(82 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a personal lubricant, with no mention of AI or ML technology.
No.
The device is a personal lubricant used for moisturizing and enhancing comfort during sexual activity, not for treating or preventing a disease or health condition.
No
The device is a personal lubricant intended to lubricate and moisturize to enhance sexual activity, not to diagnose a condition.
No
The device description clearly states it is a water-based personal lubricant with a specific chemical formulation and is sold in a physical bottle. This indicates it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a personal lubricant for external application to enhance sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The description reinforces its use as a lubricant and lists its ingredients, which are typical for a personal lubricant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue), detecting biomarkers, or providing information about a patient's health status or disease.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, all of which relate to the physical properties and safety of a lubricant, not its diagnostic accuracy.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
JO CUMPLAY 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.
Product codes
NUC
Device Description
JO CUMPLAY Personal Lubricant is a non-sterile, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Its formulation consists of Water (Aqua), Propylene Glycol, Dimethicone, Dimethiconol, Lauryl Glucoside, Aloe Barbadensis Leaf Powder, Vitamin E Acetate, Hydroxyethylcellulose, PEG-90M, Hydrogenated Polydecene, Acrylic Copolymer, Sodium Acrylates/Beheneth-25 Metharylate Crosspolymer, and Chlorphenesin.
JO CUMPLAY Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in a 4 fl. Oz./120 mL polyethylene terephthalate bottle and capped with matte black Polypropylene (PP) pump closure.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was 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. " The following testing was conducted:
- 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 testing support the biocompatibility of the device materials.
The subject device has a shelf-life of 2.5 years. Results from real-time testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.
The compatibility of JO CUMPLAY Personal Lubricant with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed JO CUMPLAY Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed JO CUMPLAY Personal Lubricant not to be compatible with polyurethane condoms.
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 20, 2022
CC Wellness LLC Marlent Perez Quality/Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K221908
Trade/Device Name: JO CUMPLAY Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 27, 2022 Received: June 30, 2022
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.
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/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,
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
2
Indications for Use
510(k) Number (if known) K221908
Device Name JO CUMPLAY Personal Lubricant
Indications for Use (Describe)
JO CUMPLAY 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K221908 JO CUMPLAY Personal Lubricant
1. Submitter Information
Applicant: CC Wellness LLC Contact: Marlent Perez Regulatory Affairs Specialist Bruce Albert Chief Scientific Officer Address: 29000 N. Hancock Parkway Valencia, CA 91355 Phone: (661) 481-6390 Phone: (661) 295-1700, ext. 231
2. Correspondent Information
Contact: Marlent Perez Address: 29000 N. Hancock Parkway Valencia, CA 91355 Phone: (661) 481-6390 Email: mperez@ccwellness.com
3. Date prepared: August 26, 2022
4. Subject Device Information
Device Trade Name: JO CUMPLAY Personal Lubricant Common Name: Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Product Code: NUC (lubricant, personal) Device Class: Class II
5. Predicate Device Information
Device Name: Coconut Infused Hybrid Personal Lubricant 510(k) Number: K180712 Manufacturer: United Consortium
The predicate device has not been subject to a design-related recall.
6. Device Description
JO CUMPLAY Personal Lubricant is a non-sterile, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Its formulation consists of Water (Aqua), Propylene Glycol, Dimethicone, Dimethiconol, Lauryl Glucoside, Aloe Barbadensis Leaf Powder, Vitamin E Acetate, Hydroxyethylcellulose, PEG-90M, Hydrogenated Polydecene, Acrylic Copolymer, Sodium Acrylates/Beheneth-25 Metharylate Crosspolymer, and Chlorphenesin.
4
JO CUMPLAY Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in a 4 fl. Oz./120 mL polyethylene terephthalate bottle and capped with matte black Polypropylene (PP) pump closure.
Device specifications for the JO CUMPLAY Personal Lubricant are listed in Table 1.
| Property | Specification |
|---|---|
| Appearance | Viscous liquid |
| Color | White to off-white |
| Odor | Odorless |
| Viscosity (per USP) | 7800 - 8800 cps |
| pH (per USP) | 6.8 – 8.0 |
| Osmolality (per USP) | 700 – 1000 mOsm/kg |
| Total Aerobic Microbial Count (TAMC, per | |
| USP ) | ) |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli | Absent |
| Salmonella/Shigella | Absent |
| Antimicrobial Effectiveness Testing (per | |
| USP | Specification |
| Bacteria | Meets USP criteria for category 2. |
| No less than 2.0 log reduction from initial | |
| count at 14 days and no increase from the 14- | |
| day count at 28 days | |
| Yeast and Molds | No increase from the initial calculated count at |
| 14 and 28 days |
Table 1: Device Specifications for JO CUMPLAY Personal Lubricant
7. Indications for Use
JO CUMPLAY 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.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
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Table 2: Intended Use and Technological Characteristics Comparison of the Subject and Predicate Device
| | JO CUMPLAY Personal
Lubricant
K221908
Subject Device | Coconut Infused Hybrid
Personal Lubricant
K180712
Predicate Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | JO CUMPLAY 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. | 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 |
| Base type | Water | Water |
| Primary ingredients | Water (Aqua), Propylene Glycol,
Dimethicone, Dimethiconol, Lauryl
Glucoside, Aloe Barbadensis Leaf
Powder, Vitamin E Acetate,
Hydroxyethylcellulose, PEG-90M,
Hydrogenated Polydecene, Acrylic
Copolymer, Sodium
Acrylates/Beheneth-25 Metharylate
Crosspolymer, Chlorphenesin | 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 |
| Rx/OTC | OTC | OTC |
| Sterile | No | No |
| Appearance | Viscous liquid | Translucent, semi-viscous cream |
| Color | White to off-white | White to off-white |
| Odor | Odorless | Odorless |
| Viscosity | 7,800 - 8800 cps | 20,000 - 31,000 cps |
| pH | 6.8 - 8.0 | 5.7 - 6.3 |
| Osmolality | 700 - 1000 mOsm/Kg | 450-900 mOsm/kg |
| Total Aerobic Microbial
count (TAMC) |