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 blastocyst collapse prior to vitrification procedures.

Device Description

This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The LaserShot M components include a laser module (1.48 um infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25X), USB camera, EyeWare Software, and an optional target pointer and footswitch. The NaviLase includes the same components as the LaserShot M. but also includes a motion module and a motion controller. These additional components allow the NaviLase to work in two modes, fixed and dynamic. In fixed mode, the NaviLase operates similarly to the LaserShot M. In dynamic mode, the laser can be directed to any location within the field of view. In addition, dynamic mode allows automated laser firing along a user-defined path (straight line, arc, etc.). The EveWare controls the device components, operates the laser, and takes images and records videos of embryo undergoing laser procedures. The software determines how many holes are drilled along this line and controls/restricts laser firing parameters to minimize localized heating of the embryo during these procedures. These laser devices have been designed to be fitted to compatible inverted microscopes.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study details:

Overall Assessment: The provided document is a 510(k) summary for a medical device (NaviLase, LaserShot M). It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or extensive study results that would typically be seen in a clinical trial report.

As such, there is no direct mention of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or a formal clinical "study" in the sense of a statistical power calculation or clinical outcomes trial proving the device meets such criteria. The 'Performance Testing' section describes engineering and functional tests to ensure the device operates as intended and is safe, but not a study to prove a specific clinical performance metric against a defined threshold.

The document primarily relies on comparing the subject device's technological features and performance to a legally marketed predicate device to establish substantial equivalence.

Detailed Breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no specific quantitative acceptance criteria (e.g., target accuracy, sensitivity, specificity) listed for the device's clinical effectiveness in terms of diagnostic or therapeutic outcomes, nor are there explicit "reported device performance" metrics against such criteria.

The "Performance Testing" section outlines tests conducted for:

Reprocessing: Implicit acceptance criterion is compliance with the 2015 FDA guidance document.
Electrical Safety and Electromagnetic Compatibility (EMC): Implicit acceptance criterion is compliance with IEC 60601-1:2005/AMD1:2012 (electrical safety) and IEC 61326-1:2012 (EMC).
Software and Cybersecurity: Implicit acceptance criterion is compliance with 2005 FDA guidance for software (minor level of concern) and 2014 FDA guidance for cybersecurity.
Laser Performance: Implicit acceptance criterion is compliance with recommendations in Section 7 of FDA's 2004 guidance document "Assisted Reproduction Laser Systems." Additional tests included demonstrating:
- Compatibility with different microscope systems.
- Alignment of the target pointer with the laser beam.
- Validation of NaviLase dynamic targeting within the field of view.
- Validation of NaviLase dynamic targeting system's ability to complete automated ablations under specific treatment modes (hole, hatching, thinning, trophectoderm).

No numerical performance metrics (e.g., laser ablation success rate, embryo viability post-procedure) are provided in this summary. The conclusion states that the testing "demonstrate[s] that the subject device is substantially equivalent to the predicate device," implying the performance was comparable and acceptable without providing specific numbers.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified. The document refers to "testing" and "validation" but does not provide details on the number of embryos, oocytes, or experimental runs used for any of the performance tests.
Data Provenance: Not specified. Given the nature of these tests (engineering, software, laser characteristics), it's likely internal lab testing rather than human subject data. There is no mention of country of origin or whether it's retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts/Qualifications: Not specified. For the laser performance and dynamic targeting validation, it's implied that there were either internal experts or a defined methodology to assess the successful completion of ablations and targeting. However, no details on the number or qualifications of these individuals, if any, are provided.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified. Given the nature of the tests (electromechanical, software, laser characteristics), it's unlikely a clinical adjudication method like 2+1 or 3+1 was used. These would typically involve objective measurements or pass/fail criteria based on engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. The document does not describe an MRMC study. This device is an Assisted Reproduction Laser System, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases. Therefore, the concept of human readers improving with AI assistance is not applicable in this context.

