pjur® AQUA Baseline 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

pjur® AQUA Guarana 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

pjur® BACK DOOR anal Provitamin B5 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

pjur® AQUA ProVitamin B5 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Device Description

The piur® AQUA Baseline, pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 are water-based personal lubricants provided non-sterile. These personal lubricants are for over-the-counter use. They are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The products are provided in 30 mL and 100 mL polyethylene bottles.

The pjur® AQUA Baseline consists of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, and citric acid. The pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 have the same formulation and consist of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyltrimonium chloride, propylene glycol, hydroxyethylcellulose, panthenol, polysorbate 20, citric acid, chamomilla recrutita (matricaria) flower extract, paullinia cupana seed extract, cananga odorata flower oil, alcohol, 1,2hexanediol, decylene glycol, lactic acid, sodium benzoate, and potassium sorbate.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.

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

The acceptance criteria are presented as "Specifications" in "Table 1: Device Specifications" on page 4. The reported device performance is implicitly stated as meeting these specifications.

Parameter	Acceptance Criteria (pjur® AQUA Baseline)	Reported Device Performance (pjur® AQUA Baseline)	Acceptance Criteria (pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, pjur® AQUA ProVitamin B5)	Reported Device Performance (pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, pjur® AQUA ProVitamin B5)
Appearance	Clear fluid	Clear fluid (Implied from meeting specifications)	Clear fluid	Clear fluid (Implied from meeting specifications)
Odor	Product typical	Product typical (Implied from meeting specifications)	Product typical	Product typical (Implied from meeting specifications)
pH	4.1-4.7	Meets 4.1-4.7 (Implied)	4.1-4.7	Meets 4.1-4.7 (Implied)
Viscosity (mPa*s)	750 - 1250	Meets 750 - 1250 (Implied)	690 - 1100	Meets 690 - 1100 (Implied)
Osmolality (mOsmol/kg)	500-625 (diluted 1:3.9)	Meets 500-625 (diluted 1:3.9) (Implied)	500-625 (diluted 1:4.1)	Meets 500-625 (diluted 1:4.1) (Implied)
Total Yeast and Mold Count (TYMC)	<10 cfu/g	<10 cfu/g (Implied)	<10 cfu/g	<10 cfu/g (Implied)
Total Aerobic Microbial Count (TAMC)	<100 cfu/g	<100 cfu/g (Implied)	<100 cfu/g	<100 cfu/g (Implied)
Presence of Pathogenic Organisms	Pseudomonas aeruginosa Absent, Staphylococcus aureus Absent, Candida albicans Absent	Absent (Implied)	Pseudomonas aeruginosa Absent, Staphylococcus aureus Absent, Candida albicans Absent	Absent (Implied)
Antimicrobial Preservation (Category 2 Topical)	Bacteria: ≥ 2.0 log reduction at 14 days, no increase at 28 days. Yeast/Molds: no increase at 14 and 28 days.	Meets criteria (Implied)	Bacteria: ≥ 2.0 log reduction at 14 days, no increase at 28 days. Yeast/Molds: no increase at 14 and 28 days.	Meets criteria (Implied)

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes used for each of the non-clinical tests (condom compatibility, biocompatibility, shelf-life) or the precise data provenance for these tests. It only states that testing was "performed."

Data Provenance: Not explicitly stated (e.g., country of origin). The submitter is based in Luxembourg. The testing standards (ASTM, ISO, USP) are international/US standards.
Retrospective or Prospective: Not explicitly stated, but typically these types of performance and stability studies are conducted prospectively on manufactured batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. The testing for personal lubricants involves objective, laboratory-based measurements against established standards (e.g., USP monographs, ISO 10993, ASTM D7661) rather than expert interpretation of a test set for diagnostic accuracy (which is common for AI/ML devices in imaging, for example).

4. Adjudication method for the test set

Not applicable. As noted above, these are objective laboratory tests, not subjective assessments requiring adjudication.

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 device is a personal lubricant, not an AI/ML-enabled diagnostic or assistance device. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

Not applicable. This refers to AI/ML device performance validation, which is not relevant for a personal lubricant.

7. The type of ground truth used

The "ground truth" for the acceptance criteria and performance data is based on:

Established physical and chemical properties: pH, viscosity, osmolality, appearance, odor. These are measured according to standardized methods (USP<791>, USP<912>, USP<785>).
Microbiological standards: Total microbial counts and absence of specific pathogens, measured according to USP<61> and USP<62>.
Antimicrobial effectiveness: Standardized challenge tests per USP<51>.
Safety standards: Biocompatibility testing conforms to ISO 10993 series for cytotoxicity, sensitization, irritation, and systemic toxicity.
Functionality standards: Condom compatibility testing follows ASTM D7661-10.
Stability standards: Real-time and accelerated aging studies for shelf-life determination.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a personal lubricant's physical, chemical, and biological testing. These are direct measurements of manufactured product characteristics.

