(88 days)
Not Found
No
The device is a personal lubricant and the summary describes its physical properties, intended use, and biocompatibility testing, with no mention of AI or ML.
No.
The intended use is to lubricate and moisturize to enhance the ease and comfort of intimate sexual activity, which is not a therapeutic purpose.
No
Explanation: The provided text explicitly states that the devices are "personal lubricants...intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." There is no mention of these devices being used to diagnose any condition or disease.
No
The device is a physical substance (lubricant) and the description focuses on its chemical composition, biocompatibility, and physical properties, not software functionality.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
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 application of the lubricant.
- Performance Studies: The performance studies described (biocompatibility, shelf-life, condom compatibility) are related to the safety and functionality of a personal lubricant, not to diagnosing a condition or analyzing a sample from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. The devices described here do not fit this definition.
N/A
Intended Use / Indications for Use
JO Agapé Original 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.
MUSE Essence Water-Based 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 lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.
#LubeLife Water-Based 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.
#LubeLife Water-Based Anal 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 lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are clear/water white, viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants 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. All of these devices contain the same formulation.
The JO Agapé Original Personal Lubricant product is to be sold as an over-the-counter (OTC) product in sizes of 1 fl. oz./30 mL 2 fl. oz./60 mL and 4 fl. oz./120 mL. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc tops. The 2 oz. and 4 oz. size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. This product is also available in 3 mL and 10 mL polyester-faced laminated pouches.
The MUSE Essence Water-Based Lubricant product is to be sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size bottles. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with matte black Polypropylene (PP) pump closures. The bottles are then placed in Solid Bleached Sulfate (SBS) cartons and sealed with a clear Biaxially-Oriented Polypropylene (BOPP) sticker on the top and bottom of each carton. This product is also available in 10 mL size polyester-faced laminated pouches.
#LubeLife Water-Based Lubricant product is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL and 12 fl. oz./360 mL sizes. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
LubeLife Water-Based Anal Lubricant product is to be sold as an over-the-counter (OTC) product in 12 fl. oz./360 mL size bottles. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
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. The results of this testing demonstrated that the subject lubricants are only slightly cytotoxic with a passing reactivity score, mildy-irritating with a passing reactivity score, non-sensitizing and non-systemically toxic.
Shelf-Life: The subject devices are non-sterile personal lubricants with a two-year shelf-life in accordance with the results of accelerated aging studies on the various packaging types available for the lubricants, i.e., bottles with cap, bottles with pump closure and pouches. All device specifications listed in Table 1 were evaluated for the largest volumes associated with each packaging type which were considered worst case for evaluating shelf-life.
Condom Compatibility: The compatibility of the subject devices 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 indicated that JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are compatible with natural rubber latex and polyisoprene condoms. These products are 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 shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 4, 2019
United Consortium Stephanie Morris Global Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K183384
Trade/Device Name: JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 5, 2018
Dear Stephanie Morris:
Received: December 6, 2018
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: K183384
Device Name
JO Agapé Original Personal Lubricant MUSE Essence Water-Based Lubricant #LubeLife Water-Based Lubricant #LubeLife Water-Based Anal Lubricant
Indications for Use (Describe)
JO Agapé Original 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.
MUSE Essence Water-Based 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 lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.
#LubeLife Water-Based 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.
#LubeLife Water-Based Anal 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 lates and polyisoprene condoms. 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) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
_ | 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
Image /page/3/Picture/1 description: The image contains a logo and some text. The logo is a stylized letter 'U' in blue and gray, with the words 'UNITED CONSORTIUM' written below it in a smaller font. To the right of the logo, the text 'JO Agap' is written in bold, followed by '#Lub' on the next line. The text is black and appears to be part of a larger message or title.
JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant
510(k) Summary
| 510(k) Owner: | United Consortium |
|---|---|
| Street Address: | 29000 N. Hancock Parkway |
| Valencia, CA 91355 | |
| Contact Person: | Stephanie Morris |
| Global 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: | December 5, 2018 |
| Trade Name: | JO Agapé Original Personal Lubricant
MUSE Essence Water-Based Lubricant
#LubeLife Water-Based Lubricant
#LubeLife Water-Based Anal Lubricant |
| Device Classification: | Common Name: Personal Lubricant
Classification Name: Condom
Classification Number: 21 CFR § 884.5300
Product Code: NUC (lubricant, personal)
Device Class: Class II |
| Predicate Device: | Product Name: Wet Original® Personal Lubricant
510(k) Number: K160211
Manufacturer: Trigg Laboratories, Inc.
Product Code: NUC (lubricant, personal)
Device Class: Class II |
The predicate device has not been subject to a design-related recall.
Device Description:
JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are clear/water
4
Image /page/4/Picture/2 description: The image features a stylized logo for "UNITED CONSORTIUM." The logo consists of a large, abstract shape resembling the letter 'U,' with the left side in a dark blue color and the right side in a light gray. The words "UNITED CONSORTIUM" are printed in a smaller, sans-serif font below the shape, aligned to the left.
JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant
white, viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants 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. All of these devices contain the same formulation.
The JO Agapé Original Personal Lubricant product is to be sold as an over-the-counter (OTC) product in sizes of 1 fl. oz./30 mL 2 fl. oz./60 mL and 4 fl. oz./120 mL. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc tops. The 2 oz. and 4 oz. size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. This product is also available in 3 mL and 10 mL polyester-faced laminated pouches.
The MUSE Essence Water-Based Lubricant product is to be sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size bottles. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with matte black Polypropylene (PP) pump closures. The bottles are then placed in Solid Bleached Sulfate (SBS) cartons and sealed with a clear Biaxially-Oriented Polypropylene (BOPP) sticker on the top and bottom of each carton. This product is also available in 10 mL size polyester-faced laminated pouches.
#LubeLife Water-Based Lubricant product is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL and 12 fl. oz./360 mL sizes. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
LubeLife Water-Based Anal Lubricant product is to be sold as an over-the-counter (OTC) product in 12 fl. oz./360 mL size bottles. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
The device specifications are listed in the table below:
| Table 1: Device Specifications for JO Agapé Original Personal Lubricant, MUSE Essence | |
|---|---|
| Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based | |
| Anal Lubricant | |
| Property | Specification |
| Appearance | Clear, viscous liquid |
| Color | Clear, water white |
| Odor | Odorless |
| Viscosity (cps) | 2400 cps to 3100 cps |
| pH | 3.6 to 4.5 |
5
Image /page/5/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two shades of gray and blue. The blue portion of the 'U' is in the foreground, while the gray portion is behind it, creating a layered effect. Below the logo, the words 'UNITED CONSORTIUM' are written in a sans-serif font.
IO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant
| Specific Gravity | 1.020 to 1.026 |
|---|---|
| Osmolality | 600 to 700 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 |
Indications for Use:
JO Agapé Original 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.
MUSE Essence Water-Based 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.
#LubeLife Water-Based 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.
#LubeLife Water-Based Anal 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 indications for use and technological characteristics of the subject and predicate devices.
6
Image /page/6/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two tones. The left side of the 'U' is a dark blue, while the right side is a light gray. Below the 'U', the words 'UNITED CONSORTIUM' are written in a sans-serif font, with 'UNITED' stacked above 'CONSORTIUM'.
JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant
Table 2: Comparator Table for Subject Devices – JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant and Predicate Device Wet Original® Personal Lubricant
| Feature | JO Agapé Original Personal Lubricant
MUSE Essence Water-Based Lubricant
#LubeLife Water-Based Lubricant
#LubeLife Water-Based Anal Lubricant | Wet Original® Personal
Lubricant (K160211) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | JO Agapé Original 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.
MUSE Essence Water-Based 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.
#LubeLife Water-Based 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. | The Trigg Laboratories Wet
Original® 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,
polyisoprene, and
polyurethane condoms. |
| Feature | JO Agapé Original Personal Lubricant
MUSE Essence Water-Based Lubricant
#LubeLife Water-Based Lubricant
#LubeLife Water-Based Anal Lubricant | Wet Original® Personal
Lubricant (K160211) |
| | #LubeLife Water-Based Anal 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. | |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Propanediol, hydroxyethylcellulose,
water (aqua), gluconolactone, sodium
benzoate, citric acid | Glycerin, water, pentylene
glycol, potassium sorbate,
sodium carboxymethylcellulose |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene | Latex, Polyisoprene,
Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 2 years |
7
Image /page/7/Picture/1 description: The image shows a logo with a stylized letter 'U' in blue and gray. The blue part of the 'U' is in the foreground, while the gray part is behind it, creating a layered effect. Below the 'U', the words 'UNITED CONSORTIUM' are written in a sans-serif font, with 'UNITED' stacked above 'CONSORTIUM'. The logo has a clean and modern design.
JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant
The subject and predicate devices have similar indications for use. The indications for the subject devices has been expanded to also include anal use. This change does not represent a new intended use as the intended use of these devices is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations, and condom compatibility. The different technological characteristics of the subject devices does 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 accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices –
8
JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant
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 lubricants are only slightly cytotoxic with a passing reactivity score, mildy-irritating with a passing reactivity score, non-sensitizing and non-systemically toxic.
Shelf-Life:
The subject devices are non-sterile personal lubricants with a two-year shelf-life in accordance with the results of accelerated aging studies on the various packaging types available for the lubricants, i.e., bottles with cap, bottles with pump closure and pouches. All device specifications listed in Table 1 were evaluated for the largest volumes associated with each packaging type which were considered worst case for evaluating shelf-life.
Condom Compatibility:
The compatibility of the subject devices 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 indicated that JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that the JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are as safe and effective as the predicate device and supports a determination of substantial equivalence.