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510(k) Data Aggregation
(168 days)
The Stork® OTC 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 Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.
The Stork® OTC package includes: one Instructions for Use, one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.
The provided text describes "The Stork® OTC," a conception assistance kit, and studies conducted to support its over-the-counter (OTC) use.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| User Understanding (Self-Selection & Labeling Comprehension) | Understanding the Indications for Use | All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met. |
| Understanding the Selection of the Device | All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met. | |
| Understanding the Contraindications for Use | All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met. | |
| Understanding Warnings | All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met. | |
| Understanding When to Use the Device | All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met. | |
| Understanding Activity Limitations While Wearing the Cervical Cap | All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met. | |
| Understanding that the Device Does Not Guarantee Pregnancy | All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met. | |
| Understanding How Long To Use the Device Without Successful Results Before Contacting a Physician | All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met. | |
| Physical Usability (Simulated Use) | Male Endpoints: | Male Performance: |
| Correctly Place the Conceptacle on a Penis | Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen"). | |
| Correctly Remove the Conceptacle from a Penis | Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen"). | |
| Correctly Separate the Condom from the Cervical Cap | Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen"). | |
| Collect and Contain Semen Using the Conceptacle (Usability only) | Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen"). | |
| Female Endpoints: | Female Performance: | |
| Correctly Place the Cervical Cap in the Applicator | Successfully completed ("All primary endpoints were achieved" for simulated use, and confirmed "All subjects were able to...effectively position and place the Conceptacle® in the vaginal tract using the applicator, and remove the cervical cap from the vaginal tract"). | |
| Correctly Close the Applicator | Successfully completed. | |
| Correctly Insert the Applicator into a Vaginal Tract | Successfully completed. | |
| Correctly Position the Applicator Near the Cervical Os | Successfully completed. | |
| Correctly Open the Cervical Cap with the Applicator | Successfully completed. | |
| Correctly Engage the Trigger Button to Release the Cervical Cap | Successfully completed. | |
| Leave the Cap in Place as Directed (Usability only) | Successfully completed. | |
| Correctly Avoid Sexual Activity While the Cervical Cap is in Place (Usability only) | Successfully completed. | |
| Correctly Withdraw Device from the Vaginal Tract | Successfully completed. | |
| Correctly Treat the Device as Single Use | Successfully completed. | |
| Safety (Clinical Human Factors/Usability & Physical Examination) | No evidence of trauma or injury to the vaginal tract or cervical os during use and removal. | "These steps [collection, placement, removal] were successfully completed without any evidence of trauma or injury to the vaginal tract or cervical os." This was verified by visual inspection and physical examination by the primary investigator. |
| Biocompatibility | Materials are non-cytotoxic, non-irritating, and non-sensitizing. | Testing demonstrated that the Stork® OTC materials are considered non-cytotoxic, non-irritating, and non-sensitizing. Colorant safety also deemed acceptable through Colorant Leachables Testing and Toxicological Risk Assessment. |
| Material/Mechanical Properties | Pull strength of the withdrawal cord is met. | Bench testing demonstrated that the pull strength of the withdrawal cord was met for all systems tested. |
| Shelf-Life | All components function properly and according to design intent after a specified shelf life. | A 6-month shelf-life study was performed, and all components were shown to function properly and according to design intent. (Note: Data from the predicate device was used for Condom Mechanical Testing and Shelf-life for the Conceptacle itself). |
| Human Sperm Survival Assay (HSSA) | (Implicitly, the device should not adversely affect sperm viability). | Data from the predicate device (Focus Touch® Conception System) was used for Human Sperm Survival Assay (HSSA), implying the Stork® OTC also meets this. |
| Condom Mechanical Testing | (Implicitly, the condom-like sheath should meet mechanical standards). | Data from the predicate device (Focus Touch® Conception System) was used for Condom Mechanical Testing, implying the Stork® OTC also meets this. |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the self-selection, labeling comprehension, simulated use, or clinical human factors/usability studies. It states "All primary endpoints were achieved in all three sections of the study" and "All subjects were able to use the device." Without specific numbers, the sample size remains unknown from the provided text.
- Data Provenance: The studies were described as "Performance Testing - Clinical" and "Performance Testing - Bench." These were conducted prospectively to demonstrate the device's suitability for over-the-counter use and safe application by lay users. The country of origin for the studies is not explicitly stated, but given the context of a 510(k) submission to the FDA, it's highly likely they were conducted in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the clinical human factors/usability testing where safety was assessed, it states: "These endpoints were verified by visual inspection and physical examination by the primary investigator." This indicates at least one expert (the primary investigator) was involved in establishing safety ground truth.
