LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING

K961323 · Acme United Corp. · KMF · Jun 19, 1996 · General Hospital

Device Facts

• Record ID: K961323
• Device Name: LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
• Applicant: Acme United Corp.
• Product Code: KMF · General Hospital
• Decision Date: Jun 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Lyofoam® Extra "C" Odor Absorbing dressing is intended for the treatment of moderately to heavily exuding wounds.

Device Story

Lyofoam® Extra "C" is a wound dressing combining polyurethane foam with an activated carbon layer. Device functions as a passive dressing to absorb wound exudate and neutralize odors. Used in clinical or home settings by patients or healthcare providers. Increased fluid capacity compared to predicate allows for longer wear time between changes. Benefits include improved exudate management and odor control for patients with heavily exuding wounds.

Clinical Evidence

Bench testing only. Safety data referenced from predicate files K952565 and K864084.

Technological Characteristics

Materials: Polyurethane foam, activated carbon. Form factor: Wound dressing. Sterilization: Gamma radiation (SAL 10⁻⁶). Packaging: Paper/foil peel pouch.

Indications for Use

Indicated for patients with moderately to heavily exuding wounds requiring an absorbent, non-adherent, odor-absorbing dressing.

Regulatory Classification

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

• Lyofoam® "C" Odor Absorbing Wound Dressing (K864084)
• Lyofoam® Extra Absorbent, Non-Adherent Polyurethane Foam Dressing (K952565)

Submission Summary (Full Text)

{0}

K 961323
Page 12

JUN 19 1996

Acme United Corporation

510(K) SUMMARY

Submitter's Name: Acme United Corporation
75 Kings Highway Cutoff
Fairfield, CT 06430

Contact Person: Thomas E. Flynn, Director of Regulatory
Affairs and Quality Assurance

Telephone Number: 203-332-7330
Fax Number: 203-576-0007
Date of Submission:

"This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

The assigned 510(K) number is:

Proprietary Name of Device: Lyofoam® Extra "C" Odor Absorbing
Common/Usual Name: Wound Dressing. Extra absorbent, non-adherent, odor absorbing, wound dressing.
Classification Name: Dressing, Class I
Product Claiming
Equivalence To: Lyofoam® "C" Odor Absorbing Wound Dressing and Lyofoam® Extra Absorbent, Non-Adherent Polyurethane Foam Dressing.
Description of Device: Lyofoam® Extra "C" Extra Absorbent, Non-Adherent Polyurethane Foam Dressing with activated carbon for odor absorption.

75 Kings Highway Cutoff • Fairfield, CT 06430 • Phone: [phone] • Fax: [phone]

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K 961320
Page 13

# Acme United Corporation

Intended Use, Comparison To Predicate Device:

The Lyofoam® Extra "C" Odor Absorbing Wound Dressing is a combination of the Lyofoam® Extra product and the Lyofoam® "C" Odor Absorbing Wound Dressing Product. The main difference between them is that Lyofoam® Extra is used in place of the regular Lyofoam® for the wound dressing segment of this product. Both have the same activated carbon layer for odor absorption.

The inner absorbent layer of Lyofoam® Extra "C" Odor Absorbing Wound Dressing holds more excess wound fluid than Lyofoam® "C". This would allow the Lyofoam® Extra "C" to be left on the wound without changing for a longer period of time. The Lyofoam® Extra "C" Odor Absorbing dressing is intended for the treatment of moderately to heavily exuding wounds, while Lyofoam® "C" would be used to treat lightly to moderately exuding wounds. Performance data for the Lyofoam® Extra dressing segment of this product can be found in the Lyofoam® Extra 510(K) file K952565.

75 Kings Highway Cutoff • Fairfield, CT 06430 • Phone: [phone] • Fax: [phone]

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K961323
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# Asme United Corporation

## Safety:

Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Lyofoam® "C" Odor Absorbing Wound Dressing 510(K) file; K864084. All safety data is summarized in those files and indicates product is safe for use.

## Sterility and Packaging:

Lyofoam® Extra "C" Odor Absorbing Wound Dressing is packaged in a paper/foil peep pouch and is sterilized using gamma radiation and has a SAL 10⁻⁶.

75 Kings Highway Cutoff • Fairfield, CT 06430 • Phone: [phone] • Fax: [phone]