(354 days)
Not Found
No
The device description and intended use clearly define the product as a personal lubricant with no mention of any computational or analytical capabilities, let alone AI/ML. The performance studies focus on physical properties and biocompatibility.
No.
The intended use of the devices listed is to "moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication," which is not considered a therapeutic effect.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device described is a personal lubricant, which is a physical substance (a liquid or gel) intended for topical application. It is not software.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these products are "personal lubricants 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 describes a product for direct application to the body for physical lubrication, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details the physical form (water-based lubricants in bottles) and composition of the products. It does not mention any components or mechanisms for performing diagnostic tests on biological samples.
- Performance Studies: The performance studies focus on condom compatibility, biocompatibility (cytotoxicity, sensitization, systemic toxicity, vaginal irritation), and shelf-life. These are relevant to a topical medical device for lubrication, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided text describes devices for direct application to the body for physical lubrication, which falls under a different category of medical devices.
N/A
Intended Use / Indications for Use
pjur® WOMAN Aloe is a personal lubricant 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® med Moisturising glide is a personal lubricant for penile, vaginal 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® BACK DOOR water-based is a personal lubricant 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® analyse me! water-based is a personal lubricant 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® med NATURAL glide is a personal lubricant 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
We-Vibe® Lube made by pjur® is a personal lubricant 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 and polvisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
The pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR water-based, pjur® med Moisturising glide, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are water-based personal lubricants provided non-sterile. These over-the-counter products have similar formulations and contain neither a contraceptive nor a spermicide. The pjur® analyse me! waterbased, pjur® BACK DOOR water-based, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
The pjur® WOMAN Aloe has a formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, citric acid, potassium sorbate, aloe barbadensis leaf juice powder. This lubricant is provided in 30 ml, 100 ml, and 250 ml polyethylene bottles. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have the same formulation that includes the same components as the lubricant above, without aloe barbadensis leaf juice powder. The pjur® med NATURAL glide device is provided in 10 ml and 100 ml polyethylene bottles. We-Vibe® Lube made by pjur® is provided in 30 ml polyethylene bottles, and 125 ml polyethylene/polypropylene pump bottles. The pjur® analyse me! water-based, pjur® BACK DOOR water-based, and pjur® med Moisturising glide have the same formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, potassium sorbate, citric acid, sodium hyaluronate. The pjur® analyse me! water-based is provided in 10 ml, 100ml, and 250 ml polyethylene bottles. pjur® BACK DOOR water-based is provided in 10 ml, 100 ml, and 250 ml polyethylene bottles. pjur® med Moisturising qlide is provided in 10 ml and 100 ml polyethylene bottles.
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
Not Found
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)
NON-CLINICAL TESTING/PERFORMANCE DATA:
CONDOM COMPATIBILITY:
Condom compatibility testing was performed in accordance with ASTM D7661 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Testing demonstrated that the pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR waterbased, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
BIOCOMPATIBILITY:
Biocompatibility studies were performed in accordance with the 2020 FDA quidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing" as follows:
- . Cytotoxicity: ISO 10993-5:2009
- Sensitization: ISO 10993-10:2010 ●
- Systemic Toxicity: ISO 10993-11:2017
- Vaginal Irritation: ISO 10993-10:2010 .
The results of the testing show that the formulations of the subject devices are biocompatible.
SHELF-LIFE:
pjur® WOMAN Aloe, pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® analyse me! water-based, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have a shelf-life of 4 years when packaged in polyethylene bottles and a shelf-life of 3 years when packaged in polyethylene/ polypropylene pump bottles, in accordance with the results of real-time aged stability studies. Results from testing demonstrated that the devices can maintain their specifications as shown in Table 1 over the stated shelf-life duration.
CONCLUSION:
The results of the performance testing demonstrate that the pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® analyse me! water-based, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® personal lubricants are as safe and effective as the predicate device and support a substantial equivalence determination.
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.
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 shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 19, 2021
pjur group Luxembourg SA % Candace Cederman Consultant Candace F. Cederman 722 Arjean Drive Wilmington, NC 28411
Re: K200527
Trade/Device Name: pjur® WOMAN Aloe, pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® analyse me! water-based, pjur® med NATURAL glide, We-Vibe® Lube made by pjur® Regulation Number: 21 CFR§ 884.5300
Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 20, 2021 Received: January 21, 2021
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 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing 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) K200527
Device Name
pjur® WOMAN Aloe, pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® med NATURAL glide, We-Vibe® Lube made by pjur®
Indications for Use (Describe)
pjur® WOMAN Aloe is a personal lubricant 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® med Moisturising glide is a personal lubricant for penile, vaginal 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® BACK DOOR water-based is a personal lubricant 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® analyse me! water-based is a personal lubricant 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® med NATURAL glide is a personal lubricant 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
We-Vibe® Lube made by pjur® is a personal lubricant 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 and polvisoprene condoms. This product is not compatible with polyurethane condoms.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/Picture/1 description: The image shows the logo for Pjur Group. The logo consists of the word "pjur" in a stylized font, with a yellow circle above the "j". Below "pjur" is the word "group" in a smaller, gray font. Below the logo is the text "510(k) Summary K200527".
