Medline Natural Lubricating Liquid

K143322 · Medline Industries, Inc. · NUC · Jul 20, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K143322
• Device Name: Medline Natural Lubricating Liquid
• Applicant: Medline Industries, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Medline Natural 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, polyisoprene and polyurethane condoms.

Device Story

Medline Natural Lubricating Liquid is a non-sterile, aqueous-based personal lubricant. It is applied topically to the penis or vagina to provide moisture and lubrication during intimate sexual activity. The device is intended for over-the-counter use by consumers. It functions by supplementing the body's natural lubrication, thereby enhancing comfort during use. The product is packaged in PETG bottles with polypropylene closures. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms, ensuring it does not compromise condom integrity during use. The device is used in a home setting by the patient.

Clinical Evidence

A 10-day prospective in-use clinical study was conducted with 27 subjects applying the lubricant once daily. The study demonstrated the device is safe for its intended use. Additional non-clinical evidence includes biocompatibility testing per ISO 10993-5, -10, and -11, and condom compatibility testing per ASTM D7661-10.

Technological Characteristics

Aqueous-based personal lubricant. Ingredients include water, hydroxyethylcellulose, pectin, aloe vera gel, xylitol, chlorhexidine gluconate, glucono delta lactone, tocopherol acetate, chamomile extract, and sodium benzoate. Non-sterile. Packaged in PETG bottles. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms per ASTM D7661-10. Shelf life validated per ASTM F1980-07:2011.

Indications for Use

Indicated for individuals requiring personal lubrication to moisturize and lubricate during intimate sexual activity. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Astroglide Natural (K141581)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2015

Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

Re: K143322

> Trade/Device Name: Medline Natural Lubricating Liquid Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 22, 2015 Received: May 26, 2015

Dear Jennifer Mason:

This letter corrects our substantially equivalent letter of July 2, 2015.

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.

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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 device-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 [phone] or [phone] 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" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# 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)

Device Name

Medline Natural Lubricating Liquid

#### Indications for Use (Describe)

Medline Natural Lubricating Liquid is a personal lubricant, for penile 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, polyisoprene and 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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Image /page/3/Picture/0 description: The image shows the Medline logo. The word "MEDLINE" is written in blue, with a stylized blue starburst symbol behind it. The starburst has four points and a curved base, giving it a distinctive appearance.

## 510(k) Summary (as required per 21 CFR 807.92)

## Summary Preparation Date

July 1, 2015

#### Submitter / 510(k) Sponsor

Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060

## Contact Person

Jennifer Mason Sr. Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

## Device Name / Classification

Device Name: Medline Natural Lubricating Liquid Proprietary Name: Medline Natural Lubricating Liquid Common Name: Personal Lubricants Classification Name: Condom (21 CRF 884.5300, product code - NUC)

## Predicate Device

Astroglide Natural, K141581

## Device Description

The Medline Natural Lubricating Liquid is a non-sterile aqueous personal lubricant. Medline Natural Liquid is clear, odorless and colorless. The ingredients are similar to other personal lubricants currently on the market.

The Medline Natural Lubricating Liquid is compatible with natural rubber latex, polyisoprene and polyurethane condoms. The product will be offered in two sizes, a 2.5 fluid ounce and a 5 fluid ounce. The primary packaging consists of a polyethylene terephthalate (PETG) bottle with a screw down, flip top polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.

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Image /page/4/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in blue, with a stylized blue starburst shape below it. The starburst has four points and a curved line connecting the bottom two points.

#### Indications for Use

Medline Natural 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, polyisoprene and polyurethane condoms.

#### Summary of Technological Characteristics

Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's Natural Lubricating Liquid and the cited predicate device.

| Feature | Proposed Device | Predicate Device | Comparison |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Name | Medline Natural Lubricating Liquid | Astroglide Natural K141581 | N/A |
| Intended Use | 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 only compatible with natural rubber latex, polyisoprene and polyurethane condoms. | 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 only compatible with natural rubber latex and polyisoprene condoms. | Same |
| Aqueous Formulation | Yes | Yes | Same |
| Ingredients | Water Hydroxyethylcellulose Pectin Aloe Vera Gel Xylitol Chlorhexidine Gluconate Glucono Delta Lactone Tocopherol Acetate Chamomile Extract Sodium Benzoate | Water Hydroxyethylcellulose Pectin Aloe Barbadensis Leaf Juice Xylitol Potassium ascorbyl tocopheryl phosphate Chamomilla Recutita (Matricaria) Flower Extract Phenoxyethanol Lactic Acid | Similar |

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Image /page/5/Picture/0 description: The image shows the Medline logo in blue. The word "MEDLINE" is written in a bold, sans-serif font. Above and below the word is a stylized compass rose or star shape, also in blue. The logo is simple and clean, with a focus on the company name and a symbol that suggests direction or guidance.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486

| Non-sterile | Yes | Yes | Same |
|--------------------------|---------------------------------------------------------|---------------------------------------------------------|---------|
| Packaging | Primary packaging - bottle<br>Secondary packaging - box | Primary packaging - bottle<br>Secondary packaging - box | Same |
| Over-the-<br>Counter Use | Yes | Yes | Same |
| Condom<br>Compatibility | Natural Rubber Latex,<br>Polyisoprene, Polyurethane | Natural Rubber Latex and<br>Polyisoprene | Similar |

The proposed Medline Natural Lubricating Liquid is identical in intended use and function to the Astroglide Natural cleared under K141581. Both lubricants are clear, water based lubricants. The ingredients in the Medline Natural Lubricating Liquid are very similar to the Astroglide Natural, with the primary difference being the preservative and pH adjuster used. The results of biocompatibility testing, condom compatibility testing and the in use clinical study support that these differences do not affect the safety and effectiveness of the device when used as labeled.

#### Summary of Non-Clinical Testing

The safety and effectiveness of Medline's Natural Lubricating Liquid is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Biocompatibility testing of the Medline Natural Lubricating Liquid was conducted in accordance with ANSI/AAMI/ISO 10993:1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The following biocompatibility tests were performed:

Cytotoxicity according to ISO 10993-5:2009 Sensitization according to ISO 10993-10:2010 Vaginal Irritation according to ISO 10993-10:2010 Systemic Toxicity according to ISO 10993-11:2006 (2010)

The results of the biocompatibility tests demonstrated that the Medline Natural Lubricating Liquid is biocompatible.

#### Condom Compatibility

Condom compatibility testing was performed in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms". The testing evaluated the compatibility of the Medline Natural Lubricating Liquid with various types of condoms including natural rubber latex, polyisoprene and polyurethane. The results show the Medline Natural Lubricating Liquid met the acceptance criteria per ASTM D7661 and is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

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Image /page/6/Picture/0 description: The image shows the logo for Medline. The word "MEDLINE" is written in blue, block letters. Below the text is a blue, four-pointed star-like shape. The logo is simple and clean, with a focus on the company name and a recognizable symbol.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486

## Shelf Life

Accelerated and real time shelf life studies were performed on the Medline Lubricating Liquid per ASTM F1980-07:2011. Preservative effectiveness was demonstrated at critical time-points throughout stability testing. These studies demonstrated that the product specifications were maintained throughout the shelf life period.

## Summary of Clinical Testing

A ten day in use clinical study was performed on the subject device. The study was conducted over a 10 day period with 27 subjects applying the Natural Lubricating Liquid once per day. The results of the study demonstrated that the Natural Lubricating Liquid is safe when used as intended.

#### Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Natural Lubricating Liquid is safe, effective and substantially equivalent to the predicate device, Astroglide Natural K141581, as described herein.