(139 days)
Not Found
No
The 510(k) summary describes a personal lubricant and its physical properties and testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat or cure a medical condition or disease.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, not to diagnose any condition.
No
The device description clearly states it is a physical product (a gel) packaged in a bottle with a pump, and includes details about the materials used for the packaging and dispensing mechanism. It is 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 clearly stated as a personal lubricant for enhancing sexual activity and supplementing natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and composition of the lubricant, its packaging, and its compatibility with condoms. There is no mention of it being used to test or analyze biological samples (like blood, urine, or tissue) to diagnose a condition or disease.
- Performance Studies: The performance studies listed (Biocompatibility, Condom Compatibility, Shelf Life) are all related to the safety and functionality of the lubricant for its intended physical use. They do not involve diagnostic accuracy or performance metrics.
- Lack of Diagnostic Elements: There are no mentions of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
The Sex Gel is a non-sterile, water-based, over-the-counter personal lubricant, formulated to be a clear liquid. The device contains a blend of ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, or polyurethane condoms during intimate sexual activity. The device formula is neither a contraceptive nor a spermicide.
The product is packaged in (50 ml / 1.7 oz) bottles made from high density polypropylene (POLY WHITE P 8555). The bottle is fitted with a pump for dispensing lubricant made of polypropylene, butyl, and steel. Each bottle is packaged in a paperboard carton, which constitutes the device's individual carton.
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
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
The device contact duration with the user is A-limited
§ 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 10, 2018
Necessaire, Inc. % Louie Goryoka Regulatory Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301
Re: K181078 Trade/Device Name: The Sex Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 8, 2018 Received: July 16, 2018
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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181078
Device Name The Sex Gel
Indications for Use (Describe)
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.
| 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."
3
| Company Name: | Necessaire, Inc. |
|---|---|
| Company Address: | 10 Arbolado Court |
| Manhattan Beach, California 90266 | |
| Contact Number: | Phone: (512) 560-5750 |
| Email: randi@necessaireinc.com | |
| Contact Person: | Louie Goryoka – Regulatory & Quality Consultant |
| Med-Device Consulting, Inc. | |
| Phone: (818) 735-0488 | |
| Email: mdci@m-dci.us | |
| Summary Preparation Date: | August 17, 2018 |
| Device Trade Name: | The Sex Gel |
| Common Name: | Personal Lubricant |
| Classification Name(s): | Condom |
| Classification Regulation: | 21 CFR §884.5300 (Condom) |
| Product Code: | NUC (lubricant, personal) |
| Device Class: | Class II |
| Predicate Devices | Aqua Lube Natural Lubricants Personal Lubricant |
| 510(k) Number: | K130345 |
| Manufacturer: | Mayer Laboratories, Inc. |
| Product Code: | NUC |
| Device Class: | Class II |
The predicate device has not been subject to a design-related recall.
Device Description
The Sex Gel is a non-sterile, water-based, over-the-counter personal lubricant, formulated to be a clear liquid. The device contains a blend of ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, or polyurethane condoms during intimate sexual activity. The device formula is neither a contraceptive nor a spermicide.
The product is packaged in (50 ml / 1.7 oz) bottles made from high density polypropylene (POLY WHITE P 8555). The bottle is fitted with a pump for dispensing lubricant made of polypropylene, butyl, and steel. Each bottle is packaged in a paperboard carton, which constitutes the device's individual carton.
The device specifications are listed in the table below:
Table 1: Device Specifications for The Sex Gel Personal Lubricant
| Property | Specification |
|---|---|
| Appearance | Clear to slightly hazy |
| Color | Colorless |
4
| Odor | Characteristic |
|---|---|
| Viscosity (cps) | 3,000 cps - 5,000 cps |
| Specific Gravity | 1.01 to 1.06 |
| pH | 4.0 to 5.0 |
| Osmolality | 435 to 535 mOsm/kg |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP and | and |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella | Absent |
| E. Coli | Absent |
| Candida albicans | Absent |
Indications for Use
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 rubber latex, polyisoprene and polyurethane condoms.
Predicate Device Comparison:
The table below lists the comparative intended use and technological characteristics of the subject and predicate device.
Table 2: Comparator Table for Subject Device – The Sex Gel Personal Lubricant and Predicate Device Aqua Lube Natural Lubricants Personal Lubricant.
| Characteristic/Feature | The Sex Gel Lubricant (K181078) | Aqua Lube Natural Lubricants
Personal Lubricant (k) number
K130345 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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 and
polyisoprene and polyurethane
condoms. | 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 and
polyisoprene condoms.
It is not compatible with
polyurethane condoms. |
5
| Water Based | Yes | Yes |
|---|---|---|
| Primary ingredients | Water, aloe barbadensis leaf juice, | |
| sorbitol, hydroxyethylcellulose, | ||
| allantoin, lactic acid / tocopherols | ||
| (vitamin E), sodium hyaluronate, | ||
| sodium benzoate & potassium | ||
| sorbate | Water, aloe, | |
| hydroxyethylcellulose, sorbitol, | ||
| and tocopherols (vitamin E). | ||
| Over-the-Counter Use | Yes | Yes |
| Labeled condom | ||
| compatible | Yes | Yes |
| compatible with latex | ||
| and polyisoprene | ||
| condoms | Yes | Yes |
| compatible with | ||
| polyurethane condoms | Yes | No |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| The product is not a | ||
| contraceptive and does | ||
| not contain spermicide | Yes | Yes |
| Sterile | No | No |
| Shelf life | 6 months | Three years |
The subject and predicate device have the same intended use - for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The Sex Gel contains similar ingredients to other cleared lubricants, including the predicate device. However, the subject and predicate device have slightly different formulations and different shelf life. These differences do not raise different types of safety and effectiveness questions. Performance testing, as described below, was utilized to demonstrate the subject device is as safe and effective as the predicate device.
Summary of Performance Data:
Biocompatibility
The device contact duration with the user is A-limited