(335 days)
K95 1094
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No
The summary describes a modification to an existing blood gas sensor, focusing on increased lifespan and measurement capacity. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The device measures standard blood gas parameters using established methods.
No
Explanation: The device is described as a "Point-of-Care Blood gas Monitor System" and is intended to "provide on-demand arterial blood gas monitoring." This indicates that it is a diagnostic or monitoring device, not a device that directly treats a condition.
Yes
The device is intended to provide on-demand arterial blood gas monitoring, which involves measuring key parameters (PO2, PCO2, and pH) to assess a patient's physiological state. This information is used by medical professionals to understand the patient's condition and make informed decisions, which is a diagnostic function.
No
The device description explicitly states it is a "modified SensiCath Sensor," which is a physical component that measures blood gas parameters. It is part of a larger "Point-of-Care Blood Gas Monitor System," which also implies hardware.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Measures blood gas parameters: The device measures PO2, PCO2, and pH, which are parameters measured in blood samples.
- Used with a blood sample: The intended use states it provides "on-demand arterial blood gas monitoring," implying it analyzes blood drawn from an arterial line.
- Analyzes a biological sample outside the body: While the sensor is placed within the arterial line, the analysis of the blood gas parameters is performed on the blood itself, which is a biological sample. The term "in vitro" means "in glass" or "outside the body."
The fact that it's a "Point-of-Care Blood gas Monitor System" further supports its IVD nature, as these systems are designed for rapid analysis of biological samples at the patient's location.
N/A
Intended Use / Indications for Use
The modified SensiCath Sensor, when used as part of the Point-of-Care Blood gas Monitor System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients requiring an arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated.
Product codes
73 CCC, 73 CBZ, 73 CCE
Device Description
It is the intention of Optical Sensors Incorporated (OSI) and Marquette Electronics Incorporated (MEI) to introduce into commercial distribution a modification to the SensiCath Arterial Blood Gas Sensor. The modified sensor has a longer useful life and allows a greater number of ABG measurements. The modified sensor is substantially equivalent to the SensiCath Sensor presented in the SensiCathTM Point-of-Care Blood Gas Monitor System which received Food and Drug Administration (FDA) clearance to market, 510(k) K95 1094. The modified SensiCath Sensor operates with the SensiCath Point-of-Care Blood Gas Monitor System, just as the predicate SensiCath Sensor. As with the predicate sensor, the modified SensiCath Sensor measures blood gas parameters of partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2) and the blood's hydrogen ion concentration, (pH). The modified SensiCath Sensor is manufactured and sterilized by Optical Sensors Incorporated, as is the predicate SensiCath Sensor.
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
Arterial blood
Indicated Patient Age Range
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Intended User / Care Setting
Attending qualified medical professional, operating room and at the bedside for critically ill patients.
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)
Precision and accuracy tests were conducted on the modified SensiCath Sensor. Tonometered bovine blood was equilibrated with several gas mixtures. At different levels of carbon dioxide, pH and oxygen, measurements were taken using the sensor as part of the Point-of Care Blood Gas Monitor. The performance of the modified SensiCath Sensor meets the same performance specifications as the predicate SensiCath Sensor over 144 hours of use and 200 ABG measurements. The results of this performance testing concludes there are no new safety or effectiveness issues with this labeling change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
K95 1094
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1150 Indwelling blood carbon dioxide partial pressure (P
2CO2 ) analyzer.(a)
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
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Image /page/0/Picture/0 description: The image shows a diagram of an optical sensor, with the text "OPTICAL SENSORS INCORPORATED" printed next to it. The diagram consists of a series of parallel lines connected to a diamond shape with a circle in the middle. The text "K961790" is printed above the company name, and the date "APR - 9 1997" is printed below the diagram.
510(k) SUMMARY AND CERTIFICATION 3.0
A 510(k) Summary of Safety and Effectiveness, Class III Certification and Class III Summary of Safety and Effectiveness Problems is presented here.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 3.1
This Summary of Safety and Effectiveness information is submitted in accordance with the requirements of SMDA 1990.
| Re: | 510(k) Pre-market Notification
SensiCath™ Arterial Blood Gas Sensor. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Optical Sensors Incorporated
7615 Golden Triangle Drive
Minneapolis, MN 55344 |
| Date: | 5/1/96 |
| Contact Person: | Denise Schottler,
Director Quality Assurance, Regulatory Affairs. |
| Device Name: | SensiCath™ Arterial Blood Gas Sensor. |
| Common Name: | Blood Gas Sensor. |
| Trade Name: | SensiCath™ Arterial Blood Gas Sensor |
| Classification Name: | 73 CCC 21 CFR 868.1150 Indwelling blood carbon dioxide partial (PCO2) analyzer. 73 CBZ 21 CFR 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. 73 CCE 21 CFR 868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer. |
| Predicate Device: | 510(k) K95 1094 |
SensiCath The Point-of-Care Blood Gas Monitor System
7615 GORDER TRIANGLE DR. TECHNOLOGY PARK FIVE MINNEAPOLIS, MN 55344 PHONE 612 . 944 . 5857
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3.1.1 DESCRIPTION OF THE DEVICE:
It is the intention of Optical Sensors Incorporated (OSI) and Marquette Electronics Incorporated (MEI) to introduce into commercial distribution a modification to the SensiCath Arterial Blood Gas Sensor. The modified sensor has a longer useful life and allows a greater number of ABG measurements. The modified sensor is substantially equivalent to the SensiCath Sensor presented in the SensiCath™ Point-of-Care Blood Gas Monitor System which received Food and Drug Administration (FDA) clearance to market, 510(k) K95 1094. The modified SensiCath Sensor operates with the SensiCath Point-of-Care Blood Gas Monitor System, just as the predicate SensiCath Sensor.
As with the predicate sensor, the modified SensiCath Sensor measures blood gas parameters of partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2) and the blood's hydrogen ion concentration, (pH). The modified SensiCath Sensor is manufactured and sterilized by Optical Sensors Incorporated, as is the predicate SensiCath Sensor.
3.1.2 STATEMENT OF INTENDED USE OF THE DEVICE
The modified SensiCath Sensor, when used as part of the Point-of-Care Blood gas Monitor System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients requiring an arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated. The intended use of the modified SensiCath Sensor is the same as the predicate SensiCath Sensor.
3.1.3 COMPARISON
The modified SensiCath Sensor is equivalent to the predicate SensiCath Sensor in design, materials, clinical application and intended use. The modified SensiCath Sensor allows 144 hours of single patient use and a greater number of ABG measurements. The predicate SensiCath Sensor is limited to 72 hours of single patient use. The change in duration of use and number of ABG measurements result in labeling changes.
The affect of duration of use and number of ABG measurements has been evaluated. Performance data demonstrating the modified SensiCath Sensor meets performance specifications has been provided.
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3.1.4 DISCUSSION OF PERFORMANCE DATA SUBMITTED IN SUPPORT OF THE SAFETY AND EFFICACY CLAIMS FOR THE MODIFIED SENSICATH SENSOR
Precision and accuracy tests were conducted on the modified SensiCath Sensor. Tonometered bovine blood was equilibrated with several gas mixtures. At different levels of carbon dioxide, pH and oxygen, measurements were taken using the sensor as part of the Point-of Care Blood Gas Monitor. The performance of the modified SensiCath Sensor meets the same performance specifications as the predicate SensiCath Sensor over 144 hours of use and 200 ABG measurements.
The results of this performance testing concludes there are no new safety or effectiveness issues with this labeling change. This information causes Optical Sensors Incorporated to conclude that no new or unanswered issues of safety or effectiveness are raised.
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