(88 days)
No
The summary describes a liquid skin protectant and its physical and biological properties. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No.
The device description and intended use focus on protecting the skin from irritation and mechanical forces rather than treating a disease or condition. While it aids in skin health, its primary function is protective, not therapeutic in the sense of healing or curing.
No
The device description and intended use indicate that TearRepair is a skin protectant, creating a barrier to protect the skin from damage and irritation. It does not mention diagnosing any conditions.
No
The device description clearly states it is a "rapid-drying liquid barrier film" and describes its physical application and properties, indicating it is a physical 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 describes protecting the skin from external forces and irritants. This is a topical application for physical protection, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a liquid barrier film applied to the skin. This aligns with a topical protective device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties (mechanical testing, setting time, etc.) and biocompatibility, which are typical for topical medical devices, not IVDs.
Therefore, TearRepair is a topical skin protectant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, olothing. shoes, or any material that may damage the skin. TearRepair can also be used to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.
Product codes
KMF
Device Description
TearRepair Liguid Skin Protectant is a rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair will wear off, naturally, and is provided as a singleuse, sterile device provided as Rx Only.
The healthcare provider actuates the device by squeezing the applicator walls, crushing the glass ampoule within allowing the adhesive to flow to the application tip. The adhesive is applied as a liquid and polymerizes, adhering to the contours of the skin to form a transparent, flexible film. TearRepair wears off naturally as the skin regenerates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Adults over the age of 21
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)
Bench Testing:
- Mechanical Testing/Adhesive strength testing
- Heat of Polymerization .
- Moisture Vapor Transmission Rate .
- . Setting Time of Liquid Skin Protectant
- Applicator Functionality
Biocompatibility:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10) ●
- Irritation (ISO 10993-10) ●
- . Acute systemic toxicity (ISO 10993-11)
- Material-mediated pyrogenicity (ISO 10993-11, USP )
- Subacute toxicity (ISO 10993-11) .
- . Implantation (ISO 10993-6)
The results of these tests indicate that TearRepair is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows 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.
September 27, 2024
OptMed, Inc. % Allison Komiyama VP, MedTech Innovations Ram+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146
Re: K241916
Trade/Device Name: TearRepair Liquid Skin Protectant Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: Class I, reserved Product Code: KMF Dated: June 28, 2024 Received: July 1, 2024
Dear Allison Komiyama:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241916
Device Name TearRepair Liquid Skin Protectant
Indications for Use (Describe)
TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, olothing. shoes, or any material that may damage the skin. TearRepair can also be used to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.
| 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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4
510(k) SUMMARY
DATE PREPARED
September 23, 2024
MANUFACTURER AND 510(k) OWNER
OptMed. Inc. 745 Fifth Ave., Suite 500 New York, New York 10151 Telephone: Official Contact: Nitasha Yajnik, Associate Director, Quality and Regulatory Assurance
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., RAC (RQM+) Lucie Dalet, Ph.D. (RQM+) Bhoomika Joyappa (Medical Device Academy, Inc.) Telephone: +1 (412) 816-8139 Email: akomiyama@rqmplus.com ldalet@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | TearRepair Liquid Skin Protectant |
|---|---|
| Common Name: | Bandage, Liquid |
| Regulation Number: | 21 CFR 880.5090 |
| Class: | I |
| Product Code: | KMF |
| Premarket Review: | Office of Surgical and Infection Control Devices (OHT4) |
| Infection Control and Plastic and Reconstructive Surgery | |
| Devices (DHT4B) | |
| Review Panel: | General & Plastic Surgery |
PREDICATE DEVICE IDENTIFICATION
TearRepair is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|---------------|-----------------------------------------------------------------------------------------|----------------------|
| K133443 | Marathon No Sting Liquid Skin Protectant/ Advanced
Medical Solutions (Plymouth) Ltd. | ✓ |
The predicate device has not been subject to a design related recall.
5
DEVICE DESCRIPTION
TearRepair Liguid Skin Protectant is a rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair will wear off, naturally, and is provided as a singleuse, sterile device provided as Rx Only.
INDICATIONS FOR USE
TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, clothing, shoes, or any material that may damage the skin. TearRepair can also be used to protect skin exposed to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
OptMed, Inc. believes that the TearRepair is substantially equivalent to the predicate device based on the information summarized here:
The subject device has a similar design and uses similar materials as the device cleared in K133443. The subject device has the similar intended use and similar technological characteristics to the devices cleared in K133443. The device has similar instrumentation to the device cleared in K133443. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates.
