HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM

K080966 · Aoti , Ltd. · KPJ · Aug 6, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080966
• Device Name: HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
• Applicant: Aoti , Ltd.
• Product Code: KPJ · General, Plastic Surgery
• Decision Date: Aug 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5650
• Device Class: Class 2
• Attributes: Therapeutic

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 o - amputations/infected stumps o - skin grafts o - burns o - frostbite o

Device Story

Hyper-Box Topical Wound Oxygen System is a non-invasive device for applying topical oxygen at slightly above atmospheric (hyperbaric) pressure to extremity wounds and ulcers. Device facilitates oxygen delivery to wound sites to support treatment of acute/chronic wounds. Used in clinical settings; operated by healthcare professionals. System design includes chamber for extremity enclosure. Output is controlled topical oxygen environment. Benefits include localized oxygen therapy for wound healing. Device incorporates software for system control and monitoring.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, design analysis, and compliance with voluntary international standards for safety and effectiveness.

Technological Characteristics

Topical oxygen chamber for extremities. Materials and design similar to predicate devices. Compliant with EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, and UL 2601-1:1994. Operates by delivering topical oxygen at hyperbaric pressure.

Indications for Use

Indicated for patients with open acute or chronic wounds, including diabetic skin ulcerations, venous stasis, post-surgical infections, gangrenous lesions, decubitus ulcers, amputations/infected stumps, skin grafts, burns, and frostbite.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Advanced Hyperbaric Technologies Inc. Topical Hyperbaric Oxygen Extremity Chamber (N/A)
• Vascular One, Inc VX-400 Topical Hyperbaric Oxygen Chamber (K022028)
• GWR Medical O2 Boot device (K971507)
• Metro Medical Manufacturing HEC 1000 Topical Oxygen Chamber for Extremities (K020466)

Submission Summary (Full Text)

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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<br>Technologies Inc. Topical<br>Hyperbaric Oxygen<br>Extremity Chamber | N/A (Pre-<br>Amendment) | Class III per 21<br>CFR 878.5650 |
| Vascular One, Inc VX-400<br>Topical Hyperbaric Oxygen<br>Chamber | K022028 | Class III per 21<br>CFR 878.5650 |
| GWR Medical O2 Boot device | K971507 | Class III per 21<br>CFR 878.5650 |
| Metro Medical Manufacturing<br>HEC 1000 Topical Oxygen<br>Chamber for Extremities | K020466 | Class III per 21<br>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.

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#### 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.

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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.

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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

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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K080966

# 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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