(264 days)
For use in assisted reproduction procedures to ablate or thin the zona pellucida of an oocyte or embryo to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres). The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for pre-implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.
The Saturn 5 is the latest generation of ART laser systems manufactured by Research Instruments Limited. It is offered in two versions, the fixed and the active models and is designed to enable laser assisted hatching (LAH), laser assisted biopsy (LAB) and related procedures in assisted reproduction clinics. The system has been designed to be fitted to most commercially available inverted microscopes e.g. Olympus, Nikon and is also used with a PC and camera to provide an optical system and means of firing the laser. A foot pedal for firing the laser is available as an optional extra. The Saturn system comprises hardware, software and firmware. Hardware components include a control unit, armoured fibre optic patch lead, special 40x objective, a mirror module, motor module (active models only), IR filter and foot pedal (optional). This Saturn 5 system delivers two lasers; the main ablation laser and the pilot laser. Both laser beams are launched from the end of a fibre optic and collimated by an achromatic collimator. Saturn 5, RI Viewer software controls the movement of the laser, fires the laser and allows the user to take measurements and store images.
This document is a 510(k) Summary for the Saturn 5 Laser System, which is an assisted reproduction laser system. It outlines the device's characteristics, its intended use, and a comparison to its predicate device, the Saturn 3 Laser Systems.
Here's the breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define "acceptance criteria" in a quantitative manner with reported performance values in a table. Instead, it relies on demonstrating substantial equivalence to a predicate device (Saturn 3 Laser Systems) and compliance with relevant safety and performance standards. The "reported device performance" is largely qualitative and based on compliance with these standards and the lack of reported incidents in a similar market.
However, we can infer the acceptance criteria and performance based on the summaries provided.
Inferred Acceptance Criteria and Reported Performance (Qualitative)
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Safety - Electrical | Compliance with electrical safety standards for medical devices. | The system complies with IEC 60601-1:2005 3rd edition safety standards. This exceeds standards met by the predicate (general laboratory equipment standards vs. medical device standards). |
| Safety - EMC | Compliance with electromagnetic compatibility standards for medical devices. | The system complies with EN 60601-1-2:2007 for EMC. This exceeds standards met by the predicate. |
| Safety - Laser | Classification of lasers as safe according to international standards. | Both pilot and main lasers are classified as Class I in accordance with IEC60825:2008 and US 21CFR 1040.10. The Saturn 5 uses the same lasers as the Saturn 3. |
| Software Performance | Verification and validation of software for medical devices according to FDA guidance, with a moderate level of concern. | Software verification and validation testing were conducted and documentation provided as recommended by FDA guidance. The software was considered a "moderate" level of concern, matching the predicate. Biopsy mode, a new feature, performs like single-shot mode, ensuring heat dissipation and safety. |
| Functional Equivalence | The device should perform its indicated functions (ablating or thinning zona pellucida for assisted hatching, recovering cells for PGD, biopsy of trophectoderm cells, blastocyst collapse) in a manner functionally equivalent and safe to the predicate device, even with new indications. Specifically, the new biopsy mode should not introduce new risks given the same laser settings and operating principles. | The Saturn 5 operates on the same technological principle as Saturn 3 for ablating the zona pellucida. Key parameters (laser interaction, wavelength, power, pulse duration, classification, target alignment, objective magnification, focal length, computer-generated target, exclusion zone, image capture, measurement functions) are the same. The new indications for use (blastomere and trophectoderm biopsy) are achieved using the same technique as assisted hatching. Biopsy mode executes the same fire command as single shot mode, with same calculations and inhibit time for heat dissipation. |
| Clinical Safety/Performance | Absence of reported incidents regarding safety or performance in clinical use. | The Saturn 5 laser system has been used extensively in the European market since May 2012 with no reported incidents with regard to safety or performance when used as intended, including biopsy use. |
Summary of the Study provided (Non-Clinical Data)
The document describes a set of non-clinical tests and comparisons to establish substantial equivalence rather than a single, formal "study" with a specific design (like an RGD study).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No explicit "test set" in the traditional sense of a dataset for an algorithm. The testing involves compliance with standards and functional comparisons.
- Data Provenance: The document states "The Saturn 5 laser system has been used extensively in the European market since May 2012." This suggests retrospective observation of real-world use for clinical safety and performance, but not a formally structured prospective study with a defined test set. The electrical safety, EMC, laser, and software tests are conducted in a controlled, prospective manner following established standards.
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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 as this is not a study requiring expert-derived ground truth for an AI/CAD system. The evaluation is based on compliance with engineering standards and functional similarity to a predicate.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not a study requiring adjudication of expert disagreement.
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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 laser system, not an AI/CAD system for interpretation by human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a tool operated by humans, not an autonomous algorithm for diagnosis or image interpretation. Its "performance" is assessed by its adherence to safety standards and its functional capability when used by an operator.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the various tests would be:
- Electrical Safety & EMC: Compliance with the specifications and limits defined in IEC 60601-1:2005 and EN 60601-1-2:2007.
- Laser Safety: Compliance with IEC60825:2008 and US 21CFR 1040.10 for laser classification.
- Software Verification & Validation: Adherence to the specified functional requirements and absence of critical errors, as outlined in FDA's guidance for software in medical devices.
- Functional Equivalence: Direct comparison of technological characteristics and operating principles with the legally marketed predicate device (Saturn 3 Laser Systems).
- Clinical Safety/Performance: Absence of reported adverse events or incidents during "extensive" use in the European market.
- The "ground truth" for the various tests would be:
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The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a training set for an algorithm.
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How the ground truth for the training set was established
- Not applicable.
§ 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.