SATURN 5 LASER

K141434 · Research Instruments , Ltd. · MRX · Feb 18, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K141434
• Device Name: SATURN 5 LASER
• Applicant: Research Instruments , Ltd.
• Product Code: MRX · Obstetrics/Gynecology
• Decision Date: Feb 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6200
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K141434 · Feb 18, 2015	SATURN 5 LASER	Research Instruments , Ltd.	European market postmarket surveillance data	The sponsor utilized postmarket performance data from the European market to support the safety and effectiveness of the Saturn 5 laser system, noting extensive use since 2012 without reported safety incidents.	postmarket surveillance; European market experience

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
European market postmarket surveillance; Postmarket surveillance / Real-world usage monitoring; Follow-up/Duration: May 2012 to December 2014; Study Period: May 2012 - December 2014	Patients undergoing assisted reproduction procedures in the European market	Not applicable for this study	Safety and performance (reported incidents)

Indications for Use

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 Story

Saturn 5 is an ART laser system for assisted hatching, biopsy, and blastocyst collapse; used in assisted reproduction clinics by embryologists. System integrates with inverted microscopes; includes control unit, fiber optic patch lead, 40x objective, mirror/motor modules, IR filter, and optional foot pedal. Inputs: user-defined target points on embryo via PC/camera interface. Operation: main ablation laser and pilot laser; RI Viewer software controls laser movement, firing, and imaging. Active model features 'Biopsy Mode' for automated series of ablation holes along a user-defined path. Output: laser pulses to ablate zona pellucida. Clinical benefit: facilitates genetic diagnosis and embryo preparation for vitrification. Safety: software restricts firing parameters to minimize localized heating; same laser settings as predicate.

Clinical Evidence

No clinical trials performed. Evidence based on bench testing, electrical safety/EMC compliance (IEC 60601-1:2005, EN 60601-1-2:2007), and software verification/validation. Laser classification (Class I) verified per IEC 60825:2008 and 21 CFR 1040.10. Post-market performance data from European market (since 2012) indicates no reported safety or performance incidents.

Technological Characteristics

Laser-based ablation system for ART. Components: control unit, fiber optic lead, 40x objective, mirror/motor modules, IR filter. Laser: Class I (IEC 60825:2008, 21 CFR 1040.10). Connectivity: PC-based with camera interface. Software: RI Viewer for laser control, measurement, and image storage. Standards: IEC 60601-1:2005 (electrical safety), EN 60601-1-2:2007 (EMC).

Indications for Use

Indicated for assisted reproduction procedures requiring zona pellucida ablation or thinning in oocytes or embryos, including assisted hatching, blastomere biopsy, trophectoderm cell biopsy for pre-implantation genetic diagnosis, and blastocyst collapse prior to vitrification.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Saturn 3 Laser Systems (K083208, K060764)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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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: [phone] [International [phone]] Fax: [phone] [International [phone]] e-mail: [e-mail] www.research-instruments.com

#### 510(k) Summary

#### Submitter

| Company Name: | Research Instruments Ltd. |
|----------------------|-------------------------------------------------------------------------------------------|
| Registration Number: | 9617095 |
| Address: | Bickland Industrial Park<br>Falmouth,<br>Cornwall TR11 4TA<br>United Kingdom |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact person: | David Lansdowne, Technical Director |
| Contact email: | [e-mail] |
| Date prepared : | Thursday, 18 December 2014 |
| Device | |
| Trade Name: | Saturn 5 Laser Systems, Model - Saturn 5 Active Laser System and<br>Saturn 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 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 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 trophectoderm<br>biopsy |
| 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.