(24 days)
Johnson and Johnson Vitros Chemistry System DT6011, Buchler Digital Chloridometer
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No
The summary describes a system utilizing microelectrode technology and a microprocessor for data collection and control. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making. The performance studies focus on traditional accuracy and precision metrics.
No.
The device is a diagnostic tool that measures various analytes in blood to assess a patient's condition, not to treat or cure a disease.
Yes
The device is clearly indicated for "professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na , K , iCa BUN. CI'. and Hct. in whole blood are performed such as the clinical laboratory or the patient bedside." The measured values are explicitly used to "assess acid-base status and state of oxygenation," "assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance," "assess disease states such as thyroid abnormalities, renal failure or transplant," and "monitor renal disease, dialysis --patients, and hyperalimentation." These uses are all diagnostic in nature.
No
The device description explicitly states the system comprises an electronic instrument and disposable cartridges, indicating significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for "professional use in those settings where direct measurement of blood... are performed such as the clinical laboratory or the patient bedside." It also details how the measurements are used to assess various physiological states and aid in the diagnosis and monitoring of diseases. This clearly indicates the device is used to examine specimens derived from the human body (blood) to provide information for diagnostic purposes.
- Device Description: The device description details how the system measures various analytes in "whole blood" using microelectrode technology. This confirms that the device is performing tests on a biological specimen.
- Performance Studies: The performance studies describe testing conducted on "whole blood samples" and "aqueous samples similar to commercially available control materials." This further supports the use of the device for in vitro testing.
- Predicate Devices: The predicate devices listed are a "Chemistry System" and a "Chloridometer," which are typically used for in vitro diagnostic testing of blood or other biological fluids.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, including blood, derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The IRMA Blood Analysis System fits this definition perfectly.
N/A
Intended Use / Indications for Use
The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na , K , iCa BUN. CI'. and Hct. in whole blood are performed such as the clinical laboratory or the patient bedside.
The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include: cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance.
The electrolyte measurements (Na . K . Cl) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states which utilize these measurements for diagnosis are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.
The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients.
The measurement of blood urea nitrogen is used to monitor renal disease, dialysis --patients, and hyperalimentation.
The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia.
With the addition of BUN and Cr, the IRMA Blood Analysis System will measure: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit. The sensor arravs of the cartridge will also be packaged in various combinations.
Product codes (comma separated list FDA assigned to the subject device)
CGZ, CDS, GKG, JFP, JGS, CHL, CEM
Device Description
The current IRMA Blood Analysis System comprises a system of an electronic instrument and disposable cartridges (single-use or multi-use) intended for the measurement of blood gases (pCO2 and pO2), pH, potassium, sodium, ionized calcium, and hematocrit in blood.
The new system will measure the above mentioned analytes plus blood urea nitrogen (BUN) and chloride (Cl) in blood on the single-use cartridge. Except for the addition of these two analytes and their associated changes, the system will remain the same as the current system. A description of the new system follows.
The IRMA analyzer can use either battery or AC power. The system's operation utilizes a microprocessor which is controlled by internal electronics and diagnostics. The microprocessor controls the touch screen, analog electronics which collect the digital signals from the sensors and the controls the printer. The printer provides a hard copy of the measured and calculated values.
Samples are introduced via syringe or capillary injections with the IRMA Capillary Collection Device. The minimum sample volumes are 200uL from a syringe injection and 125uL from a Capillary Collection Device injection. Other capillary collection devices which require aspiration are not compatible with the system.
The cartridges utilize microelectrode technology for the measurement of the following blood analytes: pH, pCO2, pO2, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit.
