(246 days)
Not Found
No
The description focuses on standard oxygen concentration technology (pressure swing adsorption) and demand-flow delivery based on sensing the inhalation cycle. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to provide supplemental oxygen to patients with conditions like COPD, which is a therapeutic intervention aimed at improving their health and well-being.
No
The device is an oxygen concentrator used to supply supplemental oxygen, not to diagnose a condition.
No
The device description clearly outlines hardware components such as a compressor, molecular sieve beds, valves, sensors, and an accumulator reservoir, in addition to embedded software.
Based on the provided text, the Inogen One Oxygen Concentrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Inogen One Function: The Inogen One Oxygen Concentrator is a medical device that provides supplemental oxygen directly to a patient through a nasal cannula. It works by concentrating oxygen from ambient air.
- Lack of Specimen Analysis: The description clearly states the device's function is to deliver oxygen to the patient. There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, the Inogen One Oxygen Concentrator falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile.
The Inogen One Oxygen Concentrator provides approximately 90% oxygen to the patient on a demand flow basis at an "equivalent" rate of 1.0 liters per minute to 5.0 liters to minute in increments of 0.5 liters per minute.
The Inogen One Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110 -- 220 VAC, 12 -- 14 VDC or rechargeable batteries.
The Inogen One Oxygen Concentrator uses molecular sieve / pressure swing adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sicve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a manifold with precision valves, sensors and embedded software to control the cycle are used to make the system function.
Oxygen is delivered to the patient on a demand flow basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Inogen One Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient.
The design of the Inogen One Oxygen Concentrator has focused on maximizing subsystem efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use.
The basic technology of the Inogen One Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.
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
Home, institution, vehicles 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)
Benchtop performance testing has demonstrated that the Inogen One Oxygen Concentrator is equivalent to the AirSep LifeStyle Oxygen Concentrator.
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 Section 14
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
The assigned 510(k) number is: KO32 818
SUBMITTER INFORMATION
| Submitter: | Inogen, Inc.
120 Cremona Drive, Suite F
Goleta, CA 93117 |
|--------------------|----------------------------------------------------------------|
| Contact: | John Wells
Director of Operations |
| Telephone:
Fax: | 805-562-0500
805-961-1409 |
| Date Prepared: | 9 September 2003 |
DEVICE NAME AND CLASSIFICATION
| Proprietary Name: | Inogen One Oxygen Concentrator |
|---|---|
| Common Name: | Oxygen Concentrator |
| Product Code: | CAW |
| Medical Specialty: | Anesthesiology |
| Device Classification: | Class 2 |
| Regulation Number: | 21 CFR section 868.5440 |
PREDICATE DEVICE INFORMATION
Substantial equivalence of the Inogen One Oxygen Concentrator is claimed to the following legally marketed predicate devices:
- AirSep Corporation, Life Style Oxygen Concentrator, 510(k) # K020324 .
1
DEVICE DESCRIPTION
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile.
The Inogen One Oxygen Concentrator provides approximately 90% oxygen to the patient on a demand flow basis at an "equivalent" rate of 1.0 liters per minute to 5.0 liters to minute in increments of 0.5 liters per minute.
The Inogen One Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110 -- 220 VAC, 12 -- 14 VDC or rechargeable batteries.
The Inogen One Oxygen Concentrator uses molecular sieve / pressure swing adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sicve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a manifold with precision valves, sensors and embedded software to control the cycle are used to make the system function.
Oxygen is delivered to the patient on a demand flow basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Inogen One Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient.
The design of the Inogen One Oxygen Concentrator has focused on maximizing subsystem efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use.
The basic technology of the Inogen One Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.
2
INDICATIONS for USE
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.
TECHNOLOGICAL CHARACTERISTICS
The Inogen One Oxygen Concentrator utilizes well established technologies. Molecular sieve / pressure swing adsorption technology has been used for many years to produce oxygen. Demand flow delivery systems have been in use on portable oxygen sources for many years. The capability of AC, DC or rechargeable battery power has also been in use.
Technologies utilized by the Inogen One Oxygen Concentrator brings forth no new questions of safety and effectiveness. These technologies are also currently being used in the identified predicate device.
Benchtop performance testing has demonstrated that the Inogen One Oxygen Concentrator is equivalent to the AirSep LifeStyle Oxygen Concentrator.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem that resembles a stylized eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Mr. John Wells Director of Operations Inogen, Incorporated 120 Cremona Drive, Suite B Goleta, CA 93117
Re: K032818
Trade Name: Inogen One Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: April 2, 2004 Received: April 5, 2004
Dear Mr. Wells:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Mr. John Wells
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Scellons 35 described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA inding of Substanced of the more of the spermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs of the may of the many of the Alance and the regulation entitled If you desire specific advice for your ac nec on on 6. Also, nease note the regulation entitled.
contact the Office of Compliance at (301) 594-4646. Also, please note the reg contact the Office of Comphalice at (301) 391 10 10 (21CFR Part 807.97). You may obtain " Misbranding by reference to premation notified onder the Act from the Division of Small
on of Small information on your responsibilities under the Act from the 4800 638-200 other general information on your responsionities and its toll-free number (800) 638-2041 or '
Manufacturers, International and Consumer Assistance at its toll-dremain html Manufacturers, International and Consumer Pleasonal Collections of the Marian.html.
Sincerely yours,
Suad Junow
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K032818
Device Name: Inogen One Oxygen Concentrator
Indications for Use:
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients The Inogen one Uxygen Oven. It supplies a high concentration of oxygen and is requiring Supplemental oxygentian oxygen from the concentrator to the used with a nogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cimpson
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K052818