Not Found
No
The description focuses on the physical properties and function of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is intended for the management of oral wounds, injuries, and ulcerations, and operates to relieve pain by adhering to and protecting affected tissues, thereby allowing healing. This falls under the definition of a therapeutic device as it treats or alleviates a condition.
No
The device is described as a "wound dressing" and a "non-sterile bandage to protect oral wounds," which functions by adhering to and protecting tissues to allow healing and relieve pain. It does not perform any diagnostic function such as detecting, analyzing, or identifying a medical condition.
No
The device description clearly states it is comprised of physical components (oral mucosa adhesive side and a protection side) made of polymers, indicating it is a physical medical device, 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 the device is for the "management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa." This is a therapeutic purpose, not a diagnostic one. It aims to treat or protect a physical condition, not to diagnose a disease or condition based on in vitro examination of specimens.
- Mechanism of Action: The device operates by "adhering to and protecting affected tissues from further irritation, thereby allowing healing." This is a physical barrier and protective mechanism, not an in vitro test or analysis of biological samples.
- Device Description: The description details the physical components and how they function as a "non-sterile bandage to protect oral wounds." This aligns with a wound dressing, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.
In summary, the device functions as a physical barrier and protective dressing for oral wounds, which falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intra-oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.
Intra-oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
Product codes (comma separated list FDA assigned to the subject device)
OLR, MGQ
Device Description
Intra-oral Wound Dressing is a device comprised of an oral mucosa adhesive side and a protection side. The oral mucosa adhesive side is composed of a water soluble polymer that when exposed to moisture in the oral cavity changes into a gel state to achieve adhesion to the wound area. The protection side consists of a waterinsoluble polymer which covers the wound to protect the applicable area from the environment in the oral cavity. Intra-oral Wound Dressing is simply a non-sterile bandage to protect oral wounds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral wounds, injuries and ulcerations of the gingival and 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
Safety Test
1) 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 & Standards:
- 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
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.
Test Items & Standards:
- Microbial Limit Test: USP 40NF35 , USP 40NF35 , USP
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.
Test Items & Standards:
- Accelerated Aging Test: ASTM F 1980
Performance Test
The following tests were performed to assess effectiveness of the product performance. The tests were performed in accordance with following standards.
Although the bench testing report indicate there is a difference with the physical property (adhesion) between subject device and predicate device, the difference does not raise any concerns of safety and effectiveness.
Test Items & Standards:
- Absorbency: EN 13726-1:2002
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 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.
January 11, 2022
Milly Milly, Regulatory Affairs Consultant KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 SOUTH KOREA
Re: K211851
Trade/Device Name: Ora-Aid Regulatory Class: Unclassified Product Code: OLR, MGQ Dated: June 4, 2021 Received: June 15, 2021
Dear Milly Milly:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing 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 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.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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
Indications for Use
510(k) Number (if known) K211851
Device Name Intra-oral Wound Dressing
Intra-oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and illfitting dentures, and lesions associated with oral surgery.
Intra-oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
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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3
510(k) SUMMARY K211851
Issue Date: June 4, 2021 (Revision Date: Jan 11, 2022)
1. INFORMATION
1.1 Submitter Information
- ' Submitter Name: TBM Corporation
- . Address
- : B-301, 313, Cheomdangwagi-ro, Buk-gu, Gwangju, 61008, Korea
- . Telephone Number: +82-62-971-2845
. Fax: +82-62-971-2815
Fax: +82-2-2672-0579
1.2 Contact Person
I
- l Name: Milly (Consultant / KMC, Inc.)
- . Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, 08390, Republic of Korea
- . . Telephone Number: +82-70-8965-5554
- E-mail: milly@kmcerti.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: Ora-Aid (Model: AD12, OB23, OB53)
- 2.2 Common Name: Intra-oral Wound Dressing
- 2.3 Classification Name: Dressing, wound and burn, hydrogel
- 2.4 Product Code: MGQ, OLR
- 2.5 Classification Regulation: Unclassified
- 2.6 Device Class: Unclassified
- 2.7 Classification Panel: Dental
3. PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Manufacturer | MIZ Implants Technologies Ltd. |
| Device Name (Trade Name) | PerioPatch |
| 510(k) Number | K110750 |
4. SUBJECT DEVICE DESCRIPTION
Intra-oral Wound Dressing is a device comprised of an oral mucosa adhesive side and a protection side. The oral mucosa adhesive side is composed of a water soluble polymer that when exposed to moisture in the oral cavity changes into a gel state to achieve adhesion to the wound area. The protection side consists of a waterinsoluble polymer which covers the wound to protect the applicable area from the environment in the oral cavity. Intra-oral Wound Dressing is simply a non-sterile bandage to protect oral wounds.
5. INDICATON FOR USE
4
Intra-oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery. Intra-oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | TBM Corporation | MIZ Implants Technologies Ltd. |
| Product Name | Intra-oral Wound Dressing | PerioPatch |
| Device Name | Ora-Aid | PerioPatch |
| 510(k) Number | K211851 | K110750 |
| Product Code | MGQ, OLR | MGQ, FRO |
| Indications for Use | Intra-oral Wound Dressing is intended | |
| for the management of all types of oral | ||
| wounds, injuries and ulcerations of the | ||
| gingival and oral mucosa, including | ||
| stomatitis, minor chafing and traumaticill-fitting dentures, and lesions associated | ||
| with oral surgery. Intra-oral Wound | ||
| Dressing operates to relieve pain by | ||
| adhering to and protecting affected | ||
| tissues from further irritation, thereby | ||
| allowing healing. | PerioPatch is intended for the | |
| management of all types of oral wounds, | ||
| injuries and ulcerations of the gingivalminor chafing and traumatic ulcers, | ||
| abrasions caused by braces and ill-fitting | ||
| dentures, and lesions associated with oral | ||
| surgery. PerioPatch operates to relieve | ||
| pain by adhering to and protecting | ||
| affected tissues from further irritation, | ||
| thereby allowing healing. | ||
| Prescription or | ||
| OTC | Prescription Use | Prescription Use |
| Mechanism of | ||
| Action | It reverts to a soft and gel-type thin sheet | |
| in the oral environment and adheres to | ||
| and protects affected tissue as a physical | ||
| barrier to reduce irritation and pain. | It reverts to a soft and gel-type thin sheet | |
| in the oral environment and adheres to | ||
| and protects affected tissue as a physical | ||
| barrier to reduce irritation and pain. | ||
| Adhesion time | 4 hours | 30 to 45 minutes |
| Structure | Polymer | Polymer |
| Sterility | None | None |
| Single Use | Yes | Yes |
| Size | AD12: 12mm x (0.3~0.399)mm [DxT] | |
| OB23: 25mm x 15mm x (0.3~0.399)mm | ||
| [WxLxT] | ||
| OB53: 50mm x 15mm x (0.3~0.399)mm | ||
| [WxLxT] | 24mm x 8 mm x 190mm [WxLxT] | |
| 25mm x 8 mm x 190mm [WxLxT] | ||
| Material | Refer to Reference 1 | Refer to Reference 2 |
| 1) W (Wide) x L (Length) x T (Thickness) or D (Diameter) x T (Thickness) |
6. SUBSTANTIAL EQUIVALENCE
6.1 Material Comparative Table
| No | Reference 1
(Subject Device) | Reference 2
(Predicate Device) | Function |
|----|---------------------------------|-----------------------------------|-------------|
| 1 | Povidone | Polyvinylacetate | Film former |
| 2 | Hydroxyethyl cellulose | Hydroxypropyl methylcellulose | Thickner |
| 3 | Carbomer940 | - | Thickner |
| 4 | Glycerin | - | Humectant |
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Image /page/5/Picture/0 description: The image shows a logo with the letters 'TM' inside of a cube on the left side. To the right of the logo, the words 'TECHNOLOGY' and 'BIO - MATERIALS' are written in a simple, sans-serif font. The text is aligned to the left and is in all caps.
