pjur WOMAN Nude pjur med SENSITIVE glide

K200730 · Pjur Group Luxembourg S.A. · NUC · Dec 17, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K200730
• Device Name: pjur WOMAN Nude pjur med SENSITIVE glide
• Applicant: Pjur Group Luxembourg S.A.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Dec 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

Device Story

Water-based personal lubricant; intended for penile, vaginal, and/or anal application to moisturize and lubricate during intimate sexual activity. Over-the-counter product; applied by user. Formulation includes water, propylene glycol, ethyoxydiglycol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, sodium saccharin, and citric acid. Provided in polyethylene bottles. Compatible with natural rubber latex condoms; incompatible with polyurethane and polyisoprene condoms. Enhances ease and comfort of sexual activity by supplementing natural lubrication.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-5, -10, -11), condom compatibility (ASTM D7661-10), and real-time stability testing supporting a 4-year shelf life. Microbial limits and antimicrobial effectiveness testing (USP <61>, <62>, <51>) performed.

Technological Characteristics

Water-based lubricant. Ingredients: water, 1,2 propylene glycol, ethyoxydiglycol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, sodium saccharin, citric acid. pH 4.0-4.5; viscosity 4000-5600 mPa*s; osmolality 500-700 mOsm/kg. Non-sterile. Packaged in polyethylene bottles. Biocompatibility per ISO 10993. Condom compatibility per ASTM D7661-10.

Indications for Use

Indicated for individuals requiring penile, vaginal, or anal lubrication to enhance comfort during sexual activity and supplement natural lubrication. Compatible with natural rubber latex condoms; contraindicated for use with 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

• KY Grosz Jelly (K201186)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 17, 2020

pjur group Luxembourg SA % Candace Cederman Consultant Candace F. Cederman 722 Ariean Drive Wilmington, NC 28411

Re: K200730

> Trade/Device Name: pjur® med SENSITIVE glide, pjur® WOMAN Nude Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 14, 2020 Received: November 17, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200730

Device Name pjur® med SENSITIVE glide, pjur® WOMAN Nude

Indications for Use (Describe)

pjur@ med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
|----------------------------------------------|---------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |

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| DATE PREPARED: | 16 December 2020 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | pjur group Luxembourg SA<br>87 esplanade de la Moselle<br>L-6637 Wasserbillig, Luxembourg<br>Telephone: [phone]<br>Fax: [phone] |
| CONTACT: | Andrea Giebel, Quality Management Representative |
| TRADE NAME: | • pjur® med SENSITIVE glide<br>• pjur® WOMAN Nude |
| COMMON NAME: | Personal Lubricant |
| REGULATION NUMBER: | 21 CFR §884.5300 |
| REGULATION NAME: | Condom |
| PRODUCT CODE: | NUC (Lubricant, Personal) |
| DEVICE CLASS: | 2 |
| PREDICATE DEVICE: | KY Grosz Jelly, K201186<br>The predicate device has not been subject to a design-related recall. |

# DEVICE DESCRIPTION:

The pjur® med SENSITIVE glide and pjur® WOMAN Nude are water-based personal lubricants provided non-sterile. These over-the-counter products have an identical formulation and contain neither a contraceptive nor a spermicide. They are compatible with natural rubber latex condoms and are not compatible with polyurethane or polyisoprene condoms. The pjur® med SENSITIVE glide is provided in 100 mL polyethylene bottles and the pjur® WOMAN Nude is provided in either 10 mL or 100 mL polyethylene bottles.

The pjur® med SENSITIVE glide and pjur® WOMAN Nude consists of water, 1,2 propylene glycol, ethyoxydiglycol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, sodium saccharin, and citric acid.

| Parameter | Method | Specification |
|---------------------------|-----------|---------------------------------|
| Appearance | | Clear fluid |
| Odor | | Odorless |
| pH | USP<791> | 4.0-4.5 |
| Viscosity<br>(mPa*s) | USP<912> | 4000-5600 |
| Osmolality<br>(mOsmol/kg) | USP <785> | 500-700 mOsm/kg [diluted 1:9.6) |

Table 1: Device Specifications

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| Parameter | Method | Specification |
|--------------------------------------------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Total Yeast and<br>Mold Count<br>(TYMC) | USP<61> | <10 CFU/g |
| Total Aerobic<br>Microbial Count<br>(TAMC) | USP<61> | <100 CFU/g |
| Presence of<br>pathogenic<br>organisms | USP<62> | <i>Pseudomonas aeruginosa</i> |
| | | <i>Staphylococcus aureus</i> |
| | | <i>Candida albicans</i> |
| Antimicrobial<br>Preservation | USP<51> | Category 2 - Topical, bacteria should show not less than 2.0 log<br>reduction at 14 days and no increase from 14-day count at the 28-<br>day count. Yeast and molds should show no increase from the<br>initial calculated count at 14 and 28 days. |

