PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!

K141913 · Pjur Group Luxembourg S.A. · NUC · Apr 6, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K141913
• Device Name: PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
• Applicant: Pjur Group Luxembourg S.A.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms.

Device Story

Non-sterile, silicone-based personal lubricant; formulated as clear, non-irritating, non-greasy, odorless viscous liquid. Contains Cyclopentasiloxane, Dimethicone, Dimethiconol, and jojoba. Intended for over-the-counter use by consumers to moisturize and lubricate during intimate sexual activity. Applied topically to penile, vaginal, or anal areas. Enhances comfort by supplementing natural lubrication. Compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms. No contraceptive or spermicidal properties.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation) showed non-cytotoxic, non-sensitizing, and non-irritant results. Condom compatibility testing per ASTM D7661-10 confirmed compatibility with natural latex, polyurethane, and polyisoprene condoms. Shelf-life testing supports at least 1 year.

Technological Characteristics

Silicone-based lubricant; ingredients: Cyclopentasiloxane, Dimethicone, Dimethiconol, jojoba. Viscosity 600-1000 cps; density 0.900-0.950 g/ml; anhydrous. Condom compatibility tested per ASTM D7661-10. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for individuals requiring personal lubrication for penile, vaginal, and/or anal application to enhance comfort during intimate sexual activity and supplement natural lubrication. Compatible with natural rubber latex, synthetic 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

• Wet Platinum Premium Lubricant (K130012)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

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

April 6, 2015

pjur group Luxembourg SA % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, NC 28408

Re: K141913

> Trade/Device Name: pjur® Backdoor Anal Glide and pjur® Analyse Me! Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: July 14, 2014 Received: July 17, 2014

Dear Cheryl Wagoner,

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 device

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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" (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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Herbert P. Lerner -S

for Benjamin Fisher, PhD Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K141913

Device Name pjur® Backdoor Anal Glide or pjur® Analyse Me!

#### Indications for Use (Describe)

pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application . intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for the "pjur group". The logo features the word "pjur" in a bold, sans-serif font, with a yellow circle above the letter "j". Below the word "pjur" is the word "group" in a smaller, sans-serif font. The logo also includes the registered trademark symbol.

# 510(k) Summary

(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 | 2/23/2015 |

| Trade Name | pjur® silicone based lubricant under the brand names of pjur®<br>Backdoor Anal Glide or pjur® Analyse Me! |
|---------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name | Personal Lubricant |
| Classification Name | Condom<br>(21 CFR §884.5300, Product Code NUC) |
| Class | Class II |

Wet Platinum Premium Lubricant®, K130012 Predicate Devices

| Description | The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a non-<br>sterile, silicone-based personal lubricant. This over-the-counter<br>product is formulated to be clear, non-irritating, non-greasy, and<br>odorless. The pjur® Backdoor Anal Glide or pjur® Analyse Me! Device<br>is a silicone based lubricant contains neither a contraceptive nor a<br>spermicide. The product contains Cyclopentasiloxane, Dimethicone,<br>Dimethiconol, and jojoba. |
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| Indications for Use | pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Technological<br>Characteristics | The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a<br>silicone based lubricant that contains a blend of silicone fluid<br>ingredients similar to ingredients found in other lubricants currently on |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | the U.S. markets and substantially equivalent to the predicate device.<br>Both the Subject and predicate devices contain Cyclopentasiloxane,<br>Dimethicone, Dimethiconol. Both devices also contained a plant-<br>derived oil additive that is present in very small amounts and has no |
| | impact upon safety or effectiveness. In the case of The pjur® Backdoor<br>Anal Glide or pjur® Analyse Me! device the additive is jojoba which is<br>commonly used in food and cosmetic devices. The additive for Wet<br>Platinum Premium Lubricant®, K130012 is Vitamin E. This plant based<br>additive, as with the Subject device, does not negatively impact risk or<br>biocompatibility. The presence of jojoba oil in the Subject device and<br>Vitamin E in the Predicate device do not raise any new questions of<br>safety or effectiveness nor does it represent a new technology. |
| | These products are compatible with natural rubber latex, synthetic<br>polyisoprene, and polyurethane condoms. |
| | The intended use of the Subject device is the same as its predicate.<br>Both are intended as non-sterile, over-the-counter personal lubricants.<br>The indications for use for the Subject and Predicate devices are not<br>identical, but are substantially equivalent. Both the Subject device and<br>the predicate are indicated as a personal lubricant for intimate sexual<br>activity and have been fully tested to ensure that there are no new<br>questions of safety or effectiveness related to this usage nor does it<br>represent new technology. |

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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: | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| | Test Performed | Results |
| | ISO 10993-5 Cytotoxicity (Direct<br>contact) | Non-cytotoxic |
| | ISO 10993-10 Guinea Pig<br>Maximization Sensitization test | No sensitization response. |
| | ISO 10993-10 | Non-irritant |
| | • Irritation (Direct contact) | |
| | • Irritation( Intracutanteous injection) | |
| | • Vaginal Irritation (repeat insult) | |
| | Shelf-Life Testing | At least 1 year |
| | Viscosity | 600-1000 cps |
| | Density | 0.900-0.950 g/ml |
| | Appearance | Viscous liquid |
| | Turbidity | Clear, no turbidity |
| | Color | Slightly yellow |
| | Odor | None |
| | Microbial Limits | <100 cfu/g TAMC, <10 cfu/g<br>TYMC, absence of<br>pathogenic organisms |
| | Water Activity | <0.3 Aw |
| | pH and Osmolaltity | N/A since product is<br>anhydrous |
| | Condom compatibility testing was performed using the methods<br>outlined in ASTM D7661-10 including burst volume, burst pressure,<br>force of break and elongation until break. Testing results demonstrate<br>that the pjur® pjur® Backdoor Anal Glide or pjur® Analyse Me! device<br>is compatible with natural latex, , polyurethane, and polyisoprene<br>condoms. | |

| Conclusion | The pjur® Backdoor Anal Glide or pjur® Analyse Me! device has the<br>same intended use as that of its predicate. The ingredients in the pjur®<br>formulation are the similar to the Wet Platinum Premium Lubricant,<br>K130012. The labeling claims and indications for use of the pjur®<br>Backdoor Anal Glide or pjur® Analyse Me! device are the similar to<br>those of the predicates. |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The labeling of the pjur® Backdoor Anal Glide or pjur® Analyse Me!<br>device formulation contains the same warnings and precautions as<br>those in the labeling of the predicate. |
| | Any differences that exist between t The pjur® Backdoor Anal Glide<br>or pjur® Analyse Me! device and the predicates have no significant<br>effect on the safety or effectiveness. |

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| T The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is |
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| substantially equivalent to other personal lubricant products cleared |
| lin the US in terms of biocompatibility, technology, intended use, |
| lindications, and suitability characteristics. |