The principles of measurement are similar to traditional electrode methodologies for blood gas and electrolyte measurements. The pH, pCO2, Na*, K*, iCa**, BUN, and Cli utilize ion-selective potentiometric electrodes including a reference electrode. The pO2 electrode is an amperometric Clark electrode. The hematocrit sensor utilizes a conductivity electrode. Further description of the principles of operation for the electrodes can be found in the draft labeling of the user manual.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional use in those settings where direct measurement of blood... such as the clinical laboratory or the patient bedside.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Accuracy Data: Split sample studies were conducted to determine chloride and BUN accuracy using whole blood samples measured by both the IRMA system and a reference method. The method of least squares was used to determine the best fit line. Testing was conducted by three laboratory personnel. Heparinized whole blood samples were prepared by spiking with varying concentrations of electrolytes to allow testing throughout the reportable range.
- Key Result: The data indicated substantial equivalence between Chloride and BUN sensors on the IRMA Blood Analysis System and the predicate devices.
- Precision Data: To determine precision of the Cl- and BUN sensors of the IRMA system, samples at a given level were tested. The samples consisted of three levels of aqueous solutions similar to commercially available control materials. Each day of testing, each operator tested five replicates from each of the three levels.
- Key Result: Precision data for both Cl- and BUN aqueous solutions were provided, showing acceptable standard deviations and coefficients of variation across different levels and operators.
- Display Range: Graphs showed the tested linear range of the product. The data, along with blood accuracy data, justified the displayed ranges.
- IRMA Cl : Range evaluated = 10.6 - 146.8 mM
- IRMA BUN: Range evaluated = 7.3 - 124.5 mg/dL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient (r) for linear fit:
IRMA Cl : r = 0.9976
IRMA BUN: r = 0.9996
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Johnson and Johnson Vitros Chemistry System DT6011, Buchler Digital Chloridometer
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.
0
MAY 1 1998
510(k) Summary
| 1. Submitter | Diametrics Medical, Inc. |
|---|---|
| 2658 Patton Road | |
| Roseville, MN 55113 | |
| 2. Establishment Registration Number: | 2183953 |
| 3. Device Names | |
| Proprietary Name: | IRMA Blood Analysis System |
Common Name:
Blood Gas/Electrolyte/Hematocrit Analyzer
Classification Name:
Blood gases (pCO2, pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit test systems
-
- Device Classification
The blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, chloride, blood urea nitrogen and hematocrit systems have been classified under Clinical Chemistry Test Systems 21 CFR 862.1120, 862.1665, 862.1600, 862.1145, 862.1170, 862.1770 and under Hematology and Pathology Devices, 864.6400. All are Class II devices.
- Device Classification
-
- Compliance to Classification Requirements No performance standards have been established for the above referenced systems. Diametrics Medical intends to comply with any standards applicable to this product developed in the future.
-
- Proposed labels, labeling, and advertisements The proposed labeling appears in Appendix B (Pouch and cartridge label), Appendix C (Package insert) and Appendix D (User manual). There are no required changes to the current device label. Diametrics Medical, Inc. does not intend to advertise the product at this time.
1
7 . System Description and Statement of Substantial Equivalence
System Description
The current IRMA Blood Analysis System comprises a system of an electronic instrument and disposable cartridges (single-use or multi-use) intended for the measurement of blood gases (pCO2 and pO2), pH, potassium, sodium, ionized calcium, and hematocrit in blood.
The new system will measure the above mentioned analytes plus blood urea nitrogen (BUN) and chloride (Cl) in blood on the single-use cartridge. Except for the addition of these two analytes and their associated changes, the system will remain the same as the current system. A description of the new system follows.
The IRMA analyzer can use either battery or AC power. The system's operation utilizes a microprocessor which is controlled by internal electronics and diagnostics. The microprocessor controls the touch screen, analog electronics which collect the digital signals from the sensors and the controls the printer. The printer provides a hard copy of the measured and calculated values.
Samples are introduced via syringe or capillary injections with the IRMA Capillary Collection Device. The minimum sample volumes are 200uL from a syringe injection and 125uL from a Capillary Collection Device injection. Other capillary collection devices which require aspiration are not compatible with the system.
