(195 days)
The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or unanticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.
Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis system and are used for the collection and dispensing of capillary blood samples with epoc Test Cards.
The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium -Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct.
The Blood Gas Electrolyte (BGEM) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2, Hematocrit - Hct and Glucose -Glu.
Measurement of sodium is used in diagnosis and treatment of diseases involving electrolyte imbalance.
Measurement of potassium is used in diagnosis and treatment of diseases involving electrolyte imbalance.
Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Measurement of pH, pCO2, pO2 (blood gases) is used in the diagnosis and treatment of lifethreatening acid-base disturbances.
Measurement of Hct distinguishes normal from abnormal states of blood volume, such as anemia and erythrocytosis.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell tumors.
The epoc Blood Analysis System consists of three (3) components:
- epoc Test Card: single use blood test card with sensors, fluidic channel, and on-board calibrator.
- epoc Card Reader: raw-signal acquisition peripheral with card orifice, mechanical actuation assembly, bar code scanner, electrical contact array, thermal subsystem, and circuits for signal processing and wireless transmission.
- epoc Host: dedicated-use Personal Digital Assistant (PDA) computing device with custom software for displaying test results.
The epoc Care-Fill Capillary Tube is intended for use only with epoc Blood Analysis System for the collection and dispensing of capillary blood samples.
Acceptance Criteria and Study Details for epoc® Blood Analysis System for Capillary Samples
The epoc® Blood Analysis System sought clearance to use capillary blood specimens and to remove the limiting labeling regarding the glucose test using neonatal samples. The acceptance criteria were implicitly established by demonstrating substantial equivalence to the predicate device, the i-STAT® Model 300 Portable Clinical Analyzer, primarily through method comparison studies and precision studies. The core of the acceptance criteria is the observed bias between the epoc system and the i-STAT system, and the precision (SD and %CV) of the epoc system.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as numerical thresholds in the provided document. Instead, the study aims to demonstrate that the epoc system's performance, when using capillary blood, is "substantially equivalent" to the predicate device (i-STAT Model 300). This is assessed by comparing the biases and precision against the predicate device in clinical and non-clinical settings.
For both method comparison studies, the key performance indicator is the average(Yii-Xii), which represents the bias between the epoc system (Y) and the predicate i-STAT system (X). For precision, SD and %CV are used.
Implicit Acceptance Criteria (interpreted from "Substantially Equivalent" and comparison to predicate):
- Bias (epoc vs. i-STAT): The measured biases should be clinically acceptable and comparable to or better than previously cleared devices and clinical standards. The document presents the observed biases without stating explicit thresholds for acceptance a priori.
- Precision (epoc system): The standard deviation (SD) and coefficient of variation (%CV) for each analyte should be within clinically acceptable ranges and consistent with expected performance for point-of-care blood gas and electrolyte analyzers.
Reported Device Performance (from studies):
The following table summarizes the reported performance of the epoc system when using capillary samples, compared to the i-STAT system, and its precision.
| Parameter | Performance Metric | Reported Value (Method Comparison: epoc/CareFill vs i-STAT/CliniTube, Clinical Study) | Reported Value (Precision Study: epoc/CareFill, Field Trial) - Example Range |
|---|---|---|---|
| pH | Average Bias (Y-X) | -0.02 | N/A (Bias not measured against a predicate in precision study) |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.006-0.013 (0.1%-0.2%) | |
| pCO2 | Average Bias (Y-X) | 1.5 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.5-1.2 (1.6%-2.8%) | |
| pO2 | Average Bias (Y-X) | 2.3 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 1.2-9.1 (1.6%-7.4%) | |
| Na | Average Bias (Y-X) | -2.5 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.5-1.5 (0.4%-1.0%) | |
| K | Average Bias (Y-X) | -0.2 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.04-0.24 (1.4%-3.5%) | |
| iCa | Average Bias (Y-X) | -0.041 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.008-0.028 (0.8%-2.5%) | |
| Glu | Average Bias (Y-X) | 0.53 (for all capillary) | N/A |
| Average Bias (Y-X) - Neonatal Capillary | 1.8 (at Decision Level 1), -5.2 (at Decision Level 2) | N/A | |
| SD (%CV) - Example from Clinical Precision Study | N/A | 1.5-8.6 (2.9%-3.9%) | |
| Hct | Average Bias (Y-X) | -4.5 | N/A |
| SD (%CV) - Example from Clinical Precision Study | N/A | 0.3-1.4 (1.4%-2.9%) |
2. Sample Sizes and Data Provenance
Equivalence of Care-Fill vs. Syringe (Non-Clinical Study):
- Sample Size: N = 42 for all analytes.
