(86 days)
DURAFIBER Ag is an effective antimicrobial dressing that is intended to provide a moist wound environment for use in the management of partial and full thickness wounds including first and second degree burns. Appropriate wounds types include:
- Chronic wounds including diabetic ulcers, leg ulcers, pressure ulcers and sores (partial & full thickness);
- surgical wounds left to heal by secondary intent;
- traumatic wounds:
- wounds that are prone to minor bleeding, such as wounds that have been mechanically or surgically debrided.
DURAFIBER Ag is a non-woven dressing made of cellulose and cellulose ethylsulphonate with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The silver provides the antimicrobial properties intended to reduce or inhibit microbial colonization of the device.
The silver is present in the device in the form of silver chloride. Upon contact with wound fluid, silver ions are produced from the dissociation of silver and chloride atoms. The ionic form of silver is the active antimicrobial agent.
This is a 510(k) premarket notification for the medical device DURAFIBER Ag, an antimicrobial wound dressing. The document describes the device, its intended use, and a comparison to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting study information:
Description of Acceptance Criteria and Supporting Study
The provided document, a 510(k) summary, does not detail specific acceptance criteria for a new AI/software device or a formal clinical study proving its performance against such criteria. Instead, this document is focused on establishing substantial equivalence for a modified physical medical device (a wound dressing) to a previously cleared predicate device.
The "acceptance criteria" here are implicitly related to demonstrating that changes to the device (specifically, reduced silver content) do not negatively impact its safety and effectiveness compared to the predicate. The "study" in this context refers to non-clinical bench testing rather than a clinical trial with a test set, ground truth, or human readers as you would expect for an AI/software device.
Therefore, many of your specific questions are not directly applicable to this type of regulatory submission and device.
However, I will extract the information that is present and indicate where information is not applicable or not provided.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a submission for a modified physical wound dressing and not an AI/software device, formal acceptance criteria in terms of metrics like sensitivity, specificity, or AUC are not specified. The "performance" is demonstrated through non-clinical bench testing to ensure the modified device remains equivalent to its predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Physical Properties remain unchanged despite reduced silver content (compared to predicate). | "Results showed that the reduced silver content of the dressing did not alter the physical properties of the dressing." |
| Silver Release (although different, the change is characterized) | "Results showed that the subject device released a lower amount of silver over a seven day test period compared to the predicate device." (This is a description of the change, not necessarily an "acceptance criterion" in the sense of a target value, but rather a characterization supporting equivalence). |
| Antimicrobial Properties remain unchanged despite reduced silver content (compared to predicate). | "Results showed that the reduced silver content of the subject device did not alter the antimicrobial properties of the dressing." |
| Biocompatibility for intended use. | "DURAFIBER Ag has been evaluated in accordance with ISO 10993-1 and is considered safe for its intended use." |
| Safety and Effectiveness not raising new issues (compared to predicate). | "The subject device does not raise any new issues of safety and effectiveness." (This is the overarching conclusion drawn from the physical, silver release, and microbiology testing, along with the identical design, materials, manufacturing, and indications for use as the predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The "tests" were non-clinical bench tests (physical properties, silver release, microbiology, biocompatibility) of the device itself and not based on patient data or a "test set" in the context of an AI/software algorithm.
- Data Provenance: Not applicable. The data is from laboratory bench testing rather than clinical data.
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. There was no "ground truth" derived from expert consensus for a test set, as this involved laboratory testing of a physical product, not an AI/software diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for the non-clinical tests was determined by established laboratory measurement methods and standards relevant to the physical and antimicrobial properties of wound dressings (e.g., standard tests for material properties, silver elution, and bacterial inhibition).
8. The sample size for the training set
Not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study (Bench Testing) for DURAFIBER Ag Modification
The "study" presented here consists of non-clinical, bench-top testing to demonstrate that a modified version of the DURAFIBER Ag wound dressing (with reduced silver content) is substantially equivalent to its predicate device. This was achieved by confirming:
- The physical properties of the dressing were not altered.
- The silver release profile, while different (lower amount released), was characterized.
- The antimicrobial properties were not altered despite the reduced silver content.
- The device met biocompatibility standards (ISO 10993-1).
