(551 days)
Love Alchemy's Love 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 not for use with condoms.
Love Alchemy's Love 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. Love Lotion ingredients are Shea Butter, Coconut Oil, Grapeseed Oil, Lavender Oil, Orange Peel Oil, Jasmine Oil, Sandalwood Oil, Patchouli Oil and Ylang-Ylag Oil. Device specifications are color, odor, appearance, viscosity, total aerobic microbial count, total yeast and mold count, absence of pathogenic microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.
The provided document is a 510(k) summary for a personal lubricant, "Love Alchemy's Love Lotion," and therefore does not contain information related to an AI/ML medical device. As such, the requested details regarding acceptance criteria for an AI device, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set size are not applicable and cannot be extracted from this document.
The document discusses the substantial equivalence of the lubricant to a predicate device based on non-clinical performance testing.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2017
Love Alchemy LLC Eric Weiss CEO 421 Kingsley Ave, #200 Orange Park, FL 32073
Re: K151857 Trade/Device Name: Love Alchemy's Love Lotion Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: December 20, 2016 Received: December 22, 2016
Dear Eric Weiss,
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
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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
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Indications for Use
510(k) Number (if known) K151857
Device Name Love Alchemv's Love Lotion
Indications for Use (Describe)
Love Alchemy's Love 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 not for use with 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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510(k) Summary
510(k) NUMBER: K151857
1. Owner Information
| PRODUCT NAME: | Love Alchemy's Love Lotion |
|---|---|
| OWNER: | Love Alchemy, LLC |
| ADDRESS: | 421 Kingsley Ave. Suite 200Orange Park, FL 32073 |
| CONTACT NAME: | Eric A. Weiss |
| TELEPHONE NUMBER: | 904-612-3434 |
| DATE PREPARED: | January 9, 2017 |
| 2. Device Information | |
| TRADE NAME: | Love Alchemy's Love Lotion |
| COMMON NAME: | Personal Lubricant |
| CLASSIFICATION NAME: | Condom, 21 CFR 884.5300 |
| PRODUCT CODE | NUC (Lubricant, Personal) |
| DEVICE CLASS | Class II |
3. Predicate Device Information
PREDICATE NAME: Elegant Woman's Lubricant (K070587)
The predicate device has not been subject to a design related recall.
4. Description of Device
Love Alchemy's Love 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.
Love Lotion ingredients are Shea Butter, Coconut Oil, Grapeseed Oil, Lavender Oil, Orange Peel Oil, Jasmine Oil, Sandalwood Oil, Patchouli Oil and Ylang-Ylag Oil.
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Device specifications are color, odor, appearance, viscosity, total aerobic microbial count, total yeast and mold count, absence of pathogenic microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.
5. Indication for Use
Love Alchemy's Love 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 not for use with condoms.
The intended use of the subject device is similar to the predicate device.
6. Technological Characteristics of Device Compared to Predicate Devices
The subject and predicate device have different technological characteristics, including their formulation and specifications. These differences do not raise different questions of safety and effectiveness because these differences are routinely encountered during 510(k) reviews of personal lubricants.
7. Summary of Nonclinical Performance Testing
Below is the summary of the performance testing used to support substantial equivalence:
- Condom Compatibility Testing The lubricant is not compatible with condoms. ●
- Microbiological Testing Tested was performed in accordance with the following . standards and passed.
- USP <61> Microbiological Examination of Non-sterile Products: Microbial -Enumeration
- USP <62> Microbiological Examination of Non-sterile Products: Tests for -Specified Microorganisms
- USP <51> Antimicrobial Effectiveness Testing category 2 -
- Biocompatibility Testing Biocompatibility was evaluated in accordance with ISO 10993 -. Biological Evaluation of Medical Devices. Tests for cytotoxicity, vaginal irritation, sensitization, and acute systemic toxicity were completed and passed.
- -Acute Systemic Toxicity: ISO 10993-11:2006
- Cytotoxicity: ISO 10993-5:2009 -
- -Vaginal Irritation Testing: ISO 10993-10:2010
- Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010 -
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- Shelf life The shelf life of Love Alchemy's Love Lotion is 1year. This is based on the . results of real time aging studies that demonstrated that the device maintains its specifications over the duration of its shelf life.
8. Conclusion
Based on the performance data, Love Alchemy's Love Lotion is substantially equivalent to the predicate device for safety and effectiveness.
§ 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.