| | Subject Device
TearRepair Liquid Skin
Protectant | Primary Predicate
Device
Marathon No Sting Liquid
Skin Protectant | Comparison |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | OptMed, Inc. | Advanced Medical
Solutions | N/A |
| 510(k)
Number | TBD | K133443 | N/A |
| Device Image | Image: TearRepair Liquid Skin Protectant | Image: Marathon No Sting Liquid Skin Protectant | N/A |
| Single-Use | Yes | Yes | Equivalent |
| Patient
Population | Adults over the age of 21 | Unknown | Equivalent |
| | Subject Device
TearRepair Liquid Skin
Protectant | Primary Predicate
Device
Marathon No Sting Liquid
Skin Protectant | Comparison |
| Indications
for Use | TearRepair is intended to be
used in areas exposed to
mechanical forces such as
friction and shear from
bedding, clothing, shoes, or
any material that may
damage the skin. TearRepair
can also be used to protect
skin exposed to irritation
from moisture such as urine,
feces, digestive juices,
perspiration, and wound
drainage. TearRepair can
also help protect the skin
against irritation caused by
adhesive products. | Marathon No Sting Liquid
Skin Protectant helps
protect skin exposed to
Irritation from moisture
such as urine, feces,
digestive juices,
perspiration, and wound
drainage.
Marathon No Sting
Liquid Skin Protectant
can also be used in areas
that are exposed to
friction and shear from
bedding, clothing, shoes,
or any material that will
rub against the skin.
Marathon No Sting
Liquid Skin Protectant
helps protect the skin
against Irritation caused
by adhesive products. | Equivalent |
| Type of Use | Prescription (Rx Only) | Prescription (Rx Only) | Equivalent |
| Operating
Principle | The healthcare provider
actuates the device by
squeezing the applicator
walls, crushing the glass
ampoule within allowing
the adhesive to flow to the
application tip. The
adhesive is applied as a
liquid and polymerizes,
adhering to the contours of
the skin to form a
transparent, flexible film.
TearRepair wears off
naturally as the skin
regenerates. | The adhesive is accessed
by crushing the glass
ampoule. This is
achieved by holding it
vertically with the tip
upper most, and then the
glass ampoule is broken
by squeezing the
applicator walls between
finger and thumb.
The adhesive is
expressed by inverting
the applicator and gently
squeezing the applicator
body until the adhesive
wets the tip of the
applicator. The adhesive | Equivalent |
| | Subject Device
TearRepair Liquid Skin
Protectant | Primary Predicate
Device
Marathon No Sting Liquid
Skin Protectant | Comparison |
| | | is applied to the required
area as a thin film and
allowed to polymerize
solid. | |
| Monomer | Methylidene malonate | Cyanoacrylate | Similar; both are
monomer/polymer
materials; does
not raise issues of
safety and
effectiveness based on
performance,
biocompatibility,
sterilization and
shelf-life testing. |
| Dispenser | Applicator sleeve
containing a glass
ampoule that, when
crushed, allows for
expressing the adhesive
through the tip;
Polyolefin/PP Molded tip | Applicator sleeve
containing a glass
ampoule that, when
crushed, allows for
expressing the adhesive
through the tip; Sponge
applicator | Similar;
applicator tip of
subject device is
made of a
polyolefin/PP
molded part while
the predicate
device has a
sponge applicator.
Performance
testing does not
raise new issues
of safety and
effectiveness. |
| Outer Plastic
Tube | Yes | Yes | Equivalent |
| Applicator Tip
Shape | Domed | Deerfoot | Similar;
applicator
functionality
testing
performed to
support
equivalent |
| | Subject Device
TearRepair Liquid Skin
Protectant | Primary Predicate
Device
Marathon No Sting Liquid
Skin Protectant | Comparison |
| | | | performance to
the predicate. |
| Adhesive | Yes | Yes | Equivalent |
| Stability and
Shelf-life | Real Time Aged Product Environmental Conditioning and Distribution Testing Product Stability Testing Package integrity | Unknown; Redacted from
510(k). | Similar; testing
demonstrates that
the device is
substantially
equivalent to
predicate |
| Sterilization | Gamma Irradiation | EtO | Similar; both
products sterilized
according to
validated processes |
6
7
8
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for TearRepair. The following tests were performed to demonstrate safety based on current industry standards:
Bench Testing:
- Mechanical Testing/Adhesive strength testing
- Heat of Polymerization .
- Moisture Vapor Transmission Rate .
- . Setting Time of Liquid Skin Protectant
- Applicator Functionality
Biocompatibility:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10) ●
- Irritation (ISO 10993-10) ●
- . Acute systemic toxicity (ISO 10993-11)
- Material-mediated pyrogenicity (ISO 10993-11, USP )
- Subacute toxicity (ISO 10993-11) .
- . Implantation (ISO 10993-6)
The results of these tests indicate that TearRepair is substantially equivalent to the predicate device.
9
CONCLUSION
Based on the testing performed, including wound closure strength, shear strength, and tensile strength, and biocompatibility testing, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed TearRepair are assessed to be substantially equivalent to the predicate device.