6. Standalone (Algorithm Only) Performance Study:

Standalone Performance: Not applicable in the sense of an algorithm. The device has "EyeWare Software" that controls components, operates the laser, and determines ablation patterns. The "Validation of NaviLase dynamic targeting system's ability to complete automated ablations under specific treatment modes" could be considered a form of standalone performance evaluation for the software's ability to execute laser patterns, but it's not described as an "algorithm only" study comparing its output to a gold standard as one might see for an AI diagnostic algorithm.

7. Type of Ground Truth Used:

Ground Truth: For the "Laser performance testing," the ground truth was likely based on physical measurements and visual confirmation (e.g., successful ablation, correct hole size, accurate targeting) against predefined technical specifications for the laser system's operation. For other tests (reprocessing, electrical safety, software), the ground truth is adherence to established regulatory and technical standards.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This device is a laser system, not a machine learning model that requires a "training set" in the conventional sense for learning patterns from data.

9. How Ground Truth for the Training Set Was Established:

Training Set Ground Truth: Not applicable for the reasons stated above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through compliance with recognized standards and functional performance tests for a medical device. It does not contain the level of detail regarding clinical acceptance criteria, study design, sample sizes, or ground truth establishment that would be present in a submission for an AI/ML-driven diagnostic device or a comprehensive clinical trial report.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

March 25, 2020

Vitrolife GmbH Susanne Schweitzer Manager QA/QC/RA Dr .- Pauling-Str. 9 Bruckberg, Bavaria 84079 GERMANY

K192008 Re:

Trade/Device Name: NaviLase, LaserShot M Regulation Number: 21 CFR 884.6200 Regulation Name: Assisted Reproduction Laser System Regulatory Class: II Product Code: MRX Dated: February 19, 2020 Received: February 24, 2020

Dear Susanne Schweitzer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 may 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192008

Device Name NaviLase, LaserShot M

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K192008

Submitter

Company Name Address

Contact person

Name Company Address

Phone FAX Email

Date Prepared

Subject device

Trade name Common Name Regulation Name Requlation Number Product code Requlatory Class

Predicate device

510(k) number Device name Manufacturer

Vitrolife GmbH Dr .- Pauling-Str. 9 84079 Bruckberg Germany

Susanne Schweitzer Vitrolife GmbH Dr.-Pauling-Str. 9 84079 Bruckberg Germany +49 (0) 8765 / 939 90-19 +49 (0) 8765 / 939 9070 SSchweitzer@vitrolife.com

March 22, 2020

NaviLase, LaserShot M Assisted Reproduction Laser System Assisted Reproduction Laser System 884.6200 MRX (System, Assisted Reproduction Laser) =

K141434 Saturn 5™ Laser Systems Research Instruments Ltd

The predicate device has not been subject to a design-related recall

Device Description

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minimize localized heating of the embryo during these procedures. These laser devices have been designed to be fitted to compatible inverted microscopes.

