The Sex Gel 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 latex, polyisoprene, and polyurethane condoms.

Device Description

The Sex Gel is a non-sterile, water-based, over-the-counter personal lubricant, formulated to be a clear liquid. The device contains a blend of ingredients similar to ingredients found in the predicate device.

The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, or polyurethane condoms during intimate sexual activity. The device formula is neither a contraceptive nor a spermicide.

The product is packaged in (50 ml / 1.7 oz) bottles made from high density polypropylene (POLY WHITE P 8555). The bottle is fitted with a pump for dispensing lubricant made of polypropylene, butyl, and steel. Each bottle is packaged in a paperboard carton, which constitutes the device's individual carton.

AI/ML Overview

The provided document is a 510(k) premarket notification for "The Sex Gel," a personal lubricant. It describes various performance tests and acceptance criteria to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Specification (Acceptance Criteria)	Reported Device Performance
Physical/Chemical Properties
Appearance	Clear to slightly hazy	Met
Color	Colorless	Met
Odor	Characteristic	Met
Viscosity (cps)	3,000 cps - 5,000 cps	Met
Specific Gravity	1.01 to 1.06	Met
pH	4.0 to 5.0	Met
Osmolality	435 to 535 mOsm/kg	Met
Microbiological Properties
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products	Met
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<10 cfu/g	Met
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g	Met
Presence of Pathogens per USP <62>
Pseudomonas aeruginosa	Absent	Met (Absent)
Staphylococcus aureus	Absent	Met (Absent)
Salmonella	Absent	Met (Absent)
E. Coli	Absent	Met (Absent)
Candida albicans	Absent	Met (Absent)
Biocompatibility
Cytotoxicity	Not cytotoxic (per ISO 10993-5:2009)	Met
Sensitization	Not sensitizing (per ISO 10993-10:2010)	Met
Vaginal Irritation	Not irritating (per ISO 10993-10:2010)	Met
Penile Irritation	Not irritating (per ISO 10993-10:2010)	Met
Acute Systemic Toxicity	Not acutely systemically toxic (per ISO 10993-11:2006)	Met
Condom Compatibility	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (per ASTM D7661-10)	Met
Shelf Life	6 months shelf life (per ASTM F1980-15 for Accelerated Aging)	Met

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of animals for irritation studies, number of batches for physical/chemical tests, number of condoms tested). It refers to tests being conducted "in accordance with" specific ISO and ASTM standards, which would typically define appropriate sample sizes.

Data Provenance: The studies were conducted by "Independent third-party laboratories." The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though biocompatibility and condom compatibility testing are inherently prospective in nature.

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

The studies described are laboratory tests of a physical/chemical product, not a diagnostic device requiring expert interpretation of results. Therefore, there were no "experts" in the sense of radiologists or clinicians establishing ground truth for a diagnostic test set. The "ground truth" for these tests is defined by the objective criteria and methodologies outlined in the referenced ISO and ASTM standards. The "experts" involved would be the qualified laboratory personnel performing the tests according to the standards. Their qualifications are implicitly that they are trained and competent in conducting these specific standardized tests.

4. Adjudication Method for the Test Set

Not applicable. As described above, these were objective laboratory tests against pre-defined specifications rather than subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance, to assess diagnostic performance. This document concerns a personal lubricant, which does not involve human interpretation of medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. "The Sex Gel" is a personal lubricant, not an algorithm or AI-powered device. Therefore, a standalone algorithm performance study is not relevant. The performance studies described are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth used for "The Sex Gel" studies is based on:

Standardized objective measurements: For physical and chemical properties (e.g., viscosity, pH, osmolality).
Defined microbiological limits: For microbial counts and absence of specific pathogens.
Biological response criteria: For biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity), where observed biological reactions are compared against established acceptance criteria from ISO standards.
Material compatibility tests: For condom compatibility, where the integrity and performance of condoms after lubricant exposure are evaluated against ASTM standards.

Essentially, the ground truth is established by universally recognized and validated laboratory testing standards and their associated acceptance criteria.

8. The Sample Size for the Training Set

Not applicable. "The Sex Gel" is a physical product, not a machine learning model. Therefore, 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 a physical product, there is no ground truth to be established for it.

Summary

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September 10, 2018

Necessaire, Inc. % Louie Goryoka Regulatory Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301

Re: K181078 Trade/Device Name: The Sex Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 8, 2018 Received: July 16, 2018

Dear Louie Goryoka:

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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.