- Data Provenance: Retrospective, "in house" experiments. The origin of the blood samples (e.g., human, animal, spiked, etc.) and country are not explicitly stated, but the context implies laboratory-controlled samples, potentially modified to extend analyte ranges.
In-house Method Comparison (Capillary samples, epoc vs. i-STAT):
- Sample Size: N = 51 for pH/pCO2, N = 52 for pO2/Na/K/Ca/Glu/Hct.
- Data Provenance: Retrospective, "in-house" study using capillary blood samples. Origin and country are not specified.
Clinical Precision Study (Care-Fill capillary tubes):
- Sample Size: N = 10 replicates per study, across 6 precision studies (3 pools of blood, 2 POC locations, 6 different operators). So, 60 measurements per analyte in total, distributed.
- Data Provenance: Prospective, patient samples, collected at "2 POC locations" (Nursery and NICU), implying a hospital setting. Country not explicitly stated but implied to be where epoc is manufactured/marketed (Canada/USA).
Clinical Method Comparison (Capillary samples, epoc vs. i-STAT):
- Sample Size: N = 47 for pH/iCa/Hct, N = 48 for pCO2/pO2/Na/K/Glu. For neonatal glucose specifically, N = 36.
- Data Provenance: Prospective, patient samples of whole blood (12 adult capillary, 36 neonatal capillary). Performed "at a hospital" in "four (4) locations: NICU, Wellbaby Nursery and two (2) different outpatient drawing areas." Country not explicitly stated, but implied as per above.
3. Number of Experts and Qualifications for Ground Truth
The concept of "experts" and "ground truth" as typically used in AI/image analysis studies (e.g., radiologists interpreting images) is not directly applicable here. This submission is for a medical device that measures physiological parameters.
- Ground Truth Establishment: The ground truth or reference standard for comparison in these studies is the predicate device, the i-STAT Model 300 Portable Clinical Analyzer. The i-STAT system itself is a cleared device already accepted as an accurate measurement tool for these parameters. There is no mention of human experts establishing a separate "ground truth" or reference, beyond the inherent accuracy of the predicate device.
4. Adjudication Method
Not applicable. As explained in point 3, the ground truth is established by the predicate device, not by human interpretation or consensus that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers interpreting cases (e.g., medical images) with and without AI assistance. It is a device performance study comparing a new device (epoc) to a predicate device (i-STAT) for quantitative measurements. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance."
6. Standalone Performance Study
Yes, a standalone performance study was conducted.
- Equivalence of Care-Fill vs. Syringe (Non-Clinical Study): This study directly compared two delivery methods on the epoc system, not against an external reference, to ensure the new capillary tube delivery method did not alter results.
- Clinical Precision Study: This study evaluated the precision (repeatability) of the epoc system itself when using capillary samples collected via the Care-Fill tubes, without direct comparison to a predicate device for each measurement. It assessed the algorithm's consistency and reliability in real-world use.
7. Type of Ground Truth Used
The ground truth used for the comparative studies (method comparison) was the measurements obtained from the predicate device, the i-STAT Model 300 Portable Clinical Analyzer. This is considered "reference method" ground truth, where a previously validated and cleared device serves as the standard.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" as would be typical for machine learning algorithms. The epoc system is described as having "on-board calibrator" and "custom software that displays the test results" and "software to control the test and calculate analytical values from raw sensor signals." This implies a rule-based or empirically calibrated system rather than a machine learning model that requires a distinct training phase with a labeled dataset in the contemporary sense. The calibration and development likely involved extensive in-house testing and engineering, but these are not referred to as a "training set."
