PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE

K133336 · Pjur Group Luxembourg S.A. · NUC · Jul 24, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K133336
• Device Name: PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
• Applicant: Pjur Group Luxembourg S.A.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur® Med Premium Glide are personal lubricants, for genital area 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 latex, polyurethane, and polyisoprene condoms.

Device Story

Silicone-based personal lubricants; formulated as clear, non-irritating, non-greasy, odorless gels. Applied topically to genital area by users to supplement natural lubrication and enhance comfort during sexual activity. Compatible with natural latex, polyurethane, and polyisoprene condoms. No contraceptive or spermicidal properties. Over-the-counter use.

Clinical Evidence

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

Technological Characteristics

Silicone-based lubricant blend. Non-sterile. Formulated to be clear, non-irritating, non-greasy, and odorless. Tested for biocompatibility per ISO 10993-1 and condom compatibility per ASTM D7661-10.

Indications for Use

Indicated for individuals requiring personal lubrication for genital area application to moisturize, lubricate, and enhance comfort during intimate sexual activity. Compatible with natural 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 2 4 2014

K133336 pg 1 of 2

### Traditional 510(k) Premarket Notification

pjur group of silicone based lubricants : pjur� Silicone Gel, pjur� Basic Personal Glide, pjur� Light, pjur® Med Premium Glide

Image /page/0/Picture/4 description: The image shows the logo for "pjur group". The logo is black and white. The word "pjur" is in a larger font than the word "group", and there is a circle above the "j" in "pjur". There is a registered trademark symbol to the right of the circle.

## 510(k) Sum

(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 | October 17th, 2013 |

| Trade Name | pjur® family of silicone based lubricants<br>- pjur® Silicone Gel (pjur006)<br>- pjur® Basic Personal Glide (pjur008)<br>- pjur® Light (pjur009)<br>- pjur® Med Premium Glide (pjur021) | Predicate Devices | Erozone Glide, K040428<br>KY® Intrigue Premium Personal Lubricant, K062796<br>Wet Platinum Premium Lubricant®, K130012 | Technological<br>Characteristics | The pjur® family of silicone based lubricants contain a blend of<br>silicone fluid ingredients similar to ingredients found in the predicate<br>devices. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Personal Lubricant | Description | The pjur® family of silicone based lubricants are non-sterile, silicone-<br>based personal lubricants. These over-the-counter products are<br>formulated to be clear, non-irritating, non-greasy, and odorless. The<br>pjur® family of silicone based lubricants contains neither a<br>contraceptive nor a spermicide. | 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 Acute irritation Vaginal Irritation and Systemic Toxicity Sensitization via analogue conclusion of testing af pjur002 The results of the testing show that the pjur® family of silicone based<br>lubricants are not cytotoxic, non-sensitizing, non-irritating, and did not<br>show any sign of systemic toxicity or vaginal irritation.<br><br>Testing per ISO 10993-10: 2010 using the Guinea Pig Maximization<br>Study demonstrated that the subject devices produced no signs of<br>allergenic potency. The sensitization rate was 0%. All test results<br>were satisfactory and suport that the subject devices poses no undue<br>biocompatibility risk.<br><br>Condom compatibility testing was performed using the methods<br>outlined in ASTM D7661-10 "Standard Test Method for Determining<br>Compatibility of Personal Lubricants with Natural Rubber Latex<br>Condoms." Testing results demonstrate that the pjur® family of<br>silicone based lubricants are compatible with natural latex natural<br>latex, polyurethane, and polyisoprene condoms. |
| Classification Name | Condom<br>(21 CFR §884.5300, Product Code NUC) | Intended Use | pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur®<br>Med Premium Glide are personal lubricants, for genital area<br>application, intended to moisturize and lubricate, enhance the ease<br>and comfort of intimate sexual activity and supplement the body's<br>natural lubrication. These products are compatible with natural latex, | Conclusion | The pjur silicone based lubricant has the same intended use as that<br>of Erozone Glide, Wet Platinum Premium Lubricant® and KY®<br>Intrigue. The ingredients in the pjur formulation are the same as in<br>the Erozone Glide. The labeling claims of the pjur silicone based<br>personal lubricant are the similar as 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 silicone based personal lubricant is substantially equivalent<br>to other personal lubricant products cleared in the US in terms of<br>biocompatibility, technology, intended use and suitability<br>characteristics. |
| Class | Class II | | | | |

polyurethane, and polyisoprene condoms.

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## K133336

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## page 2 of 2

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Traditional 510(k) Premarket Notification
pjur group of silicone based lubricants : pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur® Med Premium Glide

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Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line. The words are black against a white background.

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

July 24, 2014

pjur® goup Luxembourg S.A. % Candance F. Cederman Consultant Candace F. Cederman 722 Arjean Drive Wilmington, NC 28411

K133336 Re:

> Trade Name: pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur® Med Premium 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 Candance F. 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, 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

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Page 2 - Candance F. Cederman

(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 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 (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin Masher -S

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): _K133336

Device Name: pjur group family of silicone based lubricants

- piur® Silicone Gel -
- pjur® Basic Personal Glide ー
- pjur® Light -
- pjur® Med Premium Glide, -

Indications for Use:

pjur® Silicone Gel, pjur® Basic Personal Glide, pjur� Light, pjur� Med Premium Glide are personal lubricants, for genital area 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 latex, polyurethane, and polyisoprene condoms.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ x (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)

Beniamin 2014.07.24 04'00'

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