The conclusion is that these tests collectively demonstrate that the modified device does not raise new questions of safety and effectiveness, supporting its substantial equivalence to the previously cleared predicate.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2016
Smith & Nephew Medical Limited % Ms. Amy Campbell Smith & Nephew, Inc. 3909 Hulen St Fort Worth, Texas 76107
Re: K161289
Trade/Device Name: Durafiber Ag Regulatory Class: Unclassified Product Code: FRO Dated: May 6, 2016 Received: May 9, 2016
Dear Ms. Campbell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161289
Device Name DURAFIBER Ag
DURAFIBER Ag is an effective antimicrobial dressing that is intended to provide a moist wound environment for use in the management of partial and full thickness wounds including first and second degree burns. Appropriate wounds types include:
- Chronic wounds including diabetic ulcers, leg ulcers, pressure ulcers and sores (partial & full thickness);
- surgical wounds left to heal by secondary intent;
- traumatic wounds:
- wounds that are prone to minor bleeding, such as wounds that have been mechanically or surgically debrided.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
General Information
| Submitter Name/ Address: | Smith & Nephew Medical Limited101 Hessle Road,Hull,HU3 2BNUnited Kingdom |
|---|---|
| Establishment registration Number: | 8043484 |
| Contact Person: | Samantha Neilson, Regulatory Affairs Manager |
| Phone Number: | +44 1482 673790 |
| Date Prepared: | August 2, 2016 |
| Application Correspondent: | Smith & Nephew Inc.3909 Hulen Street,Fort Worth,Texas, 76107,USA |
| Contact Person: | Amy Campbell, Senior Manager Regulatory Affairs |
| Phone Number: | 1-817-302-3901 |
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Device Description
| Trade Name: | DURAFIBER™ Ag |
|---|---|
| Common or Usual Name: | Silver Absorbent, Gelling Dressing |
| Device Classification: | Dressing, Wound, Drug |
| Product Code: | FRO |
Predicate Device Information
| 510(k)# | Device | Clearance Date |
|---|---|---|
| K103793 | DURAFIBER Ag | May 02, 2011 |
Device Description
DURAFIBER Ag is a non-woven dressing made of cellulose and cellulose ethylsulphonate with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The silver provides the antimicrobial properties intended to reduce or inhibit microbial colonization of the device.
The silver is present in the device in the form of silver chloride. Upon contact with wound fluid, silver ions are produced from the dissociation of silver and chloride atoms. The ionic form of silver is the active antimicrobial agent.
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Indications for Use
DURAFIBER Ag is an effective antimicrobial dressing that is intended to provide a moist wound environment for use in the management of partial and full thickness wounds including first and second degree burns. Appropriate wound types include:
- . Chronic wounds including diabetic ulcers, leg ulcers, pressure ulcers and sores (partial & full thickness);
- surgical wounds left to heal by secondary intent; .
- . traumatic wounds;
- wounds that are prone to minor bleeding, such as wounds that have been mechanically or surgically debrided.
Comparison between New and Predicate Devices
The Indications for Use statement for DURAFIBER Ag is identical to the predicate device.
The physical characteristics for both the subject and predicate devices are the same whilst the antimicrobial characteristics for the subject device and predicate are similar. DURAFIBER Ag comprises of a blend of cellulose ethylsulphonte fibres and silver. The primary difference presented between the subject device and the predicate device is a reduction in the amount of silver incorporated into the product. The subject device does not raise any new issues of safety and effectiveness.
The design, materials and manufacturing methods of the subject and predicate devices are the same.
Non-Clinical Tests (Bench)
The following non-clinical (bench) testing has been carried out:
- · Physical properties testing of the subject and predicate devices: Results showed that the reduced silver content of the dressing did not alter the physical properties of the dressing.
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- Silver release testing: Results showed that the subject device released a lower amount of . silver over a seven day test period compared to the predicate device.
- . Microbiology testing: Results showed that the reduced silver content of the subject device did not alter the antimicrobial properties of the dressing.
Biocompatibility Testing
DURAFIBER Ag has been evaluated in accordance with ISO 10993-1 and is considered safe for its intended use.
Conclusion
In establishing substantial equivalence to the currently marketed predicate device, Smith & Nephew Medical Limited evaluated the indications for use, materials, design, product specifications and manufacturing requirements of the device. Performance testing, biocompatibility testing assessment, and microbiology testing has been successfully completed to demonstrate that the modified DURAFIBER Ag is substantially equivalent to the predicate device for the intended use.
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