(125 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Orapeutic™ Oral Pain Gel device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Orapeutic™ Oral Pain Gel) | Conclusion Regarding Acceptance |
|---|---|---|---|
| Material Properties | pH | The pH was tested and results were "substantially equivalent" to the predicate device (Sock It! Oral Pain Gel). | Met |
| Barrier Function | Hydrogel Barrier Testing | The hydrogel barrier function was tested and results were "substantially equivalent" to the predicate device. | Met |
| Microbial Safety | Microbial Testing | Microbial testing was performed, and results were "substantially equivalent" to the predicate device. | Met |
| Chemical Safety | Formulation (all food-grade ingredients) | Device is "composed entirely of food grade ingredients including a food grade preservative system" with "established safety profiles." This addresses safety by design. | Met |
| Efficacy | Manage oral pain, adhere to oral tissue, form protective barrier, provide moist wound environment | The device's primary mode of action and intended use are consistent with the predicate, and non-clinical testing demonstrated comparable performance. | Met (via substantial equivalence to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Bench testing comparing Oral Pain Gel and Sock It! were performed," implying comparative tests, but does not provide specific numbers of samples or replicates used for pH, Hydrogel Barrier Testing, or Microbial Testing.
- Data Provenance: The studies were non-clinical performance testing (bench testing). The country of origin is not specified, but the submission is to the U.S. FDA, implying the data would be expected to originate from, or be acceptable to, a U.S. regulatory context. These were likely prospective bench tests designed to compare the new device to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as there was no clinical study involving human patients, and therefore no "ground truth" established by clinical experts or readings of patient data. The "ground truth" for the non-clinical tests was likely established by standard laboratory methods and equipment, and the comparison was to the performance of the legally marketed predicate device.
4. Adjudication Method for the Test Set
- This is not applicable as there were no human readers or subjective interpretations in the non-clinical bench testing that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was conducted."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a hydrogel wound dressing, not an algorithm or AI-based product. Therefore, no standalone algorithm performance testing was performed.
7. The Type of Ground Truth Used
- For the non-clinical performance testing, the "ground truth" was established by objective laboratory measurements of physical and chemical properties (pH) and functional characteristics (hydrogel barrier, microbial presence). The primary form of "ground truth" for demonstrating equivalence was the performance of the legally marketed predicate device (Sock It! Oral Pain Gel) as measured by these objective tests.
8. The Sample Size for the Training Set
- This is not applicable as there is no AI/algorithm involved in this device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as there is no AI/algorithm involved in this device, and thus no training set or associated ground truth.
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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 LLC10401 Greenbough, Ste 100Stafford, TX 77477Ph: 855-696-7254Fax: 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.
| ComparisonParameters | Subject Device | Predicate |
|---|---|---|
| Orapeutic™ Oral Pain Gel | Sock It! (K063148) | |
| Intended Use | • Management of oral pain• Adheres to oral tissue forming aprotective barrier• Provides moist environment | • Management of oral pain• Adheres to oral tissue forming aprotective 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 andblunt tip | Gel in syringe provided with cap andblunt 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.
N/A