(268 days)
Not Found
No
The document describes a physical liquid bandage product and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device covers and protects the skin, but it does not treat medical conditions or restore bodily function, which are characteristics of a therapeutic device.
No
The device, Aleo BME Liquid Bandage, is described as a skin protectant intended to cover and protect the skin. Its function is to form a physical barrier, not to diagnose any medical condition.
No
The device description clearly indicates it is a physical liquid bandage 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 clearly states that the device is for covering and protecting the skin from external factors like dirt and microbes in minor wounds and irritations. This is a topical application for physical protection, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description reinforces that it's a physical barrier applied to the skin.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Predicate Devices: The predicate devices listed are also liquid bandages, which are topical wound coverings, not IVDs.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
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.
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
Not Found
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)
Physical, mechanical and preservative effectiveness testing results confirm that the Aleo BME Liquid Bandage meets the product design specifications. Where applicable, performance testing of the Aleo BME Liquid Bandage was compared to the predicate devices.
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.
3M NexcareTM Liquid Bandage, K053409, KeriCure's Natural SealTM Liquid Bandage, K131384, NewSkin® Liquid Bandage, Pre-amendment
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
§ 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.
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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 Blvd
Ste. 210A
State College, PA 16803
Phone: (814) 954 7381
Fax: (814) 826 4447 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | LeAnn Latham
M Squared Associates, Inc.
E-mail: leann.latham@hotmail.com
Phone: (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 Code
and Panel | KMF, General & Plastic Surgery |
| Predicate Devices | 3M NexcareTM Liquid Bandage, K053409
KeriCure's Natural SealTM Liquid Bandage, K131384
NewSkin® Liquid Bandage, Pre-amendment |
| Device Description | 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. |
| Intended Use | 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. |
| Biocompatibility
Testing | Aleo BME Liquid Bandage passed biocompatibility testing requirements
according to ISO 10993 for Cytotoxicity (ISO 10993-5), Irritation (ISO
10993-10), sensitization (ISO 10993-10), acute systemic toxicity (ISO
10993-11), 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 formulation
inhibits microbial growth for preservation of the liquid bandage while in
the 15 mL glass vial and on the shelf. Shelf life studies have been
performed and the results indicate that the Aleo BME Liquid Bandages is
safe and effective for use for the labeled shelf life. |
| Performance Testing | Physical, mechanical and preservative effectiveness testing results
confirm that the Aleo BME Liquid Bandage meets the product design
specifications. Where applicable, performance testing of the Aleo BME
Liquid Bandage was compared to the predicate devices. |
| Substantial
Equivalence | Characterization and performance tests of Aleo BME Liquid Bandage
have confirmed that it is substantially equivalent in design, function and
intended use to the predicate devices and confirmed that there are no
significant differences between the proposed and predicate devices that
raise new questions of safety or efficacy. |
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