HANSON SCAR ADE

K040307 · Hanson Medical, Inc. · MDA · Aug 12, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040307
• Device Name: HANSON SCAR ADE
• Applicant: Hanson Medical, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended for use in the management of hypertrophic and keloid scarring resulting from surgery, laser abrasion, chemical peels and other trauma. HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.

Device Story

Hanson Scar Ade is a topical silicone gel for scar management. Applied by patient to healed scars (e.g., post-surgical, laser, trauma) to reduce erythema and discoloration. Non-sterile; packaged in plastic tubes. Acts as a topical barrier for hypertrophic and keloid scars. Used in home settings; OTC availability.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Topical silicone gel. Non-sterile. Packaged in 0.5 oz and 1 oz plastic tubes.

Indications for Use

Indicated for topical management of keloid and hypertrophic scars in patients with healed surgical, laser abrasion, chemical peel, or trauma-related scars. Contraindicated for use on open wounds.

Regulatory Classification

Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Predicate Devices

• Kelo-Cote topical gel (Advanced Bio-Technologies)

Submission Summary (Full Text)

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K040307

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## AUG 1 2 2004

## SECTION 9

## 510(k) SUMMARY STATEMENT

February 6, 2004

| Applicant: | Hanson Medical, Inc.<br>PO Box 1160, Kingston, Washington, 98346<br>Tel: [phone] Fax: [phone] |
|----------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact<br>Representative: | John Harrison, PhD<br>Medical Devices Associates, International<br>Tel/Fax: [phone]) Email: [e-mail]) |

"HANSON SCAR ADE" Proprietary Name: Elastomer, Silicone, for Scar Management Classification Name: Silicone gel for hypertrophic and keloid scar management Common Name: Class I Classification:

HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended HANSON SCAR ADE is a topical got mace from would and keloid scarring resulting from OTC for ass in many surgery, laser abrasion, chemical peels and other trauma.

This product is offered non-sterile. For convenience it is packaged in half ounce and one ounce plastic tubes. Each tube will have Directions for Use, and Cautions.

HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.

Hanson Medical HANSON SCAR ADE is substantially equivalent to Kelo-Cote topical gel (Advanced Bio-Technologies).

John Harrison, PhD (Consultant) Tel/Fax: [phone] Email: [e-mail]

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Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three curved lines forming its wings and body, giving it a sense of motion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2004

Mr. Erik Hanson Vice President Hanson Medical, Inc. P.O. Box 1160 Kingston, Washington 98346

Re: K040307

Trade/Device Name: Hanson Scar Ade Regulatory Class: Unclassified Product Code: MDA Dated: July 27, 2004 Received: July 27, 2004

Dear Mr. Hanson:

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). and Oosmetie For ( roo ) roo ) roo, 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 If your device 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 or any I 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. Erik Hanson

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 premarket notification. The sults 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 n you active 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 other general mitotal 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,

Muriam C. Provost

(Celia 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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## Indications for Use

510(k) Number (if known): K040307

HANSON SCAR ADE Device Name:

HANSON SCAR ADE is indicated for the topical Indications For Use: management of keloid and hypertrophic scars

Prescription Use (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)

Miriam C. Provost

Division of General, Restorative. and Neurological Devices

**510(k) Number** k040307