(86 days)
Not Found
No
The device description and intended use clearly define the product as a personal lubricant with no mention of any computational or analytical capabilities, let alone AI/ML. The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are standard evaluations for this type of device and do not involve AI/ML.
No
The device is described as a personal lubricant intended to lubricate and moisturize to enhance ease and comfort during intimate sexual activity, which does not fall under the definition of a therapeutic device. It does not treat, cure, or prevent any disease or condition.
No
The device's intended use is to lubricate and moisturize to enhance sexual activity, not to diagnose any medical conditions or diseases.
No
The device description clearly states it is a physical product (lubricant) composed of chemical ingredients and packaged in bottles. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is a personal lubricant for application to the body (penile, anal, and/or vaginal) to enhance sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The description of the device and its intended use does not involve any testing of bodily samples or the diagnosis of any condition. It is purely a physical lubricant.
The information provided, such as biocompatibility studies and condom compatibility, are relevant to the safety and performance of a personal lubricant, but they do not indicate a diagnostic function.
N/A
Intended Use / Indications for Use
Premium Cooling 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, polyisoprene and polyurethane condoms.
Premium Anal Cooling Lubricant is a personal lubricant for 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, polyisoprene and polyurethane condoms.
Product codes
NUC
Device Description
Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are clear, semi-viscous personal lubricants that are compatible with natural rubber latex, polyisoprene and 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 supplement the body's natural lubrication.
Premium Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
Premium Anal Cooling Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
These devices are composed of Dimethicone, Dimethiconol and Menthol.
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
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility studies 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 10993-1:20019 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal 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, non-irritating, non-sensitizing and nonsystemically toxic.
Shelf-Life:
The subject devices are non-sterile personal lubricants 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 devices 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 that Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Key Metrics
- Viscosity (cps) per USP : 800 to 1,075
- Specific Gravity per USP : 0.875 to 1.020
- Antimicrobial effectiveness per USP : Meets USP acceptance criteria for Category 2 products.
- Total aerobic microbial count (TAMC) per USP and : Less than 100 cfu/g
- Total yeast and mold count (TYMC) per USP and : Less than 10 cfu/g
- Presence of Pathogens per USP :
- Pseudomonas aeruginosa: Absent
- Staphylococcus aureus: Absent
- Salmonella/Shigella: Absent
- Escherichia coli: Absent
- Candida albicans: Absent
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 3, 2020
CC Wellness LLC Marlent Perez Quality Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K200602
Trade/Device Name: Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 5, 2020 Received: March 9, 2020
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 (OS) 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 medical devices and radiation-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
Jason R. Roberts, Ph.D. Acting 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)
Device Name Premium Cooling Personal Lubricant Premium Anal Cooling Lubricant
Indications for Use (Describe)
Premium Cooling 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, polyisoprene and polyurethane condoms.
Premium Anal Cooling Lubricant is a personal lubricant for 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, polyisoprene and polyurethane condoms.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows a logo with the letters "CC" in a stylized, cursive font. The word "WELLNESS" is written in smaller, sans-serif letters below the "CC". The overall design is simple and elegant, suggesting a focus on health and well-being.
510(k) Summary - K200602 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant
| 510(k) Owner: | CC Wellness LLC | |
|---|---|---|
| Street Address: | 29000 N. Hancock | |
| Parkway Valencia, CA | ||
| 91355 | ||
| Contact Person: | Marlent Perez | |
| Quality Specialist | ||
| Bruce Albert | ||
| Head of Technical Services | ||
| Contact Numbers: | Phone: (661) 295-1700, ext. 1007 | |
| Phone: (661) 295-1700, ext. 231 | ||
| Summary Preparation Date: | May 29, 2020 | |
| Trade Name: | Premium Cooling Personal Lubricant | |
| Premium Anal Cooling Lubricant | ||
| Common Name: | Personal Lubricant | |
| Device Classification: | Common Name: | |
| Regulation Name: | ||
| Regulation Number: | ||
| Product Code: | ||
| Device Class: | Personal Lubricant | |
| Condom | ||
| 21 CFR § 884.5300 | ||
| NUC (lubricant, | ||
| personal) Class II | ||
| Predicate Device: | Product Name: | Trojan Chain Reaction Personal |
| Lubricant | ||
| 510(k) Number: | K161544 | |
| Sponsor: | Church & Dwight Co., Inc | |
| Product Code: | NUC (lubricant, | |
| personal) Class II | ||
| Device Class: | NUC (lubricant, | |
| personal) Class II |
The predicate device has not been subject to a design-related recall.
