(192 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties, chemical composition, and compatibility with condoms. There is no mention of any computational or analytical functions that would involve AI or ML.
No.
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, which is not a therapeutic function.
No
This device is a personal lubricant intended to moisturize and lubricate; it does not diagnose a condition or disease.
No
The device description clearly states it is a "non-sterile water based personal lubricant" and describes its physical form (liquid) and packaging (bottles, sachets), indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ID Free® Personal Lubricant's Intended Use: The intended use of ID Free® Personal Lubricant is for topical application to the body (penile, anal, and/or vaginal) to provide lubrication and enhance comfort during sexual activity. It does not involve testing samples taken from the body.
- Device Description: The device description clearly states it is a personal lubricant for external application.
The information provided about biocompatibility testing, shelf life testing, and condom compatibility testing are relevant for a medical device, but they do not indicate that the device is an IVD. These tests are performed to ensure the safety and effectiveness of the lubricant for its intended use.
N/A
Intended Use / Indications for Use
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.
Product codes
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, anal and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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)
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4
510(K) Summary – K240745
ID Free® Personal Lubricant
Submitter l.
| Applicant
Address: | Westridge Laboratories, Inc
1671 E Andrew Pl
Santa Ana, CA 92706 |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Telephone | 714-259-9400 |
| Contact Person:
Contact Title:
Email:
Date Prepared | Erica Loring
Regulatory Consultant
Erica.Loring@yahoo.com
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 | |
| 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 ) | ) |
| (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) | Absent |
| Antimicrobial effectiveness (USP ) | Meets USP acceptance criteria |
| 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
(Subject Device) | Astroglide Glycerin & Paraben
Free (Predicate Device) |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification | Lubricant, personal | Lubricant, personal |
| Product Code | NUC | NUC |
| Classification | Class II | Class II |
| Indications for Use | 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. | Astroglide Glycerin & Paraben Free
is a personal lubricant for penile,
vaginal, and/or anal 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 |
| Over
the
Counter use | Yes | Yes |
| Ingredients | Water, Propanediol,
Hydroxyethylcellulose,
Carbomer, PEG 45M, EDTA,
Tetrahydroxypropyl
Ethylenediamene,
Caprylhydroxamic acid,
Sucrose | Purified Water, Xylitol, Butylene
Glycol, Methyl Gluceth-20,
Propylene Glycol, Polyquaternium-
7, Hydroxyethylcellulose,
Potassium Sorbate, Sodium
Benzoate, Citric Acid |
| Condom
compatibility | Natural Rubber Latex and
Polyisoprene | Natural Rubber Latex and
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
(USP , USP
, USP ) | 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.