(272 days)
pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
The pjur® med SENSITIVE glide and pjur® WOMAN Nude are water-based personal lubricants provided non-sterile. These over-the-counter products have an identical formulation and contain neither a contraceptive nor a spermicide. They are compatible with natural rubber latex condoms and are not compatible with polyurethane or polyisoprene condoms. The pjur® med SENSITIVE glide is provided in 100 mL polyethylene bottles and the pjur® WOMAN Nude is provided in either 10 mL or 100 mL polyethylene bottles.
The pjur® med SENSITIVE glide and pjur® WOMAN Nude consists of water, 1,2 propylene glycol, ethyoxydiglycol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, sodium saccharin, and citric acid.
The document describes pjur® med SENSITIVE glide and pjur® WOMAN Nude personal lubricants. These devices are intended for penile, vaginal, and/or anal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. They are compatible with natural rubber latex condoms but not with polyurethane and polyisoprene condoms.
Here's the breakdown of the acceptance criteria and supporting studies:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are presented as "Specification" in two tables (Table 1 and a continuation for Microbial Limits). The reported device performance is implicitly stated as meeting these specifications since the document concludes that performance testing demonstrates the devices are safe and effective and support "substantial equivalence determination."
| Parameter | Method | Specification | Reported Device Performance (Implicitly Met) |
|---|---|---|---|
| Physical/Chemical Characteristics | |||
| Appearance | - | Clear fluid | Clear fluid |
| Odor | - | Odorless | Odorless |
| pH | USP | 4.0-4.5 | 4.0-4.5 |
| Viscosity (mPa*s) | USP | 4000-5600 | 4000-5600 |
| Osmolality (mOsmol/kg) | USP | 500-700 mOsm/kg (diluted 1:9.6) | 500-700 mOsm/kg (diluted 1:9.6) |
| Microbial Limits | |||
| Total Yeast and Mold Count (TYMC) | USP | ||
| Presence of pathogenic organisms (Staphylococcus aureus) | USP | Absent | Absent |
| Presence of pathogenic organisms (Candida albicans) | USP | Absent | Absent |
| Antimicrobial Preservation | USP | Category 2 - Topical (specific log reduction and no increase criteria) | Met Category 2 criteria |
| Other Performance Criteria | |||
| Condom Compatibility | ASTM D7661-10 | Compatible with natural rubber latex condoms; Not compatible with polyurethane and polyisoprene condoms | Compatible with natural rubber latex condoms; Not compatible with polyurethane and polyisoprene condoms |
| Biocompatibility | ISO 10993 | Biocompatible | Biocompatible |
| Shelf-Life | Real-time stability study | 4 years while maintaining specifications | 4 years while maintaining specifications |
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 explicitly state the sample sizes for the specific tests. It refers to standardized testing methods (e.g., USP, ASTM, ISO standards). For example, condom compatibility was performed in accordance with ASTM D7661-10, biocompatibility studies in accordance with ISO 10993, and microbial tests according to USP standards. These standards typically define appropriate sample sizes and methodologies for prospective testing. The provenance of the data (country of origin) is not specified. The studies appear to be prospective as they are performance tests conducted to demonstrate compliance with specifications.
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 section is not applicable as the device is a personal lubricant, and its performance is evaluated against established physical, chemical, and microbiological standards, as well as material compatibility tests, rather than a diagnostic interpretation where expert ground truth is typically required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the evaluation relies on objective measurements against specified standards, not on expert adjudication of diagnostic outcomes.
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 a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is geared towards AI/algorithmic devices and is not applicable to a personal lubricant. The "standalone" performance here relates to the product's inherent physical, chemical, and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established industry standards and regulatory guidelines for personal lubricants and medical devices. These include:
- Physical/Chemical Properties: Measured values against specified ranges (e.g., pH, viscosity, osmolality defined by USP standards).
- Microbial Purity: Absence of specific pathogens and adherence to microbial limits (defined by USP standards).
- Antimicrobial Effectiveness: Performance against challenge organisms as per USP standards.
- Biocompatibility: Results from tests showing no adverse biological reactions as per ISO 10993 standards.
- Condom Compatibility: Demonstrated non-degradation of condoms tested according to ASTM D7661-10.
- Shelf-Life: Stability over time as demonstrated by a real-time stability study.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.