Indications for Use

	Subject DeviceLaserShotM/NaviLaseK181776	Predicate DeviceSaturn 5K141434	Comparison
Indications forUse	For use in assistedreproductionprocedures to ablate orthin the zona pellucidaof an embryo tofacilitate assistedhatching or recovery ofcells for pre-implantation geneticdiagnosis(blastomeres). Thedevice can also beused on blastocyststage embryos forbiopsy oftrophectoderm cells forpreimplantationdiagnosis procedures,and blastocyst collapseprior to vitrificationprocedures.	For use in assistedreproduction proceduresto ablate or thin the zonapellucida of an oocyte orembryo to facilitateassisted hatching orrecovery of cells for pre-implantation geneticdiagnosis (blastomeres).The device can also beused on blastocyst stageembryos for biopsy oftrophectoderm cells forpre-implantationdiagnosis procedures,and blastocyst collapseprior to vitrificationprocedures	Different: Theindications for use forthe subject andpredicate devicesdiffer, as the subjectdevice is to be used toablate or thin the zonapellucida of an embryo,while the predicate isto be used for thesame uses for oocytesor embryos. Thisdifference does notrepresent a newintended use.Therefore, the indenteduses are the same.
Systemconfiguration	· Laser unit· Target pointer· 25X objective· EyeWare software· Installation adapters· Mirror module· Motion control unit(NaviLase Only)· Digital camera· Foot switch	· Control unit (laserunit)· 40X objective· Mirror module· Motor module (Activeversion only)· RI Viewer software· Installation adapters· Control unit· Camera· Foot switch	Different: The subjectand predicate deviceshave similarcomponents, butdifferences exist (e.g.,objective magnification,target pointer, etc.).These differences donot raise differentquestions of Safetyand Effectiveness(S&E).
Modes ofAction	LaserShot M - Fixedlaser system where theuser moves the sampleto the target area.NaviLase - Operates infixed (similar toLaserShot M) anddynamic modes. Thedynamic mode allowsthe user to move thelaser target to thesample within the fieldof view on the displayscreen.	Fixed mode and activemode. Active modeallows the user to movethe laser within the fieldof view.	Same
Laser Details	1.48 µm diode laserClass 1M laser	1.48 µm diode laserClass 1 laser	Different: The class oflasers are different.This difference doesnot raise differentquestions of S&E.
Energydelivered	140 mW and 200 mW	400 mW	Different: The subjectdevice has a lowerenergy output. Thisdifference does notraise differentquestions of S&E.
MaximumPulse Length	10 ms	2ms	Different: The subjectdevice has a longermaximum pulse lengththan the predicatedevice. This differencedoes not raise differentquestions of S&E.
Multi-PulseMode	Yes - NaviLasedynamic mode allowsuser to ablate a seriesof holes along a set,pre-determined path.	Yes - active versionallows user to ablate aseries of holes along aset, pre-determined path.	Same
Hole SizeIndicator	Yes	Yes	Same
Laser firingmechanism	Mouse or foot pedal	Mouse or foot pedal	Same
MicroscopeCompatibility:	Compatible with variousmodels of invertedmicroscopes	Compatible with variousmodels of invertedmicroscopes	Same
Hole SizeIndication:	Yes	Yes	Same

Substantial Equivalence Comparison

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As noted in the table above, there are differences in the indications for use statements and technological features of the subject and predicate devices. However, as stated in the table, the

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differences in indications for use do not represent a new intended use, and the differences in technological features do not raise different questions of safety and effectiveness.

Performance Testing

The following performance data were provided in support of the substantial equivalence determination:

. Reprocessing: Validation testing conducted in accordance with the 2015 FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Electrical Safety and Electromagnetic Compatibility Testing:
- Electrical Safety Testing: IEC 60601-1:2005/AMD1:2012 o
- EMC Testing: IEC 61326-1:2012 O
Software and Cybersecurity:
- Software documentation in accordance with the 2005 FDA quidance document o "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" to support device software with a minor level of concern.
- Cybersecurity information in accordance with the 2014 FDA quidance document o "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
Laser performance testing: Testing was performed in accordance with recommendations ● in Section 7 of FDA's 2004 quidance document "Assisted Reproduction Laser Systems – Class II Special Controls Guidance Document for Industry and FDA Staff." Additional testing included the following:
- Compatibility of the devices with different microscope systems. O
- Target pointer alignment validation to demonstrate that the center of the target o pointer marker was aligned with the center of the ablation laser beam.
- Validation of NaviLase dynamic targeting within the field of view. O
- Validation of the NaviLase dynamic targeting system's ability to complete o automated ablations under specific treatment modes (e.g., hole, hatching, thinning, and trophectoderm).

Conclusion

The results of the testing described above demonstrate that the subject device is substantially equivalent to the predicate device.

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.