9. How the Ground Truth for the Training Set Was Established
Given that a distinct "training set" in the context of machine learning is not mentioned (see point 8), the concept of establishing ground truth for it also does not directly apply. The calibration and performance optimization of the epoc system's algorithms/software would have been established through a combination of:
- Reference materials/standards: Calibrators are mentioned as "on-board" the test card.
- Extensive laboratory testing: Comparison against established laboratory methods and reference analyzers during the development and validation phases.
- Empirical data collection: Using various blood samples (e.g., with known concentrations, or compared to highly accurate laboratory instruments) to optimize the sensor responses and calculation algorithms.
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e pocal
2060 Walkley Road Ottawa Ontario, Canada K1G 3P5
MAR 3 0 2010
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K092849 |
|---|---|
| -------------------------------- | --------- |
Summary Prepared: Sept 11, 2009
Submitted by:
Epocal Inc. 2060 Walkley Road, Ottawa, Ontario, Canada K1G 3P5 Telephone: (613) 738-6192 Fax: (613) 738-6195
Contact: Roy Layer Director of Quality Assurance and Regulatory Affairs.
Identification of the Device 5.1
| Device Name: | epoc® Blood Analysis System |
|---|---|
| Proprietary / Trade Name: | epoc Blood Analysis System |
| Common Name: | Portable Blood Analyzer |
| Classification Name: | See Table 5.1 Below |
| Device Classification: | See Table 5.1 Below |
| Regulation Number: | See Table 5.1 Below |
| Panel: | See Table 5.1 Below |
| Product Code: | See Table 5.1 Below |
| Name | Class | RegulationNumber | Panel | ProductCode |
|---|---|---|---|---|
| Electrode Measurement, Blood-Gases (PCO2, PO2) and Blood pH | II | 862.1120 | ClinicalChemistry | CHL |
| Electrode, Ion Specific, Sodium | II | 862.1665 | ClinicalChemistry | JGS |
| Electrode, Ion Specific, Potassium | II | 862.1600 | ClinicalChemistry | CEM |
| Electrode, Ion Specific, Calcium | II | 862.1145 | ClinicalChemistry | JFP |
| Glucose | II | 862.1345 | ClinicalChemistry | CGA |
| Hematocrit | II | 864.6400 | Hematology | JPI |
Figure 5.1 - Table - epoc™ Blood Analysis System with Blood Gas, Electrolytes and Metabolytes (BGEM) Test Card
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5.2 Identification of the Predicate Device
i-STAT® Model 300 Portable Clinical Analyzer
5.3 Description of the New Device
The epoc System is a point-of-care device currently in use in hospitals. The epoc System was previously cleared for use with arterial and venous blood in 510(k) submissions K061597 and K090109. In this submission we are seeking clearance to use capillary blood specimens on the epoc System and to remove the limiting labeling regarding the glucose test using neonatal samples.
The epoc Blood Analysis System consists of three (3) components:
-
- epoc Test Card
The single use blood test card comprises a port for introduction of a blood sample to an array of sensors on a sensor module. The sensor module is mounted proximal to a fluidic channel contained in a credit-card sized housing. The card has an on-board calibrator contained in a sealed reservoir fluidically connected to the senor array through a valve.
- epoc Test Card
-
- epoc Card Reader
The reader is a minimally featured raw-signal acquisition peripheral. The reader comprises a card orifice for accepting a test card, and a mechanical actuation assembly for engaging the test card after it is inserted into the card orifice. Within the reader's card orifice there is a bar code scanner, an electrical contact array for contacting the card's sensor module, and a thermal subsystem for heating the card's measurement region to 37℃ during the test. The reader also comprises circuits for amplifying, digitizing and converting the raw sensor signals to a wireless transmittable Bluetooth™ format,
- epoc Card Reader
-
- epoc Host
The host is a dedicated-use Personal Digital Assistant (PDA) computing device with custom software that displays the test results. The reader and host computer together constitute all of the subsystems generally found in a traditional analyzer that operates on unit-use sensors and reagents
- epoc Host
5.3.1 epoc Care-Fill Capillary Tube
The epoc Care-Fill Capillary Tube has been developed to introduce capillary samples into the epoc Test card. The epoc Care-Fill Capillary Tube is intended for use only with epoc Blood Analysis System and is the only method, other than using a syringe, to introduce samples into the epoc test cards.
