INA Moisturizing Intimate Water-Based 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, polyurethane, and polyisoprene condoms.

Device Description

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is a non-sterile, water-based, personal lubricant that is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is sold as an over-the-counter (OTC) product in a 3 fl. oz./ 90 mL Polyethylene vinyl alcohol bottle with Polypropylene flip cap. The Tube will be packaged in an outer box. This product is composed of Deionized Water, Organic Certified Aloe Vera Gel, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Propanediol, Sclerotium Gum, Sodium Hyaluronate, Tremella Fuciformis Sporocarp Extract, Xanthan Gum, Lactic Acid, Red Alga Gel EC, Sodium Benzoate, Potassium Sorbate, Moringa Oleifera Seed Oil, Cariborg Sea Buckthorn Oil Refined.

AI/ML Overview

The provided text is a 510(k) summary for the medical device "INA Moisturizing Intimate Water-Based Personal Lubricant". It details the device's characteristics and its comparison to a predicate device, as well as the performance data used to establish its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Specification)	Reported Device Performance (Summary of results)
Appearance	Translucent Viscous Gel	Test results demonstrated compliance with "Translucent Viscous Gel".
Color	Straw	Test results demonstrated compliance with "Straw".
Odor	None	Test results demonstrated compliance with "None".
Viscosity	8,000 - 10,400 cps	Test results demonstrated compliance within the range of 8,000 - 10,400 cps.
pH	4.3 - 5.3	Test results demonstrated compliance within the range of 4.3 - 5.3.
Osmolality (mOSm/kg)	1394 - 1428 mOSm/kg	Test results demonstrated compliance within the range of 1394 - 1428 mOSm/kg.
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<100 cfu/g	Test results demonstrated compliance with "<100 cfu/g".
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g	Test results demonstrated compliance with "<10 cfu/g".
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products (bacteria log reduction <2.0 at 14 days, no increase from 14 to 28 days; yeast/mold no increase from initial at 14 and 28 days).	Test results demonstrated compliance with USP <51> acceptance criteria for Category 2 products.
Presence of Pathogens per USP <62>	Absent ( Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, E. coli, coliforms, Salmonella, and enrichment pathogens)	Test results demonstrated absence of specified pathogenic organisms.
Biocompatibility: Cytotoxicity (ISO 10993-5)	Non-cytotoxic	Demonstrated to be non-cytotoxic.
Biocompatibility: Sensitization (ISO 10993-10)	Non-sensitizing	Demonstrated to be non-sensitizing.
Biocompatibility: Vaginal Irritation (ISO 10993-23)	Non-irritating	Demonstrated to be non-irritating.
Biocompatibility: Acute Systemic Toxicity (ISO 10993-11)	Not systemically toxic	Demonstrated to be not systemically toxic.
Condom Compatibility	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (per ASTM-D7661-10)	Determined to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms per ASTM-D7661-10.
Shelf Life	6 months (maintaining all device specifications)	Demonstrated a 6-month shelf life utilizing real-time aging, with device specifications maintained.

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

The document does not specify the exact sample sizes for each individual test (e.g., number of lubricant batches for viscosity, number of animals for biocompatibility tests, number of condoms for compatibility).

Regarding data provenance, the testing was performed in accordance with international standards, such as ISO and ASTM, and USP pharmacopeia, indicating a standardized and controlled environment for generating technical data. The tests were conducted on the "subject lubricant" (INA Moisturizing Intimate Water-Based Personal Lubricant) and are thus prospective data from laboratory testing specifically for this device. The country of origin of the data is not explicitly stated, but adherence to international standards implies global applicability.

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

This information is not applicable to this type of device and testing. The "ground truth" for the performance specifications of a personal lubricant is established by international standards (e.g., ISO, ASTM, USP) and scientific methodologies, not by expert consensus on clinical cases. The interpretation of these test results would be performed by qualified laboratory personnel following the specified test methods.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic evaluations where human readers provide interpretations that need to be resolved. For laboratory-based performance testing of a lubricant, results are objectively measured against predefined specifications.

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

This is not applicable. An MRMC comparative effectiveness study is relevant for AI-powered diagnostic devices or systems where human readers interpret medical images or data. The device in question is a personal lubricant, not a diagnostic or AI-driven system.

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

This is not applicable. This question pertains to AI algorithms. The device is a personal lubricant, which does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on objective measurements and interpretations of established international standards and laboratory test methodologies. For example:

Chemical/Physical properties: Measured values (pH, viscosity, osmolality) compared to defined numerical ranges.
Microbial limits: Laboratory culture results compared to specified CFU/g limits and absence criteria for pathogens.
Biocompatibility: In vitro and in vivo test results (e.g., cell viability, skin reactions) interpreted against ISO standard criteria.
Condom compatibility: Physical properties of condoms after exposure to the lubricant, measured and compared to ASTM standard criteria.
Shelf life: Real-time stability testing to confirm that all specified properties are maintained over the claimed period.

8. The sample size for the training set

This is not applicable. The device is a physical product (lubricant), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The product formulation is developed through research and development, not by training on data.

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

This is not applicable for the same reason as point 8.

Summary

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December 6, 2024

Project Chemistry, Inc. % Louie Goryoka Sr. Consultant RA/QA Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301

Re: K242645

Trade/Device Name: INA Moisturizing Intimate Water-Based Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 4, 2024 Received: September 9, 2024

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 (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.

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 Rule"). 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.

