(75 days)
Not Found
No
The summary describes a wound dressing with activated carbon for odor absorption. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies refer to previous 510(k)s for similar foam dressings.
No
The device is a wound dressing designed to absorb exudate and odors, which are supportive functions for healing, but it does not directly treat a disease or condition as a therapeutic device would.
No
The device description indicates it is a wound dressing designed for absorbing exudate and odor, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a polyurethane foam dressing with activated carbon, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating wounds by absorbing exudate and odor. This is a direct treatment applied to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a wound dressing made of foam and activated carbon. This is a physical device for wound care, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or laboratory equipment
- Measuring analytes or biomarkers
The device is clearly a wound dressing, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Lyofoam® Extra "C" Odor Absorbing dressing is intended for the treatment of moderately to heavily exuding wounds
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Lyofoam® Extra "C" Extra Absorbent, Non-Adherent Polyurethane Foam Dressing with activated carbon for odor absorption.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 19 1996
Image /page/0/Picture/1 description: The image shows the logo for Acme United Corporation. The logo consists of a black circle with a white image of scissors inside. To the right of the logo is the text "Acme United Corporation" in black font.
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. |
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K 461320 Page 13
Image /page/1/Picture/1 description: The image shows the logo for Acme United Corporation. The logo consists of a black circle with a white design inside, resembling a pair of scissors or the letters 'A' and 'B' intertwined. To the right of the logo, the text "Acme United Corporation" is written in a simple, sans-serif font.
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 Lycfoam®"C" would be used to treat lightly to moderately exuding wounds. Performance date for the Lyofoam® Extra dressing segment of this product an be found in the Lyofoam® Extra 510(K) file K952565.
2
1461:
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Image /page/2/Picture/2 description: The image shows a logo consisting of a white stylized letter 'A' and 'B' intertwined within a black circle. The 'A' and 'B' are designed with rounded shapes, giving them a soft, almost floral appearance. The logo is simple and modern, using a high contrast color scheme to make it stand out.
cme 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.