Device Description:
Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are clear, semi-viscous personal lubricants that are compatible with natural rubber latex, polyisoprene and 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 supplement the body's natural lubrication.
4
Image /page/4/Picture/1 description: The image shows a logo with two stylized cursive letters, likely 'CC', connected by a flowing line. Below the letters, the word "WELLNESS" is written in small, sans-serif font with wide spacing between the letters. The overall design is simple and elegant, suggesting a brand related to health, beauty, or lifestyle.
510(k) Summary - K200602 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant
Premium Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
Premium Anal Cooling Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
These devices are composed of Dimethicone, Dimethiconol and Menthol.
The device specifications are listed in the table below:
| Table 1: Device Specifications for Premium Cooling Personal Lubricant and Premium | |
|---|---|
| Anal Cooling Lubricant | |
| Property | Specification |
| Appearance | Semi-viscous liquid |
| Color | Colorless |
| Odor | Odorless |
| Viscosity (cps) per USP | 800 to 1,075 |
| Specific Gravity per USP | 0.875 to 1.020 |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 |
| products. | |
| Total aerobic microbial count (TAMC) per USP | |
| and | Less than 100 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:
Premium Cooling 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, polyisoprene and polyurethane condoms.
Premium Anal Cooling 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, polyisoprene and polyurethane condoms.
5
Image /page/5/Picture/1 description: The image shows a logo with two stylized cursive letters, possibly 'CC', connected by a flourish. Below the letters, the word 'WELLNESS' is written in smaller, sans-serif font. The logo has a clean and elegant design, suggesting a brand related to health, beauty, or lifestyle.
510(k) Summary – K200602 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant
Predicate Device Comparison:
The table below lists the comparative indications for use and technological characteristics of the subject and predicate device.
Table 2: Comparator Table for Subject Device – Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant and Predicate Device – Trojan Chain Reaction Personal Lubricant
| Feature | Premium Cooling Personal Lubricant
Premium Anal Cooling Lubricant | Trojan Chain Reaction Personal
Lubricant (K161544) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | Premium Cooling 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,
polyisoprene and polyurethane
condoms.
Premium Anal Cooling 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,
polyisoprene and polyurethane
condoms. | Trojan Chain Reaction Personal
Lubricant is a personal lubricant
for penile and/or vaginal
application, intended to lubricate
and moisturize, to enhance the
ease and comfort of intimate
sexual activity and supplement the
body's natural lubrication. This
product is compatible with natural
rubber latex and polyisoprene
condoms. Not compatible with
polyurethane condoms. |
| Water soluble | No | No |
| Ingredients | Dimethicone
Dimethiconol
Menthol | Dimethicone
Dimethiconol
Sensate |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex, Polyisoprene
and Polyurethane | Natural Rubber Latex and
Polyisoprene |
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Image /page/6/Picture/1 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 a 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) Summary - K200602 Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant
| Biocompatibility Tested | Yes | Yes |
|---|---|---|
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 2 years |
The subject and predicate devices 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 primary 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 devices have different technological characteristics; for example, different formulations. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness questions.
Summary of Performance Data:
Biocompatibility
Biocompatibility studies 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 10993-1:20019 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal 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, non-irritating, non-sensitizing and nonsystemically toxic.
Shelf-Life:
The subject devices are non-sterile personal lubricants 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 devices 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 that Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are as safe and effective as the predicate device and supports a determination of substantial equivalence.