Intended Use of the Device 5.4
The epoc System .is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or unanticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.
The BGEM test card panel configuration includes sensors for sodium (Na), potassium (K), ionized calcium (iCa), pH, pCO2, pO2, glucose (Gluc) and hematocrit (Hct).
Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis System and are used for the collection and dispensing of capillary blood samples with epoc Test Cards.
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| 510(k) #Item | epoc Blood Analysis SystemK061597 and K090109Device | I-STAT Model 300K001387Predicate | Same /Different | |||
|---|---|---|---|---|---|---|
| Intendeduse | The epoc Blood Analysis System isintended for use by trained medicalprofessionals as an in vitro diagnosticdevice for the quantitative testing ofsamples of whole blood using theBGEM (Blood Gas ElectrolyteMetabolyte), BGE (Blood GasElectrolyte) and ABG (Arterial BloodGas) test card panels. | The i-STAT Model 300 Portable ClinicalAnalyzer is intended to be used bytrained medical professionals for usewith i-STAT test cartridges andMediSense blood glucose test strips.i-STAT cartridges comprise a varietyof clinical chemistry tests and testpanels. | same | |||
| Where used | hospital | hospital | same | |||
| Measuredparameters | pH, pCO2, pO2, Na, K, iCa, Gluc, Hct | pH, pCO2, pO2, Na, K, iCa, Gluc, Hct | same | |||
| Calculatedparameters | TCO2, HCO3, BE, SO2, Hgb | TCO2, HCO3, BE, SO2, Hgb | same | |||
| Sample type | Venous, arterial and capillary wholeblood | Venous, arterial and capillary wholeblood | same | |||
| Reportableranges | pHpCO2pO2NaKiCaGluHct | 6.5 - 8.05 - 2505 - 75085 - 1801.5 - 120.25 - 420 - 70010 - 75 | pHpCO2pO2NaKiCaGluHct | 6.5 - 8.25 - 1305 - 800100 - 1802.0 - 9.00.25 - 2.520 - 70010 - 75 | pH unitsmm Hgmm Hgmmol/Lmmol/Lmmol/Lmg/dL%PCVmmol/Lmmol/Lmmol/Lmmol/L%g/dL | differentdifferentsamedifferentdifferentdifferentsamesame |
| TCO2HCO3BEecfBEbSO2Hb | 1 - 851 - 85-30 - +30-30 - +300 - 1003.3 - 25 | TCO2HCO3BEectBEbSO2Hb | 5 - 501 - 85-30 - +30-30 - +300 - 1003 - 26 | mmol/Lmmol/Lmmol/Lmmol/L%g/dL | differentsamesamesamesamesame | |
| Samplevolume | Non volumetric over 90 μL | 100μL | same | |||
| Test card | Unit-use card with- on-board calibrator in sealedreservoir- an electrochemical multi-sensorarray- port for sample introduction- fluid waste chamber | Unit-use cartridge with- on-board calibrator in sealedreservoir- an electrochemical multi-sensorarray- port for sample introduction- fluid waste chamber | same | |||
| Test cardstorage | Room temperature until expiry date | Storage at 2-8°C until expiry dateincluding max 2 weeks at roomtemperature | different | |||
| Sensor array | A laminated foil sensor module | A micro-fabricated chip-set | different | |||
| Tests/sensorcomponents | pH - PVC ion selective electrodepCO2 - QH modified Severinghaus typepO2 - membrane coated gold cathodeNa - PVC ion selective electrodeK - PVC ion selective electrodeiCa - PVC ion selective electrodeGlu - Enzymatic (glucose oxidasebased), amperometric peroxidedetectionHct - conductivity, gold electrodes | pH - PVC ion selective electrodepCO2 - QH modified Severinghaus typepO2 - membrane coated gold cathodeNa - PVC ion selective electrodeK - PVC ion selective electrodeiCa - PVC ion selective electrodeGlu - Enzymatic (glucose oxidasebased), amperometric peroxidedetectionHct - conductivity, gold electrodes | samesamesamesamesamesamesamesame | |||
