PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE

K133233 · Pjur Group Luxembourg S.A. · NUC · Jul 18, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K133233
• Device Name: PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
• Applicant: Pjur Group Luxembourg S.A.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide are personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Device Story

Non-sterile, silicone-based personal lubricants; formulated to be clear, non-irritating, non-greasy, and odorless. Intended for over-the-counter use to moisturize and lubricate during intimate sexual activity. Applied topically to penile and/or vaginal areas. Compatible with natural rubber latex, polyurethane, and polyisoprene condoms. Contains no contraceptives or spermicides. Benefits include enhanced ease and comfort of sexual activity and supplementation of natural lubrication.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, intracutaneous irritation, sensitization, vaginal irritation, systemic toxicity) showed no adverse effects. Guinea Pig Maximization Study (ISO 10993-10:2010) showed 0% sensitization rate. Condom compatibility testing per ASTM D7661 confirmed compatibility with natural rubber latex, polyurethane, and polyisoprene condoms.

Technological Characteristics

Silicone-based lubricant blend. Non-sterile. Compatible with natural rubber latex, polyurethane, and polyisoprene condoms. Biocompatibility testing performed per ISO 10993-1 and ISO 10993-10:2010. Condom compatibility testing performed per ASTM D7661.

Indications for Use

Indicated for adults requiring penile and/or vaginal lubrication to enhance comfort during sexual activity and supplement natural lubrication. Compatible with natural rubber latex, polyurethane, and polyisoprene 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

• Erozone Glide (K040428)
• KY® Intrigue Premium Personal Lubricant (K062796)
• Wet Platinum Premium Lubricant® (K130012)

Submission Summary (Full Text)

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JUL 1 8 2014

K133233 Pg. 1 of 2

Traditional 510(k) Premarket Notification
pjur® group silicone based lubricants – pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide

Image /page/0/Picture/4 description: The image shows the logo for "pjur group" with a registered trademark symbol in the upper right corner. Below the logo, the text "510(k) Summary" is visible. The text is in a simple, sans-serif font and appears to be part of a document or presentation.

(as required by 21 CFR 807.92)

| Submitter | pjur group Luxembourg SA |
|---------------------------------|--------------------------|
| 87 esplanade de la Moselle | |
| L-6637 Wasserbillig, Luxembourg | |
| Telephone: [phone] | |
| Fax: [phone] | |
| Contact Person | Patrick Giebel |
| | Quality Manager |
| | [e-mail] |
| Date Prepared | June 10, 2014 |

| Trade Name | pjur® group silicone based lubricants:<br>pjur®Original pjur®Woman pjur®MAN Extreme Glide |
|---------------------|-------------------------------------------------------------------------------------------|
| Common Name | Personal Lubricant |
| Classification Name | Condom<br>(21 CFR §884.5300, Product Code NUC) |
| Class | Class II |

| Predicate Devices | Erozone Glide, K040428 |
|-------------------|--------------------------------------------------|
| | KY® Intrigue Premium Personal Lubricant, K062796 |
| | Wet Platinum Premium Lubricant®, K130012 |

| Description | The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide |
|-------------|-----------------------------------------------------------------------|
| | lubricants are non-sterile, silicone-based personal lubricants. These |
| | over-the-counter products are formulated to be clear, non-irritating, |
| | non-greasy, and odorless. The pjur® silicone based lubricants |
| | contains neither a contraceptive nor a spermicide. |

| Intended<br>Use/Indications for<br>Use | pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide are<br>personal lubricants, for penile and/or vaginal application, intended to<br>moisturize and lubricate, enhance the ease and comfort of intimate<br>sexual activity and supplement the body's natural lubrication. These<br>products are compatible with natural rubber latex, polyurethane, and<br>polyisoprene condoms. |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Technological<br>Characteristics | The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide<br>lubricants contain a blend of silicone fluid ingredients similar to<br>ingredients found in the predicate devices. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Performance Data | Biocompatibility testing was performed in accordance with ISO 10993-<br>1, "Biological evaluation of medical devices – Part 1: Evaluation and<br>testing" including:<br>Cytotoxicity Intracutaneous Irritation Sensitization Vaginal Irritation and Systemic Toxicity The results of the testing show that the pjur® Original, pjur® Woman,<br>and pjur® MAN Extreme Glide lubricants are not cytotoxic, non-<br>sensitizing, non-irritating, and did not show any sign of systemic<br>toxicity or vaginal irritation.<br><br>Testing per ISO 10993-10: 2010 using the Guinea Pig Maximization<br>Study demonstrated that the subject device produced no signs of<br>allergenic potency. The sensitization rate was 0%. All test results<br>were satisfactory and suport that the subject device poses no undue<br>biocompatibility risk.<br><br>Condom compatibility testing was performed using the methods<br>outlined in ASTM D7661. Testing results demonstrate that the pjur®<br>Original, pjur® Woman, and pjur® MAN Extreme Glide lubricants are<br>compatible with natural latex, polyurethane, and polyisoprene<br>condoms. |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide<br>lubricants have the same intended use as that of Erozone Glide, Wet<br>Platinum Premium Lubricant® and KY® Intrigue. The ingredients in<br>the pjur formulation are the same as in the Erozone Glide. The<br>labeling claims of the pjur silicone based personal lubricants are<br>similar to those of the predicates.<br><br>The labeling of the pjur formulation contains the same warnings and<br>precautions as those in the labeling of the predicates.<br><br>Any differences that exist between the pjur silicone based personal<br>lubricant formulation and the predicates have no significant effect on<br>the safety or effectiveness.<br><br>The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide<br>lubricants are substantially equivalent to other personal lubricant<br>products cleared in the US in terms of biocompatibility, technology,<br>intended use and suitability characteristics. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

July 18, 2014

Piur Group Luxembourg SA Candace Cederman Consultant 722 Arjean Drive Wilmington, NC 28411

Re: K133233

> Trade/Device Name: Pjur Original, Pjur Woman, Pjur Man Extreme Glide Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 13, 2014 Received: June 16, 2014

Dear Candace Cederman,

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. Ilisting 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 (21CFR 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

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Page 2 - Candace Cederman

forth in 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (21CFR Part 803), please go to

http://www.fda.gov/McdicalDevices/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 (30))796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/8 description: The image shows the name "Benjamin RAsher -S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The letters "RA" in the middle of the name are stylized with a decorative design.

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): K133233

Device Name:

pjur group silicone based lubricants

- pjur® Original l
- pjur® Woman
- pjur® MAN Extreme Glide -

Indications for Use:

pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide are personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Prescription Use (Parl 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Benjamin R. Fisher -S 2014.07.18 12:21:46 -04'00'

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