The cartridges utilize microelectrode technology for the measurement of the following blood analytes: pH, pCO2, pO2, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit.
The principles of measurement are similar to traditional electrode methodologies for blood gas and electrolyte measurements. The pH, pCO2, Na*, K*, iCa**, BUN, and Cli utilize ion-selective potentiometric electrodes including a reference electrode. The pO2 electrode is an amperometric Clark electrode. The hematocrit sensor utilizes a conductivity electrode. Further description of the principles of operation for the electrodes can be found in the draft labeling of the user manual.
Calibration
The IRMA sensors are calibrated prior to each test using a calibrant prepackaged over the sensors. The calibrant is manufactured and tested with NIST traceable gases and salt standards. Calibration of the cartridge is completed when information determined at the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.
Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.
The user may also output the stored data via a RS232 serial port to IDMS ( IRMA Data Management System) or to a LIS.
2
Cartridge operation
Upon insertion of the cartridge, the user will enter a calibration code and the software's checksums will determine whether the code is appropriate for that cartridge type. Screen prompts will guide the user through the calibration process and sample analysis
For a more detailed description of the sample sequence refer to Section 2 of the User Manual Draft Labeling which is located in Appendix D.
Intended Use Comparison
The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na* , K* , iCa* , Cl; BUN, and Hct in whole blood are performed such as the clinical laboratory or the patient bedside.
Substantial Equivalence
This notification demonstrates that the IRMA Blood Analysis System's BUN and Cl sensors are substantially equivalent to several other commercially cleared products: Johnson and Johnson Vitros Chemistry System DT6011 (BUN) and the Buchler Digital Chloridometer (CI).
The IRMA and Vitros analysis systems are similar in that both systems are intended for the measurement of blood urea nitrogen (BUN) by enzymatic methods which utilize an urease reaction. The IRMA and Buchler Digital Chloridometer systems are similar in that both systems are intended for the measurement of chloride by electrochemical methods.
The predicate systems and proposed IRMA Blood Analysis System are compared in Tables #1-2.
3
| IRMA | Vitros | |
|---|---|---|
| Detection Method | enzymatic electrochemical | |
| urease reaction | enzymatic colorimetric | |
| urease reaction | ||
| Analytes measured | pH, pCO2, pO2, Na+, K+, iCa++, | |
| BUN, CI-, Hct | ||
| *BUN and Cl- not available on | ||
| multi-use | BUN, ammonia, amylase, | |
| cholesterol, creatinine, | ||
| glucose, HDL cholesterol, | ||
| hemoglobin, lactate, | ||
| magnesium, neonatal bilirubin, | ||
| phosphorus, total bilirubin, | ||
| total protein, triglycerides, | ||
| uric acid | ||
| Measuring Range | BUN 0 - 150 mg/dL | BUN 1 - 100 mg/dL |
| Operating Temp. | 15-30°C (59-86°F) | 15.5-29.4℃ (60-85°F) |
| Operating Humidity | 0-80% | 15-75%* |
| *Upper RH value dependent of | ||
| temperature. | ||
| Sample | Whole blood | |
| 0.2 - 3.0 mL, syringe | ||
| 0.125 mL from capillary | ||
| collection device | Serum/plasma | |
| 10 µL per test | ||
| Power | 7.2 V NiCAD rechargeable | |
| battery | ||
| or | ||
| AC adapter | 120 VAC 1 amp | |
| 240 VAC 0.5 amp | ||
| Reagents | Supplied in self-contained | |
| disposable cartridge | Supplied in self-contained | |
| disposable slide | ||
