(28 days)
Not Found
Not Found
No
The device description and intended use describe a standard wound dressing with no mention of AI/ML capabilities or image processing. The performance studies focus on biocompatibility, not algorithmic performance.
Yes
The device is intended to treat and protect various types of wounds, aiding in their healing process. While it doesn't directly cure the underlying condition, it actively supports the therapeutic management of the wound.
No
The device is described as an absorbent film dressing intended for wound care, specifically to absorb, protect, and maintain a moist environment in wounds. Its function is therapeutic and protective, not diagnostic.
No
The device description clearly describes a physical wound dressing, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a wound dressing designed to absorb, protect, and maintain a moist environment for various types of wounds. This is a therapeutic function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a sterile, self-adhesive absorbent dressing. This aligns with the physical characteristics of a wound care product, not an in vitro diagnostic device which typically involves reagents, instruments, or test kits for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The function is purely related to wound management.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.
Product codes
KMF
Device Description
The Alldress Absorbent Film Dressing is a sterile moisture vapor permeable selfadhesive absorbent dressing.
The Alldress dressing is individually sealed in medical grade paper pouches and packaged in cartons of ten (10) pouches each. The Alldress dressing is available in three sizes: 10x10cm (4" x 4"), 15x15cm (6" x 6") and 15x20cm (6" x 8").
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)
Alldress sterile moisture vapor permeable selfadhesive absorbent dressing have been shown in laboratory tests to be nontoxic.
Alldress have been found to be non-toxic and non-irritating when tested by the above biological tests in accordance with the ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alldress® Multi-Layered Wound Dressing
Reference Device(s)
Not Found
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
NOV 10 1998
1983554
510(k) SUMMARY
| Applicant: | Mölnlycke Health Care
500 Baldwin Tower
Eddystone, PA 19022 |
|-------------------|------------------------------------------------------------------------------|
| Proprietary Name: | Alldress® Absorbent Film Dressing |
| Contact Person: | Miguel A. Negron, Manager, Regulatory Affairs & Quality
Tel. 610-499-3383 |
| Substantially | |
Equivalent Device:
Alldress® Multi-Layered Wound Dressing
The Alldress Absorbent Film Dressing is a sterile moisture vapor permeable selfadhesive absorbent dressing.
The Alldress dressing is individually sealed in medical grade paper pouches and packaged in cartons of ten (10) pouches each. The Alldress dressing is available in three sizes: 10x10cm (4" x 4"), 15x15cm (6" x 6") and 15x20cm (6" x 8").
Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.
Alldress sterile moisture vapor permeable selfadhesive absorbent dressing have been shown in laboratory tests to be nontoxic.
Alldress have been found to be non-toxic and non-irritating when tested by the above biological tests in accordance with the ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995).
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top half of the eagle.
NOV 10 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Miguel A. Negron Manager, Regulatory Affairs & Quality Molnlycke Health Care 500 Baldwin Tower Eddystone, Pennsylvania 19022
Re: K983554
Trade Name: Alldress® Absorbent Film Dressing Regulatory Class: Unclassified Product Code: KMF Dated: October 08, 1998 Received: October 13, 1998
Dear Mr. Negron:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against
2
Page 2 - Mr. Miguel A. Negron
misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
3
11-03-1998 12:55PM
FKUM M. INEGKUN DUSSAS I YZ
NOV 100 1998
Indications for Use Statement Section 8:
PREMARKET NOTIFICATION
(983554
INDICATIONS FOR USE STATEMENT
510(k) Number:
Mölnlycke Health Care
Device Name:
Alldress® Absorbent Film Dressing
Indications for Use:
Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acce
ision Sign-Off
Division of General Restorative Devices
510(k) Number K9803554
Prescription Use (Per 21 CFR 801.109)
Or Over-The-Counter Use
Premarket Notification: Alldress®
Mölnlycke Health Care