(177 days)
No
The description focuses on the chemical and physical properties of the rinse and its function as a protective barrier and moisturizer. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to manage pain, form a protective barrier for wounds, and provide a moist environment for optimal wound healing, which are therapeutic functions.
No
Explanation: The device description and intended use clearly state that Synvaza is designed to manage pain and provide a protective barrier for oral wounds, facilitating healing. There is no mention of it being used to detect, diagnose, or monitor a disease or condition. It is a therapeutic product, not a diagnostic one.
No
The device description clearly states it is an "oral wound rinse" supplied in "plastic bottles," indicating it is a physical substance and packaging, 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 pain and provide a protective barrier for oral wounds, mouth sores, injuries, and ulcers. This is a therapeutic and protective function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a rinse that forms a protective coating and provides a moist wound environment. This aligns with a topical treatment or protective barrier, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis or monitoring of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to directly treat and protect the oral mucosa.
N/A
Intended Use / Indications for Use
Synvaza manages the pain in many types 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 contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.
Product codes (comma separated list FDA assigned to the subject device)
OLR, MGO, MGQ
Device Description
Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing.
Synvaza is supplied in plastic bottles with and without a hand pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa / mouth
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 Performance Testing: Biocompatibility and preservative data were collected to show equivalence in safety of the product.
Tests include: Cytotoxicity (Result: Not Cytotoxic), Maximization test for delayed-type hypersensitivity (Result: Not Sensitizing), Dermal irritation (Result: Not irritating to dermal tissue), Oral mucosal irritation (Result: Not irritating to oral tissue), Acute systemic toxicity (Result: Not systemically toxic).
Preservation: Synvaza meets the challenges tested based on USP "Category 3" for aqueous products that are used in the oral cavity.
Clinical Performance Testing: In an open label, single arm study of preselected study subjects who used your proposed device at least twice a day for 72 hours, study subjects reported experience of pain relief for the study duration.
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.
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 & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
May 27, 2020
Christopher Ryan, COO Synedgen, Inc. 1420 North Claremont Blvd. Suite 105D Claremont, California 91711
Re: K193336
Trade/Device Name: Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse Regulatory Class: Unclassified Product Code: OLR, MGO Dated: April 29, 2020 Received: April 30, 2020
Dear Christopher Ryan:
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
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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.
for Srinivas "Nandu" Nandkumar, Ph.D. 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
510(k) Number (if known) K193336
Device Name Synvaza Oral Wound Rinse
Indications for Use (Describe)
Synvaza manages the pain in many types 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 contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.
| 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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510(k) Summary K193336
Synedgen, Inc.
Synvaza and Synvaza II
Submitter:
Synedgen, Inc. 1420 North Claremont Blvd, Suite 105D Claremont, CA 91711 Phone: 909-447-6858 909-447-6801 Fax: Contact Person: Christopher Ryan Date Prepared: Mav 23, 2020
Device:
Name of Device: Synvaza and Synvaza II
Common or Usual name: Dressing, wound and burn, hydrogel w/drug and/or biologic
Classification: Unclassified
Product Code: MGQ
Primary Predicate Device:
"Sock It!" Oral Pain Gel (K063148)
Reference Predicate Devices:
Gengigel Rinse (K053342) Moisyn (K173237)
Device Description:
Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing.
Synvaza is supplied in plastic bottles with and without a hand pump.
Indications for Use:
Synvaza manages the pain in many types 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 and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers: aphthous ulcers.
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Comparison of Technology:
Both the predicate and proposed devices are aqueous-based formulas that contain polysaccharides to form films on the mucosal surface and protect it from irritation. Like the predicate, Synvaza contains mucoadhesive film formers, chitosan derivatives, which adhere to oral tissues and form a protective barrier between wounds and further irritation or contamination. Like the predicate, the ingredients in Synvaza, chitosan derivatives in combination with glycerol and sorbitol, provide a moist wound environment required for optimal wound healing.
The non-substantial difference in design between Synvaza and Gengigel in comparison to "Sock it!" gel is the time at which water is incorporated. With Synvaza and Gengigel, the water is incorporated at the factory when the product is made. With "Sock it!", the water is incorporated in the mouth with saliva. Synvaza, Gengigel, and "Sock It!" all adhere to the surface of the wound surface and provide a barrier to manage pain.
Non-clinical Performance Testing:
Biocompatibility and preservative data were collected to show equivalence in safety of the product. A clinical study shows equivalence in efficacy.
| Test | Result |
|---|---|
| Cytotoxicity | Not Cytotoxic |
| Maximization test for delayed-type hypersensitivity | Not Sensitizing |
| Dermal irritation | Not irritating to dermal tissue |
| Oral mucosal irritation | Not irritating to oral tissue |
| Acute systemic toxicity | Not systemically toxic |
Biocompatibility Testing
Preservation
Synvaza meets the challenges tested based on USP "Category 3" for aqueous products that are used in the oral cavity.
Clinical Performance Testing:
In an open label, single arm study of preselected study subjects who used your proposed device at least twice a day for 72 hours, study subjects reported experience of pain relief for the study duration.
Conclusions:
The candidate device, Synvaza, is substantially equivalent to the predicate device, "Sock It!" Gel (K063148). Synvaza has the same intended use, indications for use, and substantially equivalent technological characteristics as the predicate device.
Based upon similarities in the Indications for Use as well as technology, together with the results of non-clinical and clinical performance testing, we conclude that Synvaza and Synvaza II are substantially equivalent to the predicate device K063148.