(269 days)
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 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.LIL Y 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.
The FERTI.LILY Conception Cup is a non-sterile, silicone, 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. After intercourse, the device is placed in the vagina, the cup-like receptable is deployed using an integrated deployment cord, and the device is positioned over the cervix to physically situate semen near the cervical os. The FERTI.LIL Y Conception Cup can be left in the vagina for a maximum duration of one hour. The FERTI.LILY Conception Cup includes a stem to assist with removal from the vagina.
The provided document describes the FERTI.LILY Conception Cup and studies demonstrating its safety and effectiveness. However, it does not present a formal "acceptance criteria" table with specific quantified performance metrics and how the device explicitly meets them for clinical outcomes. The document focuses on non-clinical performance (biocompatibility, shelf life, reprocessing, use-life) and clinical usability/label comprehension studies.
Therefore, I cannot create a table of acceptance criteria for clinical efficacy from the provided text, as those specific criteria are not explicitly stated for clinical outcomes. The clinical studies primarily assess usability, label comprehension, and successful insertion/removal, rather than a direct measure of conception success compared to a numerical target.
However, I can extract the reported performance from the studies provided and infer the "acceptance criteria" based on the successful outcomes and study goals as described in the text.
Here's the information parsed from the provided text:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
| Performance Metric (Inferred Acceptance Criteria) | Reported Device Performance |
|---|---|
| Non-Clinical Performance | |
| Biocompatibility (Non-irritating, non-sensitizing, not acutely/systemically toxic) | The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic. |
| Shelf Life (Maintain specifications over 36 months for color, appearance, odor, dimensions, volume, tensile testing, hardness, HSSA) | A real-time shelf-life study verified the FERTI.LILY Conception Cup maintained its specifications over its entire 36-month shelf-life for the assessed parameters. |
| Reprocessing (No protein or total organic carbon residuals after reprocessing) | Reprocessing validation found protein and carbon residuals did not remain on the FERTI.LILY Conception Cup after full reprocessing. |
| Use-Life (Maintain specifications after maximum simulated deployment and reprocessing for 3 months for color, appearance, odor, dimensions, volume, tensile testing, hardness, HSSA) | Testing on newly manufactured devices and devices after maximum simulated deployment and reprocessing steps (for 3 months use-life) showed devices were within specification range for each assessed parameter. |
| Human Sperm Survival Assay (HSSA) (≥ 80% motility after 2-hour exposure to the Conception Cup) | Yes, ≥ 80% motility after 2-hour exposure to the Conception Cup. |
| Clinical Performance (Usability & Label Comprehension) | |
| Self-Selection, Label Comprehension, Virtual Simulated Use (80% comprehension for each knowledge endpoint) | First Study: Prespecified target comprehension level of 80% for each knowledge endpoint related to self-selection, label comprehension, and simulated-use was met. |
| Labeling Revisions Comprehension (80% comprehension for each knowledge endpoint) | Second Study: The target comprehension level (80%) of each knowledge endpoint tested was met. |
| At-Home Usability (Successful insertion) & Label Comprehension (Clear understanding) | Third Study (FCC-001): 87% of subjects were able to successfully insert the device. 15 subjects demonstrated clear understanding of the package directions. |
| Usability and Safety (Successful use, correct insertion, no device-related adverse events or deficiencies) | Fourth Study (FCC-002): All 15 subjects were able to successfully use the device in both in-clinic and at-home settings. All (100%) subjects correctly inserted the device, and no device-related adverse events or device deficiencies were observed. All specified outcomes were met. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not detail specific "test sets" in the context of a machine learning or AI algorithm. Instead, it describes human subject studies. Based on the description:
- Clinical Studies (Test for Usability/Comprehension):
- First Study: 75 naive subjects enrolled, 74 completed.
- Second Study: 41 naive subjects completed.
- Third Study (FCC-001): 15 subjects enrolled.
- Fourth Study (FCC-002): 15 subjects enrolled, all 15 completed.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study participants. However, it mentions "demographic information representative of the US population" in the conclusion of the clinical studies section, suggesting participants were likely from the US or a population representative of the US. All studies appear to be prospective clinical studies as they involve subject enrollment and active data collection related to device use and comprehension.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" and "experts" as typically seen in AI/ML validation (e.g., radiologist interpreting images) is not directly applicable here. The "ground truth" for the usability and comprehension studies was established by the study design itself and the observation/assessment of subject actions and self-reported understanding.
