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510(k) Data Aggregation
(464 days)
The Seaforia™ Sperm Separation Assistance System Disposable Kit is intended for preparing motile sperm using the swim-up (SU) separation method and holding sperm for use in assisted reproductive procedures such as intrauterine insemination (IUI), intracervical insemination (ICI) and in-vitro fertilization (IVF). The Seaforia™ Sperm Separation Assistance System Disposable Kit is indicated for incubation periods not exceeding one (1) hour.
The Seaforia ™ Sperm Separation Assistance System Heating Device is indicated for use only with the Seaforia ™ Sperm Separation Assistance System Disposable Kit to maintain the temperature (37°C ±0.5) of sperm during the swim-up (SU) separation procedure.
The SeaforiaTM Sperm Separation Assistance System separates motile/progressively motile sperm cells from debris and non-motile sperm cells from the original semen sample for further use in assisted reproductive procedures, including intrauterine insemination (IUI), intra-cervical insemination (ICI) and in-vitro fertilization (IVF). The system provides conditions such as temperature 37°C ±0.5 and effective surface area for the separation of motile human sperm cells. Note: The separation media is not included with the Seaforia" Sperm Separation Assistance System. LOTUS BIO® requires that the media used with the Seaforia'™ Sperm Separation Assistance System be a media cleared for use in the United States that is indicated for sperm handling, washing, or swim-up procedures with a formulation compatible with use outside of a CO2 environment.
The system is composed of the following units:
- . Seaforia™ Sperm Separation Assistance System Disposable Kit - includes designated containers (separators) for the separation media available in various volumes and labware accessories such as syringes, polypropylene tips, pipette and vials. Five versions of the kit will be available to accommodate sperm samples ranging from 0.5-6 ml (Versions 0.5-2 ml. 2.5-3.0 ml. 3.5-4.0 ml, 4.5-5.0 ml, and 5.5-6.0 ml).
- Seaforia™ Sperm Separation Assistance System Heating Device capable . of maintaining the sperm sample at the required temperature (37℃ ±0.5).
The sperm separation procedure takes place within the separator and is based on the original swim-up technique. Media is layered over the liquefied semen sample and during a subsequent incubation period of 30 minutes in the Seaforia™ Sperm Separation Assistance System Heating Device, the motile sperm cells migrate from the semen layer into the media.
Acceptance Criteria and Study for the Seaforia™ Sperm Separation Assistance System
This response outlines the acceptance criteria and the study conducted to demonstrate the performance of the Seaforia™ Sperm Separation Assistance System, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes performance testing for both the disposable kit and the heating device components of the Seaforia™ Sperm Separation Assistance System.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Disposable Kit | ||
| HSSA (Human Sperm Survival Assay) | ≥ 70% motility following 1 hour of exposure | HSSA ≥ 70% motility following 1 hour |
| Endotoxin (LAL) | < 20.0 EU/Device | < 20.0 EU/ Device |
| Cytotoxicity | Non-cytotoxic (per ISO 10993-5:2009) | Non-cytotoxic |
| Sterility | SAL 10⁻⁶ via gamma irradiation | SAL 10⁻⁶ via gamma irradiation |
| Heating Device | ||
| Temperature Maintenance | 37°C ± 0.5°C | Met the acceptance criteria (temperature maintenance at 37 ± 0.5°C) |
| Overall System Efficacy | Yield an end product with improved characteristics (motile sperm with progressive motility and improved normal morphology) relative to the original semen sample. | Media overlaying semen in the separators was enriched with motile sperm cells characterized by progressive motility and improved percentage of normal morphology. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the efficacy testing of sperm preparation. For HSSA and LAL testing, these are described as "lot specific testing parameters per release activities," implying ongoing quality control rather than a single fixed test set for this 510(k).
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
The document does not mention the use of experts to establish ground truth for the test set. The performance data seems to be based on laboratory measurements and analytical methods rather than expert assessment of subjective outcomes.
4. Adjudication Method
No adjudication method is mentioned or implied, as the performance testing focuses on objective laboratory measurements rather than subjective assessments requiring dispute resolution.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is for separating sperm, not for diagnostic interpretation by human readers.
6. Standalone Performance Study (Algorithm Only)
The Seaforia™ system is a physical device for sperm separation, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable. The efficacy testing described is for the device's physical function.
7. Type of Ground Truth Used
The ground truth for the performance testing appears to be based on:
- Laboratory measurements/analytical methods: For HSSA (motility), LAL (endotoxin), cytotoxicity assays, and thermal verification.
- Direct observation/quantification: For the "Efficacy testing of sperm preparation," which assessed characteristics like progressive motility and normal morphology in the separated sperm. This is an objective characteristic of the sperm sample.
8. Sample Size for Training Set
The document does not refer to a "training set" as the device is not an AI/ML-based system requiring such data. The performance testing described validates the physical and biological characteristics of the separated sperm and the heating device's function.
9. How Ground Truth for Training Set was Established
Given that there is no AI/ML component, there is no "training set" and therefore no ground truth established for a training set.
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