(135 days)
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No
The device description and performance studies focus on the chemical composition, physical properties, biocompatibility, and condom compatibility of a personal lubricant. There is no mention of AI or ML technology in the provided text.
No.
The intended use of BioNude is to moisturize and lubricate for comfort during sexual activity, not to treat or prevent a disease or condition. While it has a biological effect (lubrication), it is not for therapeutic purposes.
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose any condition.
No
The device is a personal lubricant, which is a physical substance applied to the body, not a software program. The description details its chemical composition, physical properties, and packaging.
Based on the provided information, BioNude is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of BioNude is for personal lubrication during sexual activity, applied to the penile and/or vaginal areas. This is a direct application to the body for a physical purpose.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health or condition. They are used outside of the body (in vitro).
- Device Description: The description of BioNude focuses on its physical properties (gel consistency, ingredients, pH, viscosity, etc.) and its compatibility with condoms. These are characteristics of a topical or applied product, not a diagnostic test.
- Performance Studies: The performance studies described (biocompatibility, condom compatibility, shelf life) are relevant to a personal lubricant applied to the body, not to the accuracy or reliability of a diagnostic test performed on a specimen.
Therefore, BioNude clearly falls outside the definition and typical characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BioNude is a personal lubricant for penile 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. It is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
BioNude is a 100% isotonic water-based formula with ingredients including lactic acid, hydroxyethylcellulose, carrageenan, sodium chloride, potassium sorbate, sodium benzoate, carob gum, xanthan gum, sodium hydroxide, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: BioNude has undergone biocompatibility testing including cytotoxicity per ISO 10993-5:2009, human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2006. The testing found that BioNude is biocompatible.
Condom Compatibility: BioNude was tested for condom compatibility per ASTM D7661-10 and was found to be compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms.
Shelf Life: The results of shelf life testing demonstrate that BioNude maintains its specifications over the duration of their proposed shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 1, 2018
Good Clean Love, Inc. % Abhishek Gurnani Partner Amin Talati Upadhye, LLP 100 S. Wacker Drive, Suite 2000 Chicago, Illinois 60606
Re: K180136 Trade/Device Name: BioNude Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: May 2, 2018 Received: May 4, 2018
Dear Abhishek Gurnani:
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K180136
Device Name BioNude Lubricant
Indications for Use (Describe)
BioNude is a personal lubricant for penile 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. It is not compatible with 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 BioNude Lubricant - K180136
This summary uses the format provided in 21 CFR 807.92:
| (a)(1) | Submitter/Owner: | Good Clean Love, Inc.
207 West 5th Avenue
Eugene, OR 97401
Contact: Wendy Strgar
Phone: 541-344-4483
Fax: 541-685-1335
Email: wendy@goodcleanlove.com |
|--------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Preparer/Contact: | Abhishek K. Gurnani
Amin Talati Upadhye, LLP
100 South Wacker Drive, Suite 2000
Chicago, IL 60606
Phone: 312-327-3325
Fax: 312-884-7352
Email: Abhishek@AminTalati.com |
| | Summary Prepared: | May 31, 2018 |
| (a)(2) | Trade Name: | BioNude Lubricant |
| | Common Name: | Personal Lubricant |
| | Regulation Number: | 21 CFR 884.5300 |
| | Regulation Name: | Condom |
| | Regulatory Class: | Class II |
| | Product Code: | NUC (lubricant, personal) |
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(a)(3) Identification of Predicate Device: Sheffield Laboratories Warming LubriGel Personal Lubricant (K052162)
The predicate device has not been subject to a design related recall. -
(a)(4) Device Description: BioNude is a 100% isotonic water-based formula with ingredients including lactic acid, hydroxyethylcellulose, carrageenan, sodium chloride, potassium sorbate, sodium benzoate, carob gum, xanthan gum, sodium hydroxide, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and
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absence of pathogenic organisms. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
-
(a)(5) Indications for Use Statement: BioNude 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. It is not compatible with polyurethane condoms.
The subject and predicate device have the same intended use. -
(a)(6) Comparison of Technological Characteristics: The following table summarizes the key technological characteristics of the subject and predicate device:
| K80136 | K052162 | |
|---|---|---|
| Subject Device | Predicate Device | |
| Sponsor | Good Clean Love Inc. | Sheffield Laboratories |
| Regulation Number | 884.5300 | 884.5300 |
| Product Code | NUC | NUC |
| Device Class | II | II |
| Base Type | Water | Water |
| Primary Ingredients | Water | |
| Lactic Acid | ||
| Hydroxyethylcellulose | Propylene glycol | |
| Polyethylene glycol | ||
| Hydroxypropyl cellulose | ||
| Lactic Acid | ||
| Condom Compatibility | Natural Rubber Latex | |
| Polyisoprene | Natural Rubber Latex |
The subject and predicate device have differences in technological characteristics, including formulation and specifications. However, those differences do not raise new questions on safety or effectiveness.
(b) Summary of Performance Data:
Biocompatibility
BioNude has undergone biocompatibility testing including cytotoxicity per ISO 10993-5:2009, human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2006. The testing found that BioNude is biocompatible.
Condom Compatibility
BioNude was tested for condom compatibility per ASTM D7661-10 and was found to be compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms.
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Shelf Life
The results of shelf life testing demonstrate that BioNude maintains its specifications over the duration of their proposed shelf life.
Conclusion:
The results of performance testing demonstrate that the subject and predicate device are substantially equivalent.