(124 days)
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The device description focuses on the physical mechanism of applying topical oxygen.
Yes
The device is described as a "Topical Wound Oxygen System" intended for the "treatment of open acute or chronic wounds," which aligns with the definition of a therapeutic device.
No
The device is described as a "Topical Wound Oxygen System" intended for the "treatment of open acute or chronic wounds," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a "non-invasive device" and a "system" intended for applying topical oxygen, implying hardware components are involved in delivering the oxygen.
Based on the provided information, the AOTI Hyper-Box Topical Wound Oxygen System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment of open acute or chronic wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description states the device is "non-invasive" and applies topical oxygen to wounds. This is a physical treatment method, not a method for examining specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. The AOTI Hyper-Box is a device that directly interacts with and treats a wound on the body.
N/A
Intended Use / Indications for Use
The Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as;
- skin ulcerations due to diabetes, venous stasis, post surgical infections o and gangrenous lesions
- decubitus ulcers 0
- amputations/infected stumps o
- skin grafts O
- burns O
- frostbite o
The AOTI Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as;
- skin ulcerations due to diabetes, venous stasis, post surgical infections 0 and gangrenous lesions
- decubitus ulcers O
- amputations/infected stumps 0
- skin grafts O
- burns O
- frostbite o
Product codes (comma separated list FDA assigned to the subject device)
KPJ
Device Description
The Hyper-Box Topical Wound Oxygen System is a non-invasive device intended to allow the application of topical oxygen at slightly above atmospheric (hyperbaric) pressure to wounds and ulcers of the extremities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
extremities
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)
Not Found
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.
N/A (Pre-Amendment), K022028, K971507, K020466
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
K0ε0966
510(K) SUMMAR Y
SUBMITTER:
COMMON NAME;
AOTI Ltd..
DATE:
PROT. Lq.
31 March 2008
AUG - 6 2008
Topical Oxygen Therapy System
PROPRIETARY NAME: Hyper-Box Topical Wound Oxygen System
CONTACT:
Robbie Walsh VP Quality Assurance and Regulatory Affairs AOTI Ltd, Qualtech House, Parkmore Business Park West, Galway, Ireland. Tel: + 353 87 2355402 Fax: + 353 91 752418
CLASSIFICATION:
Class III per 21 CFR 878.5650
PREDICATE DEVICES:
AOTI Ltd. is claiming substantial equivalence to the following predicate medical devices:
| Predicate Device | 510(k) Number | Classification |
|---|---|---|
| Advanced Hyperbaric | ||
| Technologies Inc. Topical | ||
| Hyperbaric Oxygen | ||
| Extremity Chamber | N/A (Pre- | |
| Amendment) | Class III per 21 | |
| CFR 878.5650 | ||
| Vascular One, Inc VX-400 | ||
| Topical Hyperbaric Oxygen | ||
| Chamber | K022028 | Class III per 21 |
| CFR 878.5650 | ||
| GWR Medical O2 Boot device | K971507 | Class III per 21 |
| CFR 878.5650 | ||
| Metro Medical Manufacturing | ||
| HEC 1000 Topical Oxygen | ||
| Chamber for Extremities | K020466 | Class III per 21 |
| CFR 878.5650 |
Device Description: A
The Hyper-Box Topical Wound Oxygen System is a non-invasive device intended to allow the application of topical oxygen at slightly above atmospheric (hyperbaric) pressure to wounds and ulcers of the extremities.
1
B Intended Use:
The Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as;
- skin ulcerations due to diabetes, venous stasis, post surgical infections o and gangrenous lesions
- decubitus ulcers 0
- amputations/infected stumps o
- skin grafts O
- burns O
- frostbite o
Substantial Equivalence C
The Hyper-Box Topical Wound Oxygen System is substantially equivalent to other legally marketed medical devices with the same intended use and similar technological features. The predicate devices described within this submission consist of;
- Advanced Hyperbaric Technologies Inc. Topical Hyperbaric Oxygen Extremity . Chamber device (pre-amendment device).
- Vascular One, Inc VX-400 Topical Hyperbaric Oxygen Chamber (K022028) ﺖ
- ﺴ GWR Medical O2 Boot device (K971507)
- Metro Medical Manufacturing HEC 1000 Topical Oxygen Chamber for -Extremities (K020466)
The materials and design of the Hyper-Box Topical Wound Oxygen System are similar to those of the predicate devices. The technical characteristics of this device do not introduce new questions regarding safety or effectiveness. Furthermore, the labeling associated with the Hyper-Box Topical Wound Oxygen System provides similar information as the predicate devices.
Information provided in the 510(k) submission supports the determination of substantial equivalence. Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 11 2005, as a guidance and per internal company requirements. The Hyper-Box Topical Wound Oxygen System design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994 and 93/42/EEC Medical Device Directive.
The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
2
In summary AOTI Ltd. has demonstrated the Hyper-Box Topical Wound Oxygen System to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices which have been previously cleared by FDA.
28
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2008
AOTI, Ltd. % Mr. Robbie Walsh Quality Assurance & Regulatory Affairs Qualtech House Parkmore Business Park West Galway, Ireland
Re: K080966
Trade/Device Name: Hyper-Box Topical Wound Oxygen System Regulation Number: 21 CFR 878.5650 Regulation Name: Topical oxygen chamber for extremeties Regulatory Class: III Product Code: KPJ Dated: June 30, 2008 Received: July 3, 2008
Dear Mr. Walsh:
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. Ilsting 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
4
Page 2 - Mr. Robbie Walsh
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number:
Device Name:
Hyper-Box Topical Wound Oxygen System
Indications for Use:
The AOTI Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as;
- skin ulcerations due to diabetes, venous stasis, post surgical infections 0 and gangrenous lesions
- decubitus ulcers O
- amputations/infected stumps 0
- skin grafts O
- burns O
- frostbite o
Prescription Use X
AND/OR
Over-The-Counter-Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Eyaluation (ODE)
Mark A. Mulkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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