(269 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and condom compatibility of a personal lubricant, with no mention of AI or ML.
No.
The intended use is to moisturize and lubricate to enhance comfort during sexual activity, which is not considered a therapeutic function.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not for diagnosing any medical condition.
No
The device description clearly indicates it is a physical product (personal lubricant) composed of various chemical ingredients and packaged in a tube. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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 function, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "non-sterile, water-based personal lubricant" with a list of ingredients. This aligns with a personal care product, not a diagnostic test kit or instrument.
- Lack of Diagnostic Purpose: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic within a sample (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility and compatibility with condoms, which are relevant to a personal lubricant's safety and function during use, not its diagnostic accuracy.
In summary, the device's purpose is to facilitate sexual activity through lubrication, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended 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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Exsens Personal Lubricants are non-sterile, water-based personal lubricants that provide personal lubrication during intimate sexual activity. They are made up of Glycerin, Water, Propylene Glycol, Aroma (Flavor), Aloe Barbadensis (aloe vera) leaf juice, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Sodium Saccharin and citric acid. The product is packaged in a 70ml polyethylene white tube with a flip-top cap and protective sleeve. It is for over-the-counter (OTC) use.
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
Over-The-Counter Use
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
Biocompatibility studies were conducted on the subject device, including cytotoxicity, sensitization, irritation, and acute systemic toxicity. Each study was conducted in accordance with GLP requirements and requirements of the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1:Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
The results of testing demonstrated the device materials to be biocompatible.
The compatibility of the subject device with natural rubber latex, polyisoprene, and polyurethane male condoms was evaluated in accordance with ASTM D 7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber latex Condoms. The results of this test demonstrated that the subject device is compatible with natural rubber latex and polyisoprene male condoms. This product is not compatible with polyurethane condoms.
Exsens Personal Lubricants are shown to have a 12 month shelf life according to ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Testing on samples at 3 months of accelerated aging showed that the subject device specifications as listed in this 510(k) summary.
The results of the performance testing described above demonstrate that the Exsens Personal Lubricants are as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K-Y Marilyn Pleasure Gel, K151884
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 features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2017
NEO COSMETIQUE % Gayle Lyne Official Correspondent Technic, Inc. 47 Molter Avenue Cranston, RI 02910
Re: K163674
Trade/Device Name: Exsens Personal Lubricant - Pure Aqua / Exsens Personal Lubricant - Aloe Vera / Exsens Personal Lubricant - Fresh Mint / Exsens Personal Lubricant - Candy Apple / Exsens Personal Lubricant - Raspberry
Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 10, 2017 Received: August 21, 2017
Dear Gayle Lyne:
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. Iisting 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.
1
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 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,
Charles Viviano -S
For
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163674
Device Name
Exsens Personal Lubricant - Pure Aqua / Exsens Personal Lubricant - Aloe Vera /Exsens Personal Lubricant - Fresh Mint / Exsens Personal Lubricant - Candy Apple / Exsens Personal Lubricant - Raspberry
Indications for Use (Describe)
Intended 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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are 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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3
cosm
A TECHNIC COMPANY
510(K) No : K163674
510(k) Summary
| Submitter name: | NEO COSMETIQUE
15, rue Montjoie
93212 Saint Denis
France |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Nathalie Vernin
President
Tel: 331 49 46 51 05
Fax: 331 49 46 51 05
nathalie.vernin@technic.fr
Veronique Laroche
Regulatory Operations Lead
Tel: 334 42 29 09 06
Fax: 334 42 29 09 20
veronique.laroche@technic.fr |
| Date prepared: | 21 September 2017 |
| Device name: | Exsens Personal Lubricant - Pure Aqua
Exsens Personal Lubricant - Aloe Vera
Exsens Personal Lubricant - Fresh Mint
Exsens Personal Lubricant - Candy Apple
Exsens Personal Lubricant - Raspberry |
| Common name: | Personal lubricant |
| Classification Name: | Condom |
| Classification Number: | 21 CFR § 884.5300 |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | Class II |
| Panel: | Obstetrics/Gynecology |
| Predicate Device: | K-Y Marilyn Pleasure Gel, K151884 |
| | The predicate device has not been subject to a design-related recall. |
| Device Description: | Exsens Personal Lubricants are non-sterile, water-based personal
lubricants that provide personal lubrication during intimate sexual activity.
They are made up of Glycerin, Water, Propylene Glycol, Aroma (Flavor),
Aloe Barbadensis (aloe vera) leaf juice, Hydroxyethylcellulose, Sodium
Benzoate, Potassium Sorbate, Sodium Saccharin and citric acid. The
product is packaged in a 70ml polyethylene white tube with a flip-top cap
and protective sleeve. It is for over-the-counter (OTC) use. |
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Image /page/4/Picture/0 description: The image is a logo for Néo Cosmétique, a Technic Company. The word "néo" is in a bold, sans-serif font, with an accent mark over the "e". To the right of the "o" is a blue water droplet. Below "néo" is the word "cosmétique" in a smaller, sans-serif font. Below that is the text "A TECHNIC COMPANY" in a smaller, sans-serif font.
510(K) No : K163674
| Parameter | Specification |
|---|---|
| Appearance | Clear gel |
| Odor | Neutral, mint, candy |
| apple, raspberry | |
| pH | 5.0 - 6.0 |
| Viscosity | 7000 - 12,000 mPa |
| Density | 1.14 |
| Osmolality | 600 - 700 mOsmol/kg |
| Antimicrobial Effectiveness | Meets acceptance |
| criteria for Category 2 | |
| products | |
| Total Microbial Count |