(153 days)
Not Found
No
The document describes a standard oxygen concentrator using pressure swing adsorption and does not mention any AI or ML components or functionalities.
Yes
The device is described as an oxygen concentrator intended for patients with respiratory disorders who require supplemental oxygen, which directly fulfills a therapeutic purpose.
No
The device is an oxygen concentrator intended to supply supplemental oxygen to patients with respiratory disorders; it does not perform any diagnostic functions.
No
The device description clearly outlines hardware components such as a molecular sieve, pressure swing adsorption methodology, filters, compressor, sieve beds, oxygen reservoir, and various power supply options (AC to DC, DC to DC, battery). This indicates it is a physical medical device, not software-only.
Based on the provided text, the Invacare Flyer (Model XPO100) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients with respiratory disorders. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details how the device produces and delivers oxygen. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The Invacare Flyer is clearly described as a medical device used for treatment by providing oxygen directly to the patient.
N/A
Intended Use / Indications for Use
The Invacare Flyer is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device is not intended to sustain or support life.
The basic technology of the Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device. The oxygen concentration level of the output gas ranges from 87% to 95.6%. The oxygen is delivered to the patient through the use of a nasal cannula. When the demand for oxygen is detected, the oxygen is delivered through pulsed flow with pulse flow settings of 1 through 5.
The Invacare Flyer uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath.
The Invacare Flyer is capable of operation by the patient in a home environment, in an institutional environment, in a vehicle or other mobile environment. Device standard power options include an AC to DC switching power supply operating from AC power outlet (120 VAC/ 60 Hertz nominal), a DC to DC switching power supply operating from accessory outlets typically found in a mobile vehicle type environment (12 VDC nominal) and an external rechargeable battery.
The Invacare Flyer has several lights and indicators providing the user with information regarding the operation of the device:
- Start-Up Indicator the Flyer will briefly light all LEDs and output a brief audible beep when first turned on to indicate the unit is operational.
- Breath Detect Indicator the Flyer will output a defined pulse of oxygen each time it detects an inhalation. The blue flow setting indicator light will blink each time an inhalation is detected and the Flyer outputs a pulse of oxygen.
- Internal Battery Charging Indicator the battery gauge will be illuminated during charging to indicate the internal batter charge status. When the battery is fully charged, all four battery gauge display LEDs will illuminate continuously.
- Low Battery Warning when the Flyer's internal battery (or external battery, if applicable) charge level falls to 25% capacity, a brief audible beep will sound and the lowest level battery gauge display LED will blink.
- Low Battery Alarm when the Flyer's internal battery (or external battery, if applicable) charge level falls to 15% capacity, a brief audible double beep will sound and the lowest level battery gauge display LED will blink rapidly..
- Battery Discharged Alarm when the Flyer's internal battery (or external battery, if applicable) charge level falls to a minimum capacity, a brief audible triple beep will sound, the lowest level battery gauge display LED will blink very rapidly and the unit will shutdown.
- No Breath Detect Alarm when the Flyer is operating but does not sense breathing within a predetermined time period (e.g 60 seconds), a constant audible alarm sounds and the red alarm indicator light will illuminate continuously.
- Breath Rate Over Capacity Alarm if the breathing rate exceeds the capacity of the Flyer, a rapid audible beep sounds and the red alarm indicator light will illuminate intermittently.
- System Too Hot/Cold for Start Alarm if the Flyer senses temperatures outside factory set levels upon start-up, the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 1 & 2 blue indicator lights will illuminate.
- System Too Hot/Cold Running Alarm if the Flyer senses temperatures outside factory set levels during operation, the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 1 & 3 blue indicator lights will illuminate.
- Battery Too Hot/Cold Alarm if the Flyersinternal battery senses temperatures outside a factory defined temperature range while the unit is operating, the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will stop running and the flow setting 1 & 4 blue indicator lights will illuminate.
- Stuck Button Alarm During power up of the unit, if it detects that a button is stuck or being pressed too early, the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 1 & 5 blue indicator lights will illuminate.
- Operating Alarm If units detects abnormal operating conditions in the unit (such as over and under pressure), the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 3 & 4 blue indicator lights will illuminate.
- Compressor Alarm If units detects abnormal compressor conditions (such as Locked Rotor or RPM error), the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 4 & 5 blue indicator lights will illuminate.
- System Alarm If units detects abnormal system conditions (such as Watchdog Timer error), the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 3,4 & 5 blue indicator lights will illuminate.
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
patients with respiratory disorders who require supplemental oxygen.
Can be used in a home, institution, vehicle and various mobile environments.