| Analyzercomponents | Two housings;1 - The reader comprising- Orifice for test card introduction- electrical connector to card | A single housing comprising- Orifice for test card introduction- electrical connector to card | differentsamesame |
Comparison of Technological Characteristics To Predicate 5.5 vice
epoc Capillary Samples 510(k) Submission
:
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| mechanical card engagementdevice for making electrical contactto card's sensors for rupture of calibratorreservoir moving calibrator tosensors engaging heaters withcard | mechanical card engagementdevice for making electrical contactto card's sensors for rupture of calibratorreservoir moving calibrator tosensors engaging heaters with card | same | |
|---|---|---|---|
| op-amp sensor signal detectorsIQC monitoring devicesThermal controllersMUXA/DBluetooth stack for wirelesstransmission of digitized raw | op-amp sensor signal detectorsIQC monitoring devicesThermal controllersMUXA/Dwire transmission of digitized rawsensor signals to computingsubsystem in same housing | samesamesamesamesamedifferent | |
| sensor signals to computingdevice | |||
| bar code scanner for acquiringcard info | n/a | different | |
| internal electronic reader self-testcircuit2 - The computing device comprisinga PDA | internal and external electronicself-test circuit | different | |
| microprocessormemorycolor LCD displaykeyboardi/o for communicating test resultsto other devicessoftware to control the test andcalculate analytical values fromraw sensor signalsbattery operated withrechargeable batteries via plug inplug-in power supply | microprocessormemorymonochrome LCD displaykeyboardi/o for communicating test resultsto other devicessoftware to control the test andcalculate analytical values fromraw sensor signalsbattery operated withrechargeable batteries viaexternal power supply indownloader cradle | samesamedifferentsamesamesamesame | |
| Measurement | 37°C | 37°C | same |
| temperature | |||
| Measurementsequence | Calibrate test card-introduce sample-measure | Introduce sample-calibrate testcartridge-measure | different |
| Measurementtime | 35sec from sample introduction | 130-200 sec from sample introduction | different |
| Errordetection | IQC system to detect user errorsIQC system for reader self-checkIQC system to detect card non- | IQC system to detect user errorsIQC system for reader self-checkIQC system to detect card non-conformance | samesamesame |
Figure 5.2 – Table Comparing epoc Device Performance Characteristics With Predicate Device
In this 510(k) submission we demonstrate that the epoc System is substantially equivalent to the predicate device when using capillary blood. This submission also includes glucose data on neonatal capillary whole blood and therefore offers ground to remove the current labeling limitation on the epoc glucose test.
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Summary of Non-Clinical Test Performance in Support of 5.6 Substantial Equivalence
Equivalence of the epoc Test Results Between Samples 5.6.1 Delivered from a Syringe Versus Samples Delivered from Care-Fill Capillary Tubes
Experiments were performed in house to demonstrate that the collection and delivery method using Care-Fill cap tubes yields test results equivalent with those where a syringe is used as a sample delivery method. This study was also used as the only opportunity to test the capillary delivery over extended ranges of the various analytes, as capillary samples are difficult to modify.
The table in Figure 5.3. below shows the results of a method comparison between the two means of sample delivery: X-svringe and Y-Care-Fill capillary tube.