| DATE PREPARED: | 19 February 2021 |
|---|---|
| APPLICANT: | 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 |
| TRADE NAME: | • pjur® WOMAN Aloe |
| • pjur® analyse me! water-based | |
| • pjur® BACK DOOR water-based | |
| • pjur® med Moisturising glide | |
| • pjur® med NATURAL glide | |
| • We-Vibe® Lube made by pjur® | |
| COMMON NAME: | Personal Lubricant |
| REGULATION NUMBER: | 21 CFR 884.5300 |
| REGULATION NAME | Condom |
| PRODUCT CODE | NUC (Lubricant, Personal) |
| DEVICE CLASS: | II |
| PREDICATE DEVICE: | KY Banksy Moisture, K183505 |
| The predicate device has not been subject to a design-related recall. |
DEVICE DESCRIPTION:
The pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR water-based, pjur® med Moisturising glide, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are water-based personal lubricants provided non-sterile. These over-the-counter products have similar formulations and contain neither a contraceptive nor a spermicide. The pjur® analyse me! waterbased, pjur® BACK DOOR water-based, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
The pjur® WOMAN Aloe has a formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, citric acid, potassium sorbate, aloe barbadensis leaf juice powder. This lubricant is provided in 30 ml, 100 ml, and 250 ml polyethylene bottles. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have the same formulation that includes the same components as the lubricant above, without aloe barbadensis leaf juice powder. The pjur® med NATURAL glide device is provided in 10 ml and 100 ml polyethylene bottles. We-Vibe® Lube made by pjur® is provided in 30 ml polyethylene bottles, and 125 ml polyethylene/polypropylene pump bottles. The pjur® analyse me! water-based, pjur® BACK DOOR water-based, and pjur® med Moisturising glide have the same formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, potassium sorbate, citric acid, sodium hyaluronate. The pjur® analyse me! water-based is provided in 10 ml, 100ml, and 250 ml polyethylene bottles. pjur® BACK DOOR water-based is provided in 10 ml, 100 ml, and 250 ml polyethylene bottles. pjur® med Moisturising qlide is provided in 10 ml and 100 ml polyethylene bottles.
5
| Table 1: Device Specifications | |
|---|---|
| -------------------------------- | -- |
| Parameter | Method | Specification
• pjur® WOMAN Aloe | Specification
• pjur® med Moisturising
glide
• pjur® BACK DOOR
water-based
• pjur® analyse me! water-
based | Specification
• pjur® med NATURAL
glide
• We-Vibe® Lube made by
pjur® |
|-----------------------------------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Visual | Opaque fluid | Opaque fluid | Opaque fluid |
| Odor | Olfactory | Characteristic | Odorless | Odorless |
| pH | USP | 4.0-4.5 | 4.0-4.5 | 4.0-4.5 |
| Viscosity
(mPa*s) | USP | 8500-9500 | 9000-12000 | 8000-9500 |
| Osmolality
(mOsmol/kg) | USP | 400 - 550 (1:9.5 dilution) | 400 - 550 (1:9.8 dilution) | 400 - 600 (1:9.5 dilution) |
| Total Aerobic
Microbial
Count
(TAMC) | USP | | | Pseudomonas
aeruginosa
Staphylococcus
aureus
Candida
albicans | Absent
Pseudomonas
aeruginosa
Staphylococcus
aureus
Candida
albicans | Absent
Pseudomonas
aeruginosa
Staphylococcus
aureus
Candida
albicans |
| 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. | 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. |
INDICATIONS FOR USE:
pjur® WOMAN Aloe is a personal lubricant 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® med Moisturising glide is a personal lubricant 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® BACK DOOR water-based is a personal lubricant 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.
