IT HYDROCOLLOID WITH ZINC

K973855 · Innovative Technologies , Ltd. · FRO · Dec 1, 1997 · SU

Device Facts

• Record ID: K973855
• Device Name: IT HYDROCOLLOID WITH ZINC
• Applicant: Innovative Technologies , Ltd.
• Product Code: FRO · SU
• Decision Date: Dec 1, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Innovative Technologies' Hydrocolloid with Zinc Wound Dressings may be used for the management of wounds including: Partial full thickness wounds, ie. arterial, venous, diabetic ulcers Post-operative surgical wounds . Superficial burns (1st & 2nd degree) . . Donor Sites Trauma Wounds . Dermal Lesions . . Protective dressing

Device Story

Hydrocolloid with Zinc Wound Dressing is a sterile, conformable, primary wound dressing; composed of hydrocolloid and polyurethane film; contains zinc, Vitamin B-6, and Vitamin A. Used for management of moderate to heavily exuding wounds. Applied by clinicians or patients to cover wounds; provides moist environment; low profile allows use under clothing or pressure garments. Dressing remains in place until exuding phase is complete; may be covered with breathable polyurethane film for protection. Benefits include protection of new tissue from mechanical trauma and maceration.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by previous biocompatibility testing and market history of predicate devices. Sterility validated via gamma irradiation per EN 552, JEN556, and ANSI/AAMI/ISO11137-1994.

Technological Characteristics

Hydrocolloid and polyurethane film construction; contains zinc, Vitamin B-6, and Vitamin A. Extruded and laminated surface. Sterile, single-use blister/pouch packaging. Gamma irradiation sterilization per EN 552, JEN556, and ANSI/AAMI/ISO11137-1994 (SAL 10^-6).

Indications for Use

Indicated for management of partial to full thickness wounds including arterial, venous, and diabetic ulcers, post-operative surgical wounds, 1st and 2nd degree superficial burns, donor sites, trauma wounds, and dermal lesions. Not indicated for 3rd degree burns.

Predicate Devices

• Dermagran-B Hydrophilic Wound Dressing (K951499)
• Innovative Technologies' Intelligent Hydrocolloid Wound Dressing (K971126)

Reference Devices

• Innovative Technologies' Film Wound Dressing (K9204008)

Submission Summary (Full Text)

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## Innovative Technologies Ltd

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

# K973855

Innovative Technologies' Hydrocolloid with Zinc Wound Dressing

79 MGP Wound & Burn, Occlusive DEC - I Hydrocolloid Wound Dressing Priscilla Whitehead Cox, Director of QA/RA Monday, October 6, 1997 Monday, Ookobor of Hydrocolloid with Zinc Wound Dressings is a combination of two products with existing 510(k)s: 510(k) #K951499, Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, and 510(k) #K971126, Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressing.

Innovative Technologies' Hydrocolloid with Zinc Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The low profile of the of the of the dressing allows for ease in the use of pressure garments and normal clothing. The hydrocolloid dressing may be left in place until the exuding phase is complete. The wound may then be covered with a breathable polyurethane film such as Innovative Technologies' Film Wound Dressing 510(k) #K9204008 which protects the new tissue from mechanical trauma and maceration.

Dressings are supplied sterile in single use blisters / pouches. Product is gamma irradiated in accordance with EN 552, JEN556, and ANSI / AAMI / ISO11137-1994, Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition, Method 1 for dosimetric release with a sterility assurance level of 10°

Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products.

The Innovative Technologies' Hydrocolloid with Zinc Wound Dressings are similar in design, composition and function to Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, 510(k) #K951499 and Innovative Technologies' Intelligent Hydrocolloid Dressing, 510(k) #K971126.

| Characteristics | IT Hydrocolloid with Zinc | Derma Sciences Dermagran-B Hydrophilic Wound Dressing | IT Intelligent Hydrocolloid |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Composition | Hydrocolloid & polyurethane film / | Modified USP petrolatum based ointment | Hydrocolloid & polyurethane film / |
| Non-Theraputic Additives | Zinc / B-6 / Vitamin A | Zinc / B-6 / Vitamin A | N/A |
| Surface | Extruded and laminated | N/A | Extruded and laminated |
| Indications For Use | Dermal ulcers, superficial wounds, burns (1st & 2nd degree), donor sites, post operative wounds, protective dressings | Management of venous stasis ulcers, surgical incisions, pressure sores, minor thermal burns, superficial lacerations, cuts and abrasions, other superficial injuries | Dermal ulcers, superficial wounds, burns (1st & 2nd degree), donor sites, post operative wounds, protective dressings |
| Self adhesive | Yes | No | Yes |
| Packaging | Blister Pack / Pouch | Poly Tube | Blister Pack / Pouch |
| Sterilisation Method | Gamma Irradiation | Preservatives | Gamma Irradiation |

## COMPARATIVE FEATURE

#### Head Office

Road Three, Winsford Industrial Estate, Winsford, Cheshire CW7 3PD U.K. Tel: [phone] Fax: [phone] Registered in England 2666957

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Tarvin Sands Complex Tarvin, Cheshire, CH3 8JF U.K. Tel: [phone] Fax: [phone]

180 9001 EN 46001

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - I 1997

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

Re: K973855

Innovative Technologies Hydrocolloid with Zinc Wound Dressings Regulatory Class: Unclassified Product Code: MGP Dated: October 7, 1997 Received: October 9, 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 (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:

- This device may not be labeled for use on third degree burns. 1 .
- 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.
- This device may not be labeled as a treatment or a cure for any type of 4. 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

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#### Page 2 - Ms. Priscilla Whitehead Cox

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.

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,

Celta 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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# K973855 510(k) Number (if known):

Device Name: Innovative Technologies Hydrocolloid with Zinc Wound Dressings

#### Indications For Use:

Innovative Technologies' Hydrocolloid with Zinc Wound Dressings may be used for the management of wounds including:

- Partial full thickness wounds, ie. arterial, venous, diabetic ulcers ●
- Post-operative surgical wounds .
- Superficial burns (1st & 2nd degree) .
- . Donor Sites
- Trauma Wounds ●
- Dermal Lesions .
- . Protective dressing

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

**OR Over The Counter Use**

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