(23 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial effects of the bandage, with no mention of AI or ML technologies.
No
The device aids in healing and provides an antimicrobial effect for minor wounds, but it does not claim to diagnose, treat, cure, or prevent any disease, which is typically characteristic of a therapeutic device in a regulatory context. Its indication for "first aid" of common minor injuries suggests it's more of a wound dressing than a therapeutic device.
No
The device description and intended use clearly state that it is a wound dressing for treatment and healing, not for diagnosing conditions.
No
The device description clearly states it is a physical bandage with hydrocolloid adhesive and silver, indicating it is a hardware medical device, not software-only.
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 minor cuts, scrapes, etc., on the skin and wound surface. This is a direct application to the body for therapeutic purposes.
- Device Description: The description details a wound dressing that interacts with the wound environment and has an antimicrobial effect on bacteria in direct contact with the dressing. This is a topical treatment.
- Lack of In Vitro Diagnostic Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the examination of specimens outside the body.
The device is a wound dressing with antimicrobial properties, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SureSkin Silver bandages provide an antimicrobial barrier to microbial colonization in the dressing and help eliminate microbial penetration through the dressing.
SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters, and scalds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
SureSkin Silver bandages are sterile, single-use dressings that consist of silver -containing hydrocolloid adhesive bonded to an outer polyurethane film cover for an antimicrobial effect.
The hydrocolloid adhesive is designed to interact with moisture from the skin and wound surface where it forms a gel and creates a moist wound environment that is known to speed the healing process faster than commonly used bandages
Once the bandage begins to interact with moisture the silver in the adhesive is activated and helps to kill bacteria which are in direct contact with the dressing.
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)
Antimicrobial effectiveness and Microbial Barrier testing was performed on the predicate device and showed that it provides an effective microbial barrier in the dressing. Biocompatibility testing was performed. Test results demonstrated that the device is suitable for its intended use. SureSkin Silver Bandages are identical in formulation, packaging materials and produced under same manufacturing processes to the predicate device. Thus safety and effectiveness is not affected in any manner. The dressing under this submission is identical to the predicate device except over-the-counter use.
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
N/A
0
K081274
page 1 of 3
MAY 2 8 2008
Image /page/0/Picture/2 description: The image shows the logo for EuroMed. The logo consists of a medical symbol on the left, followed by the word "EuroMed" in a bold, sans-serif font. Below the word "EuroMed" is some smaller text that is difficult to read. The medical symbol appears to be a caduceus, which is a symbol of medicine.
510(k) Summary SureSkin Silver Bandage
Submitter's name, address, phone and fax numbers
EuroMed Inc. 25 Corporate Drive Orangeburg, NY 10962 USA Phone: 845 359 4039 Fax: 845 359 1315
Contact Person at EuroMed Inc.
Subhash Chander Regulatory Affairs Manager Phone: 845 359 4039 ext. 321 Email: schander@euromedinc.com
Date 510(k) Prepared
April 30, 2008
Name of the medical device
Trade Name: SureSkin Silver Bandage Common Name: Wound Dressing Classification Name: Occlusive wound dressing (21CFR878.4020)
Occlusive wound dressings with added drugs have not yet been classified by the FDA or given a Product Code. Occlusive wound dressings without drugs have been designated as Class I (general controls) with Product Code "NAD" and exempt from the pre-market notification 510(k) submission requirements. Other wound dressings with antimicrobial properties have not been classified but given the product code, 'FRO''.
Legally marketed device to which substantial equivalence is claimed
SureSkin Silver is substantially equivalent in function, construction, and chemical composition to Euromed SureSkin III with Silver Wound Dressings (Rx) cleared by FDA (K050032). The primary purpose of this 510(k) is to seek clearance for Over-The-Counter (OTC) marketing of this dressing with revised indications.
1
K081274
page 2 of 3
Device Description
SureSkin Silver bandages are sterile, single-use dressings that consist of silver -containing hydrocolloid adhesive bonded to an outer polyurethane film cover for an antimicrobial effect.
The hydrocolloid adhesive is designed to interact with moisture from the skin and wound surface where it forms a gel and creates a moist wound environment that is known to speed the healing process faster than commonly used bandages
Once the bandage begins to interact with moisture the silver in the adhesive is activated and helps to kill bacteria which are in direct contact with the dressing.
In vitro laboratory testing has demonstrated the dressings antimicrobial effectiveness on fresh clinical isolates of Staph aureus (MRSA), E. coli, and P. aeruginosa.
Intended Use
The SureSkin Silver bandages provide an antimicrobial barrier to microbial colonization in the dressing and help eliminate microbial penetration through the dressing.
SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters, and scalds.
2
K 0712-74
page 3 of 3
Comparison to predicate device
| Company | Euromed, Inc. | Euromed, Inc. |
|---|---|---|
| Proprietary Name | SureSkin Silver | |
| Bandage | SureSkin III with | |
| Silver Wound | ||
| Dressing | ||
| 510 (k) Number | Not assigned | K050032 |
| Form | Adhesive Dressing | Adhesive Dressing |
| Is the device provided | ||
| sterile? | ✓ | ✓ |
| Is the device intended for | ||
| single use? | ✓ | ✓ |
| Sterilization Method | Gamma irradiation | Gamma irradiation |
| Packaging | Pouch | Pouch |
| Intended Use | Over-the counter use | Prescription Use |
| 21 CFR 807 Subpart C | 21 CFR 801 | |
| Subpart D |
Technological Characteristics comparison with Predicate Device
The SureSkin Silver Bandage is equivalent to the referenced predicate device in that it is composed of identical materials, same antimicrobial characteristics i.e. to provide barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing with an occlusive polyurethane backing.
Non-clinical and Performance Testing
Antimicrobial effectiveness and Microbial Barrier testing was performed on the predicate device and showed that it provides an effective microbial barrier in the dressing. Biocompatibility testing was performed. Test results demonstrated that the device is suitable for its intended use. SureSkin Silver Bandages are identical in formulation, packaging materials and produced under same manufacturing processes to the predicate device. Thus safety and effectiveness is not affected in any manner. The dressing under this submission is identical to the predicate device except over-the-counter use.
3
Image /page/3/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" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 2008
Euromed, Inc. % Subhash Chander Regulatory Affairs Manager 25 Corporate Drive Orangeburg, New York 10962
Re: K081274
Trade/Device Name: SureSkin Silver Bandage Regulatory Class: Unclassified Product Code: FRO Dated: April 30, 2008 Received: May 5, 2008
Dear Subhash Chander:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Subhash Chander
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 3 – Subhash Chander
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 (DGRND/PRSB) D.O. f/t:SRA:tlm:5-23-08
OC Numbers:
| Division of Enforcement A | 240-276-
0115 |
|------------------------------------------------------------------------------------|------------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-
0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-
0115 |
| General Hospital Devices Branch | 240-276-
0115 |
| General Surgery Devices Branch | 240-276-
0115 |
| Division of Enforcement B | 240-276-
0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-
0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices and
Radiological Devices | 240-276-
0120 |
:
Last Updated: Brandi Stuart – 7/9/07
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Image /page/6/Picture/0 description: The image shows the logo for EuroMed Personalized Health Technologies. The logo consists of a caduceus symbol on the left and the word "EuroMed" on the right. Below the word "EuroMed" is the phrase "Personalized Health Technologies" in a smaller font. The logo is black and white.
Indications for Use
510(k) Number (if known): _ Ko 812 74
Device Name: SureSkin Silver Bandage
Indications for Use:
SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters and scalds.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nail R.P. Oglin for mxm
Division Sign Off
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number K081274