(79 days)
Kaltostat® Alginate Wound Dressings, Granuflex™ (Duoderm®) Hydrocolloid Dressings
Not Found
No
The device description and intended use focus on the material properties and function of a wound dressing, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a wound dressing that provides a moist healing environment; it does not actively treat or cure a disease or condition.
No
The device description states its purpose is to manage wounds by providing a moist healing environment, not to identify or diagnose medical conditions.
No
The device description clearly describes a physical wound dressing made of Alginate/Pectin fibers, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for managing wounds by providing a moist healing environment. This is a direct interaction with the wound itself, not a test performed on a sample taken from the body.
- Device Description: The description details a wound dressing that reacts with wound exudate to form a gel. This is a physical interaction with the wound, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing diagnostic information about a patient's health status
This device falls under the category of a wound care product, which is a medical device but not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
KMF
Device Description
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 10-6. 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 Convatec.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the letters "IT" on the left side of the image. To the right of the letters is a graphic of a cross inside of a circle. The bottom half of the circle is shaded with a pattern of dots.
Innovative Technologies Ltd
Safety & Effectiveness Summary: Classification Name: Common / Usual Name: Contact: Prepared:
NOV 27 1996
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 10-6. 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 Convatec.
COMPARATIVE FEATURES
| Characteristics | Innovative Tech | Kaltostat | Granuflex |
|---|---|---|---|
| Material | Calcium Alginate / | ||
| Citrus Pectin | Calcium Alginate | Gelatin, Pectin | |
| CMC | |||
| Surface | Needled / Nip rolled | Needled | Extruded/laminated |
| Integrity | Integral | Integral | 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 |
Riscialla Whitelead 9/2/96
Priscilla Whitehead, Director OA/RA
Road Three, Winsford Industrial Estate, Winsford, Cheshire CW7 3PD U.K.