The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.

Device Description

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are specifically formulated as an artificial saliva substitute with water, moisturizers, humectants, sweeteners, and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth (xerostomia).

AI/ML Overview

The provided document, a 510(k) Pre-market Notification for GuruNanda Dry Mouth Oral Rinse and Spray, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-based medical devices.

This document is a Substantial Equivalence (SE) Determination letter for a non-AI/ML device (dry mouth rinse and spray). In such cases, the primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a predicate device that is already legally marketed. This typically involves comparing intended use, technological characteristics, materials, and performance to the predicate device.

Therefore, many of the specific questions you've asked, which are highly relevant to the evaluation of AI/ML-based medical devices (e.g., sample size for test sets, number of experts, MRMC studies, standalone performance, ground truth establishment), are not applicable to this submission.

Here's a breakdown of what can be extracted from the document in relation to your questions, and what cannot:

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

Not Applicable in the traditional sense for this type of device. The 'acceptance criteria' for this submission are rooted in demonstrating substantial equivalence to the predicate device (Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray, K123731).
The "reported device performance" is essentially the comparison table on pages 5-6, which shows an identical intended use, similar design, materials, chemical composition (with minor, stated differences in preservatives), and performance characteristics (e.g., appearance, color, odor, method of use, target population).
Performance is demonstrated through:
- Biocompatibility testing: "Cytotoxicity, sensitization, irritation tested and passed in conformity with ISO 10993-5, ISO 10993-10, 10993-23." This is a key safety performance aspect for a device that contacts mucosal membranes.
- Chemical composition comparison: The document states that differences are minor and do not affect safety and effectiveness, and variations are "designated as GRAS ingredients, food additives or have a significant history of use in dental and medical or food applications."

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

Not Applicable. This is not an AI/ML device that underwent a clinical performance study with a test set of patient data. Performance is primarily demonstrated through bench testing (like biocompatibility and chemical analysis) and comparison to a predicate.

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 the context of diagnostic or AI performance, is not a concept that applies to this type of device submission.

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

Not Applicable.

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

Not Applicable. This is not an imaging or diagnostic device that would use human readers or AI assistance.

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

Not Applicable. This is not an algorithm-based device.

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

Not Applicable. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device, and the demonstration that the new device shares fundamentally similar characteristics.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable.

Summary of Device Acceptance/Proof based on this Document:

The acceptance of the GuruNanda Dry Mouth Oral Rinse and Spray is based on its demonstration of Substantial Equivalence (SE) to a legally marketed predicate device (Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray, K123731). The "study" proving this meets criteria is primarily a comparison and analysis of attributes rather than a clinical trial or AI performance study:

Intended Use: Identical ("Relieve the symptoms of dry mouth: refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.")
Technological Characteristics: Very similar design, materials, and chemical composition. Minor differences in chemical composition (e.g., preservatives) are justified as not impacting safety or effectiveness, citing GRAS status or history of safe use.
Performance: Demonstrated through:
- Biocompatibility testing: Confirmed to meet ISO standards (ISO 10993-5, 10993-10, 10993-23) for cytotoxicity, sensitization, and irritation.
- Chemical analysis: The variations in formula/composition are stated not to alter function or safety.
- Physical characteristics: Similar appearance, color, odor.
- Shelf-life: While the predicate had a 3-year shelf life and the new device a 2-year shelf life, this difference was presumably accepted as not raising new questions of safety or effectiveness.

In essence, the "proof" is that the device is so similar to an already cleared device that it does not raise new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 22, 2023

GuruNanda LLC Chetan Patel Director, Formulation Development and Regulatory Affairs 6645 Caballero Blvd. Buena Park, California 90620

Re: K231205

Trade/Device Name: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray Regulatory Class: Unclassified Product Code: LFD Dated: April 27, 2023 Received: April 27, 2023

Dear Chetan Patel:

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.

Bobak Shirmohammadi -5

For Michael E. Adjodha, M. ChE., CQIA 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

N/A

Device Name

GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are stacked on top of each other in a brown, cursive font. There is a curved line above the word "Nanda".

Caballero Blvd. Buena Park, CA 90620 | (866) 421-0309 Office | www.GuruNanda.com

K231205 - 510(k) Summary

510(k) Owner:

Puneet Nanda GuruNanda LLC 6645 Caballero Blvd. Buena Park, CA 90620 Telephone: 714-410-0466 E-Mail: puneet@gurunanda.com

Contact Person:

Chetan Patel GuruNanda LLC 6645 Caballero Blvd. Buena Park, CA 90620 Establishment Registration Number: 3014468707 Telephone:714-322-5024 E-Mail: chetan@gurunanda.com

Date: July 6, 2023

Common/Usual Names: Common Name	Common / Classification Name
Dry Mouth Oral Rinse	Saliva, Artificial
Dry Mouth Oral Spray	Saliva, Artificial

Classification Name: Saliva, Artificial

Product Code: LFD

Identification of a Legally Marketed Predicate Device:

Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray (K123731).

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Image /page/4/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are written in a brown, sans-serif font. There is a curved line above the word "Nanda". The "R" symbol is located at the bottom right of the logo.

LERO BLVD. BUENA PARK, CA 90620 | (866) 421-0309 OFFICE | www.GURUNANDA.com

General Description

Indications for Use:

Indications for Use Discussion:

The only difference between the subject device (GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray) and the predicate device is in the name.

Technological Characteristics

The proposed and predicate devices are similar in design and packaging. Any difference in the chemical compositions between the subject device and predicate device are minor and do not affect the safety and effectiveness.

