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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.

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.

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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

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.

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