(48 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on pressure swing adsorption technology and demand flow, with no mention of AI/ML features.
Yes
The device is used by patients requiring supplemental oxygen, which directly addresses a physiological need for therapeutic purposes.
No
The device provides supplemental oxygen; it does not diagnose a medical condition.
No
The device description clearly states it is an oxygen concentrator which is a hardware device that uses molecular sieve pressure swing adsorption technology. It is not solely software.
Based on the provided information, the LifeChoice Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used by patients requiring supplemental oxygen. It provides high concentration oxygen directly to the patient for therapeutic purposes.
- Device Description: The description reinforces that it's a prescription use device for patients needing supplemental oxygen and describes the mechanism of action (molecular sieve pressure swing adsorption) which is a physical process for gas separation, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on biological samples to gain information about a person's health status. The LifeChoice Oxygen Concentrator is a therapeutic device that delivers oxygen to the patient.
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 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
CAW
Device Description
The LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life supporting. The device provides approximately 90% oxygen to patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 5.0 liters per minute in increments of 1.0 liter per minute.
The LifeChoice is a portable device which can be used in a home, institution or travel environment. The device uses molecular sieve pressure swing adsorption technology. This is a proven technology to concentrate room air into high concentration oxygen.
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
Used on a prescriptive basis by patients. May be used continuously in a home, institution or travel environment.
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 and comparison of performance characteristics have demonstrated that the modified LifeChoice is substantially equivalent to the previously marketed version.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo for LifeChoice by InovaLabs. The logo is black and white and features the words "LifeChoice" in a bold, sans-serif font. Below the word "LifeChoice" is the phrase "by InovaLabs" in a smaller font. To the right of the logo is a black and white image of a medical device.
DEC 2 8 2011
Special 510(k) Summary (reference 510(k) #K072688)
Non-confidential Summary of Safety and Effectiveness
Submitter Information:
Inova Labs, Inc. 3500 Comsouth Dr. Suite 100 Austin, TX 78744
Contact:
H. David Shockley V.P. 512-617-1700 off. 512-617-1692 fax
Date: Submitted: November, 2011
Device Classification Name: Generator, Oxygen, Portable Product Code: CAW Classification: Class II Regulation No .: 21 CFR 868.5440 Panel: Anesthesiology Specific Device Name: LifeChoice Oxygen Concentrator Model: OXY1000
Description of the Device: The LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life supporting. The device provides approximately 90% oxygen to patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 5.0 liters per minute in increments of 1.0 liter per minute.
The LifeChoice is a portable device which can be used in a home, institution or travel environment. The device uses molecular sieve pressure swing adsorption technology. This is a proven technology to concentrate room air into high concentration oxygen.
Indications for Use: The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental 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: The LifeChoice Oxygen Concentrator utilizes well established technologies. Molecular sieve pressure swing adsorption technology has been used for many years to produce high concentration oxygen. Also, demand flow delivery systems have been in use on portable oxygen devices for many years. 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 modifications to the LifeChoice Oxygen Concentrator do not create any new questions of safety and effectiveness. Benchtop performance testing and comparison of performance characteristics have demonstrated that the modified LifeChoice is substantially equivalent to the previously marketed version.
Inova Labs Inc. | 3500 Comsouth Road, Suite 100 | Austin, Texas 78744 P 512-326-3237 | F 512-326-3299 LifeChoiceOxvgen.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 8 2011
Mr. H. David Shockley Vice President Inova Labs, Incorporated 3500 Comsouth Drive, Suite 100 Austin, Texas 78744
Re: K113317
Trade/Device Name: LifeChoice Concentrator, Model OXY 1000 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 16, 2011 Received: December 20, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
2
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K113317_____________________________________________________________________________________________________________________________________
Device Name: Inova Labs 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 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.
X 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 OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
(Division Sign=Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Production of Anesthesion And Bayanas Division of Antrol, Dental Devices
| 510(k) Number: | K113317 |
|---|---|
| ---------------- | ---------------- |
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