HYDROCOLLOID WOUND DRESSINGS

K971126 · Innovative Technologies , Ltd. · FRO · Jun 24, 1997 · SU

Device Facts

• Record ID: K971126
• Device Name: HYDROCOLLOID WOUND DRESSINGS
• Applicant: Innovative Technologies , Ltd.
• Product Code: FRO · SU
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including: - Partial - full thickness wounds, i.e. arterial, venous, diabetic ulcers - Post-operative surgical wounds - Donor Sites - Trauma Wounds - Dermal Lesions - Protective dressing

Device Story

Sterile, conformable, primary wound dressing; hydrocolloid and polyurethane film/foam construction. Reacts with wound exudate to form gelatinous mass; maintains moist healing environment; facilitates atraumatic dressing changes. Used in clinical settings for chronic wound management. Applied by healthcare professionals. Benefits include protection of peri-wound tissue and support of healing environment. Not for third-degree burns; not a cure or artificial skin.

Clinical Evidence

No clinical data. Biocompatibility testing (cytotoxicity, acute systemic toxicity, skin irritation, and sensitization) performed per ISO/Tripartite guidelines. Sterilization validated per ANSI/AAMI/ISO 11137-1995 and AAMI TIR8-1991.

Technological Characteristics

Hydrocolloid and polyurethane film/foam construction. Extruded and laminated surface. Sterile, single-use. Gamma irradiation sterilization (SAL 10^-6). Self-adhesive.

Indications for Use

Indicated for management of partial to full thickness wounds including arterial, venous, and diabetic ulcers, post-operative surgical wounds, donor sites, trauma wounds, dermal lesions, and as a protective dressing. Not indicated for third-degree burns.

Predicate Devices

• Duoderm CGF / Extra Thin Hydrocolloid Dressings (Convatec)

Submission Summary (Full Text)

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K971126
IT
INNOVATIVE TECHNOLOGIES LTD

# Innovative Technologies Ltd

Safety & Effectiveness
Summary:
Classification Name:
Common / Usual Name:
Contact:
Prepared:

Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings
KMF Liquid Bandage / 79 MGP Wound & Burn, Occlusive Hydrocolloid Wound Dressing
Priscilla Whitehead, Director of QA/RA
March 25, 1997

Innovative Technologies' Hydrocolloid Wound Dressings, are highly conformable, sterile, primary wound dressings-intended to provide an environment ideally suited for chronic wound management. The dressings are soft conformable hydrocolloid preparations for heavy to light exuding partial-full thickness wounds.

The hydrocolloid preparations react with wound exudate to form an gelatinous mass providing for a moist healing environment. The dressing may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes.

Dressings are supplied sterile in single use blister packs. Product is gamma irradiated in accordance with the Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition (ANSI/AAMI/ISO11137-1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification of Method 1 for dosimetric release with a sterility assurance level of $10^{-6}$.

Biocompatibility testing including cytotoxicity, acute systemic toxicity, skin irritation and sensitisation has been successfully completed per ISO/Tripartite guidelines.

The Innovative Technologies' Hydrocolloid and Intelligent Hydrocolloid Wound Dressings are similar in design, composition and function to Duoderm CGF / Extra Thin Hydrocolloid Dressings manufactured by Convatec.

## COMPARATIVE FEATURES

| Characteristics | Innovative Technologies | Convatec |
| --- | --- | --- |
| Composition | Hydrocolloid & polyurethane film / Hydrocolloid, polyurethane foam & polyurethane film | Hydrocolloid & polyurethane film / Hydrocolloid, polyurethane foam & polyurethane film |
| Surface | Extruded and laminated | Extruded and laminated |
| Indications For Use | Dermal ulcers, superficial wounds, burns (1st & 2nd degree), donor sites, post operative wounds, protective dressings | Dermal ulcers, superficial wounds, burns (1st & 2nd degree), donor sites, post operative wounds, protective dressings |
| Transparent | Yes | Yes |
| Self adhesive | Yes | Yes |
| Packaging | Blister Pack | Pouch |
| Sterilisation Method | Gamma Irradiation | Gamma Irradiation |

Priscilla Whitehead, Director QA/RA

Road Three, Winsford Industrial Estate, Winsford
Cheshire CW7 3PD U.K

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 24 1997

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

Re: K971126
Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound
Dressings
Regulatory Class: Unclassified
Product Code: MGP
Dated: March 25, 1997
Received: March 27, 1997

Dear Ms. Whitehead:

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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

1. This device may not be labeled for use on third degree burns.
2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
4. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Ms. Priscilla Whitehead

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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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 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 301-443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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Jun-97 15:56
P.10
IT
Innovative Technologies Ltd
Page 1 of 1

510(k) Number (if known) K971126

Device Name: Innovative Technologies Hydrocolloid & Intelligent Hydrocolloid
Wound Dressings

## Indications For Use:

Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used
for the management of wounds including:
- Partial - full thickness wounds, i.e. arterial, venous, diabetic ulcers
- Post-operative surgical wounds
- Donor Sites
- Trauma Wounds
- Dermal Lesions
- Protective dressing


(Division Sign-Off)
Division of General Restorative Device
510(k) Number K971126

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
(Per 21 CFR 801.109)

OR Over The Counter Use ☐

(Optional Format 1-2-96)

Broad Drive, Winsford, Industrial Estate, Winsford,
Cheshire CW7 4PD U.K.
Tel: [phone], Fax: [phone]
Registered in England 2007/5