(90 days)
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No
The document describes a personal lubricant and does not mention any AI or ML components or functionalities.
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity, which is not considered a therapeutic function.
No
This device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose any condition.
No
The device description clearly indicates it is a physical, liquid personal lubricant, not a software application.
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. This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and composition of the lubricant, and its compatibility with condoms. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result or interpretation.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf life, which are relevant to a personal lubricant, not a diagnostic device.
- Predicate Device: The predicate device is also a personal lubricant (Love Liquid® Personal Lubricant), further indicating the device's classification.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Just Like Me Personal 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 compatible with natural latex, polyisoprene, and polyurethane condoms.
Product codes
NUC
Device Description
The Just Like Me Personal Lubricant is a non-sterile, water based, over-the- counter personal lubricant formulated to be a clear, non-irritating, non-greasy, odorless liquid.
The proposed device contains a blend of ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, and polyurethane condoms during intimate sexual activity as evidenced by condom compatibility testing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Biocompatibility:
Cytotoxicity (Direct Contact) - Product is Non-toxic
ISO GUINEA PIG MAXIMIZATION SENSITIZATION TEST- (Method for Liquid Test Articles) - Product does not elicit a sensitization response
Vaginal Mucosa Irritation with Histopathology - Product is considered a non-irritant to vaginal tissue
Acute Systemic Toxicity - There is no evidence of system toxicity
Condom Compatibility:
Testing performed in accordance with ASTM D7661-10; "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" on three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms.
Results: This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Shelf Life Testing:
The Just Like Me Personal Lubricant has a 2-years shelf life based on the results of an accelerated aging study. The accelerated aging study evaluated the single version of packaging (3.8 oz.) 4 oz. packaging. Following aging, the product met its specifications for viscosity, specific gravity, appearance, color, odor passed the testing, Preservative Effectiveness and Antimicrobial Effectiveness Testing based on USP , Total Microbial Aerobic Count (TAMC) and Total Yeast and Mold Count (TYMC) based on USP , and Absence of Pathogenic organism based on USP .
Key Metrics
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Predicate Device(s)
Love Liquid® Personal Lubricant, K152168
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
WTFN - dba Classic Erotica/Holiday Products % Louie Goryoka Regulatory Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301
Re: K161385
Trade/Device Name: Just Like Me Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 12, 2016 Received: May 19, 2016
Dear Louie Goryoka,
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.
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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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Benjamin R. Fisher -S
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
510(k) Number (if known) K161385
Device Name Just Like Me Personal Lubricant
Indications for Use (Describe)
Just like Personal 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 compatible with natural latex, polyisoprene, and 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 Just Like Me Personal Lubricant
| Company Name:
Company Address: | WTFN - dba Classic Erotica
20950 Lassen Street
Chatsworth, California 91311 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Med-Device Consulting Inc.
Louie Goryoka - Regulatory Consultant
Phone 1 (818) 735-0488
mdci@m-dci.us |
| Summary Preparation Date: | August 16, 2016 |
| Device Trade Name:
Common Name:
Classification Name(s):
Classification Regulation:
Device Code:
Advisory Panel:
Predicate Devices | Just Like Me Personal Lubricant
Personal Lubricant
Condom
21 CFR §884.5300, Class II
NUC
Obstetrics and Gynecology
Love Liquid® Personal Lubricant
510(k) number K152168 |
Device Description
The Just Like Me Personal Lubricant is a non-sterile, water based, over-the- counter personal lubricant formulated to be a clear, non-irritating, non-greasy, odorless liquid.
The proposed device contains a blend of ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, and polyurethane condoms during intimate sexual activity as evidenced by condom compatibility testing.
Indication for Use Statement
The Just Like Me Personal 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 compatible with natural latex, polyisoprene, and polyurethane condoms.
Technological Characteristics
The Just Like Me Personal Lubricant has the same intended use as the predicate device.
The Just Like Me Personal Lubricant has similar technological characteristics to the predicate device. It contains ingredients that are similar to those found in the predicate device.
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Performance Data
Biocompatibility
The device contact duration with the user is A-limited , Total Microbial Aerobic Count (TAMC) and Total Yeast and Mold Count (TYMC) based on USP , and Absence of Pathogenic organism based on USP .
Conclusion
The results of performance testing demonstrate that the Me Personal Lubricant is substantially equivalent to predicate devices.