ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)

K072560 · Teikoku Pharma USA, Inc. · NAD · Jun 17, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072560
• Device Name: ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
• Applicant: Teikoku Pharma USA, Inc.
• Product Code: NAD · General, Plastic Surgery
• Decision Date: Jun 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4020
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

- For use in the management of psoriasis and the protection of psoriatic plaques - As a protective dressing - For management of superficial, dry to lightly exudating dermal wounds.”

Device Story

Envela™ is an occlusive wound dressing; functions as a protective barrier for psoriatic plaques and superficial, dry to lightly exudating dermal wounds. Device applied topically to skin; provides moisture-retentive environment. Used in clinical or home settings; intended for over-the-counter use. Benefits include protection of affected skin areas and management of wound exudate.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Occlusive wound dressing; hydrocolloid-based material. Class I device under 21 CFR 878.4020. No specific material standards or software components described.

Indications for Use

Indicated for patients requiring management of psoriasis, protection of psoriatic plaques, or management of superficial, dry to lightly exudating dermal wounds.

Regulatory Classification

Identification

An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Predicate Devices

• DuoDerm® Extra Thin (Extra Thin® CGF Dressing)
• Compeed Psoriasis Dressing
• Hydrocolloid Dressing for Psoriasis

Submission Summary (Full Text)

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# JUN 1 7 2008

### 510(k) Summary Statement for Envela™ (Hydrohesive™ Occlusive Dressing)

| Device Classification Name: | Occlusive dressing |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Occlusive dressing |
| Proprietary Name: | Envela™ (Hydrohesive™ Occlusive Dressing) |
| Classification: | Class I General Controls<br>(21 CFR 878.4020, 4022) |
| Performance Standards: | Not Applicable |
| Predicate Devices: | DuoDerm® Extra Thin (Extra Thin® CGF Dressing) for<br>its moisturizing and occlusive properties; Compeed<br>Psoriasis Dressing and Hydrocolloid Dressing for<br>Psoriasis for management of psoriasis and protection<br>of psoriatic plaques. |
| Sponsor/Establishment: | Teikoku Pharma USA, Inc<br>1718 Ringwood Avenue<br>San Jose, CA 95131-1711 |
| Establishment Registration Number: | To be assigned. |
| Contact Person: | Andrew Korey, PhD<br>Chief Scientific Officer |
| Summary Date: | June 6, 2008 |
| Statement of Intended Use: | - For use in the management of psoriasis and the<br>protection of psoriatic plaques<br>- As a protective dressing<br>- For management of superficial, dry to lightly<br>exudating dermal wounds." |
| Comparison to Predicate Device: | Envela™ is substantially similar in terms of component<br>materials, shape, dimensions, and mode of action to<br>existing occlusive wound dressings. |
| Performance Standards: | Not applicable to Class I occlusive dressings;<br>subject to General Controls. |
| Proposed Labeling: | The text for the individual foil envelope, carton label,<br>Package Insert (including Instructions for Use) will be<br>updated if and when the Indications for Use have been<br>cleared by FDA. Promotional literature and advertising<br>for the device have not yet been prepared. |

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 7 2008

Teikoku Pharma USA, Inc. % Margie Nemcik-Cruz, MA, RAC Regulatory Affairs Consultant 1718 Ringwood Avenue San Jose, California 95131-1711

Re: K072560

Trade/Device Name: Envela™ (Hydrohesive " Occlusive Dressing) Regulation Number: 21 CFR 878.4020 Regulation Name: Occlusive wound dressing Regulatory Class: I Product Code: NAD Dated: June 6, 2008 Received: June 9, 2008

Dear Ms. Nemcik-Cruz:

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 - Margie Nemcik-Cruz, MA, RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark N. Millican

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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K07J60

### Indications for Use Statement

(Food Drug and Cosmetic Act, Section 502(f)(1))

| 510(k) Number (if known): | To be assigned |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | EnvelaTM (HydrohesiveTM Occlusive Dressing) |
| Indications for Use: | - For use in the management of psoriasis and the protection<br>of psoriatic plaques<br><br>- As a protective dressing<br><br>- For management of superficial, dry to lightly exudating<br>dermal wounds.” |

Prescription Use

OR

Over-the-Counter Use _ V

(21 CFR 801 SUBPART D)

(21 CFR 801 SUBPART C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K072560

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