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.

AI/ML Overview

Please note that the provided document is a 510(k) summary for a medical device (Salivea Dry Mouth Moisturizing Gel), which is a non-AI/ML device. Therefore, many of the requested criteria related to AI/ML model development and validation (e.g., test set data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, manufacturing, and non-clinical performance (biocompatibility, stability, physical properties).

Here's an analysis based on the information provided, highlighting what is applicable and what is not:

Acceptance Criteria and Study for Salivea Dry Mouth Moisturizing Gel

1. Table of Acceptance Criteria and Reported Device Performance

For this non-AI/ML device, "acceptance criteria" are typically related to physical properties, biocompatibility, and stability, rather than machine learning performance metrics. The document confirms that these criteria were met.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance	Comments
Biocompatibility	Following ISO 10993-1:	Established as safe:	Standard practice for medical devices.
	- Mucosal irritation	Met
	- Sensitization	Met
	- Acute Oral Toxicity	Met
Stability	Demonstrated stability	Stable	Ensures product integrity over shelf life.
Physical Properties	Comparable to predicate:	Comparable to predicate
	- pH	Met
	- Viscosity	Met
	- Specific Gravity	Met
Clinical Performance	(Not Applicable)	No clinical tests performed	Substantial equivalence relied on non-clinical data and similarity to predicates.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the context of a "test set" for performance evaluation in the way an AI/ML model would have one. For physical and biocompatibility testing, standard sample sizes according to relevant test methods would have been used but are not detailed here.
Data Provenance: Not applicable in the context of a "test set" as understood for AI/ML. The data comes from the manufacturer's internal testing. The document does not specify the country of origin of the raw materials or testing facilities, nor does it refer to retrospective or prospective data collection from patients, as no clinical studies were performed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a non-AI/ML device. "Ground truth" in the AI/ML sense (e.g., expert annotations on images) is not relevant to its evaluation. The performance is assessed through biochemical and physical testing, and safety (biocompatibility) and stability studies, which rely on established laboratory standards and qualified technicians/scientists performing the tests.

4. Adjudication Method for the Test Set

Not Applicable. No human "adjudication" of results in the AI/ML sense (e.g., resolving discrepancies in expert labels) was required. Test results are objective measurements from laboratory equipment or standardized biological assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for evaluating the impact of AI on human interpretation (e.g., radiologists reading images). Since this is a moisturizing gel and its evaluation did not involve human readers interpreting data, an MRMC study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm. Therefore, "standalone performance" of an AI algorithm is not relevant.

7. The Type of Ground Truth Used

Not Applicable in the AI/ML sense. For this device, "ground truth" equates to:
- Validated laboratory test methods: For pH, viscosity, specific gravity, and stability.
- Standardized biocompatibility assays: Following ISO 10993 for irritation, sensitization, and toxicity.
- Predicate device characteristics: The existing, legally marketed predicate devices serve as a benchmark for comparison regarding intended use, technological characteristics, and physiological purpose.

8. The Sample Size for the Training Set

Not Applicable. This is a non-AI/ML device. There is no AI model, and therefore no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no AI model or training set, "ground truth" establishment for a training set is not part of this submission.

Summary

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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).

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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

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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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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510 (k) Summary - K240508

Submission By:	Laclede, Inc.
Address:	2103 E. University DriveRancho 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:

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.

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Product	SaliveaDryMouth Gel	OralBalance Gel(K061331)PrimaryPredicate	Oral7MoisturizingGel(K142549)ReferencePredicate	Biotene OralBalance Gel(K123731)ReferencePredicate	SaliveaDryMouthMouthwash,Salivea DryMouthMouthSpray(K180680)Reference
Intended Use	SymptomaticTreatment ofxerostomia	SymptomaticTreatment ofxerostomia	SymptomaticTreatmentofxerostomia	SymptomaticTreatment ofxerostomia	SymptomaticTreatment ofxerostomia
MethodofUse	Ready to useGel	Ready to useGel	Ready to useGel	Ready to useGel	Ready to useGel
Applicationsper 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
TypeofProduct	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.

Regulation Number and Section

N/A