(220 days)
Not Found
No
The summary describes a wound dressing with a physical structure and chemical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a dressing used for wound healing, which falls under the definition of a therapeutic device.
No
The device is a wound dressing designed for healing and protection, not for diagnosing medical conditions.
No
The device description clearly states it is a physical dressing with a trilaminate structure composed of polyurethane films and foam, indicating it is a hardware 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 clearly states that the Allevyn Ag Dressings are for use on wounds on the body (decubitus ulcers, diabetic ulcers, burns, donor sites). This is a topical application for wound management.
- Device Description: The description details a dressing with a trilaminate structure designed for exudate absorption and barrier protection on a wound. This is consistent with a wound care product applied externally.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue) to diagnose a condition or provide information about a physiological state. IVDs are used in vitro (in glass, or outside the body) to analyze biological samples.
The in-vitro testing mentioned in the "Summary of Performance Studies" refers to testing the dressing's barrier characteristics against bacteria in a lab setting, not using the dressing to diagnose a condition in a patient.
N/A
Intended Use / Indications for Use
The Allevyn Ag Dressings are indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites. Allevyn Ag may be used over debrided and partial thickness wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Allevyn Ag has a trilaminate structure composed of a polyurethane top film, polyurethane central Silver Sulfadiazine (SSD) containing foam pad and polyurethane perforated wound contact film. This design allows Allevyn Ag to provide continual exudate absorption and barrier protection for up to seven days, while creating and maintaining a moist wound-healing environment in a presentation that is comfortable for the patient and easy to use, apply and remove for the user.
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)
In-vitro testing studies showed that Allevyn Ag dressing has demonstrated to have barrier characteristics to bacterial strains: P. geruginosa, S. aureus, E. coli, K. pneumoniae, A. calcoaceticus, S. pyogenes, E. faccalis, MRSA, C. perfringens, B. fragilis, and P. melaninogenica. The biocompatibility of Allevyn Ag has been demonstrated through appropriate in vivo and in vitro tests on the foam as well as a literature review for the use of SSD. The product has been assessed in accordance with ANSI/AAMI/ISO 10993 and does not introduce any additional safety risk over the predicate devices Acticoat Moisture Control (K050030) or Allevyn Foam (K963096).
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
5063835
page 1 of 3
510(k) SUMMARY
AUG - 3 2007
1. Trade (Proprietary) Name
Allevyn Ag Dressings
2. Common/Classification Name
Common Name: Silver Sulfadiazine Containing Antibacterial Barrier Dressings
Classification Name: Dressing
Classification Code: FRO
3. Applicant's Name & Address
Smith & Nephew Inc 11775 Starkey Road, PO Box 1970, Largo, Florida, FL 33779-1970 Phone: 727-392-1261 Fax: 727-399-3468
4. Contact Information
Terry McMahon Regulatory Affairs Manager Phone: 727-399-3785 Email: terry.momahon@smith-nephew.com
Date Prepared: 01 August 2007
1
5. Device classification and Panel
A final classification for "Dressing" has not been implemented; however, a Class II classification has been proposed by the General and Plastic Surgery Devices Panel. At this time however, Classification Code FRO is unclassified.
6. Predicate devices
Allevyn Ag is similar in form and function to Acticoat Moisture Control Dressing (K050030) while being a modification of the Allevyn Foam Dressing (K963096) via the incorporation of Silver Sulfadiazine (SSD) within the absorbent foam core. Allevyn Ag has all the features and benefits associated with an absorbent foam dressing as well as the added benefit of an antibacterial barrier dressing. In-vitro testing studies showed that Allevyn Ag dressing has demonstrated to have barrier characteristics to bacterial strains: P. geruginosa, S. aureus, E. coli, K. pneumoniae, A. calcoaceticus, S. pyogenes, E. faccalis, MRSA, C. perfringens, B. fragilis, and P. melaninogenica.
7. Performance Standards
No applicable performance standards have been established under Section 514 of the FD&C Act. Biocompatibility tests were done in conformance with relevant requirements of ANSI/AAMI/ISO-10993.
8. Indications for Use:
The Allevyn Ag Dressings are indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1ª and 2ª degree burns, and donor sites. Allevyn Ag may be used over debrided and partial thickness wounds.
Date Prepared: 01 August 2007
2
Image /page/2/Picture/0 description: The image shows handwritten text. The top line reads "K063835". The second line reads "page 3 of 3". The text appears to be part of a document or record, possibly indicating a page number or identification code.
9. Device Description
Allevyn Ag has a trilaminate structure composed of a polyurethane top film, polyurethane central Silver Sulfadiazine (SSD) containing foam pad and polyurethane perforated wound contact film. This design allows Allevyn Ag to provide continual exudate absorption and barrier protection for up to seven days, while creating and maintaining a moist wound-healing environment in a presentation that is comfortable for the patient and easy to use, apply and remove for the user.
10. Biocompatability
The biocompatibility of Allevyn Ag has been demonstrated through appropriate in vivo and in vitro tests on the foam as well as a literature review for the use of SSD. The product has been assessed in accordance with ANSI/AAMI/ISO 10993 and does not introduce any additional safety risk over the predicate devices Acticoat Moisture Control (K050030) or Allevyn Foam (K963096).
11. Summary of Substantial Equivalence *
Allevyn Ag is comparable to Allevyn Foam and Acticoat Moisture Control in design, materials and manufacturing methods and does not raise any additional risks in terms of safety or performance; which is supported by product specifications and testing. This is further reflected in the similar labelled indications and directions for use for that of Allevyn Ag and the predicate devices.
Date Prepared: 01 August 2007
I Any statement made in conjunction with this submits to any other product only other product only relates the product can be lawfully market without premarket approval or classification and is not to be interpreted as an admission or used as evidence in patent infringement litigation.
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2007
Smith & Nephew % Mr. Terry McMahon Manager Regulatory Affairs P.O. Box 1970 11775 Starkey Road Largo, Florida 33779-1970
Re: K063835 Trade/Device Name: Allevyn Ag Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 26, 2007
Dear Mr. McMahon:
Received: June 27, 2007
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, listing 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 – Mr. Terry McMahon
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.
Mark M. Mckenna
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Dossier Reference: Allevyn Ag
- smith&nephew
Page 12 of 141 Ko63835
ALLEVYN AG DRESSING
KO63828 510(k) Number:
Device Name: Allevyn Ag Dressing
Indications for Use:
The Allevyn Ag Dressings are indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites. Allevyn Ag may be used over debrided and partial thickness wounds.
X Prescription (Per 21 CFR 801.109)
Over the Counter Use
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Miller
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number