(58 days)
No
The device description and performance studies focus on the chemical composition and physical properties of the gel, with no mention of AI or ML.
Yes
The device is described as relieving and treating symptoms, and it has a predicate device (K061331) which is also a therapeutic device.
No
The device is described as an artificial saliva gel that relieves symptoms of dry mouth. Its intended use is to moisturize, soothe, and lubricate, not to diagnose a condition.
No
The device description clearly states it is a gel supplied in a tube and foil pack, indicating a physical product, 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 relieve symptoms of dry mouth, refresh, moisturize, soothe oral irritation, and lubricate oral dryness. This is a therapeutic or palliative use, not a diagnostic one.
- Device Description: The device is described as an artificial saliva gel with moisturizing and lubricating properties. It does not mention any components or functions related to testing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like saliva, blood, etc.), detecting specific markers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on biocompatibility, stability, and physical properties, which are relevant for a topical or oral therapeutic device, not an IVD. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to alleviate symptoms directly in the oral cavity.
N/A
Intended Use / Indications for Use
Relieve symptoms of dry mouth, refresh, moisturize, soothes oral irritation, and lubricate oral dryness.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
Salivea Dry Mouth Moisturizing Gel are specially formulated artificial saliva which contain moisturizers, humectants and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth. The Salivea Dry Mouth Moisturizing Gel is supplied in 1 oz tube and sample foil pack.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
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)
Nonclinical Testing:
Biocompatibility was established generally following 10993-1. The Mucosal irritation, Sensitization (maximization), Acute Oral toxicity.
Stability studies demonstrated that the formulations are safe and stable.
Comparative physical properties testing with predicate device was performed. The results were comparable. Physical testing includes pH, Viscosity and Specific gravity.
No clinical tests were performed.
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 and 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".
April 19, 2024
Laclede, Inc. Rajvinder Atwal Quality Assurance 2103 E. University Dr. Rancho Dominguez, California 90220
Re: K240508
Trade/Device Name: Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) Regulatory Class: Unclassified Product Code: LFD Dated: February 21, 2024 Received: February 21, 2024
Dear Rajvinder Atwal:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
Indications for Use (Describe)
Relieve symptoms of dry mouth, refresh, moisturize, soothes oral irritation, and lubricate oral dryness.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510 (k) Summary - K240508
| Submission By: | Laclede, Inc. |
|---|---|
| Address: | 2103 E. University Drive |
| Rancho Dominguez, Ca 90220 | |
| Telephone: | 310-605-4280 |
| Facsimile: | 310-605-4288 |
| Contact Name: | Stephen Pellico |
| Email: | spellico@laclede.com |
| Correspondent Name: | Rajvinder Atwal |
| Email: | ratwal@laclede.com |
| Date 510(k) Summary Prepared: | 4/18/2024 |
| Trade Name/Device Name: | SALIVEA DRY MOUTH MOISTURIZING GEL |
| Regulation Number: | Unclassified |
| Regulation Name: | Saliva, Artificial |
| Product Code: | LFD |
Primary Predicate Device:
Oral Balance Gel. Laclede. Inc., K061331
Reference Predicate Device:
Oral 7 Moisturizing Gel, J.C.E.C Company Inc., K142549 Salivea Dry Mouth Mouthwash. Salivea Dry Mouth MouthSpray, Laclede, Inc., K180680 Biotene Oral Balance Gel, GSKCH, K123731
Device Description:
Salivea Dry Mouth Moisturizing Gel are specially formulated artificial saliva which contain moisturizers, humectants and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth. The Salivea Dry Mouth Moisturizing Gel is supplied in 1 oz tube and sample foil pack.
Indications for use:
Relieve symptoms of dry mouth, refresh, moisturize, soothes oral irritation, and lubricate oral dryness.
Substantial Equivalence:
Salivea products have the same intended use, technical characteristics and physiological purpose. Any minor variations in formula/composition are to allow proper dispensing and use of product and do not affect the function, indications, or equivalency of proposed product.
5
| Product | Salivea
Dry
Mouth Gel | Oral
Balance Gel
(K061331)
Primary
Predicate | Oral7
Moisturizing
Gel
(K142549)
Reference
Predicate | Biotene Oral
Balance Gel
(K123731)
Reference
Predicate | Salivea
Dry
Mouth
Mouthwash,
Salivea Dry
Mouth
MouthSpray
(K180680)
Reference |
|-------------------------|-------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended Use | Symptomatic
Treatment of
xerostomia | Symptomatic
Treatment of
xerostomia | Symptomatic
Treatment
of
xerostomia | Symptomatic
Treatment of
xerostomia | Symptomatic
Treatment of
xerostomia |
| Method
of
Use | Ready to use
Gel | Ready to use
Gel | Ready to use
Gel | Ready to use
Gel | Ready to use
Gel |
| Applications
per Day | As needed | As needed | As needed | As needed | As needed |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity |
| Type
of
Product | Gel | Gel | Gel | Gel | Gel |
| Presentation | Non-Sterile,
tube | Non-Sterile,
tube | Non-Sterile,
tube | Non-Sterile,
tube | Non-Sterile,
bottle |
Discussion and conclusions from the Nonclinical Testing:
Biocompatibility was established generally following 10993-1. The Mucosal irritation, Sensitization (maximization), Acute Oral toxicity.
Stability studies demonstrated that the formulations are safe and stable.
Comparative physical properties testing with predicate device was performed. The results were comparable. Physical testing includes pH, Viscosity and Specific gravity.
No clinical tests were performed.
Conclusion:
Salivea Dry Mouth Moisturizing Gel has the same intended use and similar technological properties as primary and reference predicate devices. Salivea Dry Mouth Moisturizing Gel and Oral Balance Gel are similar formulation. Minor differences between Salivea Dry Mouth Moisturizing Gel and Oral Balance Gel formula do not affect device safety and effectiveness. All ingredients in the Salivea Dry Mouth Moisturizing Gel are commonly used for their intended functions.
The performance data demonstrate that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.
Given the similarities in chemical composition, available delivery forms and physical properties between subject and primary predicate devices, Salivea Dry Mouth Moisturizing Gel are safe and effective as the primary and reference predicate devices.