← Product Code [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF) · K962421 # SORBCEL ALGINATE/CMC WOUND DRESSING (K962421) _Innovative Technologies , Ltd. · KMF · Jul 11, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K962421 ## Device Facts - **Applicant:** Innovative Technologies , Ltd. - **Product Code:** [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF.md) - **Decision Date:** Jul 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5090 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for 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). ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: 44 (0) 1606 86 3500 Fax: 44 (0) 1606 86 3600 Registered in England 2666057 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K962421](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K962421) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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