(307 days)
Not Found
No
The device description and intended use clearly define the product as a water-based personal lubricant with a specific chemical formulation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are standard biocompatibility and shelf-life tests for a topical product.
No
The product is a personal lubricant intended to moisturize, lubricate, and enhance comfort during sexual activity, which is a supportive role and not explicitly a therapeutic action to treat a medical condition or disease.
No
The device is a personal lubricant intended to moisturize, lubricate, and enhance sexual activity. Its purpose is not to identify, detect, or monitor a medical condition.
No
The device description clearly states the product is a water-based personal lubricant provided in polyethylene bottles, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This is a physical function, not a diagnostic one.
- Device Description: The device is described as a "water-based personal lubricant." This aligns with its intended use for lubrication and moisturizing.
- Lack of Diagnostic Function: There is no mention of the device being used to test for, diagnose, monitor, or screen for any medical condition or disease. IVDs are designed to perform tests on samples from the human body (like blood, urine, tissue) to provide information for diagnosis or monitoring.
- Performance Studies: The performance studies focus on condom compatibility, biocompatibility, and shelf-life, which are relevant to a personal lubricant, not a diagnostic device.
Therefore, the pjur® products described are personal lubricants and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, vaginal and/or anal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Astroglide® Organix® Liquid, K200114
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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)
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.
| 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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3
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 SA |
| 87 esplanade de la Moselle | |
| L-6637 Wasserbillig, Luxembourg | |
| Telephone: | |
| +352 74-8989 | |
| Fax: | |
| +352 74-8990 | |
| Contact: Andrea Giebel, Quality Management Representative | |
| DEVICE INFORMATION: | Trade name: |
| • pjur® AQUA Baseline | |
| • pjur® AQUA Guarana | |
| • pjur® BACK DOOR anal Provitamin B5 | |
| • pjur® AQUA ProVitamin B5 | |
| Common name: Personal Lubricant | |
| Regulation Number: 21 CFR 884.5300 | |
| Regulation Name: Condom | |
| Product Code: NUC (Lubricant, Personal) | |
| Class: II | |
| PREDICATE DEVICE: | Astroglide® Organix® Liquid, K200114 |
| The predicate device has not been subject to a design- | |
| related recall. |
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.
4
| Parameter | Method | Specifications for
pjur® AQUA Baseline | Specifications for
pjur® AQUA Guarana, pjur®
BACK DOOR anal
Provitamin B5, and pjur®
AQUA ProVitamin B5 |
|--------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | | Clear fluid | Clear fluid |
| Odor | | Product typical | Product typical |
| pH | USP | 4.1-4.7 | 4.1-4.7 |
| Viscosity (mPa*s) | USP | 750 - 1250 | 690 - 1100 |
| Osmolality
(mOsmol/kg) | USP | 500-625 (diluted 1:3.9) | 500-625 (diluted 1:4.1) |
| Total Yeast and Mold
Count (TYMC) | USP | | | Pseudomonas
aeruginosa
Absent
Staphylococcus
aureus
Absent
Candida albicans
Absent | Pseudomonas
aeruginosa
Absent
Staphylococcus
aureus
Absent
Candida albicans
Absent |
| Antimicrobial
Preservation | USP | Category 2 - Topical, bacteria
should show not less than 2.0
log reduction at 14 days and
no increase from 14-day count
at the 28-day count. Yeast
and molds should show no
increase from the initial
calculated count at 14 and 28
days. | Category 2 - Topical, bacteria
should show not less than 2.0
log reduction at 14 days and
no increase from 14-day count
at the 28-day count. Yeast
and molds should show no
increase from the initial
calculated count at 14 and 28
days. |
Table 1: Device Specifications
INDICATIONS FOR USE:
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, 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.
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.
5
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES
| | pjur® AQUA Baseline, pjur®
AQUA Guarana, pjur® BACK
DOOR anal Provitamin B5, and
pjur® AQUA ProVitamin B5
K200731
Subject Devices | Astroglide® Organix® Liquid
K200114
Predicate Device | Comparison |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indications for Use | 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. | Astroglide® Organix® Liquid is a
personal lubricant for penile and/or
vaginal application, intended to
moisturize and lubricate, to
enhance the ease and comfort of
intimate sexual activity and
supplement the body's natural
lubrication. This product is
compatible with natural rubber
latex and polyisoprene condoms.
The product is not compatible with
polyurethane condoms. | Same
intended use |
| Rx / OTC
Base Type | OTC
Water | OTC
Water | Same
Same |
| Primary Ingredients | pjur® AQUA Baseline:
Water, Glycerin, Ethoxydiglycol,
Phenoxyethanol, Hydroxypropyl
Guar Hydroxypropyltrimonium | Water, Glycerin, Xanthan Gum,
Aloe Barbabensis Powder,
Chamomilla Recutita (Matricaria)
Flower Extract, Calendula
Officinalis Flower Extract, | Different |
| | pjur® AQUA Baseline, pjur®
AQUA Guarana, pjur® BACK | Astroglide® Organix® Liquid
K200114 | Comparison |
| | DOOR anal Provitamin B5, and
pjur® AQUA ProVitamin B5 | Predicate Device | |
| | K200731
Subject Devices | | |
| | Chloride, Hydroxyethylcellulose,
and Citric acid
pjur® AQUA Guarana, pjur® BACK
DOOR anal Provitamin B5, and | Vaccinium Macrocarpon
(Cranberry) Fruit Extract, Passiflora
Incarnata Flower Extract, Sodium
Benzoate, Potassium Sorbate,
Citric Acid | |
| | pjur® AQUA ProVitamin B5:
Water, Glycerin, Ethoxydiglycol,
Phenoxyethanol, Hydroxypropyl
Guar Hydroxypropyltrimonium
Chloride, Propylene Glycol,
Hydroxyethylcellulose, Panthenol,
Polysorbate 20, Citric Acid,
Chamomilla Recrutita (Matricaria)
Flower Extract, Paullinia Cupana
Seed Extract, Cananga Odorata
Flower Oil, Alcohol, 1,2-
Hexanediol, Decylene Glycol,
Lactic Acid, Sodium Benzoate,
Potassium Sorbate | | |
| Appearance | Clear Liquid | Colorless to slightly yellow, hazy
liquid | Different |
| Odor | Product typical (characteristic) | Odorless | Different |
| Viscosity | pjur® AQUA Baseline:
750-1250 mPas
pjur® AQUA Guarana, pjur® BACK
DOOR anal Provitamin B5, and
pjur® 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® BACK
DOOR anal Provitamin B5, and
pjur® 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): | | | |
| | pjur® AQUA Baseline, pjur®
AQUA Guarana, pjur® BACK
DOOR anal Provitamin B5, and
pjur® AQUA ProVitamin B5
K200731
Subject Devices | Astroglide® Organix® Liquid
K200114
Predicate Device | Comparison |
| Antimicrobial
Effectiveness
Testing (USP
Category 2) | Yes | Yes | Same |
| Sterile | No | No | Same |
| Biocompatibility
Tested | Yes | Yes | Same |
| Condom
Compatibility | Not compatible with natural rubber
latex, polyisoprene and
polyurethane condoms | Compatible with natural rubber
latex and polyisoprene condoms.
Not compatible with polyurethane
condoms | Different |
| Packaging | Polyethylene bottles | Polyethylene terephthalate bottles
and 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:
6
7
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.
8
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.