(87 days)
Not Found
No
The description focuses on standard microprocessor control, alarms based on preset thresholds, and basic self-checks, with no mention of AI or ML capabilities.
No.
The device is an oxygen monitor, used for continuous, direct monitoring of oxygen mixtures. It does not provide any therapeutic intervention.
No
Explanation: The device is described as an oxygen monitor that provides continuous, direct monitoring of oxygen mixtures. It measures oxygen concentrations and sets alarms based on these measurements. This is for monitoring, not for diagnosing a patient's condition.
No
The device description clearly outlines physical hardware components including a battery, microprocessor, touch sensitive keypad, LCD, LEDs, an oxygen sensor with electrodes, cables, and accessories like a tee adapter and retaining strap. This is not a software-only device.
Based on the provided information, the MiniOX® 3000 Oxygen Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to monitor oxygen mixtures in medical applications like anesthesiology, respiratory therapy, and oxygen therapy. This involves monitoring gases breathed by the patient or delivered to the patient, not analyzing samples taken from the patient (like blood, urine, or tissue).
- Device Description: The device measures oxygen concentration directly in a gas mixture using a sensor. It does not perform any tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, sample preparation, or analysis of biological specimens, which are hallmarks of IVD devices.
Therefore, the MiniOX® 3000 Oxygen Monitor is a medical device used for monitoring gas concentrations in a clinical setting, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MiniOX® 3000 Oxygen Monitor provides continuous, 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). The MiniOX® 3000 Oxygen Monitor is to be used by trained health care professionals under the supervision, or on the order. of a physician in a hospital (or other clinical setting) and during emergency transport.
Product codes
868.1720
Device Description
Battery operated and microprocessor controlled, the MiniOX® 3000 Oxygen Monitor measures oxygen concentrations in the 0 - 100% range. The performance features include a calibration function; high and low oxygen concentration alarms; low and depleted battery alarms: oxygen sensor indicator: automatic error detection: battery test and oxygen concentration alarm test.
The calibration function allows calibration of the device against room air (21% O.) or 100% O2. Audible and visual alarms alert the operator when monitor calibration is required. High and low oxygen concentration alarms may be set in the ranges of 19%-100% (high alarm) and 18%-99% (low alarm) or the default high/low settings may be used (50% and 18% respectively). Audible and visual alarms activate when oxygen concentrations fall below the preset (or default) low alarm setting or rise above the preset (or default) high alarm setting. The MiniOX® 3000 Oxygen Monitor detects low and depleted battery conditions and activates audible and visual alarms. The MiniOX® 3000 Oxygen Monitor also alarms for sensor disconnection or malfunction and for various internal operating errors.
The MiniOX® 3000 Oxygen Monitor conducts self checks at power-up (battery installation), turn-on, and during operation. Additionally, the monitor has two operator initiated test functions. The Alarm Test verifies the operation of the high and low oxygen level alams; the Battery Test assesses the relative remaining battery life.
The MiniOX® 3000 Oxygen Monitor consists of two components: the instrument and the oxygen sensor. The portable, hand-held instrument features a touch sensitive keypad; a liquid crystal display (LCD) that shows monitor status, continuous oxygen concentrations, and preset alarm levels; and two red light emitting diodes (LED) which serve as visual alarms. The back of the instrument case has a bail bar which allows the instrument to "stand" on a horizontal surface during monitoring operations. A plastic wedge on the back of the instrument slides into an optional bracket for mounting the instrument on a horizontal or vertical pole.
The oxygen sensor used in the MiniOX® 3000 Oxygen Monitor is the same oxygen sensor used in Mine Safety Appliances Company oxygen monitoring medical devices for the past 15 years. Connected to the instrument by a coiled cable, the galvanic oxygen sensor consists of a deflector assembly and a plastic housing containing two electrodes. A coiled cable connects the sensor to the instrument. Plugs at each end of the cable snap into jacks (one located in the sensor housing and one located in the instrument) and are held securely in place by twist collars.
In addition to the mounting bracket, the device has two accessories: a tee adapter and a retaining strap. The oxygen sensor is introduced into a breathing circuit through a Mine Safety Appliances Tee Adapter which connects two lengths of tubing. The sensor/tee assembly is positioned with the sensor deflector pointing downward to ensure that moisture does not collect on the sensor membrane. A Retaining Strap ensures that the sensor remains securely in place in the Tee Adapter.
