(196 days)
The intended use of the O2 Boot™ is to provide hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. Increasing the oxygen concentration above chronic open wounds with the use of this topical hyperbaric oxygen device, may promote the rate of healing and suppress bacterial growth.
Indications for the O-Boot are 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitus ulcers 3) amputations/infected stumps 4) skin grafts 5) burns 6) frostbite.
The GWR O2 Boot™ is a Topical Oxygen Chamber for Extremities. It is composed of a flexible plastic film shaped into a large boot. At the open end of the device there is a layer of white fabric impregnated with an acrylic adhesive and is used to secure the boot to the patient being treated. There are two tubes that pass through the film; one is to inject the O2 and the other contains a pressure relief valve that is set to maintain the proper pressure to inflate the boot, yet not over inflate the boot for treatment of the patient. In addition, plastic tubes are a part of the device and are used to transport the O2 from the O2 supply to the boot and create the oxygen chamber.
The O2 Boot™ is designed to encapsulate the whole leg or arm and therefore treat multiple wounds that could be present on the leg in diabetic or geriatric patients. In addition, it is a single use, single patient, disposable device.
I am sorry, but based on the provided text, there is no information about a study proving the device meets acceptance criteria.
The document is a 510(k) Premarket Notification for the O2 Boot™ and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific performance metrics against acceptance criteria.
Here's why the requested information cannot be provided from this text:
- No mention of acceptance criteria or reported device performance metrics: The document does not define any quantitative or qualitative acceptance criteria for the O2 Boot's performance (e.g., healing rate percentage, bacterial reduction, etc.). Consequently, there are no reported device performance figures to compare against such criteria.
- No clinical study described: The document discusses "Non clinical testing" related to the physical properties of materials and biocompatibility, but these are about the components, not the overall therapeutic effectiveness of the device in a clinical setting. There is no description of a clinical study, human trials, or any evaluation of the device's efficacy.
- Focus on Substantial Equivalence: The core of this 510(k) submission is to argue that the O2 Boot™ is "substantially equivalent" to already marketed predicate devices. This means the manufacturer is essentially claiming that because the device is similar in design, intended use, and mechanism of action to previously cleared devices, it should be considered safe and effective without needing new clinical efficacy studies. The FDA's letter confirms this substantial equivalence determination.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, or comparative effectiveness.
§ 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.