(176 days)
The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.
The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.
The provided document is a 510(k) summary for the Joylux Intimacy Gel (PG3100), a water-based personal lubricant. It describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance/Color | Clear, colorless | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Odor | Odorless | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| pH | 4.0-5.0 | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Viscosity | 900-7800 cps | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Osmolality | 250-420 mOsm/kg (1:10 dilution factor) | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Antimicrobial Effectiveness | Meets USP <51> acceptance criteria for Category 2 products. Bacteria: not less than 2.0 log reduction from the initial count at 14 days, and no increase from 14-days count at 28 days. Yeasts and Molds: no increase from the initial calculated count at 14 and 28 days. | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Total Aerobic Microbial Count (TAMC) | Less than 10 cfu/mL | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Total Yeast and Mold Count (TYMC) | Less than 10 cfu/mL | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Absence of Pathogenic Organisms (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus) | Absent | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Biocompatibility | Tested per ISO 10993-5, -10, -23, -11 | Supported (Results "support the biocompatibility") |
| Shelf Life | 24-month shelf-life (maintaining all specifications) | Achieved (per real-time and accelerated aging study) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms. | Met (Results show compatibility with NR latex and polyisoprene, not with polyurethane) |
2. Sample size used for the test set and the data provenance
The document does not specify typical "test set" sample sizes in the way one might for an AI/ML device. Instead, the testing described is analytical and performance testing for a personal lubricant.
- Biocompatibility: The sample size for animals or cell cultures used in these tests (Cytotoxicity, Guinea Pig Maximization, Vaginal Irritation, Acute Systemic Toxicity) is not explicitly stated.
- Shelf Life: Not specified, but standard aging study protocols typically involve multiple units tested at various time points.
- Condom Compatibility: The specific number of condoms or lubricant samples tested is not provided, but it would adhere to the ASTM D7661-18 standard method.
The data provenance is from non-clinical performance testing conducted on the Joylux Intimacy Gel device itself, likely performed in laboratories according to recognized international standards (ISO, USP, ASTM). It is prospective in the sense that the testing was conducted specifically for this submission. The country of origin of the data is not specified but is implicitly from testing labs adhering to these international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device. The ground truth for the performance of a personal lubricant is established through objective laboratory testing against defined physical, chemical, and biological specifications, not through expert consensus on interpretation of data like in medical imaging.
4. Adjudication method for the test set
Not applicable. As described above, the determination of meeting specifications is based on objective laboratory measurements and adherence to test standards, not on subjective expert interpretation requiring adjudication.
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 AI/Machine Learning device or an imaging device requiring 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 AI/Machine Learning device. The performance testing is for the physical and chemical properties of the lubricant itself.
7. The type of ground truth used
The ground truth for this device is based on:
- Established industry standards and methods: USP (United States Pharmacopeia) for pH, viscosity, osmolality, and microbial limits; ISO 10993 series for biocompatibility; ASTM D7661-18 for condom compatibility, and ASTM F1980-21 for accelerated aging.
- Pre-defined specifications: The specific quantitative and qualitative acceptance criteria listed in Table 1 for parameters like pH, viscosity, microbial counts, appearance, and odor.
8. The sample size for the training set
Not applicable. This is not an AI/Machine Learning device, so 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 this type of device.
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March 20, 2025
Joylux, Inc % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K242958
Trade/Device Name: Joylux Intimacy Gel (PG3100) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Received: February 20, 2025
Dear Prithul Bom:
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.
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"
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(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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
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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,
Michael T. Bailey -S
For
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) K242958
Device Name Joylux Intimacy Gel (PG3100)
Indications for Use (Describe)
The Joylux Intimacy Gel is a water-based personal lubricant for vaginal application, intended to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane 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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510(k) Summary – K242948 Joylux Intimacy Gel (PG3100)
l. General Information on Submitter
| Applicant:Address:Telephone:Contact Person:Contact Title:Email: | Joylux, Inc.120 Lakeside Avenue, Suite300, Seattle, WA 98122 USA206-219-6444Colette CourtionCEO info@joylux.com |
|---|---|
| Correspondent Information | |
| Contact Person: | Sarah Lacey RobbinsQuality Manager / Quality & RegulatoryConsultant, Rook Quality Systems,1155 Mount Vernon Hwy, Suite 800Dunwoody, GA 30338 |
| Phone: | 813-220-3686 |
| Email: | sarah.robbins@rookqs.com |
| Date Prepared: | March 19, 2025 |
| Device Information | |
| Trade Name: | Joylux Intimacy Gel (PG3100) |
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number | 21 CFR 884.5300 |
| Device Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
Predicate Device IV.
