(97 days)
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML components or functionalities.
No.
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate for enhancing comfort during sexual activity, which is not a therapeutic function. It is classified as an over-the-counter personal lubricant and not for treating or diagnosing any medical condition.
No
Explanation: The provided text describes Überlube as a personal lubricant intended to moisturize and lubricate for enhancing sexual activity. There is no mention of the device being used to diagnose any medical condition, disease, or provide diagnostic information.
No
The device description clearly states it is a "clear, colorless, semi-viscous silicone-based personal lubricant," which is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Überlube is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The description details a lubricant with physical properties (clear, colorless, semi-viscous) and compatibility with condoms. It does not describe any components or functions related to testing biological samples or diagnosing conditions.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on compatibility with condoms, biocompatibility, microbial limits, and shelf life – all relevant to a personal lubricant, not an IVD.
- Predicate Device: The predicate device is also a personal lubricant, further confirming the device's classification.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. Überlube does not fit this definition.
N/A
Intended Use / Indications for Use
Überlube 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Überlube is a clear, colorless, semi-viscous silicone-based personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is normally packaged in glass bottles with pump tops or in foil samples. It may also be packaged in stoppered glass vials or plastic bottles. The specifications for Überlube include appearance, odor, viscosity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
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
Testing per ASTM D7661-10 indicated that Überlube is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
Biocompatibility testing per ISO 10993-1, including cytotoxicity, vaginal irritation, sensitization and systemic toxicity, demonstrate that Überlube is biocompatible.
Microbial limits testing conducted per USP and USP indicated microbial quality.
Real-time aging tests indicate a 3-year shelf life for the lubricant.
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.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked slightly on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2015
Uberlube, LLC % John Ziobro Principal Consultant SpectraMedEx, LLC 117 West South Street Oconomowoc. WI 53066
Re: K151647
Trade/Device Name: Überlube® Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 16, 2015 Received: June 25, 2015
Dear John Ziobro,
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,
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) K151647
Device Name Uberlube
Indications for Use (Describe)
Überlube 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
| Type of Use ( Select one or both, as applicable ): |
|---|
| ----------------------------------------------------------- |
| Research Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) |
|---|---|
| -------------------------------------------------------- | --------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for "überlube". The logo consists of a black Erlenmeyer flask on the left, followed by the word "überlube" in a simple, sans-serif font. The two dots above the "u" in "überlube" are also visible.
Überlube LLC® Personal Lubricant Traditional 510(k) Summary
K151647
- Überlube LLC 1. Applicant Name: 2611 Hartzell St. Evanston, IL 60201 Phone: 847-372-3127 Establishment Registration Number: pending
- Submission Correspondent: On behalf of Überlube LLC, the following consultant is assigned the responsibility 2. of submission correspondence:
John F. Ziobro Principal Consultant SpectraMedEx, LLC 117 W. South Street Oconomowoc, WI 53066 262-719-8922
-
- Trade Name: Überlube
-
- Common Name: Personal Lubricant
- Überlube is a clear, colorless, semi-viscous silicone-based personal lubricant that is Description: న్. compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is normally packaged in glass bottles with pump tops or in foil samples. It may also be packaged in stoppered glass vials or plastic bottles. The specifications for Überlube include appearance, odor, viscosity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
6. Classification Regulation, Class & Product Code & Panel:
Regulation: 21 CFR 884.5300, Condom Classification: Class II Product Code: NUC Panel: Obstetrics/Gynecology
-
- Reason for Traditional 510(k):
New Device
- Reason for Traditional 510(k):
| 8. | Predicate Device(s): | 510(k) Number: | K132954 |
|---|---|---|---|
| Manufacture: | United Consortium | ||
| Trade Name: | JO Premium Personal Lubricant | ||
| Product Code: | NUC | ||
| Classification: | Class II |
-
- Summary Date: May 15, 2015
10. Indication for Use
Überlube 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
4
Image /page/4/Picture/0 description: The image shows the logo for "überlube". The logo consists of a black flask on the left and the word "überlube" on the right. The word is in a sans-serif font and is all lowercase.
Überlube LLC® Personal Lubricant Traditional 510(k) Summary
11. Comparison to Predicates
Überlube has the same intended use and technological characteristics as the predicate device.
12. Performance Data
Testing per ASTM D7661-10 indicated that Überlube is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
Biocompatibility testing per ISO 10993-1, including cytotoxicity, vaginal irritation, sensitization and systemic toxicity, demonstrate that Überlube is biocompatible.
Microbial limits testing conducted per USP and USP indicated microbial quality.
Real-time aging tests indicate a 3-year shelf life for the lubricant.
13. Conclusion
Überlube is substantially equivalent to the predicate device.