(265 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML.
No
The device is described as a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not for treating a disease or condition.
No
The intended use of the device is to moisturize and lubricate for sexual activity, not to diagnose any medical condition. Performance studies focus on biocompatibility and physical properties, not diagnostic accuracy.
No
The device description clearly states it is a "non-sterile, silicone-based personal lubricant" and lists chemical ingredients, 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 for personal lubrication during sexual activity, not for diagnosing a disease or condition.
- Device Description: The device is a personal lubricant, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device's function is purely for lubrication.
N/A
Intended Use / Indications for Use
pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application . intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms.
Product codes
NUC
Device Description
The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a non-sterile, silicone-based personal lubricant. This over-the-counter product is formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® Backdoor Anal Glide or pjur® Analyse Me! Device is a silicone based lubricant contains neither a contraceptive nor a spermicide. The product contains Cyclopentasiloxane, Dimethicone, Dimethiconol, and jojoba.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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:
Test Performed: ISO 10993-5 Cytotoxicity (Direct contact)
Results: Non-cytotoxic
Test Performed: ISO 10993-10 Guinea Pig Maximization Sensitization test
Results: No sensitization response.
Test Performed: ISO 10993-10 Irritation (Direct contact), Irritation (Intracutanteous injection), Vaginal Irritation (repeat insult)
Results: Non-irritant
Shelf-Life Testing: At least 1 year
Viscosity: 600-1000 cps
Density: 0.900-0.950 g/ml
Appearance: Viscous liquid
Turbidity: Clear, no turbidity
Color: Slightly yellow
Odor: None
Microbial Limits:
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2015
pjur group Luxembourg SA % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, NC 28408
Re: K141913
Trade/Device Name: pjur® Backdoor Anal Glide and pjur® Analyse Me! Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: July 14, 2014 Received: July 17, 2014
Dear Cheryl Wagoner,
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin Fisher, PhD Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141913
Device Name pjur® Backdoor Anal Glide or pjur® Analyse Me!
Indications for Use (Describe)
pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application . intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for the "pjur group". The logo features the word "pjur" in a bold, sans-serif font, with a yellow circle above the letter "j". Below the word "pjur" is the word "group" in a smaller, sans-serif font. The logo also includes the registered trademark symbol.
510(k) Summary
(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@pjur.com | |
| Date Prepared | 2/23/2015 |
| Trade Name | pjur® silicone based lubricant under the brand names of pjur®
Backdoor Anal Glide or pjur® Analyse Me! |
|---------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name | Personal Lubricant |
| Classification Name | Condom
(21 CFR §884.5300, Product Code NUC) |
| Class | Class II |
Wet Platinum Premium Lubricant®, K130012 Predicate Devices
| Description | The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a non-
sterile, silicone-based personal lubricant. This over-the-counter
product is formulated to be clear, non-irritating, non-greasy, and
odorless. The pjur® Backdoor Anal Glide or pjur® Analyse Me! Device
is a silicone based lubricant contains neither a contraceptive nor a
spermicide. The product contains Cyclopentasiloxane, Dimethicone,
Dimethiconol, and jojoba. |
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Indications for Use | pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms. |
|---|---|
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Technological
Characteristics | The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a
silicone based lubricant that contains a blend of silicone fluid
ingredients similar to ingredients found in other lubricants currently on |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | the U.S. markets and substantially equivalent to the predicate device.
Both the Subject and predicate devices contain Cyclopentasiloxane,
Dimethicone, Dimethiconol. Both devices also contained a plant-
derived oil additive that is present in very small amounts and has no |
| | impact upon safety or effectiveness. In the case of The pjur® Backdoor
Anal Glide or pjur® Analyse Me! device the additive is jojoba which is
commonly used in food and cosmetic devices. The additive for Wet
Platinum Premium Lubricant®, K130012 is Vitamin E. This plant based
additive, as with the Subject device, does not negatively impact risk or
biocompatibility. The presence of jojoba oil in the Subject device and
Vitamin E in the Predicate device do not raise any new questions of
safety or effectiveness nor does it represent a new technology. |
| | These products are compatible with natural rubber latex, synthetic
polyisoprene, and polyurethane condoms. |
| | The intended use of the Subject device is the same as its predicate.
Both are intended as non-sterile, over-the-counter personal lubricants.
The indications for use for the Subject and Predicate devices are not
identical, but are substantially equivalent. Both the Subject device and
the predicate are indicated as a personal lubricant for intimate sexual
activity and have been fully tested to ensure that there are no new
questions of safety or effectiveness related to this usage nor does it
represent new technology. |
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| Performance Data | Biocompatibility testing was performed in accordance with ISO 10993–
1, "Biological evaluation of medical devices – Part 1: Evaluation and
testing" including: | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| | Test Performed | Results |
| | ISO 10993-5 Cytotoxicity (Direct
contact) | Non-cytotoxic |
| | ISO 10993-10 Guinea Pig
Maximization Sensitization test | No sensitization response. |
| | ISO 10993-10 | Non-irritant |
| | • Irritation (Direct contact) | |
| | • Irritation( Intracutanteous injection) | |
| | • Vaginal Irritation (repeat insult) | |
| | Shelf-Life Testing | At least 1 year |
| | Viscosity | 600-1000 cps |
| | Density | 0.900-0.950 g/ml |
| | Appearance | Viscous liquid |
| | Turbidity | Clear, no turbidity |
| | Color | Slightly yellow |
| | Odor | None |
| | Microbial Limits |