(90 days)
JO Coconut Hybrid Warming Personal Lubricant is a 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.
JO Coconut Hybrid Warming Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal 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.
JO Coconut Hybrid Warming Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Niacin, Polyisobutene, Polysorbate 20, Dipropylene Glycol, Vanillyl Butyl Ether,PEG-45M, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Polysorbate 80, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin, Beeswax, Glyceryl Stearate, Hydroxypropylcellulose, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, Polyquaternium-67.
The provided text is a 510(k) summary for a personal lubricant (JO Coconut Hybrid Warming Personal Lubricant). It details the device's characteristics, comparison to a predicate device, and non-clinical performance data (biocompatibility, shelf-life, and condom compatibility).
However, the text does not contain any information about an AI/ML-based medical device study. It does not mention:
- Acceptance criteria for an AI/ML model
- Sample sizes for test or training sets for AI/ML
- Provenance of data for AI/ML
- Number or qualifications of experts for AI/ML ground truth
- Adjudication methods for AI/ML ground truth
- Multi-reader multi-case (MRMC) studies
- Standalone algorithm performance
- Type of ground truth used for AI/ML (e.g., pathology, outcomes)
- How ground truth for training data was established for an AI/ML model
Therefore, I cannot fulfill your request for the tables and study details related to an AI/ML device's acceptance criteria and proven performance based on the input text. The information provided is for a traditional, non-AI medical device (a lubricant).
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2023
CC Wellness LLC Marlent Perez Regulatory Affairs Specialist II 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K232090
Trade/Device Name: JO Coconut Hybrid Warming Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 11, 2023 Received: July 13, 2023
Dear Marlent Perez:
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. 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 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.
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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, 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
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Indications for Use
510(k) Number (if known) K232090
Device Name
JO Coconut Hybrid Warming Personal Lubricant
Indications for Use (Describe)
JO Coconut Hybrid Warming Personal Lubricant is a 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) | |
|---|---|
_ | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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WELLNESS
510(k) Traditional Submission IO Coconut Hybrid Warming Personal Lubricant
510(k) Summary – K232090
| 510(k) Owner: | CC Wellness LLC |
|---|---|
| Street Address: | 29000 N. Hancock Parkway Valencia, CA 91355 |
| Contact Person: | Marlent PerezRegulatory Affairs Specialist II |
| Bruce AlbertChief Scientific Officer | |
| Contact Numbers: | Phone: (661) 481-6390Phone: (661) 295-1700 |
| Summary Preparation Date: | October 5, 2023 |
Subject Device Information:
| Trade Name: | JO Coconut Hybrid Warming Personal Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Product Code: | NUC (lubricant, personal) |
| Device Class: | Class II |
Predicate Device Information:
| Product Name: | Coconut Infused Hybrid Personal Lubricant |
|---|---|
| 510 (k) number: | K180712 |
| Manufacturer: | United Consortium |
| Product Code: | NUC (lubricant, personal) |
| Device Class: | Class II |
The predicate device has not been subject to a design-related recall.
Device Description:
JO Coconut Hybrid Warming Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and
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moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.
JO Coconut Hybrid Warming Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Niacin, Polyisobutene, Polysorbate 20, Dipropylene Glycol, Vanillyl Butyl Ether,PEG-45M, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Polysorbate 80, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin, Beeswax, Glyceryl Stearate, Hydroxypropylcellulose, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, Polyquaternium-67.
| Property | Specification |
|---|---|
| Appearance | Viscous opaque liquid |
| Color | Opaque, off-white |
| Odor | Mild Coconut |
| Viscosity (cps) per USP <911> | 10,000 – 19,000 |
| pH per USP <971> | 4.00 – 5.25 |
| Specific Gravity per USP <841> | 0.925 – 1.050 |
| Osmolality per USP <785> | 800 - 1075 mOsm/kg |
| Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for Category 2 products. |
| Total aerobic microbial count (TAMC) per USP <61> and <1111> | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP <61> and <1111> | Less than 10 cfu/g |
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
The device specifications are listed in the table below:
Table 1: Device Specifications for JO Coconut Hybrid Warming Personal Lubricant
Indications for Use:
JO Coconut Hybrid Warming Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease
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WELLNESS
510(k) Traditional Submission JO Coconut Hybrid Warming Personal Lubricant
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.
