(17 days)
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/CarboxymethyIcellulose 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.
The provided text describes a wound dressing product (Sorbcel™ Alginate/CMC Wound Dressing) and compares it to two similar products (Kaltostat® and Aquacel™). However, it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The document focuses on the product's description, composition, intended use, sterilization, biocompatibility, and a comparative features table with similar products.
Therefore, I cannot extract the requested information from the provided document.
To answer your request, I would need a document that describes:
- Specific, quantifiable acceptance criteria for the device's performance (e.g., minimum absorbency, maximum irritation index, specific efficacy rates).
- Details of a study conducted to evaluate the device against those criteria, including methodology, results, and conclusions regarding meeting the acceptance criteria.
{0}------------------------------------------------
<962421 I
Image /page/0/Picture/1 description: The image contains two sets of the letter 'T'. The first set consists of two clearly defined, uppercase 'T's, positioned side by side. The second set features a single, uppercase 'T' that appears more stylized and partially obscured by what seems to be a cloud-like or faded effect around its base.
Innovative Technologies Ltd
Safety & Effectiveness Summary: Classification Name: Common / Usual Name: Contact: Prepared:
Image /page/0/Picture/4 description: The image shows the date "JUL 11 1986" in a bold, sans-serif font. The letters and numbers are closely spaced, creating a compact appearance. The date format is month-day-year, with the month abbreviated to three letters.
Sorbcel™ Alginate/CMC Wound Dressing KMF Hydrophilic Wound Dressing Alginate Wound Dressing Priscilla Whitehead, Director QA/RA Thursday, June 20, 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/CarboxymethyIcellulose 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 quidelines. 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 Carboxy-methylcellulose | Calcium Alginate | Sodium Carboxy-methylcellulose |
| Surface | Needled / Nip rolled | Needled | Needled |
| Integrity | Integral | Integral | Integral |
| Absorbancy (BP) | 20 g/g | 17 g/g | 18 g/g |
| Indications | Moderate to severeexuding wounds i.e.pressure, venousdiabetic & arterialulcers, donor sites,trauma wounds,dermal lesions andincisions, 1st & 2nddegree burns | Moderate to severeexuding wounds i.e.pressure, venousdiabetic & arterialulcers, donor sites,bleeding surfacewounds, traumainjuries, incisions | Moderate to severeexuding wounds i.e.pressure, venousdiabetic & arterialabrasions, donorsites, lacerationsincisions, 1st and2nd degree burns,trauma wounds |
| Packaging | Paper / Paper Pouchor Blister Pack | Paper / PolyPouch | Blister Pack |
| Sterilisation Method | Gamma Radiation | Gamma Radiation | Gamma Radiation |
Priscilla Whitehead, Director QA/RA 20/6/96
§ 880.5090 Liquid bandage.
(a)
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.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.