← Product Code [NUC](/productcode/NUC) · K140304 # SIMPLY SLICK PERSONAL LUBRICATING LOTION (K140304) _Simply Solutions, LLC · NUC · Oct 7, 2014 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K140304 ## Device Facts - **Applicant:** Simply Solutions, LLC - **Product Code:** [NUC](/productcode/NUC.md) - **Decision Date:** Oct 7, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5300 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** 3rd-Party Reviewed ## Indications for Use Simply Slick™ Personal Lubricating Lotion 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 compatible with natural rubber latex, polyurethane, and synthetic polyisoprene condoms. ## Device Story Simply Slick™ Personal Lubricating Lotion is a water-soluble, non-greasy, fragrance-free personal lubricant. It is applied topically to the penis or vagina to provide moisture and lubrication during intimate sexual activity. The device is intended for over-the-counter use by consumers. It is packaged in a 2 oz polyethylene squeeze bottle. The lubricant is not a contraceptive or spermicide. It functions by reducing friction during sexual activity, thereby enhancing comfort. It is compatible with natural rubber latex, polyurethane, and synthetic polyisoprene condoms. ## Clinical Evidence Bench testing only. Testing included ISO 10993-1 biological evaluation (cytotoxicity, sensitization, irritation), antimicrobial preservative effectiveness (USP 34, <51>), ASTM D4169-09, ASTM D7661-10 (condom compatibility), and water solubility (USP 35). Microbial limits testing (USP <61>, <62>, <1111>) on real-time aged samples confirmed a 36-month shelf life. ## Technological Characteristics Water-soluble, white, viscous liquid. Non-sterile. Packaged in 2 oz polyethylene squeeze bottle. Tested per ISO 10993-1, USP 34/35, ASTM D4169-09, and ASTM D7661-10. Shelf life: 36 months. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - CVS Personal Lubricant and Moisturizer ([K062682](/device/K062682.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. To the left of the profiles is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 7, 2014 Simply Solutions, LLC % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313 Re: K140304 > Trade/Device Name: Simply Slick™ Personal Lubricating Lotion Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 30, 2014 Received: October 1, 2014 Dear Mark Job, 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. 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 801); medical device reporting (reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Joyce M. Whang -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}------------------------------------------------ Page 1 of 1 ## Indications for Use Statement 510(k) Number (if known): K140304 Device Name: Simply Slick™ Personal Lubricating Lotion Indications for Use: Simply Slick™ Personal Lubricating Lotion 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 compatible with natural rubber latex, polyurethane, and synthetic polyisoprene condoms. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ ## 510(k) Summary Simply Solutions, LLC Simply Slick™ Personal Lubricating Lotion | 510(k) Summary | This 510(k) summary is being submitted in accordance with the
requirements of 21 C.F.R § 807.92. | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant | Simply Solutions LLC | | Submitter | Simply Solutions LLC
2949 Venture Dr., Suite 170
Janesville, WI 53546-8501
Tel: 608-563-5555
Fax: none | | Contact Person | John Goepfert, CEO | | Date Prepared | September 23, 2014 | | Device Trade Name | Simply Slick™ Personal Lubricating Lotion | | Device Common Name | Personal Lubricant | | Classification Name | 21 CFR 884.5300, Condom, NUC | | Classification Panel | Obstetrics and Gynecology | | Predicate Devices | K062682, CVS Personal Lubricant and Moisturizer, Lake
Consumer Products, Inc. | | Indications for Use | Simply Slick™ Personal Lubricating Lotion 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 compatible with natural rubber
latex, polyurethane, and synthetic polyisoprene condoms. | | Device Description | Device specifications include pH, viscosity, preservation
effectiveness, appearance, odor, and testing for bioburden,
aerobes, fungi, spore, and obligate anaerobe. It is a
biocompatible, water soluble, white, viscous liquid and is non-
sterile. It is neither a contraceptive nor a spermicide and is sold
over-the-counter in a 2 oz / 59 ml polyethylene squeeze bottle
with a screw-on, disc press-flip up cap. A cap liner is placed
over the opening of the bottle before the lid is screwed on the
bottle. One bottle is placed into a plastic display carton which
constitutes the device outer packaging. Simply Slick™ Personal
Lubricating Lotion is a non-greasy and fragrance-free
formulation and is to be stored at room temperature. | | Performance data | Simply Slick™ Personal Lubricating Lotion was tested to and
meets the performance specifications for ISO 10993-1 Biological
evaluation of medical devices - Part 1: general requirements | {4}------------------------------------------------ | | (cytotoxicity, sensitization, irritation), antimicrobial preservative
effectiveness test (USP 34, <51>), ISTA P2A (2011), ASTM
D4169-09, ASTM D7661-10 Standard Test method for
Determining Compatibility of Personal Lubricants with Natural
Rubber Latex Condoms and water solubility per USP 35. Testing
for pH, viscosity, color, feel, scent, aerobic, fungi, spores and
obligate anaerobes confirmed a shelf life of 36 months. USP
<61> and <1111> and USP <62> microbial limits testing on
real-time aged samples indicated microbial quality. Results from
this testing provide assurance that the proposed device has been
designed and tested to assure conformance to the requirements
for its intended use. | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Substantial
Equivalence | The Simply SlickTM Personal Lubricating Lotion has the same
technological characteristics as the predicate device. It shares the
following similarities to the predicate device: major ingredients;
highly lubricious; liquid form; biocompatible; does not contain
fragrance; non-sterile; over-the-counter; water soluble;
compatible with natural rubber latex, synthetic polyisoprene, and
polyurethane condoms; and packaging material. | | Conclusion | Based on the similar indications for use, technological
characteristics and performance testing, Simply Solutions LLC
believes the proposed device, Simply SlickTM Personal
Lubricating Lotion, is substantially equivalent to the CVS
Personal Lubricant and Moisturizer (K062682). | --- **Source:** [https://fda-staging.innolitics.com/device/K140304](https://fda-staging.innolitics.com/device/K140304) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com