(264 days)
No
The description focuses on the hardware and software controlling a laser for assisted reproduction procedures. There is no mention of AI or ML capabilities for image analysis, decision-making, or automation beyond basic laser control and image capture.
Yes
The device is used in assisted reproduction procedures to ablate/thin the zona pellucida of an oocyte or embryo, facilitate assisted hatching, recover cells for pre-implantation genetic diagnosis, biopsy trophectoderm cells, and blastocyst collapse prior to vitrification. These actions are intended to treat or prevent medical conditions related to reproduction.
No
The "Intended Use" section states the device is used 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)" and "for biopsy of trophectoderm cells for pre-implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures." These are all therapeutic or preparatory procedures, not diagnostic ones. While the device facilitates the recovery of cells for PGD, it doesn't perform the diagnosis itself.
No
The device description explicitly states that the Saturn 5 system comprises hardware, software, and firmware, and lists several hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed on biological material (oocytes, embryos) to modify it (ablate or thin the zona pellucida, biopsy cells, collapse blastocysts). This is a therapeutic or procedural intervention, not a diagnostic test performed on a sample to determine a medical condition or state.
- Device Description: The device is a laser system designed to physically interact with and modify the biological material. It's a tool used in a procedure, not a system for analyzing a sample to obtain diagnostic information.
- Lack of Diagnostic Claims: There are no claims or descriptions of the device being used to diagnose a condition, measure a biomarker, or provide information about a patient's health status based on analysis of a sample.
- Performance Studies: The performance studies focus on safety (electrical, EMC, laser classification) and software validation, which are typical for medical devices used in procedures, but not specifically for validating the diagnostic accuracy of an IVD.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to facilitate procedures in assisted reproduction, which is a therapeutic/procedural application.
N/A
Intended Use / 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.
Product codes
MRX
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 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 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.
Mentions image processing
Saturn 5, RI Viewer software controls the movement of the laser, fires the laser and allows the user to take measurements and store images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Park |
| Falmouth, | |
| Cornwall TR11 4TA | |
| United 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 and |
| 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
4
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 |
| 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.
5
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.