- In the Third Study (FCC-001) and Fourth Study (FCC-002), a "physician" or "HCP (Health Care Provider)" assessed correct deployment and positioning over the cervical os, semen remaining in the cup, and potential vaginal injury/trauma. The number or specific qualifications (e.g., years of experience) of these HCPs/physicians are not specified.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1 or 3+1) are typically used when multiple human readers interpret data, and discrepancies need to be resolved. This is not mentioned as part of the usability or comprehension studies described, as they primarily involve objective observation or direct assessment by a single observer (e.g., study staff, physician) of a subject's actions or understanding.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The studies focused on the performance, usability, and comprehension of the FERTI.LILY Conception Cup itself, not on comparing AI assistance to unassisted human readers, as this is not an AI-driven device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone algorithm performance study was done because the FERTI.LILY Conception Cup is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the studies was primarily based on:
- Observed actions/behavior: Successful insertion, deployment, removal, adherence to instructions.
- Subject self-reporting: Ease of use, satisfaction (FCC-001).
- Direct assessment by HCP/physician: Correct positioning over the cervical os, semen volume, vaginal injury/trauma (FCC-001, FCC-002).
- Defined knowledge endpoints: Correct answers to comprehension questions related to labeling.
8. The Sample Size for the Training Set
The concept of a "training set" is not relevant here as the device is a physical product and not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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June 23, 2023
Rosesta Medical BV % Jill Matzat CEO CRA Solutions, Inc. 6250 Coral Ridge Drive, Suite 100 Coral Springs, FL 33076
K222969 Re:
Trade/Device Name: FERTI.LILY Conception Cup Regulation Number: 21 CFR§ 884.5250 Regulation Name: Cervical Cap Regulatory Class: II Product Code: HDR Dated: May 19, 2023 Received: May 22, 2023
Dear Jill Matzat:
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 (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 located 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.
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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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
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Indications for Use
510(k) Number (if known) K222969
Device Name FERTI.LILY Conception Cup
Indications for Use (Describe)
The FERTI.LLY 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 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.LIL Y 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.
| 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) |
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510(k) Summary K222969 FERTI.LILY Conception Cup
1. Submitter Information
| Applicant: | Rosesta Medical BV |
|---|---|
| Address: | Mr. Treublaan 7, 1097DPAmsterdam, The Netherlands |
| Contact: | Robert Stal |
| Phone: | +31622377804 |
| Email: | robert@rosesta.com |
2. Submission Correspondent
| Company: | CRA Solutions, Inc |
|---|---|
| Contact: | Jill Matzat |
| Phone: | (954) 778-0146 |
| Email: | jmatzat@cra-training.com |
3. Date prepared: June 22, 2023
4. Device Information
| Device Name: | FERTI.LILY Conception Cup |
|---|---|
| Common Name: | Cervical Cap |
| Regulation Number: | 21 CFR 884.5250 |
| Regulation Name: | Cervical Cap |
| Product Code: | HDR (Cap, Cervical) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | Oves Cervical Cap |
|---|---|
| 510(k) Number: | K993953 |
| Sponsor: | Veos Ltd. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The FERTI.LILY Conception Cup is a non-sterile, silicone, 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. After intercourse, the device is placed in the vagina, the cup-like receptable is deployed using an integrated deployment cord, and the device is positioned over the cervix to physically situate semen near the cervical os. The FERTI.LIL Y Conception Cup can be left in the vagina for a maximum duration of one hour.
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The FERTI.LILY Conception Cup includes a stem to assist with removal from the vagina.
7. Indications for Use Statement
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 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 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.
