SINCLAIR WOUND AND SKIN EMULSION

K024367 · Sinclair Pharmaceuticals, Ltd. · MGQ · Jul 28, 2003 · SU

Device Facts

• Record ID: K024367
• Device Name: SINCLAIR WOUND AND SKIN EMULSION
• Applicant: Sinclair Pharmaceuticals, Ltd.
• Product Code: MGQ · SU
• Decision Date: Jul 28, 2003
• 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 Wound and Skin Emulsion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound and Skin Emulsion may be used to relieve the pain of first and second degree burns. Sinclair Wound and 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 Wound and 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 Wound and Skin Emulsion with a dressing of choice. Description OTC Product: Sinclair Wound and Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. Sinclair Wound and Skin Emulsion may also be used to soothe minor burns, including sunburn.

Device Story

Non-sterile viscous emulsion/gel formulation; applied topically to skin or wounds. Forms protective barrier; maintains moist environment to support healing. Used in clinical settings under physician supervision (Rx) or by patients (OTC) for symptom relief. Output is physical barrier/moisturizing effect; aids pain management and skin nourishment. No complex processing or electronic components.

Clinical Evidence

Bench testing only; functional and performance testing conducted to assess safety and effectiveness with satisfactory results.

Technological Characteristics

Non-sterile viscous emulsion/gel formulation. Topical application. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring management of burning, itching, and pain associated with dermatoses (radiation, atopic, allergic contact dermatitis) and first/second degree burns; also indicated for general minor skin irritations and sunburns.

Predicate Devices

• Biafene Wound Dressing Emulsion (K964240)
• Carrasyn® Hydrogel Wound Dressing (K961758)

Submission Summary (Full Text)

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#### Attachment 6

# 510(kg){"g":"g":"g":"2003

KOZ4367

#### December 30, 2002

#### 1. Submission Applicant & Correspondent:

Sinclair Pharmaceuticals, Ltd. Name: Borough Road Address: Godalming Surrey GU7 2AB United Kingdom

1-972-939-2442 Phone No .: Michael Killeen Contact Person:

| 2. Name of Device: | SINCLAIR WOUND AND SKIN EMULSIONTM |
|-------------------------------|--------------------------------------------------------|
| Trade/Proprietary/Model Name: | SINCLAIR WOUND AND SKIN EMULSIONTM |
| Common or Usual Name: | Dressing, Wound & Burn, Hydrogel w/Drug or<br>Biologic |
| Classification Names: | Dressing, Wound & Burn, Hydrogel w/Drug or<br>Biologic |

#### 3. Devices to Which New Device is Substantially Equivalent:

- Biafene Wound Dressing Emulsion (Radiodermatitis Emulsion) in 510(k) K964240, from ● Medix Pharmaceuticals Americas Inc. and
- Carrasyn® Hydrogel Wound Dressing 510(k) K961758, which is also marketed ● under the name RadiaCare Gel Hydrogel Wound Dressing.

#### 4. Device Description:

D

Sinclair Wound and Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over-thecounter (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:

All products referenced are non sterile emulsion/gel types that are applied topically to relieve the symptoms of various dermatoses.

#### 7. Tests and Conclusions:

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

Sinclair Pharmaceuticals Ltd 510(k) Submission for Sinclair Wound and Skin Emulsion

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2003

Mr. Michael Killeen Executive Director Sinclair Pharmaceuticals, Ltd. Borough Road Godalming, Surrey United Kingdom GU7 2AB

Re: K024367

Trade/Device Name: Sinclair Wound and Skin Emulsion™ Regulation Name: Hydrogel wound dressing and burn dressing Regulatory Class: Unclassified Product Code: MGQ Dated: April 25, 2003 Received: May 6, 2003

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 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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Page 2 - Mr. Michael Killeen

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

iriam C. Provost

Colia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KOZY367

| Attachment 3 - Indications for Use Statement | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | NA |
| Device Name | SINCLAIR WOUND AND SKIN EMULSION ™ |
| Indications for Use | FOR TOPICAL DERMATOLOGICAL USE ONLY |
| | Description Rx Product:<br>Under the supervision of a healthcare professional, Sinclair Wound and Skin<br>Emulsion is indicated to manage and relieve the burning, itching and pain<br>experienced with various types of dermatoses, including radiation<br>dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound<br>and Skin Emulsion may be used to relieve the pain of first and second<br>degree burns. Sinclair Wound and Skin Emulsion helps to relieve dry waxy<br>skin by maintaining a moist wound & skin environment, which is beneficial<br>to the healing process. |
| | Directions For Use (Rx and OTC):<br>Apply Sinclair Wound and Skin Emulsion to the affected skin areas 3<br>times per day (or as needed), and massage gently into the skin. If the skin is<br>broken, cover Sinclair Wound and Skin Emulsion with a dressing of<br>choice. |
| | Description OTC Product:<br>Sinclair Wound and Skin Emulsion helps to nourish skin and relieve the<br>burning and itching associated with many common types of skin irritation.<br>Sinclair Wound and Skin Emulsion may also be used to soothe minor burns,<br>including sunburn. |
| | PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF<br>NEEDED |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| | <i>Miriam C. Provost</i><br>(Division Sign-Off)<br>Division of General, Restorative<br>and Neurological Devices |
| Prescription Use<br>(per 21 CFR 801.109) | |
| 510(k) Number | K0 24367 |
| Over-The Counter Use | |

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