(100 days)
The OxySure™ System is intended to produce oxygen for emergency use.
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 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.
The provided text describes the OxySure™ Portable Oxygen Generator, Model 615, and its substantial equivalence to a predicate device. However, it does not explicitly state formal acceptance criteria in a table format with numerical targets or a detailed study proving the device meets acceptance criteria as one would expect for a diagnostic or AI-driven device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Canogen Portable Oxygen Generator Model 615, K982243) based on intended use and performance characteristics relevant to an oxygen generator. The "Testing" section describes the methodology used to assess the device's performance.
Here's an interpretation of the information provided, framed to address your questions as much as possible given the nature of this submission for an oxygen generator rather than a diagnostic or AI device:
1. Table of Acceptance Criteria and Reported Device Performance
Formal acceptance criteria with specific thresholds are not explicitly laid out, but the "Testing" section implies that the device had to generate medical-grade oxygen at a certain flow rate for a specified duration. We can infer the performance targets from the description.
| Acceptance Criteria (Inferred from Device Description & Testing) | Reported Device Performance |
|---|---|
| Production of medically pure [USP] oxygen | Creates medically pure [USP] oxygen |
| Average flow rate | 6.5 liters per minute |
| Duration of oxygen production | For 15 minutes |
| Chemical reaction commencement | Commenced instantaneously |
| No stirring/agitation required | No stirring, swirling, or agitation administered or required |
| Maintenance of properties over time (implicitly) | Measurements of flow rate, oxygen purity, humidity, and temperature recorded at 15-second intervals. (Implies these characteristics met appropriate thresholds, though explicit thresholds are not given). |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an algorithm or diagnostic device. For this oxygen generator, the "Testing" section describes a process of combining predetermined amounts of base powder, water, and catalyst. It doesn't mention a sample size for multiple units of the device being tested, nor does it specify the provenance of data (e.g., country of origin, retrospective/prospective), as this type of information is typically for clinical data. The testing appears to be a laboratory-based performance assessment of the device's chemical reaction and output.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an oxygen generator, not a diagnostic tool requiring expert interpretation of results to establish ground truth. Its performance is assessed through direct physical measurements (flow rate, purity, humidity, temperature).
4. Adjudication method for the test set
Not applicable. There's no "test set" in the sense of clinical cases requiring expert adjudication.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
Not applicable. An MRMC study is relevant for diagnostic imaging or interpretation tasks involving human readers and AI assistance. This device is an oxygen generator.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI. It is a physical device that produces oxygen through a chemical reaction. The "Testing" described is a standalone performance assessment of the device itself.
7. The type of ground truth used
The "ground truth" for this device's performance would be the direct physical measurements taken during the "Testing" phase, such as:
- Oxygen Purity (USP standard)
- Oxygen Flow Rate (6.5 LPM)
- Duration of Oxygen Production (15 minutes)
- Humidity levels
- Temperature of the oxygen
These are objective, measurable outcomes, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This device does not employ machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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.
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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.
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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
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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)
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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).