(72 days)
No
The description focuses on the physical properties and materials of a wound dressing, with no mention of AI, ML, image processing, or data analysis.
Yes
The device is intended for the management of various wounds, which falls under the definition of a therapeutic purpose.
No
The device description indicates it is a wound dressing designed for the management of various wounds, not for diagnosing them. Its function is to cover and protect wounds, not to identify or analyze medical conditions.
No
The device description clearly describes a physical wound dressing made of foam and film, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for the management of various types of wounds. This is a topical application for wound care, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details the physical characteristics of a wound dressing (foam and film sides, non-adherent, semi-occlusive). This aligns with the function of a wound dressing, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to cover and manage wounds externally.
N/A
Intended Use / Indications for Use
For the management of partial and full thickness wounds including the following:
- Second Degree Burns
- Skin Graft Donor Sites
- Autograft Sites
- Abrasions
- Lacerations
- Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic)
- Skin Tears
Product codes
MGP
Device Description
Silon® Dual-Dress™ is a single dressing with two different sides. One side consists of an open-celled hydrophilic foam. The other side consists of a non-adherent semi-occlusive film. The semi-occlusive film is perforated to allow wound exude to wick away from the wound.
With the foam side of the dressing down against the wound, the product provides an adhesive surface for difficult fixation conditions. With the film side down, the dressing provides a non-adherent covering for fragile and sensitive wounds. One side of the dressing is clearly marked with the product name and the words "Foam on Other Side" printed with a biocompatible ink.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for Bio Med Sciences, Inc. The logo features the letters "BMS" in a bold, sans-serif font, with a solid black square to the left of the "B". Below the letters is the company name, "Bio Med Sciences, Inc.", in a smaller font. The logo is simple and professional, and the use of black and white gives it a clean and modern look.
101 Technology Drive ● Bethlehem. PA 18015 Phone: (610) 974-8801 FAX: (610) 974-8831 Toll Free: 1-800-25-SILON 1257-4566) http://www.silon.com
XIII. 5100 SUMMARY
SILON® DUAL-DRESS™
PRODUCT DESCRIPTION
Silon® Dual-Dress™ is a single dressing with two different sides. One side consists of an open-celled hydrophilic foam. The other side consists of a non-adherent semi-occlusive film. The semi-occlusive film is perforated to allow wound exude to wick away from the wound.
With the foam side of the dressing down against the wound, the product provides an adhesive surface for difficult fixation conditions. With the film side down, the dressing provides a non-adherent covering for fragile and sensitive wounds. One side of the dressing is clearly marked with the product name and the words "Foam on Other Side" printed with a biocompatible ink.
INDICATIONS FOR USE
For the management of partial and full thickness wounds including the following:
- Second Degree Burns ●
- Skin Graft Donor Sites
- Autograft Sites �
- Abrasions ●
- . Lacerations
- Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic)
- Skin Tears
Contraindications (either side down);
- Third Degree Burns .
SUBSTANTIAL FOUITALENCE
Bio Med Sciences claims substantial equivalency for Silon® Dual-Dress™ to the following devices:
-
- Epitec® Dressing
(Rynel Ltd, Inc. 510K #K971337)
- Epitec® Dressing
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three overlapping, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1999
Mr. Mark E. Dillon President BioMed Sciences, Inc. 101 Technology Drive Bethlehem, Pennsylvania 18015
Re: K990042 Trade Name: Silon Dual-Dress Regulatory Class: Unclassifed Product Code: MGP Dated: January 4, 1999 Received: January 6, 1999
Dear Mr. Dillon:
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 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 misbranding and adulteration.
2
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
Enclosure
3
Page 1 of 1
K990042 510 (k) Number (if KNOHN):
Silon Dual-Dress DEVICE NAME:
INDICATIONS FOR USE:
For the management of partial and full thickness wounds including the following:
- Second Degree Burns b
- Skin Graft Donor Sites .
- 이 Autograft Sites
- 이 Abrasions
- Lacerations 1
- Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic)
- Skin Tears
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990042