ALLDRESS MULTI LAYERED WOUND DRESSING

K955863 · Molnlycke/Scott Health Care · NAD · Mar 13, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955863
• Device Name: ALLDRESS MULTI LAYERED WOUND DRESSING
• Applicant: Molnlycke/Scott Health Care
• Product Code: NAD · General, Plastic Surgery
• Decision Date: Mar 13, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 878.4020
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For the dressing and management of chronic/open wounds.

Device Story

Sterile multi-layered wound dressing; absorbent layer with non-adherent contact surface; adhesive backing layer secures dressing to skin. Used in clinical settings for wound management. Modified version of predicate; improved backing layer composition enhances wound barrier properties. Applied by clinicians to cover wounds; provides barrier against bacteria and viruses. Benefits patient by protecting wound site and managing exudate.

Clinical Evidence

Bench testing only. Biocompatibility: intracutaneous toxicity, systemic toxicity, muscle implantation, primary skin irritation, hemolysis, cytotoxicity, and delayed hypersensitivity. Performance: bacterial strike-through (S. aureus, P. aeruginosa) and viral penetration (phiX174 bacteriophage) testing conducted.

Technological Characteristics

Multi-layered sterile dressing; absorbent layer; adhesive backing layer. Dimensions: 2.25"x2.25", 4"x4", 6"x6", 6"x8". Scored siliconized release paper. Barrier performance validated via ASTM viral penetration testing.

Indications for Use

Indicated for patients with chronic or open wounds requiring dressing and management.

Regulatory Classification

Identification

An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Predicate Devices

• AllDress® Multi Layered Wound Dressing (K945206)

Reference Devices

• Comfeel® Plus Ulcer Dressing (K941263)

Submission Summary (Full Text)

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MAR 13 1996
510 (k) SUMMARY
K955863

# 1. ADMINISTRATIVE

Submitter: Mölnlycke/Scott Health Care
500 Baldwin Tower
Eddystone, PA 19022

Contact Person: Mike Drummond
[phone]

Date of Preparation: December 26, 1995

# II. DEVICE NAME

Proprietary Name: AllDress®
Common Name: Sterile Multi-Layered Wound Dressing
Classification Name: Wound Dressing
Regulatory Class: Unclassified
Product Code: 79FRO

# III. PREDICATE DEVICE

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 2¼" x 2¼" (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

Premarket Notification: AllDress Multi-Layered Wound Dressing (modified)
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IV. DEVICE DESCRIPTION (continued)

viral penetration test with $\phi X174$ bacteriophage were conducted to demonstrate the effective performance of the dressing as a bacterial and viral barrier.

V. INTENDED USE

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.

Premarket Notification: AllDress Multi Layered Wound Dressing (modified)
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