Curasite

K161991 · Izun Pharmaceuticals · FRO · Mar 3, 2017 · SU

Device Facts

• Record ID: K161991
• Device Name: Curasite
• Applicant: Izun Pharmaceuticals
• Product Code: FRO · SU
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the supervision of a healthcare professional, Curasite is intended for the management of the following: - Diabetic foot ulcers - Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - Pressure ulcers/sores (partial and full thickness) - 1st and 2nd degree partial thickness burns For Over-the-Counter (OTC) use, Curasite may be used for the management of: - Minor abrasions - Minor lacerations - Minor cuts - Minor scalds and minor burns

Device Story

Curasite is a topical wound management device. It is applied to the wound site to assist in the management of various ulcer types, burns, and minor skin injuries. The device is intended for use by healthcare professionals in clinical settings for complex wounds and by patients for minor injuries in home or point-of-care settings. It functions as a physical barrier or dressing to support the wound healing environment. The device does not involve electronic processing, software, or automated decision-making.

Indications for Use

Indicated for management of diabetic foot ulcers, leg ulcers (venous, arterial, mixed), pressure ulcers (partial/full thickness), and 1st/2nd degree partial thickness burns under professional supervision. Also indicated for OTC management of minor abrasions, lacerations, cuts, scalds, and burns.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0

March 3, 2017

Izun Pharmaceuticals c/o Richard E. Lowenthal, MS. MBA Pacific-Link Consulting 8195 Run of the Knolls Court San Diego, CA 92127

Re: K161991

Trade/Device Name: Curasite Regulatory Class: Unclassified Product Code: FRO Dated: January 19, 2017 Received: January 23, 2017

Dear Mr. Lowenthal:

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161991

Device Name Curasite

Indications for Use (Describe) For Prescription Use Indication:

Under the supervision of a healthcare professional, Curasite is intended for the management of the following:

- · Diabetic foot ulcers
- · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
- · Pressure ulcers/sores (partial and full thickness)
- · 1st and 2nd degree partial thickness burns

For Over-the-Counter Use Indication:

For Over-the-Counter (OTC) use, Curasite may be used for the management of:

- · Minor abrasions
- Minor lacerations
- Minor cuts
- · Minor scalds and minor burns

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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