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510(k) Data Aggregation
(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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