Salivea Dry Mouth Mouthwash and Salivea Dry Mouth Mouthspray are specially formulated saliva substitute 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 MouthSpray is supplied in non-pressurized pump action spray white Polyethylene terephthalate bottle.

The Salivea Dry Mouth Mouthwash is supplied in white Polyethylene terephthalate bottle.

AI/ML Overview

This document is a 510(k) Summary for the Salivea Dry Mouth Mouthwash and Mouthspray. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on nonclinical testing.

Here's a breakdown of the requested information, however, it's crucial to understand that this document DOES NOT contain information on clinical studies involving human patients or complex AI algorithms that would require MRMC studies, multi-reader consensus, or large training/test sets for AI models. This is a clearance for a simple medical device (a mouthwash/mouthspray) based on nonclinical testing for biocompatibility and physical properties, not a high-tech AI diagnostic device.

Therefore, many of the requested points are not applicable to this 510(k) submission.

1. A table of acceptance criteria and the reported device performance

The document provides acceptance criteria for nonclinical testing (biocompatibility and physical properties) and states that the results met these criteria. It does not provide detailed quantitative performance data for these tests other than stating they "met the acceptance criteria" or "were comparable."

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Following ISO 10993 (specifically ISO 10993-10 for Mucosal Irritation and Sensitization, and ISO 10993-5 for Oral Toxicity). This generally implies no significant irritation, sensitization, or toxicity observed compared to controls or established safety profiles.	"The results met the acceptance criteria of testing." (Specifically mentioned: Mucosal Irritation (ANSI/ADA/ISO993-10), Sensitization (M&K, GPMT / ISO993-10), Oral toxicity (ANSI/ADA/ISO10993-5)). This signifies the device did not elicit unacceptable biological responses.
Physical Properties	pH, Viscosity, and Specific Gravity. The specific quantitative range for acceptance is not provided, but it's implied to be within acceptable limits for the product type and comparable to the predicate devices.	"Comparative physical properties testing with predicate device was performed and results were comparable."
Real-time Stability	Appearance, pH, viscosity, and specific gravity maintaining within acceptable ranges over time, demonstrating product stability. Specific acceptance ranges not provided.	"Real time stability testing on physical properties i.e., Appearance, pH, viscosity and specific gravity were examined and met acceptance criteria."

2. Sample sizes used for the test set and the data provenance

Test Set Sample Size: Not applicable. This refers to the number of subjects or cases in a clinical trial or AI model validation. For the nonclinical tests referenced (biocompatibility, physical properties, stability), the "sample size" would relate to the number of test articles or batches tested, which is not specified in this summary. These are laboratory tests, not human trials or large image datasets.
Data Provenance: Not applicable in the context of clinical data. These are laboratory test results, presumably conducted by or for the manufacturer (Laclede, Inc.) in the US, as the company is based in California. The tests are standard industry practices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in this context typically refers to expert labels for clinical data (e.g., radiologists interpreting images). This device clearance is based on laboratory testing, not expert clinical interpretation of patient data. The "ground truth" for these tests are the objective measurements and observations from the validated laboratory assays themselves (e.g., pH meter readings, visual assessment for irritation, etc.).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are used in clinical studies or AI model evaluations where multiple human readers disagree on a diagnosis or finding. This document describes laboratory testing where outcomes are objective measurements or standardized observations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers in interpreting clinical data. This is a simple medical device (mouthwash/mouthspray) where there is no AI component or human reader interpretation involved.

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

Not Applicable. There is no algorithm for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Objective Laboratory Test Results: The "ground truth" for the nonclinical testing were the established scientific methods and resulting measurements/observations from biocompatibility tests (e.g., lack of inflammation, no signs of toxicity) and physical property measurements (e.g., pH values, viscosity measurements). There is no "pathology" or "outcomes data" in the clinical sense for this type of device clearance.

8. The sample size for the training set

Not Applicable. This device is not an AI model, so there is no training set.

9. How the ground truth for the training set was established

Not Applicable. Since there is no training set, there is no ground truth for a training set to be established.

In summary, this 510(k) Summary focuses on demonstrating the substantial equivalence of a general medical device (mouthwash/mouthspray) to legally marketed predicate devices through nonclinical bench testing and ingredient comparison. It does not involve complex clinical studies, AI algorithms, or extensive human reader evaluations typically associated with the detailed questions posed.

