(252 days)
No
The device description and intended use clearly define a personal lubricant, a chemical formulation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, which addresses a physiological need or condition, aligning with the definition of a therapeutic device.
No.
The device is a personal lubricant intended to moisturize and lubricate for enhancing comfort during sexual activity, not to diagnose a condition.
No
The device described is a physical product (lubricating liquid) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the product 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 describes a product for direct application to the body for physical lubrication, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical properties of the liquid (clear, odorless, pH, viscosity, etc.) and its compatibility with condoms. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic devices. The performance study described is a clinical study on human subjects using the product as intended, not a study evaluating the accuracy of a diagnostic test.
In summary, the device is a personal lubricant intended for topical application and physical effect, not for performing tests on biological samples outside the body.
N/A
Intended Use / Indications for Use
Ultrasmooth Lubricating Liquid 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 and polyisoprene condoms.
Medline Lubricating Liquid and Vaginal Moisturizer 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 and polyisoprene condoms.
Product codes
NUC
Device Description
The UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer are non-sterile aqueous personal lubricants. Both lubricants are clear, odorless. The ingredients for the UltraSmooth Lubricating Liquid are similar to other personal lubricants currently on the market. The specifications for UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer include color, pH, viscosity, lubricity, osmolarity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
Both the UltraSmooth, and Medline Lubricating Liquid and Vaginal Moisturizer are compatible with natural rubber latex and polyisoprene condoms.
The UltraSmooth Lubricating Liquid product will be offered in two sizes, a 2 fluid ounce and a 6 fluid ounce. The primary packaging consists of a high density polyethylene (HDPE) bottle with a polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.
The Medline Lubricating Liquid and Vaginal Moisturizer will be offered in two sizes, 2.5 fluid ounces and 4 fluid ounces. The primary packaging consists of a high density polyethylene (HDPE) bottle with a polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A ten day in use clinical study was performed on the subject devices. The study was conducted over a 10-day period with 30 subjects applying the Medline's Lubricating Liquid and Vaginal Moisturizer and 29 subjects applying UltraSmooth Lubricating Liquid once per day. The results of the study demonstrated that Medline's Lubricating Liquid and Vaginal Moisturizer and UltraSmooth Lubricating Liquid are safe when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-Y UltraGel, K020827
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 logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundlelein, Illinois 60060
Re: K143529
Trade/Device Name: Ultrasmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer Regulation Number: 21 CFR 884.5300
Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: July 21, 2015 Received: July 22, 2015
Dear Jennifer Mason:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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) K143529
Device Name
Ultrasmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
Indications for Use (Describe)
Ultrasmooth Lubricating Liquid 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 and polyisoprene condoms.
Medline Lubricating Liquid and Vaginal Moisturizer 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 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)
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 required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters slightly slanted to the right. To the right of the word is a blue star-like symbol with four points. The logo is simple and clean, with a professional appearance.
Medline Industries. Inc. One Medline Place Mundelein, IL 60060-4486
510(k) Summary (as required per 21 CFR 807.92)
Summary Preparation Date
August 20, 2015
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Contact Person
Jennifer Mason Sr. Regulatory Affairs Specialist Phone: 847-643-3652 Fax: 847-643-4482
Device Name / Classification
Device Name: UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer Proprietary Name: UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer Common Name: Personal Lubricants Classification Name: Condom (21 CRF 884.5300, product code - NUC)
Predicate Device
K-Y UltraGel, K020827
Device Description
The UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer are non-sterile aqueous personal lubricants. Both lubricants are clear, odorless. The ingredients for the UltraSmooth Lubricating Liquid are similar to other personal lubricants currently on the market. The specifications for UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer include color, pH, viscosity, lubricity, osmolarity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
Both the UltraSmooth, and Medline Lubricating Liquid and Vaginal Moisturizer are compatible with natural rubber latex and polyisoprene condoms.
The UltraSmooth Lubricating Liquid product will be offered in two sizes, a 2 fluid ounce and a 6 fluid ounce. The primary packaging consists of a high density polyethylene (HDPE) bottle with
4
Medline Industries. Inc. One Medline Place Mundelein, IL 60060-4486
a polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.