| Weight | 5 lbs. | 19 lbs. |
| Results | Display and printer on board | Display and printer on board |
| Calibration | Automatic with each sample | User initiated process upon |
| installation, changing of slide | ||
| lots, when QC is out, or as | ||
| needed for system verification. | ||
| Sensors | disposable single-use | |
| or | ||
| multi-use | disposable single-use |
Table #1 Comparison of IRMA to Vitros System Features
ﺰ ﺳﻴﺒﻴﺎ
:
:
4
| IRMA | Buchler Chloridometer | |
|---|---|---|
| Detection Method | electrochemical | electrochemical |
| Analytes measured | pH, pCO2, pO2, Na+, K+, iCa++, | |
| BUN, Cl-, Hct | ||
| *BUN and Cl- not available on | ||
| multi-use | Cl- | |
| Measuring Range | Cl- 30-150 mM or mEq/L | Cl- 1.0-999.9 mEq/L |
| Operating Temp. | 15-30°C (59-86°F) | Room temperature (range not |
| specifically defined) | ||
| Operating Humidity | 0-80% | Not defined |
| Blood Sample | Whole blood | |
| 0.2 - 3.0 mL, syringe | ||
| 0.125 mL from capillary | ||
| collection device | serum/plasma | |
| 10 μL on low range | ||
| 100 μL on high range | ||
| Power | 7.2 V NICAD rechargeable | |
| battery | ||
| or | ||
| AC adapter | 115 VAC, 60 Hz | |
| 230 VAC, 50 Hz | ||
| Reagents | Supplied in self-contained | |
| disposable cartridge | Chloridometer acid reagent | |
| which is manually measured | ||
| Weight | 5 lbs. | 10 lbs. |
| Results | Display and printer on board | Display on board |
| Calibration | Automatic with each sample | Manual blank adjustment of |
| reagents and check with | ||
| chloride standard | ||
| Sensors | disposable single-use | |
| or | ||
| multi-use | reusable silver wire |
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Table, #2, Comparison of IRMA to Buchler Chloridometer System Features
:
5
8 . Performance Characteristics: Supporting data for Substantial Equivalence
This section provides blood and aqueous data generated in-house using the IRMA Blood Analysis System's chloride and BUN sensors. The samples used in the study were spiked heparinized blood and prepared aqueous standards.
- A. Accuracy Data
To determine chloride and BUN accuracy of the IRMA Blood Analysis, split sample studies were conducted using whole blood samples measured by both the IRMA system and a reference method (refer to Table #3). The method of least squares was used to determine the best fit line. Testing was conducted by three laboratory personnel. The IRMA system was cleared in a previous 510k submission for use by non-laboratory personnel therefore this submission does not include data by non-laboratory personnel such as nurses. The heparinized whole blood samples were prepared by spiking with varying concentrations of electrolytes to allow testing throughout the reportable range.
The data shown below in Table #4 and the x-y plots located in Appendix A indicate substantial equivalence between CI- and BUN sensors on the IRMA Blood Analysis System and the predicate devices.
Table #3 Reference methods
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Table #4 Blood Accuracy: The method of least squares was used to determine the best fit line.
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r = correlation coefficient
6
B. Precision Data
r recision Data
To determine precision of the Cl' and BUN sensors of the IRMA system, samples at a given level ro determine problem of the samples used in the study consisted of three levels of aqueous were testion reportionly. The our problement of the control materials. Each day of testing, each solutions similar to commercially a familians from each of the three levels. Data from this study are shown in Tables #5-6.
