(265 days)
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.
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.
This document is a 510(k) Pre-market Notification for a medical device, specifically personal lubricants. It does not contain information about an AI/ML powered medical device study with acceptance criteria. Instead, it details the substantial equivalence of the "pjur® Backdoor Anal Glide or pjur® Analyse Me!" personal lubricants to a predicate device, "Wet Platinum Premium Lubricant® (K130012)".
The "acceptance criteria" discussed are related to the performance of the lubricant itself and its compatibility with condoms, rather than the performance of an AI algorithm.
Here's a breakdown of the requested information based on the provided document, noting where the information is not applicable to AI/ML studies:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Parameter) | Reported Device Performance (Results) |
|---|---|
| ISO 10993-5 Cytotoxicity (Direct contact) | Non-cytotoxic |
| ISO 10993-10 Guinea Pig Maximization Sensitization test | No sensitization response. |
| ISO 10993-10 Irritation (Direct contact) | Non-irritant |
| ISO 10993-10 Irritation (Intracutaneous injection) | Non-irritant |
| ISO 10993-10 Vaginal Irritation (repeat insult) | Non-irritant |
| Shelf-Life | 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 | <100 cfu/g TAMC, <10 cfu/g TYMC, absence of pathogenic organisms |
| Water Activity | <0.3 Aw |
| pH and Osmolality | N/A since product is anhydrous |
| Condom compatibility (ASTM D7661-10) | Compatible with natural latex, polyurethane, and polyisoprene condoms (including burst volume, burst pressure, force of break and elongation until break) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a 510(k) submission for a personal lubricant, not an AI/ML device study. The "tests" here refer to physical, chemical, and biological compatibility tests of the lubricant. Specific sample sizes for each of these tests are not provided in this summary, nor is the country of origin or retrospective/prospective nature of the test data detailed beyond stating "Biocompatibility testing was performed in accordance with ISO 10993–1".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as there is no "ground truth" in the context of an AI/ML study to be established by experts. The tests performed are laboratory-based and measure physical, chemical, and biological properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no adjudication method described as it's not an expert-based evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document does not describe an AI/ML powered medical device, therefore no MRMC study involving human readers and AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document does not describe an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI/ML study. The "ground truth" for the lubricant's performance is determined by the results of standardized physical, chemical, and biological tests (e.g., cytotoxicity, irritation, viscosity, condom compatibility as per ASTM D7661-10).
8. The sample size for the training set
This is not applicable as there is no AI/ML algorithm and therefore no training set.
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML algorithm and therefore no ground truth for a training set.
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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
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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)
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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-counterproduct is formulated to be clear, non-irritating, non-greasy, andodorless. The pjur® Backdoor Anal Glide or pjur® Analyse Me! Deviceis a silicone based lubricant contains neither a contraceptive nor aspermicide. 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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| TechnologicalCharacteristics | The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is asilicone based lubricant that contains a blend of silicone fluidingredients 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® BackdoorAnal Glide or pjur® Analyse Me! device the additive is jojoba which iscommonly used in food and cosmetic devices. The additive for WetPlatinum Premium Lubricant®, K130012 is Vitamin E. This plant basedadditive, as with the Subject device, does not negatively impact risk orbiocompatibility. The presence of jojoba oil in the Subject device andVitamin E in the Predicate device do not raise any new questions ofsafety or effectiveness nor does it represent a new technology. | |
| These products are compatible with natural rubber latex, syntheticpolyisoprene, 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 notidentical, but are substantially equivalent. Both the Subject device andthe predicate are indicated as a personal lubricant for intimate sexualactivity and have been fully tested to ensure that there are no newquestions of safety or effectiveness related to this usage nor does itrepresent 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 andtesting" including: | |
|---|---|---|
| Test Performed | Results | |
| ISO 10993-5 Cytotoxicity (Directcontact) | Non-cytotoxic | |
| ISO 10993-10 Guinea PigMaximization 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 | <100 cfu/g TAMC, <10 cfu/gTYMC, absence ofpathogenic organisms | |
| Water Activity | <0.3 Aw | |
| pH and Osmolaltity | N/A since product isanhydrous | |
| Condom compatibility testing was performed using the methodsoutlined in ASTM D7661-10 including burst volume, burst pressure,force of break and elongation until break. Testing results demonstratethat the pjur® pjur® Backdoor Anal Glide or pjur® Analyse Me! deviceis compatible with natural latex, , polyurethane, and polyisoprenecondoms. |
| Conclusion | The pjur® Backdoor Anal Glide or pjur® Analyse Me! device has thesame intended use as that of its predicate. The ingredients in the pjur®formulation are the similar to the Wet Platinum Premium Lubricant,K130012. The labeling claims and indications for use of the pjur®Backdoor Anal Glide or pjur® Analyse Me! device are the similar tothose of the predicates. |
|---|---|
| The labeling of the pjur® Backdoor Anal Glide or pjur® Analyse Me!device formulation contains the same warnings and precautions asthose in the labeling of the predicate. | |
| Any differences that exist between t The pjur® Backdoor Anal Glideor pjur® Analyse Me! device and the predicates have no significanteffect on the safety or effectiveness. |
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| T The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is |
|---|
| substantially equivalent to other personal lubricant products cleared |
| lin the US in terms of biocompatibility, technology, intended use, |
| lindications, and suitability characteristics. |
§ 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.