(94 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and condom compatibility of a personal lubricant, with no mention of AI or ML technology.
No.
The primary purpose of device is to moisturize and lubricate to enhance comfort during intimate activity, not to treat or cure a disease or condition.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose a medical condition.
No
The device description clearly states it is a water-based personal lubricant, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This is a physical function, not a diagnostic one.
- Device Description: The description details a personal lubricant for topical application. It does not mention any components or mechanisms for testing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue), detecting biomarkers, or providing any kind of diagnostic result.
- Performance Studies: The performance studies focus on biocompatibility and condom compatibility, which are relevant to a personal lubricant, not a diagnostic device.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
Key results: The results of this testing demonstrate that the subject lubricant is non-irritating, nonsensitizing, and not systemically toxic.
Condom compatibility studies were performed per ASTM-D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms".
Key results: INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant was determined to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
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.
Key results: Testing on samples showed that the subject device specifications listed in Table 1 above across the device shelf-life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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.
2
3
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
3
Indications for Use
510(k) Number (if known) K242645
Device Name
INA Moisturizing Intimate Water-Based Personal Lubricant
Indications for Use (Describe)
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.
| 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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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 Goryoka |
| Sr. VP. Regulatory and Quality Consultant | |
| Med-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
5
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 and | and |
| Presence of Pathogens per USP | Specification |
| Absence of pathogenic organisms ( Staphylococcus aureus , Pseudomonas aeruginosa , Candida albicans , E. coli , coliforms, Salmonella , and enrichment pathogens) per USP | 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.
6
| Characteristic/Feature | INA Moisturizing Intimate
Lubricant Water-Based
Personal Lubricant
Subject Device (K242645) | The Sex Gel Water-Based
Personal Lubricant
Predicate Device (K181078) |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | 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. |
| 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
Category 2) | Yes | Yes |
| Condom Compatibility | Compatible with natural
latex, | Compatible with natural latex,
polyisoprene, and polyurethane |
| Primary ingredients | 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. | Water, aloe barbadensis leaf
juice, sorbitol,
hydroxyethylcellulose,
allantoin, lactic acid/tocopherols
(vitamin E), sodium hyaluronate,
sodium benzoate & potassium
sorbate |
| Sterile | No | No |
| Shelf life | 6 months | 6 months |
7
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.
8
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.