(281 days)
OraCure® is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.
OraCure® is an oral wound dressing comprising a mucous-adhesive side on a protection side, wherein the adhesive side has a strong adhesion when it is applied and hydrated on mucus. Adhesive side is water-soluble polymer that reacts with moisture (water and saliva) in the mouth within a short time and changes into a gel state. The protection side for protection of the mucous-adhesive side consists of water-insoluble polymer on the protection side is insoluble in the water and covers the wound to protect the applicable area from the environment (bacteria, saliva, food, etc.) in the mouth. OraCure® does not contain any biological additives or drugs with respect to wound treatment, but it is simple non-sterile bandage to protect ulcer tissue.
The provided text describes the OraCure® oral wound dressing and its substantial equivalence to a predicate device, Ulceloocin™ Oral Ulcer Patch. The document focuses on non-clinical data to support this claim, rather than a clinical study involving human patients. Therefore, information regarding acceptance criteria, device performance in terms of clinical outcomes, sample sizes for test and training sets, number of experts for ground truth, adjudication methods, or MRMC comparative effectiveness studies are not present.
However, the document does list the acceptance criteria in terms of safety and performance tests performed and indicates that the device meets these criteria through the successful completion of these tests.
Here's a summary of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
The device performance is reported as meeting the standards for each test listed. The document concludes that "the safety and performance test reports are supported to the safety and effectiveness of the subject device."
| Test Item | Standards Used | Reported Device Performance |
|---|---|---|
| Biocompatibility Tests | Passed, demonstrating no undue risks from biological hazards. | |
| Cytotoxicity | ISO 10993-5:2009 | Passed |
| Sensitization | ISO 10993-10:2010 | Passed |
| Intracutaneous Reactivity Test | ISO 10993-10:2010 | Passed |
| Acute Systemic Toxicity Test | ISO 10993-11:2016 | Passed |
| Material-Mediated Pyrogen Test | ISO 10993-11:2016 | Passed |
| Subacute/Subchronic Toxicity Test | ISO 10993-11:2016 | Passed |
| Genetoxicity | ISO 10993-3:2014 | Passed |
| Implantation | ISO 10993-6:2016 | Passed |
| Microbial Limit Test (MLT) | Passed, indicating acceptable levels of microorganisms in the non-sterile product. | |
| Microbial Limit Test | USP 40NF35 <61>, <62>, <1111> | Passed |
| Shelf-life Test | Passed, establishing the expiration date and stability of physical properties. | |
| Accelerated Aging Test | ASTM F 1980 | Passed |
| Performance Test | Demonstrated effectiveness of product performance. | |
| Absorbency | EN 13726-1:2002 | Passed |
| Moisture Vapour Transmission Rate | EN 13726-2:2002 | Passed |
| Conformability | EN 13726-4:2003 | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The study described is a series of laboratory-based non-clinical tests rather than a clinical trial with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical laboratory testing, not a study requiring expert interpretation of results for ground truth establishment. The "ground truth" here would be defined by the Pass/Fail criteria of the respective international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there were no subjective assessments requiring adjudication described in the non-clinical tests.
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
This information is not applicable. The document describes a medical device (wound dressing), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on the objective criteria and analytical methods defined by the international standards listed (e.g., ISO, USP, ASTM, EN standards). These standards outline specific methodologies and acceptance ranges for each test item.
8. The sample size for the training set
This information is not provided and is not applicable as the document refers to non-clinical testing of a physical medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable as no training set was used.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
September 18, 2019
TBM Corporation % Ryan Hwang Consultant KMC, Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, 08375 REPUBLIC OF KOREA
Re: K183436
Trade/Device Name: OraCure® (Model: CR12, OB23, OB53) Regulatory Class: Unclassified Product Code: OLR Dated: June 14, 2019 Received: June 17, 2019
Dear Ryan Hwang:
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. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 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 (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Michael Adjodha Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183436
Device Name OraCure® (Model: CR12, OB23, OB53)
Indications for Use (Describe)
OraCure® is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.
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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Image /page/3/Picture/1 description: The image shows a logo for a company called "TECH BIO - MED". The logo consists of a cube with the letters "T", "B", and "M" arranged to form a heart shape on the front face of the cube. The text "TECH BIO - MED" is located to the right of the cube logo.
510(k) SUMMARY
This summary of 510(k) -safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: December 7, 2018
1. INFORMATION
1.1 Submitter Information
- I Submitter Name: TBM Corporation
- . Address
- : B-301, Gwangju High-tech Center, 313, Cheomdangwagi-ro, Buk-gu, Gwangju, 61008, Korea
- . Telephone Number: +82-62-971-2845 . Fax: +82-62-971-2815
1.2 Contact Person
- . Name: DongHa Lee (Consultant / KMC, Inc.)
- . Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea
- . י Telephone Number: +82-70-8965-5554 Fax: +82-2-2672-0579
- . E-mail: dhlee@kmcerti.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: OraCure® (Model: CR12, OB23, OB53)
- 2.2 Common Name: Oral Wound Dressing
- 2.3 Classification Name: dressing, wound and burn, hydrogel w/drug and/or biologic
- 2.4 Product Code: MGQ
- 2.5 Classification Regulation: Unclassified
- 2.6 Device Class: Unclassified
- 2.7 Classification Panel: General & Plastic Surgery
3. PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Manufacturer | Sunshine International Group, Inc., |
| Device Name (Trade Name) | UlceloocinTM Oral Ulcer Patch |
| 510(k) Number | K070842 |
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Image /page/4/Picture/0 description: The image shows a logo with the letters 'T' and 'M' inside of a cube. The cube has a heart shape on the top face. The logo is in black and white and has a simple, modern design. The letters 'T' and 'M' are in a bold, sans-serif font.
