(242 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.
Yes.
The document explicitly states that the device is intended for "moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication," which describes a therapeutic effect.
No
The description indicates the device is a personal lubricant for sexual activity, not a diagnostic tool for identifying medical conditions.
No
The device is a personal lubricating lotion, which is a physical substance, not software. The description details its physical properties, packaging, and performance testing related to its chemical and physical characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied to the penile and/or vaginal areas. This is a topical application for physical comfort and enhancement, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description focuses on the physical properties of the lotion and its compatibility with condoms. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility, shelf life, and compatibility with condoms. These are relevant for a personal lubricant, but not for an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, test strips, or analytical equipment described.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
NUC
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.
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
Not Found
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
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 (cytotoxicity, sensitization, irritation), antimicrobial preservative effectiveness test (USP 34, ), 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 and and USP 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.
Key Metrics
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.
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
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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, ), 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
and and USP 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). |