(90 days)
The Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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.
The Bloomi Smooth Water Based Personal Lubricant is a non-sterile, water-based 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Its formulation consists of Water, Hydroxyethylcellulose, Microcare SB (water, sodium benzoate, potassium sorbate), Activsoft S (Cyamopsis Tetragonoloba (Guar) Gum), Citric Acid, Sodium Hyaluronate, Organic Sunflower Extract, Organic Green Tea Extract (Organic Camellia Sinensis Leaf (Green Tea) Extract).
The Bloomi Smooth Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box for OTC use.
This document describes the acceptance criteria and the studies performed to demonstrate that the Bloomi Smooth Water Based Personal Lubricant meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Test Method) |
|---|---|---|
| Absence of particulate matter | Clear viscous liquid | Clear viscous liquid |
| Color | Off-white | Off-white |
| Odor | None | None |
| Viscosity | 1,800 - 4,500 cps | Within specification (1,800 - 4,500 cps) |
| Osmolality | 110 - 140 mOsm/kg | Within specification (110 - 140 mOsm/kg) |
| pH | 4.0 - 5.0 | Within specification (4.0 - 5.0) |
| Total yeast/mold count (TYMC) | ) | ) |
| Antimicrobial effectiveness | Meets USP acceptance criteria for Category 2 products. | Meets USP acceptance criteria for Category 2 products. |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic (ISO 10993-5:2009/(R)2014) | Non-cytotoxic |
| Sensitization | Non-sensitizing (ISO 10993-10:2010/(R)2014) | Non-sensitizing |
| Vaginal Irritation | Non-irritating (ISO 10993-10:2010/(R)2014) | Non-irritating |
| Acute Systemic Toxicity | Not systemically toxic (ISO 10993-11:2017) | Not systemically toxic |
| Condom Compatibility | ||
| Natural rubber latex condoms | Compatible (ASTM D7661-18) | Compatible |
| Polyisoprene condoms | Compatible (ASTM D7661-18) | Compatible |
| Polyurethane condoms | Not compatible (ASTM D7661-18) | Not compatible |
| Shelf Life | ||
| Maintenance of device specifications | Meets specifications across shelf-life | Met specifications at all time points, supporting 8.5-month shelf-life |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for each specific test within the non-clinical performance evaluations (Biocompatibility, Shelf Life, Condom Compatibility). The data provenance is derived from these non-clinical performance studies conducted on the device itself. The studies appear to be prospective, as they were carried out to demonstrate the device's characteristics for regulatory submission. There is no indication of country of origin of the data beyond the standards used (ISO, USP, ASTM).
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The device is a personal lubricant, and the evaluations performed are non-clinical (laboratory and in-vitro testing). Therefore, there is no "ground truth" established by human experts in the context of clinical interpretation, like radiologists or pathologists. The ground truth for these tests is based on established scientific and regulatory standards (e.g., ISO, USP, ASTM methods) and objective measurements.
4. Adjudication Method for Test Set
This information is not applicable. As explained above, the tests are non-clinical, objective measurements based on established protocols, not subjective human interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or other data, and the AI's assistance is evaluated. This is not relevant for a personal lubricant.
6. Standalone Performance (Algorithm Only)
This information is not applicable. The device is a physical product (personal lubricant), not an algorithm or AI system. Therefore, the concept of "standalone performance" without human-in-the-loop is not relevant.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance testing (biocompatibility, shelf life, condom compatibility) is based on:
- Established scientific and regulatory standards: ISO 10993 series for biocompatibility, USP , , for microbial limits and antimicrobial effectiveness, and ASTM D7661-18 for condom compatibility.
- Objective laboratory measurements: Viscosity, Osmolality, pH, microbial counts, etc.
- Defined acceptance criteria: These criteria are based on scientific understanding and regulatory expectations for the safety and performance of personal lubricants.
8. Sample Size for the Training Set
This information is not applicable. As the device is a personal lubricant and not an AI/ML algorithm, there is no "training set." The product's formulation and manufacturing processes are developed and refined based on general scientific principles and quality control measures, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is 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.