(269 days)
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.
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.
The document describes the acceptance criteria and performance data for Exsens Personal Lubricants. This information is presented in the context of a 510(k) premarket notification to the FDA, where the device is compared to a predicate device (K-Y Marilyn Pleasure Gel, K151884) to demonstrate substantial equivalence.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Exsens Personal Lubricant) |
|---|---|---|
| Appearance | Clear gel | Clear gel (Implicitly met as it's a characteristic, not a pass/fail test) |
| Odor | Neutral, mint, candy apple, raspberry | Neutral, mint, candy apple, raspberry (Implicitly met based on product description) |
| pH | 5.0 - 6.0 | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Viscosity | 7000 - 12,000 mPa | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Density | 1.14 | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Osmolality | 600 - 700 mOsmol/kg | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Antimicrobial Effectiveness | Meets acceptance criteria for Category 2 products | Met (Explicitly stated "Meets acceptance criteria for Category 2 products") |
| Total Microbial Count | <100 cfu/g | Met (Explicitly stated "<100 cfu/g") |
| Fungal/Yeast/Mold Limits | <10 cfu/g | Met (Explicitly stated "<10 cfu/g") |
| Absence of Pathogenic Organisms | Absent | Absent (Explicitly stated "Absent") |
| Biocompatibility: Cytotoxicity | Biocompatible | Demonstrated to be biocompatible |
| Biocompatibility: Sensitization | Biocompatible | Demonstrated to be biocompatible |
| Biocompatibility: Vaginal Irritation | Biocompatible | Demonstrated to be biocompatible |
| Biocompatibility: Acute Systemic Toxicity | Biocompatible | Demonstrated to be biocompatible |
| Condom Compatibility (Natural Rubber Latex) | Compatible | Compatible |
| Condom Compatibility (Polyisoprene Male) | Compatible | Compatible |
| Condom Compatibility (Polyurethane) | Not compatible | Not compatible |
| Shelf-life | 12 months | Showed 12 months shelf-life based on accelerated aging |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each test. For example, in biocompatibility testing, it mentions "Biocompatibility studies were conducted on the subject device," implying a sample was used, but the quantity is not given. Similarly, for condom compatibility, it states "The compatibility of the subject device... was evaluated," without specifying the number of lubricants or condoms tested.
- Data Provenance: The studies were conducted by the manufacturer, NEO COSMETIQUE, to support their 510(k) submission to the FDA. The document does not explicitly state the country of origin of the data beyond the manufacturer's address in France. The studies appear to be laboratory-based and conducted under specific standards (e.g., GLP, ISO, ASTM), suggesting controlled, prospective testing for the purpose of regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests described (biocompatibility, condom compatibility, stability, and chemical/physical properties) are objective laboratory tests with defined protocols and acceptance criteria based on established standards (ISO, ASTM). They do not involve expert interpretation or subjective ground truth establishment by medical professionals like radiologists.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The testing described involves objective laboratory measurements and adherence to specified standards, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and therefore not provided. This document pertains to the regulatory submission of a personal lubricant, not an AI or imaging device that would typically involve MRMC studies or human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and therefore not provided. The device is a personal lubricant, not an algorithm or software. Its performance is evaluated through material and biological compatibility tests, not algorithmic output.
7. The Type of Ground Truth Used
The ground truth for the performance claims are based on:
- Established laboratory standards and protocols: e.g., ISO 10993 for biocompatibility, ASTM D 7661-10 for condom compatibility, ASTM F1980-07 for shelf-life.
- Objective measurements: pH, viscosity, density, osmolality, microbial counts, and visual/olfactory characteristics.
- Pass/fail criteria: defined within these standards or as part of the product specification.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The device is a physical product (personal lubricant), not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As there is no training set, this question is not relevant.
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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.