# INDICATIONS FOR USE:

pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

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## SUMMARY OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE IN COMPARISON TO THE PREDICATE DEVICE:

| | pjur® med SENSITIVE<br>glide/pjur® WOMAN Nude<br>K200730<br>Subject Device | KY Grosz Jelly<br>K201186<br>Predicate Device | Comparison |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indications for Use | pjur® med SENSITIVE glide for<br>penile, vaginal and/or anal<br>application, intended to moisturize<br>and lubricate, enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. This product is<br>compatible with natural rubber<br>latex condoms. This product is not<br>compatible with polyurethane and<br>polyisoprene condoms.<br>pjur® WOMAN Nude for penile,<br>vaginal and/or anal application,<br>intended to moisturize and<br>lubricate, enhance the ease and<br>comfort of intimate sexual activity<br>and supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber<br>latex condoms. This product is not<br>compatible with polyurethane and<br>polyisoprene condoms. | This product is intended for penile,<br>vaginal and/or anal application to<br>moisturize and lubricate, to<br>enhance the ease and comfort of<br>intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber<br>latex and polyisoprene condoms.<br>This product is not compatible with<br>polyurethane condoms. | Same<br>intended use |
| Rx / OTC | OTC | OTC | Same |
| Base Type | Water | Water | Same |
| Primary Ingredients | Purified water<br>1,2 propylene glycol<br>Ethyoxydiglycol<br>Hydroxypropyl guar<br>hydroxypropyltrimonium chloride<br>Hydroxyethylcellulose<br>Sodium Saccharin<br>Citric Acid | Water<br>Propylene glycol<br>Hydroxyethylcellulose<br>Benzoic acid<br>Carbomer<br>Sodium hydroxide | Different |
| Appearance | Clear liquid | Clear and translucent jelly | Different |
| Odor | Odorless | No objectionable odor | Different |
| Viscosity | 4000-5600 mPa*S | 40,000-100,000 cPs | Different |
| pH | 4.0-4.5 | 3.5-4.5 | Similar |
| Osmolality | 500-700 mOsm/kg [diluted 1:9.6) | 780-1180 mOsm/kg | Different |
| Microbial Limits | TAMC: <100 cfu/g<br>TYMC: <10 cfu/g<br>Pathogenic Organisms: Absent | TAMC: <100 cfu/g<br>TYMC: <10 cfu/g<br>Pathogenic Organisms: Absent | Same |
| Antimicrobial<br>Effectiveness<br>Testing (USP<51><br>Category 2) | Yes | Yes | Same |
| Sterile | No | No | Same |
| Biocompatibility<br>Tested | Yes | Yes | Same |
| | pjur® med SENSITIVE<br>qlide/pjur® WOMAN Nude<br>K200730<br>Subject Device | KY Grosz Jelly<br>K201186<br>Predicate Device | Comparison |
| Condom<br>Compatibility | Compatible with natural rubber<br>latex condoms. Not compatible<br>with polyurethane and<br>polyisoprene condoms | Compatible with natural rubber<br>latex and polyisoprene condoms.<br>Not compatible with polyurethane<br>condoms | Different |
| Packaging | Polyethylene bottles | Polyethylene bottle and foils | Different |
| Shelf Life | 4 years | 1.5 years | Different |

Table 2: Comparison of Intended Use and technological characteristics of the subject and predicate devices:

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The subject and predicate device indications for use are not identical due to differences in condom compatibility; however, they have intended use (i.e., provide lubrication during intimate sexual activity).

The subject devices and the predicate device have different technological characteristics, including different formulations, specifications, shelf-life, packaging, etc. as identified in the table above. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

## NON-CLINICAL TESTING/PERFORMANCE DATA:

# 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." Testing demonstrated that the subject devices are compatible with natural rubber latex condoms and are not compatible with polyurethane and polyisoprene condoms.

## BIOCOMPATIBILITY:

Biocompatibility studies were performed in accordance with the 2016 FDA quidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" as follows:

- . Cytotoxicity: ISO 10993-5:2009
- Sensitization: ISO 10993-10:2010 ●
- Vaginal Irritation: ISO 10993-10:2010 ●
- Systemic Toxicity: ISO 10993-11:2017

The results of the testing show that the formulation of the subject devices is biocompatible.

## SHELF-LIFE:

The pjur® med SENSITIVE glide and pjur® WOMAN Nude lubricants have a shelf-life of four years in accordance with the results of a real-time stability study. Results from testing demonstrated that the device can maintain its specifications as shown in Table 1 over the duration of its shelf-life.

## CONCLUSION:

The results of the performance testing demonstrate that the pjur® med SENSITIVE glide and pjur® WOMAN Nude personal lubricants are as safe and effective as the predicate and support a substantial equivalence determination.