(220 days)
PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
PerioStom™ Dental Dressing can be utilized for the pain relief and protection of oral mucosa due to irritation, trauma, or following iatrogenic procedures such as scaling and root planing.
PerioStom™ Dental Dressing is a powder based wound dressing comprised entirely of spray-dried chitosan. PerioStom™ Dental Dressing is provided to the clinician in a stainless steel container and can be applied to the tissue via a dental instrument of their choice (e.g. a Prichard or Howard Periosteal Elevator) or a dry gloved finger. PerioStom™ Dental Dressing is also supplied in preloaded cartridges for application to harder to reach areas of the oral mucosa via the FS Dispenser™.
This FDA submission describes a medical device, the PerioStom™ Dental Dressing, and seeks substantial equivalence to a predicate device. However, this submission does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
The provided document describes a dental dressing, which is a physical barrier intended for temporary protection of oral mucosal tissue and to provide pain relief. This is a traditional medical device, not an AI/ML-driven device. Therefore, the requested information pertaining to AI/ML device testing (such as performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (HemCon® Dental Bandage K060363) through:
- Comparison of technological characteristics: Both are spray-dried chitosan-based dressings that form a bioadherent gel.
- Non-clinical performance testing: Viscosity, pH, microbial testing, and wound barrier testing. The results were found to be "substantially equivalent" for the subject and predicate devices.
- Biocompatibility testing: According to ISO 10993 standards (Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity). The device met these requirements.
No clinical performance testing was conducted or deemed necessary for this type of device and submission.
Therefore, I cannot provide the requested table and information as it pertains to AI/ML device performance and testing. This document describes a non-AI physical medical device.
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December 22, 2022
Forward Science LLC Brian Pikkula Chief Scientific Officer 10810 Criaghead Dr Houston, Texas 77025
Re: K221428
Trade/Device Name: PerioStom Dental Dressing Regulatory Class: Unclassified Product Code: OLR, MGQ Dated: November 22, 2022 Received: November 23, 2022
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 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 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 -S
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
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Indications for Use
510(k) Number (if known) K221428
Device Name PerioStom™ Dental Dressing
Indications for Use (Describe)
PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | X | X | Prescription Use (Part 21 CFR 801 Subpart D) |
|---|---|---|---|
| X | X | Prescription Use (Part 21 CFR 801 Subpart D) | |
| X | |||
| Over-The-Counter Use (21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart D) | |||
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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Forward Science LLC
510(k) SUMMARY
| Submitted by: | Forward Science LLC10801 Craighead Dr.Houston, TX 77025Ph: 855-696-7254Fax: 855-329-6725 |
|---|---|
| Contact Person: | Brian Pikkula, PhD |
| Date Prepared: | November 22, 2022 |
| Proprietary Name: | PerioStom™ Dental Dressing |
| 510(k) Number: | K221428 |
| Common Name: | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic |
| Device Class: | Unclassified (Pre-Amendment) |
| Panel: | General & Plastic Surgery |
| Product Code: | MGQ |
| Predicate: | HemCon® Dental Bandage (K060363) |
Device Description:
PerioStom™ Dental Dressing is a powder based wound dressing comprised entirely of spray-dried chitosan. PerioStom™ Dental Dressing is provided to the clinician in a stainless steel container and can be applied to the tissue via a dental instrument of their choice (e.g. a Prichard or Howard Periosteal Elevator) or a dry gloved finger. PerioStom™ Dental Dressing is also supplied in preloaded cartridges for application to harder to reach areas of the oral mucosa via the FS Dispenser™.
Indications For Use:
PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
Intended Use:
PerioStom™ Dental Dressing can be utilized for the pain relief and protection of oral mucosa due to irritation, trauma, or following iatrogenic procedures such as scaling and root planing.
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Forward Science LLC
Substantial Equivalence
PerioStom™ Dental Dressing is technologically equivalent to the predicate device, Hemcon Dental Dressing; both are dried chitosan based dressings that are applied to oral mucosal surfaces. Both devices, when exposed to saliva, blood or crevicular fluids, become a bioadherent gel acting as a physical barrier for the mucosal tissue.
PerioStom™ Dental Dressing is substantially equivalent to Hemcon Dental Dressing as evidenced in Table 1. There are no technological differences between the subject and predicate devices.
Both the subject device and the predicate consist of chitosan that when exposed to oral fluids form a protective layer over the compromised mucosa. Both PerioStom™ Dental Dressing and Hemcon Dental Dressing provide pain relief by coating damaged mucosa and protecting it from further contamination and irritation. Therefore, PerioStom™ Dental Dressing and its predicate, Hemcon Dental Dressing, are substantially equivalent.
| ComparisonParameters | Subject Device | Predicate |
|---|---|---|
| PerioStom™ | HemCon Dental Bandage(K060363) | |
| Intended Use | oral wound dressing intended as aphysical barrier for temporaryprotection of oral mucosal tissue andto provide pain relief | oral wound dressing intended as aphysical barrier for temporaryprotection of oral mucosal tissue andto provide pain relief |
| Area of Use | Oral Mucosa | Oral Mucosa |
| ChemicalCharacteristics | Dried chitosan | Dried chitosan |
| Applications | Once per wound | Use as needed |
| Use | Single use | Single use |
| Prescription/OTC | Prescription | Prescription |
| Intended User | Dental Professional | Dental Professional |
| Type of Product | Ready for use | Ready for use |
Table 1. Comparison of Subject Device and Predicates
Non-clinical Performance Testing:
Bench testing comparing PerioStom™ Dental Dressing and Hemcon Dental Dressing were performed. The results were substantially equivalent for PerioStom and the predicate, providing further evidence of substantial equivalence. The testing consisted of:
- Viscosity
- pH
- Microbial Testing
- Wound Barrier Testing ●
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Forward Science LLC
10810 Craighead Dr. Houston, TX 77025 USA Ph: 855-696-7254
Biocompatibility:
In vitro and in vivo biocompatibility testing according to ISO 10993 standards for Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity were performed. The testing demonstrated that PerioStom™ Dental Dressing met the ISO 10993 requirements for biocompatibility.
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, and in vitro & in vivo biocompatibility testing, we believe that PerioStom™ Dental Dressing is substantially equivalent to the predicate K060363.
N/A