(22 days)
Not Found
No
The description details a standard oxygen concentrator technology based on pressure swing adsorption and a programmable logic device for control. There is no mention of AI or ML.
Yes
The device is described as an "oxygen concentrator" intended to "provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe." This clearly indicates a therapeutic purpose.
No
The device is an oxygen concentrator, which provides supplemental oxygen to patients. It does not perform any diagnostic functions or analyze patient data to determine a medical condition.
No
The device description clearly outlines hardware components such as a compressor, molecular sieve containers, valve system, and a printed circuit board, indicating it is a physical medical device with integrated software for control.
Based on the provided text, the Puritan-Bennett Aeris 590 oxygen concentrator with OCI is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air they breathe. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a mechanical process of separating oxygen from air. It does not involve analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition or monitor a patient's health status.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample handling, or analysis of biological markers.
Therefore, the Puritan-Bennett Aeris 590 oxygen concentrator with OCI is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aeris 590 oxygen concentrator with OCI is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patient would normally receive the oxygen mixture via a nasal cannula. The device delivers over 90% oxygen at flow rates ranging from 0 to 5 liters per minute. It is primarily intended to be used in the patient's homes but may also be used in nursing homes or sub-acute care environments. It is not intended as life sustaining or life supporting device. The device has no contraindications.
Product codes (comma separated list FDA assigned to the subject device)
73 CAW
Device Description
An oxygen concentrator takes in room air, filters it and separates the nitrogen from the air under pressure, allowing only oxygen and trace gases to pass through to the oxygen outlet connection to the patient while exhausting a nitrogen-rich air mixture back into the room. The principle components of the Aeris 590 oxygen concentrator include a compressor, two molecular sieve containers, a valve system and a printed circuit board. The compressor draws in room air, pressurizes it and forces it through the pneumatic circuit of the device. As the air passes through one sieve container, the nitrogen bonds with the molecular sieve material within the pressurized container and allows only the oxygen and trace gases to flow out of the container. This oxygen rich mixture (+90% oxygen) is then delivered to the patient at a regulated pressure and flowrate. The valve system regulates the airflow through the sieve containers alternately. While one is pressurized and producing oxygen, the other is being depressurized and exhausting the nitrogen in preparation for the next cycle. A programmable logic device on the printed circuit board controls the timing of this cycling process. The OCI (Oxygen Concentration Indicator) provides an indication of the oxygen concentration of the output gas and includes alarm features.
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
pediatric and adult patients
Intended User / Care Setting
patient's homes, nursing homes or sub-acute care 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 Aeris 590 with OCI successfully passed tests in the following areas;
- Electrical Safety
- Electromagnetic Compatibility (EMC)
- Mechanical/Climatic
- Software
- Device Performance
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
Image /page/0/Picture/2 description: The image shows the word "MALLINCKRODT" in all capital letters. The "M" is partially obscured by a black square on the left side of the image. The font is a sans-serif typeface, and the text is horizontally oriented.
510(k) Summary
Puritan-Bennett Aeris 590 Oxygen Concentrator
Submitter Information
| Submitter: | Puritan-Bennett Corporation
(a subsidiary of Mallinckrodt Inc.)
3 Missouri Research Park Drive
St. Charles, MO 63304. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tony Keaveney
Regulatory Affairs Manager |
| Tel: | (314) 498 3365 |
| Fax: | (314) 939 5535 |
| Preparation Date: | 13 September 1999 |
Device Name
| Proprietary Name: | Aeris 590 with OCI |
|---|---|
| Common Name: | Oxygen concentrator |
| Classification Name: | Portable oxygen generator (73 CAW) as per 21 CFR 868.5440 |
Predicate Device Equivalence
Puritan-Bennett is claiming substantial equivalence to the Puritan-Bennett Companion 590 oxygen concentrator with OCI (Oxygen Concentration Indicator), K895141.
Device Description
An oxygen concentrator takes in room air, filters it and separates the nitrogen from the air under pressure, allowing only oxygen and trace gases to pass through to the oxygen outlet connection to the patient while exhausting a nitrogen-rich air mixture back into the room. The principle components of the Aeris 590 oxygen concentrator include a compressor, two molecular sieve containers, a valve system and a printed circuit board. The
1
compressor draws in room air, pressurizes it and forces it through the pneumatic circuit of the device. As the air passes through one sieve container, the nitrogen bonds with the molecular sieve material within the pressurized container and allows only the oxygen and trace gases to flow out of the container. This oxygen rich mixture (+90% oxygen) is then delivered to the patient at a regulated pressure and flowrate. The valve system regulates the airflow through the sieve containers alternately. While one is pressurized and producing oxygen, the other is being depressurized and exhausting the nitrogen in preparation for the next cycle. A programmable logic device on the printed circuit board controls the timing of this cycling process. The OCI (Oxygen Concentration Indicator) provides an indication of the oxygen concentration of the output gas and includes alarm features.
Intended Use
The Aeris 590 oxygen concentrator with OCI is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patient would normally receive the oxygen mixture via a nasal cannula. The device delivers over 90% oxygen at flow rates ranging from 0 to 5 liters per minute. It is primarily intended to be used in the patient's homes but may also be used in nursing homes or sub-acute care environments. It is not intended as life sustaining or life supporting device. The device has no contraindications.
Comparison of Technological Characteristics
The Aeris 590 with OCI will continue to use the same enclosure, the same compressor assembly, the same methods of gas filtration, the same method of pressure regulation and the same molecular sieve material as the Companion 590 device. It will continue to have the same audible and visual alarms as the unmodified device and the same set of accessories are also specified. Both devices are capable of supplying oxygen at flow rates of 0 to 5 L/min.
The intended use of the device remains unchanged as does its risk classification. The modified device will continue to be indicated for use for both pediatric and adult patients and will continue to be a prescription only devices are intended only as sources of supplemental oxygen and are not intended to be life supporting devices. Neither device have any contraindications.
The valve system in the Companion 590 is a pneumatic valve system controlled by low voltage solenoids. In the Aeris 590, the valve system has changed to a directly actuated valve system. The reservoir tank has been removed from the pneumatic circuit of the Aeris 590 and the sieve canister assembly has been made easier to assembly.
The oxygen concentration performance of the Companion 590 has been improved in the Aeris 590. It has an improved tolerance in the 1 to 4 L/min range and performs better at 5 L/min.
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Summary of Performance Testing
The Aeris 590 with OCI successfully passed tests in the following areas;
- Electrical Safety ●
- Electromagnetic Compatibility (EMC) .
- Mechanical/Climatic .
- Software .
- Device Performance .
Conclusions
In summary, Puritan-Bennett has demonstrated that the Aeris 590 oxygen concentrator is safe and effective. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 18 1999
Mr. Tony Keaveney Puritan-Bennett Corporation 2200 Faraday Avenue 63304 St. Charles, MO
Re: K993088 ·Aeris 590 with OCI Regulatory Class: II (two) Product Code: 73 CAW September 13, 1999 Dated: Received: September 16, 1999
Dear Mr. Keaveney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Tony Keaveney
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
Aeris 590 Oxygen Concentrator with OCI Device name: The Puritan-Bennett Aeris 590 oxygen concentrator Indications for with OCI is intended to provide supplemental oxygen Use: to patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used with both pediatric and adult patients. It is not intended as life sustaining or life supporting device. The device has no contraindications. Prescription Use: Yes
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
$\frac{4}{5}$
or
Over-The-Counter Use:
Premarket Notification 510(k) Number:
K 993088
(Division Sign Off)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number