SORBCEL ALGINATE/CMC WOUND DRESSING

K962421 · Innovative Technologies , Ltd. · KMF · Jul 11, 1996 · General Hospital

Device Facts

• Record ID: K962421
• Device Name: SORBCEL ALGINATE/CMC WOUND DRESSING
• Applicant: Innovative Technologies , Ltd.
• Product Code: KMF · General Hospital
• Decision Date: Jul 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Innovative Technologies' Sorbcel™ Alginate/CMC 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/Carboxymethylcellulose 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.

Device Story

Sorbcel™ is a sterile, non-woven, primary wound dressing composed of calcium alginate and sodium carboxymethylcellulose (CMC) fibers. Designed for moderate to heavily exuding wounds; dressing reacts with wound exudate to form a gelatinous mass, maintaining a moist healing environment. Gel structure allows for easy removal, minimizing peri-wound tissue trauma during dressing changes. Used in clinical or home settings by healthcare providers or patients. Benefits include effective exudate management and protection of delicate wound tissue.

Clinical Evidence

Bench testing only. Biocompatibility testing completed per ISO/Tripartite guidelines including cytotoxicity, haemolysis, acute systemic toxicity, skin irritation, and sensitisation. Performance testing compared absorbency (BP method) against predicates: Sorbcel (20 g/g) vs. Kaltostat (17 g/g) and Aquacel (18 g/g).

Technological Characteristics

Material: Calcium Alginate/Sodium Carboxymethylcellulose blend. Form: Non-woven, needled/nip-rolled integral dressing. Sterilization: Gamma radiation per ANSI/AAMI/ISO11137-1994 and AAMI TIR8-1991; SAL 10⁻⁶. Absorbency: 20 g/g (BP method).

Indications for Use

Indicated for 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 (Courtaulds)
• Aquacel™ Hydrofiber Wound Dressings (Convatec)

Submission Summary (Full Text)

{0}

K962421 IT T

Innovative Technologies Ltd

Safety & Effectiveness

Summary: Sorbcel™ Alginate/CMC Wound Dressing

Classification Name: KMF Hydrophilic Wound Dressing

Common / Usual Name: Alginate Wound Dressing

Contact: Priscilla Whitehead, Director QA/RA

Prepared: Thursday, June 20, 1996

JUL 11 1996

Innovative Technologies' Sorbcel™ Alginate/CMC 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/Carboxymethylcellulose 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 10⁻⁶. Biocompatibility testing including cytotoxicity, haemolysis, acute systemic toxicity, skin irritation and sensitisation has been successfully completed per ISO/Tripartite guidelines. The Innovative Technologies' Sorbcel™ Alginate/CMC Wound Dressings are similar in design, composition and function to Kaltostat® Alginate Wound Dressings manufactured by Courtaulds and Aquacel™ Hydrofiber Wound Dressings manufactured by Convatec.

## COMPARATIVE FEATURES

| Characteristics | Innovative Tech | Kaltostat | Aquacel |
| --- | --- | --- | --- |
| Material | Calcium Alginate / Sodium Carboxymethylcellulose | Calcium Alginate | Sodium Carboxymethylcellulose |
| Surface Integrity | Needled / Nip rolled Integral | Needled Integral | Needled Integral |
| Absorbancy (BP) | 20 g/g | 17 g/g | 18 g/g |
| 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.

Tel: [phone] Fax: [phone]

Registered in England 2666057