6
pjur® analyse me! water-based is a personal lubricant 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® med NATURAL glide is a personal lubricant 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
We-Vibe® Lube made by pjur® is a personal lubricant 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES:
| | pjur® WOMAN
Aloe
K200527
Subject Device | pjur® med
Moisturising glide
pjur® BACK DOOR
water-based
pjur® analyse me!
water-based
K200527
Subject Device | pjur® med
NATURAL glide
We-Vibe® Lube
K200527
Subject Device | KY Banksy
Moisture
K183505
Predicate Device | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indications for
Use | pjur® WOMAN Aloe
is a personal
lubricant 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. | [Product name] is a
personal lubricant
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. | [Product name] is a
personal lubricant
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
and polyisoprene
condoms. This
product is not
compatible with
polyurethane
condoms. | This product is
intended 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
and polyisoprene
condoms. This
product is not
compatible with
polyurethane
condoms. | Same
intended use |
| Rx / OTC | OTC | OTC | OTC | OTC | Same |
| Base Type | Water | Water | Water | Water | Same |
| Primary
Ingredients | Water, Glycerin,
Xanthan Gum,
Benzyl Alcohol,
Sodium Benzoate,
Citric Acid,
Potassium Sorbate,
Aloe Barbadensis | Water, Glycerin,
Xanthan Gum,
Benzyl Alcohol,
Sodium Benzoate,
Potassium Sorbate,
Citric Acid, Sodium
Hyaluronate | Water, Glycerin,
Xanthan Gum,
Benzyl Alcohol,
Sodium Benzoate,
Potassium Sorbate,
Citric Acid | Xanthan Gum,
Propanediol,
Glycerin, Benzoic
Acid, Purac BF
P/41, Sodium
hyaluronate, Water | Different |
Table 2: Comparison of Intended Use and technological characteristics of the subject and predicate devices:
7
| | Leaf Juice Powder
(Aloe Vera) | | | | |
|--------------------------------|----------------------------------|----------------------|------------------------------------------------------------------------|----------------------|-----------|
| Appearance | Opaque Liquid | Opaque Liquid | Opaque Liquid | Clear | Different |
| Odor | Characteristic | Odorless | Odorless | Odorless | Similar |
| Viscosity | 8500 - 9500 mPas | 9000 - 12000 mPas | 8000 - 9500 mPas | 3000 - 8000 cps | Different |
| pH | 4.0-4.5 | 4.0-4.5 | 4.0-4.5 | 3.5-4.5 | Similar |
| Osmolality | 400-550 mOsm/kg | 400-550 mOsm/kg | 400-600 mOsm/kg | 850-1200 mOsm/kg | Different |
| | (1:9.5 dilution) | (1:9.8 dilution) | (1:9.5 dilution) | | |
| Microbial Limits | TAMC: | | | | | |
| Category 2) | | | | | |
| Sterile | No | No | No | No | Same |
| Biocompatibility | Yes | Yes | Yes | Yes | Same |
| Tested | | | | | |
| Condom | Compatible with | Compatible with | Compatible with | Compatible with | Similar |
| Compatibility | natural rubber latex | natural rubber latex | natural rubber latex | natural rubber latex | |
| | condoms. Not | condoms. Not | and polyisoprene | and polyisoprene | |
| | compatible with | compatible with | condoms. Not | condoms. Not | |
| | polyurethane and | polyurethane and | compatible with | compatible with | |
| | polyisoprene | polyisoprene | polyurethane | polyurethane | |
| | condoms | condoms | condoms | condoms | |
| Packaging | Polyethylene bottles | Polyethylene bottles | Polyethylene bottles
Polyethylene/
Polypropylene
Pump bottles | Polyethylene bottles | Similar |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Shelf Life | 4 years (bottles) | 4 years (bottles) | 4 years (bottles) | 2 years | Different |
The indications for use for the subject and predicate devices are not identical as there are differences in condom compatibility for some of the predicate devices (i.e., not compatible with 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, specifications, shefi-life, packaging, etc. as identified in 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 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Testing demonstrated that the pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR waterbased, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
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BIOCOMPATIBILITY:
Biocompatibility studies were performed in accordance with the 2020 FDA quidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing" as follows:
- . Cytotoxicity: ISO 10993-5:2009
- Sensitization: ISO 10993-10:2010 ●
- Systemic Toxicity: ISO 10993-11:2017
- Vaginal Irritation: ISO 10993-10:2010 .
The results of the testing show that the formulations of the subject devices are biocompatible.
SHELF-LIFE:
pjur® WOMAN Aloe, pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® analyse me! water-based, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have a shelf-life of 4 years when packaged in polyethylene bottles and a shelf-life of 3 years when packaged in polyethylene/ polypropylene pump bottles, in accordance with the results of real-time aged stability studies. Results from testing demonstrated that the devices can maintain their specifications as shown in Table 1 over the stated shelf-life duration.
CONCLUSION:
The results of the performance testing demonstrate that the pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® analyse me! water-based, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® personal lubricants are as safe and effective as the predicate device and support a substantial equivalence determination.