(335 days)
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.
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.
The document describes a medical device, the SensiCath™ Arterial Blood Gas Sensor, and a modification to it. It details the device's intended use and compares the modified version to a predicate device. The performance data section focuses on demonstrating that the modified sensor meets predetermined specifications.
Here's an analysis of the provided text in relation to the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the modified SensiCath Sensor "meets the same performance specifications as the predicate SensiCath Sensor over 144 hours of use and 200 ABG measurements." However, it does not provide a quantifiable table of acceptance criteria or specific performance values for precision and accuracy. It mentions that precision and accuracy tests were conducted, but the actual results or the specific numerical thresholds for acceptance are not detailed.
Without specific numerical acceptance criteria from the document, a precise table cannot be generated. However, based on the text, the implicit acceptance criteria are:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Precision: Must meet specifications of predicate SensiCath Sensor. | Tests confirm performance meets specifications. |
| Accuracy: Must meet specifications of predicate SensiCath Sensor. | Tests confirm performance meets specifications. |
| Duration of Use: Must perform over 144 hours of single patient use. | Performance verified over 144 hours of use. |
| Number of ABG Measurements: Must perform for 200 ABG measurements. | Performance verified for 200 ABG measurements. |
| Safety and Effectiveness: No new safety or effectiveness issues compared to the predicate. | Concluded that no new safety or effectiveness issues are raised. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample size (number of sensors, number of tests, or number of blood samples) used for the precision and accuracy tests. It only mentions that "Tonometered bovine blood was equilibrated with several gas mixtures" and "measurements were taken."
- Data Provenance: The tests were conducted using "Tonometered bovine blood." This indicates that the data is from a controlled laboratory setting, likely a bench study rather than human clinical data. The study appears to be prospective in the sense that the modified device was tested in a controlled environment to gather performance data. The country of origin of the data is not specified, but the submitting entity is in Minneapolis, MN, USA, suggesting the testing was likely conducted in the USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The study described is a technical performance test of a sensor, not a diagnostic study requiring expert interpretation of results to establish ground truth about a patient's condition. The "ground truth" for the sensor's measurements (PO2, PCO2, pH) would be established by the reference measurements from the tonometered blood, not by human experts.
4. Adjudication Method for the Test Set:
Not applicable. This type of performance study does not typically involve an adjudication method as seen in clinical studies where multiple reviewers assess images or clinical outcomes. The "ground truth" for the sensor measurements is determined by the preparation of the tonometered blood, not through human consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. The reported study focuses on the standalone performance of the device against predefined specifications, not on how human readers' performance with or without the device's assistance.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance study was done. The document describes tests to evaluate the "performance of the modified SensiCath Sensor" itself. This involved measuring its precision and accuracy when applied to tonometered bovine blood. This is an evaluation of the device's technical specifications in a controlled setting, which is inherently a standalone performance assessment.
7. The Type of Ground Truth Used:
The ground truth for the sensor measurements (PO2, PCO2, pH) was established by the known concentrations/parameters of the tonometered bovine blood. Tonometering involves equilibrating biological fluids with gas mixtures of precisely known concentrations, effectively creating a "gold standard" for the gas parameters.
8. The Sample Size for the Training Set:
Not applicable. This document describes a performance validation study for a sensor, not a machine learning model. Therefore, there is no concept of a "training set" in the context of this submission.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device validation.
{0}------------------------------------------------
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 NotificationSensiCath™ Arterial Blood Gas Sensor. |
|---|---|
| Submitted By: | Optical Sensors Incorporated7615 Golden Triangle DriveMinneapolis, 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
原
10
{1}------------------------------------------------
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.
PAGE
{2}------------------------------------------------
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.
赢
§ 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.”