- Qualifications of the expert(s): The qualifications of the primary investigator are not explicitly detailed beyond being a "primary investigator" for a clinical study involving physical examination. It can be inferred they are a medical professional, likely a physician or gynecologist, qualified to conduct such examinations and verify safety endpoints related to the vaginal tract and cervical os.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not detail any specific adjudication method like 2+1 or 3+1 for the user studies or the primary investigator's findings. The verification appears to have been carried out by the "primary investigator" directly. Therefore, it implicitly suggests a "none" or "single expert review" adjudication for the clinical safety aspects. For user performance, the "correctness" of actions was likely directly observed and recorded.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (conception kit), not an AI-powered diagnostic tool requiring human reader interpretation of images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is a physical medical device and does not involve an algorithm. The testing focused on the standalone performance of users correctly applying the device without professional medical supervision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Usability and Safety: The ground truth was primarily established through direct observation of user performance (for correct steps) and physical examination by a primary investigator (for safety endpoints like trauma/injury). This constitutes a form of expert assessment of physical outcomes.
- For Biocompatibility and Mechanical Testing: The ground truth was established through laboratory testing against established ISO standards and internal specifications (e.g., ISO 10993-1: 2009 for biocompatibility, specific pull strength measurements).
8. The sample size for the training set:
- The document does not mention a training set for the device's studies. The studies described are performance testing (self-selection, comprehension, simulated use, clinical human factors/usability, bench testing), which are typically considered validation or verification tests rather than training data for a device or algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for the device's studies is mentioned in the provided text.
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(402 days)
The Focus Touch Conception System is indicated for assisted insemination in instances where low sperm count, sperm immobility, or hostile vaginal environment has been diagnosed. The system (cervical cap in a condom-like silicone sheath) is used to collect semen into a cervical cap, and then deliver the cap to the outside of the cervix as an aid to conception. It is to be used at home following physician instruction. The Focus Touch Conception System should not be left in place for longer than 6 hours.
The Focus Touch™ Conception System includes detailed Instructions for Use, one Conceptacle and one plastic applicator. The system can be purchased packaged in a quantity of one (1) or three (3) individually packaged systems.
Once the couple has decided to attempt to become pregnant, the Focus Touch™ Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cao is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervical cap is loaded onto the applicator (while it is still outside of the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intravaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.
The provided text describes the Focus Touch™ Conception System and its substantial equivalence to a predicate device. It details various aspects of the device and the testing performed, but it does not provide acceptance criteria in a quantitative format or a comprehensive study report with detailed performance metrics. The information is primarily focused on demonstrating equivalence through comparison and summary of tests.
Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging where specific details are missing:
Acceptance Criteria and Device Performance for Focus Touch™ Conception System
The provided documentation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with explicit quantitative acceptance criteria and detailed performance results. The "performance" is largely reported as successful completion of specific tests, indicating the device met the implicit requirements for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission, precise numerical acceptance criteria and corresponding reported device performance for clinical effectiveness are not provided. Instead, the document outlines types of tests performed and their successful completion for demonstrating safety and functionality.