| EPOC-CareFill vs EPOC-Syringe | ||||||||
|---|---|---|---|---|---|---|---|---|
| pH | pCO2 | pO2 | Na | K | Ca | Glu | Hct | |
| N | 42 | 42 | 42 | 42 | 42 | 42 | 42 | 42 |
| Sxx | 0.004 | 0.8 | 3.1 | 0.5 | 0.06 | 0.018 | 4.7 | 0.41 |
| Syy | 0.005 | 1.4 | 2.5 | 0.7 | 0.10 | 0.019 | 4.0 | 0.60 |
| intercept | 0.446 | 3.8 | 0.4 | 2.7 | 0.06 | -0.010 | -2.5 | 1.6 |
| slope | 0.940 | 0.885 | 0.996 | 0.981 | 0.981 | 0.991 | 1.037 | 0.946 |
| Syx | 0.008 | 1.1 | 2.2 | 1.0 | 0.07 | 0.037 | 4.07 | 0.7 |
| X min | 6.721 | 14.0 | 22.7 | 102.5 | 1.2 | 0.389 | 16.0 | 10.5 |
| X max | 7.555 | 143.6 | 383.0 | 176.0 | 12.0 | 2.868 | 530.5 | 76.7 |
| R2 | 0.997 | 0.996 | 0.999 | 0.994 | 0.999 | 0.994 | 0.998 | 0.997 |
| Decision Level 1 | 7.3 | 35 | 30 | 135 | 3 | 0.8 | 45 | 33 |
| Bias | 0.005 | -0.3 | 0.3 | 0.1 | 0.01 | -0.018 | -0.8 | -0.18 |
| Bias 95% Conf. Hi | 0.007 | 0.0 | 1.0 | 0.3 | 0.03 | -0.007 | 0.2 | 0.04 |
| Bias 95% Conf. Lo | 0.003 | -0.5 | -0.4 | -0.2 | -0.01 | -0.029 | -1.8 | -0.39 |
| Decision Level 2 | 7.5 | 50 | 80 | 150 | 5.8 | 1.4 | 180 | 55 |
| Bias | -0.007 | -2.0 | 0.1 | -0.2 | -0.04 | -0.024 | 4.3 | -1.34 |
| Bias 95% Conf. Hi | -0.004 | -1.7 | 0.6 | 0.1 | -0.03 | -0.015 | 5.4 | -1.13 |
| Bias 95% Conf. Lo | -0.010 | -2.2 | -0.4 | -0.5 | -0.06 | -0.032 | 3.1 | -1.54 |
Figure 5.3 - Table - Summary results of the Care-Fill vs. Syringe method comparison study
5.6.2 In-house Method Comparison study using capillary samples
This study was performed in-house to establish analytical performance versus the predicate device when using capillary blood samples.
The table in Figure 5.4. below shows the results of the study between the two testing methods: X-i-STAT-CG8 using CLINITUBES and Y-epoc-BGEM using Care-Fill.
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| Y: EPOC/CareFill vs X:i-STAT/CliniTube | ||||||||
|---|---|---|---|---|---|---|---|---|
| pH | pCO2 | pO2 | Na | K | Ca | Glu | Hct | |
| N | 51 | 51 | 52 | 52 | 52 | 52 | 52 | 52 |
| Sxx | 0.015 | 1.3 | 6.7 | 0.8 | 0.13 | 0.020 | 2.6 | 0.85 |
| Syy | 0.007 | 1.5 | 4.5 | 0.8 | 0.10 | 0.014 | 3.8 | 0.82 |
| X min | 7.357 | 30.4 | 56.5 | 135.0 | 3.75 | 1.210 | 81 | 36.0 |
| X max | 7.478 | 48.7 | 100.0 | 143.5 | 4.8 | 1.435 | 414 | 51.0 |
| average X | 7.425 | 39.1 | 76.5 | 140.5 | 4.1 | 1.273 | 122.2 | 43.6 |
| average Y | 7.403 | 39.1 | 82.3 | 139.2 | 4.1 | 1.197 | 122.4 | 40.2 |
| average(Yij-Xij) | -0.023 | 0.5 | 6.0 | -1.0 | -0.1 | -0.075 | 0.8 | -2.3 |
| Table 5.4 - Table - Average readings and biases for epoc/Care-Fill vs. i- | ||||
|---|---|---|---|---|
| STAT/CLINITUBE |
5.7 Summary of Clinical Tests Submitted in Support of Substantial Equivalence
Blood precision when using Care-Fill capillary tubes as 5.7.1 delivery method
We performed six (6) precision studies in two (2) POC locations having six (6) different operators testing from three (3) different pools of blood with n=10 replicates per study.
