(242 days)
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 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.
Here's a breakdown of the acceptance criteria and the study information for the Simply Slick™ Personal Lubricating Lotion, based on the provided text:
Important Note: The provided document is a 510(k) summary for a personal lubricant. It focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing related to safety, biocompatibility, and compatibility with condoms. It does not involve AI algorithms, image analysis, or expert human readers interpreting data in the way medical diagnostic devices do. Therefore, many of the requested categories related to algorithm performance, expert review, and MRMC studies are not applicable to the information contained in this document.
Acceptance Criteria and Reported Device Performance
Since this is a personal lubricant, the "acceptance criteria" are based on meeting established standards for safety, biocompatibility, and intended use as defined by international and national standards organizations, and demonstrated through specific tests.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 (cytotoxicity, sensitization, irritation) | Demonstrated through specific testing conforming to the standard. |
| Antimicrobial Preservative Effectiveness | Meets USP 34, <51> | Demonstrated through testing. |
| Packaging Integrity/Shipping Performance | Meets ISTA P2A (2011) and ASTM D4169-09 | Demonstrated through testing to ensure product stability during transport. |
| Compatibility with Natural Rubber Latex Condoms | Meets ASTM D7661-10 (Standard Test method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms) | Critical for product compatibility claim and safety. |
| Water Solubility | Meets USP 35 | Demonstrated through testing. |
| pH | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Specific values not given, but confirmed to meet requirements. |
| Viscosity | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Specific values not given. |
| Color | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Specific values not given. |
| Feel | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Subjective, but confirmed to meet internal specifications. |
| Scent | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Subjective, but confirmed to meet internal specifications. |
| Microbial quality (Aerobes, Fungi, Spores, Obligate Anaerobes) | Confirmed within acceptable limits for 36 months shelf life | Part of shelf-life stability testing (USP <61>, <1111>, <62>). |
| Shelf Life | Confirmed to be 36 months | Demonstrated through real-time aged sample testing for various parameters. |
Study Details (Applicable to this type of device)
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Sample Size for the Test Set and Data Provenance:
- The document does not specify a "test set" in the context of diagnostic performance (e.g., patient data).
- For the performance testing mentioned (e.g., ISO, ASTM, USP standards), the sample sizes would be dictated by the specific test methodology outlined in each standard. These would involve quantities of the lubricant product itself, or materials (like condoms) interacting with the lubricant.
- The data provenance is not explicitly stated as retrospective or prospective data from human subjects, as this is a product performance study, not a clinical trial of a diagnostic device. The tests are performed on the product itself or in benchtop/in vitro setups.
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Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This device does not involve a "ground truth" established by human experts in the context of interpreting medical images or data. Performance is measured against physical, chemical, and biological standards.
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Adjudication Method for the Test Set:
- Not applicable. There is no ambiguous result requiring adjudication by multiple readers or experts. Test outcomes are quantitative or pass/fail based on established standards.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) with and without AI assistance. This is a personal lubricant, not a diagnostic device.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device does not involve an AI algorithm.
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Type of Ground Truth Used:
- The "ground truth" in this context is defined by established international and national standards (e.g., ISO 10993-1, USP 34, ASTM D7661-10) and internal specifications for physical/chemical properties (pH, viscosity, etc.). The device performance is measured against these objective criteria.
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Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that sense. The product's formulation and manufacturing processes are developed through R&D and tested against specification.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, for the same reason as above.
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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
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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
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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)
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510(k) Summary Simply Solutions, LLC Simply Slick™ Personal Lubricating Lotion
| 510(k) Summary | This 510(k) summary is being submitted in accordance with therequirements of 21 C.F.R § 807.92. |
|---|---|
| Applicant | Simply Solutions LLC |
| Submitter | Simply Solutions LLC2949 Venture Dr., Suite 170Janesville, WI 53546-8501Tel: 608-563-5555Fax: 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, LakeConsumer Products, Inc. |
| Indications for Use | Simply Slick™ Personal Lubricating Lotion is a personallubricant, for penile and/or vaginal application, intended tomoisturize and lubricate, to enhance the ease and comfort ofintimate sexual activity and supplement the body's naturallubrication. This product is compatible with natural rubberlatex, polyurethane, and synthetic polyisoprene condoms. |
| Device Description | Device specifications include pH, viscosity, preservationeffectiveness, appearance, odor, and testing for bioburden,aerobes, fungi, spore, and obligate anaerobe. It is abiocompatible, water soluble, white, viscous liquid and is non-sterile. It is neither a contraceptive nor a spermicide and is soldover-the-counter in a 2 oz / 59 ml polyethylene squeeze bottlewith a screw-on, disc press-flip up cap. A cap liner is placedover the opening of the bottle before the lid is screwed on thebottle. One bottle is placed into a plastic display carton whichconstitutes the device outer packaging. Simply Slick™ PersonalLubricating Lotion is a non-greasy and fragrance-freeformulation and is to be stored at room temperature. |
| Performance data | Simply Slick™ Personal Lubricating Lotion was tested to andmeets the performance specifications for ISO 10993-1 Biologicalevaluation of medical devices - Part 1: general requirements |
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| (cytotoxicity, sensitization, irritation), antimicrobial preservativeeffectiveness test (USP 34, <51>), ISTA P2A (2011), ASTMD4169-09, ASTM D7661-10 Standard Test method forDetermining Compatibility of Personal Lubricants with NaturalRubber Latex Condoms and water solubility per USP 35. Testingfor pH, viscosity, color, feel, scent, aerobic, fungi, spores andobligate anaerobes confirmed a shelf life of 36 months. USP<61> and <1111> and USP <62> microbial limits testing onreal-time aged samples indicated microbial quality. Results fromthis testing provide assurance that the proposed device has beendesigned and tested to assure conformance to the requirementsfor its intended use. | |
|---|---|
| Summary of SubstantialEquivalence | The Simply SlickTM Personal Lubricating Lotion has the sametechnological characteristics as the predicate device. It shares thefollowing similarities to the predicate device: major ingredients;highly lubricious; liquid form; biocompatible; does not containfragrance; non-sterile; over-the-counter; water soluble;compatible with natural rubber latex, synthetic polyisoprene, andpolyurethane condoms; and packaging material. |
| Conclusion | Based on the similar indications for use, technologicalcharacteristics and performance testing, Simply Solutions LLCbelieves the proposed device, Simply SlickTM PersonalLubricating Lotion, is substantially equivalent to the CVSPersonal Lubricant and Moisturizer (K062682). |
§ 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.