(89 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a personal lubricant, with no mention of AI or ML.
No.
The document states that the device is a personal lubricant intended to enhance the ease and comfort of intimate sexual activity, which focuses on comfort and function rather than treating or preventing a disease or condition.
No
This device is a personal lubricant intended to enhance comfort during sexual activity, not to diagnose any medical condition.
No
The device description clearly indicates it is a physical product (a gel-type personal lubricant) and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a device used on the body for physical lubrication, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details the physical form of the lubricant and its packaging, consistent with a topical product for personal use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not an IVD.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
JO Classic Hybrid Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
JO Classic Hybrid Personal Lubricant is an off-white, semi-viscous, translucent gel type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, anal and/or vaginal
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)
Biocompatibility studies were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Penile Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
The results of this testing demonstrated that the subject lubricant is biocompatible.
Shelf-Life: The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time and accelerated aging study. All device specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.
Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that JO Classic Hybrid Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a blue square.
August 27, 2018
United Consortium Stephanie Morris Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K181408
Trade/Device Name: JO Classic Hybrid Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 25, 2018 Received: May 30, 2018
Dear Stephanie Morris:
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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -
for 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)
Device Name
JO Classic Hybrid Personal Lubricant
Indications for Use (Describe)
JO Classic Hybrid Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in dark blue, with a gray curved shape above it, creating a sense of depth. Below the symbol, the words 'UNITED CONSORTIUM' are written in a simple, sans-serif font, with 'UNITED' stacked above 'CONSORTIUM'.
K181408 - JO Classic Hybrid Personal Lubricant
| 510(k) Owner: | United Consortium | |||
|---|---|---|---|---|
| Street Address: | 29000 N. Hancock Parkway | |||
| Valencia, CA 91355 | ||||
| Contact Person: | Stephanie Morris | |||
| Regulatory Specialist | ||||
| Contact Numbers: | Bruce Albert | |||
| Head of Technical Services | ||||
| Phone: (661) 295-1700, ext. 232 | ||||
| Phone: (661) 295-1700, ext. 231 | ||||
| FAX: (661) 295-1800 | ||||
| Preparation Date: | August 9, 2018 | |||
| Trade Name: | JO Classic Hybrid Personal Lubricant | |||
| Common Name: | Personal Lubricant | |||
| Device Classification: | Regulation Name: | |||
| Regulation Number: | ||||
| Product Code: | ||||
| Device Class: | Condom | |||
| 21 CFR § 884.5300 | ||||
| NUC (lubricant, personal) | ||||
| Class II | ||||
| Predicate Device: | Product Name: | |||
| 510(k) Number: | ||||
| Manufacturer: | TROJAN™ LUBRICANTS Continuous | |||
| Silkiness Personal Lubricant | ||||
| K120751 | ||||
| Church & Dwight Co., Inc. | ||||
K181408 - 510(k) Summary
The predicate device has not been subject to a design-related recall.
Product Code:
Device Class:
Device Description:
JO Classic Hybrid Personal Lubricant is an off-white, semi-viscous, translucent gel type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
NUC Class II
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Image /page/4/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two colors. The left side of the 'U' is a dark blue, while the right side is a light gray. Below the 'U', the words 'UNITED CONSORTIUM' are written in a smaller, sans-serif font, also in dark blue. The overall design is simple and modern.
This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
The device specifications are listed in the table below:
| Property | Specification |
|---|---|
| Appearance | Opaque thick liquid |
| Color | Off-white |
| Odor | Odorless |
| Viscosity (cps) | 15,000 cps to 34,000 cps |
| pH | 6.20 to 7.20 |
| Specific Gravity | 0.950 to 1.075 |
| Osmolality | 350 - 599 mOsm/kg (diluted 1:10 with purified water) and 600 - |
| 990 mOsm/kg (undiluted) | |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for Category 2 |
| products | |
| Total aerobic microbial count (TAMC) per USP | |
| and | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP | |
| and | Less than 10 cfu/g |
| Presence of Pathogens per USP | |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
Table 1: Device Specifications for JO Classic Hybrid Personal Lubricant
Indications for Use:
JO Classic Hybrid Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
Predicate Device Comparison:
The table below lists the comparative indications for use and technological characteristics of the subject and predicate device.
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Image /page/5/Picture/0 description: The image shows a logo for an organization called "UNITED CONSORTIUM". The logo features a stylized letter "U" in blue and gray. The blue portion of the "U" is more prominent, while the gray portion is in the background. The text "UNITED CONSORTIUM" is written in a smaller font below the "U" symbol.
Table 2: Comparator Table for Subject Device – JO Classic Hybrid Personal Lubricant and Predicate Device TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant
| Feature | JO Classic Hybrid Personal Lubricant | TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant (K120751) |
|---|---|---|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | JO Classic Hybrid Personal Lubricant | |
| is a personal lubricant for penile, | ||
| anal and/or vaginal application, | ||
| intended to lubricate and | ||
| moisturize, 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. | TROJAN™ LUBRICANTS Continuous | |
| Silkiness Personal Lubricant is a | ||
| personal lubricant, for penile | ||
| and/or vaginal application, | ||
| intended to lubricate and | ||
| moisturize, 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. Not compatible with | ||
| polyurethane or other condoms. | ||
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Propylene Glycol, Water (Aqua), | |
| Phenoxyethanol, Dimethicone, | ||
| Cellulose Gum, Cyclopentasiloxane, | ||
| Sodium Polyacrylate, Trideceth-6, | ||
| PEG/PPG-18/18 Dimethicone | Propylene Glycol, Water, | |
| Dimethicone, Dimethicone/Vinyl | ||
| Dimethicone Crosspolymer, | ||
| Hydroxyethyl Acrylate, Sodium | ||
| Acryloyl Dimethyl Taurate | ||
| Copolymer, Methylparaben, | ||
| Propylparaben | ||
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex, Polyisoprene | Natural Rubber Latex, |
| Polyisoprene | ||
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 2 years |
The subject and predicate device have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate device have different technological characteristics, including differences in formulation and a different shelf life. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
Summary of Performance Data:
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Image /page/6/Picture/1 description: The image features a stylized logo for "UNITED CONSORTIUM." The logo consists of a large, bold letter "U" in a deep blue color, with a subtle gray element behind it, creating a sense of depth. Below the "U," the words "UNITED CONSORTIUM" are printed in a smaller, sans-serif font, emphasizing the organization's name. The overall design is clean and modern, suggesting a professional and unified entity.
K181408 - JO Classic Hybrid Personal Lubricant
Biocompatibility
Biocompatibility studies were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Penile Irritation (ISO 10993-10:2010)
- . Acute Systemic Toxicity (ISO 10993-11:2006)
The results of this testing demonstrated that the subject lubricant is biocompatible.
Shelf-Life:
The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time and accelerated aging study. All device specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.
Condom Compatibility:
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that JO Classic Hybrid Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that the JO Classic Hybrid Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.