(77 days)
No
The device description and performance studies focus solely on the physical properties and barrier function of a wound dressing, with no mention of AI or ML capabilities.
No.
The device is a wound dressing described for the "dressing and management of chronic/open wounds," which is a supportive rather than therapeutic function.
No
The device is a wound dressing designed for the management of chronic/open wounds, not for diagnosing medical conditions.
No
The device description clearly describes a physical wound dressing composed of absorbent and adhesive layers, with no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the dressing and management of chronic/open wounds." This describes a device used directly on the body for therapeutic purposes (wound care).
- Device Description: The description details a physical wound dressing with absorbent and adhesive layers. It focuses on its physical properties and how it functions as a barrier and absorbent material.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the AllDress® Multi Layered Wound Dressing does not involve any such testing or analysis of biological samples.
The mention of "hemolysis test (In Vitro)" and "cytotoxicity test (In Vitro)" refers to testing of the device itself to ensure its safety and biocompatibility, not the device being used to perform in vitro diagnostic tests on a patient's sample.
N/A
Intended Use / Indications for Use
For the dressing and management of chronic/open wounds.
Product codes
79FRO
Device Description
The AllDress® Multi Layered Wound Dressing is a sterile wound dressing composed of an absorbent layer with a non-adherent wound contact surface. The absorbent layer is bonded to an adhesive backing layer which secures the dressing to the skin around the wound. Dressings are supplied in sizes of 2 ¼ "x 2 ¼ (1"x 1" wound contact surface); 6"x 6" (4"x 4" wound contact surface); 4"x 4" (2"x 2" wound contact surface); and 6"x 8" (4"x 6" wound contact surface). The wound contact side of the dressing is covered with scored siliconized release paper to permit aseptic application.
The AllDress® Multi Layered Wound Dressing represents a modified version of the currently marketed AllDress® Multi Layered Wound Dressing (K945206) and is identical to the predicate device with respect to function and intended use. to the Comfeel® Plus Ulcer Dressing (K941263). The composition of the backing layer of the modified product has been changed to improve the wound barrier properties of the dressing.
Biocompatibility of the modified device has been established by intracutaneous toxicity test (rabbit), systemic toxicity test (mice), muscle implantation test (rabbit), primary skin irritation test (rabbit), hemolysis test (In Vitro), cytotoxicity test (In Vitro), and delayed hypersensitivity test (guinea pig). In addition, bacterial penetration (strike-through) studies with S. aureus and P. aeruginosa and ASTM viral penetration test with фХ174 bacteriophage were conducted to demonstrate the effective performance of the dressing as a bacterial and viral barrier.
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)
Biocompatibility of the modified device has been established by intracutaneous toxicity test (rabbit), systemic toxicity test (mice), muscle implantation test (rabbit), primary skin irritation test (rabbit), hemolysis test (In Vitro), cytotoxicity test (In Vitro), and delayed hypersensitivity test (guinea pig). In addition, bacterial penetration (strike-through) studies with S. aureus and P. aeruginosa and ASTM viral penetration test with фХ174 bacteriophage were conducted to demonstrate the effective performance of the dressing as a bacterial and viral barrier.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510 (k) SUMMARY
K95 5863
ADMINISTRATIVE 1.
| Submitter: | Mölnlycke/Scott Health Care
500 Baldwin Tower
Eddystone, PA 19022 |
|----------------------|-------------------------------------------------------------------------|
| Contact Person: | Mike Drummond
(610) 499-3375 |
| Date of Preparation: | December 26, 1995 |
DEVICE NAME =
| Proprietary Name: | AllDress® |
|---|---|
| Common Name: | Sterile Multi-Layered Wound Dressing |
| Classification Name: | Wound Dressing |
| Regulatory Class: | Unclassified |
| Product Code: | 79FRO |
PREDICATE DEVICE 111.
AllDress® Multi Layered Wound Dressing (Scott Health Care; K945206)
IV. DEVICE DESCRIPTION
The AllDress® Multi Layered Wound Dressing is a sterile wound dressing composed of an absorbent layer with a non-adherent wound contact surface. The absorbent layer is bonded to an adhesive backing layer which secures the dressing to the skin around the wound. Dressings are supplied in sizes of 2 ¼ "x 2 ¼ (1"x 1" wound contact surface); 6"x 6" (4"x 4" wound contact surface); 4"x 4" (2"x 2" wound contact surface); and 6"x 8" (4"x 6" wound contact surface). The wound contact side of the dressing is covered with scored siliconized release paper to permit aseptic application.
The AllDress® Multi Layered Wound Dressing represents a modified version of the currently marketed AllDress® Multi Layered Wound Dressing (K945206) and is identical to the predicate device with respect to function and intended use. to the Comfeel® Plus Ulcer Dressing (K941263). The composition of the backing layer of the modified product has been changed to improve the wound barrier properties of the dressing.
Biocompatibility of the modified device has been established by intracutaneous toxicity test (rabbit), systemic toxicity test (mice), muscle implantation test (rabbit), primary skin irritation test (rabbit), hemolysis test (In Vitro), cytotoxicity test (In Vitro), and delayed hypersensitivity test (guinea pig). In addition, bacterial penetration (strike-through) studies with S. aureus and P. aeruginosa and ASTM
Product Nodules, AllDerm, Multi-Layered Wound Dressing (modified)
1
IV. DEVICE DESCRIPTION (continued)
viral penetration test with фХ174 bacteriophage were conducted to demonstrate the effective performance of the dressing as a bacterial and viral barrier.
INTENDED USE V.
For the dressing and management of chronic/open wounds.
vi. CONCLUSION
The technological characteristics of the modified AllDress® Multi Layered Wound Dressing are the same as to those of the predicate device, except for compositional changes intended to improve its wound barrier properties of the product. Biocompatibility and performance testing of the modified device have demonstrated safety as well as effective wound barrier performance. Accordingly, Mölnlycke/Scott Health Care has concluded that the modified device is safe and effective for its intended use and performs at least as well as the legally marketed predicate device.