(157 days)
To secure devices such as indwelling catheters, drains, monitoring leads and airway management apparatus to patients skin. For use as a cover dressing or in direct contact of wounds such as pressure ulcers, stasis ulcers, sites, davice incention its cond degree burns, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donors sites.
The new product is sterile single use silver antimicrobial adherent transparent film. Sterility assurance will conform to AAMI/ANSI/ISO 11137-1994.
The provided text is a 510(k) summary for the AcryDerm Silver Antimicrobial Thin Film. It describes the device, its intended use, and pre-clinical testing for antimicrobial effectiveness and biocompatibility. However, it does not contain information about specific acceptance criteria or performance studies as typically understood for AI/ML-driven medical devices.
Instead, the document details a regulatory submission process to demonstrate "substantial equivalence" to legally marketed predicate devices, which is a different type of assessment than proving a device meets specific performance criteria through clinical or analytical studies with defined metrics.
Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or detailed device performance metrics in the way one would for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC, recall). The primary performance criteria mentioned relate to antimicrobial effectiveness and biocompatibility, which are qualitative or based on standard test methods rather than statistical thresholds from a clinical study.
| Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Antimicrobial Efficacy | Zone of Inhibition Studies against clinical isolates | Effective against: - Coagulase negative Staphylococcus sp. - E. coli - Pseudomonas aeruginosa - Staphylococcus aureus (MRSA) - Candida albicans - Enterococcus sp. - Klebsiella pneumoniae (3 strains) - Candida parapsilosis - Candida galbrata - Bacillus subtilis - Enterobacter cloacae (2 strains) - Enterococcus faecalis (2 strains) - Aspergillus niger - Serratia marcescens - Citrobacter diversus - Citrobacter kasseri - Staphylococcus saprophyticus |
| Antimicrobial Duration | In vitro serial transfer testing | Active for in excess of 7 days |
| Safety & Biocompatibility | ISO 10993 (Biological Evaluation of Medical Devices) Part-1 | Established in accordance with the standard |
| Sterility | Sterility Assurance | Will conform to AAMI/ANSI/ISO 11137-1994 |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The document refers to "pre-clinical testing" which typically involves laboratory-based studies (e.g., microbiology cultures, biocompatibility assays) rather than human subject test sets for performance evaluation.
- Data Provenance: The pre-clinical testing describes in vitro studies ("zone of inhibition studies against clinical isolates," "in vitro serial transfer testing"). This data would be generated in a laboratory setting rather than being retrospective or prospective patient data from a specific country.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. Ground truth, in this context, would be determined by laboratory assays (e.g., presence/absence of microbial growth, measurement of zone of inhibition) rather than expert consensus on complex medical images or clinical outcomes.
- Qualifications of Experts: N/A. The "experts" would be laboratory technicians or scientists performing standard microbiological and biocompatibility tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., radiology reads) to establish consensus ground truth when individual expert opinions might differ. This document describes laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done, as this is a device for antimicrobial properties and wound dressing, not an AI-assisted diagnostic or decision support system intended to improve human reader performance.
6. Standalone Performance Study
- Standalone Performance Study: The "Pre-Clinical Testing" section describes a form of standalone performance evaluation for the device's antimicrobial properties. This involves direct testing of the film against various microorganisms and for its duration of activity. However, it's not a "standalone algorithm performance" study as would be conducted for AI/ML.
7. Type of Ground Truth Used
- Type of Ground Truth: For antimicrobial efficacy, the ground truth is based on microbiological assays (e.g., inhibition of microbial growth, measured zone of inhibition). For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993 Part-1 standards. For sterility, compliance with AAMI/ANSI/ISO 11137-1994 ensures sterility.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML model that requires a training set. The "training" in manufacturing refers to quality systems and production processes, not data for machine learning.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned for an AI/ML model.
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510(k) Summary
OCT - 6 2006
| Sponsor: | AcryMed, Inc.9560 SW Nimbus AvenueBeaverton, OR 97008 |
|---|---|
| Contact Person: | Dr. Bruce L. Gibbins; (503)-624-9830 |
| Device Name | AcryDerm Silver Antimicrobial Thin Film |
| Common Name: | Tape and Bandage, Adhesive |
| Classification Product Code: | MGP |
| Classification Advisory Panel: | General and Plastic Surgery |
Legally marketed device(s) for substantial equivalence comparison:
SilvaSorb Silver Antimicrobial Wound Dressing (AcryMed, Inc., OR) Opsite Dressing (Smith & Nephew, FL) Arglaes Antimicrobial Wound Dressing (Maersk Medical, MO)
Description of Device: The new product is sterile single use silver antimicrobial adherent transparent film. Sterility assurance will conform to AAMI/ANSI/ISO 11137-1994.
Intended Use of the Device: AcryDerm Silver Antimicrobial Thin Film is indicated for use on intact and breached skin. This device is intended for use in for securing devices to the skin and as a primary and secondary wound dressing. This product aids in securing devices such as indwelling catheters, drains, monitoring leads and airway management apparatus to patients skin. It is also intended as a cover dressing or in direct contact of wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
Technological Characteristics: The AcryDerm Silver Antimicrobial Thin Film is a polyurethane adhesive film that contains ionic silver. The combination functions as an antimicrobial barrier when used as intended.
Pre-Clinical Testing: The AcryDerm Silver Antimicrobial Thin Film has been tested and shown to be effective by zone of inhibition studies against clinical isolates of coagulase negative Staphylococcus sp., E. coli, Pseudomonas aeruginosa, Staphylococcus aureus (MRSA), Candida albicans, and Enterococcus sp. The product has also been shown to be antimicrobial against Klebsiella pneumoniae (3 strains), Candida parapsilosis, Candida galbrata , Bacillus subtilis, Enterobacter cloacae (2 strains), Enterococcus faecalis (2 strains), Aspergillus niger, Serratia marcescens, Citrobacter diversus, Citrobacter kasseri, and Staphylococcus saprophyticus. Silver antimicrobial wound gauze has been shown by in vitro serial transfer testing to be active for in excess of 7 days. Safety and biocompatibility assurance has been established in accordance with Part-1 of the ISO standard (Biological Evaluation of Medical Devices).
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Manufacturing: AcryDerm Silver Antimicrobial Wound Gauze will be manufactured according is Manufacturing: AcryDenn Silver Andmercolar + other = practices that ensure the device is safe and effective for its intended use.
Performance Standards: No performance standards are prescribed for the new product.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with a human figure superimposed on it. The caduceus is depicted with a staff entwined by two snakes, and the human figure is shown in a dynamic pose, suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AcryMed % Bruce Gibbins, Ph.D Chief Technical Officer 9560 SW Nimbus Avenue Beaverton, Oregon 97008
OCT - 6 2006
Re: K061232
Trade/Device Name: AcryDerm Silver Antimicrobial Adhesive Thin Film Regulatory Class: Unclassified Product Code: FRO Dated: August 24, 2006 Received: September 1, 2006
Dear Dr. Gibbins:
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.
Barbara Baemm
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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Page 5 of 12
Indications for Use
510(k) Number (if known):
Device Name:
AcryDerm Silver Antimicrobial Adhesive Thin Film
Indications For Use: To secure devices such as indwelling catheters, drains, monitoring leads and airway management apparatus to patients skin.
For use as a cover dressing or in direct contact of wounds such as pressure ulcers, stasis ulcers, sites, davice incention its cond degree burns, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donors sites.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
ED) NEEDED)
Concurrence of CDRHgOffice of Dev ice Evaluation (ODE)
Barbara Machin
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061232
AcryDerm Silver Pre-market Notification 510(k)
N/A