GLISSANT Intimate Lubricant Fragrance Free/Sea Salt & Caramel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Device Description

GLISSANT Intimate Lubricant is a water-based, non-sterile, colorless, viscous personal lubricant It does not contain a contraceptive or spermicidal component. The device is packaged in a polyethylene bottle with a lockdown pump. The primary packaging is plastic placed inside of a display box (dimensions 1.375" width x 1.375" depth x 4.75" height).

AI/ML Overview

This document is a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, many of the requested elements for describing acceptance criteria and study proving device performance (especially those related to AI/ML and associated ground truth, expert readers, and human-in-the-loop studies) are not applicable.

However, I can extract the relevant information regarding the acceptance criteria for the GLISSANT Intimate Lubricant and the studies performed to demonstrate its performance, primarily non-clinical bench testing.

Device Name: GLISSANT Intimate Lubricant

Device Type: Personal lubricant (Class II medical device)

Regulatory Product Code: NUC (Condom)

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are presented as specifications for various parameters, and the reported device performance is that the device "met its specifications" for these parameters at baseline and after accelerated aging.

Parameter	Specification Acceptance Criteria	Reported Device Performance
Appearance	Clear, viscous	Met specifications (Clear, viscous)
Color	Colorless	Met specifications (Colorless)
Odor	Odorless	Met specifications (Odorless)
pH	3.9 – 4.1	Met specifications (within 3.9 – 4.1)
Specific gravity	1.003 g/mL	Met specifications (1.003 g/mL)
Viscosity	250 – 500 cps	Met specifications (within 250 – 500 cps)
Osmolarity	160 – 222 mOsm/kg	Met specifications (within 160 – 222 mOsm/kg)
Antimicrobial effectiveness	Per USP <51> (Category 2)	Met specifications (Per USP <51>)
Total microbial count	Per USP <61> (<100 cfu/g)	Met specifications (Per USP <61>, <100 cfu/g)
Fungal/yeast/mold limits	Per USP <61> (<10 cfu/g)	Met specifications (Per USP <61>, <10 cfu/g)
Absence of pathogenic organisms	Per USP <62> (absent)	Met specifications (Per USP <62>, absent for listed organisms)

In addition, the following performance aspects were evaluated:

Biocompatibility:
- Acceptance Criteria: Non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
- Reported Performance: The subject lubricants were found to be non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic based on ISO 10993 testing.
Condom Compatibility:
- Acceptance Criteria: Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (as per claim).
- Reported Performance: Compatible with natural rubber latex, polyisoprene, and polyurethane condoms, based on ASTM D7661-10.
Shelf Life (Stability):
- Acceptance Criteria: Maintain specifications for 12 months.
- Reported Performance: 12 months shelf life established based on accelerated aging study (ASTM F1980-16), with all aforementioned specifications met at baseline and post-aging.

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

This document describes non-clinical, laboratory-based performance testing rather than a clinical trial or a machine learning study with a "test set" in the conventional sense. Therefore, "sample size" refers to the number of units or replications tested in the various benchtop studies. The document does not specify the exact number of samples tested for each parameter (e.g., how many bottles were tested for pH, or how many organisms for microbial counts).

Data Provenance: The studies were performance-based, non-clinical tests conducted likely in a laboratory setting. The country of origin of the data is not specified, but the testing standards (USP, ISO, ASTM) are international. This was clearly retrospective data gathered for a premarket submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI/ML device requiring expert annotation for ground truth. Ground truth for chemical and physical properties (pH, viscosity, etc.) is established by measurements against defined physical/chemical standards. Biocompatibility and microbial testing results are determined by laboratory assays following established protocols.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML device requiring expert adjudication of results. Laboratory tests have defined acceptance criteria and measurement methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. This is not an AI/ML device; therefore, no MRMC study was conducted or relevant.

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

Not applicable. This is not an AI/ML device. Performance is inherent to the product's physicochemical properties and biological interactions, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Industry Standards & Regulations: Defined by USP (United States Pharmacopeia) monographs for microbial limits and antimicrobial effectiveness, ISO (International Organization for Standardization) standards for biocompatibility (ISO 10993 series), and ASTM (American Society for Testing and Materials) standards for condom compatibility (ASTM D7661-10) and accelerated aging (ASTM F1980-16).
Physicochemical Measurements: Direct measurements of properties like pH, specific gravity, viscosity, and osmolarity using standard laboratory equipment and methods.
Biological Assays: In vitro and in vivo (for some biocompatibility tests) biological assays to assess cellular toxicity, irritation, sensitization, and presence/absence of specific microorganisms.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment process for it. Performance specifications are based on intended use, regulatory requirements, and comparison to predicate devices, verified through non-clinical testing.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

July 8, 2019

Vjuvenate, LLC Karyn Eilber President. CEO 3435 Santa Monica Blvd. Suite 107 Santa Monica, CA 90405

Re: K183050 Trade/Device Name: GLISSANT Intimate Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 31, 2019 Received: June 7, 2019

Dear Karyn Eilber:

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

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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 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 medical devices and radiation-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,

Sharon Andrews Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology 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) K183050

Device Name GLISSANT Intimate Lubricant

Indications for Use (Describe)

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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K183050 - Traditional 510(k) Premarket Notification GLISSANT Intimate Lubricant

