(197 days)
No
The device description and performance studies focus on the material properties and antimicrobial efficacy of a wound dressing, with no mention of AI or ML.
Yes
The device is described as a wound dressing intended to promote healing by absorbing exudate and maintaining a moist environment, and is listed for various wound types, aligning with the definition of a therapeutic device.
No
This device is a wound dressing designed for the management and healing of wounds, not for diagnosing conditions. Its primary function is to absorb exudate, create a moist healing environment, and act as a barrier to bacterial penetration.
No
The device description clearly states it is a "Gelling Fibre Dressing" consisting of a "polyvinyl alcohol (PVA) pad or ribbon," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Exufiber Ag+ is a wound dressing. Its function is to absorb wound exudate, create a moist healing environment, and act as a barrier to bacterial penetration. It is applied externally to the wound.
- Intended Use: The intended use describes the conditions and types of wounds the dressing is designed to manage. This involves direct application to the wound surface, not analysis of a sample taken from the body.
- Device Description: The description details the physical composition and mechanism of action of the dressing, which is related to wound management, not diagnostic testing.
- Performance Studies: The performance studies focus on parameters relevant to wound dressings, such as cytotoxicity, irritation, sensitization, wound healing, and antimicrobial efficacy. These are not typical performance metrics for IVDs.
Therefore, the Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the supervision of a healthcare professional; For over-the-counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
No clinical data was required to support substantial equivalence.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Aquacel Aq Extra Hydrofiber Dressing with Silver and Strengthening Fiber (K121275)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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, LLC |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Registration number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Official Correspondent: | Megan Bevill |
| Manager, Regulatory Affairs | |
| Tel: 470-375-0049 | |
| Fax: 678-245-7746 | |
| email: 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 and |
| Strengthening 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 for | |||
| inclusion | 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 for | |||
| use/Intended | |||
| use | For over-the-counter use, Exufiber Ag+ may be used for: | ||
| AbrasionsLacerationsMinor cutsMinor 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 | |||
| ulcersPressure ulcers (partial and full thickness)Partial thickness burnsDonor sites and other wounds that are prone to | |||
| bleeding, such as debrided woundsTraumatic woundsSurgical 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 incisionsOncology 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. | For over-the-counter use, Aquacel Ag Extra may be used | ||
| for: | |||
| AbrasionsLacerationsMinor cutsMinor scalds and burns | |||
| Under the supervision of a healthcare professional, | |||
| Aquacel Ag Extra may be used for the management of: | |||
| Wounds as an effective barrier to bacterial | |||
| penetration of the dressing as this may help | |||
| reduce infectionPartial thickness (2nd degree) burnsDiabetic foot ulcers, leg ulcers, (venous stasis | |||
| ulcers, arterial ulcers and leg ulcers of mixed | |||
| etiology) and pressure ulcers/sores (partial and | |||
| full thickness)Surgical wounds left to heal by secondary | |||
| intention such as dehisced surgical incisionsSurgical wounds that heal by primary intent such | |||
| as dermatological and surgical incisions (e.g., | |||
| orthopedic and vascular)Traumatic woundsWounds that are prone to bleeding, such as | |||
| wounds that have been mechanically or | |||
| surgically debrided and donor sitesOncology wounds with exudate, such as | |||
| fungoides-cutaneous tumors, fungating | |||
| carcinoma, cutaneous metastasis, Kaposi's | |||
| sarcoma, and angioarcomaPainful woundsInfected wounds | The subject device is indicated for the | ||
| same wound types as the predicate | |||
| Physical | |||
| design | Nonwoven pad or ribbon | Nonwoven pad or ribbon | Same as predicate |
| Dressing | |||
| properties | Highly absorbent, cohesive, gel forming | Highly absorbent, cohesive, gel forming | Same as predicate |
| Dressing | |||
| material | Polyvinyl alcohol (PVA) fibres | Carboxymethylcellulose (CMC) fibres | The subject and predicate devices are |
| both manufactured from highly | |||
| absorbent base materials. Exufiber | |||
| Ag+ has been shown to be suitable for | |||
| its intended use through | |||
| biocompatibility and bench testing. |
PVA has been cleared for use in
wound care applications under
K122634 (Iodofoam Iodophor Foam
Dressing), and others. |
| Antimicrobial
agent and
content | Silver, in the form of silver sulfate
0.2 mg/cm², as silver | Ionic silver
0.18 mg/cm² | The subject and predicate devices
utilize similar antimicrobial agents but
in different chemical forms.
The silver sulfate used in the subject
device is the same silver sulfate that is
used in other Mölnycke silver
dressings, including Mepilex Transfer
Ag (K123892) and Mepitel Ag
(K130040). |
| Single use or
Reusable | Single Use | Single Use | Same as predicate |
| Sterility | Sterile (EtO) | Sterile (gamma) | The subject and predicate devices are
both provided sterile and are sterilized
by traditional methods.
Mölnlycke's Mepilex Transfer Ag
(K123892) and Mepitel Ag (K130040)
dressings are sterilized using the same
EtO process as the subject device. |
6
7
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.