(270 days)
pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide are personal lubricants, for penile and/or vaginal 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 rubber latex, polyurethane, and polyisoprene condoms.
The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide 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® silicone based lubricants contains neither a contraceptive nor a spermicide.
The provided document is a 510(k) Premarket Notification for silicone-based personal lubricants (pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide). It describes the device, its intended use, and performance data from various tests. However, it does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested, which is typically associated with AI/ML device evaluations in a clinical context.
The document instead focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. The "performance data" section details the results of biocompatibility and condom compatibility testing, which are the types of tests conducted to support safety and effectiveness for this kind of medical device.
Therefore, many of the requested fields are not applicable or cannot be extracted from this specific document, as it pertains to a chemical-based product, not an AI/ML device requiring clinical study data, ground truth establishment, or human reader performance metrics.
Here's an attempt to answer based on the spirit of the request, interpreting "acceptance criteria" as the successful demonstration of safety standards for a personal lubricant, and explaining why other fields are not applicable:
Description of Acceptance Criteria and Device Performance for pjur® Group Silicone-Based Lubricants
This document describes the regulatory submission for personal lubricants, not an AI/ML device. Therefore, the "acceptance criteria" are related to established safety and performance standards for personal lubricants, primarily encompassing biocompatibility and condom compatibility, rather than typical AI/ML performance metrics like accuracy, sensitivity, or specificity against a clinical ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Regulatory Standards) | Specific Acceptance Criteria (Implied/Explicit from test results) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must not be cytotoxic. Device must not be sensitizing. Device must not be irritating (intracutaneous, vaginal). Device must not show systemic toxicity. Device must not produce signs of allergenic potency. | Cytotoxicity: Not cytotoxic. Intracutaneous Irritation: Non-irritating. Sensitization: Non-sensitizing (sensitization rate: 0% in Guinea Pig Maximization Study). Vaginal Irritation: Non-irritating. Systemic Toxicity: No signs of systemic toxicity. Allergenic Potency: No signs of allergenic potency. "All test results were satisfactory and support that the subject device poses no undue biocompatibility risk." |
| Condom Compatibility | Device must be compatible with natural rubber latex condoms. Device must be compatible with polyurethane condoms. Device must be compatible with polyisoprene condoms. | Testing using ASTM D7661 demonstrated that the pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide lubricants are compatible with natural latex, polyurethane, and polyisoprene condoms. |
Details on the "Study" (Performance Testing)
The "study" in this context refers to the performance testing conducted to demonstrate the safety and effectiveness of the personal lubricants according to established medical device standards, primarily ISO 10993-1 and ASTM D7661.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of samples (e.g., animals for biocompatibility, lubricant batches for condom testing) used in each test. It refers to general testing procedures (ISO 10993-1, ISO 10993-10 for sensitization, ASTM D7661 for condom compatibility).
- Data Provenance: The document implies the data was generated specifically for this regulatory submission by the submitter (pjur group Luxembourg SA). The location of the testing laboratories is not specified, nor is the country of origin of the test materials (e.g., condoms, test chemicals). It is prospective testing for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the device is not an AI/ML algorithm or requires interpretation by human experts to establish "ground truth" in a diagnostic sense. The "ground truth" for these tests comes from established laboratory methodologies and measurements (e.g., absence of cell lysis for cytotoxicity, skin reaction scores for irritation, condom burst pressure for compatibility).
4. Adjudication method for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in evaluating diagnostic AI outputs. The evaluation of lubricant performance is based on objective laboratory measurements against defined thresholds.
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 question is not applicable. This document describes a personal lubricant, not an AI/ML system, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a personal lubricant, not a standalone algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on objective laboratory measurements and tests against established biological and material science standards. For example:
- Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) biological responses measured according to ISO 10993 series.
- Condom Compatibility: Physical properties of condoms (e.g., burst pressure, volume) measured after lubricant exposure according to ASTM D7661.
8. The sample size for the training set
- This question is not applicable. "Training set" refers to data used to train an AI/ML model. This document describes a physical product (lubricant) which does not have a training set in this context. The formulation development and optimization of the lubricant would have involved various experimental iterations, but these are not referred to as a "training set."
9. How the ground truth for the training set was established
- This question is not applicable for the same reasons as point 8.
