SINCLAIR SEBORRHEA EMULSION

K050158 · Sinclair Pharmaceuticals, Ltd. · FRO · Oct 11, 2006 · SU

Device Facts

• Record ID: K050158
• Device Name: SINCLAIR SEBORRHEA EMULSION
• Applicant: Sinclair Pharmaceuticals, Ltd.
• Product Code: FRO · SU
• Decision Date: Oct 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

FOR TOPICAL DERMATOLOGICAL USE ONLY Description Rx Product: Under the supervision of a healthcare professional, Sinclair Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Sinclair Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Directions For Use (Rx and OTC): Apply Sinclair Skin Emulsion to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover Sinclair Skin Emulsion with a dressing of choice. Description OTC Product: Sinclair Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation and wounds.

Device Story

Sinclair Skin Emulsion is a non-sterile, viscous emulsion/gel formulation applied topically to skin or wounds. It functions as a protective barrier to maintain a moist environment, aiding healing and relieving symptoms of dermatoses. Used in clinical settings under physician supervision (Rx) or by patients (OTC) for minor irritations. Healthcare providers use the product to manage seborrheic dermatitis symptoms; patients apply it to affected areas as needed. The device benefits patients by nourishing skin and reducing discomfort associated with inflammation and minor wounds.

Clinical Evidence

Bench testing only. Functional and performance testing conducted to assess safety and effectiveness; results reported as satisfactory.

Technological Characteristics

Non-sterile viscous emulsion/gel formulation. Applied topically. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for patients with seborrhea and seborrheic dermatitis (Rx use) to manage itching, erythema, scaling, and pain; also indicated for general population (OTC use) for relief of burning and itching associated with minor skin irritations and wounds.

Predicate Devices

• Sinclair Wound and Skin Emulsion (K024367)

Submission Summary (Full Text)

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# KOSO 128

## Attachment 6

## CONFIDENTIAL

| March 5, 2004 | | OCT 11 2006 | |
|-------------------------------------------------------------|-----------------------------------------------------|-------------|--|
| 1. Submission Applicant & Correspondent: | | | |
| Name: | Sinclair Pharmaceuticals, Ltd. | | |
| Address: | Borough Road | | |
| | Godalming | | |
| | Surrey | | |
| | GU7 2AB | | |
| | United Kingdom | | |
| Phone No.: | 1-972-478-4380 | | |
| Contact Person: | Michael Killeen | | |
| 2. Name of Device: | SINCLAIR SKIN EMULSION | | |
| Common or Usual Name: | Dressing, Wound & Burn, Hydrogel w/Drug or Biologic | | |
| Classification Names: | Dressing, Wound & Burn, Hydrogel w/Drug or Biologic | | |
| 3. Devices to Which New Device is Substantially Equivalent: | | | |
| | Sinclair Wound and Skin Emulsion 510(k) K024367 | | |

4. Device Description:

Sinclair Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is
presented for both Prescription (requires physician diagnosis of disease state) and over-
the-counter (OTC) use.

5. Intended Use of the Device:

The prescription product requires a physician to diagnose the disease state, while the
OTC product is indicated for general symptoms such as burning and itching in minor
skin irritations and minor burns. This formulation, when applied to the burn, injured
tissue or skin, forms a protective barrier that helps to keep the wound moist.

6. Summary of Technological Characteristics of the Device Compared to the Predicate
Devices:

Products referenced are non sterile emulsion/gel types that are applied topically to relieve
the symptoms of certain dermatoses.

7. Tests and Conclusions:

Functional and performance testing has been conducted to assess the safety and
effectiveness of SINCLAIR SKIN EMULSION ™ and all results are satisfactory.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT I 1 2006

Sinclair Pharmaceuticals Limited % Mr. Michael Killeen Executive Vice President North America Borough Road Godalming Surrey GU7 2AB United Kingdom

Re: K050158

Trade/Device Name: SINCLAIR SKIN EMULSION™ Regulatory Class: Unclassified Product Code: FRO, MGQ Dated: July 27, 2006 Received: July 28, 2006

Dear Mr. Killeen:

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.

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. Michael Killeen

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

M. 1 N. M. 11

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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| Attachment 3 - Indications for Use Statement | | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---|
| 510(k) Number | 050158 | | |
| Device Name | SINCLAIR SKIN EMULSION TM | | |
| Indications for Use | FOR TOPICAL DERMATOLOGICAL USE ONLY | | |
| | Description Rx Product:<br>Under the supervision of a healthcare professional, Sinclair Skin Emulsion<br>is indicated to manage and relieve the signs and symptoms of seborrhea and<br>seborrheic dermatitis such as itching, erythema, scaling and pain. Sinclair<br>Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound<br>& skin environment, which is beneficial to the healing process. | | |
| | Directions For Use (Rx and OTC):<br>Apply Sinclair Skin Emulsion to the affected skin areas 3 times per day (or<br>as needed), and massage gently into the skin. If the skin is broken, cover<br>Sinclair Skin Emulsion with a dressing of choice. | | |
| | Description OTC Product:<br>Sinclair Skin Emulsion helps to nourish skin and relieve the burning and<br>itching associated with many common types of skin irritation and wounds. | | |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div> <span>✓</span> AND/OR </div> | Over-The-Counter Use<br>(21 CFR 807 Subpart C) | ✓ |
| | PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF<br>NEEDED | | |
| | Concurrence of CDRN, Office of Device Evaluation (ODE) | | |
| | (Division Sign-Off) | | |
| | Division of General, Restorative,<br>and Neurological Devices | | |
| 510(k) Number | 14050158 | | |

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