(560 days)
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No
The device description and performance studies focus on the chemical composition, biocompatibility, and physical properties of a personal lubricant, with no mention of AI or ML.
No.
The lubricant is intended to moisturize and lubricate to enhance comfort during sexual activity, not to treat a disease, injury, or other medical condition.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for enhancing comfort during sexual activity, not for diagnosing any medical condition.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its chemical composition and physical properties.
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 of comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a topical application for physical comfort and lubrication during sexual activity.
- Device Description: The device is a "personal silicone base lubricant" applied externally.
- Lack of In Vitro Testing: The description of performance studies focuses on biocompatibility, condom compatibility, and stability. There is no mention of testing biological samples (like blood, urine, tissue, etc.) outside of the body to diagnose a condition or provide information about a physiological state.
IVD devices are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.
Product codes
NUC
Device Description
Durex® RealFeel™ Pleasure Gel is a non-sterile, personal silicone base lubricant. The lubricant is comprised of cyclopentasiloxane and dimethiconol. Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device The specifications for Durex® RealFeel™ Gel include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans).
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: Four biocompatibility studies were conducted on the subject device. The endpoints evaluated included cvtotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits. Each study was conducted in accordance with GLP requirements and the applicable ISO 10993-1 standard. The results demonstrate that the subject device is biocompatible.
Condom Compatibility: The condom compatibility testing was conducted in accordance with ASTM D7661-2010. The results demonstrate that the Durex® RealFeel™ Pleasure Gel is compatible with polyurethane condoms but in not compatible with natural rubber latex and polyisoprene condoms.
Stability: The results of accelerated and real time studies demonstrate that the subject lubricant maintains its specifications over the duration of its shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized emblem. The emblem consists of three abstract human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2014
Reckitt Benckiser, LLC Shahper Rahman Regulatory Strategic Lead Morris Corporate Center IV 399 Interpace Parkway Parsippany, NJ 07054
Re: K131643
Trade/Device Name: Durex® RealFeel™ Pleasure Gel Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 18, 2014 Received: November 19, 2014
Dear Shahper Rahman,
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,
Herbert P. Lerner -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
Indications for Use
510(k) Number (if known): K131643
Device Name: Durex ® RealFeel™ Pleasure Gel Personal Lubricant
Indications For Use:
Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Reckitt Benckiser. The logo consists of a pink triangle with the letters "rb" inside, followed by the words "Reckitt Benckiser" in a dark gray sans-serif font. The words are stacked on top of each other, with "Reckitt" on top and "Benckiser" on the bottom.
510(k) Summary K131643
Submitted by:
| Submitted by: | Reckitt Benckiser, LLC
Morris Corporate Center IV
399 Interpace Parkway
Parsippany, NJ 07054
973-404-2781 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shahper Rahman, Regulatory Strategic Lead, Reckitt Benckiser, LLC |
| Date Prepared: | November 18, 2014 |
| Proprietary Name: | Durex® Personal Lubricant-Silicone |
| Trade Name: | Durex® RealFeel™ Pleasure Gel Personal Lubricant |
| Common Name: | Personal Lubricant |
| Classification Name: | Condom (21CFR 884.5300) |
| Product Code: | NUC (lubricant, personal) |
| Predicate Devices: | ONE® Silicone Lubricant
One
510(k) Control Number: K110690 |
Description of Device:
Durex® RealFeel™ Pleasure Gel is a non-sterile, personal silicone base lubricant. The lubricant is comprised of cyclopentasiloxane and dimethiconol. Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device The specifications for Durex® RealFeel™ Gel include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans).
Intended Use of the Device:
Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.
4
Image /page/4/Picture/0 description: The image shows the logo for Reckitt Benckiser. The logo consists of a pink triangle with the letters "rb" in white inside of it. To the right of the triangle are the words "Reckitt Benckiser" in a dark gray sans-serif font, with "Reckitt" on the top line and "Benckiser" on the bottom line.
Comparison of Technological Characteristics with the Predicate Device
Intended Use Comparison
The table below shows the indication statements for the Durex® RealFeel™ Pleasure Gel and the predicate devices:
| Durex® RealFeel™ Pleasure Gel | ONE Silicone Lubricant | |
|---|---|---|
| 510(k) Number | K131643 | K110690 |
| Indication for Use | Durex® RealFeel™ Pleasure Gel | |
| Personal Lubricant is intended for penile | ||
| and/or vaginal application and 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 polyurethane condoms. | ||
| It is not compatible with natural | ||
| rubber latex and polyisoprene | ||
| condoms. | ONE Silicone Lubricant is an over the | |
| counter personal lubricant for penile and/or | ||
| vaginal application, intended to moisturize | ||
| and lubricate, to enhance the ease of comfort | ||
| of intimate sexual activity and supplement the | ||
| body's natural lubrication. This product is | ||
| compatible with natural rubber latex, | ||
| polyisoprene, and polyurethane condoms |
The only difference in the intended use Durex® RealFeel™ Pleasure Gel in comparison to predicate device is condom compatibility. This difference does not represent a new intended use. Therefore, to the Durex® RealFeel™ Pleasure Gel and the predicate device have the same intended use.
Technological Characteristics:
The Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device.
The Durex® Embrace Pleasure Gels and the predicate device have technological characteristics.
Performance Data:
The performance data provided in the 510(k) submission are summarized below.
Biocompatibility:
Four biocompatibility studies were conducted on the subject device. The endpoints evaluated included cvtotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits. Each study was conducted in accordance with GLP requirements and the applicable ISO 10993-1 standard. The results demonstrate that the subject device is biocompatible.
5
Image /page/5/Picture/0 description: The image shows the logo for Reckitt Benckiser. The logo consists of a pink triangle with the letters "rb" in white inside of it. To the right of the triangle is the company name, "Reckitt Benckiser", in a dark gray sans-serif font.
Condom Compatibility:
The condom compatibility testing was conducted in accordance with ASTM D7661-2010. The results demonstrate that the Durex® RealFeel™ Pleasure Gel is compatible with polyurethane condoms but in not compatible with natural rubber latex and polyisoprene condoms.
Stability:
The results of accelerated and real time studies demonstrate that the subject lubricant maintains its specifications over the duration of its shelf life.
Conclusion:
Based on the results of biocompatibility testing and nonclinical performance testing, Durex® RealFeel™ Pleasure Gel is substantially equivalent to the predicate device.