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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,

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) K242645

Device Name

INA Moisturizing Intimate Water-Based Personal Lubricant

Indications for Use (Describe)

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

Submitter Information

A. Company Name:	Project Chemistry
B. Company Address:	18241 Gothard St.Huntington Beach, CA 92648
C. Company Phone:	(714) 587-9011
D. Company Contact	Jessica Graham – Sr. Director, Product Development
E. Submission Correspondent:	Louie GoryokaSr. VP. Regulatory and Quality ConsultantMed-Device Consulting, Inc.Email: mdci@m-dci.us(818) 585-7488

F. Summary Preparation Date: December 4, 2024

Device Identification

A. Device Trade Name:	INA Moisturizing Intimate Water-Based Personal Lubricant
B. Common Name:	Personal Lubricant
C. Regulation Name:	Condom
D. Regulation Number:	21 CFR §884.5300
E. Device Class:	Class II
F. Product Code:	NUC (lubricant, personal)
H. Predicate Devices	The Sex Gel Personal Lubricant, K181078.

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

Indications for Use Statement

INA Moisturizing Intimate Water-Based Personal Lubricant 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, polyurethane, and polyisoprene condoms.

Device Description

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is a non-sterile, water-based, personal lubricant that is compatible with natural rubber latex, polyisoprene, and polyurethane

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condoms. The device is for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is sold as an over-the-counter (OTC) product in a 3 fl. oz./ 90 mL Polyethylene vinyl alcohol bottle with Polypropylene flip cap. The Tube will be packaged in an outer box.

This product is composed of Deionized Water, Organic Certified Aloe Vera Gel, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Propanediol, Sclerotium Gum, Sodium Hyaluronate, Tremella Fuciformis Sporocarp Extract, Xanthan Gum, Lactic Acid, Red Alga Gel EC, Sodium Benzoate, Potassium Sorbate, Moringa Oleifera Seed Oil, Cariborg Sea Buckthorn Oil Refined.

The device specifications are listed in the table below:

Property	Specification
Appearance	Translucent Viscous Gel
Color	Straw
Odor	None
Viscosity	8,000 - 10,400 cps
pH	4.3 - 5.3
Osmolality (mOSm/kg)	1394 - 1428 mOSm/kg
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<100 cfu/g
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products. Category 2 bacteria should show a log reduction of less than 2.0 at 14 days and no increase from the 14-day count to the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days
Presence of Pathogens per USP <62>	Specification
Absence of pathogenic organisms ( Staphylococcus aureus , Pseudomonas aeruginosa , Candida albicans , E. coli , coliforms, Salmonella , and enrichment pathogens) per USP <62>	Absent

Table 1: Device Specifications for INA Moisturizing Intimate Water-Based Personal Lubricant

Comparison of Intended Use and Technological Characteristics with Predicate Device:

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

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Characteristic/Feature	INA Moisturizing IntimateLubricant Water-BasedPersonal LubricantSubject Device (K242645)	The Sex Gel Water-BasedPersonal LubricantPredicate Device (K181078)
Indications for Use	INA Moisturizing IntimateWater-Based PersonalLubricant is a personallubricant, for penileand/or vaginalapplication, intended tomoisturize and lubricate,to enhance the ease andcomfort of intimate sexualactivity and supplementthe body's naturallubrication. This productis compatible with naturalrubber latex,polyurethane, andpolyisoprene condoms.	The Sex Gel is a personallubricant, for penile and/orvaginal application, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural latex,polyisoprene, and polyurethanecondoms.
Water-Based Lubricant	Yes	Yes
Over the Counter	Yes	Yes
Non-sterile	Yes	Yes
Odor	Odorless	Characteristic
Viscosity	8,000 cps - 10,400 cps	3,000 cps - 5,000 cps
pH	4.3 -5.3	4.0 - 5.0
Osmolality	1394 – 1428 mOsm/kg	435-535 mOsm/kg
Microbial Limits	Total mold/yeast count<10 cfu/gTotal aerobic microbialcount <100 cfu/gAbsence of pathogenicorganisms	Total mold/yeast count <10 cfu/gTotal aerobic microbialcount <10 cfu/gAbsence of pathogenic organisms
AntimicrobialEffectivenessTesting(USP<51> Category 2)	Yes	Yes
Condom Compatibility	Compatible with naturallatex,	Compatible with natural latex,polyisoprene, and polyurethane
Primary ingredients	Deionized Water, OrganicCertified Aloe Vera Gel,Madecassoside,Asiaticoside, CentellaAsiatica Leaf Extract,Propanediol, SclerotiumGum, SodiumHyaluronate, TremellaFuciformis SporocarpExtract, Xanthan Gum,Lactic Acid, Red Alga GelEC, Sodium Benzoate,Potassium Sorbate,Moringa Oleifera Seed Oil,Cariborg Sea BuckthornOil Refined.	Water, aloe barbadensis leafjuice, sorbitol,hydroxyethylcellulose,allantoin, lactic acid/tocopherols(vitamin E), sodium hyaluronate,sodium benzoate & potassiumsorbate
Sterile	No	No
Shelf life	6 months	6 months

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The subject and predicate device have similar indications for use and have the same intended use (i.e., provides lubrication during intimate sexual activity). The subject and predicate device have different technological characteristics, including variations and specifications (e.g., pH, osmolality, etc.). The differences in the technological characteristics of the subject and predicate do not raise different questions of safety and effectiveness.

Performance Data

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", 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-irritating, nonsensitizing, and not systemically toxic.

Condom Compatibility

Condom compatibility studies were performed per ASTM-D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" on INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant and was determined to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

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Shelf Life Testing

The INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is shown to have a 6 month shelf life utilizing real time aging. Testing on samples showed that the subject device specifications listed in Table 1 above across the device shelf-life.

Conclusion

The results of the performance testing described above demonstrate that the INA Moisturizing Intimate Lubricant Water-Based Personal 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.