8. 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.
| K222969 | K993953 | Comparison | |
|---|---|---|---|
| Device Name | FERTI.LILY | Oves Cervical | -- |
| Cap | |||
| Device Classification | II | II | Same |
| Product Code | HDR | HDR | Same |
| Indications for Use | The FERTI.LILYConception Cup isindicated for over-the-counter home use. It isfor couples who havebeen unable toconceive naturally andwho have received adiagnosis of lowsperm count, spermimmobility orunfavorable vaginalenvironment. Afterintercourse, theFERTI.LILYConception Cup isplaced around thecervix. It retainssemen near thecervical os (thepassage between thevaginal cavity and theuterus) as an aid toconception. TheFERTI.LILY | The oves cervicalcap is indicatedfor use in artificialinseminationprocedures insituations inwhich low spermcount, spermimmotility, orhostile vaginalenvironment havebeen diagnosed.The oves cervicalcap removessemen from thevaginalenvironment andconcentrates thesperm at theopening of thecervical os, thusfacilitating spermcontact withcervical mucosa. | The subject andpredicate deviceindications are notidentical. Differencesinclude the subjectdevice is for OTC homeuse while the predicateis for prescription usein a clinical setting.Also, the subject deviceis used afterintercourse, while thepredicate is loadedbefore vaginalplacement. Thedifferences between theindications for use forthe two devices do notrepresent a newintended use as bothdevices are intended tomaintain a pool ofsemen/sperm near thecervical os as an aid toconception. |
| Conception Cupshould be used duringthe ovulatory phase ofthe menstrual cycle.The FERTI.LILYConception Cupshould not be left inplace for longer thanone hour. | |||
| Sterile | No (non-sterile) | Not known | Different: Informationregarding predicatedevice sterility is notknown. However,differences in sterilityfor these vaginal-usedevices do not raisedifferent questions ofsafety and effectiveness(S&E) |
| Device components | Cervical Cup, storagebag | Cervical Cap | Similar |
| Use environment | OTC, homeenvironment | RX, clinicalenvironment | Different: Thedifference in useenvironment of thesubject and predicatedevices do not raisedifferent questions ofS&E. |
| Patient Population | Couples with lowsperm motility, lowsperm count, orunfavorable vaginalenvironment | Couples with lowsperm motility,low sperm count,or unfavorablevaginalenvironment | Same |
| Patient ContactMaterial | Silicone | Silicone | Same |
| Cap loading | Placed in vagina afterintercourse | Semen added tocap beforeplacement | Different: The subjectdevice is placed afterintercourse, while thepredicate is loaded withsperm before delivery.These differences donot raise differentquestions of S&E (e.g.,device design maintainssperm near the cervical |
| Human Sperm Survival Assay (HSSA) Conducted | |||
| Yes, ≥ 80% motility after 2-hour exposure to the Conception Cup | Not known | Different – Testing assessing the compatibility of the predicate device with sperm is not known. This difference between the subject and predicate device does not raise different questions of S&E. | |
| Wear time | |||
| < 1 hours | Not known | Different: Information regarding predicate device wear time is not known. The difference in wear-time between the subject and predicate device does not raise different questions of S&E. | |
| Shelf-life | |||
| Shelf Life: 36 months | Not known | Different – The predicate device shelf-life is not known. Differences in shelf-life duration do not raise different questions of S&E. | |
| Reprocessing and Reuse | |||
| Use Life: 3 monthsDevice is reprocessed between uses. | Single-use only | Different – The predicate device is for single use only, while the subject device can be reprocessed and re-used. These differences do not raise different questions of S&E | |
| Dimensions | |||
| Cap Dimensions:OD: 1.27 ± 0.05 inCap Depth: 0.85 ± 0.035 inTotal length (with retrieval): 4.33 ± 0.05 in | Not known | Different – The predicate device dimensions are not known. Differences in dimensions do not raise different questions of S&E. | |
| Volume | |||
| 13.8 ± 0.3 mL | Not known | Different – The volume of the predicate device is not known. Differences in volume do not raise different questions of S&E. |
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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
{7}------------------------------------------------
technological differences identified in size, wear-time, delivery method (i.e., after intercourse vs. loading before delivery), re-use vs. single use, sperm testing methods, etc. do not raise different questions of safety and effectiveness as compared to the predicate device.