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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; 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 mediation-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,

Sharon M. Andrews -S

for

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

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Indications for Use

510(k) Number (if known) K181078

Device Name The Sex Gel

Indications for Use (Describe)

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)

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Company Name:	Necessaire, Inc.
Company Address:	10 Arbolado CourtManhattan Beach, California 90266
Contact Number:	Phone: (512) 560-5750Email: randi@necessaireinc.com
Contact Person:	Louie Goryoka – Regulatory & Quality ConsultantMed-Device Consulting, Inc.Phone: (818) 735-0488Email: mdci@m-dci.us
Summary Preparation Date:	August 17, 2018
Device Trade Name:	The Sex Gel
Common Name:	Personal Lubricant
Classification Name(s):	Condom
Classification Regulation:	21 CFR §884.5300 (Condom)
Product Code:	NUC (lubricant, personal)
Device Class:	Class II
Predicate Devices	Aqua Lube Natural Lubricants Personal Lubricant
510(k) Number:	K130345
Manufacturer:	Mayer Laboratories, Inc.
Product Code:	NUC
Device Class:	Class II

The predicate device has not been subject to a design-related recall.

Device Description

The device specifications are listed in the table below:

Table 1: Device Specifications for The Sex Gel Personal Lubricant

Property	Specification
Appearance	Clear to slightly hazy
Color	Colorless

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Odor	Characteristic
Viscosity (cps)	3,000 cps - 5,000 cps
Specific Gravity	1.01 to 1.06
pH	4.0 to 5.0
Osmolality	435 to 535 mOsm/kg
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<10 cfu/g
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g
Presence of Pathogens per USP <62>	Specification
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Salmonella	Absent
E. Coli	Absent
Candida albicans	Absent

Indications for Use

Predicate Device Comparison:

The table below lists the comparative intended use and technological characteristics of the subject and predicate device.

Table 2: Comparator Table for Subject Device – The Sex Gel Personal Lubricant and Predicate Device Aqua Lube Natural Lubricants Personal Lubricant.

Characteristic/Feature	The Sex Gel Lubricant (K181078)	Aqua Lube Natural LubricantsPersonal Lubricant (k) numberK130345
Indications for Use	Personal lubricant, for penile and/orvaginal application, intended tomoisturize and lubricate, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication.This product is compatible withnatural rubber latex andpolyisoprene and polyurethanecondoms.	Personal lubricant, for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatible withnatural rubber latex andpolyisoprene condoms.It is not compatible withpolyurethane condoms.

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Water Based	Yes	Yes
Primary ingredients	Water, aloe barbadensis leaf juice,sorbitol, hydroxyethylcellulose,allantoin, lactic acid / tocopherols(vitamin E), sodium hyaluronate,sodium benzoate & potassiumsorbate	Water, aloe,hydroxyethylcellulose, sorbitol,and tocopherols (vitamin E).
Over-the-Counter Use	Yes	Yes
Labeled condomcompatible	Yes	Yes
compatible with latexand polyisoprenecondoms	Yes	Yes
compatible withpolyurethane condoms	Yes	No
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
The product is not acontraceptive and doesnot contain spermicide	Yes	Yes
Sterile	No	No
Shelf life	6 months	Three years

The subject and predicate device have the same intended use - 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. The Sex Gel contains similar ingredients to other cleared lubricants, including the predicate device. However, the subject and predicate device have slightly different formulations and different shelf life. These differences do not raise different types of safety and effectiveness questions. Performance testing, as described below, was utilized to demonstrate the subject device is as safe and effective as the predicate device.

Summary of Performance Data:

Biocompatibility

The device contact duration with the user is A-limited <24 hours, per ISO 10993-1:2009.

Independent third-party laboratories conducted biocompatibility studies on the subject device. These included Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing; each were performed in accordance with 2016 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 Direct Contact Method, ISO 10993-5:2009)
Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010) ●

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Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010) ●
Penile Irritation (ISO Penile Irritation Study in Rabbits, ISO 10993-10:2010)
Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2006) ●

The results of testing demonstrated the subject device is not cytotoxic, not sensitizing, not irritating and is not acutely systemically toxic.

Condom Compatibility

Condom compatibility testing was performed per ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" on three marketed brands of natural rubber latex condoms, one brand of polyisoprene condoms, and one brand of polyurethane condoms. Results demonstrated the Sex Gel is compatible with natural latex, polyisoprene, and polyurethane condoms.

Shelf Life Testing

The Sex Gel Personal lubricant is shown to have a 6 months shelf life utilizing Arrhenius Equation, as detailed according to ASTM F1980-15 for Accelerated Aging. Testing on samples at accelerated aging showed that the subject device met all device specifications.

Conclusion

The subject device has the same intended use as the predicate device: to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The subject device has similar technological characteristics as the predicate device, as described in the table above. Differences in technological characteristics between the subject and predicate device were evaluated through performance testing, which included biocompatibility, shelf-life and condom compatibility testing. Performance testing demonstrated that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate.

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.