(228 days)
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No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.
No.
The intended use states it is for moisturization and lubrication to enhance sexual activity, not for treating a disease or condition.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition. This product is a personal lubricant intended to moisturize and lubricate to enhance sexual activity, not to diagnose any condition.
No
The device is a physical product (a liquid lubricant) and not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Climax Personal Lubricant is 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 describes a topical application for physical comfort and enhancement of sexual activity.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: Climax Personal Lubricant does not perform any tests on bodily samples to diagnose or detect anything. It is applied externally for lubrication.
- Device Description: The description focuses on the physical properties and ingredients of a lubricant, not on any diagnostic components or testing procedures.
- Performance Studies: The performance studies listed are related to biocompatibility, condom compatibility, and shelf life, which are relevant for a personal lubricant, not an IVD.
Therefore, based on the provided information, Climax Personal Lubricant is a personal lubricant and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Climax 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 rubber latex, polyurethane, and polyisoprene condoms.
Product codes
NUC
Device Description
Climax Personal Lubricant is a non-sterile, water soluble, viscous liquid which is intended to be used as a personal lubricant. The ingredients are Purified Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Diazolidinyl Urea, Methylparaben, Propylparaben. The product specifications include appearance, color, odor, pH, viscosity, specific gravity, osmolality, total aerobic microbial count per USP , total yeast and mold count per USP , absence of pathogenic organisms per USP , and antimicrobial effectiveness per USP . Climax Personal Lubricant is packaged in 5 fl. oz, and 6.5 fl. oz. bottles.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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: Climax Personal Lubricant has undergone biocompatibility testing including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing per ISO 10993-1:2009, ISO 10993-10:2010 and ISO 10993-11:2006. The testing found that Climax Personal Lubricant is biocompatible.
Condom Compatibility: Climax Personal Lubricant was tested for condom compatibility per ASTM D7661-10 and was found to be compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Shelf Life: The results of shelf life testing demonstrate that the subject device 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)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 21, 2017
WSM Investment LLC, dba Topco Sales Julie Casagrande Quality Control Manager 3990 Suite B Heritage Oak Court Simi Valley, CA 93063
Re: K171044 Trade/Device Name: Climax Personal Lubricant Regulation Number: 21 CFR$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 23, 2017 Received: October 23, 2017
Dear Julie Casagrande:
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.
1
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); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.
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) K171044
Device Name Climax Personal Lubricant
Indications for Use (Describe)
Climax 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 rubber latex, polyurethane, and polyisoprene 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 K171044
General Information
- WSM Investments dba Topco Sales 510(k) Owner: 3990-B Heritage Oak Court Simi Valley, CA, 93063 Telephone: 805-842-9197
- Julie Casagrande Contact Person(s): QC/Regulatory Manager 3390-B Heritage Oak Court Simi Valley, CA 93063 Phone: 805-842-9197
- Summary Preparation Date: November 20, 2017
Device Information
| Device Trade Name: | Climax Personal Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Classification Name: | Condom |
| (21 CFR 884.5300, Class II, Product Code: NUC (lubricant, personal)) |
Predicate Device
Device Name: Astroglide Sensual Strawberry 510(k) Clearance Number: K140590
The subject device has not been subject to a design related recall.
Device Description
Climax Personal Lubricant is a non-sterile, water soluble, viscous liquid which is intended to be used as a personal lubricant. The ingredients are Purified Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Diazolidinyl Urea, Methylparaben, Propylparaben. The product specifications include appearance, color, odor, pH, viscosity, specific gravity, osmolality, total aerobic microbial count per USP , total yeast and mold count per USP , absence of pathogenic organisms per USP , and antimicrobial effectiveness per USP . Climax Personal Lubricant is packaged in 5 fl. oz, and 6.5 fl. oz. bottles.
Indications for Use
Climax 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 rubber latex, polyurethane and polyisoprene condoms.
The subject and predicate device have the same intended use.
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Technological Characteristics
| K171044 | K140590 | Comments | |
|---|---|---|---|
| General Device Characteristics | Subject | Predicate | |
| Trade Name | Climax Personal Lubricant | Astroglide Sensual Strawberry | N/A |
| Submitter | WSM Investment LLC, dba Topco | ||
| Sales | BioFilm Inc. | N/A | |
| Regulation Number | 884.5300 | 884.5300 | Same |
| Product Code | NUC | NUC | Same |
| Device Class | Class II | Class II | Same |
| Condom Compatibility | Natural Rubber Latex (NRL), | ||
| Polyurethane, and Polyisoprene | Natural Rubber Latex (NRL), | ||
| Polyurethane, and | |||
| Polyisoprene | Same | ||
| Base Type | Water | Water | Same |
| Primary Ingredients | Water | ||
| Glycerin | |||
| Propylene Glycol | |||
| Hydroxyethylcellulose | Water | ||
| Glycerin | |||
| Propylene Glycol | |||
| Hydroxyethylcellulose | Same | ||
| Packaging | polyethylene terephthalate | ||
| (PET) bottle with pump | polyethylene terephthalate | ||
| (PET) bottle with flip top | Same |
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.
Performance Testing
Biocompatibility
Climax Personal Lubricant has undergone biocompatibility testing including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing per ISO 10993-1:2009, ISO 10993-10:2010 and ISO 10993-11:2006. The testing found that Climax Personal Lubricant is biocompatible.
Condom Compatibility
Climax Personal Lubricant was tested for condom compatibility per ASTM D7661-10 and was found to be compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Shelf Life
The results of shelf life testing demonstrate that the subject device 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.