INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS

K963598 · Innovative Technologies , Ltd. · KMF · Nov 27, 1996 · General Hospital

Device Facts

• Record ID: K963598
• Device Name: INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS
• Applicant: Innovative Technologies , Ltd.
• Product Code: KMF · General Hospital
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Innovative Technologies' Alginate/Pectin 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 non-woven Alginate/Pectin fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an integral, gelatinous, mass providing for a moist healing environment. The gel may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes.

Device Story

Non-woven, sterile, primary wound dressing composed of calcium alginate and citrus pectin fibers; intended for moderate to heavily exuding wounds. Applied by clinician to wound site; reacts with wound exudate to form integral gelatinous mass; maintains moist healing environment; facilitates non-traumatic removal by lifting gel away from wound bed. Reduces peri-wound tissue damage during dressing changes. Supplied in various sizes as flat dressings or packing.

Clinical Evidence

Bench testing only. Biocompatibility testing completed including cytotoxicity, haemolysis, acute systemic toxicity, skin irritation, and sensitisation per ISO/Tripartite guidelines.

Technological Characteristics

Material: Calcium Alginate and Citrus Pectin fibers. Form: Non-woven, conformable, flat dressings or packing. Sterilization: Gamma radiation per ANSI/AAMI/ISO11137-1994 and AAMI TIR8-1991; SAL 10^-6.

Indications for Use

Indicated for management of moderate to heavily exuding partial to full thickness wounds, including pressure, venous, diabetic, and arterial ulcers, donor sites, trauma wounds, dermal lesions, incisions, and 1st and 2nd 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

• Kaltostat Alginate Wound Dressings (Convetec)
• Granuflex (Duoderm) Hydrocolloid Dressings (Convetec)

Submission Summary (Full Text)

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K963598
IT
NOV 27 1996
Innovative Technologies Ltd

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

Innovative Technologies Alginate/Pectin Wound Dressing
79 KMF Liquid Bandage, 880.5090
Alginate Wound Dressing
Priscilla Whitehead, Director QA/RA
Wednesday, September 4, 1996

Innovative Technologies' Alginate/Pectin 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 non-woven Alginate/Pectin fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an integral, gelatinous, mass providing for a moist healing environment. The gel 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 pouches or 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/ISO11137-1994) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification of Method 1 for dosimetric release with a sterility assurance level of $10^{-8}$.

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

The Innovative Technologies' Alginate/Pectin Wound Dressings are similar in design, composition and function to Kaltostat® Alginate Wound Dressings manufactured by Convetec and Granuflex™ (Duoderm®) Hydrocolloid Dressings manufactured by Convetec.

## COMPARATIVE FEATURES

| Characteristics | Innovative Tech | Kaltostat | Granuflex |
| --- | --- | --- | --- |
| Material | Calcium Alginate / Citrus Pectin | Calcium Alginate | Gelatin, Pectin CMC |
| Surface Integrity | Needled / Nip rolled Integral | Needled Integral | Extruded/laminated Integral |
| Indications | Moderate to severe exuding wounds i.e. pressure, venous diabetic & arterial ulcers, donor sites, trauma wounds, dermal lesions and incisions, 1st & 2nd degree burns | Moderate to severe exuding wounds i.e. pressure, venous diabetic & arterial ulcers, donor sites, bleeding surface wounds, trauma injuries, incisions | Moderate to severe exuding wounds i.e. pressure, venous diabetic & arterial abrasions, donor sites, lacerations incisions, 1st and 2nd degree burns, trauma wounds |
| Packaging | Paper / Paper Pouch or Blister Pack | Paper / Poly Pouch | Blister Pack |
| Sterilisation Method | Gamma Radiation | Gamma Radiation | Gamma Radiation |

Priscilla Whitehead, Director QA/RA
Road Three, Winsford Industrial Estate, Winsford, Cheshire CW7 3PD U.K.