(79 days)
Not Found
No
The 510(k) summary describes a personal lubricant and its physical properties, intended use, and performance studies related to biocompatibility, shelf-life, and condom compatibility. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The product is a personal lubricant intended to lubricate and moisturize, enhancing comfort during intimate sexual activity and supplementing natural lubrication, which aligns with the definition of a therapeutic device designed to alleviate or treat a condition (in this case, lack of lubrication or discomfort during sexual activity).
No
The device is a personal lubricant intended to moisturize and enhance the ease and comfort of intimate sexual activity, not to diagnose a medical condition.
No
The device description clearly states it is a "translucent cream" and is provided in "Polyethylene Terephthalate (PET) cylinder bottles" and "polyester-faced laminated pouches," indicating it is a physical substance and 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 lubrication and moisturizing during intimate sexual activity. This is a physical function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a personal lubricant for direct application to the body. It does not describe a device used to analyze biological samples.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This personal lubricant does not fit that definition.
N/A
Intended Use / Indications for Use
Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Coconut Infused Hybrid Personal Lubricant is a translucent cream, white to off-white in color, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This device is not compatible with polyurethane condoms.
This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
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
Not Found
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 studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing, were performed in accordance with the 2016 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 (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Penile Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Shelf-Life: The subject device device, Coconut Infused Hybrid Personal Lubricant, is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.
Condom Compatibility: The compatibility of the subject device, Coconut Infused Hybrid Personal Lubricant, with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that that the Coconut Infused Hybrid Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
June 6, 2018
United Consortium Stephanie Morris Regulatory Specialist 29000 North Hancock Parkway Valencia, CA 91355
Re: K180712
Trade/Device Name: Coconut Infused Hybrid Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 16, 2018 Received: March 19, 2018
Dear Stephanie Morris:
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 may, therefore, market the device, subject to the general controls provisions of the Act. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.
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
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Indications for Use
510(k) Number (if known) K180712
Device Name
Coconut Infused Hybrid Personal Lubricant
Indications for Use (Describe)
Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Type of Use (Select one or both, as applicable)
| Residential (Part 24 CFR 982 Subpart D) | Homeownership (Part 24 CFR 982 Subpart O) |
|---|---|
| ------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K180712 - Coconut Infused Hybrid Personal Lubricant
K180712 - 510(k) Summary
| 510(k) Owner: | United Consortium | |
|---|---|---|
| Street Address: | 29000 N. Hancock Parkway | |
| Valencia, CA 91355 | ||
| Contact Person: | Stephanie Morris | |
| Regulatory Specialist | ||
| Bruce Albert | ||
| Head of Technical Services | ||
| Contact Numbers: | Phone: (661) 295-1700, ext. 232 | |
| Phone: (661) 295-1700, ext. 231 | ||
| FAX: (661) 295-1800 | ||
| Summary Preparation Date: | June 5, 2018 | |
| Trade Name: | Coconut Infused Hybrid Personal Lubricant | |
| Common Name: | Personal Lubricant | |
| Device Classification: | RegulationName: | |
| RegulationNumber: | ||
| Product Code: | ||
| Device Class: | Condom | |
| 21 CFR § 884.5300 (Condom) | ||
| NUC (lubricant, personal) | ||
| Class II | ||
| Predicate Device: | Product Name: | |
| 510(k) Number: | ||
| Manufacturer: | ||
| Product Code: | ||
| Device Class: | Gun Oil H2O water-based lubricant | |
| K152918 | ||
| Empowered Products, Inc. | ||
| NUC | ||
| Class II |
The predicate device has not been subject to a design-related recall.
Device Description:
Coconut Infused Hybrid Personal Lubricant is a translucent cream, white to off-white in color, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This device is not compatible with polyurethane condoms.
This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1
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Image /page/4/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" formed by two curved lines. The left line is a dark blue color, while the right line is a light gray color. Below the "U" is the text "UNITED CONSORTIUM" in a sans-serif font. The word "UNITED" is stacked above the word "CONSORTIUM".
K180712 - Coconut Infused Hybrid Personal Lubricant
oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
The device specifications are listed in the table below:
| Property | Specification |
|---|---|
| Appearance | Translucent, semi-viscous cream |
| Color | White to off-white |
| Odor | Odorless |
| Viscosity (cps) | 20,000 cps to 31,000 cps |
| pH | 5.7 to 6.30 |
| Specific Gravity | 0.930 to 1.010 |
| Osmolality | 450 to 900 mOsm/kg |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP | |
| and | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP | |
| and | Less than 10 cfu/g |
| Presence of Pathogens per USP | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida Albicans | Absent |
Table 1: Device Specifications for Coconut Infused Hybrid Personal Lubricant
Indications for Use:
Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Predicate Device Comparison:
The table below lists the comparative indication for use and technological characteristics of the subject and predicate devices.
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| Feature | Coconut Infused Hybrid Personal
Lubricant | Gun Oil H2O water-based lubricant
(K152918) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indication for Use | Coconut Infused Hybrid Personal
Lubricant is a water-based personal
lubricant for penile, anal 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. This
product is compatible with natural
rubber latex and polyisoprene
condoms. This product is not
compatible with polyurethane
condoms. | Gun Oil H2O water-based is a
personal lubricant intended to
moisturize and lubricate, to
enhance the ease and comfort of
intimate sexual activity. This
product is compatible with
polyisoprene condoms. This product
is not compatible with polyurethane
or natural rubber latex condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Propylene Glycol,
Caprylic/Capric Triglyceride, Cocos
Nucifera (Coconut) Oil, Flavor
(Aroma), Phenoxyethanol,
Polyacrylate 13, Cellulose Gum
(sodium carboxymethylcellulose),
Raphanus Sativus (Radish) Seed
Extract, Polyisobutene, Polysorbate
20, PEG-45M | Purified Water, Propylene Glycol,
Hydroxyethlcellulose, Aloe
Barbadensis Leaf, Potassium
Sorbat), Tetrasodium EDTA, Panax
Ginseng Root, Paulina Cupana,
Avena Sativa, Polysorbate 20, PEG-
45, Polyquarternium-5, Citric Acid |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene | Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |
Table 2: Comparator Table for Subject Device – Coconut Infused Hybrid Personal Lubricant and Predicate Device Gun Oil H2O water-based lubricant
The subject and predicate device have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate device have different technological characteristics, including different formulations and condom compatibility. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
Summary of Performance Data:
Biocompatibility
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing, were performed in
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Image /page/6/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in blue, with a gray shadow effect behind it. Below the 'U', the words 'UNITED CONSORTIUM' are written in a smaller, sans-serif font.
K180712 - Coconut Infused Hybrid Personal Lubricant
accordance with the 2016 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 (ISO 10993-5:2009) ●
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Penile Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Shelf-Life:
The subject device device, Coconut Infused Hybrid Personal Lubricant, is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.
Condom Compatibility:
The compatibility of the subject device, Coconut Infused Hybrid Personal Lubricant, with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that that the Coconut Infused Hybrid Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that the Coconut Infused Hybrid Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.