(80 days)
The 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
- . Leq Ulcers
- Pressure Ulcers .
- Diabetic Ulcers .
- Graft and donor sites .
Silver Alginate II Dressing is indicated for external use only
The dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver, which absorbs wound exudate and releases silver ions in the presence of wound fluid. As wound exudate 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 four (4) days, based on in vitro laboratory testing. Odour reduction results from the antibacterial effect in the dressing.
The dressing is an effective barrier to penetration by microorganisms.
The dressing has a off-white appearance, and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm flat dressings; 2.7cm x 30cm, and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat dressings are packaged in pouches, and the flat rope and rope dressings are packaged in a blister pack.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Silver Alginate II Dressing.
This submission is a 510(k) for a medical device (wound dressing), which primarily demonstrates substantial equivalence to existing predicate devices rather than proving a novel therapeutic effect or clinical outcome through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the new device performs similarly to or meets the established characteristics of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Biocompatibility (per BS EN ISO 10993-1) | "The biocompatibility of Advanced Medical Solutions Ltd's Silver Alginate II Dressing has been demonstrated in accordance with BS EN ISO 10993-1 requirements." |
| Absorbency | "Comparable absorbency... have been demonstrated." (Implied to be comparable to predicate devices Acticoat® Calcium Alginate Dressing and Absorbent Antimicrobial Wound Dressing) |
| Silver Release Profile | "Comparable... silver release profile... have been demonstrated." (Implied to be comparable to predicate devices Acticoat® Calcium Alginate Dressing and Absorbent Antimicrobial Wound Dressing) |
| Antimicrobial Activity | "Comparable... antimicrobial activity have been demonstrated." (Implied to be comparable to predicate devices Acticoat® Calcium Alginate Dressing and Absorbent Antimicrobial Wound Dressing). Additionally, "The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to four (4) days, based on in vitro laboratory testing. Odour reduction results from the antibacterial effect in the dressing." |
| Protection from Microorganism Penetration | "The dressing is an effective barrier to penetration by microorganisms." |
| Maintenance of Moist Environment for Healing | "As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing." |
| Intact Removal | "allows intact removal." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for any of the in vitro tests. The data provenance is stated as "in vitro laboratory testing" conducted by Advanced Medical Solutions Ltd. (England). This indicates the data is from an in vitro (laboratory) setting and not from human clinical trials. It is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence of a wound dressing is based on established performance characteristics and standardized in vitro testing methods (e.g., ISO standards, antimicrobial efficacy tests). It does not involve expert consensus on the device's performance in a clinical scenario, as would be the case for a diagnostic AI device.
4. Adjudication Method for the Test Set
This is not applicable. The "adjudication method" refers to how discrepancies in expert opinions are resolved, typically in a clinical study context. Since the testing described is in vitro and based on measurable performance characteristics, there is no expert adjudication process in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Silver Alginate II Dressing is a therapeutic wound dressing, and its performance is evaluated through in vitro tests and comparison to predicate devices, not by human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the Silver Alginate II Dressing is a physical medical device (wound dressing), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" doesn't apply.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by:
- Established performance characteristics of predicate devices: The new device's performance (absorbency, silver release, antimicrobial activity) is compared to that of the already legally marketed predicate devices.
- Standardized in vitro testing methodologies: Biocompatibility is assessed against BS EN ISO 10993-1 requirements. Antimicrobial activity and other key performance characteristics would have been evaluated using recognized laboratory methods.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this 510(k) submission for a wound dressing. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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AUG - 5 2004
1/2
SECTION 5
510(k) SUMMARY
This 510(k) is to provide notification of substantial equivalence for Advanced Medical Solutions Ltd's Silver Alginate II Dressing, which is substantially equivalent to currently marketed devices intended for wound care.
- Advanced Medical Solutions Ltd., Submitted by: Road Three, Winsford Industrial Estate, Winsford, Cheshire, CW7 3PD, England Mr. John Greenham Contact: Requlatory Affairs Manager 44 (0)1606 545569 Telephone: 44 (0)1606 863600 Fax: john.greenham@admedsol.com e-mail: 19th July 2004 Date prepared: There is currently no classification for wound and burn Classification: dressings Not vet defined [Antimicrobial Alginate Dressing] Trade name: Silver Alginate II Dressing Common name: Acticoat® Calcium Alginate Dressing K002896 Predicate devices: Absorbent Antimicrobial Wound Dressing K013814 Indications for use: Advanced Medical Solutions Ltd's Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites
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K04 1316
| Product Description: | The dressing is a sterile, non-woven pad composed of a highG (guluronic acid) calcium alginate, carboxymethylcellulose(CMC) and ionic silver, which absorbs wound exudate andreleases silver ions in the presence of wound fluid. Aswound exudate is absorbed, the alginate forms a gel, whichassists in maintaining a moist environment for optimal woundhealing, and allows intact removal.The silver ions protect the dressing from a broad spectrum ofmicroorganisms over a period of up to four (4) days, basedon in vitro laboratory testing. Odour reduction results fromthe antibacterial effect in the dressing.The dressing is an effective barrier to penetration bymicroorganisms.The dressing has a off-white appearance, and is available invarious sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm,10cm x 20cm flat dressings; 2.7cm x 30cm, and 3cm x 44cmflat rope dressings; and 30cm x 2g rope dressings). The flatdressings are packaged in pouches, and the flat rope andrope dressings are packaged in a blister pack. |
|---|---|
| Testing: | The biocompatibility of Advanced Medical Solutions Ltd'sSilver Alginate II Dressing has been demonstrated inaccordance with BS EN ISO 10993-1 requirements.Additional in vitro testing has demonstrated that the keyperformance characteristics of the dressing are substantiallyequivalent 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 the Acticoat® Calcium Alginate Dressing and the Absorbent Antimicrobial Wound Dressing predicate devices. Comparable absorbency, silver release profile and antimicrobial activity have been demonstrated.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes on its back, representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 2004
Mr. John Greenham Regulatory Affairs Manager Advanced Medical Solutions, Ltd. Road Three, Winsford Industrial Estate, Winsford, Cheshire, CW7 3PD U.K.
Re: K041316
Trade/Device Name: Silver Alginate II Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 11, 2004 Received: May 17, 2004
Dear Mr. Greenham:
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 for associated in the 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.
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Page 2 - Mr. John Greenham
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041316
Device Name: Silver Alginate II Dressing
Indications For Use:
The 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
- . Leq Ulcers
- Pressure Ulcers .
- Diabetic Ulcers .
- Graft and donor sites .
Silver Alginate II Dressing is indicated for external use only
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 861 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_K0413/2/2/3/2/2
N/A