The Medline Lubricating Liquid and Vaginal Moisturizer will be offered in two sizes, 2.5 fluid ounces and 4 fluid ounces. The primary packaging consists of a high density polyethylene (HDPE) bottle with a polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.
Indications for Use
Ultrasmooth Lubricating Liquid 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 and polyisoprene condoms.
Medline Lubricating Liquid and Vaginal Moisturizer 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 and polyisoprene condoms.
Summary of Technological Characteristics
The UltraSmooth Lubricating Liquid and Medline Lubricating Liquid and Vaginal Moisturizer and the cited predicate device have similar technological characteristics per the table below.
| General Device Characteristics | |||
|---|---|---|---|
| Subject Device (K143529) | Subject Device (K143529) | Predicate Device | |
| Device & | |||
| Predicate | |||
| Device(s): | UltraSmooth Lubricating | ||
| Liquid | Medline Lubricating | ||
| Liquid and Vaginal | |||
| Moisturizer | K-Y UltraGel | ||
| Sponsor | Medline Industries, INC. | Medline Industries, INC. | Personal Products CO. |
| 510(k) Number | K143529 | K143529 | K020827 |
| Regulation | |||
| Number | 884.5300 | 884.5300 | 884.5300 |
| Product Code | NUC | NUC | NUC |
| Device Class | II | II | II |
| Clearance Date | N/A | N/A | 06/12/2002 |
5
Image /page/5/Picture/0 description: The image shows the logo for Medline, a healthcare company. The logo is blue and features the word "MEDLINE" in a bold, sans-serif font. Below the text is a stylized star shape, also in blue, with a curved line extending from the bottom point of the star.
Medline Industries. Inc. One Medline Place Mundelein, IL 60060-4486
| Condom
Compatibility | Yes (Natural Rubber Latex,
Polyisoprene) | Yes (Natural Rubber
Latex, Polyisoprene) | Yes (Natural Rubber Latex
only) |
|-------------------------|---------------------------------------------|---------------------------------------------|------------------------------------|
| Base Type | Water-based | Water-based | Water-based |
| OTC Use | Yes | Yes | Yes |
| Biocompatible | Yes | Yes | Yes |
| Non-Sterile | Yes | Yes | Yes |
Summary of Non-Clinical Testing
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer are biocompatible based on the results of the following biocompatibility studies:
- Cytotoxicity per ISO 10993-5:2009 using a direct contact method O
- Guinea Pig Maximization Sensitization per ISO 10993-10:2010 O
- Vaginal Irritation per ISO 10993-10:2010 O
- Systemic Toxicity according to ISO 10993-11:2006 (2010) O
The results of accelerated aging studies demonstrate that UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer maintain its specifications over the duration of its one-year shelf life.
The UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer were tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms in accordance with ASTM D7661, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Results showed that the UltraSmooth. and Medline Lubricating Liquid and Vaginal Moisturizer are compatible with natural rubber latex and polyisoprene condoms. These devices are not compatible with polyurethane condoms.
Non-staining testing was performed per AATCC Test Method 130 Soil Release: Oily Stain Release. Lubricant was applied to 9 different fabric types and allowed to age on each fabric for 24 hours prior to the fabric being run through a machine wash cycle. Each fabric type and the lubricant's staining ability were rated according to the test standard. The UltraSmooth Lubricating Liquid was concluded to be non-staining to the fabrics that were tested.
Summary of Clinical Testing
A ten day in use clinical study was performed on the subject devices. The study was conducted over a 10-day period with 30 subjects applying the Medline's Lubricating Liquid and Vaginal Moisturizer and 29 subjects applying UltraSmooth Lubricating Liquid once per day. The results of the study demonstrated that Medline's Lubricating Liquid and Vaginal Moisturizer
6
Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in blue, with a stylized blue starburst shape behind it. The starburst has four points, with the bottom point extending downwards below the text.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486
and UltraSmooth Lubricating Liquid are safe when used as intended.
Conclusion
The UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer are substantially equivalent to their predicate device.