4. SUBJECT DEVICE DESCRIPTION
OraCure® is an oral wound dressing comprising a mucous-adhesive side on a protection side, wherein the adhesive side has a strong adhesion when it is applied and hydrated on mucus. Adhesive side is water-soluble polymer that reacts with moisture (water and saliva) in the mouth within a short time and changes into a gel state. The protection side for protection of the mucousadhesive side consists of water-insoluble polymer on the protection side is insoluble in the water and covers the wound to protect the applicable area from the environment (bacteria, saliva, food, etc.) in the mouth. OraCure® does not contain any biological additives or drugs with respect to wound treatment, but it is simple non-sterile bandage to protect ulcer tissue.
5. INTENDED USE
OraCure® is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and illfitting dentures.
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | TBM Corporation | Sunshine International Group, Inc., |
| Device Name | OraCure® | UlceloocinTM Oral Ulcer Patch |
| 510(k) Number | - | K070842 |
| Product Code | MGQ | MGQ |
| Indications forUse | OraCure® is intended for use as anoral wound dressing to protect ulcertissue by forming a physical barrieron the wound tissue to avoid furtherirritation and thus to relieve pain. It isindicated for use with all types ofulcers and small wounds of the oralmucosa including canker sores,aphthous ulcers, and injuries such astraumatic ulcers caused by self-biting, braces, and ill-fitting dentures. | UlcerloocinTM Oral Ulcer Patch isintended for use as an oral wounddressing to protect ulcer tissue byforming a physical barrier on thewound tissue to avoid furtherirritation and thus to relieve pain. It isindicated for use with all types ofulcers and small wounds of the oralmucosa including canker sores,aphthous ulcers, and injuries such astraumatic ulcers caused by self-biting, braces, and ill-fitting dentures. |
| Prescription orOTC | OTC (Over The Counter) | OTC (Over The Counter) |
| Mechanism | OraCure® is a vacuum-dried gel thatadheres to oral mucosa.It slowly reverts to a soft and gel-typethin sheet in the oral environmentwhile it adheres to and protectsaffected tissue as a physical barrier toreduce irritation and pain. | UlceloocinTM Oral Ulcer Patch is avacuum-dried hydrogel that adheresto oral mucosa.It slowly reverts to a soft and gel-typethin sheet in the oral environmentwhile it adheres to and protectsaffected tissue as a physical barrier toreduce irritation and pain. |
| Structure | Polymer | Polymer |
6. SUBSTANTIAL EQUIVALENCE
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Image /page/5/Picture/0 description: The image is a logo that features the letters 'T' and 'M' arranged on a cube. The cube is depicted in a black and white color scheme. The letter 'T' is prominently displayed on the top face of the cube, while the letter 'M' is visible on the side face. The logo has a simple and modern design.
| Sterility | None | None |
|---|---|---|
| Single Use | Yes | Yes |
| Size | D: Diameter, T: ThicknessW: Wide, L: Length① Model No.: CR12- Circle Shape (DxT)1.2cm x (0.3 | D: Diameter, T: Thickness① Circle Shape (DxT)1cm x 0.3mm |
7. NON-CLINICAL DATA
7.1 Safety Test
- Biocompatibility
The biocompatibility tests were performed to protect patients from undue risks arise from biological hazards associated with materials of manufacture and final device. The tests were performed in accordance with the following standards and FDA Guidance - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
| No. | Test Items | Standards |
|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5:2009 |
| 2 | Sensitization | ISO 10993-10:2010 |
| 3 | Intracutaneous Reactivity Test | ISO 10993-10:2010 |
| 4 | Acute Systemic Toxicity Test | ISO 10993-11:2016 |
| 5 | Material-Mediated Pyrogen Test | ISO 10993-11:2016 |
| 6 | Subaccute/Subchronic Toxicity Test | ISO 10993-11:2016 |
| 7 | Genetoxicity | ISO 10993-3:2014 |
| 8 | Implantation | ISO 10993-6:2016 |
2) Microbial Limit Test
The microbial limit test (MLT) was performed to assess how many and which of certain microorganisms are present in this non-sterile product. The test was performed in accordance with following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | Microbial Limit Test | USP 40NF35 <61> |
| USP 40NF35 <62> | ||
| USP<1111> |
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3) Shelf-life Test
The shelf-life test was performed to decide expiration date and to assess a stability of physical properties of their packaging materials within the duration of the proposed shelf-life. The tests were performed in accordance with following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | Accelerated Aging Test | ASTM F 1980 |
7.2 Performance Test
The following tests were performed to assess effectiveness of the product performance. The tests were performed in accordance with following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | Absorbency | EN 13726-1:2002 |
| 2 | Moisture Vapour Transmission Rate | EN 13726-2:2002 |
| 3 | Conformability | EN 13726-4:2003 |
8. CONCLUSION
Under the comparing substantial equivalence between the subject device and the predicate device, there are the same points such as product code, indications for use, mechanism and structure.
Although there are some differences (raw material characteristics and size), the safety and performance test reports are supported to the safety and effectiveness of the subject device. In this regard, we conclude that the subject device is substantially equivalent to the predicate device.
N/A