(197 days)
For over-the-counter use, Exufiber Ag+ may be used for:
- · Abrasions
- · Lacerations
- Minor cuts
- · Minor scalds and burns
Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:
- · Leg ulcers (venous stasis ulcers and ulcers and ulcers of mixed etiology) and diabetic foot ulcers
- · Pressure ulcers (partial and full thickness)
- Partial thickness burns
- · Donor sites and other wounds that are prone to bleeding, such as debrided wounds
- Traumatic wounds
- Surgical wounds that heal by primary intention, such as dermatological incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions
- · Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.
Indicated wear time: up to seven (7) days.
Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a highly absorbent and gel-forming wound dressing that is intended to be used on medium to high exuding wound fluid, creating a soft gel and maintaining a moist wound healing environment. The dressing consists of a polyvinyl alcohol (PVA) pad or ribbon, coated on both sides with silver sulfate to act as a preservative in the dressing to inhibit or reduce microbial growth.
The provided document is a 510(k) Summary for the "Exufiber Ag+ Antimicrobial Gelling Fibre Dressing" and mainly focuses on demonstrating substantial equivalence to a predicate device ("Aquacel Ag Extra Hydrofiber Dressing with Silver and Strengthening Fiber"). It does not include detailed information about specific acceptance criteria and a study proving the device meets those criteria, as one would expect for a performance study with detailed metrics.
Instead, the document states: "In vitro and in vivo methods have been used to demonstrate the safety and effectiveness of the Exufiber Ag+ Antimicrobial Gelling Fibre Dressing with regards to the following parameters: Cytotoxicity, Irritation, Sensitization, Wound healing model, Antimicrobial efficacy against 11 strains, Silver release kinetics, Minimum effective concentration." It also explicitly states: "No clinical data was required to support substantial equivalence."
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance based on the input text. The information is not present in this regulatory submission.
However, I can extract the general categories of performance data mentioned:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria (e.g., "cytotoxicity level must be below X") or detailed quantitative reported device performance for these criteria. It only lists the types of tests performed to demonstrate safety and effectiveness.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Cytotoxicity | Demonstrated safety |
| Irritation | Demonstrated safety |
| Sensitization | Demonstrated safety |
| Wound healing model | Demonstrated effectiveness |
| Antimicrobial efficacy (against 11 strains) | Demonstrated effectiveness |
| Silver release kinetics | Performed and evaluated |
| Minimum effective concentration | Performed and evaluated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies mentioned are described as "in vitro and in vivo methods," which typically refer to laboratory and animal studies, not human clinical trials in this context.
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)
This information is not provided in the document. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant for the types of in vitro and in vivo safety/effectiveness studies mentioned in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as it's not applicable to the types of studies described (laboratory and animal studies for safety and effectiveness).
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to an antimicrobial gelling fibre dressing. The document explicitly states "No clinical data was required to support substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a medical device like a wound dressing. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mentioned studies:
- Cytotoxicity, Irritation, Sensitization: Likely based on standardized biological assay results (e.g., cell viability, skin reactions) compared against established safety thresholds.
- Wound healing model: Likely based on observable physiological changes and measurements in an animal model, compared to controls.
- Antimicrobial efficacy: Likely based on laboratory measurements of bacterial count reduction (e.g., colony-forming units) after exposure to the dressing, compared to specified acceptance criteria.
- Silver release kinetics: Likely based on analytical chemistry measurements of silver concentration over time.
- Minimum effective concentration: Likely based on microbiology experiments to determine the lowest concentration of silver needed to inhibit microbial growth.
8. The sample size for the training set
This is not applicable as the device is a physical wound dressing and does not involve a training set or AI model.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical wound dressing and does not involve a training set or AI model.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2016
Mölnlycke Health Care US, LLC Ms. Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092
Re: K160379
Trade/Device Name: Exufiber Ag+ Antimicrobial Gelling Fibre Dressing Regulatory Class: Unclassified Dated: July 22, 2016 Received: July 25, 2016
Dear Ms. Bevill:
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 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.
{1}------------------------------------------------
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" (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/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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160379
Device Name
Exufiber® Ag+ Antimicrobial Gelling Fibre Dressing
Indications for Use (Describe)
For over-the-counter use, Exufiber Ag+ may be used for:
- · Abrasions
- · Lacerations
- Minor cuts
- · Minor scalds and burns
Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:
- · Leg ulcers (venous stasis ulcers and ulcers and ulcers of mixed etiology) and diabetic foot ulcers
- · Pressure ulcers (partial and full thickness)
- Partial thickness burns
- · Donor sites and other wounds that are prone to bleeding, such as debrided wounds
- Traumatic wounds
· Surgical wounds that heal by primary intention, such as dermatological incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions
· Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.
Indicated wear time: up to seven (7) days.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | X Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------- |
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{3}------------------------------------------------
510(k) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | August 23, 2016 |
|---|---|
| Applicant: | MöInlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877 |
| Official Correspondent: | Megan BevillManager, Regulatory AffairsTel: 470-375-0049Fax: 678-245-7746email: megan.bevill@molnlycke.com |
| Trade/Proprietary Names: | Exufiber Ag+ Antimicrobial Gelling Fibre Dressing |
| Requlation Name: | Dressing, Wound, Drug |
| Device Class: | Unclassified |
| Product Code: | FRO |
| Predicate Device Name(s): | Aquacel Aq Extra Hydrofiber Dressing with Silver andStrengthening Fiber (K121275) |
Description of Device:
Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a highly absorbent and gel-forming wound dressing that is intended to be used on medium to high exuding wound fluid, creating a soft gel and maintaining a moist wound healing environment. The dressing consists of a polyvinyl alcohol (PVA) pad or ribbon, coated on both sides with silver sulfate to act as a preservative in the dressing to inhibit or reduce microbial growth.