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JUL 1 8 2014
K133233 Pg. 1 of 2
Traditional 510(k) Premarket Notification
pjur® group silicone based lubricants – pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide
Image /page/0/Picture/4 description: The image shows the logo for "pjur group" with a registered trademark symbol in the upper right corner. Below the logo, the text "510(k) Summary" is visible. The text is in a simple, sans-serif font and appears to be part of a document or presentation.
(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 | June 10, 2014 |
| Trade Name | pjur® group silicone based lubricants:pjur®Original pjur®Woman pjur®MAN Extreme Glide |
|---|---|
| Common Name | Personal Lubricant |
| Classification Name | Condom(21 CFR §884.5300, Product Code NUC) |
| Class | Class II |
| Predicate Devices | Erozone Glide, K040428 |
|---|---|
| KY® Intrigue Premium Personal Lubricant, K062796 | |
| Wet Platinum Premium Lubricant®, K130012 |
| Description | The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide |
|---|---|
| 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® silicone based lubricants | |
| contains neither a contraceptive nor a spermicide. |
| IntendedUse/Indications forUse | pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide arepersonal lubricants, for penile and/or vaginal application, intended tomoisturize and lubricate, enhance the ease and comfort of intimatesexual activity and supplement the body's natural lubrication. Theseproducts are compatible with natural rubber latex, polyurethane, andpolyisoprene condoms. |
|---|---|
| ---------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| TechnologicalCharacteristics | The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glidelubricants contain a blend of silicone fluid ingredients similar toingredients found in the predicate devices. |
|---|---|
| ---------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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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:Cytotoxicity Intracutaneous Irritation Sensitization Vaginal Irritation and Systemic Toxicity The results of the testing show that the pjur® Original, pjur® Woman,and pjur® MAN Extreme Glide lubricants are not cytotoxic, non-sensitizing, non-irritating, and did not show any sign of systemictoxicity or vaginal irritation.Testing per ISO 10993-10: 2010 using the Guinea Pig MaximizationStudy demonstrated that the subject device produced no signs ofallergenic potency. The sensitization rate was 0%. All test resultswere satisfactory and suport that the subject device poses no unduebiocompatibility risk.Condom compatibility testing was performed using the methodsoutlined in ASTM D7661. Testing results demonstrate that the pjur®Original, pjur® Woman, and pjur® MAN Extreme Glide lubricants arecompatible with natural latex, polyurethane, and polyisoprenecondoms. |
|---|---|
| Conclusion | The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glidelubricants have the same intended use as that of Erozone Glide, WetPlatinum Premium Lubricant® and KY® Intrigue. The ingredients inthe pjur formulation are the same as in the Erozone Glide. Thelabeling claims of the pjur silicone based personal lubricants aresimilar to those of the predicates.The labeling of the pjur formulation contains the same warnings andprecautions as those in the labeling of the predicates.Any differences that exist between the pjur silicone based personallubricant formulation and the predicates have no significant effect onthe safety or effectiveness.The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glidelubricants are substantially equivalent to other personal lubricantproducts cleared in the US in terms of biocompatibility, technology,intended use and suitability characteristics. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
Piur Group Luxembourg SA Candace Cederman Consultant 722 Arjean Drive Wilmington, NC 28411
Re: K133233
Trade/Device Name: Pjur Original, Pjur Woman, Pjur Man Extreme 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 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. The general controls provisions of the Act include requirements for annual registration. Ilisting 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 (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
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Page 2 - Candace Cederman
forth in the quality systems (OS) 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/Resourcesfor You/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/McdicalDevices/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 (30))796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/8 description: The image shows the name "Benjamin RAsher -S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The letters "RA" in the middle of the name are stylized with a decorative design.
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
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Indications for Use
510(k) Number (if known): K133233
Device Name:
pjur group silicone based lubricants
- pjur® Original l
- pjur® Woman
- pjur® MAN Extreme Glide -
Indications for Use:
pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide are personal lubricants, for penile and/or vaginal 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 rubber latex, polyurethane, and polyisoprene condoms.
Prescription Use (Parl 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Benjamin R. Fisher -S 2014.07.18 12:21:46 -04'00'
Page 1 of 1
§ 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.