Elegant™ 2 in 1 Vaginal Moisturizer/ Elegant™ Advanced 5 is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with polyurethane condoms. This product is not compatible with natural rubber latex and polyisoprene condoms.

Device Description

The subject device is a non-sterile, water-based, personal lubricant that provides lubrication during intimate sexual activity. The formulation contains purified water, polycarbophil, carbomer homopolymer type B, labrafac, emulfree P, sorbic acid and sodium hydroxide. Elegant™ 2 in 1 Vaginal Moisturizer is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 2ml of product. Elegant™ Advanced 5, is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product. Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are personal lubricants for over-the-counter (OTC) use.

AI/ML Overview

The provided document is a 510(k) summary for the Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5. This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device. The information required primarily applies to AI/ML medical devices, which this product (a personal lubricant) is not. Therefore, specific details like sample sizes for training/test sets, number of experts for ground truth, adjudication methods, or MRMC studies are not applicable or provided for this type of device.

However, I can extract the acceptance criteria and a summary of the studies conducted to demonstrate the device meets those criteria, as much as possible from the provided text.

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

The document provides "Device Specifications" in Table 1, which serve as the acceptance criteria for the physical and biological properties of the lubricant. It also summarizes the performance studies conducted to demonstrate compliance with these specifications and other safety/effectiveness aspects.

Parameter	Acceptance Criteria (Specification)	Reported Device Performance (Summary from studies)
Physical/Chemical Specifications (from Table 1)
Appearance	White to off-white	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Density USP <699>	0.9970 - 0.9995 g/cm²	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
pH USP <791>	2.5-3.5	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Consistency Ph.Eur 2.9.9	145 – 200 mm	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Viscosity USP <912>	120 - 220 Pa-s	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Osmolality USP <785>	15 – 35 mOsm/kg	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Microbiological Specifications (from Table 1)
Total Aerobic Microbial Count (TAMC) USP <61>	≤ 10² CFU/g	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Total combined yeasts/molds count (TYMC) USP <61>	≤ 10¹ CFU/g	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Absence of pathogenic organisms: Staphylococcus Aureus, Pseudomonas Aeruginosa and Candida Albicans USP <62>	Absent	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Antimicrobial Effectiveness USP <51>	Bacteria: No less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast/Mold: No increase from the initial calculated count at 14 and 28 count.	Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications.
Biological Safety	Non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.	Results of biocompatibility testing (Cytotoxicity, Intra-vaginal tolerance, Penile irritation, Sensitisation, Acute Systemic Toxicity) demonstrated that Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Shelf-Life	Maintain all Table 1 specifications over the stated shelf-life.	Long term data at 25°C/60% RH and accelerated data at 35°C/65% RH for the specifications in Table 1 have been generated up to 6 months, supporting an equivalent of a 12-month shelf life.
Condom Compatibility	Compatible with polyurethane condoms. Not compatible with natural rubber latex and polyisoprene condoms.	Testing conducted in accordance with ASTM D7661-10 confirmed the subject device is compatible with polyurethane condoms. It was also found to be not compatible with natural rubber latex and polyisoprene condoms, which is explicitly stated and accepted as a difference from the predicate device that does not raise different questions of safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the biological or chemical tests, which is typical for this type of submission focusing on standard test methodology and results. The studies appear to be laboratory-based and likely prospective, following recognized international and national standards (e.g., ISO, USP, ICH, ASTM). No country of origin for the data is explicitly mentioned, but the submitter is Viramal Limited, located in the United Kingdom.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to a personal lubricant. The "ground truth" for this device type is established by standardized laboratory testing methods (e.g., pH meters for pH, specific assays for microbial counts, etc.), not expert consensus on interpretations.

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

This is not applicable to a personal lubricant. Standard laboratory tests do not use adjudication methods in the way clinical studies for diagnostic algorithms do.

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

This is not applicable to a personal lubricant. MRMC studies are relevant for medical imaging or similar diagnostic AI/ML devices.

