(86 days)
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No
The description focuses on mechanical and electronic control of oxygen delivery based on the breathing cycle, with no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
Yes
The device delivers oxygen to individuals with COPD to maximize the beneficial effects of supplemental oxygen, which directly addresses a medical condition.
No
The device is described as an oxygen conserving device used to deliver supplemental oxygen to individuals with COPD. It does not perform any diagnostic functions like detecting, monitoring, or diagnosing a medical condition.
No
The device description clearly indicates it is a physical device ("The AirSep Impulse Oxygen Conserving Device") that works in conjunction with a bottled oxygen source and delivers oxygen through a nasal cannula. This involves hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AirSep Impulse Oxygen Conserving Device is described as a device that works with an oxygen source to deliver oxygen to a patient through a nasal cannula. Its function is to regulate and conserve oxygen delivery based on the patient's breathing.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples from the patient. It interacts with the patient's respiratory system and an external oxygen source.
Therefore, the AirSep Impulse Oxygen Conserving Device falls under the category of a therapeutic or life-support device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AirSep Impulse Oxygen Conserving Device is to be normally used in a home or institutional environment by persons who suffer from various forms of Chronic Obstructive Pulmonary Disease (COPD). It is to be used only when a nasal oxygen cannula is prescribed.
The Impulse has been designed to work in conjunction with a portable, regulated flow bottled oxygen source. The unit can be used with any oxygen source capable of delivering gaseous oxygen at 20 to 25 psig. Oxygen is delivered in a precise amount at the optimum point in the breathing cycle through the nasal cannula. This form of delivery maximizes the beneficial effects of supplemental oxygen while eliminating unnecessary waste, thus increasing user mobility and ambulatory duration of the user.
Product codes
73 NFB
Device Description
The AirSep Impulse Oxygen Conserving Device is intended for use in a home or institutional environment. It is designed to work with a portable, regulated flow bottled oxygen source, delivering gaseous oxygen at 20 to 25 psig. Oxygen is delivered in a precise amount at the optimum point in the breathing cycle through a nasal cannula to maximize the benefits of supplemental oxygen and reduce waste. The device includes an alarm to signal no inspiration if no breaths are detected during a 30-second period.
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
Home or institutional environment by persons who suffer from various forms of Chronic Obstructive Pulmonary Disease (COPD).
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Chad Therapeutics Oxymatic Electronic Oxygen Conserver Model 301
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other. The symbol is black and the background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Mr. George L. Small AirSep Corporation 290 Creekside Drive Amherst, NY 14228
K962766 Re:
AirSep Impulse Oxygen Conserving Device Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB
Dear Mr. Small:
This letter corrects our substantially equivalent letter of October 10, 1996, regarding the AirSep I mis letter concerving Device. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 NFB as indicated above.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 776, the enactment date of the Medical Device Amendments, or to commerce pror to ride been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic recry treef the device, subject to the general controls provisions of the Act. The r ourinay, merciolo, mainte of the Act include requirements for annual registration, listing of general oonline provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to suel additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. George L. Small
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou that I Dr o resum that your device complies with other requirements of the Act that I Dri-has made a acterimalations administered by other Federal agencies. You must of any I carated statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 607); fuccime (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sell provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow your to organization of substantial equivalence of your device to a legally prematicated predicated. The 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 11 you declie specific advices of the 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" (21CFR Part 807.97). regation on the formation on your responsibilities under the Act may be obtained from the Oiner general into.Manufacturers, International and Consumer 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,
Bram D. Zuckerman, M.D.
Acting Director
Division of Cardiovascular and
Respiratory Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
INTENDED USE 2.0
The AirSep Impulse Oxygen Conserving Device is to be normally used in a home or institutional environment by persons who suffer from various forms of Chronic Obstructive Pulmonary Disease (COPD). It is to be used only when a nasal oxygen cannula is prescribed.
The Impulse has been designed to work in conjunction with a portable, regulated flow bottled oxygen source. The unit can be used with any oxygen source capable of delivering gaseous oxygen at 20 to 25 psig. Oxygen is delivered in a precise amount at the optimum point in the breathing cycle through the nasal cannula. This form of delivery maximizes the beneficial effects of supplemental oxygen while eliminating unnecessary waste, thus increasing user mobility and ambulatory duration of the user.
The Chad Therapeutics Oxymatic Electronic Oxygen Conserver Model 301 is a legally marketed predicate device with the same intended use.
The AirSep Impulse differs from the CHAD Oxymatic in having an alarm to signal no inspiration if no breaths are detected during a 30 second time period. This difference does not adversely affect the safety and effectiveness of the device.
(Division Sign-Off) Division of Cardiovascular, F and Neurological Des 510(k) Numbe
peescription use
TR 96-001 07/15/96