(103 days)
JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are personal lubricants 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. These products are compatible with natural rubber latex, polyurethane and polyisoprene condoms.
JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are clear, viscous, amber colored, gel type personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. These devices are non-sterile personal lubricants 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. Both versions of the subject device have the same formulation, with the exception of the addition of a fragrance to the JO Naturalove Strawberry Fields Flavored Personal Lubricant. These devices are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in 0.1 oz and 0.3 oz polyester-faced laminated pouches.
The provided text describes a 510(k) premarket notification for a medical device, specifically a personal lubricant, and does not contain information about an AI/ML device or its associated studies. Therefore, I cannot provide an answer that includes acceptance criteria for an AI/ML device, sample sizes for test sets, expert qualifications, MRMC studies, or standalone algorithm performance.
The document focuses on demonstrating the substantial equivalence of the "JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant" to a predicate device (JO Gelato Flavored Personal Lubricants) based on physicochemical properties, biocompatibility, shelf-life, and condom compatibility.
Here is an analysis of the available information, structured to address parts of your request where applicable, but noting the absence of AI/ML-specific details:
1. A table of acceptance criteria and the reported device performance
The document provides a "Device Specifications" table, which functions as the acceptance criteria for the physical and chemical properties and microbial counts of the lubricant. The reported performance refers to the device meeting these specifications.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Clear, viscous gel | Met specification (implied by "The subject devices met the device specifications at all time points.") |
| Color | Amber | Met specification |
| Odor | Characteristic | Met specification |
| Viscosity (cps) | 10,500 cps to 21,000 cps | Met specification |
| pH | 5.0 to 6.3 | Met specification |
| Specific Gravity | 0.975 to 1.20 | Met specification |
| Osmolality | 650 to 800 mOsm/kg | Met specification |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2 products | Met acceptance criteria |
| Total aerobic microbial count (TAMC) per USP <61> and <1111> | Less than 10 cfu/g | Met specification |
| Total yeast and mold count (TYMC) per USP <61> and <1111> | Less than 10 cfu/g | Met specification |
| Presence of Pathogens per USP <62> (Pseudomonas aeruginosa) | Absent | Absent |
| Presence of Pathogens per USP <62> (Staphylococcus aureus) | Absent | Absent |
| Presence of Pathogens per USP <62> (Salmonella/Shigella) | Absent | Absent |
| Presence of Pathogens per USP <62> (Escherichia coli) | Absent | Absent |
| Presence of Pathogens per USP <62> (Candida albicans) | Absent | Absent |
| Biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Penile Irritation, Acute Systemic Toxicity) | Biocompatible per ISO 10993 standards | Demonstrated biocompatible |
| Shelf-Life | 2 years (maintaining all device specifications) | 2 years (met specifications at 0, 1, and 2 years) |
| Condom Compatibility (Natural rubber latex, polyisoprene, polyurethane) | Compatible per ASTM D7661-10 | Compatible |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of batches, units tested) for the performance tests (e.g., viscosity, pH, microbial counts, biocompatibility, shelf-life, condom compatibility). The data provenance (country of origin, retrospective/prospective) is also not mentioned, as these are typically internal laboratory tests conducted by the manufacturer or contracted labs.
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 to this type of device submission. Ground truth, in the context of an AI/ML device, refers to expertly verified labels or diagnoses. For a personal lubricant, "ground truth" is established by laboratory measurements against defined chemical, physical, and biological standards. There are no "experts" in the sense of clinicians interpreting outputs for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device does not involve human interpretation or adjudication of results in the way an AI/ML diagnostic device would.
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
Not applicable. This is not an AI/ML device and therefore no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and chemical properties, the "ground truth" is derived from established laboratory measurement techniques (e.g., pH meters for pH, viscometers for viscosity, osmometers for osmolality) compared against predetermined standard specifications. For microbial testing, it's based on standard microbiological culture methods. For biocompatibility, it's based on the results of specific in-vitro and in-vivo tests according to ISO 10993 standards. For condom compatibility, it's based on the standard ASTM D7661-10 test method.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.
November 14, 2018
United Consortium Stephanie Morris Global Regulatory Specialist 29000 N. Hancock Pkwy. Valencia CA 91355
Re: K182105
Trade/Device Name: JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 11, 2018 Received: October 15, 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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies.
{1}------------------------------------------------
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 -S
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant
Indications for Use (Describe)
JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are personal lubricants 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. These products are 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two shades. The lower portion of the 'U' is a dark blue, while the upper portion is a light gray. Below the 'U', the words 'UNITED CONSORTIUM' are written in a smaller, sans-serif font.
