(444 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, shelf-life, and condom compatibility of a personal lubricant, with no mention of AI or ML.
No.
The device is described as a personal lubricant intended to moisturize and lubricate for comfort during intimacy, and its predicate device is also a moisturizer. While it may provide subjective relief, its primary function is not to treat a disease or condition, but rather to facilitate a physiological process.
No
The device is described as a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device is a physical product (a lubricant) and includes physical components (tube and applicator), not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for vaginal application to moisturize and lubricate, enhance comfort during sexual activity, and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description details a water-based personal lubricant with specific ingredients. There is no mention of it being used to test or analyze samples from the human body to diagnose a condition, monitor a treatment, or screen for a disease.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility. These are relevant to the safety and functionality of a personal lubricant, not to the performance of a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
NUC
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. 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.
Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are personal lubricants for over-the-counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter (OTC) use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility Testing:
- Study Type: Biocompatibility studies
- Sample Size: Not specified
- Performance/Key Results: Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are non-cytotoxic, non-irritating, non-sensitizing, and nonsystemically toxic.
Shelf-Life:
- Study Type: Shelf-life testing
- Sample Size: Not specified
- Performance/Key Results: Device can maintain its specifications over the duration of a 12 month shelf life.
Condom Compatibility:
- Study Type: Compatibility testing
- Sample Size: Not specified
- Performance/Key Results: The subject device is compatible with polyurethane condoms. The subject device is not compatible with natural rubber latex and polyisoprene condoms.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K201612
Device Name
Elegant™ 2 in 1 Vaginal Moisturizer, Elegant™ Advanced 5
Indications for Use (Describe)
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.
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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3
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.
4
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 | 0.9970 - 0.9995 g/cm2 |
| pH USP | 2.5-3.5 |
| Consistency Ph.Eur 2.9.9 | 145 – 200 mm |
| Viscosity USP | 120 - 220 Pa-s |
| Osmolality USP | 15 – 35 mOsm/kg |
| Total Aerobic Microbial Count (TAMC) | |
| USP | ≤ 102 CFU/g |
| Total combined yeasts/molds count | |
| (TYMC) USP | ≤ 101 CFU/g |
| Absence of pathogenic organisms: | |
| Staphylococcus Aureus, Pseudomonas | |
| Aeruginosa and Candida Albicans USP | Absent |
| Antimicrobial Effectiveness USP | 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 |
5.2. Indications for Use:
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.
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
| Product
Feature | Elegant™ Device Configurations
(K201612) | Elegant™ Device Configurations
(K201612) | Predicate Device
(K101098) | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Name | Device
Configuration 1:
Elegant™ 2 in 1
Vaginal
Moisturizer | Device
Configuration 2:
Elegant™
Advanced 5 | Replens Long-Lasting
Vaginal Moisturizer | - |
| Product
Feature | 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 for
Use | 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. | Replens 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 natural rubber latex
condoms and synthetic
(polyurethane and
polyisoprene) condoms. | Difference:
The indication for use
statements differ regarding
condom compatibility,
however this difference
does not represent a new
intended use. | |
| Site of
application | For vaginal use only. | Replens is a personal
lubricant for vaginal
application. | No differences. | |
| Biocompatible | Yes | Yes | No difference. | |
| Non-sterile | Yes | Yes | No difference. | |
| Condom
Compatible
(labelled) | Yes
Compatible with polyurethane
condoms. | Yes
Compatible with natural
rubber latex,
polyurethane and
polyisoprene condoms. | Different: The condom
compatibility for the
subject and predicate
devices are different.
However, this difference
does not represent a new
intended use. | |
| Shelf Life | 17 months | 36 months | Different | |
| Delivery | Applicator | Applicator | No difference. | |
| Applied
Amount | Device
Configuration 1:
2g
Device
Configuration 2:
3 g | 2.5g | Difference:
The difference in applied
amount does not raise
different questions of safety
and effectiveness and does
not present a new intended
use. | |
5
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.
6
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.