(244 days)
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Not Found
No
The 510(k) summary describes personal lubricants and does not mention any technological components, let alone AI or ML.
No.
The intended use of the device is for moisturizing and lubricating to enhance the ease and comfort of intimate sexual activity, which is not considered a therapeutic function.
No
The intended use of the devices listed (personal lubricants) is to moisturize and lubricate for comfort during intimate activity, not to diagnose any condition or disease.
No
The provided text describes personal lubricants, which are physical products, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these products are "personal lubricants intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity." This is a direct application to the body for physical comfort and enhancement, not for the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The provided text lacks any mention of:
- Analyzing biological specimens (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological specimens.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, these devices fall under the category of personal lubricants, which are typically regulated as medical devices but not as IVDs.
N/A
Intended Use / Indications for Use
Gun Oil silicone lubricant is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.
Pink silicone lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.
Gun Oil H20 water-based is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.
Pink Water water-based lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.
Product codes
NUC
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
Over-The-Counter Use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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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 consists of the department's name encircling a symbol. The symbol features three stylized human profiles facing right, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2016
Empowered Products, Inc. % Judy Burton President Advena Usa, LLC 3010 LBJ Frwy., 12th Floor Dallas, TX 75234
Re: K152918
Trade/Device Name: Gun Oil, Pink, Gun Oil H2o, Pink Water Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: April 21, 2016 Received: May 6, 2016
Dear Judy Burton,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
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
2
Indications for Use
510(k) Number (if known) K152918
Device Name
Gun Oil silicone lubricant, Pink silicone lubricant for Women, Gun Oil H20 water-based lubricant for Women
Indications for Use (Describe)
Gun Oil silicone lubricant is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.
Pink silicone lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.
Gun Oil H20 water-based is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.
Pink Water water-based lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex 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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