| 5 | Polyethylene Glycol | - | Humectant |
|---|---|---|---|
| 6 | Citric Acid Hydrate | - | pH buffering agent |
| 7 | Trolamine | - | pH buffering agent |
| 8 | Sorbitan Monooleate | - | Emulsifier |
| 9 | Polysorbate 20 | - | Emulsifier |
| 10 | Ethanol | Alcohol | Solvent |
| 11 | Purified Water in Bulk | - | Solvent |
| 12 | Saccharin Sodium Hydrate | - | Sweetener |
| 13 | Methylparaben | - | Preservative |
| 14 | Tocopherol Acetate | - | Anti oxidant |
| 15 | Minty Flavor | - | Minty Flavor |
| 16 | Ethylcellulose | - | Film former |
| 17 | Castor Oil | - | Plasticizer |
| 18 | Ethanol | - | Solvent |
| 19 | Titanium Oxide | - | Opacifier |
| 20 | Poly | - | - |
| 21 | - | Natural Calcium | Unidentified |
| 22 | - | Silicon | Unidentified |
| 23 | - | Phosphorus Elements | Unidentified |
6.2 Narrative summary of the similarities and the differences between the Subject Device and the Predicate Device
The similarities and differences in comparative tabulation between the subject device (Ora-Aid) and predicate device (PerioPatch – K110750) are summarized below.
Both devices are prescription devices, consisting of a polymer type material for single use and provided nonsterile. Both devices revert to a soft and gel-type thin sheet in the oral environment and adheres to and protects affected tissue as a physical barrier to reduce irritation and pain.
In terms of technological differences, material, adhesion time and size differ between the subject device and the predicate device.
Although materials and material functions are different as found in the Material Comparable Table, Biocompatibility tests were conducted according to ISO 10993 and performance tests (Adhesion) according to EN 13726. These tests were conducted for assurance of the safety and the performance of the subject device on the materials and function.
Although the subject device is provided non-sterile, a microbial limit test was conducted according to KP11th standard that is described with the same test method as USP 40NF35 and USP 40NF35 to address the risk of infection to compromised oral mucosa with use of the result indicates no growth was observed. Adhesion time is different between the subject device (4hours) and the predicate device (35 ~ 45minutes) according to bench testing. Adhesion time of the subject device was noted to be longer than the predicated device. According to bench test result related to adhesion performance of the subject device is longer than the predicate device for protecting oral wounds.
Although the size including shape of the subject device is different from the predicate device, results of both the subject device and the predicate device are verified in accordance with bench testing and biocompatibility testing. Overall, the differences in technological characteristics of the subject and predicate devices do not raise any different questions of safety and effectiveness.
6
7. NON-CLINICAL DATA
7.1 Safety Test
1) 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 |
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 | USP 40NF35 | |
| Microbial Limit Test | USP 40NF35 | |
| USP |
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.
Although the bench testing report indicate there is a difference with the physical property (adhesion) between subject device and predicate device, the difference does not raise any concerns of safety and effectiveness.
| No. | Test Items | Standards |
|---|---|---|
| 1 | Absorbency | EN 13726-1:2002 |
8. CONCLUSION
In comparing for substantial equivalence between the subject device and the predicate device, similarities include product code, indications for use, mechanism of action and structure. Although there are some differences
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Image /page/7/Picture/0 description: The image shows the logo for Technological Bio-Materials. The logo consists of a cube with the letters T, B, and M on its faces, with a heart shape on the top face. To the right of the cube are the words "TECHNOLOGICAL" and "BIO - MATERIALS" stacked on top of each other.
(raw material characteristics and size), the safety and performance test reports provided do not raise concerns of safety and effectiveness of the subject device in comparison to the predicate device.
In this regard, we conclude that the subject device is substantially equivalent to the predicate device.