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)
The Invacare Flyer has been tested in accordance with the following:
EN 60601-1-2; 2nd ed. 2001 Medical Electrical Equipment – Sec 1.2 - Collateral standard: Electromagnetic compatibility
IEC 60601-1-2; 2.1 ed. Medical Electrical Equipment - Sec 1.2 - Collateral standard: Electromagnetic compatibility
EN 55011:1998 Limits and methods of measurement of radio disturbance characteristics and medical (ISM) radio-frequency equipment
CISPR 11: 2003 Limits and methods of measurement of radio disturbance characteristics and medical (ISM) radio-frequency equipment
EN61000-4-3; 2002 IEC61000-4-3; 2006 Radiated, RF, Electromagnetic Field Immunity Test Radiated, RF, Electromagnetic Field Immunity Test
EN 61000-4-4; 1995 IEC 61000-4-4; 2004 Electrical Fast Transient/Burst Immunity Test Electrical Fast Transient/Burst Immunity Test
EN 61000-4-5; 1995 IEC 61000-4-5; 2005 Surge Immunity Test Surge Immunity Test
EN 61000-4-6; 1996 IEC 61000-4-6; 2006 Immunity to Conducted Disturbances Induced by RF fields Immunity to Conducted Disturbances Induced by RF fields
EN 61000-4-8; 2001 Power Frequency Magnetic Field Immunity Tests
EN 61000-4-11; 1995 IEC 61000-4-11; 2004 Voltage Dips, Short Interruptions and Voltage Variations Immunity Tests Voltage Dips, Short Interruptions and Voltage Variations Immunity Tests
EN 61000-3-2: 2000 IEC 61000-3-2: 2005 Limits for Harmonic Current Emissions Limits for Harmonic Current Emissions
EN 61000-3-3: 1995 IEC 61000-3-3: 2005 Voltage fluctuations and flicker Tests Voltage fluctuations and flicker Tests
IEC 60601-1: 2nd ed. 1998 with Amendment 1: 1991 with Amendment 2: 1995 Medical Electrical Equipment, Part 1: General requirements for basic safety and performance
UL 60601-1: 1st ed. 2003 Medical Electrical Equipment, Part 1: General requirements for basic safety and performance
CSA 601.1 M90 Medical Electrical Equipment, Part 1: General requirements for basic safety and performance
Quasi-Static Electric Field Reviewer Guidance for premarket notification submissions 1993
FDA Reviewer's Guide:1993 Electrostatic Discharge Immunity Test per Sec. m,7,ii,a. FDA Reviewer's Guide:1993 Reviewer Guidance for Premarket Notification Submissions
Key results: The results of the testing have shown that the Invacare Flyer is safe and effective for its intended use and substantially equivalent to its predicate.
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
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY FOR THE INVACARE FLYER, Model XPO100
This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________
Date: July 10, 2007
Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190
DEC 1 2 2007
Telephone: 440-326-6356 Fax: 440-326-3458
Contact Person: Mr. Carroll Martin
Trade Name: The Flyer
Model: XPO100
Common Name: Oxygen Concentrator
Classification Name: Generator, Oxygen, Portable per 21 CFR 868.5440
Legally Marketed Predicate Device(s): Inogen One Oxygen Concentrator; K032818, May 13, 2004
Device Description: The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institutional environment or in a vehicle or other mobile environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient.
The Invacare Flyer provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6%.
Standard power options include an AC to DC switching power supply operating from AC power outlet (120 VAC/ 60 Hertz nominal), a DC to DC switching power supply operating from accessory outlets typically found in a mobile vehicle type environment (12 VDC nominal) and an external rechargeable battery.
The Invacare Flyer uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the
510(k) K071928 Response
Page 18
1
opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath.
The basic technology of the Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device.
Intended Use: The Invacare Flyer is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.
| Features | The Invacare Flyer | Predicate Device
Inogen One Oxygen Concentrator |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K032818 |
| Date Cleared | TBD | 05/13/2004 |
| Intended Use | The Invacare Flyer is intended to be used
by patients with respiratory disorders who
require supplemental oxygen. It supplies a
high concentration of supplemental
oxygen and is used with a nasal cannula to
channel oxygen from the concentrator to
the patient. The Invacare Flyer can be
used in a home, institution, vehicle and
various mobile environments. The
Invacare Flyer does not nor is it intended
to sustain or support life. | The Inogen One Oxygen Concentrator is
used on a prescriptive basis by patients
requiring supplemental oxygen. It
supplies a high concentration of oxygen
and is used with a nasal cannula to
channel oxygen from the concentrator to
the patient. The Inogen One Oxygen
Concentrator may be used in a home.
institution, vehicles and various mobile
environments. |
| Method by which
Oxygen is Released | Molecular sieve (mechanical) | Molecular sieve (mechanical) |
| Process by which
Oxygen is Released | Pressure swing adsorption | Pressure swing adsorption |
| Sieve Bed Material | Synthetic zeolite | Synthetic zeolite |
| Software/Hardware | Analog and digital electronics with
microprocessor | Analog and digital electronics with
microprocessor |
| Flow Control | Microprocessor controlled valves | Microprocessor controlled valves |
| Weight |