(195 days)
No
The summary describes a standard in vitro diagnostic device for blood analysis using electrochemical sensors and a reader. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis focuses on traditional statistical metrics like bias, slope, and R2.
No.
The device is described as an in vitro diagnostic device used for quantitative testing of blood samples to measure various analytes, which are used in the diagnosis and treatment of diseases. It does not provide therapy directly.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "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..."
No
The device description clearly states that the system consists of three components: a test card (hardware), a card reader (hardware), and a host with software. While software is a component, it is not the sole component of the medical device system.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device..."
- Nature of Testing: The system performs quantitative testing of blood samples (arterial, venous, or capillary whole blood) for various analytes (Sodium, Potassium, Calcium, pH, pCO2, pO2, Hematocrit, Glucose). This type of testing on biological samples outside of the body is the core definition of in vitro diagnostics.
- Purpose of Measurements: The text details how the measurements are used in the "diagnosis and treatment" of various diseases and conditions, which is a key characteristic of IVD devices.
Therefore, the device clearly falls under the category of an In Vitro Diagnostic.
N/A
Intended Use / 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.
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.
Product codes
CHL, JGS, CEM, JFP, CGA, JPI, GIO
Device Description
The epoc System is a point-of-care device currently in use in hospitals. 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 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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals; in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Test Performance:
-
Equivalence of epoc Test Results Between Samples Delivered from a Syringe Versus Samples Delivered from Care-Fill Capillary Tubes:
- Study Type: Method comparison.
- Sample Size: N=42 for each analyte (pH, pCO2, pO2, Na, K, Ca, Glu, Hct).
- Key Results: The study demonstrated that the collection and delivery method using Care-Fill cap tubes yields test results equivalent to those where a syringe is used as a sample delivery method. The R-squared (R2) values for all analytes were very high, ranging from 0.994 to 0.999, indicating strong correlation between the two sample delivery methods. Bias values were generally small.
-
In-house Method Comparison Study using Capillary Samples (vs. Predicate Device):
- Study Type: In-house method comparison.
- Sample Size: N=51 for pH/pCO2, N=52 for pO2, Na, K, Ca, Glu, Hct.
- Data Source: Capillary blood samples.
- Key Results: Comparison between epoc/Care-Fill and i-STAT/CliniTube showed varying biases across analytes (e.g., pH: -0.023, pCO2: 0.5, pO2: 6.0, Na: -1.0, K: -0.1, Ca: -0.075, Glu: 0.8, Hct: -2.3).
Summary of Clinical Tests in Support of Substantial Equivalence:
- Precision when using Care-Fill capillary tubes as delivery method:
- Study Type: Precision study (field trial).
- Sample Size: Six (6) precision studies, n=10 replicates per study, across three (3) different pools of blood.
- Data Source: Patient samples of whole blood at Point-of-Care (Nursery, NICU).
- Key Results: Summarized as average, SD, and %CV for pH, pCO2, pO2, Na, K, iCa, Glu, and Hct across different samples, sites, and operators. Precision varied by analyte and sample, with %CV generally low (e.g., pH typically
§ 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.
0
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 | Regulation
Number | Panel | Product
Code |
|-----------------------------------------------------------------|-------|----------------------|-----------------------|-----------------|
| Electrode Measurement, Blood-
Gases (PCO2, PO2) and Blood pH | II | 862.1120 | Clinical
Chemistry | CHL |
| Electrode, Ion Specific, Sodium | II | 862.1665 | Clinical
Chemistry | JGS |
| Electrode, Ion Specific, Potassium | II | 862.1600 | Clinical
Chemistry | CEM |
| Electrode, Ion Specific, Calcium | II | 862.1145 | Clinical
Chemistry | JFP |
| Glucose | II | 862.1345 | Clinical
Chemistry | CGA |
| Hematocrit | II | 864.6400 | Hematology | JPI |
Figure 5.1 - Table - epoc™ Blood Analysis System with Blood Gas, Electrolytes and Metabolytes (BGEM) Test Card
1
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.
2
| 510(k) #
Item | epoc Blood Analysis System
K061597 and K090109
Device | | I-STAT Model 300
K001387
Predicate | | Same /
Different | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended
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 whole blood using the
BGEM (Blood Gas Electrolyte
Metabolyte), BGE (Blood Gas
Electrolyte) and ABG (Arterial Blood
Gas) test card panels. | | The i-STAT Model 300 Portable Clinical
Analyzer is intended to be used by
trained medical professionals for use
with i-STAT test cartridges and
MediSense blood glucose test strips.