A summary of the results is presented in the table below in Figure 5.5.
| Sample | Site | Operator | Param | pH | pCO2 | p02 | Na | K | iCa | Glu | Hct |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Nursery | RN | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| 1 | Nursery | RN | avg | 7.292 | 55.2 | 75.0 | 132.1 | 3.2 | 0.873 | 52.7 | 22.1 |
| 1 | Nursery | RN | SD | 0.009 | 1.2 | 3.1 | 1.2 | 0.05 | 0.013 | 1.7 | 0.6 |
| 1 | Nursery | RN | %CV | 0.1% | 2.3% | 4.1% | 0.9% | 1.7% | 1.4% | 3.2% | 2.6% |
| 1 | Nursery | POC Tech | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| 1 | Nursery | POC Tech | avg | 7.289 | 54.8 | 72.2 | 131.4 | 3.1 | 0.860 | 52.3 | 21.9 |
| 1 | Nursery | POC Tech | SD | 0.006 | 0.9 | 1.2 | 0.5 | 0.04 | 0.009 | 1.5 | 0.3 |
| 1 | Nursery | POC Tech | %CV | 0.1% | 1.6% | 1.6% | 0.4% | 1.4% | 1.1% | 2.9% | 1.4% |
| 2 | NICU | RN | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 9 |
| 2 | NICU | RN | avg | 7.388 | 43.0 | 156.8 | 138.6 | 3.2 | 1.124 | 143.3 | 39.1 |
| 2 | NICU | RN | SD | 0.012 | 1.0 | 7.1 | 0.7 | 0.07 | 0.028 | 2.8 | 0.8 |
| 2 | NICU | RN | %CV | 0.2% | 2.3% | 4.5% | 0.5% | 2.2% | 2.5% | 2.0% | 2.0% |
| 2 | NICU | RN | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| 2 | NICU | RN | avg | 7.387 | 43.8 | 157.0 | 139.0 | 3.2 | 1.137 | 144.0 | 39.8 |
| 2 | NICU | RN | SD | 0.008 | 0.8 | 9.1 | 0.7 | 0.06 | 0.025 | 5.1 | 1.0 |
| 2 | NICU | RN | %CV | 0.1% | 1.8% | 5.8% | 0.5% | 2.0% | 2.2% | 3.5% | 2.6% |
| 3 | NICU | RN | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| 3 | NICU | RN | avg | 7.624 | 25.5 | 85.7 | 149.8 | 6.7 | 0.948 | 222.3 | 48.0 |
| 3 | NICU | RN | SD | 0.013 | 0.7 | 6.3 | 1.5 | 0.24 | 0.012 | 8.6 | 1.4 |
| 3 | NICU | RN | %CV | 0.2% | 2.8% | 7.4% | 1.0% | 3.5% | 1.3% | 3.9% | 2.9% |
| 3 | NICU | RT | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| 3 | NICU | RT | avg | 7.621 | 26.0 | 82.5 | 150.2 | 6.8 | 0.948 | 222.4 | 48.0 |
| 3 | NICU | RT | SD | 0.009 | 0.5 | 5.4 | 0.6 | 0.12 | 0.008 | 7.1 | 0.7 |
| 3 | NICU | RT | %CV | 0.1% | 2.0% | 6.6% | 0.4% | 1.8% | 0.8% | 3.2% | 1.4% |
Figure 5.5 - Table - Field Trial: Precision Study Summary
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5.7.2 Method comparison with predicate device
The method comparison studies were performed in a field trial at a hospital on patient samples of whole blood at the point of care in four (4) locations: NICU, Wellbaby Nursery and two (2) different outpatient drawing areas. The testing was performed by five (5) phlebotomists in the outpatient drawing areas, three (3) registered nurses (RN) in the Well-baby Nursery and five (5) registered nurses in the NICU. Patient specimens were 12 adult capillary blood samples and 36 neonatal capillary blood samples. The comparative method was the predicate device.
