(31 days)
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.
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 provided text is a 510(k) premarket notification for a medical device called "Medline Burn and Wound Dressing (OTC)". This document primarily focuses on demonstrating substantial equivalence to a predicate device for a change in intended use from prescription to over-the-counter.
Because this is a submission for an over-the-counter wound dressing, and not an AI-powered diagnostic device, many of the typical acceptance criteria and study details related to AI performance (like sensitivity, specificity, MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets for AI models) are not applicable to this document. The submission is about safety and effectiveness for a physical medical product, not an AI algorithm.
Here's an analysis based on the information available, addressing the relevant points and noting where information is not present due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this context are related to the safety and effectiveness of the wound dressing for its intended OTC use, primarily demonstrating substantial equivalence to predicate devices. The performance is assessed through non-clinical testing already completed for the primary predicate device.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance/Comparison |
|---|---|---|
| Substantial Equivalence | Comparison of Intended Use | Proposed Device: OTC use for minor cuts, abrasions, lacerations, burns.Primary Predicate: Professional use for ulcers, 1st/2nd degree burns, partial/full thickness wounds, surgical incisions.Secondary Predicate: OTC use for minor cuts, abrasions, lacerations, minor burns. Conclusion: Different from primary predicate (Rx vs. OTC), but similar to secondary predicate (OTC). The core device is identical to the primary predicate, just the intended use classification (Rx vs. OTC) is changing. |
| Comparison of Technological Characteristics (Design Features, Materials, etc.) | Proposed Device & Primary Predicate: Clear to translucent, water soluble, odorless, amorphous wound gel with surfactant and PHMB as preservative. Same materials (Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, PHMB). Secondary Predicate: Similar design features but different full formulation (Purified Water, Glycerol, Hydroxyethylcellulose, Undecylenamidopropyl Betaine, PHMB). Conclusion: Identical to primary predicate (K173911) in all technological characteristics. | |
| Comparison of Product Code | All (Proposed, Primary, Secondary Predicates) are FRO. Conclusion: Same. | |
| Comparison of Regulatory Class | All are Unclassified. Conclusion: Same. | |
| Comparison of Configuration | Proposed & Primary Predicate: 1.75 oz tube. Secondary Predicate: 30 ml tube. Conclusion: Same as primary predicate. | |
| Safety Testing | Biocompatibility (ISO 10993-1, breached/compromised surfaces, prolonged contact) | Previously conducted for K173911 (primary predicate) and referenced. No new tests were performed as the device formulation is identical. |
| Microbial Limits (USP<61>) | Previously conducted for K173911 and referenced. No new tests were performed as the device is identical. | |
| Microbiological Examination of Non-sterile Products (USP<62>) | Previously conducted for K173911 and referenced. No new tests were performed as the device is identical. | |
| Effectiveness Testing | Shelf Life | Previously conducted for K173911 and referenced. No new tests were performed as the device is identical. |
| Antimicrobial Effectiveness (USP<51>) | Previously conducted for K173911 and referenced. No new tests were performed as the device is identical. | |
| Wound Healing Study (Animal) | Previously conducted for K173911 and referenced (under GLP - 21 CFR 58). No new tests were performed as the device is identical. | |
| Sterile vs. Non-Sterile | Proposed & Primary Predicate: Non-sterile. Secondary Predicate: Sterile by aseptic filtration. Conclusion: Same as primary predicate. | |
| Reusable vs. Single Use | All (Proposed, Primary, Secondary Predicates) are single patient, multiple use. Conclusion: Same. | |
| Labeling | Clarity for Lay Users (OTC claim) | Implicitly addressed by the FDA guidance document "Deciding When to Submit a 510(k) for Change to an Existing Device," which requires directions for use necessary for lay users to use the device safely and effectively for OTC. While specific labeling details aren't provided in depth, the overall submission implies this was evaluated for the OTC change. |
2. Sample Size for the Test Set and Data Provenance
- Test Set (for performance testing): Not applicable in the context of an "AI test set" here. The testing was non-clinical and performed on materials/animals for the primary predicate device (K173911).
