(185 days)
Not Found
No
The device is a personal lubricant with a chemical formulation and does not involve any software or data processing that would utilize AI/ML.
No
The device is described as a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity and to supplement natural lubrication. It provides symptomatic relief rather than treating a disease or restoring function.
No
This device is a personal lubricant intended to moisturize and lubricate; it does not diagnose any condition.
No
The device is a physical product (a lubricant) packaged in a tube with a reusable applicator, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication and moisturizing for vaginal application to enhance comfort during sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description details a personal lubricant cream with specific ingredients and packaging for direct application to the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not a diagnostic test.
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™ Advanced CompHort 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 (comma separated list FDA assigned to the subject device)
NUC
Device Description
Elegant™ Advanced CompHort is a line extension to the "Elegant™" range to extend claims.
It is a non-sterile, water-based, pearly white, non-irritating, non-greasy, hormone-free, paraben-free, fragrance-free, moisturizing creams for vaginal dryness. It is a personal lubricant that provides lubrication, and it is intended for ongoing use and is not exclusively for use during intimate sexual activity.
The formulation of Elegant™ Advanced CompHort 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™ Advanced CompHort is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product.
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 Use (21 CFR 801 Subpart C)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
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'."
Tests conducted:
- Cytotoxicity per ISO 10993-5
- Vaginal Irritation per ISO 10993-10
- Sensitization per ISO 10993-10
- Acute Systemic Toxicity per ISO 10993-11:2017
Results: The subject device was also clinically tested in women and no adverse events were reported. The results of this testing demonstrate that Elegant™ Advanced CompHort are noncytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Shelf-Life:
Testing has been conducted at 25°C/60% RH and data for the specifications identified in Table 1 have been generated up to 24 months.
Results: demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of a 24-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,".
Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
December 22, 2023
Viramal Limited % Joshua Crist Senior Consultant Biologics Consulting Group, Inc. 100 Dangerfield Road, Suite 400 Alexandria, VA 22314
Re: K231794
Trade/Device Name: Elegant™ Advanced CompHort Regulation Number: 21 CFR$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 27, 2023 Received: September 27, 2023
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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 -S
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
3
Indications for Use
510(k) Number (if known) K231794
Device Name
Elegant™ Advanced CompHort
Indications for Use (Describe)
Elegant™ Advanced CompHort 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 CFR 801 Subpart D) | ☐ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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4
510(k) Summary - K231794
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: | December 19, 2023 |
| Device Proprietary Names: | Elegant™ Advanced CompHort |
| Device Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
Predicate Device to Which Substantial Equivalence is Claimed: K201612, Elegant™ Advanced 5
The predicate device has not been subject to a design-related recall.
Description of Device:
Elegant™ Advanced CompHort is a line extension to the "Elegant™" range to extend claims.
It is a non-sterile, water-based, pearly white, non-irritating, non-greasy, hormone-free, paraben-free, fragrance-free, moisturizing creams for vaginal dryness. It is a personal lubricant that provides lubrication, and it is intended for ongoing use and is not exclusively for use during intimate sexual activity.
The formulation of Elegant™ Advanced CompHort 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™ Advanced CompHort is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product.
5
Elegant™ Advanced CompHort is to be sold as an over-the-counter (OTC) product.
The device specifications are listed in Table 1:
| Parameter | Test Method | Specification |
|---|---|---|
| Appearance | Visual inspection | White to off-white |
| Density (g/cm³) | Ph. Eur 2.2.5; USP | 0.9970 - 0.9995 |
| pH | USP | 2.5-3.5 |
| Consistency (1/10mm) | Ph. Eur 2.9.9 | 145 - 200 |
| Viscosity (Pa.s) | USP | 120 - 220 |
| Osmolality (mOsm/kg) | USP | 15-35 |
| 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 Test | 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 | ||
| day |
Table 1. Device Specifications for Elegant™ Advanced CompHort
Indications for Use:
Elegant™ Advanced CompHort 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.
Comparison of the Intended Use and Technological Characteristics of the Subject and Predicate Device:
All of the technological characteristics of the subject device are identical to the legally marketed predicate device with respect to design and materials, principle of operation, function, formulation, and intended use.
The ingredients of the subject device are identical to the predicate device Elegant™ Advanced 5 (K201612).
The labeling of the subject device compared to the predicate has been updated with additional claims.