| Day | Operator | n | Level | Mean | SD | CV |
|---|---|---|---|---|---|---|
| Day 1 | 1 | 5 | 1 | 30.6 | 0.76 | 2.5 |
| 2 | 5 | 1 | 30.2 | 0.27 | 0.9 | |
| 3 | 5 | 1 | 30.8 | 0.94 | 3.0 | |
| Combined | 15 | 1 | 30.5 | 0.72 | 2.4 | |
| Day 2 | 1 | 5 | 1 | 30.5 | 0.94 | 3.1 |
| 2 | 5 | 1 | 30.2 | 0.63 | 2.1 | |
| 3 | 4 | 1 | 30.5 | 0.17 | 0.6 | |
| Combined | 14 | 1 | 30.4 | 0.65 | 2.1 | |
| Day 1 | 1 | 5 | 2 | 56.6 | 0.22 | 0.4 |
| 2 | 5 | 2 | 57.1 | 0.28 | 0.5 | |
| 3 | 5 | 2 | 57.0 | 0.43 | 0.8 | |
| Combined | 15 | 2 | 56.9 | 0.36 | 0.6 | |
| Day 2 | 1 | 5 | 2 | 57.0 | 0.30 | 0.5 |
| 2 | 5 | 2 | 57.1 | 0.15 | 0.3 | |
| 3 | 5 | 2 | 57.1 | 0.30 | 0.5 | |
| Combined | 15 | 2 | 57.1 | 0.24 | 0.4 | |
| Day 1 | 1 | 5 | 3 | 85.9 | 1.78 | 2.1 |
| 2 | 5 | 3 | 87.1 | 0.61 | 0.7 | |
| 3 | 4 | 3 | 87.0 | 0.42 | 0.5 | |
| Combined | 14 | 3 | 86.6 | 1.20 | 1.4 | |
| Day 2 | 1 | 4 | 3 | 86.0 | 1.59 | 1.9 |
| 2 | 5 | 3 | 86.2 | 1.45 | 1.7 | |
| 3 | 5 | 3 | 85.2 | 1.90 | 2.2 | |
| Combined | 14 | 3 | 85.8 | 1.60 | 1.9 |
Table #5 Cl Aqueous Precision
Combined = Results from all users combined for a day of testing.
7
| Table #6 BUN Aqueous Precision | |||
|---|---|---|---|
| -------------------------------- | -- | -- | -- |
| Day | Operator | n | Level | Mean | SD | CV |
|---|---|---|---|---|---|---|
| Day 1 | 1 | 5 | 1 | 17.5 | 2.40 | 13.7 |
| 2 | 5 | 1 | 18.0 | 1.72 | 9.6 | |
| 3 | 5 | 1 | 17.4 | 1.36 | 7.8 | |
| Combined | 15 | 1 | 17.6 | 1.76 | 10.0 | |
| Day 2 | 1 | 5 | 1 | 17.7 | 0.96 | 5.4 |
| 2 | 5 | 1 | 16.3 | 1.43 | 8.8 | |
| 3 | 5 | 1 | 17.3 | 1.06 | 6.1 | |
| Combined | 15 | 1 | 17.1 | 1.25 | 7.3 | |
| Day 1 | 1 | 5 | 2 | 33.8 | 1.40 | 4.1 |
| 2 | 5 | 2 | 34.8 | 2.98 | 8.6 | |
| 3 | 5 | 2 | 34.2 | 3.93 | 11.5 | |
| Combined | 15 | 2 | 34.3 | 2.77 | 8.1 | |
| Day 2 | 1 | 5 | 2 | 33.3 | 2.19 | 6.6 |
| 2 | 5 | 2 | 33.7 | 1.29 | 3.8 | |
| 3 | 5 | 2 | 34.5 | 2.84 | 8.2 | |
| Combined | 15 | 2 | 33.8 | 2.09 | 6.2 | |
| Day 1 | 1 | 5 | 3 | 64.1 | 4.56 | 7.1 |
| 2 | 4 | 3 | 64.8 | 1.81 | 2.8 | |
| 3 | 5 | 3 | 65.4 | 4.81 | 7.4 | |
| Combined | 14 | 3 | 64.7 | 3.82 | 5.9 | |
| Day 2 | 1 | 5 | 3 | 68.7 | 1.46 | 2.1 |
| 2 | 5 | 3 | 67.4 | 3.79 | 5.6 | |
| 3 | 5 | 3 | 67.6 | 2.55 | 3.8 | |
| Combined | 15 | 3 | 67.9 | 2.63 | 3.9 |
Combined = Results from all users combined for a day of testing.
