(268 days)
Over the counter: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration in minor cuts, scrapes, burns, skin irritations and abrasions.
Prescription Use: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration for minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
ALEO liquid bandage is a tough elastic skin protectant for covering minor skin cuts, scrapes, abrasions and cracks. When applied, it rapidly forms water-proof, breathable and transparent protection that forms an effective barrier to prevent microbial penetration from the external environment while the polymeric film remains intact.
The provided text is a 510(k) summary for the Aleo BME Liquid Bandage. It details the device's intended use, regulatory classification, and comparisons to predicate devices. However, it does not contain specific acceptance criteria or the details of a study with reported device performance metrics in the format requested.
It states that "Physical, mechanical and preservative effectiveness testing results confirm that the Aleo BME Liquid Bandage meets the product design specifications" and that "performance testing of the Aleo BME Liquid Bandage was compared to the predicate devices," but it does not provide the actual criteria or results of these tests.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on sample size, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided document.
The document focuses on the regulatory submission for substantial equivalence based on the device's design, function, and intended use being similar to existing legally marketed devices, rather than a detailed presentation of performance data against specific acceptance criteria.
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January 12, 2018
Aleo BME Inc. % LeAnn Latham Consultant M Squared Associates. Inc. 575 Eighth Avenue, Suite 1212 New York, NY 10018
Re: K171148
Trade/Device Name: Aleo BME Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: Class I Product Code: KMF Dated: December 13, 2017 Received: December 13, 2017
Dear Ms. Latham:
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 (QS) regulation (21 CFR Part 820);
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1000-1050.
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
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Indications for Use
510(k) Number (if known) K171148
Device Name
Aleo BME Liquid Bandage
Indications for Use (Describe)
Over the counter: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration in minor cuts, scrapes, burns, skin irritations and abrasions.
Prescription Use: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration for minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Aleo BME Liquid Bandage
| Sponsor: | Aleo BME, Inc.200 Innovation BlvdSte. 210AState College, PA 16803Phone: (814) 954 7381Fax: (814) 826 4447 |
|---|---|
| Contact Person: | LeAnn LathamM Squared Associates, Inc.E-mail: leann.latham@hotmail.comPhone: (703) 562 9800 |
| Date Prepared: | January 9, 2018 |
| Proprietary Name: | Aleo BME Liquid Bandage |
| Common Name | Bandage, Liquid |
| Regulatory Class | Class I, 510(k) |
| Regulation Name,Number | Liquid bandage, 21 CFR 880.5090 |
| Device Product Codeand Panel | KMF, General & Plastic Surgery |
| Predicate Devices | 3M NexcareTM Liquid Bandage, K053409KeriCure's Natural SealTM Liquid Bandage, K131384NewSkin® Liquid Bandage, Pre-amendment |
| Device Description | ALEO liquid bandage is a tough elastic skin protectant for covering minorskin cuts, scrapes, abrasions and cracks. When applied, it rapidly formswater-proof, breathable and transparent protection that forms aneffective barrier to prevent microbial penetration from the externalenvironment while the polymeric film remains intact. |
| Intended Use | Over the counter: Aleo BME Liquid Bandage is intended to cover andprotect the skin from outside dirt and microbial penetration in minorcuts, scrapes, burns, skin irritations and abrasions. |
| Prescription Use: Aleo BME Liquid Bandage is intended to cover andprotect the skin from outside dirt and microbial penetration for minorcuts, scrapes, burns, irritations and abrasions, as well as closed surgicalincisions and excisions. | |
| BiocompatibilityTesting | Aleo BME Liquid Bandage passed biocompatibility testing requirementsaccording to ISO 10993 for Cytotoxicity (ISO 10993-5), Irritation (ISO10993-10), sensitization (ISO 10993-10), acute systemic toxicity (ISO10993-11), subacute/subchronic toxicity (ISO 10993-11), implantation(ISO 10993-6) and material mediated pyrogenicity (ISO 10993-11). |
| Shelf Life | Aleo BME Liquid Bandage is provided non-sterile. Product formulationinhibits microbial growth for preservation of the liquid bandage while inthe 15 mL glass vial and on the shelf. Shelf life studies have beenperformed and the results indicate that the Aleo BME Liquid Bandages issafe and effective for use for the labeled shelf life. |
| Performance Testing | Physical, mechanical and preservative effectiveness testing resultsconfirm that the Aleo BME Liquid Bandage meets the product designspecifications. Where applicable, performance testing of the Aleo BMELiquid Bandage was compared to the predicate devices. |
| SubstantialEquivalence | Characterization and performance tests of Aleo BME Liquid Bandagehave confirmed that it is substantially equivalent in design, function andintended use to the predicate devices and confirmed that there are nosignificant differences between the proposed and predicate devices thatraise new questions of safety or efficacy. |
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§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.