GLISSANT Intimate Lubricant – K183050

510(k) Summary

Submitter	VJUVENATE, LLC3435 Ocean Park Boulevard, Suite 107Santa Monica, CA 90405(424) 835-4372
Contact person	Karyn S. Eilber, MDdreilber@vjuvenateyou.com(424) 835-4372 Office(310) 909-4967 Mobile
Date prepared	July 5, 2019
Device trade names	GLISSANT Intimate LubricantGLISSANT Intimate Lubricant - Fragrance FreeGLISSANT Intimate Lubricant - Sea Salt & Caramel
Device common name	Personal lubricant
Regulation number	21 CFR 884.5300
Regulation name	Condom
Regulatory class	Class II
Product code	NUC
Classification panel	Obstetrics/gynecology
Predicate device	Aloe CadabraⓇ Personal Lubricant and Aloe CadabraⓇFlavored/Scented Personal Lubricants (K124044)The predicate device has not been subject to a design related recall.
Indications for use	GLISSANT Intimate Lubricant Fragrance Free/Sea Salt & Caramelis a personal lubricant, for penile and/or vaginal application,intended to moisturize and lubricate, and to enhance the ease andcomfort of intimate sexual activity and supplement the body'snatural lubrication. This product is compatible with natural rubberlatex, polyisoprene, and polyurethane condoms.
Device description	GLISSANT Intimate Lubricant is a water-based, non-sterile,colorless, viscous personal lubricant It does not contain a
	contraceptive or spermicidal component. The device is packaged ina polyethylene bottle with a lockdown pump. The primarypackaging is plastic placed inside of a display box (dimensions1.375" width x 1.375" depth x 4.75" height).

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The device specifications are listed in the table below:

Parameter	Specification acceptancecriteria
Appearance	Clear, viscous
Color	Colorless
Odor	Odorless
pH	3.9 – 4.1
Specific gravity	1.003 g/mL
Viscosity	250 – 500 cps
Osmolarity	160 – 222 mOsm/kg
Antimicrobial effectiveness	Per USP <51> (Category 2)
Total microbial count	Per USP <61> (<100 cfu/g)
Fungal/yeast/mold limits	Per USP <61> (<10 cfu/g)
Absence of pathogenicorganisms (e. coli, c.salmonella sp., pseudomonasaeruginosa, s. aureus,clostridia sp., c. albicans)	Per USP <62> (absent)

SUBSTANTIAL EQUIVALENCE DISCUSSION

GLISSANT Intimate Lubricant has the same intended use when compared to the predicate device (Aloe Cadabra® Personal Lubricant and Aloe Cadabra® Flavored/Scented Personal Lubricants (K124044). The GLISSANT Intimate Lubricant has different technological characteristics compared to the predicate device; however, these differences do not raise different questions of safety or effectiveness. The following table compares GLISSANT™ Intimate Lubricant to the predicate device.

	DEVICE	PREDICATE DEVICE
	GLISSANT	ALOE CADABRA®
Trade Name	Intimate LubricantFragrance free andSea Salt & Caramel(K183050)	Personal Lubricant andFlavored/ScentedLubricants(K124044)
Regulation number	21 CFR 884.5300
Regulation name	Condom	SAME
Regulatory class	Class II
Product code	NUC
Indications for use	GLISSANT IntimateLubricant FragranceFree/Sea Salt and Caramel	Aloe Cadabra®Lubricant and AloeCadabra®
	is a personal lubricant, forpenile and/or vaginalapplication, intended tomoisturize and lubricate,and to enhance the easeand comfort of intimatesexual activity andsupplement the body'snatural lubrication. Thisproduct is compatible withnatural rubber latex,polyisoprene, andpolyurethane condoms.	Flavored/ScentedLubricants are personallubricants, for penileand/or vaginalapplication, intended tomoisturize and lubricate,to enhance the ease andcomfort of intimatesexual activity andsupplement the body'snatural lubrication. Thisproduct is compatiblewith natural rubber latexand polyisoprenecondoms. This product isnot compatible withpolyurethane condoms.
Device description	Water-based, non-sterile,unscented andflavored/scented personallubricant	Aloe-based, non-sterile,flavored/scentedpersonal lubricant
Common ingredients	Organic aloe barbadensisleaf juice, potassiumsorbate,hydroxyethylcellulose,stevia, flavor	Aloe
Biocompatibility testsper ISO-10993	Meets acceptancerequirements for allbiocompatibility tests	SAME
Condom compatibilityper ASTM D7661-10	Compatible with naturalrubber latex, polyisoprene,and polyurethane	Not compatible withpolyurethane condoms
Packaging	PETG plastic bottle withlockdown pump packagedin a carton	HDPE plastic bottle withflip top cap packaged ina carton
Shelf life	1 year	2 years
Stability tests per USP	Meets acceptancerequirements for microbial	SAME

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SUMMARY OFNON-CLINICAL PERFORMANCE DATA

Biocompatibility

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The subject device was evaluated for biocompatibility in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:

Cytotoxicity per ISO 10993-5:2009
Acute systemic toxicity per ISO 10993-11:2006
Sensitization per ISO 10993-10:2010 ●
Vaginal irritation per ISO 10993-10:2010

The results of this testing demonstrated that the subject lubricants are non-cytotoxic, nonirritating, non-sensitizing, and non-systemically toxic.

Condom compatibility

Condom compatibility was performed according to the FDA recognized consensus standard ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that JO subject lubricants are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Shelf life (stability) testing

The shelf life of GLISSANT™ Intimate Lubricant is 12 months based on an accelerated aging study per ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

At baseline and following aging, the device met its specifications for appearance, color, odor, pH. specific gravity, viscosity, osmolarity, antimicrobial preservative effectiveness based on USP <51>, total aerobic microbial count and total yeast and mold count based on USP <61>, and absence of pathogenic organisms based on USP <62>.

CONCLUSION

The results of the performance testing described above demonstrate that the GLISSANT Intimate Lubricants are as safe and effective as the predicate device and support a determination of substantial equivalence.

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.