(31 days)
Not Found
No
The device description and summary do not mention any AI or ML components or capabilities. The device is a wound dressing gel.
Yes
The device is intended to moisten and protect wounds, providing a moist environment conducive to healing, which are functions of a therapeutic device.
No
The device is described as a dressing intended to moisten and protect wounds to aid in healing, not to diagnose a condition.
No
The device description clearly indicates it is a physical gel dressing with specific ingredients, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to moisten and manage minor cuts, abrasions, lacerations, and burns. This is a direct application to the body for therapeutic purposes, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description details a gel applied to wounds. It focuses on providing a moist environment and aiding in wound debris removal. There is no mention of analyzing biological samples or providing diagnostic results.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting specific analytes (e.g., biomarkers, pathogens).
- Providing information for diagnosis, monitoring, or screening.
The device is clearly intended for wound care and management, which falls under the category of a therapeutic or wound dressing device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Over-the-Counter Use: Medline Burn and Wound Dressing is intended to moisten the management of minor cuts, minor abrasions, minor lacerations and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Medline Burn and Wound Dressing (OTC) is a translucent, biocompatible, odorless, semisolid gel intended to moisten the wound. The dressing protects the wound and provides a moist wound environment conducive to healing. Medline Burn and Wound Dressing (OTC) 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 (OTC) is provided non-sterile for single patient use. The subject device is comprised of the following ingredients: Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, and Polyhexanide (PHMB). The Medline Burn and Wound Dressing (OTC) contains a concentration of 0.1% w/w of PHMB, which acts as a preservative to inhibit the growth of microorganisms within the product. The proposed device will be available in the following design configuration:
| Medline Item Number | Description | Size |
|---|---|---|
| CST50TUBE | Medline Burn and Wound Dressing (OTC) | 1.75 oz. tube |
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
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)
Summary of Non-Clinical Testing: Medline Burn and Wound Dressing (OTC) and the primary predicate device (K173911) are the same device; these devices share the same formulation, design, manufacturing process and technological characteristics. The subject device does not raise different questions of safety and effectiveness. Biocompatibility testing in accordance to ISO 10993-1, shelf-life testing to finished product specifications, and non-clinical performance testing (animal wound healing study) were conducted in accordance with GLP (21 CFR 58) and previously submitted and cleared under K173911. The only difference between the primary predicate and the proposed device is the intended use of the proposed device is for OTC use, while the predicate is for prescription use only. There are no other changes besides the OTC indication and labeling; therefore, all testing information that was provided in the primary predicate submission (K173911) will be referenced to address the required components for this traditional 510(k) submission.
Summary of 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.
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
Not Found
N/A
0
March 8, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medline Industries, Inc. Claire Pigman Regulatory Affairs Associate Manager Three Lake Drive Northfield, Illinois 60093
Re: K190224
Trade/Device Name: Medline Burn and Wound Dressing (OTC) Regulatory Class: Unclassified Product Code: FRO Dated: January 31, 2019 Received: February 5, 2019
Dear Claire Pigman:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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. Lixin Liu -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K190224
Device Name Medline Burn and Wound Dressing (OTC)
Indications for Use (Describe)
Over-the-Counter Use:
Medline Burn and Wound Dressing is intended to moisten the management of minor cuts, minor abrasions, minor lacerations and minor burns.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
SECTION 5 510(k) Summary - K190224 [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Contact Person
Claire Pigman Regulatory Affairs Associate Manager Phone: 847-643-4071 Email: CPigman@medline.com
Summary Preparation Date
January 31, 2019 (Updated March 7, 2019)
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Medline Burn and Wound Dressing (OTC) Proprietary Name: Medline Burn and Wound Dressing (OTC) Common Name: Wound Dressing Classification Name: Dressing, Wound, Drug Product Code: FRO Classification Panel: General & Plastic Surgery Regulatory Class: Unclassified
Primary Predicate Device Medline Burn and Wound Dressing K173911
Secondary Predicate Device Prontosan Wound Gel (OTC) K101882
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
Modification to the Predicate Device
The intent of this traditional 510(k) is to expand the intended use of the previously cleared Medline Burn and Wound Dressing (K173911) in order to include an over-the-counter (OTC) use. The device that is the subject of this submission is the same device as the Medline Burn and Wound Dressing cleared under K 173911, but rather than being intended for prescription use only, is instead intended for over-the-counter use. According to the FDA guidance document, "Deciding When to Submit a 510(k) for Change to an Existing Device," a change from a prescription to OTC use requires directions for use necessary for lay users to use that same device safely and effectively. Therefore, changing a device labeled for prescription use only to a device that is labeled for OTC use requires a submission of a new 510(k). The subject device, Medline Burn and Wound Dressing (OTC) is an identical device in all other respects, including its technological characteristics, manufacturing process, and FDA classification. Therefore, the Medline Burn and Wound Dressing (K173911) will be utilized as the primary predicate device in this submission.
