(87 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 primary purpose of the device is to lubricate and moisturize, enhancing comfort during sexual activity, which is not considered a therapeutic effect.
No
The device is a personal lubricant intended to lubricate and moisturize, not to diagnose a condition.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its physical form, packaging, and compatibility with condoms, all of which are hardware-related aspects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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 topical application for physical comfort and function, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a "viscous gel-type personal lubricant" for direct application to the body. This aligns with a personal lubricant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information. The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant for a personal lubricant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
JO Premium Jelly Original 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, polyurethane and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
JO Premium Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. 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 provided in clear, polyethylene (PE) tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process. The device specifications are listed in the table below :
| Property | Specification |
|---|---|
| Appearance | Viscous gel |
| Color | Clear, water white |
| Odor | Odorless |
| Viscosity (cps) | 1375 cps to 1700 cps |
| Specific Gravity | 0.870 to 1.025 |
| 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 | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
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
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:
Studies 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.
- 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)
Results: The subject lubricant is biocompatible.
Shelf-Life:
Study type: Real-time and accelerated aging study.
Sample size: Not specified.
Results: The subject device is a non-sterile personal lubricant with a two-year shelf-life. All device specifications listed in Table 1 were tested at 0, 1 and 2 years. The subject device met the device specifications at all time points.
Condom Compatibility:
Study type: Compatibility with natural rubber latex, polyisoprene and polyurethane condoms evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
Results: JO Premium Jelly Original Personal Lubricant is compatible with natural rubber latex, polyurethane and polyisoprene 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2019
United Consortium Stephanie Morris Global Regulatory Specialist 29000 N. Hancock Pkwy. Valencia. CA 91355
Re: K191214
Trade/Device Name: JO Premium Jelly Original Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: May 3, 2019 Received: May 6, 2019
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
JO Premium Jelly Original Personal Lubricant
Indications for Use (Describe)
JO Premium Jelly Original 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, polyurethane and polyisoprene 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)
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3
510 (k) Summary - K191214
1. Submitter Information
| Applicant: | United Consortium |
|---|---|
| Contact: | Stephanie Morris |
| Global Regulatory Specialist | |
| Bruce Albert | |
| Head of Technical Services | |
| Address: | 29000 N. Hancock Parkway |
| Valencia, CA 91355 | |
| Phone: | (661) 295-1700, ext. 232 |
| Phone: | (661) 295-1700, ext. 231 |
| FAX: | (661) 295-1800 |
2. Correspondent Information
| Contact: | Stephanie Morris |
|---|---|
| Address: | 29000 N. Hancock Parkway |
| Valencia, CA 91355 | |
| Phone: | (661) 295-1700, ext. 232 |
| Fax: | (661) 295-1800 |
| Email: | smorris@systemjo.com |
3. Date prepared: July 30, 2019
4. Device Information
| Device Name: | JO Premium Jelly Original Personal Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
5. Predicate Device Information
| Device Name: | Astroglide Diamond Silicone Gel Personal Lubricant |
|---|---|
| 510(k) Number: | K163395 |
| Manufacturer: | BioFilm, Inc. |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
The predicate device has not been subject to a design-related recall.
6. Device Description
JO Premium Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. 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 provided in clear, polyethylene (PE)
4
tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process. The device specifications are listed in the table below :
| Table 1: Device Specifications for JO Premium Jelly Original Personal Lubricant | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | --------------------------------------------------------------------------------- |
| Property | Specification |
|---|---|
| Appearance | Viscous gel |
| Color | Clear, water white |
| Odor | Odorless |
| Viscosity (cps) | 1375 cps to 1700 cps |
| Specific Gravity | 0.870 to 1.025 |
| 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 | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
7. Indications for Use
JO Premium Jelly Original 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, polyurethane and polyisoprene condoms.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below lists the comparative indications for use and technological characteristics of the subject and predicate device.
Table 2: Comparator Table for Subject Device - JO Premium Jelly Original Personal Lubricant and Predicate Device Astroglide Diamond Silicone Gel Personal Lubricant
| Feature | JO Premium Jelly
Original Personal
Lubricant | Astroglide Diamond
Silicone Gel Personal
Lubricant (K163395) |
|-------------------------------|----------------------------------------------------|--------------------------------------------------------------------|
| Device Classification
Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
5
| Feature | JO Premium Jelly
Original Personal
Lubricant | Astroglide Diamond
Silicone Gel Personal
Lubricant (K163395) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | JO Premium Jelly Original
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,
polyurethane and polyisoprene
condoms. | Astroglide® Diamond Silicone
Gel Personal Lubricant is a
personal lubricant for penile
and/or vaginal application,
intended to moisturize and
lubricate, 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,
polyurethane and
polyisoprene condoms. |
| Water soluble | No | No |
| Contains water | No | No |
| Primary ingredients | Dimethicone,
Cyclopentasiloxane,
Cyclotetrasiloxane, Dimethicone
/ Vinyl Dimethicone
Crosspolymer, Dimethiconol | Dimethicone, Cyclomethicone
Dimethicone / Vinyl
Dimethicone Crosspolymer,
Cocos Nucifera (Coconut) Oil |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex,
Polyurethane, Polyisoprene | Natural Rubber Latex,
Polyurethane, Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 2 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 similar technological characteristics, including similar formulation. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing 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)
6
- 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 two-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 and 2 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 Premium Jelly Original Personal Lubricant is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
10. Conclusion
The results of the performance testing described above demonstrate that the JO Premium Jelly Original Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.