(167 days)
Not Found
No
The 510(k) summary describes a personal lubricant and its physical and chemical properties, intended use, and performance studies related to biocompatibility and compatibility with sperm and condoms. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The sections specifically mentioning "AI, DNN, or ML" and "training set" and "test set" are marked as "Not Found" or "Not Applicable".
Yes
This device is intended to moisturize and lubricate to enhance sexual activity and supplement natural lubrication, which are therapeutic claims. Furthermore, biocompatibility studies and performance studies were conducted to support its clinical use and safety.
No
The device is a personal lubricant intended to moisturize and lubricate to enhance sexual activity, and is compatible with sperm, oocytes, and embryos for couples trying to conceive. It does not perform any diagnostic function.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its composition, packaging, and physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. While it mentions compatibility with sperm, oocytes, and embryos for couples trying to conceive, this compatibility is a characteristic of the lubricant itself, not a diagnostic function performed on biological samples.
- Device Description: The description details the physical properties and composition of the lubricant. There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Function: An IVD is a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This lubricant does not perform any such examination or provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, sperm compatibility, shelf life, and condom compatibility. These are relevant to the safety and effectiveness of a personal lubricant, not to the performance of a diagnostic test.
In summary, the device is a personal lubricant intended for physical application, not for the in vitro analysis of biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Actively Trying Personal Lubricant Unfragranced is a personal lubricant for penile, and/or vaginal application, intended to moisturize and lubricate, 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
PEB
Device Description
Actively Trying Personal Lubricant Unfragranced 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 Unfragranced 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 and Arabinogalactan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, 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, 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-irritating, nonsensitizing, and not systemically toxic.
Additional biocompatibility testing performed: 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.
Shelf Life: A real time aging study demonstrated a two-year shelf-life. 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: Compatibility 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 indicate that Actively Trying Personal Lubricant Unfragranced is compatible with natural rubber latex and polyisoprene condoms, but not 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 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.
February 9, 2022
CC Wellness LLC Marlent Perez Quality/Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K212705
Trade/Device Name: Actively Trying Personal Lubricant Unfragranced Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: January 5, 2022 Received: January 10, 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
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Indications for Use
510(k) Number (if known) K212705
Device Name
Actively Trying Personal Lubricant Unfragranced
Indications for Use (Describe)
Actively Trying Personal Lubricant Unfragranced is a personal lubricant for penile, and/or vaginal application, intended to moisturize and lubricate, 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)
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510(K) Summary - K212705
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 Unfragranced 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 Unfragranced 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 Unfragranced 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 and Arabinogalactan.
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The devices specifications are listed in the table below:
Property | Specification |
---|---|
Appearance | Semi-viscous liquid |
Color | Clear |
Odor | Odorless |
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 Unfragranced | |||
---|---|---|---|
Feature | Actively Trying Personal | ||
Lubricant Unfragranced | Actively Trying Personal | ||
Lubricant (K1828585) | |||
Device Classification | |||
Name | Lubricant, Personal | Lubricant, Personal | |
Product Code | PEB | PEB | |
Indications for Use | Actively Trying Personal | ||
Lubricant Unfragranced 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 | 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
7
Trying Personal Lubricant Unfragranced is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
10. Conclusion
The results of the performance testing described above demonstrate that the Actively Trying Personal Lubricant Unfragranced is as safe and effective as the predicate device and supports a determination of substantial equivalence.