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.

Device Description

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.

AI/ML Overview

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).

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.
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.
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.
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.
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.
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 sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a training set for an algorithm.
How the ground truth for the training set was established
- Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design element connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 18, 2015

Research Instruments Ltd. David Landsdowne Technical Director Bickland Water Industrial Park Falmouth, Cornwall TR11 4TA United Kingdom

Re: K141434

Trade/Device Name: Saturn 5 Laser System Regulation Number: 21 CFR 884.6200 Regulation Name: Assisted reproduction laser system Regulatory Class: II Product Code: MRX Dated: January 14, 2015 Received: January 20, 2015

Dear David Landsdowne,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141434

Device Name Saturn 5 Laser System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/1 description: The image shows a logo with the letters 'R' and 'I' in a bold, serif typeface. A curved line is positioned beneath the letters, adding a sense of motion or elegance to the design. The logo is monochromatic, with the letters and line appearing in black against a white background, creating a stark contrast.

Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: 01326 372753 [International +44 1326 372 753] Fax: 01326 378783 [International +44 1326 378 783] e-mail: sales@research-instruments.com www.research-instruments.com

510(k) Summary

Submitter

Company Name:	Research Instruments Ltd.
Registration Number:	9617095
Address:	Bickland Industrial ParkFalmouth,Cornwall TR11 4TAUnited Kingdom
Telephone:	+44 (0) 1326 372 753
Fax:	+44 (0) 1326 378 783
Contact person:	David Lansdowne, Technical Director
Contact email:	david@research-instruments.com
Date prepared :	Thursday, 18 December 2014
Device
Trade Name:	Saturn 5 Laser Systems, Model - Saturn 5 Active Laser System andSaturn 5 Laser System
Device Name:	Assisted Reproduction Laser System
Classification Name:	Laser, Assisted Reproduction (21CFR 884.6200)
Regulatory Class:	II
Product Code:	MRX

Predicate Device

Saturn 3 Laser Systems, K083208 and K060764 This predicate has not been subject to a design related recall.

Description of the device

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 user/customer is requested to confirm their microscope set-up etc, at the point of ordering.

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.

Saturn 5 differs to the Saturn 3 - Biopsy mode is available with the active model allowing the user to ablate a series of holes along a set, pre-determined path/line. When 'Biopsy Mode' has been

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Image /page/4/Picture/1 description: The image shows a logo with the letters 'RI' in a bold, serif typeface. A curved line underlines the letters, adding a sense of elegance and motion to the design. The logo is monochromatic, with the letters and line rendered in black against a white background. The overall impression is one of sophistication and classic style.

activated, the user selects the position of the first and last hole to be drilled by clicking on the screen. A straight line is then clearly defined between these two points which may or may not, depending on user preference, be manipulated (curved) by dragging the center of the line with the mouse pointer. The software determines how many holes are drilled along this line and controls/restricts laser firing parameters e.g. pulse length, to minimize localized heating of the embryo during these procedures.

Indications for Use

For use in assisted reproduction procedures to ablate or thin the zona pellucida of an 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 preimplantation diagnosis procedures, and blastocvst collapse prior to vitrification procedures.

The indications for use statement for the Saturn 5 system is not identical to the predicate device; however the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same assisted hatching intended use.

Comparison of Technological Characteristics with the Predicate Device

The Saturn 5 and Saturn 3 laser systems operate on the same technological principle ie are used to ablate a user defined section zona pellucida of an embryo. Both devices use a pilot laser to align the main laser and each are available as fixed or moveable lasers. At a high level, other similarities are summarised below:

Saturn 3 models	Saturn 5 models
Laser interaction with target	Same
Laser wavelength	Same
Laser power	Same
Laser pulse duration	Same
Laser classification	Same
Laser preset pulse durations	Same
Laser beam target alignment	Same
Objective magnification	Same
Objective focal length	Same
Computer generated target	Same
Exclusion zone	Same
Image capture and video recording	Same
Measurement functions	Same

The following technological differences exist between the subject and predicate devices:

Saturn 3 models	Saturn 5 models
Indications for use	Same but includes blastomere and trophectodermbiopsy
Software	Same but includes Biopsy mode (active model only)

The new intended use (blastomere and trophectoderm) biopsy is achieved using the same technique as the currently cleared use assisted hatching.

Assisted hatching involves the ablation of the ZP at day 3 to promote 'hatching' of the embryo once it has been re-implanted. Biopsy procedures require the same treatment ie ablation of the ZP at day 3 but to be able to introduce a biopsy needle to the embryo or to promote the herniation of the TE cells, which can be subsequently be biopsied on day 5/6.

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Image /page/5/Picture/1 description: The image shows a logo with the letters 'RI' in a bold, serif typeface. The letters are black and appear to be connected or very close together. Below the letters, there is a curved line that resembles a wave or a swoosh, adding a dynamic element to the design. The overall impression is one of a professional and possibly sophisticated brand identity.

The same size hole would be created for both LAH and for LAB, requiring the same laser pulse length - same location on embryo.

For TE biopsy the laser is also used to dissociate the TE cells from the remaining embryo. By firing several single pulses, whilst holding embryo and extended TE cells under is used in exactly the same way using the same pre-sets as used for LAH and LAB - to weaken the connections between TE cells. Because the laser is employed using the same settings during LAB procedures as LAH procedures, the embryo is not exposed to any new risks with regard to safety and effectiveness.

Biopsy-mode is a new feature for Saturn 5 and is available with the active model only. It was designed as a time saving feature, allowing the user to ablate a series of holes in succession, along a set, pre-determined path. This mode has no behavioural differences to the single shot in that it executes the same fire command as the single shot mode, but delivers them as a series of shots. Because the same calculations and inhibit time applies as for single shot mode heat is allowed to dissipate within the same time period when using Biopsy mode. There is no limit to the length of the ablation area and this length has no effect on the amount of heat generated, so we can conclude Biopsy Mode performs and is as safe as single shot mode.

Summary of Performance Testing

The following performance data was provided in support of the substantial equivalence determination.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing have been conducted on the Saturn 5 Active Laser System. The system complies with IEC 60601-1:2005 3rd edition safety standards and EN 60601-1-2:2007 for EMC. These standards exceed those met by the predicate ie they are medical device as opposed to general laboratory equipment standards of electrical safety and EMC.

Software Verification and Validation Testing

Software verification and validation testing have been conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of premarket Submissions for software Contained in medical devices." The software for this device was considered as a "moderate" level of concern. This matches evidence provided in the predicate submission.

Laser Testing

Both pilot and main lasers are classified as Class I in accordance with IEC60825:2008 and US 21CFR 1040.10. The Saturn 5 laser system uses the same lasers as the Saturn 3 predicate device.

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.

Conclusion

This non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrate that the Saturn 5 laser systems should perform as intended in the specified use conditions.

Regulation Number and Section

§ 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.