Intended Use/Indication for Use:
For over-the-counter use, Exufiber Ag+ may be used for:
- Abrasions
- Lacerations ●
- Minor cuts
- Minor scalds and burns
Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:
- Leg ulcers (venous stasis ulcers, arterial ulcers and ulcers of mixed etiology) and diabetic foot ulcers
- Pressure ulcers (partial and full thickness)
- Partial thickness burns
- Donor sites and other wounds that are prone to bleeding, such as debrided wounds ●
- . Traumatic wounds
{4}------------------------------------------------
- Surgical wounds that heal by primary intention, such as dermatological and surgical incisions . (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions
- . Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.
Indicated wear time: up to seven (7) days.
{5}------------------------------------------------
Technological Characteristics:
| Feature | Exufiber Ag+ | Aquacel Ag Extra | Substantial Equivalence Comments |
|---|---|---|---|
| 510(k)clearance | Subject of submission | K121275 | NA |
| Rationale forinclusion | Subject of submission | Predicate device | NA |
| Manufacturer | Mölnlycke Health Care | ConvaTec Inc. | NA |
| Class name | Dressing, wound, drug | Dressing, wound, drug | Same classification as predicate |
| Class | Unclassified | Unclassified | Same classification as predicate |
| Product code | FRO | FRO | Same product code as predicate |
| Indication foruse/Intendeduse | For over-the-counter use, Exufiber Ag+ may be used for:AbrasionsLacerationsMinor cutsMinor scalds and burnsUnder the supervision of a healthcare professional,Exufiber Ag+ is intended to be used on the followingmedium to high exuding wounds:Leg ulcers (venous stasis ulcers, arterial ulcersand ulcers of mixed etiology) and diabetic footulcersPressure ulcers (partial and full thickness)Partial thickness burnsDonor sites and other wounds that are prone tobleeding, such as debrided woundsTraumatic woundsSurgical wounds that heal by primary intention,such as dermatological and surgical incisions(e.g. orthopaedic and vascular), and surgicalwounds left to heal by secondary intention, suchas dehisced surgical incisionsOncology wounds with exudate, such asfungoides-cutaneous tumours, fungatingcarcinoma, cutaneous metastasis, Kaposi'ssarcoma and angiosarcomaExufiber Ag+ may be used for management of wounds asan effective barrier to bacterial penetration of the dressing,as this may help to reduce the risk of infection.Indicated wear time: up to seven (7) days. | For over-the-counter use, Aquacel Ag Extra may be usedfor:AbrasionsLacerationsMinor cutsMinor scalds and burnsUnder the supervision of a healthcare professional,Aquacel Ag Extra may be used for the management of:Wounds as an effective barrier to bacterialpenetration of the dressing as this may helpreduce infectionPartial thickness (2nd degree) burnsDiabetic foot ulcers, leg ulcers, (venous stasisulcers, arterial ulcers and leg ulcers of mixedetiology) and pressure ulcers/sores (partial andfull thickness)Surgical wounds left to heal by secondaryintention such as dehisced surgical incisionsSurgical wounds that heal by primary intent suchas dermatological and surgical incisions (e.g.,orthopedic and vascular)Traumatic woundsWounds that are prone to bleeding, such aswounds that have been mechanically orsurgically debrided and donor sitesOncology wounds with exudate, such asfungoides-cutaneous tumors, fungatingcarcinoma, cutaneous metastasis, Kaposi'ssarcoma, and angioarcomaPainful woundsInfected wounds | The subject device is indicated for thesame wound types as the predicate |
| Physicaldesign | Nonwoven pad or ribbon | Nonwoven pad or ribbon | Same as predicate |
| Dressingproperties | Highly absorbent, cohesive, gel forming | Highly absorbent, cohesive, gel forming | Same as predicate |
| Dressingmaterial | Polyvinyl alcohol (PVA) fibres | Carboxymethylcellulose (CMC) fibres | The subject and predicate devices areboth manufactured from highlyabsorbent base materials. ExufiberAg+ has been shown to be suitable forits intended use throughbiocompatibility and bench testing.PVA has been cleared for use inwound care applications underK122634 (Iodofoam Iodophor FoamDressing), and others. |
| Antimicrobialagent andcontent | Silver, in the form of silver sulfate0.2 mg/cm², as silver | Ionic silver0.18 mg/cm² | The subject and predicate devicesutilize similar antimicrobial agents butin different chemical forms.The silver sulfate used in the subjectdevice is the same silver sulfate that isused in other Mölnycke silverdressings, including Mepilex TransferAg (K123892) and Mepitel Ag(K130040). |
| Single use orReusable | Single Use | Single Use | Same as predicate |
| Sterility | Sterile (EtO) | Sterile (gamma) | The subject and predicate devices areboth provided sterile and are sterilizedby traditional methods.Mölnlycke's Mepilex Transfer Ag(K123892) and Mepitel Ag (K130040)dressings are sterilized using the sameEtO process as the subject device. |
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Performance Data:
In vitro and in vivo methods have been used to demonstrate the safety and effectiveness of the Exufiber Ag+ Antimicrobial Gelling Fibre Dressing with regards to the following parameters:
- Cytotoxicity
- . Irritation
- . Sensitization
- Wound healing model
- . Antimicrobial efficacy against 11 strains
- Silver release kinetics ●
- . Minimum effective concentration
Clinical Data:
No clinical data was required to support substantial equivalence.
Conclusion:
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics as well as performance testing. Exufiber Ag+ is at least as safe and effective, and performs at least as well as the predicate device, Aquacel Ag Extra.
N/A