ALGINATE/ZINC WOUND DRESSING

K973283 · Innovative Technologies , Ltd. · KMF · Oct 21, 1997 · General Hospital

Device Facts

• Record ID: K973283
• Device Name: ALGINATE/ZINC WOUND DRESSING
• Applicant: Innovative Technologies , Ltd.
• Product Code: KMF · General Hospital
• Decision Date: Oct 21, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Innovative Technologies Alginate / Zinc Wound Dressings may be used for the management of moderate to heavily exuding partial to full thickness wounds such as: - Pressure Ulcers . - Arterial Ulcers .. ● - . Venous Ulcers - . Diabetic Ulcers - . l st & 2nd Degree Burns - Donor Sites . - . Trauma Wounds - Dermal Lesions

Device Story

Innovative Technologies' Alginate / Zinc Wound Dressing is a sterile, non-woven, conformable primary wound dressing. It consists of alginate fibers combined with zinc. When applied to a wound, the dressing reacts with wound exudate to form a dispersible, gelatinous mass, creating a moist healing environment. This gel facilitates easy removal during dressing changes, minimizing potential damage to delicate peri-wound tissue. The device is intended for use by healthcare professionals in clinical settings for the management of moderate to heavily exuding wounds. It is supplied in single-use pouches and sterilized via gamma radiation. The dressing is not intended for use on 3rd degree burns, nor is it labeled as a treatment, cure, or artificial skin.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established based on previous biocompatibility testing and the market history of the component products (Dermagran and Al-Gen).

Technological Characteristics

Non-woven calcium alginate fiber dressing with zinc and B-6 additives. Surface is needled/nip rolled. Dispersible integrity. Sterilized via gamma radiation per ANSI/AAMI/ISO11137-1994 (Method 1). Supplied in paper/paper or poly/poly pouches.

Indications for Use

Indicated for management of moderate to heavily exuding partial to full thickness wounds, including pressure, arterial, venous, and diabetic ulcers, 1st and 2nd degree burns, donor sites, trauma wounds, and dermal lesions. Not indicated for 3rd degree burns.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Dermagran™ Zinc-Saline Wet Dressing (K913344)
• Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing (K953781)

Submission Summary (Full Text)

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OCT 2 1 1997

K973283

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## Innovative Technologies Ltd

Innovative Technologies' Alginate / Zinc Wound Dressing

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

KMF Liquid Bandage Alginate Wound Dressing Priscilla Whitehead Cox, Director of QA/RA Friday, August 29, 1997 Innovative Technologies' Alginate / Zinc Wound Dressings is a combination of two products with existing 510(k)s: Dermagran™ Zinc-Saline Wet Dressing manufactured by Derma Sciences, 510(k) #K913344 and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing, 510(k) #K953781. Innovative Technologies' Alginate / Zinc Wound Dressings is a 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 non-woven Alginate / Zinc fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an dispersable, gelatinous, mass providing for a moist healing environment. The gel may easily be rinsed away from the wound, reducing the potential for delicate peri-wound fissue damage during dressing changes.

Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with 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 10-6

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

The Innovative Technologies' Alginate / Zinc Wound Dressings are similar in design, composition and function to Dermagran ™ Zinc-Saline Wet Dressing manufactured by Derma Sciences, . . and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing, 510(k) #K953781.

## COMPARATIVE FEATURES

| Characteristics<br>Material | IT Alginate/Zinc<br>Calcium Alginate / | Dermagran™<br>Cotton Gauze / | Al-Gen™<br>Calcium Alginate |
|-----------------------------|----------------------------------------|--------------------------------------------|---------------------------------------|
| Non-Theraputic<br>Additives | Zinc / B-6 | Zinc / B-6 Saline<br>Moisturizing Solution | N / A |
| Surface | Needled / nip rolled | Woven / Wet | Needled / nip rolled |
| Integrity | Dispersable | Integral | Dispersable |
| Indications | Moderate to severe | Management of | Moderate to severe |
| | exuding wounds, eg. | venous stasis ulcers, | exuding wounds, eg. |
| | pressure, venous | surgical incisions, | pressure ulcers |
| | diabetic and arterial | pressure sores, | wounds, leg ulcers, |
| | ulcers, donor sites, | minor thermal burns, | abrasions, donor |
| | trauma wounds, | superficial lacerations, | sites, lacerations |
| | dermal lesions and | cuts and abrasions, | incisions, 1st and |
| | incisions, 1st & 2nd | other superficial | 2nd degree burns, |
| | degree burns | injuries | trauma wounds |
| Packaging | Paper / Paper or<br>Poly / Poly Pouch | Foil /Foil<br>Pouch | Paper / Paper or<br>Poly / Poly Pouch |
| Sterilisation Method | Gamma Radiation | Steam | Gamma Radiation |

Head Office

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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 England

OCT 21 1997

Re: K973283

> Innovative Technologies Alginate/Zinc Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: August 29, 1997 Received: September 2, 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:

- 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).

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## Page 2 - Ms. Priscilla Whitehead Cox

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,

to see fo

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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Page lof 1

510(k) Number (if known): K973283

Device name: Innovative Technologies' Alginate / Zinc Wound Dressing

Indications For Use:

Innovative Technologies Alginate / Zinc Wound Dressings may be used for the management of moderate to heavily exuding partial to full thickness wounds such as:

- Pressure Ulcers .
- Arterial Ulcers .. ●
- . Venous Ulcers
- . Diabetic Ulcers
- . l st & 2nd Degree Burns
- Donor Sites .
- . Trauma Wounds
- Dermal Lesions

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973283 |

| Prescription Use (Per 21 CFR 801.109) | <div style="text-decoration: line-through;"></div> |
|---------------------------------------|----------------------------------------------------|
| OR Over The Counter Use | |

(Optional Format 1-2-96)