(218 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and shelf life of a personal lubricant, with no mention of AI or ML technology.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat a disease or condition.
No
The device is a personal lubricant intended to lubricate and moisturize for enhanced comfort during sexual activity, not to diagnose any condition.
No
The device is a physical product (a lubricant) and does not involve any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a personal lubricant for penile and/or vaginal application to enhance sexual activity. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details its composition as a water-based gel and its classification as a Class II medical device under regulations related to condoms and personal lubricants. This classification is for devices used for physical purposes, not for diagnosing conditions.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility and shelf life, which are relevant for a topical personal care product, not for evaluating the accuracy of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This personal lubricant does not fit that description.
N/A
Intended Use / Indications for Use
WLX & Bio Human Lubricant is a water based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
WLX & Bio Human Lubricant is a non-sterile, water-based, clear gel personal lubricant. It is a Class II medical device classified under 21 CFR 884.5300 (condom) and product code NUC (lubricant, personal). It contains Water, Glycerin, Propylene Glycol, Carbomer, Hydroxyethylcellulose, Triethanolamine, and Phenoxyethanol. The lubricant is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The lubricant is packaged in polyethylene (PE) bottles of 100 mL capacity (Model -WLX100).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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:
- Tests: 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).
- Key Results: The subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
Shelf Life:
- Study Type: Real time and accelerated aging study per ASTM F1980-16.
- Key Results: The device has a 6-month shelf-life and met all device specifications listed in Table 1 across all time points.
Condom Compatibility:
- Study Type: Testing was not conducted.
- Key Results: The subject device is not compatible with natural rubber latex, polyisoprene, and polyurethane 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
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
August 16, 2024
Jiangxi Wulinxiang Biological Technology Co., Ltd. Yang Qi GM 1F,Building 1,Nanchang LED Industry Innovation Demonstration Park, No. 1111 Changdong Avenue, Qingshan, Nanchang, Jiangxi 330012 CHN
Re: K240081
Trade/Device Name: WLX & Bio Human Lubricant Regulation Number: 21 CFR$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 11, 2024 Received: July 15, 2024
Dear Yang Qi:
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.
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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
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Indications for Use
510(k) Number (if known) K240081
Device Name WLX & Bio Human Lubricant
Indications for Use (Describe)
WLX & Bio Human Lubricant is a water based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart G) |
|_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary — K240081 WLX & Bio Human Lubricant
l. General Information on Submitter
| Applicant: | Jiangxi Wulinxiang Biological |
|---|---|
| Address: | 1F, Building 1, Nanchang LED |
| Industry Innovation | |
| Demonstration Park, No. 1111 | |
| Changdong Avenue, Qingshan | |
| Nanchang, Jiangxi 330012 | |
| CHN | |
| Telephone: | 86 (791) 881-10717 |
| Contact Person: | Yang Qi, |
| Contact Title: | GM |
| Email: | 13755676363@163.com |
| Date Prepared: | August 15, 2024 |
II. General Information on Device
| Trade Name: | WLX & Bio Human Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number | 21 CFR 884.5300 |
| Device Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
lll. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| pjur@ AQUA Baseline | K200731 |
The predicate device has not been subject to a design-related recall.
IV. Description of Device
WLX & Bio Human Lubricant is a non-sterile, water-based, clear gel personal lubricant. It is a Class II medical device classified under 21 CFR 884.5300 (condom) and product code NUC (lubricant, personal). It contains Water, Glycerin, Propylene Glycol, Carbomer, Hydroxyethylcellulose, Triethanolamine, and Phenoxyethanol. The lubricant is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
5
The lubricant is packaged in polyethylene (PE) bottles of 100 mL capacity (Model -WLX100).
The specifications for WLX & Bio Human Lubricant are described in Table 1.
| Parameter | Test
Method | Specification |
|---------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance/Color | Visual | Clear gel |
| Odor | Olfactory | Odorless |
| pH | USP | 5.5-7.5 |
| Viscosity | USP | 100-300 (cps at 25°C) |
| Osmolality | USP | 750-950 mOsm/kg |
| Antimicrobial Effectiveness | USP | Meets USP acceptance
criteria for Category 2
products. Category 2, bacteria should
show not be less than 2.0 log reduction
at 14 days and no increase from 14-day
Count at the 28 day count. Yeasts and
molds should show no increase from
the initial calculated count at 14 and 28
days. |
| Total Aerobic Microbial Count
(TAMC) | USP | Less than 100 cfu/mL |
| Total Yeast and Mold Count
(TYMC) | USP | Less than 10 cfu/mL |
| Absence of Pathogenic
Organisms (Candida
albicans, Pseudomonas
aeruginosa, Staphylococcus
aureus) | USP | Absent |
Table 1. Device Specifications
V. Indications for Use
WLX & Bio Human Lubricant is a water based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
VI. Substantial Equivalence Discussion
The following table compares the intended use and technological characteristics of the subject and predicate device:
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| Characteristic /
Feature | WLX & Bio Human Lubricant
(subject device) | pjur@ AQUA Baseline
(predicate device) - K200731 | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | WLX & Bio Human Lubricant is a
water based personal lubricant, for
penile and/or vaginal application,
intended to lubricate and moisturize,
to enhance the ease and comfort of
intimate sexual activity and
supplement the body's natural
lubrication. This product is not
compatible with natural rubber latex,
polyurethane, and polyisoprene
condoms. | Pjur@ AQUA Baseline for penile,
vaginal and/or anal application,
intended to moisturize and lubricate,
enhance the ease and comfort of
intimate sexual activity and
supplement the body's natural
lubrication. This product is not
compatible with natural rubber latex,
polyisoprene, and polyurethane
condoms. | Similar: The
subject and
predicate
devices have
similar
indications for
use, and they
have the same
intended use. |
| Water-Based
Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not a
contraceptive or
Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary
Ingredients | Water, Glycerin, Propylene Glycol,
Carbomer, Hydroxyethylcellulose,
Triethanolamine, and Phenoxyethanol | water, glycerin, ethoxydiglycol,
phenoxyethanol, hydroxypropyl
guar hydroxypropyltrimonium
chloride, hydroxyethylcellulose,
and citric acid | Different |
| Microbial Limits | Total mold/yeast count