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.

Device Description

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: ID Free® Personal Lubricant
Regulation Name: Condom (as a personal lubricant, product code NUC)

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Specification)	Reported Device Performance (as implied by successful testing)
Color	No color to slight yellow tint	Met specification (implied, no specific value given)
Appearance	Clear viscous gel	Met specification (implied, no specific value given)
Odor	Odorless	Met specification (implied, no specific value given)
Viscosity (Spindle #63 @ 30 RPM)	2,200 - 4,400 cps	Met specification (implied, no specific value given)
pH	5.0 - 5.5	Met specification (implied, no specific value given)
Osmolality	250 - 500 mOsm/kg	Met specification (implied, no specific value given)
Total yeast/mold count (TYMC) (USP <61>)	< 10 cfu/mL	Met specification (implied, no specific value given, "Met USP <51> acceptance criteria for Category 2 products" implies passing USP <61> as well)
Total aerobic microbial count (TAMC) (USP <61>)	< 100 cfu/mL	Met specification (implied, no specific value given, "Met USP <51> acceptance criteria for Category 2 products" implies passing USP <61> as well)
Presence of Pathogenic Organisms (USP <62>) (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans)	Absent	Met specification (implied, no specific value given, "Met USP <51> acceptance criteria for Category 2 products" implies passing USP <62> as well)
Antimicrobial effectiveness (USP <51>)	Meets USP <51> acceptance criteria for Category 2 products	Met specification (explicitly stated: "Meets USP <51> acceptance criteria for Category 2 products")
Biocompatibility: Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic	Demonstrated non-cytotoxic
Biocompatibility: Guinea Pig Maximization Sensitization (ISO 10993-10:2010)	Non-sensitizing	Demonstrated non-sensitizing
Biocompatibility: Vaginal Irritation (ISO 10993-10:2010)	Non-irritating	Demonstrated non-irritating
Biocompatibility: Acute Systemic Toxicity (ISO 10993-11:2017)	Not systemically toxic	Demonstrated not systemically toxic
Shelf Life (24 months at 25°C)	Device met specifications in Table 1 at all time points	Met specifications in Table 1 across 24-month shelf-life
Condom Compatibility (Natural Rubber Latex) (ASTM D7661-18)	Compatible	Compatible
Condom Compatibility (Polyisoprene) (ASTM D7661-18)	Compatible	Compatible
Condom Compatibility (Polyurethane)	Not compatible (stated directly)	Not compatible

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

The document does not specify exact sample sizes for each test in phrases like "The results of this testing demonstrate..." or "The results of the testing demonstrate that...". It refers to the standards (e.g., USP <61>, USP <62>, USP <51>, ISO 10993 series, ASTM D7661-18) which would define the sample sizes required for each specific test.

Data Provenance: The studies are non-clinical performance tests conducted for regulatory submission. There is no mention of country of origin for the data or whether it was retrospective or prospective in terms of patient data, as these are in vitro and in vivo animal (for some biocompatibility) tests, not human trials.

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

Not applicable. The ground truth for this medical device (a personal lubricant) is established by adherence to recognized international and national standards and test methods (e.g., ISO, ASTM, USP) for specific physical, chemical, microbiological, and biological properties, rather than expert consensus on a diagnostic outcome. The "experts" would be the scientists and technicians conducting the tests according to the specified methodologies.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or human-reader performance evaluations, particularly for image-based diagnostics. The performance of this device is determined by quantitative and qualitative measurements against established specifications in laboratory settings.

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

No. An MRMC study is not relevant for this device. It is a type of study used to evaluate diagnostic imaging systems where multiple human readers interpret cases, often with and without AI assistance, to assess the impact of AI on diagnostic performance. This device is a personal lubricant, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical product (personal lubricant), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Defined Specifications: Physical and chemical properties (color, appearance, odor, viscosity, pH, osmolality) have explicit numerical ranges or descriptions that must be met.
Standardized Test Methods and Criteria:
- Microbiological: Adherence to USP <61> (Total microbial counts) and USP <62> (Absence of specified objectionable microorganisms), and USP <51> (Antimicrobial Effectiveness Test) acceptance criteria. These standards define the "ground truth" for microbiological safety.
- Biocompatibility: Adherence to ISO 10993 series standards outcomes (non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic).
- Condom Compatibility: Adherence to ASTM D7661-18 for compatibility with specific condom materials.
Real-time Stability Data: The device maintained its specifications over a 24-month shelf-life at a specified condition (25°C).

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

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.

ApplicantAddress:	Westridge Laboratories, Inc1671 E Andrew PlSanta Ana, CA 92706
Telephone	714-259-9400
Contact Person:Contact Title:Email:Date Prepared	Erica LoringRegulatory ConsultantErica.Loring@yahoo.comSeptember 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.

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
ViscositySpindle #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>)(Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans)	Absent
Antimicrobial effectiveness (USP <51>)	Meets USP <51> acceptance criteriafor Category 2 products.

Table 1. Device Specifications

Indications for Use V.

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(Subject Device)	Astroglide Glycerin & ParabenFree (Predicate Device)
DeviceClassification	Lubricant, personal	Lubricant, personal
Product Code	NUC	NUC
Classification	Class II	Class II
Indications for Use	ID Free® Personal Lubricant isa personal lubricant, for penile,anal and/or vaginal applicationintended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatible withpolyurethane condoms.	Astroglide Glycerin & Paraben Freeis a personal lubricant for penile,vaginal, and/or anal applicationintended to moisturize and lubricate,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubber latexand polyisoprene condoms. Thisproduct is not compatible withpolyurethane condoms
OvertheCounter use	Yes	Yes
Ingredients	Water, Propanediol,Hydroxyethylcellulose,Carbomer, PEG 45M, EDTA,TetrahydroxypropylEthylenediamene,Caprylhydroxamic acid,Sucrose	Purified Water, Xylitol, ButyleneGlycol, Methyl Gluceth-20,Propylene Glycol, Polyquaternium-7, Hydroxyethylcellulose,Potassium Sorbate, SodiumBenzoate, Citric Acid
Condomcompatibility	Natural Rubber Latex andPolyisoprene	Natural Rubber Latex andPolyisoprene
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(USP <51>, USP<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.

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.