TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING

K973312 · Innovative Technologies , Ltd. · MGP · Oct 22, 1997 · SU

Device Facts

• Record ID: K973312
• Device Name: TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
• Applicant: Innovative Technologies , Ltd.
• Product Code: MGP · SU
• Decision Date: Oct 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Innovative Technologies' Transparent Film & Intelligent Film Dressings are conformable, sterile wound dressings intended to provide a moist healing environment for partial thickness wounds, eg. pressure sores, abrasions, lacerations, donor sites and superficial burns. The dressings may also be used for IV sites or as secondary fixation devices for products such as alginates, gels and foams used for venous stasis and diabetic ulcers.

Device Story

Transparent and Intelligent Film Dressings are sterile, conformable polyurethane film wound dressings with pressure-sensitive acrylic adhesive. Designed to provide a moist healing environment for partial thickness wounds; also used for IV site protection or as secondary fixation for other wound care products (alginates, gels, foams). Intelligent Film variant features pattern-coated adhesive for specific moisture vapor transmission rates. Dressings are applied topically by clinicians or patients to the wound site. Benefits include protection of the wound bed and maintenance of an optimal healing environment. Supplied in single-use blister packs, sterilized via gamma irradiation.

Clinical Evidence

Bench testing only. Biocompatibility testing including cytotoxicity, acute systemic toxicity, skin irritation, and sensitization was successfully completed per ISO/Tripartite guidelines. Sterilization validation performed per ANSI/AAMI/ISO 11137-1995 and AAMI TIR8-1991.

Technological Characteristics

Polyurethane film with pressure-sensitive acrylic adhesive. Intelligent Film uses pattern-coated adhesive (50+30%). MVTR: <2500 g/m²/24hrs (Transparent) or 3000-15000 g/m²/24hrs (Intelligent). Sterile, single-use. Gamma irradiation sterilization per ANSI/AAMI/ISO 11137-1995.

Indications for Use

Indicated for partial thickness wounds including pressure sores, superficial burns, abrasions, lacerations, post-operative surgical wounds, donor sites, trauma wounds, dermal lesions, IV sites, and as a fixation device.

Predicate Devices

• Hydroderm Breathable (K935796)

Submission Summary (Full Text)

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K973312

Image /page/0/Picture/1 description: The image contains the letters "IT" on the left side of the image. To the right of the letters is a symbol that looks like a cross with a curved line above it. The cross has a horizontal line at the top, a vertical line in the middle, and a horizontal line at the bottom. The curved line above the cross is dotted.

## Innovative Technologies Ltd

| Safety & Effectiveness | Innovative Technologies' Transparent Film and Intelligent Film<br>Dressings | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------|
| Classification Name: | 79 FRO, Dressing | OCT 22 1997 |
| Common / Usual Name: | Film Wound Dressing | |
| Contact: | Priscilla Whitehead Cox, Director of QA/RA | |
| Prepared: | Monday, September 1, 1997 | |
| Innovative Technologies' Transparent Film & Intelligent Film<br>Dressings are conformable, sterile wound dressings intended to<br>provide a moist healing environment for partial thickness wounds,<br>eg. pressure sores, abrasions, lacerations, donor sites and<br>superficial burns. The dressings may also be used for IV sites or as<br>secondary fixation devices for products such as alginates, gels and<br>foams used for venous stasis and diabetic ulcers. | | |
| Dressings are supplied sterile in single use blister packs. Product is<br>gamma irradiated in accordance with the Sterilisation Of<br>Health Care Products - Requirements For Validation and Routine<br>Control - Radiation Sterilisation, 3rd Edition (ANSI/AAMI/<br>ISO11137-1995) and Microbiological Methods for Gamma<br>Sterilisation (AAMI TIR8-1991) for qualification of Method 1 for<br>dosimetric release with a sterility assurance level of 10-6. | | |
| Biocompatibility testing including cytotoxicity, acute systemic<br>toxicity, skin irritation and sensitisation has been successfully<br>completed per ISO/Tripartite guidelines. | | |
| The Innovative Technologies' Film & Intelligent Film Dressings are<br>similar in design, composition and function to Hydroderm Breathable | | |

Simmar in actigh, Complex #K935796. A table of comparative features may be found below.

| Characteristics | IT Transparent Film | IT Intelligent Film | Hydroderm™ |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Polyurethane film and<br>pressure sensitive<br>acrylic adhesive | Polyurethane film and<br>pressure sensitive acrylic<br>adhesive | Polyurethane film and<br>pressure sensitive<br>acrylic adhesive |
| Adhesive Coverage | 100% | Pattern coated 50 + 30% | Pattern Coated 40% |
| MVTR g/m²/24hrs | < 2500 | 3000-15000 | 8,000 |
| Transparent | Yes | Yes | Yes |
| Indications For Use | Partial thickness<br>wounds, eg. pressure<br>sores, abrasions,<br>superficial burns,<br>lacerations, donor sites,<br>IV sites, fixation device | Partial thickness wounds.<br>eg. pressure sores,<br>abrasions, superficial<br>burns, lacerations, donor<br>sites, IV sites, fixation<br>device | Partial thickness<br>wounds, eg. pressure<br>sores, abrasions,<br>superficial burns,<br>lacerations, donor sites,<br>IV sites, fixation device |
| Packaging | Printed Pouch | Printed Pouch | Printed Pouch |
| Sterilisation Method | Gamma Irradiation | Gamma Irradiation | ETO |

## COMPARATIVE FEATURES

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT 2 2 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Ms. Priscilla Whitehead Cox .Director, Quality Assurance/Regulatory Affairs Innovative Technologies, Ltd Road Three, Winsford Industrial Estate Winsford, Cheshire CW7 3PD United Kingdom

Re: K973312

> Trade Name: Innovative Technologies Transparent Film & Intelligent Film Dressings Regulatory Class: Unclassified Product Code: MGP Dated: September 1, 1997 Received: September 3, 1997

Dear Ms. Cox:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Priscilla Whitehead Cox

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Aadeep

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

Enclosure

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510(k) Number (if known): K973312

Device name: Innovative Technologies' Transparent Film & Intelligent Film Dressings

Indications For Use:

Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on partial thickness wounds including:

- Pressure sores
- . Superficial burns ~===========================================================================================================================================================
- Abrasions
- . Lacerations
- . Post-operative surgical wounds
- . Donor Sites
- . Trauma Wounds
- Dermal Lesions
- IV Sites .
- Fixation device ●

biotela

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use - 2

OR over the Counter Use -