II.
III.
| Predicate Device | 510(k) Number |
|---|---|
| Bloomi Smooth Water Based Lubricant | K221328 |
The predicate device has not been subject to a design-related recall.
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V. Description of Device
Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.
The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.
The specifications for Joylux Intimacy Gel are described in Table 1.
| Parameter | TestMethod | Specification |
|---|---|---|
| Appearance/Color | Visual | Clear, colorless |
| Odor | Olfactory | Odorless |
| pH | USP<791> | 4.0-5.0 |
| Viscosity | USP<912> | 900-7800 |
| Osmolality | USP<785> | 250-420 mOsm/kg (1:10 dilution factor) |
| Antimicrobial Effectiveness | USP <51> | Meets USP <51> acceptance criteria forCategory 2 products. Bacteria: not lessthan 2.0 log reduction from the initialcount at 14 days, and no increase from14-days count at 28 days.Yeasts and Molds: no increase from theinitial calculated count at 14 and 28days. |
| Total Aerobic Microbial Count(TAMC) | USP<61> | Less than 10 cfu/mL |
| Total Yeast and Mold Count(TYMC) | USP<61> | Less than 10 cfu/mL |
| Absence of PathogenicOrganisms (Candidaalbicans, Pseudomonasaeruginosa, Staphylococcusaureus) | USP<62> | Absent |
Table 1. Device Specifications
VI. Indications for Use
The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, enhance the ease and
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K242948 Page 3 of 5
comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
VII. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The following table compares the intended use and technological characteristics of the subject and predicate device:
| Characteristic /Feature | Joylux Intimacy Gel (subjectdevice) | Bloomi Smooth Water BasedLubricant (predicate device) -K221328 | Comparison |
|---|---|---|---|
| Indications for use | The Joylux Intimacy Gel is a water-based personal lubricant for penileand/or vaginal application, intendedto lubricate and moisturize, enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms. | The Bloomi Smooth Water BasedPersonal Lubricant is a water-basedpersonal lubricant for penile and/orvaginal application, intended tolubricate and moisturize, enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubber latexand polyisoprene condoms. Thisproduct is not compatible withpolyurethane condoms. | The subjectand predicatedevices havethe sameintended use. |
| Water-BasedLubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not acontraceptive orSpermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Ingredients | DI Water, Hydroxyethylcellulose,Polyquaterium-5, Propylene Glycol,PEG-45, Aloe Vera 200x Powder,Sodium Hyaluronate, Geogard Ultra(gluconolactone & sodium benzoate) | Water, Microcare SB, MicrocareSB, Hydroxyethylcellulose,Cyamopsis Tetragonoloba(Guar) Gum, Citric Acid,Sodium Hyaluronate, OrganicHelianthus (Sunflower) SeedExtract, Organic CamelliaSinensis Leaf(Green Tea) Extract. | Different |
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| Microbial Limits | TYMC <10 cfu/mL | TYMC <10 cfu/mL | Similar |
|---|---|---|---|
| TAMC <10 cfu/mL | TAMC <100 cfu/mL | ||
| Absence of pathogenic organismstesting | Absence of pathogenic organismstesting | ||
| Antimicrobial effectiveness testing | Antimicrobial effectiveness testing | ||
| Viscosity | 900-7800 cps | 1800-4500 cps | Different |
| Osmolality | 250-420 mOsm/kg (1:10 dilution factor) | 110-140 mOsm/kg | Different |
| pH | 4.0-5.0 | 4.0-5.0 | Same |
| CondomCompatibility | Compatible with natural rubber latex and polyisoprene condoms. | Compatible with natural rubber latex and polyisoprene condoms | Same |
The subject and predicate devices have similar indications for use and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different questions of safety and effectiveness.
VIII. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility testing on the subject lubricant was performed in accordance with the 2023 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/(R)2014) ●
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021) ●
- Vaginal Irritation (ISO 10993-23: 2021)
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
The results of the testing conducted support the biocompatibility of the subject device.
Shelf Life
The subject device is a non-sterile personal lubricant packaged in polyethylene tubes
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K242948 Page 5 of 5
with a 24-month shelf-life in accordance with the results of real time and an accelerated aging study per ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.
Condom Compatibility
The subject device was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Joylux Intimacy Gel is compatible with natural rubber latex and polyisoprene condoms. Joylux Intimacy Gel is not compatible with polyurethane condoms.
IX. Conclusion
The results of the testing described above demonstrate that Joylux Intimacy Gel is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.