(154 days)
Not Found
No
The 510(k) summary describes a sensor that measures oxygen concentration and displays the reading. There is no mention of AI, ML, or any complex data processing that would suggest the use of these technologies. The description focuses on the sensor's function and integration with existing monitoring systems.
No
The device is described as an oxygen concentration monitor for ambient air, indicating it is a diagnostic or monitoring tool rather than providing therapy to a patient.
No
The device monitors the oxygen level of ambient air, not a patient's physiological state. While it contributes to patient care by ensuring a safe oxygen environment, it does not directly diagnose a condition in a patient.
No
The device description explicitly states it is a "FiO2 Sensor," which is a hardware component that measures oxygen concentration. It also mentions being an "addition to the Siemens INFINITY patient monitoring series" and working "in conjunction with the INFINITY NeoMed pod," further indicating hardware integration.
Based on the provided information, the Siemens FiO2 sensor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Siemens FiO2 sensor measures the oxygen concentration of ambient air in non-pressurized environments. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use is to monitor the oxygen level of the air the patient is breathing, not to diagnose a condition based on a biological sample.
Therefore, the device falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Siemens FiO2 Sensor is to monitor the oxygen level of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods.
Siemens FiO2 sensor is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to monitor the oxygen level of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods.
Product codes (comma separated list FDA assigned to the subject device)
CCL
Device Description
The FiO2 Sensor is an addition to the Siemens INFINITY patient monitoring series that measures the oxygen concentration of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods. In conjunction with the INFINITY NeoMed pod, the FiO2 Sensor permits oxygen concentration monitoring to be displayed on the INFINITY modular bedside monitors, MultiView WorkStations, and PC's via the INFINITY network.
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
Infant
Intended User / Care Setting
In an environment where healthcare is provided by healthcare professionals.
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)
Assessment of non-clinical performance data for equivalence: Exhibit T
Assessment of clinical performance data for equivalence: Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).
0
NOV - 3 1999
510(k) SUMMARY
as required per 807.92(c)
- Submitters Name, Address:
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Regulatory Submissions Manager Date submission was prepared: May 25, 1999
Trade Name, Common Name and Classification Name: 2.
- A. Trade Name: Siemens FiO2 Sensor
Common Name, Classification Name, Class and Regulation Number: B.
| Common Name | Classification
Number | Class | Regulation Number |
|--------------------------------------|--------------------------|-------|-------------------|
| Analyzer, Gas, Oxygen, Gaseous-Phase | 73CCL | II | 868.1720 |
- Predicate Device Identification: 3. Mine Safety Appliances Company MiniOX® 3000 Oxygen Monitor 510(k) K961644
4. Device Description:
The FiO2 Sensor is an addition to the Siemens INFINITY patient monitoring series that measures the oxygen concentration of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods. In conjunction with the INFINITY NeoMed pod, the FiO2 Sensor permits oxygen concentration monitoring to be displayed on the INFINITY modular bedside monitors, MultiView WorkStations, and PC's via the INFINITY network.
5. Intended Use:
The intended use of Siemens FiO2 Sensor is to monitor the oxygen level of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods.
1
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
1
6. Table of Device Similarities and differences to predicate device
| | Substantial Equivalent Device | Applicant | Explanation of
Differences |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Manufacturer | Mine safety Appliances Company
MiniOx® 3000 Oxygen Monitor | Siemens Medical Systems
FiO2 Sensor | |
| 510(k) Number | K961644 | To be assigned | |
| Intended Use | Direct monitoring of oxygen
mixtures in a wide variety of
medical applications such as
anesthesiology (e.g., anesthesia
machines), respiratory therapy
(e.g., respirators, ventilators,
pediatric incubators), and oxygen
therapy (e.g., oxygen tents). | Siemens FiO2 sensor is used to
monitor the oxygen level of
ambient air in non-pressurized
environments such as that
found in infant incubators and
oxygen hoods. | Siemens FiO2 is not
intended for use in
ventilator breathing
circuits. |
| Intended | All patient populations | Infant | |
| Population | | | |
| Intended | Hospital or other clinical setting | In an environment where | |
| Environment | and during emergency transport. | healthcare is provided by
healthcare professionals. | |
| 02 Alarm System | Low/High O2 Alarm | Same | |
| Calibration | 21% O2 or 100%O2 | Same | |
| Measuring range | 0-100% | 5-100% | Measuring range is
appropriate for intended
use and intended
population. |
| Accuracy | $\pm$ 1% FS (at RTP) |