- Data Provenance: The study (non-clinical performance testing, e.g., wound healing study) that supports the current device's performance was conducted under GLP (21 CFR 58) for the primary predicate device K173911. The origin of the animal study data (e.g., country) is not specified in this document. It was retrospective to this particular 510(k) but prospective for the original K173911 application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as the evaluation relies on non-clinical (biocompatibility, shelf-life, animal wound healing) studies rather than expert-adjudicated clinical data for an AI algorithm. The "ground truth" for these tests would be the measured scientific outcomes (e.g., tissue reaction, microbial growth, wound closure rates).
4. Adjudication Method for the Test Set
- Not applicable, as there isn't a "test set" requiring expert adjudication in the context of an AI device.
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
- Not applicable. This device is a wound dressing, not an AI diagnostic or assistance tool, so no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a wound dressing, not an AI algorithm.
7. The type of ground truth used
- The "ground truth" for the device's safety and effectiveness is derived from non-clinical testing results:
- Biocompatibility: Measured biological reactions per ISO 10993-1.
- Shelf Life: Product stability and retention of specifications over time.
- Antimicrobial Effectiveness: Measured reduction in microbial load.
- Microbial Limits/Examination: Measured absence or presence of specific microorganisms.
- Wound Healing Study: Measured physiological endpoints of wound repair in an animal model (e.g., wound closure, tissue regeneration).
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI model was used.
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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
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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
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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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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.
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| DEVICECHARACTERISTIC | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE | COMPARISONANALYSIS |
|---|---|---|---|---|
| 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 isintended to moisten the wound and forthe management of minor cuts, minorabrasions, minor lacerations and minorburns. | Professional Use:Medline Burn and Wound Dressing isintended to cleanse and moisten the woundbed and for the management of ulcers(including diabetic foot and leg ulcers andpressure ulcers), 1st and 2nd degree burns,partial and full thickness wounds, andsurgical incisions. It can be used to providea moist environment that supports autolyticdebridement of necrotic tissue. | Over-the-Counter Use:Prontosan Wound Gel is intended to cleanseand moisten the wound bed and for themanagement of minor cuts, abrasion,laceration, and minor burns. | Different (PrimaryPredicate)Similar (SecondaryPredicate) |
| Regulation Number | Unclassified | Unclassified | Unclassified | Same |
| Rx vs. OTC | OTC | Rx | OTC | Different (PrimaryPredicate)Same (SecondaryPredicate) |
| Configurations | 1.75 oz tube | 1.75 oz tube | 30 ml tube | Same (PrimaryPredicate)Similar (SecondaryPredicate) |
| Design Features | Clear to translucent, water soluble,virtually odorless, amorphous wound gelwith a surfactant and PHMB as apreservative | Clear to translucent, water soluble, virtuallyodorless, amorphous wound gel with asurfactant and PHMB as a preservative | Clear, colorless, and virtually odorlessaqueous wound gel with a surfactant andPHMB as a preservative | Same |
| Materials | Poloxamer, Purified Water, Glycerin,Sucrose, Sodium Phosphate Dibasic,Citric Acid, PHMB | Poloxamer, Purified Water, Glycerin,Sucrose, Sodium Phosphate Dibasic, CitricAcid, PHMB | Purified Water, Glycerol,Hydroxyethylcellulose,Undecylenamidopropyl Betaine, PHMB | Same (PrimaryPredicate)Similar (SecondaryPredicate) |
| Non-Clinical Testing | -Biocompatibility in accordance to10993-1 (breached or compromisedsurfaces with prolonged contact (>24hto 30d) | -Biocompatibility in accordance to 10993-1(breached or compromised surfaces withprolonged contact (>24h to 30d)Shelf Life | -Biocompatiblity in accordance to 10993-1(breached or compromised surfaces withprolonged contact (>24h to 30d)Shelf Life | Same (PrimaryPredicate) |
| -Shelf Life-USP<51>Antimicrobial Effectiveness-USP<61>Microbial Limits-USP<62>Microbiological Examinationof Non-sterile Products-Wound Healing Study | -USP<51>Antimicrobial Effectiveness-USP<61>Microbial Limits-USP<62>Microbiological Examination ofNon-sterile Products-Wound Healing Study | -USP<51>Antimicrobial Effectiveness-USP<85> Bacterial Endotoxin Testing | Similar (SecondaryPredicate) | |
| Sterile vs. Non-Sterile | Non-sterile | Non-sterile | Sterile by aseptic filtration until first opened | Same (PrimaryPredicate)Different (SecondaryPredicate) |
| 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
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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).
N/A