EPIFLO(R)

K120764 · Neogenix, LLC · KPJ · Apr 27, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120764
• Device Name: EPIFLO(R)
• Applicant: Neogenix, LLC
• Product Code: KPJ · General, Plastic Surgery
• Decision Date: Apr 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) Pressure ulcers, 3) amputations/infected stumps, 4) Skin grafts, 5) burns, and 6) frostbite

Device Story

EPIFLO is a disposable, battery-operated oxygen delivery system. It consists of an oxygen concentrator and a sterile cannula. The device delivers 98-100% oxygen continuously at ~3.0 ml/hour for 7 or 15 days. The cannula conveys oxygen to the wound site beneath a bandage. Used for topical oxygen therapy at ambient pressure. Single-patient, single-use device. Benefits include continuous oxygen delivery to promote healing in various wound types.

Clinical Evidence

Bench testing only. Testing validated oxygen delivery per specifications for labeled durations, EMC compatibility, and sterilization validation.

Technological Characteristics

Battery-operated oxygen concentrator; sterile cannula; delivers 98-100% oxygen at ~3.0 ml/hour; ambient pressure (1 atm); single-use disposable; no software/algorithm described.

Indications for Use

Indicated for patients requiring topical oxygen therapy for skin ulcerations (diabetic, venous stasis, post-surgical, gangrenous), pressure 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)

Submission Summary (Full Text)

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K120764 pugo 1/2

### 8.0 510k Statement or Summary

### 510(k) SUMMARY FOR EPIFLO

# APR 2 7 2012

#### 1. SPONSOR

Neogenix, LLC DBA Ogenix 3401 Enterprise Pkwy, Suite 340 Beachwood, OH 44122

Contact Person: Srinivasan (Sarang) Sarangapani, President Telephone: [phone]

Date Prepared: April 26, 2012

#### 2. Device Name

| Proprietary Name: | EPIFLO System |
|----------------------|----------------------------------------------------------------------------------|
| Common/Usual Name: | Transdermal continuous Oxygen Therapy System |
| Classification Name: | Topical oxygen chamber for extremities<br>878.5650 – Class II (Special Controls) |

21 CFR

#### 3. PREDICATE DEVICES

Oxybox System - K023456

#### Device Description 4.

EPIFLO is an oxygen delivery system that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for seven or fifteen days (depending on the model) 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.

#### 5. INDICATIONS FOR USE

The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

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K120764 page 2/2

#### Technological Characteristics and Substantial Equivalence હ.

The predicate device OxyBox as well as the current device EPIFLO delivers oxygen to the wound at ambient pressure (typically 1 atmosphere). The predicate devices as well as the EPIFLO deliver near 100 percent pure oxygen to the wound site at a rate of ~ 3 mL/hr). Both the Predicate OxyBox and the EPIFLO are single patient, single use disposable devices.

#### 7. Performance Testing

Testing was conducted to validate that the EPIFLO performed according to its specifications. These tests included performance testing for oxygen delivery per the specification for labeled durations, EMC compatibility and sterilization validation.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle. The eagle is depicted with its wings spread, symbolizing protection and service. The seal is a symbol of the department's mission to enhance the health and well-being of all Americans.

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

Neogenix, LLC % Srinivasan Sarangapani, Ph.D. President 3401 Enterprise Parkway, Suite 340 Beachwood, Ohio 44122

APR 2 7 2012

Re: K120764

Trade/Device Name: EPIFLO System Regulation Number: 21 CFR 878.5650 Regulation Name: Topical oxygen chamber for extremities Regulatory Class: II Product Code: KPJ Dated: April 4, 2012 Received: April 6, 2012

Dear Dr. Sarangapani:

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.

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

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Page 2 - Srinivasan Sarangapani, Ph.D.

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.

ely yours,

J. Malkerson

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): K120764 Device Name: EPIFLO System Indications For Use:

The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) Pressure ulcers, 3) amputations/infected stumps, 4) Skin grafts, 5) burns, and 6) frostbite

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Daniel Kreider Mkim

(Division Sign-Off) Division of Surgical, Orthopedio and Restorative Devices

510(k) Number K120764