ID Free Personal Lubricant

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September 26, 2024 Westridge Laboratories, Inc. % Erica Loring Regulatory Consultant Erica Loring 3506 6th ave San Diego, California 92103 Re: K240745 Trade/Device Name: ID Free Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Received: August 27, 2024 Dear Erica Loring: 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 (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. 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" {1}------------------------------------------------ (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 OS 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 Rue"). 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. 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 {2}------------------------------------------------ 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, PhD 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240745 Device Name ID Free® Personal Lubricant Indications for Use (Describe) ID Free® Personal Lubricant is for or penile, anal 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 polyisoprenecondoms. This product 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." {4}------------------------------------------------ # 510(K) Summary – K240745 # ID Free® Personal Lubricant #### Submitter l. | Applicant<br>Address: | Westridge Laboratories, Inc<br>1671 E Andrew Pl<br>Santa Ana, CA 92706 | |--------------------------------------------------------------|---------------------------------------------------------------------------------------| | Telephone | 714-259-9400 | | Contact Person:<br>Contact Title:<br>Email:<br>Date Prepared | Erica Loring<br>Regulatory Consultant<br>Erica.Loring@yahoo.com<br>September 25, 2024 | #### Subject Device Information II. Trade Name: Common Name: Regulation Name: Requlation Number: Requlatory Class: Product Code: ID Free Personal Lubricant Personal Lubricant Condom 21 CFR 884.5300 . NUC (Lubricant, Personal) #### Predicate Device Information III. Proprietary Name: 501(k) number: Manufacturer: Requlation Name: Requlation Number: Regulatory Class: Product Code: Astroglide® Glycerin & Paraben Free K220653 BioFilm Inc. Condom 21 CFR 884.5300 = NUC (Lubricant, Personal) The predicate device has not been subject to a design-related recall. #### Device Description IV. ID Free® Personal Lubricant is a personal lubricant, for penile, anal 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. The product is intended for over-the-counter use. The device is a non-sterile water based personal lubricant with a clear, odorless formulation. The device is packaged in nonsterile 8.5 fl. oz/250 ml plastic/PET bottles {5}------------------------------------------------ with a screw-on cap and flip top closure, or in 0.14 fl. oz/4 ml foil sachets. The device is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is not a contraceptive and does not contain a spermicide. The device formulation consists of water, propanediol, hydroxyethyl cellulose, carbomer, PEG-45M, tetrahydroxypropyl ethylenediamine, EDTA, caprylhydroxamic acid, and sucralose. The specifications for ID Free Personal Lubricant are described in Table 1. | Parameter | Specification (Test Method) | |----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | Color | No color to slight yellow tint | | Appearance | Clear viscous gel | | Odor | Odorless | | Viscosity<br>Spindle #63 @ 30 RPM | 2,200 - 4,400 cps | | pH | 5.0 - 5.5 | | Osmolality | 250 - 500 mOsm/kg | | Total yeast/mold count (TYMC) (USP <61>) | <10 cfu/mL | | Total aerobic microbial count (TAMC) (USP <61>) | <100 cfu/mL | | Presence of Pathogenic Organisms (USP <62>)<br>(Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) | Absent | | Antimicrobial effectiveness (USP <51>) | Meets USP <51> acceptance criteria<br>for Category 2 products. | Table 1. Device Specifications #### Indications for Use V. ID Free® Personal Lubricant is a personal lubricant, for penile, anal 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. This product is not compatible with polyurethane condoms. #### Substantial Equivalence Discussion VI. The following table compares the intended use and key technological characteristics of the subject and predicate device: {6}------------------------------------------------ | Product Name | ID FREE® Personal Lubricant<br>(Subject Device) | Astroglide Glycerin & Paraben<br>Free (Predicate Device) | |---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device<br>Classification | Lubricant, personal | Lubricant, personal | | Product Code | NUC | NUC | | Classification | Class II | Class II | | Indications for Use | ID Free® Personal Lubricant is<br>a personal lubricant, for penile,<br>anal and/or vaginal application<br>intended to moisturize and<br>lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. This<br>product is compatible with<br>natural rubber latex and<br>polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms. | Astroglide Glycerin & Paraben Free<br>is a personal lubricant for penile,<br>vaginal, and/or anal application<br>intended to moisturize and lubricate,<br>to enhance the ease and comfort of<br>intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber latex<br>and polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms | | Over<br>the<br>Counter use | Yes | Yes | | Ingredients | Water, Propanediol,<br>Hydroxyethylcellulose,<br>Carbomer, PEG 45M, EDTA,<br>Tetrahydroxypropyl<br>Ethylenediamene,<br>Caprylhydroxamic acid,<br>Sucrose | Purified Water, Xylitol, Butylene<br>Glycol, Methyl Gluceth-20,<br>Propylene Glycol, Polyquaternium-<br>7, Hydroxyethylcellulose,<br>Potassium Sorbate, Sodium<br>Benzoate, Citric Acid | | Condom<br>compatibility | Natural Rubber Latex and<br>Polyisoprene | Natural Rubber Latex and<br>Polyisoprene | | pH | 5.0-5.5 | 3.5-5.5 | | Osmolality | 200-500 mOsm/Kg | 230-300 mOsm/kg, 1:5 dilution factor | | Sterile | No | No | | Water based | Yes | Yes | | Antimicrobial Test<br>(USP <51>, USP<br><61>, USP <62>) | Yes | Yes | The subject and predicate device have the same indications for use and have the same intended use - to provide lubrication during intimate sexual activity. The subject and predicate device are both water-based, non-sterile lubricants with differences in technological characteristics, including different formulations and device specifications. The technological characteristics differences do not raise different questions of safety and effectiveness. ## Summary of Non-Clinical Performance Testing VII. Biocompatibility Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a {7}------------------------------------------------ risk management process" and ISO 10993-1:2009 as follows: - Cytotoxicity (per ISO 10993-5:2009) ● - Guinea Pig Maximization Sensitization (per ISO 10993-10:2010) ● - Vaginal Irritation (per ISO 10993-10:2010) - Acute Systemic Toxicity (per ISO 10993-11:2017) ● The results of this testing demonstrate that the subject lubricant is noncytotoxic, non- irritating, non-sensitizing, and not systemically toxic. # Shelf Life The subject device is a non-sterile personal lubricant packaged in a 2.5 oz. bottle with a 24-month shelf-life in accordance with the results of real time aging study, conducted for 24 months at 25°C. 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 ID FREE® Personal Lubricant was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18- Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of the testing demonstrate that the subject device is compatible with natural rubber latex and polyisoprene condoms. The subject device is not compatible with polyurethane condoms. #### Conclusion VIII. The results of the performance testing described above demonstrate that the ID FREE® Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.