BioNude is a personal lubricant for penile and/or 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 and polyisoprene condoms. It is not compatible with polyurethane condoms.

Device Description

BioNude is a 100% isotonic water-based formula with ingredients including lactic acid, hydroxyethylcellulose, carrageenan, sodium chloride, potassium sorbate, sodium benzoate, carob gum, xanthan gum, sodium hydroxide, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

AI/ML Overview

The document describes the regulatory approval of the BioNude Lubricant (K180136), not a medical device in the context of an AI/ML study. Therefore, the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, and sample sizes for an AI/ML device is not available in the provided text.

The document discusses the substantial equivalence of the BioNude Lubricant to a predicate device based on its formulation, intended use, and performance tests (biocompatibility, condom compatibility, and shelf life).

Here's what can be extracted based on the provided text, modified to indicate absence where the requested information is not applicable or not provided for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a personal lubricant, not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "device performance" relating to diagnostic accuracy, sensitivity, or specificity as would be relevant for an AI/ML device does not apply in the same way. The performance data presented are for the physical and chemical properties of the lubricant:

Acceptance Criteria Category	Reported Device Performance (BioNude Lubricant)
Biocompatibility	Met per ISO 10993-5:2009 (cytotoxicity), human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2006. Found to be biocompatible.
Condom Compatibility	Met per ASTM D7661-10. Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms.
Shelf Life	Results demonstrate that BioNude maintains its specifications over the duration of their proposed shelf life.
Formulation & Specifications	100% isotonic water-based formula. Specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. (Specific numerical values for these specifications are not provided in the summary but were part of the submission.)

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable to the BioNude Lubricant as it is not an AI/ML device undergoing diagnostic performance testing. The "test sets" would refer to samples tested for biocompatibility, condom compatibility, and shelf-life, but specific sample sizes and data provenance (country of origin, retrospective/prospective) for these tests are not detailed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is not an AI/ML diagnostic tool requiring expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation studies, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance for diagnostic tasks. This is a personal lubricant, not a diagnostic device.

6. If a Standalone Performance Study Was Done

The performance studies conducted (biocompatibility, condom compatibility, shelf life) can be considered "standalone" in the sense that they evaluated the device's intrinsic properties. However, this is not analogous to a "standalone algorithm performance" study for an AI/ML device.

7. The Type of Ground Truth Used

For the BioNude Lubricant, the "ground truth" for its performance claims is based on:

Established scientific methods and standards: Biocompatibility standards (e.g., ISO 10993), condom compatibility standards (e.g., ASTM D7661-10), and internal quality control specifications for formulation and shelf life.
Laboratory testing results: The outcomes of these tests directly demonstrated the product's compliance with the relevant properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the AI context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device in the AI context.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 1, 2018

Good Clean Love, Inc. % Abhishek Gurnani Partner Amin Talati Upadhye, LLP 100 S. Wacker Drive, Suite 2000 Chicago, Illinois 60606

Re: K180136 Trade/Device Name: BioNude Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: May 2, 2018 Received: May 4, 2018

Dear Abhishek Gurnani:

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. 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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180136

Device Name BioNude Lubricant

Indications for Use (Describe)

BioNude is a personal lubricant for penile 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 and polyisoprene condoms. It is not compatible with polyurethane condoms.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

| X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY BioNude Lubricant - K180136

This summary uses the format provided in 21 CFR 807.92:

(a)(1)	Submitter/Owner:	Good Clean Love, Inc.207 West 5th AvenueEugene, OR 97401Contact: Wendy StrgarPhone: 541-344-4483Fax: 541-685-1335Email: wendy@goodcleanlove.com
	Preparer/Contact:	Abhishek K. GurnaniAmin Talati Upadhye, LLP100 South Wacker Drive, Suite 2000Chicago, IL 60606Phone: 312-327-3325Fax: 312-884-7352Email: Abhishek@AminTalati.com
	Summary Prepared:	May 31, 2018
(a)(2)	Trade Name:	BioNude Lubricant
	Common Name:	Personal Lubricant
	Regulation Number:	21 CFR 884.5300
	Regulation Name:	Condom
	Regulatory Class:	Class II
	Product Code:	NUC (lubricant, personal)

(a)(3) Identification of Predicate Device: Sheffield Laboratories Warming LubriGel Personal Lubricant (K052162)
The predicate device has not been subject to a design related recall.
(a)(4) Device Description: BioNude is a 100% isotonic water-based formula with ingredients including lactic acid, hydroxyethylcellulose, carrageenan, sodium chloride, potassium sorbate, sodium benzoate, carob gum, xanthan gum, sodium hydroxide, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and

{4}------------------------------------------------

absence of pathogenic organisms. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

(a)(5) Indications for Use Statement: BioNude is a personal lubricant for penile and/or 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 and polyisoprene condoms. It is not compatible with polyurethane condoms.
The subject and predicate device have the same intended use.
(a)(6) Comparison of Technological Characteristics: The following table summarizes the key technological characteristics of the subject and predicate device:

	K80136	K052162
	Subject Device	Predicate Device
Sponsor	Good Clean Love Inc.	Sheffield Laboratories
Regulation Number	884.5300	884.5300
Product Code	NUC	NUC
Device Class	II	II
Base Type	Water	Water
Primary Ingredients	WaterLactic AcidHydroxyethylcellulose	Propylene glycolPolyethylene glycolHydroxypropyl celluloseLactic Acid
Condom Compatibility	Natural Rubber LatexPolyisoprene	Natural Rubber Latex

The subject and predicate device have differences in technological characteristics, including formulation and specifications. However, those differences do not raise new questions on safety or effectiveness.

(b) Summary of Performance Data:

Biocompatibility

BioNude has undergone biocompatibility testing including cytotoxicity per ISO 10993-5:2009, human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2006. The testing found that BioNude is biocompatible.

Condom Compatibility

BioNude was tested for condom compatibility per ASTM D7661-10 and was found to be compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms.

{5}------------------------------------------------

Shelf Life

The results of shelf life testing demonstrate that BioNude maintains its specifications over the duration of their proposed shelf life.

Conclusion:

The results of performance testing demonstrate that the subject and predicate device are substantially equivalent.

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.