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.
| Feature | JO Coconut Hybrid Warming | Coconut Infused Hybrid Personal |
|---|---|---|
| Personal Lubricant | Lubricant (K180712) | |
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | JO Coconut Hybrid WarmingPersonal Lubricant is a personallubricant for penile, anal and/orvaginal application, intended tolubricate and moisturize, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprene condoms.This product is not compatiblewith polyurethane condoms. | Coconut Infused Hybrid PersonalLubricant is a personal lubricant forpenile, anal and/or vaginalapplication, intended to lubricateand moisturize, to enhance theease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Propylene Glycol,Caprylic/Capric Triglyceride, CocosNucifera (Coconut) Oil, Flavor(Aroma), Phenoxyethanol,Polyacrylate 13, Cellulose Gum,Raphanus Sativus (Radish) SeedExtract, Niacin, Polyisobutene,Polysorbate 20, Dipropylene Glycol,Vanilly Butyl Ether,PEG-45M,Butyrospermum Parkii (Shea) ButterExtract, Ethyl MenthaneCarboxamide, Methyl DiisopropylPropionamide, Polysorbate 80,Caprylyl Glycol, Phenethyl Alcohol,Ethylhexylglycerin, Beeswax,Glyceryl Stearate,Hydroxypropylcellulose, MenthylLactate, PEG-100 Stearate,Stearamidopropyl DimethylamineLactate, Polyquaternium-67. | Water (Aqua), Propylene Glycol,Caprylic/Capric Triglyceride, CocosNucifera (Coconut) Oil, Flavor(Aroma), Phenoxyethanol,Polyacrylate 13, Cellulose Gum,Raphanus Sativus (Radish) SeedExtract, Polyisobutene,Polysorbate 20, PEG-45M |
Table 2: Comparator Table for Subject Device – JO Coconut Hybrid Warming Personal Lubricant and Predicate Device – Coconut Infused Hybrid Personal Lubricant
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Image /page/6/Picture/0 description: The image shows a logo for a wellness company. The logo features two stylized, cursive letters that appear to be "CC". Below the letters, the word "WELLNESS" is written in smaller, sans-serif font. The overall design is simple and elegant, with a focus on the company's name and its association with wellness.
510(k) Traditional Submission O Coconut Hybrid Warming Personal Lubricant
| pH | 4.00 - 5.25 | 5.30 - 6.30 |
|---|---|---|
| Osmolarity | 800 - 1075 mOsm/kg | 300 - 950 mOsm/kg |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex andPolyisoprene | Natural Rubber Latex andPolyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |
The subject and predicate device have similar indications for use statement and have the same intended use. The subject and predicate devices have different technological characteristics including different formulations and device specifications. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Performance Data:
Biocompatibility
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation, Cytotoxicity, and Sensitization testing were performed in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of this testing demonstrated that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not acutely systemically toxic.
Shelf-Life:
The subject device is a non-sterile personal lubricant with a 3-year shelf-life in accordance with the results of a real time and accelerated aging study. Results from this testing demonstrated that the device maintains its specifications as shown in Table 1 over the duration of its shelf life.
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Image /page/7/Picture/0 description: The image shows a logo for a company called "Wellness". The logo features two stylized, cursive letters that appear to be "C"s, connected in the middle. The word "WELLNESS" is written in small, sans-serif letters to the right of the connected "C"s. The overall design is simple and elegant, with a focus on the company's name.
510(k) Traditional Submission JO Coconut Hybrid Warming Personal Lubricant
Condom Compatibility:
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms were evaluated in accordance with ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated JO Coconut Hybrid Warming Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that JO Coconut Hybrid Warming Personal Lubricant is safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.