(90 days)
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.
No.
This device is a personal lubricant for enhancing comfort during sexual activity, not for treating or diagnosing a medical condition.
No
The device is a personal lubricant intended to lubricate and moisturize to enhance sexual activity, not to diagnose any condition.
No
The device is a physical personal lubricant, not a software application. The description details its composition, packaging, and physical properties, and the performance studies focus on biocompatibility, shelf-life, and condom compatibility, all related to a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied to the body (penile, anal, and/or vaginal).
- Device Description: It's a personal lubricant, a topical product.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the body.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Agape 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Agape Cooling Personal Lubricant is a clear, semi-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. It is supplied in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes provided in clear polyethylene terephthalate (PET) cylinder bottles. 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. This device is composed of Water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Mentha Piperita (Peppermint) Leaf Extract.
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 10993-1:2018 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 lubricant is non-cytotoxic, non-irritating, non-sensitizing and non-systemically toxic.
The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at Time 0 and at the end of the three-year shelf-life. The subject device met the device specifications at all time points assessed.
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane 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 indicated that Agape Cooling Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
0
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.
July 2, 2020
CC Wellness LLC Marlent Perez Quality Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
K200894 Re: Trade/Device Name: Agape Cooling Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 2, 2020 Received: April 3, 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. 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
1
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-regulatory-information/postmarketing-safety-reportingcombination-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, 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 Agape Cooling Personal Lubricant
Indications for Use (Describe)
Agape 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 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 – K200894
Agape Cooling Personal Lubricant | | Page 1 of |
|---------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--|-----------|
| 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: | June 29, 2020 | | | |
| Trade Name: | Agape Cooling Personal Lubricant | | | |
| Common Name: | Personal Lubricant | | | |
| Device Classification: | Regulation Name:
Regulation Number:
Product Code:
Device Class: | Condom
21 CFR § 884.5300
NUC (lubricant, personal)
Class II | | |
| Predicate Device: | Product Name:
510(k) Number:
Manufacturer:
Product Code:
Device Class: | Premium Cooling Personal Lubricant
K200602
CC Wellness LLC
NUC (lubricant, personal)
Class II | | |
The predicate device has not been subject to a design-related recall.
Device Description:
Agape Cooling Personal Lubricant is a clear, semi-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.
4
Image /page/4/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 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 - K200894 Agape Cooling Personal Lubricant
oz./60 mL sizes provided in clear polyethylene terephthalate (PET) cylinder bottles. 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.
This device is composed of Water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Mentha Piperita (Peppermint) Leaf Extract.
The device specifications are listed in the table below:
| Property | Specification |
|---|---|
| Appearance | Semi-viscous liquid |
| Color | Colorless |
| Odor | Peppermint |
| Viscosity (cps) per USP | 2150 to 4000 |
| pH per USP | 3.50 to 4.50 |
| Specific Gravity per USP | 1.010 to 1.030 |
| Osmolality per USP (1:2 dilution) | 500 to 750 mOsm/kg |
| 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 |
Table 1: Device Specifications for Agape Cooling Personal Lubricant
Indications for Use:
Agape 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 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.
5
Image /page/5/Picture/0 description: The image shows a logo for a business called "Wellness". The logo features a stylized, cursive font. The word "Wellness" is written in smaller letters to the right of the cursive letters. The logo is simple and elegant, and it is likely used to represent a business that focuses on health and well-being.
Table 2: Comparator Table for Subject Device – Agape Cooling Personal Lubricant and Predicate Device – Premium Cooling Personal Lubricant
| Feature | Agape Cooling Personal
Lubricant | Premium Cooling Personal
Lubricant (K200602) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | Agape 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 and polyisoprene condoms.
This product is not compatible with
polyurethane condoms. | 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. |
| Water soluble | Yes | No |
| Contains water | Yes | No |
| Ingredients | Water, Propanediol, Gluconolactone,
Hydroxyethylcellulose, Sodium
Benzoate, Polysorbate 20, Citric Acid
and Mentha Piperita (Peppermint)
Leaf Extract | Dimethicone, Dimethiconol
and Menthol |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex and
Polyisoprene | Natural Rubber Latex, Polyisoprene
and Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |
The subject and predicate device indications for use are not identical as the predicate device indications for use also states that it is compatible with polyurethane condoms. This difference does not represent a new intended use as the intended use of the subject device is the same as the predicate device, i.e., provides lubrication during intimate sexual activity. In addition, the subject and predicate devices have different technological characteristics; for example, different formulations, water solubility, condom compatibility, etc. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
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 10993-1:2018 as follows:
6
- 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 lubricant is non-cytotoxic, non-irritating, non-sensitizing and non-systemically toxic.
Shelf-Life:
The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at Time 0 and at the end of the three-year shelf-life. The subject device met the device specifications at all time points assessed.
Condom Compatibility:
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane 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 indicated that Agape Cooling 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 Agape Cooling Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.