- Compatible with Vaginal pH
- Natural Feeling
- pH Balanced Formulation
6
- . Gynecologist Clinically Tested
Table 2 details a comparison of intended use and technological characteristics of the subject device and the predicate devices.
| Product
Feature | Subject Device
K231794 | Predicate Device
K201612 | Comparison |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Elegant™ Advanced
CompHort | Elegant™ Advanced 5 | |
| Manufacturer | Viramal Limited | Viramal Limited | |
| Base Type | Water | Water | Same |
| Over-the-
counter Use | Yes | Yes | Same |
| Indications for
Use | Elegant™ Advanced
CompHort 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. | 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. | Same: The
indications for use
for the subject and
predicate device are
the same. Therefore,
the subject and
predicate device
have the same
intended use. |
| Ingredients | Purified water, Polycarbophil,
Carbomer Homopolymer Type
B, Labrafac, Emulfree Duo,
Sorbic Acid and Sodium
Hydroxide. | Purified water, Polycarbophil,
Carbomer Homopolymer Type
B, Labrafac, Emulfree Duo,
Sorbic Acid and Sodium
Hydroxide. | Same |
| Packaging
Material | Aluminium | Aluminium | Same |
| Color | White to Off-white | White to Off-white | Same |
| pH | 2.5 - 3.5 | 2.5 - 3.5 | Same |
| Osmolality
(mOsm/kg) | 15-35 | 15-35 | Same |
| Viscosity (Pa.s) | 120 - 220 | 120 - 220 | Same |
| Microbial limits | • Total mold/yeast count ) | Category 2, bacteria should
show not less than 2.0 log
reduction at 14 days and no
increase from 14-day count at
the 28-day count. Yeast and
molds should show no increase
from the initial calculated count
at 14 and 28 days | Category 2, bacteria should
show not less than 2.0 log
reduction at 14 days and no
increase from 14-day count at
the 28-day count. Yeast and
molds should show no increase
from the initial calculated count
at 14 and 28 days | Same |
| Product
Feature | Subject Device
K231794 | Predicate Device
K201612 | Comparison |
| Biocompatible | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Condom
Compatibility | Compatible with polyurethane
condoms. | Compatible with polyurethane
condoms. | Same |
| Delivery | Applicator | Applicator | Same |
| Applied
Amount | 3g | 3g | Same |
| Claims | Relief from vaginal dryness
and discomfort
Compatible with vaginal pH
Natural Feeling
pH Balanced Formulation
Gynecologist Clinically Tested | Relief from vaginal dryness
and discomfort | Different: The
subject and
predicate device
have different
labeling claims.
Differences in
labeling claims do
not raise different
questions of S&E. |
| Shelf-Life | 24 months | 17 months | Different: The
subject and
predicate device
have different shelf-
life durations.
Differences in shelf-
life durations do not
raise different
questions of S&E. |
Table 2. Comparison of Intended Use and Technological Characteristics
7
The indications for use and the intended use of the subject and predicate device are the same (i.e., provides lubrication during intimate sexual activity). The subject device has a 24-month shelf-life, whereas the predicate device has a 17-months shelf-life. The subject device has additional labeling claims. The differences in shelf-life and labeling claims do not raise different questions of safety and effectiveness.
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 of effectiveness.
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'." The following biological evaluation tests have been conducted to assess the biocompatibility of the subject device:
- Cytotoxicity per ISO 10993-5 ●
- . Vaginal Irritation per ISO 10993-10
- Sensitization per ISO 10993-10 ●
- Acute Systemic Toxicity per ISO 10993-11:2017 .
8
The subject device was also clinically tested in women and no adverse events were reported. The results of this testing demonstrate that Elegant™ Advanced CompHort are noncytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
K231794 Page 5 of 5
Shelf-Life
Shelf-life testing has been conducted at 25°C/60% RH and data for the specifications identified in Table 1 have been generated up to 24 months. Results from shelf-life testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of a 24-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.
Conclusion:
The results of the performance testing described above demonstrate Elegant™ Advanced CompHort for OTC use, is safe and effective for the proposed indications and substantially equivalent to the predicate device in regard to intended use, formulation, safety and fundamental technological characteristics. Any minor differences in formulation, technological characteristics or condom compatibility do not raise any new issues regarding safety or efficacy.
Elegant™