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
Not Found
Intended User / Care Setting
trained health care professionals under the supervision, or on the order. of a physician in a hospital (or other clinical setting) and during emergency transport.
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)
Non-clinical performance testing was conducted to verify that the MiniOX® 3000 Oxygen Monitor meets its specifications and demonstrates substantial equivalence to the MiniOX® III Oxygen Monitor. Tests conducted included Response Time, Reading Accuracy, Ambient Operating Temperature, Storage Temperature, Humidity/Condensation Effects, Stability, Electromagnetic Compatibility, Shock and Vibration, Battery Operation Time, Audible Alarm Output, Battery Reversal (reverse polarity), Shipping/Handling Shock Resistance, Fluid Spill, Function (Performance Features), and Oxygen Alarm Accuracy. All tests passed. The tests were based on applicable voluntary standards (ANSI Z79.10, MIL-STD 516-4, IEC 601-1, 529) and FDA guidances (Reviewer Guidance for Premarket Notification Submissions, Reviewer Guidance for Controlled Medical Devices Undergoing 510(k) Review, FDA MDS 201-0004).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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
K961644 MS
Mine Safety Appliances Company · Instrument Division · P.O. Box 427 · Pittsburgh, PA 15230
Telephone: (412) 776-8600
ﺳﺴﺴﺴ
writers direct dial no.
JUL 25 1996
510(K) SUMMARY
SUBMITTER:
Mine Safety Appliances Company P.O. Box 427 Pittsburgh, Pennsylvania 15230
Telephone: 412-776-8600 412-776-8892 FAX:
CONTACT:
Thomas P. McClory Marketing Manager, Medical Products
SUMMARY DATE:
April 17, 1996
1
| NAME OF DEVICE: | MiniOX® 3000 Oxygen Monitor |
|---|---|
| COMMON NAME: | Oxygen monitor |
| CLASSIFICATION NAME: | Oxygen gas analyzer (868.1720) |
| MARKETED DEVICE: | MiniOX® III Oxygen Monitor |
| Mine Safety Appliances Company | |
| (K833326) |
DEVICE DESCRIPTION
Battery operated and microprocessor controlled, the MiniOX® 3000 Oxygen Monitor measures oxygen concentrations in the 0 - 100% range. The performance features include a calibration function; high and low oxygen concentration alarms; low and depleted battery alarms: oxygen sensor indicator: automatic error detection: battery test and oxygen concentration alarm test.
The calibration function allows calibration of the device against room air (21% O.) or 100% O2. Audible and visual alarms alert the operator when monitor calibration is required. High and low oxygen concentration alarms may be set in the ranges of 19%-100% (high alarm) and 18%-99% (low alarm) or the default high/low settings may be used (50% and 18% respectively). Audible and visual alarms activate when oxygen concentrations fall below the preset (or default) low alarm setting or rise above the preset (or default) high alarm setting. The MiniOX® 3000 Oxygen Monitor detects low and depleted battery conditions and activates audible and visual alarms. The MiniOX® 3000 Oxygen Monitor also alarms for sensor disconnection or malfunction and for various internal operating errors.
The MiniOX® 3000 Oxygen Monitor conducts self checks at power-up (battery installation), turn-on, and during operation. Additionally, the monitor has two operator initiated test functions. The Alarm Test verifies the operation of the high and low oxygen level alams; the Battery Test assesses the relative remaining battery life.
The MiniOX® 3000 Oxygen Monitor consists of two components: the instrument and the oxygen sensor. The portable, hand-held instrument features a touch sensitive keypad; a liquid crystal display (LCD) that shows monitor status, continuous oxygen concentrations, and preset alarm levels; and two red light emitting diodes (LED) which serve as visual alarms. The back of the instrument case has a bail bar which allows the instrument to "stand" on a horizontal surface during monitoring operations. A plastic wedge on the back of the instrument slides into an optional bracket for mounting the instrument on a horizontal or vertical pole.
The oxygen sensor used in the MiniOX® 3000 Oxygen Monitor is the same oxygen sensor used in Mine Safety Appliances Company oxygen monitoring medical devices for the past 15 years. Connected to the instrument by a coiled cable, the galvanic oxygen sensor consists of a deflector assembly and a plastic housing containing two electrodes. A coiled cable connects the sensor to the instrument. Plugs at each end of the cable snap into jacks (one located in the sensor housing and one located in the instrument) and are held securely in place by twist collars.
