(117 days)
The Bloomi Delight Oil-Based Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
The Bloomi Delight Oil-Based Personal Lubricant is a non-sterile, oil-based, overthe-counter use personal lubricant that is intended for penile and vaginal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms. Its formulation consists of Extra Virgin Coconut Oil, Organic Sunflower Seed Oil, Organic Cocoa Butter, Shea Butter (low melt), Sunflower Wax and Sea Buckthorn Fruit Oil. The Bloomi Delight Oil-Based Personal Lubricant is packaged in a 3 oz tube and is secondarily packaged in an outer box.
This document is a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, the questions related to AI/ML device acceptance criteria, study design, ground truth, and human reader performance are not applicable to the provided text.
The document discusses the substantial equivalence of “Bloomi Delight Oil-Based Personal Lubricant” to a predicate device, Astroglide O Oil Personal Lubricant & Massage Oil (K171985).
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Device Performance (Non-AI/ML)
The acceptance criteria are specifications based on the physical, chemical, and microbiological properties of the lubricant. The document states that the device met these specifications, implying performance acceptance.
| Parameter | Specification (Test Method) | Reported Device Performance |
|---|---|---|
| Appearance | Semi-fluid | Semi-fluid |
| Color | Yellow | Yellow |
| Odor | Odorless | Odorless |
| Viscosity (USP) | 2,300-20,000 cps | Met specification |
| Total yeast/mold count (TYMC, USP) | ) | , including Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) |
2. Sample Size and Data Provenance (Non-AI/ML)
The document does not specify sample sizes for the performance tests (e.g., number of batches tested for viscosity, microbial counts). The studies conducted for biocompatibility and shelf-life are typically performed in a laboratory setting. No information on country of origin or retrospective/prospective data collection is provided as this is not a clinical study in the traditional sense for an AI/ML device.
3. Number of Experts and Qualifications (Not Applicable for this Device)
These questions are not relevant as the performance evaluation for a personal lubricant involves lab-based testing against defined specifications, not expert interpretation of outputs.
4. Adjudication Method (Not Applicable for this Device)
Adjudication methods like 2+1 or 3+1 are used for consensus in reader studies, which are not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not Applicable for this Device)
This is an AI/ML specific question and is not relevant to a personal lubricant.
6. Standalone (Algorithm Only) Performance (Not Applicable for this Device)
This is an AI/ML specific question and is not relevant to a personal lubricant.
7. Type of Ground Truth (Non-AI/ML)
The "ground truth" for this device's performance is established by objective laboratory testing against predefined chemical, physical, and microbiological specifications derived from relevant standards (e.g., USP monographs). For biocompatibility, it's based on the results of specific ISO 10993 tests.
8. Sample Size for Training Set (Not Applicable for this Device)
This is an AI/ML specific question and is not relevant to a personal lubricant.
9. How Ground Truth for Training Set was Established (Not Applicable for this Device)
This is an AI/ML specific question and is not relevant to a personal lubricant.
Summary of Non-Clinical Performance Testing (as described in the document):
- Biocompatibility: Tests were performed in accordance with ISO 10993-1, including Cytotoxicity (ISO 10993-5), Guinea Pig Maximization Sensitization (ISO 10993-10), Vaginal Irritation (ISO 10993-10), and Acute Systemic Toxicity (ISO 10993-11). The results concluded the lubricant is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
- Shelf Life: A six-month shelf-life was established based on real-time aging testing. The device met all listed specifications (Table 1) across all time points.
- Condom Compatibility: No testing was conducted, leading to the statement that the product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
§ 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.