(209 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a wound dressing, with no mention of AI or ML technologies.
No
The device, a burn and wound dressing, is intended to cleanse, moisten, and protect wounds to support healing, which are functions of a medical device, not a therapeutic device.
No
The device is a wound dressing intended for cleansing, moistening, and managing wounds to support healing, not for diagnosing conditions.
No
The device description clearly states it is a "semisolid gel" and a "dressing," indicating a physical, material-based product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleansing and moistening wounds, managing ulcers and burns, and supporting wound healing. This is a direct therapeutic application to the body.
- Device Description: The description details a gel applied to the wound bed to maintain moisture and aid in debris removal. This is a topical treatment.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue) to provide diagnostic information about a disease or condition. IVDs are used in vitro (outside the body) to perform tests.
The device is clearly intended for direct application to a wound on the body for therapeutic purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.
For Prescription Use: Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Medline Burn and Wound Dressing is a translucent, biocompatible, odorless, semisolid gel intended to cleanse and moisten the wound bed. The dressing maintains moisture in the wound and protects the wound from dessication to provide an optimal moist wound environment conducive to wound healing. Medline Burn and Wound Dressing contains a gentle surfactant and is water soluble to aid in the removal of wound debris in between dressing changes.
Medline Burn and Wound Dressing is provided non-sterile for single patient use. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product.
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
Professional 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)
Non-Clinical Testing:
-Biocompatibility in accordance to 10993-1
-Shelf Life
-USPAntimicrobial Effectiveness
-Wound Healing Study
These tests were conducted in accordance with GLP (21 CFR 58) to address questions of safety and effectiveness related to the device and its technological characteristics.
Clinical Testing: Not applicable.
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.
Prontosan Wound Gel K101882, Manuka Fill K131796
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.
Not Found
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 19, 2018
Medline Industries, Inc. Bethany Benoit-DiMaria Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K173911
Trade/Device Name: Medline Burn and Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 13, 2018 Received: June 14, 2018
Dear Bethany Benoit-DiMaria:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K173911
Device Name Medline Burn and Wound Dressing
Indications for Use (Describe)
Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ā Prescription Use (Part 21 CFR 801 Subpart D) | ā Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image features the Medline logo, which is set against a blue square. The word "MEDLINE" is prominently displayed in white, sans-serif font. A white, stylized starburst symbol is positioned to the right of the text, adding a visual element to the logo. A gray bar is visible on the right side of the image.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
K173911 510(k) Summary [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Bethany Benoit-DiMaria Senior Regulatory Affairs Specialist Phone: 847-643-3256 Email: BBenoit-Dimaria@medline.com
Summary Preparation Date December 21, 2017
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Medline Burn and Wound Dressing Proprietary Name: Medline Burn and Wound Dressing Common Name: Wound Cleanser, Wound Dressing Classification Name: Dressing, Wound, Drug Product Code: FRO Classification Panel: General & Plastic Surgery Regulatory Class: Unclassified
Primary Predicate Device Prontosan Wound Gel K101882
Secondary Predicate Device Manuka Fill K131796
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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in bold, sans-serif font, stacked on top of a white star-like shape. The star shape has four points, resembling a compass rose.
ledline Industries. Inc hree Lakes Drive
Device Description
Medline Burn and Wound Dressing is a translucent, biocompatible, odorless, semisolid gel intended to cleanse and moisten the wound bed. The dressing maintains moisture in the wound and protects the wound from dessication to provide an optimal moist wound environment conducive to wound healing. Medline Burn and Wound Dressing contains a gentle surfactant and is water soluble to aid in the removal of wound debris in between dressing changes.
Medline Burn and Wound Dressing is provided non-sterile for single patient use. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product.
Indications for Use
For Prescription Use: Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.
Summary of Technological Characteristics
Medline Burn and Wound Dressing was developed for the management of wounds that benefit from a moist wound environment and cleansing without unnecessary mechanical trauma. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product.
