(269 days)
Not Found
No
The device description and intended use focus on a physical barrier device and do not mention any computational or data-driven components. The performance studies are related to usability and label comprehension, not algorithmic performance.
No
The device aids conception by physically positioning semen, not by treating a disease or condition. The indicated conditions (low sperm immobility, unfavorable vaginal environment) are related to infertility but the device does not treat these conditions themselves; it acts as a mechanical aid for conception.
No.
The document describes the device as an aid to conception, not a tool for diagnosing medical conditions. It helps retain semen near the cervix for conception, rather than identifying or characterizing a disease or condition. The device description explicitly states it is "an aid to conception," and the studies focus on usability and comprehension, not diagnostic accuracy.
No
The device description explicitly states it is a "non-sterile, silicone, over-the-counter (OTC) device" and describes its physical components and mechanism of action (placement, deployment, positioning). This indicates it is a physical medical device, not software-only.
Based on the provided information, the FERTI.LILY Conception Cup is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- FERTI.LILY Function: The FERTI.LILY Conception Cup is a physical device inserted into the vagina after intercourse. Its function is to physically retain semen near the cervix to aid conception. It does not analyze any biological specimens or provide diagnostic information.
- Intended Use: The intended use clearly states it's an "aid to conception" for couples with specific challenges, not a diagnostic tool.
- Device Description: The description focuses on the physical nature and placement of the device, not on any analytical or diagnostic capabilities.
Therefore, the FERTI.LILY Conception Cup falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HDR
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. The FERTI.LILY Conception Cup includes a stem to assist with removal from the vagina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, cervical os, vaginal cavity, uterus, vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
Biocompatibility: Studies performed in accordance with ISO 10993-1, ISO 10993-5:2009/R 2014, ISO 10993-10:2010/R 2014, and ISO 10993-11:2017 showed the device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Shelf Life: A real-time shelf-life study for 36 months verified the device maintained specifications for Device Color, appearance, odor, Dimensional specifications, Volume, Tensile testing (force at break and elongation), Hardness (Shore A), and Human Sperm Survival Assay (HSSA).
Reprocessing: Validation conducted per FDA guidance (2015) with residual protein and total organic carbon (TOC) analysis to ensure no residuals after reprocessing.
Use-Life: Testing on newly manufactured and reprocessed devices confirmed specifications maintained for 3 months for Device Color, appearance, odor, Dimensional specifications, Volume, Tensile testing, Hardness (Shore A), and Human Sperm Survival Assay (HSSA).
Clinical Performance Testing:
Four clinical studies were conducted to support OTC at home use focused on Self-Selection, Label Comprehension, and Actual Use Usability.
First Study: Self-selection, label comprehension, and virtual simulated use study.
Sample size: 75 naïve subjects enrolled, 74 completed.
Key results: Prespecified target comprehension level of 80% for each knowledge endpoint related to self-selection, label comprehension, and simulated-use was met.
Second Study: Labeling comprehension study.
Sample size: 41 naïve subjects completed.
Key results: Target comprehension level (80%) of each knowledge endpoint tested was met.
Third Study (FCC-001): Usability and label comprehension study.
Sample size: 15 subjects enrolled.
Key results: All subjects demonstrated clear understanding of package directions. 87% of subjects successfully inserted the device. Transient non-serious adverse events (discomfort, irritation, cramping) were reported but did not require treatment. High ease of use and satisfaction reported.
Fourth Study (FCC-002): Usability and safety study.
Sample size: 15 subjects enrolled.
Key results: 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.
Endpoints assessed: Correctly follow instructions prior to placement, correctly insert device, correctly deploy and position device (assessed by physician), correctly avoid sexual activity and wear for maximum time, assess leakage of semen, correctly remove device, HCP assessment of semen volume remaining, HCP assessment for vaginal injury/trauma, correctly reprocess device. All outcomes were met.
Conclusion: Clinical studies demonstrated the intended use population's ability to comprehend labeling and intended use, and successfully completed all study elements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Label comprehension: 80% target met in first and second studies.
Usability/Insertion: 87% successful insertion in third study, 100% correct insertion in fourth study.
Safety: No device-related adverse events or deficiencies in fourth study.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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.
1
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
2
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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3
510(k) Summary K222969 FERTI.LILY Conception Cup
1. Submitter Information
| Applicant: | Rosesta Medical BV |
|---|---|
| Address: | Mr. Treublaan 7, 1097DP |
| Amsterdam, 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.
4
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.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 | The oves cervical | ||
| cap is indicated | |||
| for use in artificial | |||
| insemination | |||
| procedures in | |||
| situations in | |||
| which low sperm | |||
| count, sperm | |||
| immotility, or | |||
| hostile vaginal | |||
| environment have | |||
| been diagnosed. | |||
| The oves cervical | |||
| cap removes | |||
| semen from the | |||
| vaginal | |||
| environment and | |||
| concentrates the | |||
| sperm at the | |||
| opening of the | |||
| cervical os, thus | |||
| facilitating sperm | |||
| contact with | |||
| cervical mucosa. | The subject and | ||
| predicate device | |||
| indications are not | |||
| identical. Differences | |||
| include the subject | |||
| device is for OTC home | |||
| use while the predicate | |||
| is for prescription use | |||
| in a clinical setting. | |||
| Also, the subject device | |||
| is used after | |||
| intercourse, while the | |||
| predicate is loaded | |||
| before vaginal | |||
| placement. The | |||
| differences between the | |||
| indications for use for | |||
| the two devices do not | |||
| represent a new | |||
| intended use as both | |||
| devices are intended to | |||
| maintain a pool of | |||
| semen/sperm near the | |||
| cervical os as an aid to | |||
| conception. | |||
| 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 | No (non-sterile) | Not known | Different: Information |
| regarding predicate | |||
| device sterility is not | |||
| known. However, | |||
| differences in sterility | |||
| for these vaginal-use | |||
| devices do not raise | |||
| different questions of | |||
| safety and effectiveness | |||
| (S&E) | |||
| Device components | Cervical Cup, storage | ||
| bag | Cervical Cap | Similar | |
| Use environment | OTC, home | ||
| environment | RX, clinical | ||
| environment | Different: The | ||
| difference in use | |||
| environment of the | |||
| subject and predicate | |||
| devices do not raise | |||
| different questions of | |||
| S&E. | |||
| 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 | Silicone | Same |
| Cap loading | Placed in vagina after | ||
| intercourse | Semen added to | ||
| cap before | |||
| placement | Different: The subject | ||
| device is placed after | |||
| intercourse, while the | |||
| predicate is loaded with | |||
| sperm before delivery. | |||
| These differences do | |||
| not raise different | |||
| questions of S&E (e.g., | |||
| device design maintains | |||
| sperm 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 | |||