| Test Category | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials should be non-cytotoxic, non-irritating, and not elicit a sensitization response. | Demonstrated that the device is non-cytotoxic, not an irritant, and did not elicit a sensitization response. ("considered non-cytotoxic, is not an irritant and did not elicit a sensitization response.") |
| Sperm Compatibility (HSSA) | Device materials (Conceptacle) should have no deleterious effects on human sperm. For HSSA, human sperm must demonstrate forward progressive motility rate of ≥80% of the initial forward progressive motility sperm swim up after 6 hours of sample preparation. | Human Sperm Survival Assay (HSSA) testing performed on the silicone Conceptacle demonstrated "no deleterious effects on human semen." ("Conceptacle, material has no deleterious effects on human semen.") (The 80% criterion is stated for the predicate device's test, and "Same" is indicated for the proposed device, suggesting this criterion was met.) |
| Semen Collection | The Conceptacle should be comfortable (no slip, breakage, ability to ejaculate) and adequate (able to collect and contain semen) during use. | Usability and acceptability testing successfully validated that "the use of the Conceptacle for semen collection was comfortable (slip, breakage, ability to ejaculate) and adequate (able to collect and contain semen)." |
| Condom-like Sheath Material | Silicone material should be biocompatible, acceptable as a semen collection device (comfort, adequacy), and similar in malleability to standard polyurethane condoms. | Silicone material was shown to be biocompatible and acceptable with regard to comfort and adequacy in validation testing. Malleability was noted as "very similar... with a durometer of 30-40 on the Shore A scale." ("The device has been shown to be biocompatible and acceptable as a semen collection device with regard to comfort (slip, breakage, ability to ejaculate) and adequacy (ability to collect and contain semen) in validation testing.") |
| Burst Pressure & Volume | Exceed minimum requirements for commercially available condoms. | Bench testing "exceeded the minimum requirements for burst pressure and volume for commercially available condoms." |
| Pull Strength (Withdrawal Cord) | Sufficient pull strength of the collet/string attached to the cervical cap to prevent separation from the collet. | Bench testing "demonstrated that the pull strength of the withdrawal cord, specifically Cervical Cap/Collet Separation Force for the Focus Touch System, was met for all systems tested." |
| Shelf Life | All components should function correctly and according to their design intent after a specified real-time storage or accelerated aging period. | A shelf life study verified that "all components of the Focus Touch System were shown to function correctly and according to their design intent following a minimum real-time storage during and or accelerated aging period equivalent to six (6) months." |
| Usability (Study 1) | End-users should understand Instructions for Use, and manipulate, insert, and remove the cap correctly without direct supervision. Safety to the vaginal tract verified by physical examination. | "Study 1 testing was performed with the cervical cap and applicator to demonstrate that the end user can understand the Instructions for Use, and manipulate, insert and remove the cap correctly without direct supervision. ... a physical examination occurred to verify safety of the device to the vaginal tract and all success criteria were met." |
| Usability (Study 2) | Appropriate ease of use, comfort, acceptability, and safety when used during sexual intercourse as a collection device. | "Study 2 testing was performed to demonstrate appropriate ease of use, comfort and acceptability and safety when used during sexual intercourse as a collection device." The text implies success but does not explicitly state "all success criteria were met" for Study 2 as it does for Study 1. However, the subsequent conclusion of substantial equivalence implies satisfactory results. |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- No specific numerical sample sizes are provided for the usability studies or bench testing, except that "all systems tested" met the pull strength requirement.
- For the HSSA, the description "human sperm must demonstrate..." refers to the criterion for the test rather than the number of samples or subjects used in the actual test itself.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they involved active testing (bench, HSSA, usability studies).
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The "ground truth" for these tests relates to measurable physical or biological properties (biocompatibility, sperm motility, burst strength) or observable user behavior/feedback (usability studies), rather than expert interpretation of medical images or patient records. The "experts" would likely be laboratory technicians for bench tests or study coordinators/medical professionals for usability, but their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The tests described are primarily objective (e.g., measuring burst pressure, checking for cytotoxicity) or involve direct observation/user feedback that doesn't typically require an adjudication method like 2+1 or 3+1.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a physical medical device (conception assistance kit), not a diagnostic algorithm that would typically undergo an MRMC study. The study focuses on the device's physical and functional properties, biocompatibility, and usability.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is not an algorithm, but a physical device.
7. Type of Ground Truth Used
The "ground truth" for the tests mentioned includes:
- Laboratory-measured properties: Biocompatibility (cytotoxicity, irritation, sensitization), HSSA (sperm motility), mechanical properties (burst pressure, pull strength).
- User feedback/observation: For usability (comfort, ease of use, ability to manipulate and remove).
- Physical examination: To verify safety to the vaginal tract in Usability Study 1.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm requiring a "training set."
9. How Ground Truth for Training Set Was Established
Not applicable. As above, this is not an AI/ML device.
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(58 days)
The Sagami Polyurethane Semen Collection Device is intended to be used as an accessory to the Oves Cervical Cap to collect semen for transfer to the cap prior to insertion in artificial insemination procedures.
The subject device is a polyurethane condom.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Conceivex Latex-free Semen Collector:
Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results. Instead, it relies on a qualitative assessment of "no deleterious effects" compared to predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| No deleterious effects on human semen. | "Human Sperm Survival Assay... demonstrated that the condom material has no deleterious effects on human semen." |
| No deleterious effects on embryo development. | "Mouse Embryo Assay performed on the Sagami non-latex condom demonstrated that the condom material has no deleterious effects on... embryo development." |
| Equivalence in safety and effectiveness to predicate devices. | "The results of this testing demonstrate that the new devices is as safe and effective as the predicates." |
Study Details
-
Sample size used for the test set and the data provenance:
- Human Sperm Survival Assay: Not specified.