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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
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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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cosm
A TECHNIC COMPANY
510(K) No : K163674
510(k) Summary
| Submitter name: | NEO COSMETIQUE15, rue Montjoie93212 Saint DenisFrance |
|---|---|
| Contact person: | Nathalie VerninPresidentTel: 331 49 46 51 05Fax: 331 49 46 51 05nathalie.vernin@technic.frVeronique LarocheRegulatory Operations LeadTel: 334 42 29 09 06Fax: 334 42 29 09 20veronique.laroche@technic.fr |
| Date prepared: | 21 September 2017 |
| Device name: | Exsens Personal Lubricant - Pure AquaExsens Personal Lubricant - Aloe VeraExsens Personal Lubricant - Fresh MintExsens Personal Lubricant - Candy AppleExsens 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 personallubricants 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, SodiumBenzoate, Potassium Sorbate, Sodium Saccharin and citric acid. Theproduct is packaged in a 70ml polyethylene white tube with a flip-top capand 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, candyapple, raspberry |
| pH | 5.0 - 6.0 |
| Viscosity | 7000 - 12,000 mPa |
| Density | 1.14 |
| Osmolality | 600 - 700 mOsmol/kg |
| Antimicrobial Effectiveness | Meets acceptancecriteria for Category 2products |
| Total Microbial Count | <100 cfu/g |
| Fungal/Yeast/Mold Limits | <10 cfu/g |
| Absence of PathogenicOrganisms | Absent |
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.
Predicate Device Comparison:
The table below lists the comparative intended use and technological characteristics of the subject and predicate device.
| 510(K) | Device Name | Intended Use | Ingredients | PhysicalFeatures | Shelf life |
|---|---|---|---|---|---|
| K163674 | Exsens PersonalLubricant - PureAquaExsens PersonalLubricant - AloeVeraExsens PersonalLubricant - FreshMintExsens PersonalLubricant - CandyAppleExsens PersonalLubricant -Raspberry | Intended for penileand/or vaginalapplication, intendedto moisturize andlubricate, to enhancethe ease and comfortof intimate sexualactivity andsupplement the body'snatural lubrication.These products arecompatible with naturalrubber latex condomsand polyisoprene malecondoms. Theseproducts are notcompatible withpolyurethanecondoms. | Glycerin, Water, PropyleneGlycol, Aroma (Flavor) /Aloe Barbadensis (aloevera) leaf juice,Hydroxyethylcellulose,Sodium Benzoate,Potassium Sorbate, SodiumSaccharin and citric acid. | HomogeneousClear Gel, watersoluble | 1 year |
| K151884 | KY Marilyn PleasureGel | Intended for penileand/or vaginalapplication, intendedto moisturize andlubricate, to enhancethe ease and comfortof intimate sexualactivity andsupplement the body'snatural lubrication.This device is | Water, Glycerin, PropyleneGlycol,Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil,Flavor, Benzoic Acid, andSodium Hydroxide | HomogeneousClear Gel/odorless | 9 months |
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Image /page/5/Picture/0 description: The image shows the logo for Néo Cosmétique, a Technic Company. The word "néo" is written in a bold, sans-serif font, with the accent mark over the "e" in black. To the right of "néo" 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 an even smaller, sans-serif font.
K163674 Page 3 of 3
510(K) No : K163674
| compatible with naturalrubber latex andPolyisoprenecondoms. This deviceis not compatible withpolyurethanecondoms. | |||||
|---|---|---|---|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------- | -- | -- | -- | -- |
The subject and predicate device have the same intended use - for penile and/or vaginal application, intended to moisturize and lubricate, and to enhance the ease of comfort of intimate sexual activity and supplement the body's lubrication. The subject and predicate device have different technological characteristics, including different formulation and shelf life. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.. Also, all personal lubricants must independently demonstrate that they are biocompatible with condoms, and can maintain their specifications for their expected shelf life.
Summary of Performance Data:
Biocompatibility
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.
Condom Compatibility:
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.
Stability / Shelf-life:
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.
Conclusion:
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.
§ 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.