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 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.

AI/ML Overview

The document describes pjur® med SENSITIVE glide and pjur® WOMAN Nude personal lubricants. These devices are intended for penile, vaginal, and/or anal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. They are compatible with natural rubber latex condoms but not with polyurethane and polyisoprene condoms.

Here's the breakdown of the acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are presented as "Specification" in two tables (Table 1 and a continuation for Microbial Limits). The reported device performance is implicitly stated as meeting these specifications since the document concludes that performance testing demonstrates the devices are safe and effective and support "substantial equivalence determination."

Parameter	Method	Specification	Reported Device Performance (Implicitly Met)
Physical/Chemical Characteristics
Appearance	-	Clear fluid	Clear fluid
Odor	-	Odorless	Odorless
pH	USP<791>	4.0-4.5	4.0-4.5
Viscosity (mPa*s)	USP<912>	4000-5600	4000-5600
Osmolality (mOsmol/kg)	USP <785>	500-700 mOsm/kg (diluted 1:9.6)	500-700 mOsm/kg (diluted 1:9.6)
Microbial Limits
Total Yeast and Mold Count (TYMC)	USP<61>	<10 CFU/g	<10 CFU/g
Total Aerobic Microbial Count (TAMC)	USP<61>	<100 CFU/g	<100 CFU/g
Presence of pathogenic organisms (Pseudomonas aeruginosa)	USP<62>	Absent	Absent
Presence of pathogenic organisms (Staphylococcus aureus)	USP<62>	Absent	Absent
Presence of pathogenic organisms (Candida albicans)	USP<62>	Absent	Absent
Antimicrobial Preservation	USP<51>	Category 2 - Topical (specific log reduction and no increase criteria)	Met Category 2 criteria
Other Performance Criteria
Condom Compatibility	ASTM D7661-10	Compatible with natural rubber latex condoms; Not compatible with polyurethane and polyisoprene condoms	Compatible with natural rubber latex condoms; Not compatible with polyurethane and polyisoprene condoms
Biocompatibility	ISO 10993	Biocompatible	Biocompatible
Shelf-Life	Real-time stability study	4 years while maintaining specifications	4 years while maintaining specifications

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the specific tests. It refers to standardized testing methods (e.g., USP, ASTM, ISO standards). For example, condom compatibility was performed in accordance with ASTM D7661-10, biocompatibility studies in accordance with ISO 10993, and microbial tests according to USP standards. These standards typically define appropriate sample sizes and methodologies for prospective testing. The provenance of the data (country of origin) is not specified. The studies appear to be prospective as they are performance tests conducted to demonstrate compliance with specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the device is a personal lubricant, and its performance is evaluated against established physical, chemical, and microbiological standards, as well as material compatibility tests, rather than a diagnostic interpretation where expert ground truth is typically required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, the evaluation relies on objective measurements against specified standards, not on expert adjudication of diagnostic outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is geared towards AI/algorithmic devices and is not applicable to a personal lubricant. The "standalone" performance here relates to the product's inherent physical, chemical, and biological properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on established industry standards and regulatory guidelines for personal lubricants and medical devices. These include:

Physical/Chemical Properties: Measured values against specified ranges (e.g., pH, viscosity, osmolality defined by USP standards).
Microbial Purity: Absence of specific pathogens and adherence to microbial limits (defined by USP standards).
Antimicrobial Effectiveness: Performance against challenge organisms as per USP standards.
Biocompatibility: Results from tests showing no adverse biological reactions as per ISO 10993 standards.
Condom Compatibility: Demonstrated non-degradation of condoms tested according to ASTM D7661-10.
Shelf-Life: Stability over time as demonstrated by a real-time stability study.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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)	X

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DATE PREPARED:	16 December 2020
APPLICANT:	pjur group Luxembourg SA87 esplanade de la MoselleL-6637 Wasserbillig, LuxembourgTelephone: +352 74-8989Fax: +352 74-8990
CONTACT:	Andrea Giebel, Quality Management Representative
TRADE NAME:	• pjur® med SENSITIVE glide• 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, K201186The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION:

Parameter	Method	Specification
Appearance		Clear fluid
Odor		Odorless
pH	USP<791>	4.0-4.5
Viscosity(mPa*s)	USP<912>	4000-5600
Osmolality(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 andMold Count(TYMC)	USP<61>	<10 CFU/g
Total AerobicMicrobial Count(TAMC)	USP<61>	<100 CFU/g
Presence ofpathogenicorganisms	USP<62>	Pseudomonas aeruginosa
		Staphylococcus aureus
		Candida albicans
AntimicrobialPreservation	USP<51>	Category 2 - Topical, bacteria should show not less than 2.0 logreduction at 14 days and no increase from 14-day count at the 28-day count. Yeast and molds should show no increase from theinitial calculated count at 14 and 28 days.

INDICATIONS FOR USE:

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

	pjur® med SENSITIVEglide/pjur® WOMAN NudeK200730Subject Device	KY Grosz JellyK201186Predicate Device	Comparison
Indications for Use	pjur® med SENSITIVE glide forpenile, vaginal and/or analapplication, intended to moisturizeand lubricate, enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubberlatex condoms. This product is notcompatible with polyurethane andpolyisoprene condoms.pjur® WOMAN Nude for penile,vaginal and/or anal application,intended to moisturize andlubricate, enhance the ease andcomfort of intimate sexual activityand supplement the body's naturallubrication. This product iscompatible with natural rubberlatex condoms. This product is notcompatible with polyurethane andpolyisoprene condoms.	This product is intended for penile,vaginal and/or anal application tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprene condoms.This product is not compatible withpolyurethane condoms.	Sameintended use
Rx / OTC	OTC	OTC	Same
Base Type	Water	Water	Same
Primary Ingredients	Purified water1,2 propylene glycolEthyoxydiglycolHydroxypropyl guarhydroxypropyltrimonium chlorideHydroxyethylcelluloseSodium SaccharinCitric Acid	WaterPropylene glycolHydroxyethylcelluloseBenzoic acidCarbomerSodium 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/gTYMC: <10 cfu/gPathogenic Organisms: Absent	TAMC: <100 cfu/gTYMC: <10 cfu/gPathogenic Organisms: Absent	Same
AntimicrobialEffectivenessTesting (USP<51>Category 2)	Yes	Yes	Same
Sterile	No	No	Same
BiocompatibilityTested	Yes	Yes	Same
	pjur® med SENSITIVEqlide/pjur® WOMAN NudeK200730Subject Device	KY Grosz JellyK201186Predicate Device	Comparison
CondomCompatibility	Compatible with natural rubberlatex condoms. Not compatiblewith polyurethane andpolyisoprene condoms	Compatible with natural rubberlatex and polyisoprene condoms.Not compatible with polyurethanecondoms	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.

Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.