In addition to the mounting bracket, the device has two accessories: a tee adapter and a retaining strap. The oxygen sensor is introduced into a breathing circuit through a Mine Safety Appliances Tee Adapter which connects two lengths of tubing. The
2
sensor/tee assembly is positioned with the sensor deflector pointing downward to ensure that moisture does not collect on the sensor membrane. A Retaining Strap ensures that the sensor remains securely in place in the Tee Adapter.
INTENDED USE
The MiniOX® 3000 Oxygen Monitor provides continuous, 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). The MiniOX® 3000 Oxygen Monitor is to be used by trained health care professionals under the supervision, or on the order. of a physician in a hospital (or other clinical setting) and during emergency transport.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The technology used in the MiniOX® 3000 Oxygen Monitor and the MiniOX® III Oxygen Monitor is the same with the exception of the technology used in the design of the printed circuit boards.
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
Except instrument weight, the specifications of the MiniOX® 3000 Oxygen Monitor and the MiniOX® III Oxygen Monitor are identical. It was determined that it was necessary to conduct performance tests to verify that the MiniOX® 3000 Oxygen Monitor meets its specifications and, thereby, demonstrate that the monitor is substantially equivalent to the MiniOX® III Oxygen Monitor. Table 1 summarizes the tests that were conducted.
Conclusions Drawn From Testing
The MiniOX® 3000 Oxygen Monitor and the MiniOX® III Oxygen Monitor have the same specifications. Therefore, in order to demonstrate substantial equivalence, it is necessary to verify that the MiniOX® 3000 Oxygen Monitor does, indeed, perform to specification. Because many of the specifications were derived from applicable voluntary standards and FDA guidances, the MiniOX® 3000 Oxygen Monitor was tested according to test protocols based on these standards and guidances.
Tests results verified that the device conforms to the applicable sections of ANSI Z79.10, the Reviewer Guidance for Premarket Notification Submissions, and the Reviewer Guidance for Controlled Medical Devices Undergoing 510(k) Review. Test results also demonstrated that the MiniOX® 3000 Oxygen Monitor performs to specification and, therefore, is substantially equivalent to the legally marketed device, the MiniOX® III Oxygen Monitor.
3
| Non-Clinical Performance Test Summary | ||
|---|---|---|
| Test | Standard/Guidance | Results |
| Response Time | ANSI Z79.10¹ 4.3.2.1 | Pass |
| Reading Accuracy | ANSI Z79.10 3.2.1.1 | Pass |
| Ambient Operating Temperature | ANSI Z79.10 3.2.3.1 | |
| FDA MDS 201-0004² | Pass | |
| Storage Temperature | ANSI Z79.10 3.2.3.2 | |
| FDA MDS 201-0004 | Pass | |
| Humidity/Condensation Effects | ANSI Z79.10 3.2.1.4 | Pass |
| Stability | ANSI Z79.10 3.2.1.2 | Pass |
| Electromagnetic Compatibility | ANSI Z79.10 3.2.3.4 | |
| FDA MDS 201-0004 | Pass | |
| Shock and Vibration | ANSI Z79.10 3.2.3.3 | |
| FDA MDS 201-0004 | Pass | |
| Battery Operation Time | FDA MDS 201-0004 | Pass |
| Audible Alarm Output | ANSI Z79.10 3.2.2.3.1 | |
| FDA MDS 201-0004 | Pass | |
| Battery Reversal (reverse polarity) | FDA MDS 201-0004 | Pass |
| Shipping/Handling Shock Resistance | MIL-STD 516-4 | Pass |
| Fluid Spill | IEC 601-1, 529 | |
| FDA MDS 201-0004 | Pass | |
| Function (Performance Features) | FDA Guidance³ | Pass |
| Oxygen Alarm Accuracy | ANSI Z79.10 3.2.1.3 | |
| FDA MDS 201-0004 | Pass | |
| Table 1 |
1 Requirements for Oxygen Analyzers for Monitoring Patient Breathing Mixtures 2
Reviewer Guidance for Premarket Notification Submissions
3
an productions for Premarket Notification Submissions
Reviewer Guidance for Premarket Notification Submissions
Reviewer Guidance for Computer Controlled Medical Devices Unde