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.

Device Description

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.

AI/ML Overview

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 <61> and USP <62> 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.

Summary

FDA 510(k) Clearance Letter - Béa Applicator

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 2, 2025

StepOne Fertility Ltd (t/a Béa Fertility)
Tom Littleford
Quality Assurance Manager
71-75 Shelton Street
Covent Garden
London, WC2H 9JQ
UNITED KINGDOM

Re: K242031
Trade/Device Name: Béa Applicator (BAP-GB-01)
Regulation Number: 21 CFR 884.5250
Regulation Name: Cervical Cap
Regulatory Class: II
Product Code: HDR
Dated: July 11, 2024
Received: March 3, 2025

Dear Tom Littleford:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K242031 - Tom Littleford Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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K242031 - Tom Littleford Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael T. Bailey -S

For
Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K242031

Device Name: Béa Applicator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary

K242031

Béa Applicator

1. Submitter Information

Applicant: StepOne Fertility Ltd (t/a Béa Fertility)
Address: 71-75 Shelton Street Covent Garden London WC2H 9JQ United Kingdom
Contact: Dr. Tom Littleford
Phone: +447543155529
Email: tom@beafertility.com

2. Date prepared: March 31, 2025

3. Device Information

Device Name: Béa Applicator
Common Name: Cervical Cap
Regulation Number: 21 CFR 884.5250
Regulation Name: Cervical Cap
Product Code: HDR (Cap, Cervical)
Regulatory Class: Class II

4. Predicate Device Information

Device Name: FERTI.LILY Conception Cup
510(k) Number: K222969
Sponsor: Rosesta Medical BV

The predicate device has not been subject to a design-related recall.

5. Device Description

K242031
Page 1 of 6

Page 6

6. Indications for Use Statement

7. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.

	K242031	K222969	Comparison
Device Name	Béa Applicator	FERTI.LILY	--
Device Classification	II	II	Same
Product Code	HDR	HDR	Same
Indications for Use	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 FERTI.LILY Conception Cup is indicated for over-the-counter home use. It is for couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. After intercourse, the FERTI.LILY Conception Cup is placed around the cervix. It retains semen near the cervical os (the passage between the vaginal cavity and the uterus) as an aid to conception. The FERTI.LILY	Same intended use to maintain semen near the cervical opening as an aid to conception.

K242031
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Page 7

		Conception Cup should be used during the ovulatory phase of the menstrual cycle. The FERTI.LILY Conception Cup should not be left in place for longer than one hour.
Sterile	Applicator/funnel, Cervical cap – Non-sterile Semen collection container – sterile	No (non-sterile)	Different: Differences in sterility for these vaginal-use devices do not raise different questions of safety and effectiveness (S&E).
Device components	Pre-assembled applicators, semen collection containers	Cervical cup, storage bag	Different: These differences in device components do not raise different questions of S&E.
Use environment	OTC, home environment	OTC, home environment	Same
Patient Population	Couples with low sperm motility, low sperm count, or unfavorable vaginal environment	Couples with low sperm motility, low sperm count, or unfavorable vaginal environment	Same
Patient Contact Material	Silicone, ABS, Polyester	Silicone	Different: The subject and predicate devices have different patient contacting materials. These differences do not raise different questions of S&E.
Cap loading/delivery	Semen added to cap in applicator using a removable funnel. Cap delivered and deployed via applicator	Placed and deployed in vagina after intercourse	Different: The subject device is loaded with sperm before delivery, while the predicate is placed after intercourse. These differences do

K242031
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Page 8

			not raise different questions of S&E.
Human Sperm Survival Assay (HSSA) Conducted	Yes, ≥ 80% motility after 24-hour exposure to the Cervical cap, funnel, and semen collection cups	Yes, ≥ 80% motility after 2-hour exposure to the Conception Cup	Different – Testing assessing the compatibility of the sperm-contacting device components with semen are not the same. This difference between the subject and predicate device does not raise different questions of S&E.
Wear time	≤ 5 hours	≤ 1 hours	Different: The difference in wear-time between the subject and predicate device does not raise different questions of S&E.
Shelf-life	Shelf Life: 7 months	Shelf Life: 36 months	Different - The predicate device shelf-life is greater than the subject device. Differences in shelf-life duration do not raise different questions of S&E.
Reprocessing and Reuse	Single use	Use Life: 3 months Device is reprocessed between uses.	Different – The predicate device is reusable, while the subject device is single use only. These differences do not raise different questions of S&E
Dimensions	Cap Dimensions: Width (OD): 42.4 ± 0.5 mm Height: 45.8 ± 0.5 mm Applicator Dimensions: Outer diameter: 24.6 ± 0.5 mm Applicator length: 242.5 ± 0.5 mm Semen Collection Container Dimensions: Overall Width: 53.0 ± 1.0 mm	Cap Dimensions: OD: 1.27 ± 0.05 in Cap Depth: 0.85 ± 0.035 in Total length (with retrieval): 4.33 ± 0.05 in	Different – Differences in dimensions do not raise different questions of S&E.

