(100 days)
Not Found
No
The device description and performance studies focus on a chemical reaction to produce oxygen, with no mention of AI or ML.
Yes
The device is intended to produce oxygen for emergency use and delivers it to the user. Oxygen delivery for medical purposes, especially in emergencies, is a therapeutic intervention aimed at treating conditions like hypoxia or respiratory distress.
No
The intended use states it is to produce oxygen for emergency use, which is a therapeutic purpose, not diagnostic.
No
The device description clearly states it is comprised of physical components: an outer housing, disposable cartridges, and a mask and tubing system. This indicates it is a hardware device, not software-only.
Based on the provided information, the OxySure™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "produce oxygen for emergency use." This is a therapeutic or life-support function, not a diagnostic one.
- Device Description: The device creates oxygen through a chemical reaction and delivers it to the user via a mask and tubing. This is a direct intervention on the patient, not a test performed on a sample taken from the patient.
- Lack of IVD Characteristics: The description 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 biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
IVD devices are used to perform tests in vitro (outside the body) on samples to provide information about a person's health. The OxySure™ System provides a therapeutic intervention in vivo (within the body) by delivering oxygen directly to the user.
N/A
Intended Use / Indications for Use
The OxySure™ System is intended to produce oxygen for emergency use.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The OxySure™ System creates medically pure [USP] oxygen at an average flow rate of 6.5 liters per minute for 15 minutes from a catalytic reaction of dry compounds.
The OxySure System is comprised of an outer housing, self-contained disposable cartridges that house the dry compounds and water, and a single-use mask and tubing system to deliver the oxygen to the user.
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
Not Found
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)
Predetermined amounts of base powder, water and catalyst were combined in the system to commence the chemical reaction and the chemical reaction commenced instantaneously. There was no stirring, swirling, or agitation of any kind administered or required to commence the reaction. Measurements of flow rate, oxygen purity, humidity and temperature were recorded at 15-second intervals, commencing upon the addition of the catalyst.
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
DEC 9 2005
8/29/2005
Proprietary and Confidential © 2005 OxySure™ Systems, Inc. All Rights Reserved Worldwide
VIII. 510(k) Summary
| Submitted By: | OxySure Systems, Inc. |
|---|---|
| 2611 Internet Blvd. Suite 109 | |
| Frisco, Texas 75034 |
Contact:
Mr. Julian Ross Chief Executive Officer OxySure Systems, Inc. 2611 Internet Blvd, Suite 109 Frisco, Texas 75034 Telephone: (214) 618-7918 Fax: (214) 618-6494
Device:
| Device Classification Name: | Portable Oxygen Generator | |
|---|---|---|
| Device Generic Name: | Portable Oxygen Generator | |
| Device Trade Name: | OxySure™ Portable Oxygen Generator | |
| Model 615 |
Predicate Device:
Canogen Portable Oxygen Generator Model 615 Canogen International, Ltd. Syosset, New York 510(k) Number: K982243
Device Description:
The OxySure™ System creates medically pure [USP] oxygen at an average flow rate of 6.5 liters per minute for 15 minutes from a catalytic reaction of dry compounds.
Intended Use:
The OxySure™ System is intended to produce oxygen for emergency use.
Technological Characteristics:
The OxySure 1 System is comprised of an outer housing, self-contained disposable cartridges that house the dry compounds and water, and a single-use mask and tubing system to deliver the oxygen to the user.
Testing:
Predetermined amounts of base powder, water and catalyst were combined in the system to commence the chemical reaction and the chemical reaction commenced instantaneously. There was no stirring, swirling, or agitation of any kind administered or required to commence the reaction. Measurements of flow rate, oxygen purity, humidity and temperature were recorded at 15-second intervals, commencing upon the addition of the catalyst.
Conclusion:
The OxySure™ System is substantially equivalent to the legally marketed Portable Oxygen Generator device in intended use and performance.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes forming its wing, symbolizing the department's mission to protect and enhance the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 DEC 9
2005
Mr. Julian T. Ross President & CEO OxySure Systems, Incorporated 2611 Internet Boulevard, Suite 109 Frisco. Texas 75034
Re: K052396
Trade/Device Name: OxySure Portable Oxygen Generator, Model 615 Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: November 30, 2005 Received: December 1, 2005
Dear Mr. Ross:
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.
2
Page 2 - Mr. Ross
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 your 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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
3
INDICATIONS FOR USE
510(k) Number (if known):
OxySure™ Portable Oxygen Generator, Model 615 Device Name:
Indications for Use:
The OxySure™ System is intended to produce oxygen for emergency use.
Prescription Use □ (21 CFR 801 Subpart D)
And/Or
Over-The-Counter Use (21 CFR 807 Subpart C)
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aun Suliom
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