(160 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a personal lubricant, with no mention of AI or ML technology.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to diagnose, cure, mitigate, treat, or prevent disease.
No
Explanation: The intended use of the device is for lubrication and to enhance intimate sexual activity, not for diagnosing any medical condition.
No
The device is a physical product (a creme/lubricant) and its packaging, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "personal lubricant, for penile and/or vaginal application, intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a device used on the body for physical interaction, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the physical composition and form of a lubricant, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Regulatory Classification: Personal lubricants are typically regulated as medical devices, but not as IVDs. The mention of "Over-The-Counter Use (21 CFR 801 Subpart C)" further supports this, as this regulation pertains to general medical devices.
In summary, the function and purpose of this device are entirely external and related to physical lubrication during sexual activity, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is a nonsterile, anhydrous, fragranced, glycol-in-silicone emulsion that provides a warming sensation upon contact with ambient moisture on the skin. It is composed of a combination of lubricants and emollients, an antioxidant, a gelling agent, a thickener, a film former, a stabilizer, a surfactant, and a fragrance. The emulsion is off-white to beige in color with a slight hint of vanilla and/or floral scent. It has a viscosity, specific gravity, and lubricity typical for emulsions of this type.
The product will be filled in printed black 3.0 ounce high density polyethylene (HDPE) heart shaped bottles, sealed with black pump closures, and packaged in printed cartons.
Like the cleared device, the modified device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, will be marketed as a non-prescription medical device 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility evaluation:
- Cytotoxicity according to ISO 10993-5:2009
- Guinea Pig Maximization Sensitization according to ISO 10993-10:2010
- Vaginal Irritation according to ISO 10993-10:2010
- Acute Systemic Toxicity according to ISO 10993-11:2006
- Results: The results of these tests demonstrate that the K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant is biocompatible.
- Condom Compatibility:
- Testing was conducted in accordance with ASTM D7661-10.
- Results: Under current standards, the modified device may have an effect on the mechanical and/or physical integrity of natural rubber latex, synthetic polyisoprene and polyurethane condoms. Therefore, condom compatibility claims are not requested for this modified device.
- Stability:
- Shelf life testing was conducted on final devices to support the targeted two-year shelf-life.
- Results: Based on satisfactory results of this testing, the product will be labeled with a 2 year expiration date.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2015
Reckitt Benckiser Elizabeth Torre Regulatory Operations Lead Morris Corporate Center IV 399 Interpace Parkway Parsippany, NJ 07054
Re: K143511
Trade/Device Name: K-Y® Brand Touch® All-in-One Warming Caressing Crème and Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 21, 2015 Received: April 27, 2015
Dear Elizabeth Torre,
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 mav 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
1
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 yours.
Joyce M. Whang -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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143511
Device Name
K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant
Indications for Use (Describe)
K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Submitted by: | Reckitt Benckiser LLC
Morris Corporate Center IV
399 Interpace Parkway
Parsippany, NJ 07054
Phone: (973) 404-2715 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Elizabeth Torre, MPH
Regulatory Operations Lead,
Reckitt Benckiser LLC |
| Date Prepared: | December 14, 2014 |
| Proprietary Name(s): | K-Y® BRAND TOUCH® All-in-One Warming
Creme and Personal Lubricant |
| 510(k) Number: | K143511 |
| Classification Name: | Condom (21 CFR §884.5300); Class II |
| Product Code: | NUC (lubricant, personal) |
| Cleared Device/Predicate: | K081236
K-Y® Brand Intrigue™ 2-in-1 Massage Creme™ |
Indication for Use:
K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.
Description of the Device:
K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is a nonsterile, anhydrous, fragranced, glycol-in-silicone emulsion that provides a warming sensation upon contact with ambient moisture on the skin. It is composed of a combination of lubricants and emollients, an antioxidant, a gelling agent, a thickener, a film former, a stabilizer, a surfactant, and a fragrance. The emulsion is off-white to beige in color with a slight hint of vanilla and/or floral scent. It has a viscosity, specific gravity, and lubricity typical for emulsions of this type.
The product will be filled in printed black 3.0 ounce high density polyethylene (HDPE) heart shaped bottles, sealed with black pump closures, and packaged in printed cartons.
Like the cleared device, the modified device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, will be marketed as a non-prescription medical device for over-the-counter (OTC) use.
4
Technological Characteristics
The modified device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is substantially equivalent to the cleared device. The intended use is identical and the technical characteristics vary only slightly due to the addition of small amount of fragrance. Aside from the fragrance, all of the ingredients in the modified device are identical, and they are present at almost identical concentrations to those in the cleared device.
Performance Data:
Biocompatibility
K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant is varied slightly from the cleared predicate device; the only difference in the formula is the addition of a fragrance. All of the ingredients, except the fragrance, have been used in other 510k cleared marketed devices.
Biocompatibility evaluation of the K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant consisted of the following tests:
- Cytotoxicity according to ISO 10993-5:2009
- Guinea Pig Maximization Sensitization according to ISO 10993-10:2010
- Vaginal Irritation according to ISO 10993-10:2010 ●
- Acute Systemic Toxicity according to ISO 10993-11:2006
The results of these tests demonstrate that the K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant is biocompatible.
Condom Compatibility
Condom compatibility testing was conducted in accordance with ASTM D7661-10. Under current standards, the modified device may have an effect on the mechanical and/or physical integrity of natural rubber latex, synthetic polyisoprene and polyurethane condoms. Therefore, condom compatibility claims are not requested for this modified device.
Stability:
Shelf life testing was conducted on final devices to support the targeted two-year shelf-life. Based on satisfactory results of this testing, the product will be labeled with a 2 year expiration date.
Conclusion
Because the minor modifications (i.e., fragrance) to this cleared device do not raise new types of questions of safety or effectiveness, there is no change in intended use or fundamental scientific technology, and the results of additional technological characterization, biocompatibility testing, and performance testing are favorable, we conclude that the modified device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is substantially equivalent to our legally cleared predicate device, K-Y® Brand Intrigue™ 2-in-1 Massage Creme™.