8
- D. Display range
Graphs #1-2 show the tested linear range of the product. This data along with the blood accuracy data which were shown earlier justify the display ranges shown in Table #8.
| Table #8 IRMA Blood Analysis System Display Range
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Graph #1
Image /page/8/Figure/5 description: The image is a graph titled "Mean(IRMA Cl- mM) By Mean(Cl- conc (mM))". The graph shows a linear relationship between the mean concentration of chloride (Cl-) and the mean IRMA Cl- mM. The x-axis represents the Mean(Cl- conc (mM)) and ranges from 0 to 200, while the y-axis represents the Mean(IRMA Cl- mM) and ranges from 0 to 200. A linear fit line is plotted on the graph, showing a positive correlation between the two variables.
IRMA CI- Linear Range
IRMA Cl = 0.9262 Cl- conc (mM) -22.43 n = 99 samples - with mean of each level shown r = 0.9976 Sy.x =4.0 Range evaluated = 10.6 - 146.8 mM
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Graph #2
Image /page/9/Figure/1 description: The image is a graph titled "Mean IRMA BUN (mg/dL) By Mean BUN conc (mg/dL)". The graph shows a linear relationship between Mean IRMA BUN and Mean BUN concentration. The x-axis represents Mean BUN concentration in mg/dL, ranging from 0 to 150, while the y-axis represents Mean IRMA BUN in mg/dL, also ranging from 0 to 150. A line of best fit, labeled as "Linear Fit", is plotted on the graph.
I RMA BUN Linear Range
IRMA BUN= 1.0831 BUN conc (mg/ dL) + 3.7837 N = 97 samples - with mean of each level shown r = 0.9996 Sv.x = 1.5 Range evalutated = 7.3 - 124.5 mg/ dL
11. Safety and Effectiveness
The addition of the CI- and BUN sensors to the IRMA Blood Analysis System has not been found to interfere or cause any adverse effects with the operation of the IRMA instrument or other nearby equipment. There are no additional risks to the patient or user when cartridges containing these sensors are utilized with the IRMA system.
The IRMA Blood Analysis System has already been certified to the required electrical and EMI safety specifications of medical equipment such as UL 2601-1 and UL 2601-2 (or equivalent).
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11. Software Information
The IRMA Blood Analysis System's software has been developed, tested and will be validated in accordance with Diametrics' software development procedures and where applicable, the FDA's Reviewer's Guide to Computer Controlled Medical Devices (August, 1991). Based on the criteria of this document, our product is perceived to be of a low level of concern. Below is a description of the software development process.
Software requirements are developed based on approved product design requirements. All design specifications are reviewed for consistency and accuracy with respect to one another and a software hazard analysis is performed. The software hazard analysis for this product is located in Table #9. The software code is developed from the approved software requirements. Software revisions are maintained under a software version control system.
Software test plans and procedures are developed based on the software requirements specifications. Related software requirements are grouped to form the basis of test procedures. Each functional requirement (or group of requirements) is translated into a functional test and is included in a test procedure. These procedures are designed to ensure that functional requirements are met, software related system specifications fulfilled and software safety features adequately tested.
Code inspections and walk-throughs are performed by software engineers not involved in the code development in order to detect design flaws and validate software logic where functional testing is insufficient.
Written test procedures are executed and the results are reviewed to ensure that acceptance criteria have been met.
Software testing is also conducted in a less structured environment (free-form testing) by technicians and users under a variety of conditions in an attempt to "break" the software,
Considerable attention is applied to system safety throughout the verification. validation and testing of the software. A system hazard analysis which is done in the early development phase of the product is reviewed and updated as required. Safety requirements are identified in the hazard analysis and incorporated into the design specifications and tests via functional procedures. Potential error and exception conditions are also identified and tested. Stress conditions are also tested during the verification and validation phase.
All events identified as potential hazards for the IRMA Blood Analysis System have been addressed through hardware, software, or product labeling.
Changes to software requirements are documented, reviewed and approved. Each revision of the software is reviewed and evaluated for complete functionality and impact to the hazard analysis. New revisions are subjected to the same tests as the previous version. Revisions to areas that do not affect calculations may be regression tested. Each version of the software released to manufacturing will be archived with a list of the changes and validation data.