Device Description
Medline Burn and Wound Dressing (OTC) is a translucent, biocompatible, odorless, semisolid gel intended to moisten the wound. The dressing protects the wound and provides a moist wound environment conducive to healing. Medline Burn and Wound Dressing (OTC) 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 (OTC) is provided non-sterile for single patient use. The subject device is comprised of the following ingredients: Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, and Polyhexanide (PHMB). The Medline Burn and Wound Dressing (OTC) contains a concentration of 0.1% w/w of PHMB, which acts as a preservative to inhibit the growth of microorganisms within the product. The proposed device will be available in the following design configuration:
| Medline Item Number | Description | Size |
|---|---|---|
| CST50TUBE | Medline Burn and Wound Dressing | 1.75 oz. tube |
| (OTC) |
Indications for Use
Over the-Counter Use: Medline Burn and Wound Dressing is intended to moisten the wound and for the management of minor cuts, minor abrasions, minor lacerations and minor burns.
Summary of Technological Characteristics
Medline Burn and Wound Dressing (OTC) 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. Refer to Table 1 below for a comparison of the proposed and predicate devices.
5
| DEVICE
CHARACTERISTIC | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE | COMPARISON
ANALYSIS |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Product Name | Medline Burn and Wound Dressing
(OTC) | Medline Burn and Wound Dressing | Prontosan Wound Gel (OTC) | N/A |
| 510(k) Number | K190224 | K173911 | K101882 | N/A |
| Product Code | FRO | FRO | FRO | Same |
| Intended Use | Over-the-Counter Use:
Medline Burn and Wound Dressing is
intended to moisten the wound and for
the management of minor cuts, minor
abrasions, minor lacerations and minor
burns. | Professional 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. | Over-the-Counter Use:
Prontosan Wound Gel is intended to cleanse
and moisten the wound bed and for the
management of minor cuts, abrasion,
laceration, and minor burns. | Different (Primary
Predicate)
Similar (Secondary
Predicate) |
| Regulation Number | Unclassified | Unclassified | Unclassified | Same |
| Rx vs. OTC | OTC | Rx | OTC | Different (Primary
Predicate)
Same (Secondary
Predicate) |
| Configurations | 1.75 oz tube | 1.75 oz tube | 30 ml tube | Same (Primary
Predicate)
Similar (Secondary
Predicate) |
| Design Features | Clear to translucent, water soluble,
virtually odorless, amorphous wound gel
with a surfactant and PHMB as a
preservative | 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 | Same |
| Materials | Poloxamer, Purified Water, Glycerin,
Sucrose, Sodium Phosphate Dibasic,
Citric Acid, PHMB | Poloxamer, Purified Water, Glycerin,
Sucrose, Sodium Phosphate Dibasic, Citric
Acid, PHMB | Purified Water, Glycerol,
Hydroxyethylcellulose,
Undecylenamidopropyl Betaine, PHMB | Same (Primary
Predicate)
Similar (Secondary
Predicate) |
| Non-Clinical Testing | -Biocompatibility in accordance to
10993-1 (breached or compromised
surfaces with prolonged contact (>24h
to 30d) | -Biocompatibility in accordance to 10993-1
(breached or compromised surfaces with
prolonged contact (>24h to 30d)
Shelf Life | -Biocompatiblity in accordance to 10993-1
(breached or compromised surfaces with
prolonged contact (>24h to 30d)
Shelf Life | Same (Primary
Predicate) |
| | -Shelf Life
-USPAntimicrobial Effectiveness
-USPMicrobial Limits
-USPMicrobiological Examination
of Non-sterile Products
-Wound Healing Study | -USPAntimicrobial Effectiveness
-USPMicrobial Limits
-USPMicrobiological Examination of
Non-sterile Products
-Wound Healing Study | -USPAntimicrobial Effectiveness
-USP Bacterial Endotoxin Testing | Similar (Secondary
Predicate) |
| Sterile vs. Non-Sterile | Non-sterile | Non-sterile | Sterile by aseptic filtration until first opened | Same (Primary
Predicate)
Different (Secondary
Predicate) |
| Reusable vs.
Single Use | Single patient, multiple use | Single patient, multiple use | Single Patient Use, multiple use | Same |
Table 1 Proposed and Predicate Device(s) Comparison
6
Table 1 Proposed and Predicate Device(s) Comparison
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
Summary of Non-Clinical Testing
Medline Burn and Wound Dressing (OTC) and the primary predicate device (K173911) are the same device; these devices share the same formulation, design, manufacturing process and technological characteristics. The subject device does not raise different questions of safety and effectiveness. Biocompatibility testing in accordance to ISO 10993-1, shelf-life testing to finished product specifications, and non-clinical performance testing (animal wound healing study) were conducted in accordance with GLP (21 CFR 58) and previously submitted and cleared under K173911. The only difference between the primary predicate and the proposed device is the intended use of the proposed device is for OTC use, while the predicate is for prescription use only. There are no other changes besides the OTC indication and labeling; therefore, all testing information that was provided in the primary predicate submission (K173911) will be referenced to address the required components for this traditional 510(k) submission. Please refer to Appendix H, Supporting Documents, for a copy of an email correspondence with FDA, which confirms that testing can be referenced rather than submitted.
Summary of Clinical Testing
Not applicable.
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 (OTC) is as safe and as effective for its intended use as the predicate devices, Medline Burn and Wound Dressing (K173911) and Prontosan Wound Gel, OTC (K101882).