(3 days)
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:
- ·Post-operative wounds .
- Trauma wounds (dermal lesions, trauma injuries or incisions)
- Leg ulcers
- Pressure ulcers
- Diabetic ulcers
- Graft and donor sites
- Post-operative surgical wounds
- 1st and 2nd degree burns
- Partial and full thickness wounds
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 fourteen (14) 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.
Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing.
The Silver Alginate II Dressing is available various sizes: 5cm x 5cm (2" x 2"), 10cm x 10cm (4" x 4"). 10cm x 12cm (4" x 4.75"). 15cm x 15cm (6" x 6"). 10cm x 20cm (4" x 8"), 20cm x 30cm (8" x 12") and 2.7cm x 30cm (1" x 12"). The dressings are packaged in foil pouches.
This document describes a Special 510(k) Device Modification for the Advanced Medical Solutions Limited's Silver Alginate II Dressing. The modification aims to demonstrate substantial equivalence to previously cleared devices. The document references performance data but does not explicitly state acceptance criteria or the specifics of a study proving the device meets those criteria in a way that aligns with the detailed requests in the prompt.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics or thresholds. | - Antimicrobial effectiveness: "The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to fourteen (14) 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." |
| - Biocompatibility: "demonstrated to be in compliance with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices)." | |
| - Sterilization: "Sterilisation validation has been performed in compliance with ISO 11137 standards." | |
| - Overall: "The biocompatibility testing, in-vitro performance testing and microbiological assessment for the Silver Alginate II Dressing has demonstrated that the device is safe and effective for the indications of use." | |
| - Substantial Equivalence: "The indication for use, performance testing and antimicrobial activity for the Silver Alginate II Dressing is substantially equivalent to the predicate devices; Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions." |
2. Sample size used for the test set and the data provenance
The document mentions "in-vitro testing" and "microbiological assessment" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests described are laboratory/bench tests, not involving expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. The tests described are laboratory/bench tests, not involving adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document refers to in-vitro testing and biocompatibility assessments, not studies involving human readers and clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a wound dressing, not an AI algorithm. The performance described is for the physical device itself.
7. The type of ground truth used
For antimicrobial effectiveness, the ground truth appears to be based on direct observation of bacterial inhibition/reduction in in-vitro settings.
For biocompatibility, the ground truth is compliance with the requirements of international standard BS EN ISO 10993-1, which involves various biological tests.
For sterilization, the ground truth is compliance with ISO 11137 standards, which involves validated sterilization processes.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm-based device.
{0}------------------------------------------------
FEB 2 6 2009
K090453
Page 1 of 2
uuuu 19
Special 510(k) Device Modification - Summary
This Special 510(k) Device Modification is to provide substantial equivalence for the 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 legally marketed as Silver Alginate II dressing (unmodified device) and was previously cleared under 510(k) # K041316, K063173 and K070581. All submissions were made by Advanced Medical Solutions Limited.
Submitted by:-
Advanced Medical Solutions Limited Road Three Winsford Industrial Estate Winsford, Cheshire CW7 3PD United Kingdom
Contact:-
Mrs. Claire Ryan Regulatory Affairs Manager Telephone: + 44(0)1606 545569 Fax :- + 44(0)1606 863600 Email: claire.ryan@admedsol.com
20th February 2009
Silver Alginate Il Dressing
Date prepared :-
Common Name :-
Trade Names :-To be confirmed
Classification Name :-Dressing, Wound, Drug
Classification :-Unclassified
Product Code :-
Legally marketed device(s) for which substantial equivalence is claimed:-
FRO
Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions.
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 fourteen (14) 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.
{1}------------------------------------------------
R 04 0433
Page 2 of 2
Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing.
The Silver Alginate II Dressing is available various sizes: 5cm x 5cm (2" x 2"), 10cm x 10cm (4" x 4"). 10cm x 12cm (4" x 4.75"). 15cm x 15cm (6" x 6"). 10cm x 20cm (4" x 8"), 20cm x 30cm (8" x 12") and 2.7cm x 30cm (1" x 12"). The dressings are packaged in foil pouches.
Indications for use:
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as pressures ulcers, diabetic ulcers, leg ulcers, post-operative wounds, trauma wounds (dermal lesions, trauma injuries or incisions), graft and donor sites, post-operative surgical wounds, 1st and 200 degree burns.
Silver Alginate II Dressing is indicated for external use only.
Manufacturing :-
Silver Alginate II Dressing will be manufactured according to the product specification and under good manufacturing practices (GMP). A risk analysis has been performed to identify possible failure mode during manufacturing. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode.
Advanced Medical Solutions Ltd Silver Alginate II Dressing meets all the established specifications prior to release to ensure the device is safe, effective and correctly labelled for its intended use.
Testing :-
Performance data for the Silver Alginate II Dressing has been established using antimicrobial and bench 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 (Biological Evaluation of Medical Devices). Sterilisation validation has been performed in compliance with ISO 11137standards.
The biocompatibility testing, in-vitro performance testing and microbiological assessment for the Silver Alginate II Dressing has demonstrated that the device is safe and effective for the indications of use.
Statement of Substantial Equivalence:-
The indication for use, performance testing and antimicrobial activity for the Silver Alginate II Dressing is substantially equivalent to the predicate devices; Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Solutions Limited % Ms. Claire Ryan Regulatory Affairs Manager Road Three, Winsford Industrial Estate Winsford. Cheshire CW7 3PD United Kingdom
FEB 2 6 2009
Re: K090453
Trade/Device Name: Silver Alginate II Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 20, 2009 Received: February 23, 2009
Dear Ms. Ryan:
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. Ilsting 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.
{3}------------------------------------------------
Page 2 - Ms. Claire Ryan
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 yours,
f. A. m., D. for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): KO90453
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, such as:
- ·Post-operative wounds .
- Trauma wounds (dermal lesions, trauma injuries or incisions)
- Leg ulcers
- Pressure ulcers
- Diabetic ulcers
- Graft and donor sites
- Post-operative surgical wounds
- 1st and 2nd degree burns
- Partial and full thickness wounds
Silver Alginate II Dressing is indicated for external use only
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone 2/26/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K090453
N/A