9. Summary of Non-Clinical Performance Testing
Biocompatibility:
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2020 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)
- · Acute Systemic Toxicity (ISO 10993-11:2017)
The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Shelf Life:
A real-time shelf-life study was performed to verify that the FERTI.LILY Conception Cup maintained its specifications over its entire 36-month shelf-life. Specifications assessed in support of device shelf-life include the following:
- Device Color
- Device appearance ●
- Device odor
- Dimensional specifications ●
- Volume ●
- Tensile testing (force at break and elongation)
- Hardness (Shore A) ●
- Human Sperm Survival Assay (HSSA)
Reprocessing:
Reprocessing validation was conducted per the 2015 FDA guidance document, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. This validation was conducted with residual protein and residual total organic carbon (TOC) analysis on a robust sample of devices to ensure protein and carbon residuals did not remain on the FERTI.LILY Conception Cup after full reprocessing.
Use-Life:
The FERTI LILY Conception Cup has a use-life of three months. Testing below was conducted on newly manufactured devices and devices after maximum simulated deployment and reprocessing steps in accordance with the Instructions for Use. Devices were within specification range for each assessed parameter shown below:
- Device Color ●
- Device appearance .
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- Device odor ●
- Dimensional specifications
- Volume
- Tensile testing (force at break and elongation)
- . Hardness (Shore A)
- Human Sperm Survival Assay (HSSA) ●
10. Summary of Clinical Performance Testing
Data from four clinical studies was used to support the following assessments: Self-Selection, Label Comprehension, and Actual Use Usability testing for the FERTI.LILY Conception Cup to support OTC at home use of the device.
First Study: A self-selection, label comprehension, and virtual simulated use study for the FERTI-LIL Y Conception Cup was conducted to demonstrate that the target intended use population achieved acceptable comprehension of the device labeling. Seventy-five naïve subjects were enrolled and 74 subjects completed the full study protocol. The prespecified target comprehension level of 80% for each knowledge endpoint related to self-selection. label comprehension and simulated-use was met, but there were some limitations in the designation of critical tasks related to device reprocessing and re-use.
Second Study: A second labeling comprehension study was conducted to support labeling revisions in a diverse study population. Forty-one (41) naïve subjects completed the full study protocol. The target comprehension level (80%) of each knowledge endpoint tested was met.
Third Study (FCC-001): This study was conducted to evaluate the usability and label comprehension of the FERTI.LILY Conception Cup. Fifteen (15) subjects were enrolled and each demonstrated clear understanding of the package directions. The at-home usability component demonstrated that 87% of subjects were able to successfully insert the device. Transient non-serious adverse events (discomfort, irritation, cramping) were reported but did not require any treatment. A user experience survey within the study showed that subjects reported high ease of use and satisfaction with the device.
Fourth Study (FCC-002): This study was conducted to evaluate the usability and safety of the FERTI.LILY Conception Cup. Fifteen (15) subjects were enrolled and all 15 subjects were able to successfully use the device in both in-clinic (simulated use) and at-home (actual real-world use) settings. All (100%) subjects correctly inserted the device, and no device-related adverse events or device deficiencies were observed.
Furthermore, the clinical usability studies assessed the following endpoints:
- Correctly follow all instructions prior to placement in the vagina (reprocessing, wash hands ● before touching device, etc.)
- . Correctly insert the device into the vagina after sexual intercourse
- Correctly deploy and position the device over the cervical os (assessed by physician) ●
- Correctly avoid sexual activity while the device is in place and wear the device for the maximum amount of time (one hour)
- Assess leakage of semen from the vagina during the one-hour wear duration.
- Correctly remove the device from the vagina
- Health care provider (HCP) or physician assessment and documentation of the volume of semen remaining in the cup after the user removes it.
- HCP assessment for potential vaginal injury/trauma following user removal of the device,
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capturing information on events occurring during use (discomfort, dislocation, device breakage/damage, etc.).
- . Correctly reprocess the device after the actual use period
This study found that all 15 subjects were able to successfully use the device in both in-clinic and athome settings, with all above outcomes met, demonstrating simulated use and real world use respectively.
In conclusion, the clinical studies demonstrated that the intended use population across different health literacy levels was able to comprehend the FERTI.LILY Conception Cup 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.
11. Conclusion
The results of the non-clinical and clinical performance testing described above demonstrate that the FERTI.LILY Conception Cup is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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).