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

This is not applicable to a personal lubricant, as it is not an AI/ML algorithm.

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

The "ground truth" for the performance criteria (specifications) of this device is based on objective measurements obtained through standardized laboratory testing methods (e.g., USP monographs for pH, density, viscosity, osmolality, microbial counts; ISO standards for biocompatibility; ASTM standards for condom compatibility).

8. The sample size for the training set

This is not applicable to a personal lubricant, as it is not an AI/ML device and does not involve training data.

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

This is not applicable to a personal lubricant.

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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 2, 2021

Viramal Limited % Joshua Crist, M.S.E. Senior Consultant Biologics Consulting Group, Inc 1555 King Street, Suite 300 Alexandria, VA 22314

K201612 Re:

Trade/Device Name: Elegant™ 2 in 1 Vaginal Moisturizer, Elegant™ Advanced 5 Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 5, 2021 Received: August 6, 2021

Dear Joshua Crist:

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.

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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 and Part 809); medical device reporting (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-regulatoryinformation/postmarketing-safety-reporting-combination-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,

Monica D. Garcia, Ph.D. Assistant 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) K201612

Device Name

Elegant™ 2 in 1 Vaginal Moisturizer, Elegant™ Advanced 5

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CER 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K201612

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.87(h) and 21 CFR § 807.92.

Submitter:	Viramal Limited
	106 New Bond Street
	London
	W1S 1DN
	United Kingdom
Contact Person:	Simona Fiore, MD, OBGYN, MSC, PhD
	Chief Medical Officer
	Viramal Limited
	106 New Bond Street, London
	W1S 1DN, United Kingdom
Date Prepared:	September 1, 2021
Device Proprietary Names:	Elegant™ 2 in 1 Vaginal Moisturizer
	Elegant™ Advanced 5
Device Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR. 884.5300
Regulatory Class:	II
Product Code:	NUC (lubricant, personal)
Predicate Device:	K101098, Replens Long-Lasting Vaginal Moisturizer
	(Church & Dwight Co., Inc.)

The predicate device has not been subject to a design-related recall.

5.1. Description of Device:

Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5:

The subject device is a non-sterile, water-based, personal lubricant that provides lubrication during intimate sexual activity.

The formulation contains purified water, polycarbophil, carbomer homopolymer type B, labrafac, emulfree P, sorbic acid and sodium hydroxide. The quantitative formulation is considered confidential commercial information.

Elegant™ 2 in 1 Vaginal Moisturizer is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 2ml of product.

Elegant™ Advanced 5, is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product.

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Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are personal lubricants for over-the-counter (OTC) use.

The device specifications are listed in Table 1 below:

Device Specifications for Elegant™ 2 in 1 Vaginal Moisturizer and Table 1 Elegant™ Advanced 5

Parameter	Specification (Test Method)
Appearance	White to off-white
Density USP <699>	0.9970 - 0.9995 g/cm2
pH USP <791>	2.5-3.5
Consistency Ph.Eur 2.9.9	145 – 200 mm
Viscosity USP <912>	120 - 220 Pa-s
Osmolality USP <785>	15 – 35 mOsm/kg
Total Aerobic Microbial Count (TAMC)USP <61>	≤ 102 CFU/g
Total combined yeasts/molds count(TYMC) USP <61>	≤ 101 CFU/g
Absence of pathogenic organisms:Staphylococcus Aureus, PseudomonasAeruginosa and Candida Albicans USP <62>	Absent
Antimicrobial Effectiveness USP <51>	Bacteria: No less than 2.0 log reduction at14 days and no increase from 14-day countat the 28-day countYeast/Mold: No increase from the initialcalculated count at 14 and 28 count

5.2. Indications for Use:

5.3. Comparison of the Intended Use and Technological Characteristics of the Subject and Predicate Device:

Table 2 below details a comparison of intended use and technological characteristics of the subject device configurations and the predicate device.

