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.

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.

AI/ML Overview

The provided documents describe the regulatory submission for two personal lubricants, Ultrasmooth Lubricating Liquid and Medline Lubricating Liquid and Vaginal Moisturizer. The bulk of the information pertains to demonstrating substantial equivalence to a predicate device (K-Y UltraGel) through non-clinical and some clinical testing.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list formal "acceptance criteria" for the device's main function as a lubricant. Instead, they demonstrate compatibility with condoms and general safety. They mention specifications for properties like pH, viscosity, lubricity, osmolarity, and microbiological characteristics, but do not provide specific numerical criteria or reported performance values for these non-clinical attributes.

Criteria	Acceptance/Performance (as reported)
Biocompatibility
- Cytotoxicity (ISO 10993-5:2009)	Device considered biocompatible based on results using a direct contact method.
- Guinea Pig Maximization Sensitization (ISO 10993-10:2010)	Device considered biocompatible based on results.
- Vaginal Irritation (ISO 10993-10:2010)	Device considered biocompatible based on results.
- Systemic Toxicity (ISO 10993-11:2006 (2010))	Device considered biocompatible based on results.
Shelf-life	Maintain specifications over a one-year shelf life (demonstrated through accelerated aging studies).
Condom Compatibility
- Natural Rubber Latex condoms	Compatible (Tested per ASTM D7661)
- Polyisoprene condoms	Compatible (Tested per ASTM D7661)
- Polyurethane condoms	Not compatible (Tested per ASTM D7661)
Staining
- Fabric staining	Non-staining on 9 different fabric types (tested per AATCC Test Method 130 Soil Release: Oily Stain Release).
Safety (Clinical Study)
- Safety during intended use	Both devices found safe when used as intended (based on a 10-day in-use clinical study).
Other (General Device Characteristics for Equivalence)
- Base Type	Water-based (reported for both subject devices and predicate)
- OTC Use	Yes (reported for both subject devices and predicate)
- Non-Sterile	Yes (reported for both subject devices and predicate)

2. Sample sizes used for the test set and the data provenance

Clinical (in-use) study:
- Test set sample size: 30 subjects for Medline's Lubricating Liquid and Vaginal Moisturizer; 29 subjects for UltraSmooth Lubricating Liquid.
- Data provenance: Not specified (e.g., country of origin). The study is described as "a ten-day in use clinical study," which implies it was specifically conducted for this submission (prospective).
Non-clinical (biocompatibility, condom compatibility, staining) studies:
- Sample sizes are not specified for these tests. The documents state that the products "were tested" or "are biocompatible based on the results." These are likely laboratory tests on manufactured samples rather than patient data.
- Data provenance: Not specified. Implicitly, these are laboratory tests performed for the device submission (prospective in nature towards the submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the studies described are not diagnostic AI studies requiring expert ground truth for interpretation.

For the in-use clinical study, "safety when used as intended" was assessed, but the method of assessment (e.g., self-report, clinician evaluation) and the number/qualifications of any evaluating experts are not provided.

4. Adjudication method for the test set

Not applicable, as this refers to a multi-reader consensus process often used in diagnostic image interpretation studies. The studies described are not of this nature.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was conducted or described. This type of study is relevant for diagnostic AI tools, which is not the nature of these personal lubricants.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a personal lubricant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Clinical (in-use) study: The "ground truth" was likely inferred from the reported experience or observations of the subjects regarding safety during use. Specific "outcomes data" that would serve as ground truth are not detailed (e.g., no adverse events reported, satisfactory comfort, etc.). The conclusion is simply that the devices are "safe when used as intended."
Non-clinical studies: The "ground truth" for these tests (biocompatibility, condom compatibility, staining) would be established by the standardized methods themselves (e.g., ISO, ASTM, AATCC standards). Passing the test according to the defined parameters of these standards constitutes the "ground truth" of performance.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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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

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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

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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)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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

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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.

Indications for Use

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 &PredicateDevice(s):	UltraSmooth LubricatingLiquid	Medline LubricatingLiquid and VaginalMoisturizer	K-Y UltraGel
Sponsor	Medline Industries, INC.	Medline Industries, INC.	Personal Products CO.
510(k) Number	K143529	K143529	K020827
RegulationNumber	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

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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

CondomCompatibility	Yes (Natural Rubber Latex,Polyisoprene)	Yes (Natural RubberLatex, Polyisoprene)	Yes (Natural Rubber Latexonly)
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

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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.

Regulation Number and Section

§ 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.