(268 days)
Not Found
No
The device description and performance studies focus on the biocompatibility and condom compatibility of a personal lubricant, with no mention of AI or ML technology.
No.
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, which is not a therapeutic function.
No
The intended use describes the device as a personal lubricant to moisturize, lubricate, and enhance comfort during intimate activity, not to diagnose a condition.
No
The device description clearly states it is a family of silicone-based personal lubricants, which are physical products, not software. The performance studies also focus on biocompatibility and condom compatibility, which are relevant to a physical lubricant.
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 a personal lubricant for the genital area to enhance sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description details the physical properties and composition of the lubricant. There is no mention of it being used to test or analyze biological samples.
- Lack of Diagnostic Elements: There are no mentions of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility and condom compatibility, which are relevant to a personal lubricant, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur® Med Premium Glide are personal lubricants, for genital area application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural latex, polyurethane, and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
The pjur® family of silicone based lubricants are non-sterile, silicone-based personal lubricants. These over-the-counter products are formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® family of silicone based lubricants contains neither a contraceptive nor a spermicide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
genital area
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)
Biocompatibility testing was performed in accordance with ISO 10993- 1, "Biological evaluation of medical devices – Part 1: Evaluation and testing" including: Cytotoxicity Acute irritation Vaginal Irritation and Systemic Toxicity Sensitization via analogue conclusion of testing af pjur002 The results of the testing show that the pjur® family of silicone based lubricants are not cytotoxic, non-sensitizing, non-irritating, and did not show any sign of systemic toxicity or vaginal irritation.
Testing per ISO 10993-10: 2010 using the Guinea Pig Maximization Study demonstrated that the subject devices produced no signs of allergenic potency. The sensitization rate was 0%. All test results were satisfactory and suport that the subject devices poses no undue biocompatibility risk.
Condom compatibility testing was performed using the methods outlined in ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Testing results demonstrate that the pjur® family of silicone based lubricants are compatible with natural latex natural latex, polyurethane, and polyisoprene condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitization rate was 0%.
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
JUL 2 4 2014
K133336 pg 1 of 2
Traditional 510(k) Premarket Notification
pjur group of silicone based lubricants : pjur� Silicone Gel, pjur� Basic Personal Glide, pjur� Light, pjur® Med Premium Glide
Image /page/0/Picture/4 description: The image shows the logo for "pjur group". The logo is black and white. The word "pjur" is in a larger font than the word "group", and there is a circle above the "j" in "pjur". There is a registered trademark symbol to the right of the circle.
510(k) Sum
(as required by 21 CFR 807.92)
| Submitter | pjur group Luxembourg SA |
|---|---|
| 87 esplanade de la Moselle | |
| L-6637 Wasserbillig, Luxembourg | |
| Telephone: +352 74-8989 | |
| Fax: +352 74-8990 | |
| Contact Person | Patrick Giebel |
| Quality Manager | |
| pgiebel@pjurgroup.com | |
| Date Prepared | October 17th, 2013 |
| Trade Name | pjur® family of silicone based lubricants
- pjur® Silicone Gel (pjur006)
- pjur® Basic Personal Glide (pjur008)
- pjur® Light (pjur009)
- pjur® Med Premium Glide (pjur021) | Predicate Devices | Erozone Glide, K040428
KY® Intrigue Premium Personal Lubricant, K062796
Wet Platinum Premium Lubricant®, K130012 | Technological
Characteristics | The pjur® family of silicone based lubricants contain a blend of
silicone fluid ingredients similar to ingredients found in the predicate
devices. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Personal Lubricant | Description | The pjur® family of silicone based lubricants are non-sterile, silicone-
based personal lubricants. These over-the-counter products are
formulated to be clear, non-irritating, non-greasy, and odorless. The
pjur® family of silicone based lubricants contains neither a
contraceptive nor a spermicide. | Performance Data | Biocompatibility testing was performed in accordance with ISO 10993-
1, "Biological evaluation of medical devices – Part 1: Evaluation and
testing" including:
Cytotoxicity Acute irritation Vaginal Irritation and Systemic Toxicity Sensitization via analogue conclusion of testing af pjur002 The results of the testing show that the pjur® family of silicone based
lubricants are not cytotoxic, non-sensitizing, non-irritating, and did not
show any sign of systemic toxicity or vaginal irritation.
Testing per ISO 10993-10: 2010 using the Guinea Pig Maximization
Study demonstrated that the subject devices produced no signs of
allergenic potency. The sensitization rate was 0%. All test results
were satisfactory and suport that the subject devices poses no undue
biocompatibility risk.
Condom compatibility testing was performed using the methods
outlined in ASTM D7661-10 "Standard Test Method for Determining
Compatibility of Personal Lubricants with Natural Rubber Latex
Condoms." Testing results demonstrate that the pjur® family of
silicone based lubricants are compatible with natural latex natural
latex, polyurethane, and polyisoprene condoms. |
| Classification Name | Condom
(21 CFR §884.5300, Product Code NUC) | Intended Use | pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur®
Med Premium Glide are personal lubricants, for genital area
application, intended to moisturize and lubricate, enhance the ease
and comfort of intimate sexual activity and supplement the body's
natural lubrication. These products are compatible with natural latex, | Conclusion | The pjur silicone based lubricant has the same intended use as that
of Erozone Glide, Wet Platinum Premium Lubricant® and KY®
Intrigue. The ingredients in the pjur formulation are the same as in
the Erozone Glide. The labeling claims of the pjur silicone based
personal lubricant are the similar as those of the predicates.
The labeling of the pjur formulation contains the same warnings and
precautions as those in the labeling of the predicates.
Any differences that exist between the pjur silicone based personal
lubricant formulation and the predicates have no significant effect on
the safety or effectiveness.
The pjur silicone based personal lubricant is substantially equivalent
to other personal lubricant products cleared in the US in terms of
biocompatibility, technology, intended use and suitability
characteristics. |
| Class | Class II | | | | |
polyurethane, and polyisoprene condoms.
1
K133336
.
page 2 of 2
Traditional 510(k) Premarket Notification
pjur group of silicone based lubricants : pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur® Med Premium Glide
2
Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line. The words are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
July 24, 2014
pjur® goup Luxembourg S.A. % Candance F. Cederman Consultant Candace F. Cederman 722 Arjean Drive Wilmington, NC 28411
K133336 Re:
Trade Name: pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur® Med Premium Glide Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 13, 2014 Received: June 16, 2014
Dear Candance F. 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. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing
3
Page 2 - Candance F. Cederman
(21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin Masher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K133336
Device Name: pjur group family of silicone based lubricants
- piur® Silicone Gel -
- pjur® Basic Personal Glide ー
- pjur® Light -
- pjur® Med Premium Glide, -
Indications for Use:
pjur® Silicone Gel, pjur® Basic Personal Glide, pjur� Light, pjur� Med Premium Glide are personal lubricants, for genital area application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural latex, polyurethane, and polyisoprene condoms.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beniamin 2014.07.24 04'00'
Page 1 of 1