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

Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 21, 2021

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

Re: K200731

Trade/Device Name: piur® AOUA Baseline, piur® AOUA Guarana, piur® BACK DOOR anal Provitamin B5, pjur® AQUA ProVitamin B5 Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 21, 2020 Received: December 22, 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.

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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 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 (OS) 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 medical devices and radiation-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) K200731

Device Name

pjur® AQUA Baseline, pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, pjur® AQUA ProVitamin B5

Indications for Use (Describe)

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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Image /page/3/Picture/1 description: The image shows the logo for the "pjur group" with the word "pjur" in large, bold, dark gray letters with a yellow circle above the "j". Below "pjur" is the word "group" in a smaller, bold, light gray font. Below the logo is the text "510(k) Summary" followed by "K200731".

DATE PREPARED:	19 January 2021
SUBMITTER INFORMATION:	pjur group Luxembourg SA87 esplanade de la MoselleL-6637 Wasserbillig, LuxembourgTelephone:+352 74-8989Fax:+352 74-8990Contact: Andrea Giebel, Quality Management Representative
DEVICE INFORMATION:	Trade name:• pjur® AQUA Baseline• pjur® AQUA Guarana• pjur® BACK DOOR anal Provitamin B5• pjur® AQUA ProVitamin B5Common name: Personal LubricantRegulation Number: 21 CFR 884.5300Regulation Name: CondomProduct Code: NUC (Lubricant, Personal)Class: II
PREDICATE DEVICE:	Astroglide® Organix® Liquid, K200114The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION:

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Parameter	Method	Specifications forpjur® AQUA Baseline	Specifications forpjur® AQUA Guarana, pjur®BACK DOOR analProvitamin B5, and pjur®AQUA ProVitamin B5
Appearance		Clear fluid	Clear fluid
Odor		Product typical	Product typical
pH	USP<791>	4.1-4.7	4.1-4.7
Viscosity (mPa*s)	USP<912>	750 - 1250	690 - 1100
Osmolality(mOsmol/kg)	USP <785>	500-625 (diluted 1:3.9)	500-625 (diluted 1:4.1)
Total Yeast and MoldCount (TYMC)	USP<61>	<10 cfu/g	<10 cfu/g
Total AerobicMicrobial Count(TAMC)	USP<61>	<100 cfu/g	<100 cfu/g
Presence ofPathogenicOrganisms	USP<62>	PseudomonasaeruginosaAbsentStaphylococcusaureusAbsentCandida albicansAbsent	PseudomonasaeruginosaAbsentStaphylococcusaureusAbsentCandida albicansAbsent
AntimicrobialPreservation	USP<51>	Category 2 - Topical, bacteriashould show not less than 2.0log reduction at 14 days andno increase from 14-day countat the 28-day count. Yeastand molds should show noincrease from the initialcalculated count at 14 and 28days.	Category 2 - Topical, bacteriashould show not less than 2.0log reduction at 14 days andno increase from 14-day countat the 28-day count. Yeastand molds should show noincrease from the initialcalculated count at 14 and 28days.

Table 1: Device Specifications

INDICATIONS FOR USE:

pjur® AQUA Guarana for penile, vaqinal 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

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COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES

	pjur® AQUA Baseline, pjur®AQUA Guarana, pjur® BACKDOOR anal Provitamin B5, andpjur® AQUA ProVitamin B5K200731Subject Devices	Astroglide® Organix® LiquidK200114Predicate Device	Comparison
Indications for Use	pjur® AQUA Baseline 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 is notcompatible with natural rubberlatex, polyisoprene, andpolyurethane condoms.pjur AQUA Guarana 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 is notcompatible with natural rubberlatex, polyisoprene, andpolyurethane condoms.pjur BACK DOOR anal ProvitaminB5 for penile, vaginal and/or analapplication, intended to moisturizeand lubricate, enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product isnot compatible with natural rubberlatex, polyisoprene, andpolyurethane condoms.pjur® AQUA ProVitamin B5 forpenile, vaginal and/or analapplication, intended to moisturizeand lubricate, enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product isnot compatible with natural rubberlatex, polyisoprene, andpolyurethane condoms.	Astroglide® Organix® Liquid is apersonal lubricant for penile and/orvaginal application, intended 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.The product is not compatible withpolyurethane condoms.	Sameintended use
Rx / OTCBase Type	OTCWater	OTCWater	SameSame
Primary Ingredients	pjur® AQUA Baseline:Water, Glycerin, Ethoxydiglycol,Phenoxyethanol, HydroxypropylGuar Hydroxypropyltrimonium	Water, Glycerin, Xanthan Gum,Aloe Barbabensis Powder,Chamomilla Recutita (Matricaria)Flower Extract, CalendulaOfficinalis Flower Extract,	Different
	pjur® AQUA Baseline, pjur®AQUA Guarana, pjur® BACK	Astroglide® Organix® LiquidK200114	Comparison
	DOOR anal Provitamin B5, andpjur® AQUA ProVitamin B5	Predicate Device
	K200731Subject Devices
	Chloride, Hydroxyethylcellulose,and Citric acidpjur® AQUA Guarana, pjur® BACKDOOR anal Provitamin B5, and	Vaccinium Macrocarpon(Cranberry) Fruit Extract, PassifloraIncarnata Flower Extract, SodiumBenzoate, Potassium Sorbate,Citric Acid
	pjur® AQUA ProVitamin B5:Water, Glycerin, Ethoxydiglycol,Phenoxyethanol, HydroxypropylGuar HydroxypropyltrimoniumChloride, Propylene Glycol,Hydroxyethylcellulose, Panthenol,Polysorbate 20, Citric Acid,Chamomilla Recrutita (Matricaria)Flower Extract, Paullinia CupanaSeed Extract, Cananga OdorataFlower Oil, Alcohol, 1,2-Hexanediol, Decylene Glycol,Lactic Acid, Sodium Benzoate,Potassium Sorbate
Appearance	Clear Liquid	Colorless to slightly yellow, hazyliquid	Different
Odor	Product typical (characteristic)	Odorless	Different
Viscosity	pjur® AQUA Baseline:750-1250 mPaspjur® AQUA Guarana, pjur® BACKDOOR anal Provitamin B5, andpjur® AQUA ProVitamin B5:690-1100 mPas	250-310 cps	Different
pH	4.1-4.7 (all versions)	3.5-5.5	Similar
Osmolality	pjur® AQUA Baseline:500-625 mOsm/kg (diluted 1:3.9)pjur® AQUA Guarana, pjur® BACKDOOR anal Provitamin B5, andpjur® AQUA ProVitamin B5:500-625 mOsm/kg (diluted 1:4.1)	500-800 mOsm/kg (diluted1:5)	Different
Microbial Limits	Total aerobic microbial count(TAMC): <100 cfu/gTotal yeast and mold count(TYMC): <10 cfu/g	TAMC: <100 cfu/gTYMC: <10 cfu/g	Same
Absence of	Absent	Absent	Same
PathogenicOrganisms perUSP <62>
	pjur® AQUA Baseline, pjur®AQUA Guarana, pjur® BACKDOOR anal Provitamin B5, andpjur® AQUA ProVitamin B5K200731Subject Devices	Astroglide® Organix® LiquidK200114Predicate Device	Comparison
AntimicrobialEffectivenessTesting (USP<51>Category 2)	Yes	Yes	Same
Sterile	No	No	Same
BiocompatibilityTested	Yes	Yes	Same
CondomCompatibility	Not compatible with natural rubberlatex, polyisoprene andpolyurethane condoms	Compatible with natural rubberlatex and polyisoprene condoms.Not compatible with polyurethanecondoms	Different
Packaging	Polyethylene bottles	Polyethylene terephthalate bottlesand foils	Different
Shelf Life	18 months	17 months (bottles)9 months (foils)	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 application area and condom compatibility. The subject device is intended to be used for penile, vaginal and/or anal applications while the predicate device is for penile and/or vaginal application. The subject device is not compatible with natural rubber latex (NRL), polyisoprene, and polyurethane condoms while the predicate device is compatible with NRL and polyisoprene condoms. These differences do not represent a new intended use as both the subject and predicate devices are intended to provide lubrication during intimate sexual activity.

The subject and predicate devices have different technological characteristics, including different formulations, packaging, specifications, shelf-life, and condom compatibility. 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

BIOCOMPATIBILITY:

Biocompatibility studies were performed in accordance with the 2020 FDA guidance 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 formulations of the subject devices are biocompatible.

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SHELF-LIFE:

pjur® AQUA Baseline, pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 lubricants demonstrated a shelf-life of 18 months in accordance with the results of accelerated and real-time aged stability studies. 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 non-clinical testing described above demonstrate that the pjur® AQUA Baseline, pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 personal lubricants are as safe and effective as the predicate and support a determination of substantial equivalence.

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.