Substantial Equivalence Discussion

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are substantially equivalent to Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray (K123731) in intended use, design, materials, chemical composition, and performance.

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Image /page/5/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are stacked on top of each other in a brown, cursive font. There is a curved line above the word "Nanda" and a registered trademark symbol to the bottom right of the word.

Substantial Equivalence Comparison

An overview side-by-side comparison of the GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray, and Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray (K123731) as the predicate device is presented below.

	Guru Nanda Dry Mouth OralRinse and Oral Spray	Biotene Dry Mouth Oral Rinse andBiotene Moisturizing MouthSpray (K123731)
510(k) Number	K231205	K123731
Product Code	LFD	LFD
Device CommonName	Saliva, Artificial	Saliva, Artificial
Device Trade Name	GuruNanda Private LabelDry Mouth Oral Rinse andOral Spray	Biotene Dry Mouth Oral Rinse andBiotene Moisturizing Mouth Spray
FDA Class	Unclassified	Unclassified
Regulation	Unclassified	Unclassified
Manufacturer	GuruNanda, LLC	GSK Consumer Healthcare
Product Family	Oral Rinse & Oral Spray	Oral Rinse & Oral Spray
Sold Sterile	No	No
Target Population	Unsupervised consumer use	Unsupervised consumer use
Anatomical Site	Mouth	Mouth
Method of Use	Ready to use liquid	Ready to use liquid
Disease State	Xerostomia	Xerostomia
Mode of Action	Contains ingredients that	Contains ingredients that
	temporarily substitute thefeel of natural saliva tomoisturize, lubricate andrefresh the mouth, therebydiminishing dry mouthdiscomfort	temporarily substitute the feel ofnatural saliva to moisturize,lubricate and refresh the mouth,thereby diminishing dry mouthdiscomfort
Intended Use /Indications for Use	Relieve the symptoms of drymouth: refresh, moisturize,clean, soothe oral irritation,and lubricate oral dryness	Relieve the symptoms of drymouth: refresh, moisturize, clean,soothe oral irritation, and lubricateoral dryness
Labeling /Instructions for Use	Consumer use instructionson labels	Consumer use instructions onlabels
Applications Per Day	As needed	As needed
Appearance	Clear, water-thin liquid	Clear, water-thin liquid
Color	Colorless	Colorless
Odor	Characteristic (Mint)	Characteristic (Mint)
Biocompatibility	Cytotoxicity, sensitization,irritation tested and passedin conformity with ISO10993-5, ISO 10993-10,10993-23	Cytotoxicity, sensitization,irritation tested and passed inconformity with ISO 10993-5, ISO10993-10, 10993-23
Shelf-Life	2 years	3 years
Flavor	Mint Flavor	Mint Flavor
Description	The GuruNanda Dry MouthOral Rinse, GuruNanda DryMouth Oral Spray, arespecifically formulated as anartificial saliva substitutewith water, moisturizers,humectants, sweeteners,and flavors that collectivelyhave lubricating,	Biotene Dry Mouth products areformulated as an artificial salivasubstitute with water,moisturizers, humectants,sweeteners, and flavors thatcollectively have lubricating,moisturizing, soothing, andrefreshing properties to help
	moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth (xerostomia)	relieve and manage the symptoms of dry mouth (xerostomia)

Comparison of GuruNanda Dry Mouth Products with Biotene (K123731) Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are stacked on top of each other in a brown, sans-serif font. There is a swoosh-like line above the word "Nanda". The "R" symbol is in the bottom right corner of the logo.

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Image /page/7/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are stacked on top of each other in a brown, cursive font. There is a curved line above the word "Nanda" and below the word "Guru". The "R" symbol is in the bottom right corner of the logo.

6645 Caballero Blvo. Buena Park, CA 90620 | (866) 421-0309 Office | www.GuruNanda.com

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Image /page/8/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are written in a brown, sans-serif font. There is a curved line above the word "Nanda". The logo is simple and clean, and it is likely used to represent a company or brand.

Caballero Blvd. Buena Park, CA 90620 | (866) 421-0309 Office | www.GuruNanda.com

Discussion of differences:

As shown in the side-by-side comparison of the GuruNanda Dry Mouth Oral Rinse and Oral Spray and the predicate device, Biotene Dry Mouth products (K123731), the artificial saliva products are virtually identical in formulation. The variations in the formula / composition do not affect the function, indications or equivalency of the proposed products, they are primarily related to ingredients used as preservatives.

In summary, these differences in formulation to the predicate devices do not alter the function, indications, or substantial equivalency of the products. Additionally, the variations in the formula / composition are designated as GRAS ingredients, food additives or have a significant history of use in dental and medical or food applications. All components of the product have been manufactured and tested using standardized and industry accepted state of the art production/test methods. The finished products have been tested using standardized and industry accepted test methods.

Based on the side-by-side comparison table above, it is apparent that GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray are not different in intended use and share the same fundamental technological characteristics. The minor design differences in the chemical compositions between the products and the product offerings (oral rinse, spray) does not raise different questions of safety and effectiveness than the predicate device. Based on the data presented, GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are artificial saliva that are substantially equivalent to Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray.

Conclusion:

Based upon the similarity of the intended use and fundamental technology, together with the evaluation of physical and chemical characteristics, the GuruNanda Dry Mouth Oral Rinse and GuruNanda Oral Spray are substantially equivalent to Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray(K123731) in intended use, design, materials, chemical composition, and performance.

Regulation Number and Section

N/A