(15 days)
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.
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.
The provided text describes a Special 510(k) Device Modification for the Silver Alginate II Dressing. This submission primarily focuses on demonstrating substantial equivalence to a previously cleared version of the same device (K041316) and another predicate device (Aquacel Ag with hydrofibre, K013814).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (from "Testing" and "Statement of Substantial Equivalence" sections) |
|---|---|
| Biocompatibility | Compliance with the requirements of BS EN ISO 10993-1. |
| Key Performance Characteristics | Demonstrated to be substantially equivalent to predicate devices. Specifically noted: "Comparable absorbency, silver release profile and antimicrobial activity have been demonstrated." |
| Antimicrobial Activity | 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. The dressing has an effective barrier to bacterial penetration, which may help reduce infection in moderate to heavily exuding partial to full thickness wounds. |
| Absorbency | 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. (Stated in device description, reinforced by "comparable absorbency" in substantial equivalence statement). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state a specific "test set" sample size or its provenance in terms of country of origin or retrospective/prospective nature. The studies mentioned are primarily in-vitro testing and biocompatibility assessments, which typically do not involve human subject "test sets" in the same way clinical trials do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. Given that the studies appear to be in-vitro and laboratory-based (biocompatibility, microbiology, absorbency), there would likely not be a "ground truth" established by clinical experts for a "test set" in the traditional sense of diagnostic or clinical outcome studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The nature of the testing described (biocompatibility, in-vitro performance) does not typically involve adjudication methods used in clinical or image-based diagnostic studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This submission is for a medical dressing, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a wound dressing and does not involve algorithms or human-in-the-loop performance like AI systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific tests mentioned:
- Biocompatibility: The "ground truth" is adherence to the standards defined in BS EN ISO 10993-1. This is a regulatory/technical standard.
- Antimicrobial Activity, Absorbency, Silver Release Profile: The "ground truth" for these in-vitro tests would be established through laboratory measurements and comparisons to the performance characteristics of the legally marketed predicate devices. This is based on objective, quantifiable laboratory data, not expert clinical consensus or pathology in the typical sense.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of this device and its evaluation. Training sets are relevant for machine learning or AI models, which are not involved here.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth established for one.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as:
- Biocompatibility testing: This demonstrated compliance with BS EN ISO 10993-1. (Detailed results or methodology are not provided, only the statement of compliance).
- Additional in-vitro testing and microbiological assessment: These studies demonstrated "comparable absorbency, silver release profile and antimicrobial activity" to the predicate devices. The document highlights the antimicrobial effect of silver ions against a broad spectrum of microorganisms for up to 21 days (based on in-vitro testing) and the dressing's barrier function.
The overall approach to proving acceptance criteria was based on demonstrating substantial equivalence to existing legally marketed predicate devices through a combination of standard biocompatibility testing and targeted in-vitro performance assessments (absorbency, silver release, antimicrobial activity). The specific details of these in-vitro studies (e.g., sample numbers for microbial strains, specific absorbency values, raw data) are not included in this summary document, which is typical for a 510(k) submission summary. The FDA granted clearance based on this presented evidence of substantial equivalence.
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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 LimitedRoad ThreeWinsford Industrial EstateWinsfordCheshireCW7 3PDUnited Kingdom |
|---|---|
| Contact: - | Mr. Grahame SomervilleSenior 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 burndressings. |
| Common Name:- | Silver Alginate II Dressing |
| Trade Names:- | Maxsorb Extra AgSeasorb AgInvacare Silver Alginate Dressing |
| Predicate devices :- | K041316 Silver Alginate II Dressing manufactured byAdvanced Medical SolutionsK013814 Aquacel Ag with hydrofibre manufactured byConVatec, A division of E.R Squibb and Sons LLC. |
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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.
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:
K of 3173
page 3 of 3
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| Testing:- | The biocompatibility of Advanced Medical SolutionsLimited Silver Alginate II Dressing has been demonstratedto be in compliance with the requirements of BS EN ISO10993-1. Additional in-vitro testing and additionalmicrobiological assessment has demonstrated that the keyperformance characteristics of the dressing are substantiallyequivalent to the predicate devices. |
|---|---|
| Statement of:-SubstantialEquivalence | The Silver Alginate II Dressing is a non-woven calciumalginate dressing which is substantially equivalent inconstruction and/or performance to both Anticoat® CalciumAlginate Dressing and Aquacel Ag absorbent antimicrobialwound dressing predicate devices. Comparableabsorbency, silver release profile and antimicrobial activityhave been demonstrated. |
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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.
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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
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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
N/A