(125 days)
No
The device description and performance studies focus on the physical properties and barrier function of a hydrogel, with no mention of AI or ML technologies.
Yes
The device is described as managing pain and forming a protective barrier for oral wounds, which are therapeutic actions. It also has a predicate device (Sock It! Oral Pain Gel) indicating it's a medical device.
No
The device is described as a hydrogel wound dressing that manages pain and protects oral wounds, not as a tool for diagnosis. Its performance studies focus on physical and microbial properties, not diagnostic capabilities.
No
The device description clearly states it is a "viscous hydrogel wound dressing" and is provided in "10mL syringes," indicating it is a physical substance, 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 manage the pain of oral wounds, mouth sores, injuries, and ulcers by forming a protective barrier and maintaining a moist wound environment. This is a therapeutic action applied directly to the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a hydrogel wound dressing applied topically to the oral mucosa. It's a physical barrier and wound care product.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a sample (like blood, urine, saliva, etc.) to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health status, such as diagnosing a disease, monitoring treatment, or screening for conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Orapeutic™ Oral Pain Gel manages the pain of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation & contamination. Orapeutic™ Oral Pain Gel also maintains a moist wound environment.
Product codes
MGQ, OLR
Device Description
Orapeutic™ Oral Pain Gel is a viscous hydrogel wound dressing composed entirely of food grade ingredients including a food grade preservative system. It is designed to be physiologically compatible with both intact and compromised tissue in the mouth to manage the pain associated with injuries to the mouth.
Orapeutic Oral Pain Gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier. It also maintains a moist wound environment.
Orapeutic Oral Pain Gel is provided in 10mL syringes.
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
Bench testing comparing Oral Pain Gel and Sock It! were performed. The results were substantially equivalent for Orapeutic and the predicate, providing further evidence of substantial equivalence. The testing consisted of:
- pH
- Hydrogel Barrier Testing
- Microbial Testing
No clinical performance testing was conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The 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 FDA acronym is in a blue box, and the full name is in a sans-serif font.
November 27, 2019
Forward Science Brian Pikkula, Ph.D. President 10401 Greenbough, Ste 100 Stafford, Texas 77477
Re: K191987
Trade/Device Name: Orapeutic Regulatory Class: Unclassified Product Code: MGQ, OLR Dated: July 24, 2019 Received: July 25, 2019
Dear Brian Pikkula:
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
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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 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 (OS) 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,
for Srinivas Nandkumar, Ph.D. Acting 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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Indications for Use
K191987 510(k) Number:
Orapeutic™ Oral Pain Gel Device Name:
Indications For Use:
Orapeutic™ Oral Pain Gel manages the pain of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation & contamination. Orapeutic™ Oral Pain Gel also maintains a moist wound environment.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter _ (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
K191987
| Submitted by: | Forward Science LLC
10401 Greenbough, Ste 100
Stafford, TX 77477
Ph: 855-696-7254
Fax: 855-329-6725 |
|-------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brian Pikkula, PhD |
| Date Prepared: | November 27, 2019 |
| Proprietary Name: | Orapeutic™ Oral Pain Gel |
| Common Name: | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologi |
| Device Class: | Unclassified (Pre-Amendment) |
| Panel: | General & Plastic Surgery |
| Product Code: | MGQ |
| Predicate Device: | Sock It! Oral Pain Gel (K063148) |
Device Description:
Orapeutic™ Oral Pain Gel is a viscous hydrogel wound dressing composed entirely of food grade ingredients including a food grade preservative system. It is designed to be physiologically compatible with both intact and compromised tissue in the mouth to manage the pain associated with injuries to the mouth.
Orapeutic Oral Pain Gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier. It also maintains a moist wound environment.
Orapeutic Oral Pain Gel is provided in 10mL syringes.
Intended Use:
Orapeutic™ Oral Pain Gel manages the pain of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation & contamination. Orapeutic™ Oral Pain Gel also maintains a moist wound environment.
Comparison of Technology
Orapeutic™ Oral Pain Gel and Sock It! are both hydrogels that manage the pain of oral wounds by forming a protective barrier between the wound and external environment. Both are provided as gels in ready to use syringes.
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The formulations of Orapeutic™ Oral Pain Gel and Sock It! differ. The differences from the predicate does not affect the safety of the subject device because Orapeutic's components are all Food Grade with established safety profiles. The differences do not affect the efficacy of Orapeutic as demonstrated in the results of the comparative non-clinical performance testing submitted in this application.
| Comparison
| Parameters | Subject Device | Predicate |
|---|---|---|
| Orapeutic™ Oral Pain Gel | Sock It! (K063148) | |
| Intended Use | • Management of oral pain | |
| • Adheres to oral tissue forming a | ||
| protective barrier | ||
| • Provides moist environment | • Management of oral pain | |
| • Adheres to oral tissue forming a | ||
| protective barrier | ||
| • Provides moist environment | ||
| Area of Use | Oral Mucosa | Oral Mucosa |
| Applications/Day | Use as needed | Use as needed |
| Prescription/OTC | Prescription | Prescription & OTC |
| Packaging | Gel in syringe provided with cap and | |
| blunt tip | Gel in syringe provided with cap and | |
| blunt tip | ||
| Type of Product | Ready for use | Ready for use |
| Sterility | Non-sterile | Non-sterile |
Table 1. Comparison of Subject Device and Predicates
Non-clinical Performance Testing
Bench testing comparing Oral Pain Gel and Sock It! were performed. The results were substantially equivalent for Orapeutic and the predicate, providing further evidence of substantial equivalence. The testing consisted of:
- pH
- Hydrogel Barrier Testing ●
- . Microbial Testing
Clinical Performance Testing
No clinical performance testing was conducted.
Conclusions
Based upon technologic characteristics as well as the results of comparative non-clinical performance testing, we believe that Orapeutic™ Oral Pain Gel is substantially equivalent to the predicate K063148.