(126 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. Examples of wounds types which indicated are:
- 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 ethyl sulphonate with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The device provides effective 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.
The provided text describes a 510(k) summary for the DURAFIBER Ag dressing, focusing on its substantial equivalence to predicate devices rather than a direct study proving device performance against acceptance criteria. The document highlights biocompatibility testing and an animal model study, but does not present specific acceptance criteria in a quantifiable manner or a study that directly verifies those criteria with reported performance metrics.
Therefore, the following information is extracted or inferred based on the provided text. Many requested fields cannot be directly answered as the nature of this submission (substantial equivalence for a medical dressing) differs significantly from a device that would require clinical performance metrics like sensitivity, specificity, or AI assistance effect sizes.
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a wound dressing, the "acceptance criteria" are primarily related to safety, biocompatibility, and substantial equivalence to legally marketed predicate devices. The document does not specify quantitative performance metrics (like sensitivity, specificity, or error rates) that would typically be found for diagnostic or AI-driven devices.
Table of Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence Basis):
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Based on K103793) |
|---|---|
| Similar Design: Material composition, structure. | "similar design, materials and manufacturing methods" to Aquacel Ag (K080383). Made of cellulose, cellulose ethyl sulphonate with silver. |
| Similar Physical Characteristics: Absorbency, gelling properties. | "similar physical and antimicrobial characteristics" to Aquacel Ag (K080383). "absorbent fibrous dressing that gels on contact with wound fluid." |
| Similar Antimicrobial Characteristics: Silver content, mechanism of action. | "effective antimicrobial properties intended to reduce or inhibit microbial colonization of the device." Silver content similar to ACTICOAT Flex 7 (K083113) and produces silver ions upon contact with wound fluid. |
| Similar Functions: Moist wound environment, microbial reduction. | "provides similar functions to Aquacel Ag (K080383)." Provides a moist wound environment and "effective antimicrobial properties." |
| Similar Intended Use: Management of partial/full thickness wounds, burns, various wound types. | "Intended use, indications and instructions for use for the subject and predicate devices are similar." (Listed wound types in Section 9). |
| Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, safe. | "DURAFIBER Ag dressings are safe for their intended use" based on ISO 10993-1:2003 (cytotoxicity, sensitization, irritation, subchronic toxicity, genotoxicity). |
| No Deleterious Clinical Effects on Wound Healing (Animal Model): | "device had no deleterious clinical effects compared with standard treatment" in an animal model. |
| No New Issues of Safety and Effectiveness: | "The subject device does not raise any new issues of safety and effectiveness." |
Study Details
The provided text describes the basis for substantial equivalence for a wound dressing, and the "studies" mentioned are primarily pre-clinical in nature for biocompatibility and an animal model. It does not describe a clinical study in humans designed to meet specific performance criteria often seen in device clearance involving diagnosis or intricate analytical tasks.
1. Sample size used for the test set and the data provenance:
- Biocompatibility Tests: The text states these were conducted "using product that has been packaged and sterilised." It does not specify a "sample size" in terms of number of samples, but rather mentions the types of tests (cytotoxicity, sensitization, irritation, subchronic toxicity, genotoxicity). The provenance of these tests is not explicitly stated (e.g., country of origin, specific lab data).
- Animal Model Study: "an animal model" was used. The specific number of animals (sample size) is not provided. The provenance (e.g., specific animal species, location of study) is also undefined.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided as the studies described are pre-clinical (biocompatibility, animal model) and do not involve human interpretation or expert ground truth establishment in the diagnostic sense.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided for the types of studies performed (biocompatibility, animal model).
4. 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:
- No, an MRMC study was not done. This device is a medical dressing, not an AI-assisted diagnostic or interpretation device that would involve "human readers" or "AI assistance."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a physical wound dressing and does not involve an algorithm or AI.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Biocompatibility: Ground truth is established by standardized, validated assays and material science principles as per ISO 10993-1:2003, with results indicating "safe for their intended use."
- Animal Model: Ground truth was based on physiological observations and comparisons of "deleterious clinical effects" against "standard treatment." This would likely involve clinical assessment of wound healing parameters in animals.
7. The sample size for the training set:
- This information is not applicable/provided. The submission describes a medical device, not an AI/ML product requiring a training set.
8. How the ground truth for the training set was established:
- This information is not applicable/provided as there is no training set for this type of device.
