(90 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, biocompatibility, shelf-life, and condom compatibility of a personal lubricant. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a personal lubricant intended to enhance the ease and comfort of intimate sexual activity and supplement natural lubrication, not to treat or cure a medical condition.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to diagnose a medical condition.
No
The device description clearly states it is a "clear, semi-viscous personal lubricant" composed of various chemical ingredients and packaged in bottles. This indicates a physical product, not software.
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 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 describes a topical application for physical lubrication and comfort during sexual activity.
- Device Description: The description details a "clear, semi-viscous personal lubricant" applied externally.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. IVDs are designed for diagnostic purposes.
The device is clearly described as a personal lubricant for external application to facilitate sexual activity, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Agape 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Agape Warming Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. 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 and supplement the body's natural lubrication.
This product is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes 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.
This device is composed of water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Capsicum Oleoresin.
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 studies, including Acute Systemic Toxicity, Vaginal Irritation, Penile Irritation, Cytotoxicity and Sensitization 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. The results of this testing demonstrated that the subject lubricant is only slightly cytotoxic with a passing reactivity score, non-irritating, non-sensitizing and nonsystemically toxic.
The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of real-time and accelerated aging studies. All device specifications listed in Table 1 were tested and met the device specifications across the shelf-life duration.
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was 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 Agape Warming Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
April 27, 2020
CC Wellness LLC Marlent Perez Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K200208
Trade/Device Name: Agape Warming Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 23, 2020 Received: January 28, 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
1
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-regulatory-information/postmarketing-safety-reportingcombination-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
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) K200208
Device Name
Agape Warming Personal Lubricant
Indications for Use (Describe)
Agape 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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3
| | K200208
Agape Warming Personal Lubricant | K200208
Page 1 of 4 |
|---------------------------|---------------------------------------------------------------------------------------|------------------------|
| 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: | April 24, 2020 | |
| Trade Name: | Agape Warming Personal Lubricant | |
510(k) Summary
| Device Classification: | Common Name: | Personal Lubricant |
|---|---|---|
| Regulation Name: | Condom | |
| Regulation Number: | 21 CFR 884.5300 | |
| Product Code: | NUC (lubricant, personal) | |
| Device Class: | Class II | |
| Predicate Device: | Product Name: | JO Agape Original Personal |
| Lubricant | ||
| 510(k) Number: | K183384 | |
| Manufacturer: | CC Wellness LLC | |
| Product Code: | NUC (lubricant, personal) | |
| Device Class: | Class II |
The predicate device has not been subject to a design-related recall.
Device Description:
Agape Warming Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. 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 and supplement the body's natural lubrication.
This product is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes 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
4
CC
WELLNESS
Agape Warming Personal Lubricant
K200208 Page 2 of 4
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 Capsicum Oleoresin.
The device specifications are listed in the table below:
| Table 1: Device Specifications for Agape Warming Personal Lubricant | |||
|---|---|---|---|
| --------------------------------------------------------------------- | -- | -- | -- |
| Property | Specification |
|---|---|
| Appearance | Semi-viscous liquid |
| Color | Clear |
| Odor | Odorless |
| Viscosity (cps) per USP | 2,150 to 4,000 |
| pH per USP | 3.40 to 4.50 |
| Specific Gravity per USP | 0.950 to 1.035 |
| Osmolality per USP | 575 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 |
Indications for Use:
Agape 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.
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 with two stylized cursive letters that appear to be "CC". Below the letters, in a smaller, sans-serif font, is the word "WELLNESS". The overall design is simple and elegant, suggesting a brand identity focused on health and well-being.
510(k) Summary K200208 Agape Warming Personal Lubricant
| Feature | Subject Device
Agape Warming Personal
Lubricant
K200208 | Predicate Device
JO Agape Original Personal
Lubricant
K183384 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | Agape 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 Agape 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. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Propanediol,
Gluconolactone,
Hydroxyethylcellulose, Sodium
Benzoate, Polysorbate 20, Citric Acid
and Capsicum Oleoresin | Water (Aqua), Propanediol,
Gluconolactone,
Hydroxyethylcellulose, Sodium
Benzoate, Citric Acid |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene | Latex, Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |
Table 2: Comparator Table for the Subject and Predicate Devices
The subject and predicate device have similar indications for use, and the same intended use (i.e., lubrication during intimate sexual activity). The subject and predicate devices have different technological characteristics; for example, different formulations, including ingredients to provide a warming sensation. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
Summary of Performance Data:
Biocompatibility
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation, Penile Irritation, Cytotoxicity and Sensitization 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:
6
Image /page/6/Picture/1 description: The image shows a logo with the letters "CC" in a stylized, cursive font. The letters are connected by a flowing line that extends from the left side of the first "C" to the right side of the second "C". Below the letters, the word "WELLNESS" is written in smaller, sans-serif font. The logo is simple and elegant, and the use of cursive and sans-serif fonts creates a contrast that is both visually appealing and easy to read.
- 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 lubricant is only slightly cytotoxic with a passing reactivity score, non-irritating, non-sensitizing and nonsystemically toxic.
Shelf-Life:
The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of real-time and accelerated aging studies. All device specifications listed in Table 1 were tested and met the device specifications across the shelf-life duration.
Condom Compatibility:
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was 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 Agape 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 Agape Warming Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.