(220 days)
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No
The document describes a device that measures physical parameters (oxygen concentration, flow, and pressure) using sensors and provides these measurements to a service technician. There is no mention of AI or ML being used for analysis, interpretation, or decision-making based on these measurements. The performance studies focus on meeting standard electrical, mechanical, and environmental requirements, not on the performance of any AI/ML algorithm.
No
The device is described as a tool for service personnel to evaluate oxygen concentrators, not for direct patient use or therapeutic purposes.
No
This device is designed to evaluate the output of an oxygen concentrator for service personnel, not to diagnose a patient's medical condition or monitor patient-specific oxygen delivery.
No
The device description explicitly states it is a "lightweight, battery powered device which measures oxygen gas concentration, flow and pressure". This indicates it is a physical hardware device with measurement capabilities, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is explicitly stated to be a "tool for use by service personnel to evaluate the output of an oxygen concentrator." It measures the characteristics of the gas produced by the concentrator (oxygen content, flow rate, and pressure).
- Not for Patient Use: The description clearly states it is "not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to patient."
- No Biological Samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a patient's health. This device analyzes gas from a machine, not a biological sample.
The device is a diagnostic tool, but it's a diagnostic tool for evaluating the performance of a medical device (an oxygen concentrator), not for diagnosing a patient's condition using biological samples.
N/A
Intended Use / Indications for Use
The Invacare Check O2 Concentrator Analyzer device is a tool for use by service personnel to evaluate the output of an oxygen concentrator. Its intended use is to provide information to the service technician regarding oxygen content, flow rate, and pressure, of oxygen produced by an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to patient.
The Check O2 has measurement capability in the following ranges: 73% - 95.6% Oxygen Concentration 0 - 6 LPM Flow 0 - 10 PSI Pressure
Accuracy of the Device is:
± 2% Oxygen Concentration ± .3 LM Flow (5% of full scale) ± 1 digit ± 2 PSI Full Scale Pressure 0 to 68.95 kPa, ± 2% Full Scale
Product codes
73 CCL
Device Description
The Invacare Check O2 Plus is a lightweight, battery powered device which measures oxygen gas concentration, flow and pressure from an oxygen concentrator. The device is a standalone product and does not have any accessories, power supply adapters or fittings. This device is intended as a tool for use by oxygen concentrator service personnel, to evaluate the output of an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm delivery of oxygen to a patient.
The device connects to an oxygen concentrator through existing therapy tubing presently in use throughout the industry. The device is designed and calibrated for use only on the species mixture inherent with the output flow of a concentrator. Information provided is the concentrator's oxygen concentration, flow and pressure. Continuous monitoring of output gas flow between an operating concentrator and a patient is not possible. Use with any downstream devices or patient accessories is also not possible.
It is further intended that this device be used on clean, dry and unhumidified concentrator output In conjunction with the operating temperature of oxygen concentrators, the ambient gas. temperature range of the Check O2 Plus is within the range of +10 to +35 degrees Celsius and should remain in a dry indoor environment.
The concentrator gas is expected to fall within the following ranges and will be measured with the accuracy's listed below.
Concentration: 73% to 95.6% oxygen, ± 2%
Flow: 0 to 6 Liters per minute, ± 0.3 L/M (5% of full scale) ± 1 digit
Pressure: 0 to 10 PSI, ± 2% full scale
0 to 68.95 kPa, ± 2% full scale
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
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Indicated Patient Age Range
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Intended User / Care Setting
Intended Environment: The Check O2 is intended to be used in an environment where Oxygen Concentrators are serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes and Respiratory Device Service and Repair Centers.
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)
The Invacare Check O2 Plus was tested in accordance with the electrical, mechanical and environmental performance requirements for home use respiratory devices set forth in the Anesthesiology and Respiratory Devices Branch's November 1993 document entitled "Reviewer Guidance for Premarket Notification Submissions". In all instances the Check O2 Plus met the required performance criteria and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
JUL - 9 1999
510(k) SUMMARY (Revised 4/15/99)
Invacare Corporation's CHECK O2 PLUS OXYGEN ANALYZER
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person: Edward A. Kroll Director , TQM and Regulatory Affairs
Date Prepared: November 30, 1998
Name of Device and Name/Address of Sponsor
Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Common or Usual Name
Oxygen Analyzer
Classification Name
Oxygen Gas Analyzer
Predicate Devices
The Invacare Check O2 Plus is substantially equivalent to the Puritan Bennett Corporations' Model "Companion ROCI (K920338)."
1
Intended Use
The Invacare Check O2 Concentrator Analyzer device is a tool for use by service personnel to evaluate the output of an oxygen concentrator. Its intended use is to provide information to the service technician regarding oxygen content, flow rate, and pressure, of oxygen produced by an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to patient.
Intended Environment: The Check O2 is intended to be used in an environment where Oxygen Concentrators are serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes and Respiratory Device Service and Repair Centers.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Invacare Check O2 Plus is a lightweight, battery powered device which measures oxygen gas concentration, flow and pressure from an oxygen concentrator. The device is a standalone product and does not have any accessories, power supply adapters or fittings. This device is intended as a tool for use by oxygen concentrator service personnel, to evaluate the output of an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm delivery of oxygen to a patient.
The device connects to an oxygen concentrator through existing therapy tubing presently in use throughout the industry. The device is designed and calibrated for use only on the species mixture inherent with the output flow of a concentrator. Information provided is the concentrator's oxygen concentration, flow and pressure. Continuous monitoring of output gas flow between an operating concentrator and a patient is not possible. Use with any downstream devices or patient accessories is also not possible.
It is further intended that this device be used on clean, dry and unhumidified concentrator output In conjunction with the operating temperature of oxygen concentrators, the ambient gas. temperature range of the Check O2 Plus is within the range of +10 to +35 degrees Celsius and should remain in a dry indoor environment.
The concentrator gas is expected to fall within the following ranges and will be measured with the accuracy's listed below.
| Concentration: | 73% to 95.6% oxygen, ± 2% |
|---|---|
| Flow: | 0 to 6 Liters per minute, ± 0.3 L/M (5% of full scale) ± 1 digit |
| Pressure: | 0 to 10 PSI, ± 2% full scale |
| 0 to 68.95 kPa, ± 2% full scale |
2
A. Substantial Equivalence
The Invacare Check O2 Plus covered by this substantially equivalent to other legally marketed oxygen analyzer devices. Specifically, the Invacare Check O2 Plus is substantially equivalent to the Puritan Bennett Corporations' Model "Companion ROCI" (K920338 8/27/92). The Invacare Check O2 Plus is comparable this device in several aspects.
The Invacare Check O2 Plus has the same intended use, principle of operation and technological characteristics. Both devices are battery powered and have similar performance characteristics, features and specifications for accuracy of measured output. Finally, both sensors utilize ultrasonic technology for measuring oxygen concentration. This is a proven technique for measuring oxygen concentration as a function of gas density.
The Check O2 Plus differs from its predicate device in that it has the capability of measuring pressure and flow, as well as oxygen content. As such it is a more complete tool for use in analyzing concentrator output and measuring concentrator performance. Additionally, the Check O2 Plus device measures oxygen content within the range of