NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP

K112634 · Inotec Amd , Ltd. · KPJ · Jul 3, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K112634
• Device Name: NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
• Applicant: Inotec Amd , Ltd.
• Product Code: KPJ · General, Plastic Surgery
• Decision Date: Jul 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as: - Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, - Decubitis ulcers (bedsores), - Amputations/infected stumps, - Skin grafts, - Burns, and - Frostbite

Device Story

NATROX™ is a battery-powered, portable electronic device (cell-phone sized) containing an oxygen generator. It extracts oxygen from room air to produce 99% pure oxygen at ~13 mL/hour. Oxygen is delivered via a small-diameter tube to the wound bed, either directly or through an Oxygen Delivery System (ODS), Island Oxygen Delivery Pad (IODP), or patient-specific wound dressing. The system maintains a constant oxygen supply under an occlusive dressing to enhance healing in chronic, hard-to-heal wounds with compromised tissue oxygenation. Used in clinical or home settings; operated by patients or healthcare providers. The device provides continuous topical oxygenation, which is intended to support the natural wound healing process and reduce wound size and pain.

Clinical Evidence

Clinical study of 10 patients using the VELOX device (an earlier version of NATROX with identical oxygen concentration and flow). The 6-week study demonstrated significant reduction in wound size and pain with no adverse effects, supporting safety, efficacy, and usability.

Technological Characteristics

Battery-powered electronic device; oxygen generator produces 99% oxygen from room air at ~13 mL/hour; small-diameter delivery tubing; compatible with occlusive dressings. Tested to IEC 60601-1 and IEC 60601-1-2 standards.

Indications for Use

Indicated for patients with chronic wounds including diabetic ulcers, venous stasis ulcers, 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

• Oxybox System (K023456)
• TransCu O2 (K090681)

Submission Summary (Full Text)

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K112634 page 1/2

Inotec AMD Ltd

3 2012

JUL

## 510(k) Summary of Safety and Effectiveness

### Manufacturer and Submitter

Company Name: Inotec AMD Ltd. Company Address: Unit 4a Butts Business Centre, Fowlmere, Cambridge Cambridgeshire SG8 7TS, UK Tel [phone] Contact Person: Nicholas Hyde Date Summary Prepared: April 16, 2012

| Device | |
|-----------------------|---------------------------------------------------------|
| Trade/Device Name: | NATROX™ Topical Oxygen Delivery System with Accessories |
| Common/Usual Name: | Topical Oxygen Chamber |
| Classification Name: | Chamber, Oxygen, Topical, Extremity |
| Regulation Number: | 21 CFR 878.5650 |
| Product Code: | KPJ |
| Classification Panel: | General & Plastic Surgery |
| Classification: | Class II |

### Substantial Equivalence

This 510(k) submission demonstrates that the NATROX™ Topical Oxygen Delivery System is substantially equivalent to the Oxybox System (Oxyfast Corporation, K023456) and the TransCu O2 (Electrochemical Oxygen Concepts, Inc., K090681), which are similar in both technology and intended use to the subject device.

### Device Description

The NATROX™ Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces 99% oxygen from room air at a rate of approximately 13 mL/hour. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), Island Oxygen Delivery Pad (IODP) wound dressing or into the patient's own wound dressing, The NATROX™ System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.

#### Intended Use/Indications for Use

The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:

- . Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions,
- . Decubitis ulcers (bedsores),
- Amputations/infected stumps, .
- . Skin grafts,
- Burns, and .
- Frostbite

NATROX™ System Premarket Notification Application

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K112634 Page 2/2

# Inotec AMD Ltd

### Performance - Bench Testing

The NATROX™ Topical Oxygen Delivery System has been tested according to IEC 60601-1, IEC 60601-1-2 and was found to meet all requirements. Performance data also support that the NATROX™ device and accessories meet the specified criteria.

### Performance - Clinical Evaluation

A clinical study in 10 patients was conducted using to support the safety, efficacy and usability of the VELOX device, which is an earlier version of the NATROXIM that produces the same oxygen concentration and oxygen flow. This 6-week study demonstrated that use of the VELOX device significantly reduced wound size and wound pain, did not result in adverse effects, and supported the usability of the device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Inotec AMD Limited % Mandell Horwitz Consultants, LLC Ms. Diane Horwitz 2995 Steven Martin Drive Fairfax, Virginia 22031

3 2012 JUL

Re: K112634

> Trade/Device Name: NATROX™ Topical Oxygen Delivery System with Accesories Regulation Number: 21 CFR 878.5650 Regulation Name: Topical oxygen chamber for extremities Regulatory Class: Class II Product Code: KPJ Dated: June 15, 2012 Received: June 15, 2012

Dear Ms. Horwitz:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Diane Horwitz

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunel Keith

Fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K112634

Device Name: NATROX™ Topical Oxygen Delivery System

Indications For Use:

The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:

- Skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions,
- Decubitis ulcers (bedsores), .
- Amputations/infected stumps, .
- Skin grafts,
- Burns, and
- Frostbite

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kane for M/M
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112634