(188 days)
Advanced Medical Solutions Ltd's Antimicrobial Alginate. Dressing is an effective barrier to bacterial penetration, The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.
Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is a sterile, non-woven pad composed of a high G (quluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres. The sustained release of silver creates a favourable environment by protecting the dressing from bacterial contamination. The dressing absorbs exudate, maintains a moist wound healing environment and allows intact removal. The dressing has a light grey appearance, and is available in various sizes (5cm x 5cm, 11cm x 11cm, 10cm x 20cm flat dressings and 2.5cm x 30.5cm rope). The flat dressings are packaged in pouches, and the rope is packaged in a blister pack.
This document describes the 510(k) summary for Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance metrics (accuracy, sensitivity, specificity, AUC), or details of a study with sample sizes, ground truth establishment, or expert qualifications for performance evaluation.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K002896 Acticoat Calcium Alginate Dressing) based on similarities in:
- Materials (calcium alginate and silver)
- Intended use and indications for use
- Product description and functional characteristics (absorbent, sterile, sustained silver release, antimicrobial effect, barrier to bacterial penetration, maintains moist wound environment, intact removal, similar dressing change frequency)
- Biocompatibility (demonstrated in accordance with BSENISO 10993-1)
- Sterilization method (gamma irradiation)
- Contraindications
- Product sizes and variants
The document states: "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." However, it does not provide specific performance metrics or detailed results from this in vitro testing, nor does it detail a clinical study with the requested elements.
Therefore, I cannot populate the table or answer most of the questions as the provided text does not contain that specific information.
Summary of available information regarding performance and studies:
-
A table of acceptance criteria and the reported device performance:
Not provided in the document. The document focuses on demonstrating substantial equivalence rather than reporting specific performance metrics against set acceptance criteria for metrics like accuracy, sensitivity, specificity, or AUC. -
Sample size used for the test set and the data provenance:
Not provided. The document mentions "Additional in vitro testing" but does not detail sample sizes or data provenance. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no human-in-the-loop study with a test set requiring expert ground truth is described. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. -
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:
Not applicable. This device is an antimicrobial dressing, not an AI-assisted diagnostic tool. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document mentions "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." This suggests some form of standalone testing was performed to compare its characteristics to the predicate, but no specific performance metrics like those for an algorithm are detailed. The device is a physical dressing, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly stated for the "in vitro testing." Given the nature of an antimicrobial dressing, ground truth would likely relate to microbiological growth inhibition, fluid absorption, or silver release rates, rather than expert consensus on images or pathology. -
The sample size for the training set:
Not applicable, as this is not an AI/ML device with a training set in the conventional sense. -
How the ground truth for the training set was established:
Not applicable.
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SECTION 11.
510(k) SUMMARY.
JUN 3 0 2003
General information.
This 510(k) is to provide notification of substantial equivalence for Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing, which is substantially equivalent to a currently marketed device intended for wound care.
| Submitted by: | Advanced Medical Solutions Ltd.,Road Three,Winsford Industrial Estate,Winsford,Cheshire,CW7 3PD,England |
|---|---|
| Contact: | Mr. John GreenQuality Assurance and Regulatory Affairs Manager |
| Telephone: | 44 (0)1606 545612 |
| Fax: | 44 (0)1606 863600 |
| e-mail: | john.green@admedsol.com |
| Date prepared: | 12th December 2002 |
| Classification:dressings | There is currently no classification for wound and burn |
| Trade name: | Antimicrobial Alginate Dressing |
| Common name: | Alginate Dressing |
| Predicate device: | K002896 Acticoat Calcium Alginate Dressing |
| Indications for use: | Advanced Medical Solutions Ltd's Antimicrobial AlginateDressing is an effective barrier to bacterial penetration. Thebarrier functions of the dressing may help reduce infection inmoderate to heavily exuding partial and full-thicknesswounds including: pressure ulcers, venous ulcers, diabetic |
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000077
Product description: Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is a sterile, non-woven pad composed of a high G (quluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres. The sustained release of silver creates a favourable environment by protecting the dressing from bacterial contamination. The dressing absorbs exudate, maintains a moist wound healing environment and allows intact removal.
The dressing has a light grey appearance, and is available in various sizes (5cm x 5cm, 11cm x 11cm, 10cm x 20cm flat dressings and 2.5cm x 30.5cm rope). The flat dressings are packaged in pouches, and the rope is packaged in a blister pack.
Testing: The biocompatibility of Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing has been demonstrated in accordance with BSENISO 10993-1. Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device.
Statement of substantial equivalence:
The materials from which the devices are manufactured are similar, and both devices are produced from calcium alginate and incorporate silver.
The Antimicrobial Alginate Dressing and the predicate device have the same intended use, and have almost identical indications for use, (e.g. pressure ulcers, venous ulcers, diabetic ulcers, traumatic and surgical wounds).
The Antimicrobial Alginate Dressing and the predicate device consist of absorbent materials, are provided sterile to the user, and both devices provide a sustained release of broad spectrum ionic silver, when activated by moisture, to provide an antimicrobial effect to protect the dressing from bacterial contamination for up to 3 days. Both devices provide an effective barrier to bacterial penetration. The barrier functions of both dressings may help reduce infection in moderate to heavily exuding partial and full-thickness wounds.
Both devices are biocompatible, exhibit absorbent properties. maintain a moist environment for optimal wound healing,
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permit intact removal and have the same recommended frequency of dressing changes.
Both devices have a similar range of product sizes, are available in flat dressing and rope variants, are sterilised by gamma irradiation, and have similar contraindications.
Although there are some minor differences between the devices these differences are minor and raise no new questions of safety and effectiveness.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized symbol of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2003
Mr. John Green Quality Assurance and Regulatory Affairs Manager Advanced Medical Solutions Ltd. Road Three Winsford Industrial Estate Winsford, Cheshire CW7 3PD, England
Re: K024298
Trade/Device Name: Antimicrobial Alginate Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 9, 2003 Received: April 14, 2003
Dear Mr. Green:
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.
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Page 2 - Mr. John Green
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Miriam 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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Page 1 of 1
510(k) NUMBER (IF KNOWN): K024298 Antimicrobial Alginate Dressing DEVICE NAME:
INDICATIONS FOR USE:
Advanced Medical Solutions Ltd's Antimicrobial Alginate. Dressing is an effective barrier to bacterial penetration, The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per. 21 CFR 801.109) OR
Over - The - Counter - Use (Optional Format 1-2-96
Miriam C. Provost
eral, Restorative Division of Gen and Neurological Devices
510(k) Number K024298
N/A