Not Found
No
The device description and performance studies focus on the physical properties and barrier function of the wound dressing, with no mention of AI or ML.
No.
The device is described as a "simple non-sterile bandage to protect ulcer tissue" and does not contain "any biological additives or drugs with respect to wound treatment." Its function is primarily to act as a physical barrier for protection and pain relief, rather than to actively treat or cure a disease or condition in a therapeutic manner.
No
The device description states its purpose is to protect oral ulcer tissue and relieve pain by forming a physical barrier, not for diagnosing a condition.
No
The device description clearly states that OraCure® is an oral wound dressing comprising physical components (mucous-adhesive side and protection side made of polymers). It is described as a "simple non-sterile bandage," indicating 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 is to act as an oral wound dressing to protect ulcer tissue and relieve pain by forming a physical barrier. This is a physical action on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical barrier with adhesive and protective layers. It explicitly states it does not contain biological additives or drugs for wound treatment and is a "simple non-sterile bandage." This aligns with a physical wound dressing, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, saliva, tissue, etc.) to detect a condition, disease, or marker. The device's function is purely mechanical protection and pain relief.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for 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 ill-fitting dentures.
Product codes (comma separated list FDA assigned to the subject device)
OLR, MGQ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa
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)
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".
Test Items: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Intracutaneous Reactivity Test (ISO 10993-10:2010), Acute Systemic Toxicity Test (ISO 10993-11:2016), Material-Mediated Pyrogen Test (ISO 10993-11:2016), Subaccute/Subchronic Toxicity Test (ISO 10993-11:2016), Genetoxicity (ISO 10993-3:2014), Implantation (ISO 10993-6:2016). -
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: USP 40NF35 , USP 40NF35 , USP. -
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: 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: Absorbency (EN 13726-1:2002), Moisture Vapour Transmission Rate (EN 13726-2:2002), Conformability (EN 13726-4:2003).
Key results: The safety and performance test reports are supported to the safety and effectiveness of the subject device.
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.
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
N/A
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
4
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 for | ||
| 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 ill-fitting dentures. | UlcerloocinTM Oral Ulcer Patch 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. | ||
| Prescription or | ||
| OTC | OTC (Over The Counter) | OTC (Over The Counter) |
| Mechanism | OraCure® is a vacuum-dried gel that | |
| adheres to oral mucosa. | ||
| It slowly reverts to a soft and gel-type | ||
| thin sheet in the oral environment | ||
| while it adheres to and protects | ||
| affected tissue as a physical barrier to | ||
| reduce irritation and pain. | UlceloocinTM Oral Ulcer Patch is a | |
| vacuum-dried hydrogel that adheres | ||
| to oral mucosa. | ||
| It slowly reverts to a soft and gel-type | ||
| thin sheet in the oral environment | ||
| while it adheres to and protects | ||
| affected tissue as a physical barrier to | ||
| reduce irritation and pain. | ||
| Structure | Polymer | Polymer |
6. SUBSTANTIAL EQUIVALENCE
5
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: Thickness | |
| W: Wide, L: Length | ||
| ① Model No.: CR12 |
- Circle Shape (DxT)
1.2cm x (0.3~0.399)mm
② Model No.: OB23 - Rectangle Shape (WxLxT)
2.5cm x 15mm x
(0.3~0.399)mm
③ Model No.: OB25 - Rectangle Shape (WxLxT)
5cm x 15mm x
(0.3~0.399)mm | D: Diameter, T: Thickness
① 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 |
| USP 40NF35 | ||
| USP |
6
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.