| DEVICE
CHARACTERISTIC | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | SECONDARY
PREDICATE
DEVICE | COMPARISON
ANALYSIS |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Product Name | Medline Burn and Wound
Dressing | Prontosan Wound Gel | Manuka Fill | N/A |
| 510(k) Reference | K173911 | K101882 | K131796 | N/A |
| Product Code | FRO | FRO | FRO | Same as Primary
Predicate
(K101882)
Same as
Secondary
Predicate
(K131796) |
| Intended Use | Professional Use:
Medline Burn and Wound
Dressing is intended to
cleanse and moisten the | Professional Use:
Prontosan Wound Gel is
intended to cleanse and
moisten the wound bed and | Under the supervision
of a healthcare
professional, Manuka
Fill wound dressing is | Same as
Primary
Predicate |
| | wound bed and for the
management of ulcers
(including diabetic foot and
leg ulcers and pressure
ulcers), 1st and 2nd degree
burns, partial and full
thickness wounds, and
surgical incisions. It can be
used to provide a moist
environment that supports
autolytic debridement of
necrotic tissue. | for the management of
ulcers, 1st and 2nd degree
burns, partial and full
thickness wounds, and
surgical incisions. It can be
used during wound
dressing changes to soften
encrusted wound dressings. | indicated for the
management of:
Leg Ulcers, Pressure
Ulcers, 1st and 2nd
Degree Burns,
Diabetic Foot Ulcers,
Surgical Wounds,
Trauma Wounds.
Manuka Fill wound
dressing provides a
moist wound
environment. A moist
wound environment
allows autolytic
debridement of
necrotic tissue | (K101882)
Same as
Secondary
Predicate
(K131796) |
| Regulation Number | Unclassified | Unclassified | Unclassified | Same as
Primary
Predicate
(K101882)
Same as
Secondary
Predicate
(K131796) |
| Configurations | 1.75 oz tube | 30 ml tube | Individual tubes in a
variety of sizes | Similar to
Primary
Predicate
(K101882)
Similar to
Secondary
Predicate
(K131796) |
| Design Features | Clear to translucent, water
soluble, virtually odorless,
amorphous wound gel with
a surfactant and PHMB as a
preservative | Clear, colorless, and
virtually odorless aqueous
wound gel with a
surfactant and PHMB as a
preservative | Wound gel with
honey, helps maintain
a moist wound
environment
conducive to wound
healing | Similar to
Primary
Predicate
(K101882)
Similar to
Secondary
Predicate
(K131796) |
| Materials | Poloxamer, Purified Water,
Glycerin, Sucrose, Sodium
Phosphate Dibasic, Citric
Acid, PHMB | Purified Water, Glycerol,
Hydroxyethylcellulose,
Undecylenamidopropyl
Betaine, PHMB | 100% Leptospermum
scoparium honey from
New Zealand | Similar to
Primary
Predicate
(K101882) |
| | | | | Secondary
Predicate
(K131796) |
| Non-Clinical Testing | -Biocompatibility in
accordance to 10993-1
-Shelf Life
-USPAntimicrobial
Effectiveness
-Wound Healing Study | -Biocompatiblity in
accordance to 10993-1
(breached or compromised
surfaces with prolonged
contact (>24h to 30d)
-Shelf Life
-USPAntimicrobial
Effectiveness
-USP Bacterial
Endotoxin Testing | -Biocompatibility in
accordance to 10993-1
(breached or
compromised surfaces
with prolonged contact
(>24h to 30d)
-Sterilization
Validation
-Packaging Validation
-Shelf Life
-Wound Healing
Study | Similar to
Primary
Predicate
(K101882)
Similar to
Secondary
Predicate
(K131796) |
| Sterile vs. Non-
Sterile | Non-sterile | Sterile by aseptic filtration
until first opened | Sterile by gamma
irradiation | Different than
Primary
Predicate
(K101882)
Different than
Secondary
Predicate
(K131796) |
| Reusable vs.
Single Use | Single patient, multiple use | Single patient, multiple use | Single use | Same as
Primary
Predicate
(K101882)
Similar to
Secondary
Predicate
(K131796) |
Proposed and Predicate Device(s) Comparison
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Image /page/5/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The starburst is vertically oriented, with its pointed ends extending upwards and downwards from the word "MEDLINE."
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The text "MEDLINE" is in a sans-serif font. There is a white starburst-like shape to the right of the text.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
Summary of Non-Clinical Testing
Medline Burn and Wound Dressing and the predicate device have the same intended use, and similar technological characteristics that do not raise different questions of safety and effectiveness. In order to address the same questions of safety and effectiveness and demonstrate that the differences in technological characteristics do not introduce new issues of safety and effectiveness, biocompatibility testing in accordance to ISO 10993-1, shelf-life testing to finished product specifications, and nonclinical performance testing (animal wound healing study) were conducted in accordance with GLP (21 CFR 58).
Summary of Clinical Testing Not applicable.
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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, with a white starburst symbol to the right of the text. The background is a solid dark blue color. There is a gray bar on the right side of the image.
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Burn and Wound Dressing is as safe and as effective for its intended use as the predicate devices [Prontosan Wound Gel (K101882) and Manuka Fill (K131796)].