510(k) Summary
| 510(k) Owner: | United Consortium |
|---|---|
| Street Address: | 29000 N. Hancock ParkwayValencia, CA 91355 |
| Contact Person: | Stephanie MorrisGlobal Regulatory SpecialistBruce AlbertHead of Technical Services |
| Contact Numbers: | Phone: (661) 295-1700, ext. 232Phone: (661) 295-1700, ext. 231FAX: (661) 295-1800 |
| Summary PreparationDate: | November 14, 2018 |
| Trade Name: | JO Naturalove Personal LubricantJO Naturalove Strawberry Fields Flavored Personal Lubricant |
| Device Classification: | Common Name: Personal LubricantRegulation Name: CondomRegulation Number: 21 CFR § 884.5300Product Code: NUC (lubricant, personal)Device Class: Class II |
| Predicate Device: | Product Name: JO Gelato Flavored Personal Lubricants510(k) Number: K172447Manufacturer: United ConsortiumProduct Code: NUCDevice Class: Class II |
The predicate device has not been subject to a design-related recall.
Device Description:
JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are clear, viscous, amber colored, gel type personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. These devices are non-sterile personal lubricants 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. Both versions of the subject
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows a logo for the United Consortium. The logo features a stylized letter 'U' in two colors. The lower portion of the 'U' is a dark blue, while the upper portion is a light gray. Below the 'U', the words 'UNITED CONSORTIUM' are written in a sans-serif font, with 'UNITED' stacked above 'CONSORTIUM'.
510(k) JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant Traditional Submission
device have the same formulation, with the exception of the addition of a fragrance to the JO Naturalove Strawberry Fields Flavored Personal Lubricant.
These devices are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in 0.1 oz and 0.3 oz polyester-faced laminated pouches.
The device specifications are listed in the table below:
| Property | Specification |
|---|---|
| Appearance | Clear, viscous gel |
| Color | Amber |
| Odor | Characteristic |
| Viscosity (cps) | 10,500 cps to 21,000 cps |
| pH | 5.0 to 6.3 |
| Specific Gravity | 0.975 to 1.20 |
| Osmolality | 650 to 800 mOsm/kg |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP <61>and <1111> | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP <61>and <1111> | Less than 10 cfu/g |
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
Table 1: Device Specifications for JO Naturalove Personal Lubricants
Indications for Use:
JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are personal lubricants 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. These products are compatible with natural rubber latex, polyurethane and polyisoprene condoms.
Predicate Device Comparison:
The table below lists the comparative indications for use and technological characteristics of the subject and predicate devices.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows a logo for the "United Consortium". The logo features a stylized letter "U" in two shades of gray and blue. The blue portion of the "U" is in the foreground, while the gray portion is in the background, creating a layered effect. The text "UNITED CONSORTIUM" is written in a sans-serif font below the "U".
510(k) JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant Traditional Submission
Table 2: Comparator Table for Subject Device - JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant and Predicate Device JO Gelato Flavored Personal Lubricants
| Feature | JO Naturalove Personal Lubricantand JO Naturalove StrawberryFields Flavored Personal Lubricant | JO Gelato Flavored PersonalLubricants (K172447) |
|---|---|---|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | JO Naturalove Personal Lubricantand JO Naturalove StrawberryFields Flavored Personal Lubricantare personal lubricants for penile,anal and/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Theseproducts are compatible withnatural rubber latex,polyurethane and polyisoprenecondoms. | JO Gelato Flavored PersonalLubricants are water-basedpersonal lubricants for penileand/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubberlatex, polyurethane andpolyisoprene condoms. |
| Water soluble | Yes | Yes |
| Primary ingredients | Water (Aqua), Organic AgaveSyrup, Organic ChamomileConcentrate, Carrageenan,Flavor | Water (Aqua), Glycerin, PotassiumSorbate, Hydroxyethylcellulose,Flavor (Aroma), Sodium Chloride,Sucralose, Citric Acid |
| 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 devices have similar indications for use. The indication for the subject devices 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.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two shades of gray and blue. The bottom of the image has the words 'UNITED CONSORTIUM' in a sans-serif font.
510(k) JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant Traditional Submission
Summary of Performance Data:
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 lubricants are biocompatible.
Shelf-Life:
The subject devices are non-sterile personal lubricants 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 devices met the device specifications at all time points.
Condom Compatibility:
The compatibility of the subject devices 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 the subject personal lubricants are compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that the JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are as safe and effective as the predicate devices and supports a determination of substantial equivalence.
§ 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.