(45 days)
No
The summary describes a standard wound dressing and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a wound dressing, which is used for the treatment of wounds by absorbing exudate, not for therapeutic intervention to cure or alleviate a disease or condition.
No
Explanation: The device is a wound dressing, which is used for treatment, not for diagnosing a condition.
No
The device description clearly indicates it is a physical wound dressing made of polyurethane foam with an adhesive border, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of moderately to heavily exuding wounds." This describes a therapeutic application, not a diagnostic one.
- Device Description: The description is of a "Polyurethane Foam Dressing with adhesive boarder," which is a physical dressing applied to a wound.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue) or providing information about a patient's health status or disease. IVDs are designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening.
This device is a wound dressing, which falls under the category of medical devices used for wound care.
N/A
Intended Use / Indications for Use
The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds. Lyofoam® Extra "A" provides a waterproof barrier for the wound which is moisture vapor permeable and helps to prevent bacterial contaminiation of the wound.
Product codes
Not Found
Device Description
Lyofoam® Extra "A", Extra Absorbent, Non-Adherent Polyurethane Foam Dressing with adhesive boarder.
The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is a combination of the Lyofoam® Extra product and the Modified Lyofoam® Dressing Product (Lyofoam® "A"). The main difference between them is that Lyofoam® Extra Foam Dressing is used in place of the regular Lyofoam® for the wound dressing pad segment of this product. The third layer of thin foam is extended beyond the wound pad and has a adhesive coating which is used to hold the product in place over the wound.
The inner absorbent layer of Lyofoam® Extra Wound Dressing Pad holds more excess wound fluid than the Modified Lyofoam® Wound Dressing Pad which is made from regular Lyofoam®.
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
Performance data for this product can be found in the Lyofoam@ Extra 510(K) File K952565.
Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Modified Lyofoam® Dressing file; K895764. All safety data is summarized in those files and indicates product is safe for use.
Key Metrics
Not Found
Predicate Device(s)
Modified Lyofoam® Wound Dressing and Lyofoam® Extra Absorbent Wound Dressing
Reference Device(s)
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/0 description: The image shows a logo with a stylized letter 'A' inside a black circle. The 'A' is white and appears to be formed by two curved shapes that meet at the top. To the right of the logo, the beginning of a word, 'Acr,' is visible, suggesting the full word is likely 'Acronis' or a similar term.
لقارير المقاومة المستوى المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنت
)
Acme United Corporation
510(K) SUMMARY
MAY 3 | 1996
Page 12
941452
| 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 "A" Sterile Adhesive
Wound Dressing |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Extra absorbent, polyurethane foam
island dressing. |
| Classification Name: | Dressing, Class I |
| Product Claiming
Equivalence To: | Modified Lyofoam® Wound Dressing and
Lyofoam® Extra Absorbent Wound
Dressing |
| Description of Device: | Lyofoam® Extra "A", Extra Absorbent,
Non-Adherent Polyurethane Foam
Dressing with adhesive boarder. |
1
Image /page/1/Picture/0 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 shears. To the right of the logo is the text "Acme United Corporation" in a simple, sans-serif font. The text is aligned horizontally with the logo.
Paqe 13 K961452 Page 2 of 3
Intended Use, Comparison To Predicate Device:
The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is a combination of the Lyofoam® Extra product and the Modified Lyofoam® Dressing Product (Lyofoam® "A"). The main difference between them is . that Lyofoam® Extra Foam Dressing is used in place of the regular Lyofoam® for the wound dressing pad segment of this product. The third layer of thin foam is extended beyond the wound pad and has a adhesive coating which is used to hold the product in place over the wound.
The inner absorbent layer of Lyofoam® Extra Wound Dressing Pad holds more excess wound fluid than the Modified Lyofoam® Wound Dressing Pad which is made from regular Lyofoam®. The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds while the Modified Lyofoam® Wound Dressing would be used to treat lightly to moderately exuding, wounds. Lyofoam® Extra "A" provides a waterproof barrier for the wound which is moisture vapor permeable and helps to prevent bacterial contaminiation of the wound.
Medical Products Division • 75 Kings Highway Cutoff, Fairlield, Connecticut 06430 • Phone (203) 332-7330
2
Image /page/2/Picture/0 description: The image shows the logo for Acme United Corporation. The logo consists of a black circle with a white stylized image of scissors inside. To the right of the logo is the text "Acme United Corporation" in a simple, sans-serif font.
Safety:
Page 14
Page 3 of 3
Performance data for this product can be found in the Lyofoam@ Extra 510(K) File K952565.
Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Modified Lyofoam® Dressing file; K895764. All safety data is summarized in those files and indicates product is safe for use.
Sterility and Packaging:
Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is packaged in a paper/foil peel pouch and is sterilized using gamma radiation and has a SAL 10-6.