(114 days)
None
No
The summary describes a system for on-demand arterial blood gas monitoring using optical sensors and a module, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a monitoring system that provides diagnostic information (arterial blood gas monitoring), not as one that treats or prevents a disease or condition.
Yes
The device is intended to provide on-demand arterial blood gas monitoring, which involves measuring physiological parameters to assess the health status of critically ill patients, fitting the definition of a diagnostic device.
No
The device description explicitly lists three main hardware components: an optical sensor, a module, and an operator interface (monitor). This indicates it is a hardware-based system, not software-only.
Based on the provided information, the Olympus System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to provide "on-demand arterial blood gas monitoring." Blood gas analysis is a laboratory test performed on a blood sample to measure the levels of oxygen, carbon dioxide, and pH. This is a classic example of an in vitro diagnostic test.
- Device Description: The system utilizes an "optical arterial blood gas sensor" and an "ABG Module" to perform this monitoring. This indicates that it is analyzing a biological sample (arterial blood) outside of the body.
- Performance Studies: The description mentions "Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications." This further supports its function as a diagnostic device that measures specific parameters in a biological sample.
- Predicate Devices: The predicate devices listed are "Point-of-Care Blood Gas Monitor System" and "Tram® System." These are also devices used for blood gas analysis, which are typically classified as IVDs.
While the device is used at the point-of-care (operating room and bedside), the fundamental principle of analyzing a blood sample outside the body to obtain diagnostic information aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Olympus System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients with a pre-existing 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
Not Found
Device Description
It is the intention of Optical Sensors Incorporated (OSI) to introduce into commercial distribution an Olympus Critical Care Monitoring System (Olympus System). The Olympus System supports modules and sensors used in monitoring critical parameters at the patient bedside. The module and sensor referenced in this submission are the cleared-to-market arterial blood gas module (ABG Module) and SensiCath optical sensor unit (SensiCath Sensor). When the Olympus System includes an ABG Module and SensiCath Sensor, monitoring of arterial blood gas at the point-of-care is accomplished.
The Olympus System has three main components:
-
- an optical arterial blood gas sensor, hereafter referred to as the SensiCath Sensor.
-
- a module, the Arterial Blood Gas (ABG) Module, hereafter referred to as the ABG Module and,
-
- an operator interface (display, control knob) with electrical and mechanical support for the ABG Module, hereafter referred to as the Olympus Monitor.
The SensiCath Sensor is manufactured by Optical Sensors Incorporated. The ABG Module is manufactured by Marquette Medical Systems and the Olympus Monitor is manufactured by SeaMED Corporation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Attending qualified medical professional, operating room, bedside
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
Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications. The Olympus System performance meets the same performance specifications as the predicate Point-of-Care Arterial Blood Gas Monitoring System. The requirements for the Olympus System, with an ABG Module and SensiCath Sensor, require testing to the FDA "Reviewer's Guidance for Devices undergoing 510(k) review, November 1993", prior to commercial introduction.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
JAN 2 3 1997
| 4.0 | 510(K) SUMMARY AND CERTIFICATION
A 510(k) Summary of Safety and Effectiveness, Class III Certification and Class
III Summary of Safety and Effectiveness Problems is presented here. | |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| 4.1 | 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is submitted in accordance
with the requirements of SMDA 1990. | |
| | Re: | 510(k) Pre-market Notification
Olympus Critical Care Monitoring System. |
| | Submitted By: | Optical Sensors Incorporated
7615 Golden Triangle Drive
Minneapolis, MN 55344 |
| | Date: | 9/30/96 |
| | Contact Person: | Denise Schottler
Director Quality Assurance, Regulatory Affairs. |
| | Device Name: | Olympus Critical Care Monitoring System. |
| | Common Name: | Blood Gas Monitor. |
| | Trade Name: | Olympus Critical Care Monitoring System. |
| | Classification Name: Blood Gas Monitor. | |
| | Predicate Device: | Point-of-Care Blood Gas Monitor System
510(k) K951094 |
| | | Tram® System
510(k) K900598 |
DESCRIPTION OF THE DEVICE 4.1.1
It is the intention of Optical Sensors Incorporated (OSI) to introduce into commercial distribution an Olympus Critical Care Monitoring System (Olympus System). The Olympus System supports modules and sensors used in monitoring critical parameters at the patient bedside. The module and sensor referenced in this submission are the cleared-to-market arterial blood gas module (ABG Module) and SensiCath optical sensor unit (SensiCath Sensor). When the Olympus System includes an ABG Module and SensiCath Sensor, monitoring of arterial blood gas at the point-of-care is accomplished.
000019
1
The ABG Module and SensiCath Sensor received Food and Drug Administration (FDA) clearance to market, 510(k) K951094. The predicate system is referred to as the Point-of-Care Arterial Blood Gas Monitoring System.
As in the predicate cleared-to-market system, the Olympus System measures blood parameters of partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2) and the hydrogen ion concentration, (pH). The Olympus System has three main components:
-
- an optical arterial blood gas sensor, hereafter referred to as the SensiCath Sensor.
-
- a module, the Arterial Blood Gas (ABG) Module, hereafter referred to as the ABG Module and,
-
- an operator interface (display, control knob) with electrical and mechanical support for the ABG Module, hereafter referred to as the Olympus Monitor.
The SensiCath Sensor is manufactured by Optical Sensors Incorporated. The ABG Module is manufactured by Marquette Medical Systems and the Olympus Monitor is manufactured by SeaMED Corporation. The sponsor of this 510(k) pre-market notification is Optical Sensors Incorporated.
STATEMENT OF INTENDED USE OF THE DEVICE 4.1.2
The Olympus System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients with a pre-existing 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.
4.1.3 COMPARISON
The Olympus System is designed to be used specifically with the ABG Module and SensiCath Sensor. The Olympus System can accommodate up to two modules simultaneously. At the present time, the only module supported by the Olympus System is the ABG Module. Only one ABG Module is used at a time. As other modules are developed, clearance-to-market will be submitted.
The Olympus System is designed to perform ABG measurements identical to the Point-of-Care Arterial Blood Gas Monitoring System. This system was clearedto-market by 510(k) K951094.
2
The predicate system includes a Marquette Medical Systems Tram Monitoring System, (TramScope Monitor, Tram-Rac and Tram Module), ABG Module and SensiCath Sensor. When the Marquette Tram System includes an ABG Module and SensiCath Sensor, arterial blood gas monitoring can be performed. The Tram System was cleared-to-market by 510(k) K 900598.
DISCUSSION OF PERFORMANCE DATA SUBMITTED IN SUPPORT 4.1.4 OF THE SAFETY AND EFFICACY CLAIMS
Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications. The Olympus System performance meets the same performance specifications as the predicate Point-of-Care Arterial Blood Gas Monitoring System.
The requirements for the Olympus System, with an ABG Module and SensiCath Sensor, require testing to the FDA "Reviewer's Guidance for Devices undergoing 510(k) review, November 1993", prior to commercial introduction.
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No new questions of safety or effectiveness are raised.