(15 days)
Not Found
No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the management of various wounds, including post-operative wounds, trauma wounds, ulcers, and graft sites, and it aids in optimal wound healing and infection reduction.
No.
The device description and intended use clearly state that the Silver Alginate II Dressing is for the management of wounds by absorbing fluid, maintaining a moist environment, and providing an antibacterial barrier, all of which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a sterile, non woven pad composed of physical materials (calcium alginate, carboxymethylcellulose, ionic silver complex) and is available in various physical sizes and forms (flat dressings, rope dressings). This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of moderate to heavily exuding partial to full thickness wounds." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing that absorbs fluid, forms a gel, and releases silver ions for antimicrobial protection. This is consistent with a wound care product, not a device used to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide information about a patient's health status or disease.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is applied in vivo (on the body) for wound treatment.
N/A
Intended Use / Indications for Use
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including:
- Post-operative wounds
- Trauma wounds
- Leg Ulcers
- Pressures Ulcers
- Diabetic Ulcers
- Graft and donor sites
Silver Alginate II Dressing is indicated for external use only
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing. Odour reduction results from the antibacterial effect in the dressing. Silver Alginate II Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help to reduce infection in moderate to heavily exuding partial to full thickness wounds. The dressing has an off-white appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm, 20cm x 30cm flat dressings; 2.7cm x 30cm and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat rope dressings are packaged in pouches and the flat rope and rope dressings are packaged in a blister pack.
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)
The biocompatibility of Advanced Medical Solutions Limited Silver Alginate II Dressing has been demonstrated to be in compliance with the requirements of BS EN ISO 10993-1. Additional in-vitro testing and additional microbiological assessment has demonstrated that the key performance characteristics of the dressing are substantially equivalent to the predicate devices.
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
ນ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ ປີ
KO63173
NOV - 3 2006
Special 510(k): Device Modification -Summary
This Special 510(k) Device Modification is to provide substantial equivalence for Advanced Medical Solutions Limited's Silver Alginate II Dressing, which is substantially equivalent to currently marketed devices intended for wound care. This product is already equally marketed as Silver Alginate II Dressing (unmodified device) and was previously cleared under 510(k) number K041316. Both submissions have been made by Advanced Medical Solutions Limited.
| Submitted by: - | Advanced Medical Solutions Limited
Road Three
Winsford Industrial Estate
Winsford
Cheshire
CW7 3PD
United Kingdom |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: - | Mr. Grahame Somerville
Senior Regulatory Affairs Consultant |
| Telephone:- | +44(0)1606 545569 |
| Fax :- | +44(0)1606 863600 |
| Email:- | grahame.somerville@mediqol.com |
| Date prepared: - | 2nd October 2006-10-02 |
| Classification :- | There is currently no classification for wound and burn
dressings. |
| Common Name:- | Silver Alginate II Dressing |
| Trade Names:- | Maxsorb Extra Ag
Seasorb Ag
Invacare Silver Alginate Dressing |
| Predicate devices :- | K041316 Silver Alginate II Dressing manufactured by
Advanced Medical Solutions
K013814 Aquacel Ag with hydrofibre manufactured by
ConVatec, A division of E.R Squibb and Sons LLC. |
1
K 063173
page 2 of 3
Indications for Use: -Advanced Medical Solutions Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including: Post-operative wounds � Trauma wounds . . Leg Ulcers . Pressures Ulcers . Diabetic Ulcers Graft and donor sites . Silver Alginate II Dressing is indicated for external use only. Device Description:-Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing. . Odour reduction results from the antibacterial effect in the dressing. Silver Alginate II Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help to reduce infection in moderate to heavily exuding partial to full thickness wounds. The dressing has an off-white appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm, 20cm x 30cm flat dressings; 2.7cm x 30cm and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat rope dressings are packaged in pouches and the flat rope and rope dressings are packaged in a blister pack.
2
:
K of 3173
page 3 of 3
.
| Testing:- | The biocompatibility of Advanced Medical Solutions
Limited Silver Alginate II Dressing has been demonstrated
to be in compliance with the requirements of BS EN ISO
10993-1. Additional in-vitro testing and additional
microbiological assessment has demonstrated that the key
performance characteristics of the dressing are substantially
equivalent to the predicate devices. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of:-
Substantial
Equivalence | The Silver Alginate II Dressing is a non-woven calcium
alginate dressing which is substantially equivalent in
construction and/or performance to both Anticoat® Calcium
Alginate Dressing and Aquacel Ag absorbent antimicrobial
wound dressing predicate devices. Comparable
absorbency, silver release profile and antimicrobial activity
have been demonstrated. |
:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Advanced Medical Solutions Ltd. % Mr. G. Grahame Somerville Senior Regulatory Affairs Consultant Road Three, Winsford Industrial Estate Winsford. Chesire, CW7 3PD United Kingdom
Re: K063173
Trade/Device Name: Silver Alginate II Dressing Regulation Class: Unclassified Product Code: FRO Dated: October 16, 2006 Received: October 19, 2006
Dear Mr. Somerville:
We have reviewed your Scction 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 (OS) 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. G. Grahame Somerville
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,
Neil R.P. Ogle
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
000001
Indications for Use
510(k. Number (if known): K063173/K041316
Device Name: Silver Alginate II Dressing
Indications for Use:
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including:
- Post-operative wounds �
- � Trauma wounds
- � Leg Ulcers
- Pressures Ulcers �
- Diabetic Ulcers �
- Graft and donor sites e
Silver Alginate II Dressing is indicated for external use only
Preseription Use X (Fart 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Nul K.P. G.L.
furmer
Division of General, Restorative, and Neurological Devices
510(k) Number K063173