K242031
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Page 9

	Overall Height: 63.0 ± 1.0 mm
Cap Volume	13.0 mL	13.8 mL	Similar

The subject and predicate devices do not have identical indications for use or technological characteristics. As noted above, the differences in indications for use do not represent a new intended use. In addition, the technological differences identified in size, wear-time, delivery method (i.e., after intercourse vs. loading before delivery), re-use vs. single use, sperm compatibility testing methods, etc. do not raise different questions of safety and effectiveness as compared to the predicate device.

8. Summary of Non-Clinical Performance Testing

Biocompatibility:
Biocompatibility studies were performed in accordance with the 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:

Cytotoxicity (ISO 10993-5:2009/R 2014)
Sensitization (ISO 10993-10:2010/R 2014)
Vaginal Irritation (ISO 10993-10:2010/R 2014)

The results of testing demonstrate that the subject device is non-cytotoxic, non-irritating, and non-sensitizing.

Shelf Life:
A real-time shelf-life study was performed to verify that the Béa Applicator maintained its specifications over its entire 7-month shelf-life. Specifications assessed in support of device shelf-life include the following:

Visual inspection to confirm the general integrity of the packaging and the legibility of the labeling
Visual inspection for discoloration, clouding, cracking, peeling, and other visual defects
Functional testing of cervical cap deployment
The overall dimensions of the cervical cap (OD, height), the Applicator (OD, height), the semen collection container (OD, height)
Hardness of the cervical cap (Shore A)
Tear resistance of the cervical cap
Compression force of the cervical cap
Tensile strength of the cervical cap and string system
Leakage assessment to ensure minimum volume of fluid is retained in cap
HSSA
Bioburden per USP <61> and USP <62> for non-sterile components (applicator, funnel, and cervical cap)

9. Summary of Clinical Performance Testing

A US-Based human factors validation study was comprised of the following assessments: Self-Selection, Label Comprehension, Simulated Use, and Actual Use Usability testing for the Béa

K242031
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Page 10

Applicator to support OTC at home use of the device. Individuals representing the US population participated in the HF validation testing, with literacy determined by Rapid Estimate of Adult Literacy in Medicine (REALM) assessment. This comprised of 68 self-selection participants, 15 label comprehension and simulated use participants, and 26 actual use participants.

The sponsor also conducted a supplemental study with the same protocol and included self-selection, label comprehension, simulated use, and actual use testing for individuals in the low literacy cohort. 23 participants were recruited with a REALM score of less than 45 in the HF validation test, and an additional 15 for the labeling comprehension to evaluate the revised labeling, four of whom were low literacy. Eleven of the new low REALM population participated in self-selection, four for label comprehension and simulated use, and five completed actual use.

The combined simulated use and labeling comprehension study was conducted to evaluate if the Béa Applicator (including its associated documentation) is as safe and effective as the predicate device for the intended use by the intended users in the intended use environments. The following knowledge tasks were evaluated as part of simulated use testing:

When should this product be used?
How many times can the product be used?
How long can the Cervical Cap remain inside the vagina?
In what instances should someone not use the product?
If your skin gets irritated while using the product, what should you do?
What should you do if the product becomes stuck inside the vagina?
What should you check before using the product?
How should you insert the device?
How would you know that the applicator is all the way in?
Can you have sexual activity while the cervical cap is inside you?

The actual use clinical study was conducted to evaluate the following three clinical end points.

Can be positioned correctly with the Cervical Cap over the cervical os
Can retain semen in the cervical cap
Does not cause trauma/injury to the vagina

The study found that all subjects were able to successfully use the device with all above outcomes met, demonstrating simulated use and actual use respectively.

In conclusion, the clinical studies demonstrated that the intended use population across different health literacy levels was able to comprehend the Béa Applicator labeling and the intended use of the device. The study population also reported demographic information representative of the US population and successfully completed all elements of the studies.

10. Conclusion

The results of the non-clinical and clinical performance testing described above demonstrate that the Béa Applicator is as safe and effective as the predicate device and supports a determination of substantial equivalence.

K242031
Page 6 of 6

Regulation Number and Section

§ 884.5250 Cervical cap.

(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).