(272 days)
No
The device description and performance studies focus on the chemical composition, biocompatibility, and condom compatibility of a personal lubricant. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The intended use is to moisturize, lubricate, and enhance comfort during intimate activity, which are functions of a personal lubricant, not a therapeutic device.
No
Explanation: The provided text clearly states the devices are "personal lubricants" intended to "moisturize and lubricate" for sexual activity. There is no mention of these devices being used to detect, monitor, or diagnose any medical condition.
No
The device description clearly states that the devices are water-based personal lubricants, which are physical substances, not software. The summary details the chemical composition and packaging, further indicating a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to moisturize and lubricate for intimate sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The device is a personal lubricant applied externally. IVDs are typically used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on condom compatibility, biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), and shelf-life. These are relevant to the safety and efficacy of a personal lubricant, not to a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
In summary, the device's purpose and characteristics align with a personal lubricant, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
Product codes
NUC
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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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.
1
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
2
Indications for Use
510(k) Number (if known) K200730
Device Name pjur® med SENSITIVE glide, pjur® WOMAN Nude
Indications for Use (Describe)
pjur@ med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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3
Image /page/3/Picture/1 description: The image shows the logo for "pjur group" in a stylized font, with a yellow circle above the "pjur" text. Below the logo, the text "510(k) Summary" is displayed, followed by "K200730". The logo and text are centered.
| DATE PREPARED: | 16 December 2020 |
|---|---|
| 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® 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, K201186 |
| The predicate device has not been subject to a design-related recall. |
DEVICE DESCRIPTION:
The pjur® med SENSITIVE glide and pjur® WOMAN Nude are water-based personal lubricants provided non-sterile. These over-the-counter products have an identical formulation and contain neither a contraceptive nor a spermicide. They are compatible with natural rubber latex condoms and are not compatible with polyurethane or polyisoprene condoms. The pjur® med SENSITIVE glide is provided in 100 mL polyethylene bottles and the pjur® WOMAN Nude is provided in either 10 mL or 100 mL polyethylene bottles.
The pjur® med SENSITIVE glide and pjur® WOMAN Nude consists of water, 1,2 propylene glycol, ethyoxydiglycol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, sodium saccharin, and citric acid.
| Parameter | Method | Specification |
|---|---|---|
| Appearance | Clear fluid | |
| Odor | Odorless | |
| pH | USP | 4.0-4.5 |
| Viscosity | ||
| (mPa*s) | USP | 4000-5600 |
| Osmolality | ||
| (mOsmol/kg) | USP | 500-700 mOsm/kg [diluted 1:9.6) |
Table 1: Device Specifications
4
| Parameter | Method | Specification |
|---|---|---|
| Total Yeast and | ||
| Mold Count | ||
| (TYMC) | USP | |
| 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. |
INDICATIONS FOR USE:
pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
5
SUMMARY OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE IN COMPARISON TO THE PREDICATE DEVICE:
| | pjur® med SENSITIVE
glide/pjur® WOMAN Nude
K200730
Subject Device | KY Grosz Jelly
K201186
Predicate Device | Comparison |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indications for Use | pjur® med SENSITIVE glide for
penile, vaginal and/or anal
application, intended to moisturize
and lubricate, enhance the ease
and comfort of intimate sexual
activity and supplement the body's
natural lubrication. This product is
compatible with natural rubber
latex condoms. This product is not
compatible with polyurethane and
polyisoprene condoms.
pjur® WOMAN Nude for penile,
vaginal and/or anal application,
intended to moisturize and
lubricate, enhance the ease and
comfort of intimate sexual activity
and supplement the body's natural
lubrication. This product is
compatible with natural rubber
latex condoms. This product is not
compatible with polyurethane and
polyisoprene condoms. | This product is intended for penile,
vaginal and/or anal application 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.
This product is not compatible with
polyurethane condoms. | Same
intended use |
| Rx / OTC | OTC | OTC | Same |
| Base Type | Water | Water | Same |
| Primary Ingredients | Purified water
1,2 propylene glycol
Ethyoxydiglycol
Hydroxypropyl guar
hydroxypropyltrimonium chloride
Hydroxyethylcellulose
Sodium Saccharin
Citric Acid | Water
Propylene glycol
Hydroxyethylcellulose
Benzoic acid
Carbomer
Sodium hydroxide | Different |
| Appearance | Clear liquid | Clear and translucent jelly | Different |
| Odor | Odorless | No objectionable odor | Different |
| Viscosity | 4000-5600 mPa*S | 40,000-100,000 cPs | Different |
| pH | 4.0-4.5 | 3.5-4.5 | Similar |
| Osmolality | 500-700 mOsm/kg [diluted 1:9.6) | 780-1180 mOsm/kg | Different |
| Microbial Limits | TAMC:
Category 2) | Yes | Yes | Same |
| Sterile | No | No | Same |
| Biocompatibility
Tested | Yes | Yes | Same |
| | pjur® med SENSITIVE
qlide/pjur® WOMAN Nude
K200730
Subject Device | KY Grosz Jelly
K201186
Predicate Device | Comparison |
| Condom
Compatibility | Compatible with natural rubber
latex condoms. Not compatible
with polyurethane and
polyisoprene condoms | Compatible with natural rubber
latex and polyisoprene condoms.
Not compatible with polyurethane
condoms | Different |
| Packaging | Polyethylene bottles | Polyethylene bottle and foils | Different |
| Shelf Life | 4 years | 1.5 years | Different |
Table 2: Comparison of Intended Use and technological characteristics of the subject and predicate devices:
6
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.