(356 days)
The Saturn 3 Laser System is to be used to drill a small tangential hole in, or to thin, the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as: Advanced maternal age, Prior failed IVF, Cryopreserved embryos, Abnormal zona pellucida morphology.
The Saturn 3 Laser System is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.
The provided text describes a 510(k) premarket notification for the "Saturn 3 Laser System." This device is intended for assisted reproduction procedures. The submission focuses on demonstrating substantial equivalence to a predicate device, the Hamilton Thorne Zilos-tk (K050768). As such, the concept of "acceptance criteria" for performance and a study proving those criteria are met, in the sense of a new clinical trial establishing efficacy, is not explicitly presented for the Saturn 3 Laser System itself. Instead, the submission relies on demonstrating equivalence in key technical characteristics and referencing existing clinical evidence for similar technology.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not specify numerical "acceptance criteria" for the Saturn 3 Laser System's performance in the traditional sense. Instead, it asserts its equivalence to the predicate device in specific technical aspects and overall safety.
| Acceptance Criteria | Reported Device Performance (Saturn 3 Laser System) |
|---|---|
| Equivalence to Predicate Device (Hamilton Thorne Zilos-tk (K050768)) | Substantially equivalent based on multiple factors. |
| Pulse energies delivered | Comparable to the predicate device. |
| Hole size creation in embryo zona pellucida | Creates similarly sized holes to the predicate device. |
| Safety for use on human embryos | Clinical trials show the system is safe for use on human embryos when operated in the prescribed manner. |
| Method of operation | Operated in a similar way by the user compared to the predicate device. |
| Co-alignment of target and ablated hole (Non-clinical) | Within 1 µm (comparable to the predicate). |
| Laser Wavelength | Equivalent |
| Laser Power | Equivalent |
| Pulse time range | Equivalent |
| Laser classification | Equivalent |
| Number of preset pulse times | Equivalent |
| Presets user definable | Equivalent |
| Pilot laser for alignment checking | Equivalent |
| Pilot laser power | Equivalent |
| Pilot laser classification | Equivalent |
| Custom objective to focus infrared parfocal to visible | Equivalent |
| Objective magnification | Equivalent |
| Objective Numerical Aperture | Equivalent |
| Computer generated target | Equivalent |
| Hole size indicator | Equivalent |
| Still image recording | Equivalent |
| Video image recording | Equivalent |
| Measurement tools | Equivalent |
| Report generation | Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission references a clinical study for the general safety of laser drilling but doesn't detail a specific "test set" for the Saturn 3 Laser System in terms of sample size or provenance. The non-clinical testing refers to measurements, not a patient-based test set.
- Clinical Testing Sample Size: Not specified for a study specifically testing the Saturn 3 Laser System. The reference is to a published paper showing the safety of laser use on human embryos, implying it's not a de novo study for this specific device in this submission.
- Data Provenance (Clinical): "Reproductive BioMedicine Online 2005 Vol. 11, No. 6. 697-710" refers to a published scientific article, suggesting a peer-reviewed study. The text doesn't specify if it was retrospective or prospective or the country of origin of the data from that specific paper.
- Non-clinical Testing Sample Size: Not applicable in terms of patients; measurements of laser power, pulse length, and co-alignment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The clinical evidence cited is a published study on the effects of zona drilling, not a diagnostic device requiring expert consensus for ground truth on a test set. Non-clinical data involves objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no described test set requiring expert adjudication for ground truth.
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
Not applicable. The Saturn 3 Laser System is an active laser device for assisted reproduction, not a diagnostic device involving "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device with human operation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety assertion: The clinical study referenced implies outcomes data related to "development of human biopsied embryos as revealed by blastomere viability, cytoskeletal analysis and molecular cytogenetics" in comparing different zona drilling methods. This serves as the "truth" for the safety claim.
For the technical characteristics: Objective physical measurements (e.g., laser power, pulse length, co-alignment accuracy) and feature comparison against the predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that requires a training set.
§ 884.6200 Assisted reproduction laser system.
(a)
Identification. The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.