Summary

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October 11, 2018

Laclede, Inc. Rajvinder Atwal QA Manager 2103 E. University Dr. Rancho Dominguez, California 90220

Re: K180680

Trade/Device Name: Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray Regulatory Class: Unclassified Product Code: LFD Dated: September 5, 2018 Received: September 6, 2018

Dear Rajvinder Atwal:

We have reviewed vour 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S3

forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Salivea Dry Mouth Mouthwash and Salivea Dry Mouth Mouth Spray.

Indications for Use (Describe)

Relieve symptoms of dry mouth, refresh, moisturize, clean and sooth oral irritation, and oral dryness.

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

Submission By:	Laclede, Inc.
Address:	2103 E. University DriveRancho Dominguez, Ca 90220
Telephone:	310-605-4280
Facsimile:	310-605-4288
Contact Name:	Michael A. Pellico, President
Email:	mpellico@laclede.com

Date 510(k) Summary Prepared: September 13, 2018

Trade Name/Device Name:	SALIVEA DRY MOUTH MOUTHWASHSALIVEA DRY MOUTH MOUTHSPRAY
Regulation Number:	Unclassified
Regulation Name:	Saliva, Artificial
Product Code:	LFD

Primary Predicate Device:

BIOTENE MOISTURIZING MOUTHSPRAY, GSKCH, K103745 BIOTENE DRY MOUTH MOUTHWASH, GSKCH, K101477

Reference Predicate Device:

Oral 7 Moisturizing Spray and Mouthwash, J.C.E.C Company Inc., K.142549 Oral Balance Gel, Laclede, Inc., K061331

Device Description:

The Salivea Dry Mouth MouthSpray is supplied in non-pressurized pump action spray white Polyethylene terephthalate bottle.

The Salivea Dry Mouth Mouthwash is supplied in white Polyethylene terephthalate bottle.

Indications for Use:

Relieve symptoms of dry mouth, refresh, moisturize, clean and sooth oral irritation, and 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	Salivea DryMouthwash	Biotene DryMouthwash(K101477)	Salivea DryMouthSpray	BioteneMoisturizingMouthspray(K103745)
Method of Use	Ready to useliquid	Ready to useliquid	Ready to usespray	Ready to usespray
Applicationsper Day	As needed	As needed	As needed	As needed
Disease State	Xerostomia	Xerostomia	Xerostomia	Xerostomia
Area of Use	Oral Cavity	Oral Cavity	Oral Cavity	Oral Cavity
TypeofProduct	Liquid	Liquid	Liquid	Liquid
IndicationsofUse	SupportsSaliva's NaturalDefense,Refresh Breath,moisturizes,gently cleansand soothes DryOral Irritations.	Relieves thesymptoms ofdry mouth,refresh,moisturize,clean, sootheoralirritationandlubricateoral dryness.	Relieve thesymptoms ofDry Mouth,instantlymoisturizes&hydrates drytissue, refreshesbreathandsoothesirritation.	Relieves thesymptoms ofdry mouth,refresh,moisturize,clean, sootheoralirritationandlubricateoral dryness.
Presentation	Non-Sterile,PET bottle	Non-Sterile,PET bottle	Non-Sterile,PET bottle	Non-Sterile,PET bottle

Discussion and conclusions from the Nonclinical Testing:

Biocompatibility was established through testing generally following ISO 10993, and includes Mucosal Irritation, Sensitization, and Oral toxicity testing. The results met the acceptance criteria of testing.

· Mucosal irritation (ANSI/ADA/ISO993-10)
· Sensitization (M&K, GPMT / ISO993-10)
· Oral toxicity (ANSI/ADA/ISO10993-5)

Physical testing includes pH, Viscosity and Specific gravity. Comparative physical properties testing with predicate device was performed and results were comparable.

Real time stability testing on physical properties i.e., Appearance, pH, viscosity and specific gravity were examined and met acceptance criteria.

Conclusion:

The subject Salivea Products has same materials (i.e., moisturizers, humectants and salivary enzymes) as the primary predicate devices. All ingredients in the Salivea products are commonly used for their intended functions. Salivea products have the same intended use and the same technological properties as primary and reference predicate devices. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

N/A