Table 2 Comparison of Intended Use and Technological Characteristics

ProductFeature	Elegant™ Device Configurations(K201612)	Elegant™ Device Configurations(K201612)	Predicate Device(K101098)	Comparison
Device Name	DeviceConfiguration 1:Elegant™ 2 in 1VaginalMoisturizer	DeviceConfiguration 2:Elegant™Advanced 5	Replens Long-LastingVaginal Moisturizer	-
ProductFeature	Elegant™ Device Configurations(K201612)	Predicate Device(K101098)	Comparison
Manufacturer	Viramal Limited	Church & Dwight Co.,Inc.	-
Classification	884.5300	884.5300	-
Product code	NUC	NUC	-
Description	Personal lubricant	Personal lubricant	No difference.
Over-the-counter Use	Yes	Yes	No difference.
Indications forUse	Elegant™ 2 in 1 Vaginal Moisturizer/Elegant™ Advanced 5: is a personallubricant for vaginal application,intended to moisturize and lubricate,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with polyurethanecondoms.	Replens is a personallubricant for vaginalapplication, intended tomoisturize and lubricate,to enhance the ease andcomfort of intimatesexual activity andsupplement the body'snatural lubrication. Thisproduct is compatiblewith natural rubber latexcondoms and synthetic(polyurethane andpolyisoprene) condoms.	Difference:The indication for usestatements differ regardingcondom compatibility,however this differencedoes not represent a newintended use.
Site ofapplication	For vaginal use only.	Replens is a personallubricant for vaginalapplication.	No differences.
Biocompatible	Yes	Yes	No difference.
Non-sterile	Yes	Yes	No difference.
CondomCompatible(labelled)	YesCompatible with polyurethanecondoms.	YesCompatible with naturalrubber latex,polyurethane andpolyisoprene condoms.	Different: The condomcompatibility for thesubject and predicatedevices are different.However, this differencedoes not represent a newintended use.
Shelf Life	17 months	36 months	Different
Delivery	Applicator	Applicator	No difference.
AppliedAmount	DeviceConfiguration 1:2gDeviceConfiguration 2:3 g	2.5g	Difference:The difference in appliedamount does not raisedifferent questions of safetyand effectiveness and doesnot present a new intendeduse.

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The indications for use for the subject device and the predicate device are similar, and the intended use of the subject and predicate device is the same (i.e., provides lubrication during intimate sexual activity). The subject device is compatible with polyurethane condoms, whereas the predicate device is compatible with natural rubber latex, polyurethane and polyisoprene condoms. This difference in condom compatibility does not raise different questions of safety and effectiveness.

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As noted in Table 2, the subject device and the predicate device have similar technological characteristics. The differences identified in Table 2 do not raise different questions of safety and effectiveness.

5.4. Summary of Performance Data:

Biocompatibility Testing

. Biocompatibility studies were performed in accordance with the 2020 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 (ISO 10993-5:2009)
Intra-vaginal tolerance with histological examination (ISO 10993-10:2010) ●
Penile irritation (ISO 10993-10:2010) ●
Sensitisation (ISO 10993-10:2010)
Acute Systemic Toxicity (ISO 10993-11:2017)

The results of this testing demonstrate that Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are non-cytotoxic, non-irritating, non-sensitizing, and nonsystemically toxic.

Shelf-Life

Shelf-life testing has been conducted in accordance with ICH Guideline Q1A (R2) -"Stability Testing of new Drug Substances and Products". Long term data at 25°C/60% RH and accelerated data at 35°C/65% RH for the specifications identified in Table 1 have been generated up to 6 months, for an equivalent of a 12 month shelf life.

Taken together, results from shelf life testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of a 12 month shelf life.

Condom Compatibility

The compatibility of the subject device with natural rubber latex, polyisoprene, and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms,". The results of the testing indicate that the subject device is compatible with polyurethane condoms. The subject device is not compatible with natural rubber latex and polyisoprene condoms.

5.5. Conclusion:

The results of the performance testing described above demonstrate that Elegant™ 2 in 1 Vaginal Moisturizer/ Elegant™ Advanced 5 is as safe and effective as the predicate device and supports 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.