(109 days)
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No
The summary describes a standard oxygen concentrator using pressure swing adsorption technology and does not mention any AI or ML components or capabilities.
Yes
The device is used on a prescriptive basis by patients requiring supplemental oxygen, providing high concentration oxygen to alleviate their condition, which aligns with the definition of a therapeutic device.
No
The device is an oxygen concentrator used to provide supplemental oxygen to patients. Its intended use description indicates it is "used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen" and that it "will provide supplemental, high concentration oxygen to these patients." There is no mention of it being used for diagnosis, only for treatment.
No
The device description explicitly states it is an "Oxygen Concentrator" and uses "molecular sieve pressure swing adsorption technology," which are hardware components for generating oxygen.
Based on the provided text, the LifeChoice Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients requiring it. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details how the device generates and delivers oxygen, which is a physical process applied to the patient's respiratory system.
- 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 those samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The LifeChoice Oxygen Concentrator is a medical device used for treatment (providing supplemental oxygen), not for diagnosis.
N/A
Intended Use / Indications for Use
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life sustaining or to be life supporting. The LifeChoice provides approximately 90% oxygen to the patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 3.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which may be used continuously in a home, institution or travel environment. The LifeChoice uses molecular sieve pressure swing adsorption technology. This technology is well established and proven to concentrate room air into high concentration oxygen.
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
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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)
Benchtop performance testing and comparison of performance characteristics and technologies have demonstrated that the IBC LifeChoice is substantially equivalent to the identified predicate device, the AirSep LifeStyle Oxygen Concentrator.
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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§ 868.5440 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
Section 5. 510 (K) Summary
Non Confidential Summary of Safety and Effectiveness
Submitter Information:
International Biophysics Corporation (IBC) 2101 East St. Elmo Rd, Suite 275 Austin, TX 78744
Contact:
David Shockley President 512-326-3244 off. 512-326-3299 fax
JAK | ZUD:
f
Date Prepared: September 19, 2007
Proprietary Name: LifeChoice Oxygen Concentrator
Model: OXY1000
Classification Name: Portable oxygen generator (concentrator)
Product Code: CAW
Device Classification: Class II
Panel: Anesthesiology
Regulation Number: 21 CFR 868.5440
Predicate Device: AirSep Corporation, LifeStyle Oxygen Concentrator, 510(K): K020324
Device Description:
The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life sustaining or to be life supporting. The LifeChoice provides approximately 90% oxygen to the patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 3.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which may be used continuously in a home, institution or travel environment.
1
The LifeChoice uses molecular sieve pressure swing adsorption technology. This technology is well established and proven to concentrate room air into high concentration oxygen. The LifeChoice is equivalent in performance, function and principles of operation to the predicate device listed in this submission.
Indications for Use:
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable,
Technological Characteristics and Predicate Device Comparison:
The IBC LifeChoice Oxygen Concentrator utilizes well established technologies. Molecular sieve pressure swing adsorption technology has been used for many years to produce high concentration oxygen. Demand flow delivery systems have been in use on portable oxygen devices for many years also. The capability to power the device with AC, DC and/or rechargeable batteries has also been in use for many years.
The technologies used in the IBC LifeChoice Oxygen Concentrator do not create anv new questions of safety and effectiveness. These technologies are also being used in the identified predicate device. Benchtop performance testing and comparison of performance characteristics and technologies have demonstrated that the IBC LifeChoice is substantially equivalent to the identified predicate device, the AirSep LifeStyle Oxygen Concentrator. There are no significant differences between the IBC LifeChoice and the identified predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2008
Mr. David Shockley President International Biophysics Corporation 2101 East St. Elmo Road, Suite 275 Austin, Texas 78744
Re: K072688
Trade/Device Name: International Biophysics Corporation LifeChoice Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: January 3, 2008 Received: January 3, 2008
Dear Mr. Shockley:
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.
3
Page 2 - Mr. Shockley
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control 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) 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutte Y. Michaud M.D.
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
4
Indications for Use
K072688:
Device Name: International Biophysics Corporation LifeChoice Oxygen Concentrator
Indications For Use:
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.
Prescription use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K 072688
Sinite m'chan O
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