(132 days)
Not Found
No
The device description and performance studies focus on the mechanical and chemical aspects of oxygen delivery and wound healing, with no mention of AI/ML technologies or related concepts like data analysis, algorithms, or learning.
Yes
The device is described as treating various skin conditions and promoting healing by providing topical oxygen, which qualifies it as a therapeutic device.
No
The device description and intended use indicate that the OxyBox System provides topical oxygen for treatment of skin conditions, and does not mention any diagnostic capabilities.
No
The device description clearly states that the OxyBox System consists of hardware components: an oxygen concentrator, a cannula, and a bandage/wound dressing. It is a physical system delivering topical oxygen.
Based on the provided information, the OxyBox System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the OxyBox System is a topical treatment applied to the skin to deliver oxygen to wounds. It does not involve the analysis of any biological samples (like blood, urine, tissue, etc.) taken from the patient.
- The purpose of an IVD is to provide information about a patient's health status. The OxyBox System's purpose is therapeutic – to treat existing skin conditions by providing oxygen. It is not used for diagnosis, monitoring, or screening based on analyzing biological specimens.
The OxyBox System is a therapeutic medical device intended for wound treatment.
N/A
Intended Use / Indications for Use
The OxyBox System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitis ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
Product codes (comma separated list FDA assigned to the subject device)
KPJ
Device Description
OxyBox is a topical bandage system that incorporates a disposable oxygen concentrator. It consists of three separate component parts: (1) the oxygen concentrator, (2) the sterile cannula and (3) the bandage or wound dressing. Items (2) and (3) are medical grade commercial products that Oxyfast Corporation obtains from device manufacturers or distributors. The oxygen concentrator is a single patient, one time use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Testing was conducted to validate that the OxyBox performed according to its specifications. In addition, animal testing was conducted that demonstrated that topical oxygen delivered by the OxyBox provides increased epithelization compared to a control.
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
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.
0
510(k) Summary for
FEB 2 4 2003
OxyBox
1. SPONSOR
Oxyfast Corporation 11000 Cedar Avenue, Suite 449 Cleveland, OH 44106
Contact Person: Melvyn Burk Telephone:216-795-3060
Date Prepared: January 6, 2003
2. Device Name
| Proprietary Name: | OxyBox |
|---|---|
| Common/Usual Name: | Topical oxygen bandage |
| Classification Name: | Topical oxygen chamber CFR878.5650, Class III |
3. PREDICATE DEVICES
O2Boot™: K971507
4. DEVICE DESCRIPTION
OxyBox is a topical bandage system that incorporates a disposable oxygen It consists of three separate component parts: (1) the oxygen concentrator. concentrator, (2) the sterile cannula and (3) the bandage or wound dressing. Items (2) and (3) are medical grade commercial products that Oxyfast Corporation obtains from device manufacturers or distributors. The oxygen concentrator is a single patient, one time use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.
1
5. Indications for Use
The OxyBox System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitis ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The predicate devices all deliver oxygen to the wound site at very slightly enhanced pressure (1.04 atmosphere). OxyBox delivers oxygen to the wound at ambient pressure (typically 1 atmosphere). The device design is different in the sense that oxygen is generated in situ in the case of the OxyBox, and the predicate devices use an oxygen cylinder to deliver oxygen. The predicate devices as well as the OxyBox deliver near 100 percent pure oxygen to the wound site. Both the OxyBox and the predicate O2Boot™ are single use devices.
7. PERFORMANCE TESTING
Testing was conducted to validate that the OxyBox performed according to its specifications. In addition, animal testing was conducted that demonstrated that topical oxygen delivered by the OxyBox provides increased epithelization compared to a control.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oxyfast Corporation Melvyn Burk President University West Building, Suite 449 11000 Cedar Avenue Cleveland, Ohio 44106 - 3052
FEB 2 4 2003
Re: K023456
Trade/Device Name: OxyBox System Regulation Number: 878.5650 Regulation Name: Topical Oxygen Chamber Regulatory Class: Class III Product Code: KPJ Dated: October 14, 2002 Received: October 15, 2002
Dear Mr. Burk:
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 Aci 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 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
3
Page 2 - Mr. Melvyn Burk
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
-Miriaire C. Paroit
(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOZZ456 510(k) Number (if known):
OxyBox System Device Name:
Indications for Use:
The OxyBox System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitis ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023456
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Oxyfast Corporation 510(k) OxyBox
October 14, 2002