(180 days)
JO for Him H2O Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
JO for Him H2O Gel Original Personal Lubricant is a clear/water white, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile 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 sold as an over-the-counter (OTC) product in 4 oz. and 8 oz. sizes provided in matte black, polyethylene (PE) tubes. These tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process. This device is composed of Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Methylparaben, Propylparaben, Hydroxyethylcellulose and Sodium Hydroxide.
The provided document is a 510(k) summary for a personal lubricant, not a medical imaging device or AI algorithm. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this document.
The document describes the device specifications for the JO for Him H2O Gel Original Personal Lubricant and the performance testing conducted to demonstrate its safety and effectiveness relative to a predicate device.
Here's an analysis of the available information, structured as closely as possible to your request, but acknowledging the information gaps:
1. A table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Physical/Chemical Properties | ||
| Appearance | Clear, viscous liquid | Clear, viscous liquid (Implied to meet specification) |
| Color | Clear, water white | Clear, water white (Implied to meet specification) |
| Odor | Odorless | Odorless (Implied to meet specification) |
| Viscosity (cps) per USP | 38,000 cps to 75,000 cps | (Specific value not reported, but stated to meet spec) |
| pH per USP | 5.25 to 7.50 | (Specific value not reported, but stated to meet spec) |
| Specific Gravity per USP | 0.980 to 1.200 | (Specific value not reported, but stated to meet spec) |
| Osmolality per USP | 600 to 900 mOsm/kg | (Specific value not reported, but stated to meet spec) |
| Microbiological Properties | ||
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products | Met USP acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP and | Less than 100 cfu/g | (Specific value not reported, but stated to meet spec) |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | (Specific value not reported, but stated to meet spec) |
| **Presence of Pathogens per USP ** | ||
| Pseudomonas aeruginosa | Absent | Absent (Implied to meet specification) |
| Staphylococcus aureus | Absent | Absent (Implied to meet specification) |
| Salmonella/Shigella | Absent | Absent (Implied to meet specification) |
| Escherichia coli | Absent | Absent (Implied to meet specification) |
| Candida albicans | Absent | Absent (Implied to meet specification) |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic (as per ISO 10993-5:2009) | Only slightly cytotoxic (as per ISO 10993-5:2009) |
| Sensitization | Non-sensitizing (as per ISO 10993-10:2010) | Non-sensitizing (as per ISO 10993-10:2010) |
| Vaginal Irritation | Non-irritating (as per ISO 10993-10:2010) | Non-irritating (as per ISO 10993-10:2010) |
| Penile Irritation | Non-irritating (as per ISO 10993-10:2010) | Non-irritating (as per ISO 10993-10:2010) |
| Acute Systemic Toxicity | Non-systemically toxic (as per ISO 10993-11:2006) | Non-systemically toxic (as per ISO 10993-11:2006) |
| Shelf-Life | ||
| Shelf-Life Duration | 3 years (based on real-time aging study) | Met device specifications at 0, 1, 2, and 3 years |
| Condom Compatibility | ||
| Natural Rubber Latex Condoms | Compatible (as per ASTM D7661-10) | Compatible |
| Polyisoprene Condoms | Compatible (as per ASTM D7661-10) | Compatible |
| Polyurethane Condoms | Not compatible (as per ASTM D7661-10) | Not compatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies referenced are standard laboratory tests (e.g., biocompatibility testing according to ISO standards, shelf-life testing, condom compatibility testing according to ASTM standards). These typically involve a defined number of samples or animals for each test component as specified by the standards, but the exact sample sizes are not detailed in this summary. The data provenance is internal testing performed by or for United Consortium.
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 and study. The "ground truth" for the performance criteria listed (pH, viscosity, microbial counts, etc.) is established by standard laboratory methods and validated instrumentation, not by human expert consensus or interpretation as would be the case for medical imaging algorithms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic devices to resolve discrepancies in interpretation. The tests described are objective laboratory measurements.
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 to this device. An MRMC study is relevant for diagnostic imaging devices used by human readers with AI assistance. This document describes a personal lubricant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. This would apply to an AI algorithm, not a physical product like a personal lubricant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device specifications (e.g., pH, viscosity, sterility, ingredient presence) is established through standardized analytical chemistry and microbiology laboratory tests (e.g., USP and ASTM methods) and biological evaluations (e.g., ISO 10993 series). For biocompatibility, the ground truth is the biological response observed in the specified animal models or in vitro assays. For shelf-life, the ground truth is the maintenance of specifications over time. For condom compatibility, it is the performance against the ASTM standard.
8. The sample size for the training set
This is not applicable to this device. A "training set" refers to data used to train a machine learning algorithm. This document describes a physical product and its testing.
9. How the ground truth for the training set was established
This is not applicable to this device, as there is no training set mentioned or implied.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The device's performance was proven through a series of laboratory and biological tests conducted in accordance with recognized international and national standards:
- Biocompatibility Studies: Performed according to the 2016 FDA guidance document on ISO 10993-1 and specific parts of ISO 10993 (Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Penile Irritation (ISO 10993-10:2010), and Acute Systemic Toxicity (ISO 10993-11:2006)). These studies demonstrated that the lubricant is "only slightly cytotoxic, non-irritating, non-sensitizing and non-systemically toxic," meeting the safety requirements.
- Shelf-Life Study: A real-time aging study was conducted for 3 years. All device specifications listed in Table 1 (Appearance, Color, Odor, Viscosity, pH, Specific Gravity, Osmolality, Antimicrobial effectiveness, Microbial counts, and absence of specific pathogens) were tested at 0, 1, 2, and 3 years. The device "met the device specifications at all time points," thus proving its 3-year shelf-life.
- Condom Compatibility Testing: Evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results indicated compatibility with natural rubber latex and polyisoprene condoms, and incompatibility with polyurethane condoms.
- Physical, Chemical, and Microbiological Testing: The device specifications listed in Table 1 (e.g., Viscosity per USP , pH per USP , Specific Gravity per USP , Osmolality per USP , Antimicrobial effectiveness per USP , Microbiological counts per USP and , and presence of pathogens per USP ) were evaluated to ensure the product met defined quality and safety standards. While specific numerical results are not provided for each, the summary implies successful compliance with these specifications.
These studies collectively support the conclusion that the JO for Him H2O Gel Original Personal Lubricant is "as safe and effective as the predicate device 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.