| Y: EPOC/CareFill vs X:i-STAT/CliniTube | ||||||||
|---|---|---|---|---|---|---|---|---|
| pH | pC02 | p02 | Na | K | Ca | Glu | Hct | |
| N | 47 | 48 | 48 | 48 | 48 | 47 | 48 | 47 |
| Sxx | 0.011 | 1.2 | 2.9 | 0.5 | 0.15 | 0.024 | 1.1 | 0.89 |
| Syy | 0.008 | 1.4 | 2.9 | 0.9 | 0.15 | 0.020 | 1.8 | 0.75 |
| X min | 7.328 | 26.0 | 36.0 | 137.0 | 3.55 | 0.93 | 42.5 | 31.5 |
| X max | 7.552 | 49.3 | 91.0 | 149.5 | 7.05 | 1.35 | 147 | 61.0 |
| average X | 7.408 | 36.1 | 52.8 | 143.3 | 4.8 | 1.197 | 73.1 | 47.1 |
| average Y | 7.387 | 38.2 | 54.1 | 140.8 | 4.6 | 1.151 | 73.6 | 42.7 |
| average(Yii-Xii) | -0.02 | 1.5 | 2.3 | -2.5 | -0.2 | -0.041 | 0.53 | -4.5 |
Figure 5.6 - Table - Average readings and biases for Epoc/Care-Fill vs. i-STAT/CLINITUBE
In this study, the glucose results coming from neonatal blood specimens were analyzed separately. The summary of this analysis is given in the table in Figure 5.7.
| Glucose [mg/dL] | Y: EPOC/CareFill vs X:i-STAT/CliniTube |
|---|---|
| N | 36 |
| Sxx | 1.3 |
| Syy | 2.1 |
| intercept | 4.2 |
| slope | 0.948 |
| Syx | 2.30 |
| X min | 42.5 |
| X max | 134 |
| R2 | 0.982 |
| Decision Level 1 | 45 |
| Bias | 1.8 |
| Bias 95% Conf. Hi | 2.8 |
| Bias 95% Conf. Lo | 0.9 |
| Decision Level 2 | 180 |
| Bias | -5.2 |
| Bias 95% Conf. Hi | -1.3 |
| Bias 95% Conf. Lo | -9.2 |
Figure 5.7 - Table - Method Comparison Summary for qlucose readings on neonatal capillary whole blood specimens as tested on Y-Epoc/Care-Fill vs. X-i-STAT/CLINITUBE
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Summary of Conclusions Drawn from Non Clinical and 5.8 Clinical Tests
We conclude from the data presented in section 5.7 that the device performs effectively.
We conclude from the data presented in section 5.8 that the device performs effectively in the hands of the users.
We conclude from the data presented in section 5.7 and 5.8 that the clinical performance of the device when using capillary samples is substantially equivalent to the predicate device: i-STAT Model 300 Portable Clinical Analyzer.
We conclude from the data presented in section 5.8 that that the clinical performance of the epoc glucose test when using neonatal samples is substantially equivalent to the predicate device: i-STAT Model 300 Portable Clinical Analyzer.
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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare.
Epocal, Inc. c/o Roy Layer 2060 Walkley Rd., Ottawa, Ontario CANADA K1G-3P5
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
HAR 3 0 2010
Re: K092849
Trade/Device Name: epoc Capillary Blood Samples for use with epoc Blood Analysis System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CEM, CHL, JGS, JFP, JPI, CGA, GIO Dated: March 23, 2010 Received: March 24, 2010
Dear: Mr. Layer:
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. 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 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) (21 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 Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. 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
510(k) Number (if known): K092849
Device Name: epoc™ Capillary Blood Samples for use with epoc Blood Analysis System
Indications For Use:
The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or unanticoagulated arterial, venous or capillary whole blood in the laboratory or at the point/of care in hospitals, nursing homes or other clinical care institutions.
Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis system and are used for the collection and dispensing of capillary blood samples with epoc Test Cards.
The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium -Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct.
The Blood Gas Electrolyte (BGEM) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2, Hematocrit - Hct and Glucose -Glu.
Measurement of sodium is used in diagnosis and treatment of diseases involving electrolyte imbalance.
Measurement of potassium is used in diagnosis and treatment of diseases involving electrolyte imbalance.
Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092849
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Indications for Use
510(k) Number (if known): K092849
Device Name: epoc TM Capillary Blood Samples for use with epoc Blood Analysis System
Indications For Use (continued):
Measurement of pH, pCO2, pO2 (blood gases) is used in the diagnosis and treatment of lifethreatening acid-base disturbances.
Measurement of Hct distinguishes normal from abnormal states of blood volume, such as anemia and erythrocytosis.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell tumors.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092849
§ 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.