduce sample – MeasureDisplay Results | Calibrate cassetteIntroduce sample – MeasureDisplay Results | OPTI-CCA-E-Ca: Same |
| Measurementt time | 180 sec from sample introduction | 180 sec from sample introduction | OPTI-CCA-E-Ca: Similar |
| MeasurementtTemperature | 37°C | 37°C | OPTI-CCA-E-Ca: Same |
| Errordetection | QC system to detect user errorsQC system for reader self-checkQC system to detect cassette non-conformance | QC system to detect user errorsQC system for reader self-checkQC system to detect cassette non-conformance | OPTI-CCA-E-Ca: Same |
| Measurementt Principle | SO2 - Optical reflectance measurement. | SO2: Optical reflectance measurement. | OPTI-CCA-E-Ca: Similar |
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Summary of Performance Testing 4.1.
The design verification tests that were performed are listed in Table 2Fable 2.
Table 2: Summary of Performance Testing
| Verification | Standard Used | Testing Guidance Used |
|---|---|---|
| 20-Day Precision (in-house) | Claims submitted in K093280(based on CLIA 1988specifications) | CLSI EP5-A3, volume 34, Number13 |
| Within Run Precision (in-house) | Claims submitted in K093280(based on CLIA 1988specifications) | CLSI EP5-A3, volume 34, Number13 |
| Method Comparison - (in-house) | Whole blood - Tonometry/ABL90Flex | CLSI EP9-A2, Volume 22, Number19 |
| Method Comparison - Altitude | Whole blood - Tonometry/ABL90Flex | None, regression analysis andbias analysis at critical levels |
| Interference (in-house) | Whole blood samples | CLSI EP7-A2, Volume 25, Number27 |
| Stability (in-house) | OPTI Check Control Material | BS EN ISO 13640-2002 |
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4.1.1. OPTI Medical B-Lac – In-House 20-Day Precision Testing
The 20-Day precision study was carried out following the experimental protocol recommended in the CLSI guideline EP05-A3, volume 34, Number 13. Typical Within-Run (Swr) and Total (ST) precision were determined from paired samples run twice daily over 20 days on three lots of B-Lac cassettes run on OPTI CCA-TS/TS2 analyzers using three levels of aqueous quality control solution. The precision performance for the redesigned B-Lac cassette was determined to meet the performance claims made in the original B-Lac cassette submission (K093280) for all analytes.
OPTI Medical B-Lac – In-House Within Run Precision Testing 4.1.2.
Within run precision testing was performed using whole blood and aqueous solutions following the experimental protocol recommended in the CLSI guideline EP05-A3, volume 34, Number 13. Typical within run (Swr) precision was determined from multiple repeats on three lots of B-Lac cassettes run on OPTI CCA-TS/TS2 analyzers using three levels of aqueous quality controls and whole blood manipulated to 3 different levels. The precision performance for the redesigned B-Lac cassette was determined to meet the performance claims made in original B-Lac cassette submission (K093280) for all analytes.
4.1.3. OPTI Medical B-Lac Cassette – In-House Method Comparison
In-house method comparison studies following the CLSI guideline EP9-A2, Volume 22, Number 19 (2002) for the B-Lac pH, PCO2 , PO2 sensors and measured tHb and SQ2 were performed on whole blood samples tonometered to different levels using different O₂/CO₂ gas mixtures to generate test levels for pH, PCQ2 , PO2, and SO2 and samples were manipulated to obtain test levels for tHb. The results were compared to the gravimetric target for PCO2 and PO2 based on the gas concentration and to the predicate device ABL90 Flex for pH, PCO2 , PQ2, and tHb and the E series cassettes on the OPTI CCA-TS/TS2 for SO2. The performance of the redesigned B-Lac cassette was determined to meet the performance claims included in the previous 510(K) submission K093280 for all analytes.
4.1.4. OPTI Medical B-Lac – In-House Linearity Testing
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4.1.5. OPTI Medical B-Lac – In-House Interference Testing
Interference testing was performed for the PCO2, PCO2, ph, sensors and measured tHb and SO2 for the B-Lac cassette following the CLSI guideline EP07-A, volume 22, Number 27 (2002). In all 16 interferents were tested for PCO2, PCO2, ph, tHb, and SQ2. There were several interferents found for tHb, and SO2, no interferents for PCO2 and only one interferent for PO2 and pH.
Altitude testing 4.1.6.
To evaluate the performance of the B-Lac cassette PCO2, PO2, pH, sensors at a range of altitudes, method comparison studies were performed on whole blood and ampuled aqueous control materials at the following sites:
- Westbrook, Maine, USA, 75 feet (Aqueous) .
- Roswell, Georgia, USA, 1080 feet (Aqueous and Whole Blood) .
- Beech Mountain, North Caroling, USA, 5560 feet (Aqueous) .
- Leadville, Colorado, USA, 10151 feet (Aqueous and Whole Blood) .
Testing for the B-Lac cassette was performed on the OPTI CCA TS and OPTI CCA-TS platforms against the predicate device (ABL90 Flex - K092686) for whole blood. Whole blood samples were tonometered to obtain samples that span the range for PCO2, PO2, and pH, and spiked or diluted for tHb at both 1180 ft. and 10,151 ft. Aqueous solutions were measured for PCO2, pH, tHb and Saturate O2 at all sites and the results compared to the reference site in Roswell, Georgia. Analysis of the data for linearity and bias at the critical limits was calculated. The performance of the B-Lac cassette with redesigned PCO2 sensors was demonstrated to meet the performance claims included in the previous 510(K) submission K093280 when tested with whole blood samples at 1180 feet and 10151 feet (PCO2, PO2, pH, tHb) and aqueous samples at all altitudes tested (PCO2, PO2, pH, tHb, and SO2).
4.1.7. OPTI Medical B-Lac – Stability Testing
Stability testing was performed to establish the shelf life for the redesigned B-Lac cassette. The purpose of this test was to collect aqueous control data to evaluate the stability of pH, PO2, PCO2, tHb, and SO2 on the redesigned B-Lac cassette. The redesigned B-Lac cassette includes
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improvements to the PCO2 sensors while keeping the pH, PO2, tHb, and SO2 the same. The study includes an evaluation of cassettes that have been subjected to 2 cycles of simulated shipping temperature extremes prior to refrigeration. Three Lots of B-Lac cassettes were tested with one Lot being subjected to two cycles of elevated and frozen temperatures cycles. Performance of the B-Lac cassette has been demonstrated to meet the performance claims for up to 6 months shelf life. Real time testing will continue for 13 months to demonstrate that the shelf life for the new cassette is equivalent to the shelf life (12 mos.) for the B-Lac cassette included in the previous 510(K) submission K093280.
5. CONCLUSION
Analysis of the data collected during performance testing studies for the OPTI B-Lac Cassette using the OPTI CCA-TS/TS2 analyzers demonstrates that the redesigned B-Lac Cassette performance in venous whole blood in clinical laboratory setting is substantially equivalent for all analytes.
§ 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.