(154 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and physical properties of a personal lubricant. There is no mention of any computational or analytical functions that would typically involve AI/ML.
No
The device is a personal lubricant intended to enhance the ease and comfort of sexual activity and supplement natural lubrication, not to treat or cure a disease or condition.
No
Explanation: The device is described as a personal lubricant intended to lubricate and moisturize for enhanced comfort during sexual activity. Its functionalities, such as compatibility with sperm and condoms, and the performance studies conducted (e.g., biocompatibility, sperm survival, shelf life), all relate to its primary purpose as a lubricant and do not involve detecting, monitoring, or diagnosing any medical condition or physiological state.
No
The device description clearly states it is a physical personal lubricant composed of various chemical ingredients and packaged in a bottle. It does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to lubricate and moisturize for sexual activity and supplement natural lubrication. While it mentions compatibility with sperm, oocytes, and embryos for couples trying to conceive, its primary function is physical lubrication during sexual intercourse.
- Mechanism of Action: The device works by providing a physical barrier and reducing friction. It does not perform any diagnostic testing on biological samples (in vitro).
- Performance Studies: The performance studies focus on biocompatibility, sperm compatibility, shelf life, and condom compatibility. These are relevant to a personal lubricant, not an IVD.
- Key Metrics: The key metrics measured (sperm motility, endotoxin levels, microbial counts) are related to the safety and physical properties of the lubricant, not diagnostic accuracy.
- Lack of Diagnostic Claims: There are no claims about diagnosing, monitoring, or predicting any medical condition.
An IVD is a device intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of diagnosing disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This personal lubricant does not fit this definition.
N/A
Intended Use / Indications for Use
Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
PEB
Device Description
Actively Trying Personal Lubricant Rose Scented is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive.
Actively Trying Personal Lubricant Rose Scented is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process.
This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose, Arabinogalactan, and Rose water (Damascena).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, and/or vaginal application
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, 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. The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.
Additional biocompatibility testing performed included Human Sperm Survival Assay, Endotoxin Testing per USP and/or AAMI/ANSI ST72:2011/(R) 2016 (Limulus Amebocyte Lysate (LAL) Gel-Clot Method), and Lubricant Barrier Assay. The results indicate that the subject device is compatible with sperm and does not inhibit sperm motility.
The subject device is a non-sterile personal lubricant with a two-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 and 2 years. The subject device met the device specifications at all time points.
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that Actively Trying Personal Lubricant Rose Scented 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, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.
February 11, 2022
CC Wellness LLC Marlent Perez Quality/Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K212885
Trade/Device Name: Actively Trying Personal Lubricant Rose Scented Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: January 7, 2022 Received: January 12, 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,
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) K212885
Device Name
Actively Trying Personal Lubricant Rose Scented
Indications for Use (Describe)
Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.This product is compatible with natural rubber latex and polvisoprene 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K212885 Page 1 of 5
510(K) Summary - K212885
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: February 7, 2022
4. Device Information
Device Name: Actively Trying Personal Lubricant Rose Scented Common Name: Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB
5. Predicate Device Information
Device Name: Actively Trying Personal Lubricant 510(k) Number: K182585 Manufacturer: CC Wellness LLC Regulatory Class: Class II Product Code: PEB (lubricant, personal, gamete, fertilization, and embryo compatible)
The predicate device has not been subject to a design-related recall.
6. Device Description
Actively Trying Personal Lubricant Rose Scented is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive.
Actively Trying Personal Lubricant Rose Scented is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process.
This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose, Arabinogalactan, and Rose water (Damascena).
4
The devices specifications are listed in the table below:
| Property | Specification |
|---|---|
| Appearance | Semi-viscous liquid |
| Color | Clear |
| Odor | Rose Scented |
| Viscosity (cps) per USP | 8,500 - 13,000 |
| pH per USP | 7.25 - 7.80 |
| Specific Gravity per USP | 0.900 - 1.100 |
| Osmolality per USP | 300 — 410 mOsm/kg |
| Human Sperm Survival Assay (HSSA) | ≥ 80% of control motility at 24 hours after 30 |
| minutes exposure to 10% of subject lubricant | |
| Limulus Amebocyte Lysate (LAL) Gel-Clot | |
| Method USP and/or AAMI/ANSI | |
| ST72:2011/(R) 2016 | |
| 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 Actively Trying Personal Lubricant Rose Scented | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------ | -- | -- | -- |
7. Indications for Use:
Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. 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 the Predicate Device The table below compares the intended use and technological characteristics of the subject and predicate device.
5
Table 2: Comparator Table for Subject Device – Actively Trying Personal Lubricant Rose Scented and Predicate Device – Actively Trying Personal Lubricant
| Feature | Actively Trying Personal
Lubricant Rose Scented | Actively Trying Personal
Lubricant (K182585) |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | PEB | PEB |
| Indications for Use | Actively Trying Personal
Lubricant Rose Scented is a
personal lubricant for penile,
and/or vaginal application,
intended to lubricate and
moisturize, to enhance the ease
and comfort of sexual activity
and supplement the body's
natural lubrication. This product
is compatible with sperm,
oocytes and embryos and can be
used by couples trying to
conceive. This product is
compatible with natural rubber
latex and polyisoprene condoms.
This product is not compatible
with polyurethane condoms. | Actively Trying 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
condoms and polyurethane
condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Aqua, Propylene Glycol,
Hydroxyethylcellulose, Sodium
Chloride, Sodium Phosphate,
Potassium Phosphate, Propylene
Glycol, Chlorphenisen,
Fructose, Arabinogalactan, Rose
Water | Aqua, Propylene Glycol,
Hydroxyethylcellulose, Fructose,
Arabinogalactan, Sodium
Phosphate, Salta, Potassium
Phosphate, Methylparaben,
Propylparaben |
| pH | 7.25 - 7.80 | 7.25 – 7.80 |
| Osmolarity | 300 – 410 mOsm/kg | 800 – 1000 mOsm/kg |
| Human Sperm Survival
Assay (HSSA) | ≥ 80% of control motility at 24
hours after 30 minutes exposure
to 10% of subject lubricant | After exposure to 10% JO
Actively Trying for 30 minutes, ≥
80% of the control |
| Limulus Amebocyte
Lysate (LAL) Gel-Clot
Method | and/or AAMI/ANSI ST72:2011/(R) 2016 ● (Limulus Amebocyte Lysate (LAL) Gel-Clot Method)
- Lubricant Barrier Assay ●
The results indicate that the subject device is compatible with sperm and does not inhibit sperm motility.
Shelf Life
The subject device is a non-sterile personal lubricant with a two-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 and 2 years. The subject device met the device specifications at all time points.
Condom Compatibility
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that Actively Trying Personal Lubricant Rose Scented is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
7
10. Conclusion
The results of the performance testing described above demonstrate that the Actively Trying Personal Lubricant Rose Scented is as safe and effective as the predicate device and supports a determination of substantial equivalence.