(353 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical and chemical properties, biocompatibility, and shelf-life, with no mention of AI or ML.
No.
A therapeutic device is typically intended to treat or cure a disease or condition, or to restore function. This device is a personal lubricant intended to enhance comfort and ease during intimate sexual activity by moisturizing and lubricating, which is not a therapeutic function.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate to enhance comfort during intimate sexual activity. Its purpose is not to diagnose any condition or disease.
No
The device description clearly states it is a mineral oil based personal lubricant provided in a low-density polyethylene tube with a polypropylene cap and supplied with an applicator. These are physical components, not software.
No, 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 moisturize and lubricate for intimate sexual activity. This is a physical function, not a diagnostic test performed on a sample from the body.
- Device Description: The description details a physical product (a lubricant) and its physical and chemical specifications. It does not describe a test or assay.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like blood, urine, or tissue), detecting a specific substance, or providing information for diagnosing a condition.
- Performance Studies: The performance studies focus on biocompatibility and shelf-life, which are relevant for a topical medical device, not an IVD.
- Predicate Device: The predicate device is another personal lubricant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Crème de la Femme Feminine Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Crème de la Femme Feminine Lubricant is a non-sterile, mineral oil based personal lubricant designed to supplement the body's own natural lubrication fluids, and to enhance the ease and comfort of intimate sexual activity. The product is provided in a low-density polyethylene tube with a white polypropylene screw on the cap. The device will be supplied with an applicator. Its specifications include appearance, color, odor, pH, viscosity, antimicrobial effectiveness (USP), total aerobic microbial count (USP), total yeast and mold count (USP, and absence of pathogenic organisms (USP). The lubricant is not a spermicide or contraceptive. The device is not compatible with natural rubber latex, polyisoprene or polyurethane condoms.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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- 1:2009 as follows:
- o Cytotoxicity (ISO 10993-5:2009)
- o Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010) ●
- o Acute Systemic Toxicity (ISO 10993-11:2006)
The results of this testing demonstrated that the subject lubricants are biocompatible.
Condom Compatibility testing was performed in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Testing demonstrated that the subject device is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Accelerated shelf-life testing was conducted on the subject device to support its labeled shelf-life period. Results from testing demonstrated that the device can maintain its specifications over the duration of its shelf- life.
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.
December 21, 2018
Cewal, Inc. dba Premiere Enterprises % Abhishek K. Gurnani Partner Amin Talati Upadhye, LLP 100 S. Wacker Drive, Suite 2000 Chicago, IL 60606
Re: K180014
Trade/Device Name: Créme de la Femme Feminine Lubricant Regulation Number: 21 CFR& 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 28, 2018 Received: December 3, 2018
Dear Abhishek K. Gurnani:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael T. Bailey -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180014
Device Name
Crème de la Femme Feminine Lubricant
Indications for Use (Describe)
Crème de la Femme is a personal lubricant, for penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with rubber latex, polyurethane, and polyisoprene 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
510(k) Summary
K180014
Crème de la Femme Feminine Lubricant
| Submitter/Owner: | Cewal, Inc.
2806 Oakhurst Avenue
Los Angeles, CA
92127
Phone: 310-839-5000
Contact: Jerome Vozoff |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparer/Contact: | Abhishek K. Gurnani
Amin Talati Upadhye, LLP100 South Wacker Drive, Suit
2000Chicago, IL 60606Phone: 312-327-325Fax: 312-884-
7352Email: Abhishek@AminTalati.com |
| Summary Prepared: | December 21, 2018 |
| Device Trade Name: | Crème de la Femme Feminine Lubricant |
| Device Common Name: | Personal Lubricant |
| Regulation Name/Number: | Condom (21 CFR 884.5300) |
| Device Product Code: | NUC (Lubricant, Personal) |
| Device Class: | II |
Predicate Device: K171985: Astroglide® O Oil Personal Lubricant and Massage Oil.
The predicate device has not been subject to a design related recall.
Device Description:
Crème de la Femme Feminine Lubricant is a non-sterile, mineral oil based personal lubricant designed to supplement the body's own natural lubrication fluids, and to enhance the ease and comfort of intimate sexual activity. The product is provided in a low-density polyethylene tube with a white polypropylene screw on the cap. The device will be supplied with an applicator. Its specifications include appearance, color, odor, pH, viscosity, antimicrobial effectiveness (USP), total aerobic microbial count (USP), total yeast and mold count (USP, and absence of pathogenic organisms (USP). The lubricant is not a spermicide or contraceptive. The device is not compatible with natural rubber latex, polyisoprene or polyurethane condoms.
Indications for Use:
4
Crème de la Femme Feminine Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Predicate Device Comparison:
| | K1810014
Crème de la Femme
Feminine Lubricant
Subject Device | K171985
Astroglide® O Oil Personal Lubricant
and Massage Oil Predicate Device |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Feature | | |
| Indication for
Use | Crème de la Femme Feminine
Lubricant is a personal lubricant,
for penile and/or vaginal
application, intended to
moisturize and lubricate, to
enhance the ease and comfort of
intimate sexual activity and
supplement the body's natural
lubrication. This product is not
compatible with natural rubber
latex, polyurethane and
polyisoprene condoms. | Astroglide O Oil Personal Lubricant &
Massage Oil is a personal lubricant for
penile and/or vaginal application,
intended to moisturize and lubricate, to
enhance the ease and comfort of intimate
sexual activity and supplement the
body's natural lubrication. This product
is not compatible with condoms. |
| Over-the-counter Use | Yes | Yes |
| Base Type | Oil | Oil |
| Sterile | No | No |
| Primary Ingredients | Mineral Oil
Petrolatum-
Ozokerite
Paraffin | Helianthus Annuus
(Sunflower) Seed Oil, Ricinus
Communis (Castor) Seed Oil,
Cocos Nucifera (Coconut)
Oil, Prunus Amygdalus Dulcis
(Sweet Almond) Oil,
Simmondsia Chinesis (Jojoba)
Seed Oil, Argania Spinosa
Kernel (Argan Tree Nut) Oil,
Tocopherol, Cananga Odorata
(Ylang Ylang) Flower Oil |
The subject and predicate devices do not have identical indications for use statements; however, their intended uses are the same, i.e., lubrication during intimate sexual activity and not compatible with condoms.
The subject device and predicate devices also have different technological characteristics, including their color, formulation and specifications. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
5
Performance Testing:
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- 1:2009 as follows:
- o Cytotoxicity (ISO 10993-5:2009)
- o Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010) ●
- o Acute Systemic Toxicity (ISO 10993-11:2006)
The results of this testing demonstrated that the subject lubricants are biocompatible.
Condom Compatibility:
Condom Compatibility testing was performed in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Testing demonstrated that the subject device is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Shelf-Life:
Accelerated shelf-life testing was conducted on the subject device to support its labeled shelf-life period. Results from testing demonstrated that the device can maintain its specifications over the duration of its shelf- life.
Conclusions:
The results of the performance testing described above demonstrate that the Crème de la Femme Feminine Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.