i-STAT cartridges comprise a variety
of clinical chemistry tests and test
panels. | | same | |
| Where used | hospital | | hospital | | same | |
| Measured
parameters | pH, pCO2, pO2, Na, K, iCa, Gluc, Hct | | pH, pCO2, pO2, Na, K, iCa, Gluc, Hct | | same | |
| Calculated
parameters | TCO2, HCO3, BE, SO2, Hgb | | TCO2, HCO3, BE, SO2, Hgb | | same | |
| Sample type | Venous, arterial and capillary whole
blood | | Venous, arterial and capillary whole
blood | | same | |
| Reportable
ranges | pH
pCO2
pO2
Na
K
iCa
Glu
Hct | 6.5 - 8.0
5 - 250
5 - 750
85 - 180
1.5 - 12
0.25 - 4
20 - 700
10 - 75 | pH
pCO2
pO2
Na
K
iCa
Glu
Hct | 6.5 - 8.2
5 - 130
5 - 800
100 - 180
2.0 - 9.0
0.25 - 2.5
20 - 700
10 - 75 | pH units
mm Hg
mm Hg
mmol/L
mmol/L
mmol/L
mg/dL
%PCV
mmol/L
mmol/L
mmol/L
mmol/L
%
g/dL | different
different
same
different
different
different
same
same |
| | TCO2
HCO3
BEecf
BEb
SO2
Hb | 1 - 85
1 - 85
-30 - +30
-30 - +30
0 - 100
3.3 - 25 | TCO2
HCO3
BEect
BEb
SO2
Hb | 5 - 50
1 - 85
-30 - +30
-30 - +30
0 - 100
3 - 26 | mmol/L
mmol/L
mmol/L
mmol/L
%
g/dL | different
same
same
same
same
same |
| Sample
volume | Non volumetric over 90 μL | | 100μL | | same | |
| Test card | Unit-use card with
- on-board calibrator in sealed
reservoir - an electrochemical multi-sensor
array - port for sample introduction
- fluid waste chamber | | Unit-use cartridge with
- on-board calibrator in sealed
reservoir - an electrochemical multi-sensor
array - port for sample introduction
- fluid waste chamber | | same | |
| Test card
storage | Room temperature until expiry date | | Storage at 2-8°C until expiry date
including max 2 weeks at room
temperature | | different | |
| Sensor array | A laminated foil sensor module | | A micro-fabricated chip-set | | different | |
| Tests/sensor
components | pH - PVC ion selective electrode
pCO2 - QH modified Severinghaus type
pO2 - membrane coated gold cathode
Na - PVC ion selective electrode
K - PVC ion selective electrode
iCa - PVC ion selective electrode
Glu - Enzymatic (glucose oxidase
based), amperometric peroxide
detection
Hct - conductivity, gold electrodes | | pH - PVC ion selective electrode
pCO2 - QH modified Severinghaus type
pO2 - membrane coated gold cathode
Na - PVC ion selective electrode
K - PVC ion selective electrode
iCa - PVC ion selective electrode
Glu - Enzymatic (glucose oxidase
based), amperometric peroxide
detection
Hct - conductivity, gold electrodes | | same
same
same
same
same
same
same
same | |
| Analyzer
components | 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 | | different
same
same | |
Comparison of Technological Characteristics To Predicate 5.5 vice
epoc Capillary Samples 510(k) Submission
:
3
| | mechanical card engagement
device for making electrical contact
to card's sensors for rupture of calibrator
reservoir moving calibrator to
sensors engaging heaters with
card | mechanical card engagement
device for making electrical contact
to card's sensors for rupture of calibrator
reservoir moving calibrator to
sensors engaging heaters with card | same |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| | op-amp sensor signal detectors
IQC monitoring devices
Thermal controllers
MUX
A/D
Bluetooth stack for wireless
transmission of digitized raw | op-amp sensor signal detectors
IQC monitoring devices
Thermal controllers
MUX
A/D
wire transmission of digitized raw
sensor signals to computing
subsystem in same housing | same
same
same
same
same
different |
| | sensor signals to computing
device | | |
| | bar code scanner for acquiring
card info | n/a | different |
| | internal electronic reader self-test
circuit
2 - The computing device comprising
a PDA | internal and external electronic
self-test circuit | different |
| | microprocessor
memory
color LCD display
keyboard
i/o for communicating test results
to other devices
software to control the test and
calculate analytical values from
raw sensor signals
battery operated with
rechargeable batteries via plug in
plug-in power supply | microprocessor
memory
monochrome LCD display
keyboard
i/o for communicating test results
to other devices
software to control the test and
calculate analytical values from
raw sensor signals
battery operated with
rechargeable batteries via
external power supply in
downloader cradle | same
same
different
same
same
same
same |
| Measurement | 37°C | 37°C | same |
| temperature | | | |
| Measurement
sequence | Calibrate test card-introduce sample-
measure | Introduce sample-calibrate test
cartridge-measure | different |
| Measurement
time | 35sec from sample introduction | 130-200 sec from sample introduction | different |
| Error
detection | IQC system to detect user errors
IQC system for reader self-check
IQC system to detect card non- | IQC system to detect user errors
IQC system for reader self-check
IQC system to detect card non-conformance | same
same
same |
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.
4
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.
5
| 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
6
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
7
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.
8
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).
9
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.
(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 (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