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.

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).

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a personal lubricant, not a medical device that relies on an algorithm or AI for its primary function. Therefore, the questions related to AI/algorithm performance, such as acceptance criteria based on performance metrics like sensitivity/specificity, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, and training set details, are not applicable to this submission.

The document focuses on the physical and chemical properties, biocompatibility, and intended use of the lubricant to establish its substantial equivalence to a predicate device.

However, I can interpret the request in the context of the provided document by identifying the "acceptance criteria" as the device specifications and the "study that proves the device meets the acceptance criteria" as the non-clinical performance testing.

Here's an adaptation of the requested information based on the provided FDA 510(k) summary for the WLX & Bio Human Lubricant:

Acceptance Criteria and Device Performance for WLX & Bio Human Lubricant

This device, WLX & Bio Human Lubricant, is a personal lubricant. Its acceptance criteria are based on physical, chemical, and biological specifications, and its performance is demonstrated through standard non-clinical tests. This is not an AI-driven device, so metrics like sensitivity, specificity, or expert adjudication for image analysis are not relevant.

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

The acceptance criteria are the "Specification" column in Table 1 (page 6), and the "Reported Device Performance" is implied by the statement "the subject device met the specifications at all time points" from the shelf-life study (page 8).

Parameter	Test Method	Acceptance Criteria (Specification)	Reported Device Performance (Implied)
Appearance/Color	Visual	Clear gel	Meets "Clear gel"
Odor	Olfactory	Odorless	Meets "Odorless"
pH	USP <791>	5.5-7.5	Meets "5.5-7.5"
Viscosity	USP <912>	100-300 (cps at 25°C)	Meets "100-300 (cps at 25°C)"
Osmolality	USP <785>	750-950 mOsm/kg	Meets "750-950 mOsm/kg"
Antimicrobial Effectiveness	USP <51>	Meets USP <51> 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.	Meets USP <51> acceptance criteria for Category 2 products.
Total Aerobic Microbial Count (TAMC)	USP <61>	Less than 100 cfu/mL	Meets "Less than 100 cfu/mL"
Total Yeast and Mold Count (TYMC)	USP <61>	Less than 10 cfu/mL	Meets "Less than 10 cfu/mL"
Absence of Pathogenic Organisms (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus)	USP <62>	Absent	Meets "Absent"
Biocompatibility	ISO 10993-5, 10, 11, 23	Non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.	Demonstrates non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
Shelf Life (demonstration of stability up to 6 months)	ASTM F1980-16	Device specifications (from Table 1) met across the device shelf-life.	Met specifications at all time points for a 6-month shelf-life.

2. Sample sized used for the test set and the data provenance

The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for pH, viscosity, or biological assays). It states that the device was tested per relevant USP and ISO standards, which typically include specific sample size requirements.

The "data provenance" is derived from testing conducted by the manufacturer, Jiangxi Wulinxiang Biological Technology Co., Ltd. (CHN), as part of their 510(k) submission. These tests are inherently "prospective" for the purpose of demonstrating compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/algorithm-driven device requiring expert human interpretation for "ground truth." The ground truth for the physical, chemical, and biological properties is established through standardized laboratory testing methods (e.g., USP and ISO standards).

4. Adjudication method for the test set

Not applicable. There is no human interpretation or subjective assessment that would require adjudication for this type of device testing.

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 device is not an AI software.

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

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used

The ground truth used for performance assessment consists of:

Standardized Test Methods: Adherence to established pharmacopoeial standards (USP <791>, <912>, <785>, <51>, <61>, <62>) for chemical and microbial properties.
International Standards: Compliance with ISO 10993 series for biocompatibility testing (ISO 10993-5, 10, 11, 23).
Industry Standards: Compliance with ASTM F1980-16 for shelf-life testing.

These standards define the acceptable ranges and methodologies that serve as the "ground truth" for the device's performance.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable.

Summary

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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.

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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)

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

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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	TestMethod	Specification
Appearance/Color	Visual	Clear gel
Odor	Olfactory	Odorless
pH	USP<791>	5.5-7.5
Viscosity	USP<912>	100-300 (cps at 25°C)
Osmolality	USP<785>	750-950 mOsm/kg
Antimicrobial Effectiveness	USP <51>	Meets USP <51> acceptancecriteria for Category 2products. Category 2, bacteria shouldshow not be less than 2.0 log reductionat 14 days and no increase from 14-dayCount at the 28 day count. Yeasts andmolds should show no increase fromthe initial calculated count at 14 and 28days.
Total Aerobic Microbial Count(TAMC)	USP<61>	Less than 100 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

V. Indications for Use

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 awater based personal lubricant, forpenile and/or vaginal application,intended to lubricate and moisturize,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is notcompatible with natural rubber latex,polyurethane, and polyisoprenecondoms.	Pjur@ AQUA Baseline for penile,vaginal and/or anal application,intended to moisturize and lubricate,enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is notcompatible with natural rubber latex,polyisoprene, and polyurethanecondoms.	Similar: Thesubject andpredicatedevices havesimilarindications foruse, and theyhave the sameintended use.
Water-BasedLubricant	Yes	Yes	Same
Over the Counter	Yes	Yes	Same
Not acontraceptive orSpermicide	Yes	Yes	Same
Non-sterile	Yes	Yes	Same
PrimaryIngredients	Water, Glycerin, Propylene Glycol,Carbomer, Hydroxyethylcellulose,Triethanolamine, and Phenoxyethanol	water, glycerin, ethoxydiglycol,phenoxyethanol, hydroxypropylguar hydroxypropyltrimoniumchloride, hydroxyethylcellulose,and citric acid	Different
Microbial Limits	Total mold/yeast count <10 cfu/mLTotal aerobic microbial count <100cfu/mLAbsence of pathogens (Candidaalbicans, Pseudomonas aeruginosa,Staphylococcus aureus)Antimicrobial effectiveness forCategory 2, bacteria: not less than2.0 log reduction at 14 days and noincrease from 14-day count at the28 day count. Yeasts and molds: noincrease from the initial calculatedcount at 14 and 28 days.	Total mold/yeast count <10 cfu/mLTotal aerobic microbial count <100cfu/mLAbsence of pathogens (Candidaalbicans, Pseudomonas aeruginosa,Staphylococcus aureus)Antimicrobial effectiveness forCategory 2, bacteria: not less than2.0 log reduction at 14 days and noincrease from 14-day count at the28 day count. Yeasts and molds: noincrease from the initial calculatedcount at 14 and 28 days.	Same
Viscosity	100-300 cps at 25°C	750-1250	Different
Osmolality	750-950 mOsm/kg	500-625 mOsm/kg (diluted 1:3.9)	Different
pH	5.5-7.5	4.1-4.7	Different
CondomCompatibility	Not compatible with natural rubberlatex, polyurethane, andpolyisoprene condoms.	Not compatible with natural rubberlatex, polyurethane, and polyisoprenecondoms.	Same

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K240081 Page 4 of 5

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.

VII. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2023 FDA quidance 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 this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.

Shelf Life

The subject device is a non-sterile personal lubricant packaged in PE bottles of 100 mL capacity with a 6-month shelf-life in accordance with the results of real time and an accelerated aging study per ASTM F1980-16, 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

Condom compatibility testing was not conducted for the subject device. The subject

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device is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

VIII. Conclusion

The results of the testing described above demonstrate that WLX & Bio Human Lubricant 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.