- Mouse Embryo Assay: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to the biological assays (sperm survival, embryo development) which are scientific measurements rather than expert interpretations.
-
Adjudication method for the test set: Not applicable. This concept typically applies to studies where human reviewers assess data against a standard, not to laboratory assays.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study focuses on the biological safety of a device material, not on AI-assisted diagnostic effectiveness.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical semen collector, not an algorithm.
-
The type of ground truth used:
- Human Sperm Survival Assay: Biological assay measuring sperm viability/function.
- Mouse Embryo Assay: Biological assay measuring embryo development.
-
The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device, so there is no training set in the conventional sense.
-
How the ground truth for the training set was established: Not applicable, as there is no training set. The "ground truth" for the testing (assays) was established through scientific measurement in laboratory conditions.
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(141 days)
The Conceivex Conception Kit is indicated for assisted insemination in situations in which low sperm count, sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for longer than 6 hours.
The Conceivex Conception Kit includes the following literature: Instructions for Use, a "Conception Wheel" to help plan in timing a pregnancy, a "Conception Journal" booklet to assist in charting the fertility cycle and keep track of medical information, and a Medical Provider Note to alert the woman's health care provider that she is trying to become pregnant.
The kit contains three identical boxes, each of which contain: one Oves Cervical Cap, one cervical cap for practice, one Avanti Semen Collection Condom, eight Ovulation Predictors, a Pregnancy Test, and a sample of 'Pre Vaginal Lubricant. The three boxes enable the woman to try to conceive by using the Kit through three ovulation cycles.
Once the couple has visited with a physician and decides they would like to become pregnant, they begin recording details of their cycle in the Conception Journal. Next, using the ovulation predictor, they identify their most fertile day in a given month. During sex they use the semen collector and afterwards transfer the specimen into the Conception Cap. The Conception Cap is then placed over the cervix for 4-6 hours. At the end of the woman's cycle, she uses the Conceivex pregnancy test kit to determine if conception has been achieved.
The provided text K063227 describes the Conceivex Conception Kit, which focuses on assisted insemination using a cervical cap and a semen collection condom. The submission is for new indications for use for existing components (Oves Cervical Cap and Durex Avanti Polyurethane Condom) within the kit.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of predetermined acceptance criteria with quantitative targets for performance. Instead, the "acceptance criteria" are implied to be that the devices, with their new indications for use (home use for the cervical cap and semen collection for the condom), are "as safe and effective as the predicate devices."
The reported device performance is described qualitatively rather than with specific metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Condom: No deleterious effects on human semen or embryo development with new indication (semen collection). | Human Sperm Survival Assay: Demonstrated no deleterious effects on human semen. |
| Mouse Embryo Test: Demonstrated no deleterious effects on embryo development. | |
| Cervical Cap: Lay user able to understand revised Instructions for Use and correctly manipulate/insert the cap without direct supervision with new indication (home use for assisted insemination). | Clinical Testing (Cap): Demonstrated that the lay person can understand the revised Instructions for Use and manipulate and insert the cap correctly without direct supervision. |
| Overall: Devices with new Indications for Use are as safe and effective as their predicates. | Overall: The results of the testing demonstrate that the devices with the new Indications for Use are as safe and effective as their predicates, leading to a conclusion of Substantial Equivalence. |
2. Sample size used for the test set and the data provenance
- Sample size: The document does not specify the sample size for any of the tests (Human Sperm Survival Assay, Mouse Embryo Test, or the clinical testing for the cap).
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. The studies described are laboratory and user performance tests rather than diagnostic or interpretative studies requiring expert ground truth establishment in that typical sense. The "ground truth" for the cap's usability would likely be determined by observing lay users' ability to follow instructions and correctly use the device.
4. Adjudication method for the test set
Not applicable. The described tests do not involve expert adjudication in the context of diagnostic performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not conducted. This submission is for medical devices for assisted reproduction, not for an AI diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device itself (cervical cap, condom) is evaluated for its physical properties and user-friendliness with its new indications.
7. The type of ground truth used
- Condom: The ground truth for the condom's safety regarding semen and embryo development would be established through laboratory assays (Human Sperm Survival Assay and Mouse Embryo Test) designed to quantify any deleterious effects. The "ground truth" is a scientific measure of biological response.
- Cervical Cap: The ground truth for the cap's usability by a lay person would be established through direct observation and assessment of user performance against predefined criteria for correct understanding and manipulation/insertion. This is a form of usability or human factors testing where the ground truth is successful completion of tasks.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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