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K 103793 sage 1 Of
MAY - 2 2011
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Trade (Proprietary) Name
DURAFIBER Ag
2. Common/Classification Name
Common Name: Silver Absorbent, Gelling Dressing
Classification Name: Dressing
Classification Code: FRO
3. Applicant's Name & Address
Smith & Nephew, Inc. 970 Lake Carillon Drive St. Petersburg, Florida 33716 Phone: 727-392-1261 Fax: 727-399-3468
4. Contact Information
Terry McMahon Director, Regulatory Affairs and Quality, North America Phone: 727-399-3785 Email: terry.mcmahon@smith-nephew.com
Section 5 - 510(k) Summary of Safety and Effectiveness Page 1 of 4
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5. Device Classification and Panel
A final classification for "dressing" has not been implemented by the General and Plastic Surgery Devices Panel. At this time, however, classification code FRO is unclassified.
6. Predicate Device
Aquacel Ag (K080383)
The DURAFIBER Ag dressing that is the subject of this submission is substantially equivalent to other legally marketed burn and wound dressings. The DURAFIBER Ag dressing is substantial equivalent to Convatec, Aquacel Ag Wound Dressing (K080383). The subject device has all features and benefits associated with, a fibrous gelling dressing and the added benefit of an antimicrobial dressing.
7. Other Relevant Predicate Device
ACTICOAT Flex 7 (K083113)
The specified silver content of ACTICOAT Flex 7 (K083113) is similar to and slightly higher of that of the subject device DURAFIBER Ag and is used on similar wound types. The device is therefore substantially equivalent in terms of silver content.
8. Performance Standards
No applicable performance standards have been established under Section 514 of the FD&C Act. Biocompatibility tests were done in conformance with relevant requirements of AAMI/ISO-10993. Additional standards applicable to the device include the following: ISO 13485, AAMI/ISO 11137-1, and AAMI/ISO 11137-2.
Section 5 - 510(k) Summary of Safety and Effectiveness Page 2 of 4
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9. Intended 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. Examples of wounds types which indicated are:
- 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.
10. Device Description
DURAFIBER Ag is a non woven dressing made of cellulose and cellulose ethyl sulphonate with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The device provides effective 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.
Section 5 - 510(k) Summary of Safety and Effectiveness Page 3 of 4
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K 103793
Page 4 of 4
11. Biocompatability
The biocompatibility of DURAFIBER Ag dressing has been demonstrated through assessment according to ISO 10993-1: 2003 and appropriate in vivo and in vitro tests have been conducted using product that has been packaged and sterilised. These include cytotoxicity, sensitization, irritation, subchronic toxicity, and genotoxicity. These studies indicated that DURAFIBER Ag dressings are safe for their intended use.
Additionally, the effects of the device on wound healing have been evaluated in an animal model, and it was demonstrated that the device had no deleterious clinical effects compared with standard treatment.
12. Summary of Substantial Equivalence
The subject device is substantially equivalent to the predicate device Aquacel Ag (K080383). The subject device has similar physical and antimicrobial characteristics and provides similar functions to Aquacel Ag (K080383). The subject device and the predicate device Aquacel Ag (K080383) have similar design, materials and manufacturing methods. The intended use, indications and instructions for use for the subject and predicate devices are similar.
The safety of the antimicrobial agent, ionic silver, has been established by comparing the subject device to the predicate device ACTICOAT Flex 7 (K083113).
The subject device does not raise any new issues of safety and effectiveness.
Section 5 - 510(k) Summary of Safety and Effectiveness Page 4 of 4
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the border of the circle.
ﮧ ﮨ
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Terry McMahon Director of Regulatory Affairs 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716
MAY - 2 2011
Re: K103793
Trade/Device Name: DURAFIBER Ag Regulatory Class: Unclassified Product Code: FRO Dated: March 17, 2011 Received: March 22, 2011
Dear Terry McMahon:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Terry McMahon
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 100-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please the Caste of more . Ca.gov/AboutFDA/Centers: CDRH/CDRHOffices/ucm1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Alig B. Rata
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): To be assigned by FDA K I 0 3 7 9 3
Device Name: DURAFIBER Ag
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 wounds of partial and full thickness wounds including first and second degree burns. Examples of wound types which indicated are:
- 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.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division/Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103793
N/A