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510(k) Data Aggregation
(265 days)
The Béa Applicator is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Béa Applicator contains a Béa Cervical Cap which is used to contain, deliver, and retain semen near the cervical opening as an aid to conception. The Béa Applicator should be used during the ovulatory phase of the menstrual cycle. The Béa Cervical Cap should not be left in place for longer than 5 hours.
The Béa Applicator is an over-the-counter (OTC) device for use by couples as an aid to conception that have been unable to get pregnant naturally due to low sperm count, low sperm motility, or an unfavorable vaginal environment. The Applicator is provided to the users pre-assembled with the silicone cervical cap and a funnel to guide the semen into the cervical cap. Semen is poured from a sterile semen container into the cervical cap, which is located in the Applicator. The user inserts the Applicator into the vagina and deploys the cervical cap at or near the cervix by turning the handle. The Applicator is removed from the vagina and the cervical cap is left for up to five (5) hours to allow sperm to travel through the cervical canal. The user then removes the cervical cap from the vagina using its attached retrieval string and disposes of it. All components of the Béa Applicator are single-use only. The applicator and cervical cap components are non-sterile, while the semen collection container is provided sterile.
The provided FDA 510(k) clearance letter and summary for the Béa Applicator (K242031) describes the device, its intended use, comparison to a predicate device, and summaries of non-clinical and clinical performance testing. However, it does not explicitly state acceptance criteria in a quantitative, measurable format or provide a detailed study that directly proves the device meets such criteria in the way typically expected for AI/diagnostic devices.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device by showing that:
- Its indications for use are similar.
- Its technological characteristics, despite some differences, do not raise new questions of safety and effectiveness.
- Non-clinical and clinical performance testing supports its safety and effectiveness for its intended use.
Therefore, many of the requested points below cannot be directly extracted from the provided text, as they pertain more to studies evaluating the performance of a diagnostic or AI algorithm against specific, predefined performance metrics. The Béa Applicator is a physical medical device for aid to conception, not a diagnostic or AI tool.
Here's an analysis based on the information provided, addressing as many points as possible and noting where information is not available:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Béa Applicator (K242031)
Given that the Béa Applicator is a physical medical device for aid to conception and not a diagnostic or AI device, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" deviates from what would be expected for software or AI-based devices. For this device, "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device and showing the device performs its intended mechanical and biological functions safely and effectively.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA summary does not present a formal table of acceptance criteria with corresponding performance metrics in a quantitative manner as one might see for diagnostic sensitivity/specificity. Instead, the "acceptance criteria" for this type of device are implicitly met by passing various safety and functional tests and demonstrating successful usability.
| Category | Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing (per ISO 10993 standards for vaginal contact) | Cytotoxicity: Non-cytotoxic. |
| Sensitization: Non-sensitizing. | ||
| Vaginal Irritation: Non-irritating. | ||
| Shelf Life | Device maintains specifications for 7 months. | Visual Inspection: General integrity of packaging, legibility of labeling confirmed. No discoloration, clouding, cracking, peeling, or other visual defects observed. |
| Functional Testing: Cervical cap deployment confirmed. | ||
| Dimensions: Overall dimensions (OD, height) of cervical cap, applicator, and semen collection container maintained within specification. | ||
| Material Properties: Hardness (Shore A), tear resistance, and compression force of cervical cap maintained. Tensile strength of cap and string system maintained. | ||
| Leakage: Minimum volume of fluid retained in cap maintained. | ||
| HSSA (Sperm Compatibility): ≥ 80% motility after 24-hour exposure to the Cervical cap, funnel, and semen collection cups (This is a specific performance metric related to the device's function, implying a compatibility requirement). | ||
| Bioburden: Met USP and USP for non-sterile components. | ||
| Usability/Usability | Intended users can understand labeling, self-select appropriately, and use the device safely and effectively for its intended purpose at home, across different literacy levels. | Self-Selection: 68 participants in initial study, plus 11 low REALM participants. Data supports appropriate self-selection. |
| Label Comprehension: 15 participants in initial study, plus 4 low REALM participants. Data supports comprehension of "when to use," "how many times," "how long to wear," "contraindications," "what to do if irritated/stuck," "what to check," "how to insert," "how to know applicator is in," and "sexual activity while cap is in." | ||
| Simulated Use: 15 participants in initial study, plus 4 low REALM participants. Confirmed safe and effective use. | ||
| Actual Use: 26 participants in initial study, plus 5 low REALM participants. All subjects successfully positioned the Cervical Cap over the cervical os, retained semen in the cap, and experienced no trauma/injury to the vagina. | ||
| Clinical Endpoints | Device can be positioned correctly over the cervical os; retains semen; does not cause trauma/injury. | Positioning: All subjects successfully positioned the Cervical Cap over the cervical os. |
| Semen Retention: All subjects successfully retained semen in the cervical cap. | ||
| Safety: Device did not cause trauma/injury to the vagina in all subjects. |
2. Sample Size for the Test Set and Data Provenance
- Human Factors Validation Study (US-based):
- Self-Selection: 68 participants (initial study) + 11 participants (low literacy cohort) = 79 total
- Label Comprehension & Simulated Use: 15 participants (initial study) + 4 participants (low literacy cohort with revised labeling) = 19 total
- Actual Use: 26 participants (initial study) + 5 participants (low literacy cohort) = 31 total
- Data Provenance: US-based, prospective ("individuals representing the US population participated"). The study assessed different health literacy levels.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this device and study. The human factors and usability studies focused on user interaction, comprehension, and device function, not on expert-adjudicated diagnostic "ground truth." The ground truth for successful actual use (e.g., correct positioning, semen retention, no injury) was observed directly by study personnel or self-reported, not established by experts adjudicating individual cases.
4. Adjudication Method for the Test Set
This information is not applicable. There was no "ground truth" to adjudicate in the typical diagnostic sense. The results of the usability and actual use studies (e.g., successful cap placement, no trauma) appear to be direct observations or user feedback, not requiring an adjudication process for disagreement between multiple assessors.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used to compare the performance of human readers, with and without AI assistance, for diagnostic tasks. The Béa Applicator is a physical device for aid to conception, not a diagnostic tool or an AI-assisted interpretation system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. The Béa Applicator is a physical device, not an algorithm. Its performance is always in conjunction with human use. The performance tests evaluate the device's physical and biological properties (e.g., biocompatibility, semen compatibility, structural integrity) and its usability by intended users.
7. The Type of Ground Truth Used
The "ground truth" for the various tests can be categorized as:
- For Biocompatibility & Shelf-Life: Established scientific standards (ISO 10993) and predefined physical/chemical material specifications.
- For Human Sperm Survival Assay (HSSA): A defined physiological threshold (≥ 80% motility after 24 hours), which acts as a "ground truth" for sperm compatibility.
- For Usability/Actual Use: Direct observation of user actions, comprehension of instructions, and clinical outcomes (e.g., correct positioning, semen retention, absence of trauma/injury) as observed or reported by study participants and investigators.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The device's design is based on engineering principles, material science, and user research.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment for such.
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