(326 days)
Wound cover dressing for the following wounds: Acute Wounds such as: Surgical wounds, Lacerations, Donor site wounds, First and second degree burns, Skin tears, Abrasions. Chronic Wounds such as: Pressure sores, Diabetic ulcers, Venous stasis ulcers, Arterial stasis ulcers.
AcryDerm Silver Antimicrobial Barrier Wound Dressing is a moist sheet wound dressing that contains silver halide that may help to reduce growth of microbial contaminants of the dressing. The base matrix is composed of a hydrophilic polyacrylate absorbent sheet containing silver halide and stabilizers. AcryDerm Silver Antimicrobial Barrier Wound Dressing will be supplied as sterile sheets of 2x2"; 4x4"; 4x8"; of 8x8" sizes, packaged in single use heat sealed medical grade foil pouches.
The provided text describes a 510(k) summary for the AcryDerm Silver Antimicrobial Barrier Wound Dressing, focusing on its substantial equivalence to predicate devices and its intended use. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically performed for AI/ML devices.
The document is a regulatory submission for a medical device (wound dressing) that was prepared in 1999/2000. It is primarily concerned with demonstrating that the new device is "substantially equivalent" to existing legally marketed devices, rather than establishing performance against specific acceptance criteria through clinical trials.
Therefore, I cannot populate the table or answer most of your specific questions related to acceptance criteria, AI performance studies, sample sizes, expert ground truth, or MRMC studies, because this information is not present in the provided text.
Here's a breakdown of what can be extracted and why other questions cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
| The document focuses on "substantial similarity" to predicate devices, particularly in composition and manufacturing, and states that the silver may "control microbial contamination of the dressing similar to the silver in [predicate devices]". However, no specific performance metrics or acceptance criteria (e.g., a certain percentage reduction in bacteria, specific healing rates) are provided. |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. The document describes a physical wound dressing and its composition, an AI/ML device would require a "test set" of data (e.g., images, patient records). This device does not generate or analyze data in that manner. No test set for performance evaluation is mentioned.
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)
- Not Applicable. This is not an AI/ML device. Ground truth, in the context of an AI/ML device, would refer to expert-labeled data used to evaluate algorithm performance. The device is a wound dressing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- Not Applicable. See point 3.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 3.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. See point 3. The relevant "ground truth" for a wound dressing would typically involve clinical healing outcomes, but no such study is detailed in this 510(k) summary for performance evaluation.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (wound dressing) aiming for substantial equivalence to existing products. It does not involve AI/ML technology, and therefore, the concepts of acceptance criteria for AI performance, test sets, training sets, ground truth establishment by experts, or MRMC studies are not applicable to the information contained within these pages.
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510(k) Summary
| Contact Person: | Dr. Bruce L. Gibbins, Chairman & CTO |
|---|---|
| Date of preparation: | May 20, 1999 |
| Device Name (proprietary): | AcryDerm Silver Antimicrobial Barrier Wound Dressing |
| Common Name: | Moist wound dressing |
| Classification Name: | Hydrophilic wound dressing |
| Classification: | Unclassified |
Legally marketed device(s) for substantial equivalence comparison:
AcryDerm Advanced Wound Dressing, (AcryMed, Inc.) Arglaes Controlled Release Film Dressing (Maersk Medical Limited, UK)
Acticoat Silver Coated Dressing. (Westaim Biomedical Inc., NH)
Description of Device: AcryDerm Silver Antimicrobial Barrier Wound Dressing is a moist sheet wound dressing that contains silver halide that may help to reduce growth of microbial contaminants of the dressing. The base matrix is composed of a hydrophilic polyacrylate absorbent sheet containing silver halide and stabilizers. AcryDerm Silver Antimicrobial Barrier Wound Dressing will be supplied as sterile sheets of 2x2"; 4x4"; 4x8"; of 8x8" sizes, packaged in single use heat sealed medical grade foil pouches. The single use primaries will be packed, with a product insert, as 10 primaries per intermediate dispenser chipboard carton, and 5 intermediate cartons per case. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).
Intended Use of the Device: AcryDerm Silver Antimicrobial Barrier Wound Dressing is intended for use on partial and full thickness external wounds such as pressure sores, arterial ulcers, diabetic ulcers, and venous stasis ulcers and on acute wounds such as draining surgical wounds, lacerations, donor site, and exudating first and second degree burns, and abrasions. It is not intended for the treatment of third degree burns.
Technological Characteristics: AcryDerm Silver Antimicrobial Barrier Wound Dressing is a sterile, single use unsupported synthetic absorbent polyacrylate hydrogel containing silver halide and stabilizers. The product carries the general classification name, "Hydrophilic wound dressing", as would apply to AcryDerm Advanced Wound Dressing (AcryMed, Inc.). The composition of AcryDerm Silver Antimicrobial Barrier Wound Dressing is substantially similar to the predicate device, AcryDerm Advanced Wound Dressing. The method of manufacturing of the product is similar, with the exception for the addition of the silver halide, to that used for the production of the predicate device, AcryDerm Advanced Wound Dressing. AcryDerm Silver Antimicrobial Barrier Wound Dressing contains silver that may control microbial contamination of the dressing similar to the silver in Arglaes Controlled Release Film Dressing (Maersk Ltd.) and Acticoat Silver Coated Dressing (Westaim Biomedical).
Manufacturing: AcryDerm Silver Antimicrobial Barrier Wound Dressing will be manufactured according to the product specifications and under good manufacturing practices that ensure the device is safe and effective for its intended use.
Page No. 2
Bruce Rollins 3-20-00
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape at the bottom. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Bruce Gibbins, Ph.D. Chief Technology Officer AcryMed, Inc. 12232 SW Garden Place Portland, Oregon 97223
Re: K991818
Trade/Device Name: AcryDerm Silver Antimicrobial Barrier Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 20, 2000 Received: March 21, 2000
Dear Dr. Gibbins:
This letter corrects our substantially equivalent letter of April 17, 2000.
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 - Bruce Gibbins, Ph.D.
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 vours,
Milla N. Millican
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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510(k) Number (if known):
Device Name: AcryDerm Silver Antimicrobial Dressing_
Indications For Use:
Wound cover dressing for the following wounds:
Acute Wounds such as:
- Surgical wounds .
- Lacerations ●
- Donor site wounds ●
- First and second degree burns ●
- Skin tears ●
- Abrasions ●
Chronic Wounds such as:
- . Pressure sores
- Diabetic ulcers ●
- Venous stasis ulcers .
- Arterial stasis ulcers .
Contra-indications
- . Not indicated for the treatment of third degree burns
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
inver R. lochner.
(Division Sign f
Division of Ge
Restorative Devices
510(k) Numbe K991818
Prescription Use
(Per 21 CFR 801.109)
OR
i
Over-The-Counter Use
(Optional Format 1-2-96)
26
N/A