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Table #9 Software Hazard Analysis
ﺍ ﺗﻮﺻﻌﻬﺎ ﻭﺍﻟﺘﻲ ﺗﻪ ﺍﻟ
| Potential Hazard:
Inaccurate Algorithms | Action to Minimize
Hazard | Add'I
Information | Likelihood | Severity |
|--------------------------------------------|-------------------------------------------------|----------------------|------------|----------|
| Calibration | Test & Validation
plans
Development Phase | QC check | Improbable | Marginal |
| Sample Calculations | Test & Validation
plans
Development Phase | QC check | Improbable | Marginal |
| System operation | Test & Validation
plans
Development Phase | QC check | Improbable | Marginal |
| Incorrect IR reading | Test & Validation
plans
Development Phase | QC check | Improbable | Marginal |
| Temperature &
Barometric checks | Test & Validation
plans
Development Phase | QC check | Improbable | Marginal |
Table #10 Categories
| Table #10 Categories | |
|---|---|
| Likelihood | Severity |
| Frequent | Negligible |
| Probable | Marginal |
| Occasional | Critical |
| Remote | Catastrophic |
| Improbable | |
| Incredible |
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Software Certification
I certify that, in my capacity as Director of Quality Assurance and Regulatory Affairs of Diametrics Medical, Inc., prior to market release of the product, the software development process will be completed. The final documentation will include official signoff of the software requirements specifications, test plans and test completion criteria, and their results which demonstrate the system specifications and functional requirements were met along with release of the software revision.
We have shown substantial equivalence between the IRMA Blood Analysis System utilizing the multi-use cartridge and the predicate devices even though the software development process has not yet been completed.
Name of Company Official Correspondent: Steve Boeh
Signature:
e: Steve Burch
Title: Director of QA/RA
Company Name: Diametrics Medical Inc.
Date of Signature: Month/Day/Year
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13. Attachments
The proposed labeling appears in Appendix B (Pouch and Cartridge Labels), Appendix C (Cartridge Package Insert) and Appendix D (User Manual). There are no required changes to the IRMA Blood Analysis System's device label. The draft user manual which is shown contains the information which is pertinent to the addition of the new CI and BUN sensors. Any screen changes associated with these new sensors will also be made to the pictures in the user manual. This information will either be incorporated into the current IRMA SL Series 2000 User Manual or it will become an addendum to it. Diametrics Medical, Inc. does not intend to advertise the product at this time.
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Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with three stylized human profiles incorporated into its design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1 1998 MAY
Steve Boeh . Director, Quality Assurance and Regulatory Affairs Diametrics Medical, Inc. 2658 Patton Road Saint Paul, Minneapolis 55113 Minnesota K981270 Re :
IRMA® Blood Analysis System Regulatory Class: II Product Code: CGZ, CDS, GKG, JFP, JGS, CHL, CEM Dated: April 2, 1998 Received: April 7, 1998
Dear Mr. Boeh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use and Intended Use Statement
tr 981271 510(k) Number: IRMA Blood Analysis System with additional menu: blood urea nitrogen and Device Name: chloride
Indications for Use
Statement of Intended Use
The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na , K , iCa BUN. CI'. and Hct. in whole blood are performed such as the clinical laboratory or the patient bedside.
The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include: cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance.
The electrolyte measurements (Na . K . Cl) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states which utilize these measurements for diagnosis are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.
The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients.
The measurement of blood urea nitrogen is used to monitor renal disease, dialysis --patients, and hyperalimentation.
The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia.
With the addition of BUN and Cr, the IRMA Blood Analysis System will measure: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit. The sensor arravs of the cartridge will also be packaged in various combinations.
(Please DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) ✓ | OR Over-The-Counter Use | |
| (Optional Format 1-2-96) |
Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 9812