(240 days)
Not Found
No
The description focuses on automated laser firing along user-defined paths and controlling laser parameters based on pre-programmed logic, not learning from data or adapting based on experience. The software documentation follows standard FDA guidance for software in medical devices, not specific AI/ML guidance.
No.
The device facilitates assisted reproduction procedures by modifying embryos (ablating, thinning, or collapsing), which are technical interventions rather than directly treating a medical condition or disease within a living patient.
No
The device is used to ablate or thin the zona pellucida of an embryo and for biopsy of trophectoderm cells, which are interventional procedures, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including a laser module, laser adapter, mirror block, laser objective, USB camera, and for the NaviLase, a motion module and motion controller. While software (EyeWare) is a component, it controls and operates these physical hardware elements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a laser system used to physically alter the zona pellucida of an embryo or biopsy cells from an embryo. It is a tool used in assisted reproduction procedures, directly interacting with the embryo itself, not analyzing a sample taken from the body.
- Intended Use: The intended use clearly states procedures performed on the embryo (ablating, thinning, biopsy), not diagnostic testing of a sample.
Therefore, while it is a medical device used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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 blastocyst collapse prior to vitrification procedures.
Product codes
MRX
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.
Mentions image processing
Not Found
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
- 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
- EMC Testing: IEC 61326-1:2012
- Software and Cybersecurity:
- Software documentation in accordance with the 2005 FDA quidance document "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 guidance document "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.
- Target pointer alignment validation to demonstrate that the center of the target pointer marker was aligned with the center of the ablation laser beam.
- Validation of NaviLase dynamic targeting within the field of view.
- Validation of the NaviLase dynamic targeting system's ability to complete automated ablations under specific treatment modes (e.g., hole, hatching, thinning, and trophectoderm).
Key Metrics
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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K192008
Device Name NaviLase, LaserShot M
Indications for Use (Describe)
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.
| 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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3
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
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
4
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
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.
| | Subject Device
LaserShot
M/NaviLase
K181776 | Predicate Device
Saturn 5
K141434 | Comparison |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 blastocyst collapse
prior to vitrification
procedures. | 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 | Different: The
indications for use for
the subject and
predicate devices
differ, as the subject
device is to be used to
ablate or thin the zona
pellucida of an embryo,
while the predicate is
to be used for the
same uses for oocytes
or embryos. This
difference does not
represent a new
intended use.
Therefore, the indented
uses are the same. |
| System
configuration | · Laser unit
· Target pointer
· 25X objective
· EyeWare software
· Installation adapters
· Mirror module
· Motion control unit
(NaviLase Only)
· Digital camera
· Foot switch | · Control unit (laser
unit)
· 40X objective
· Mirror module
· Motor module (Active
version only)
· RI Viewer software
· Installation adapters
· Control unit
· Camera
· Foot switch | Different: The subject
and predicate devices
have similar
components, but
differences exist (e.g.,
objective magnification,
target pointer, etc.).
These differences do
not raise different
questions of Safety
and Effectiveness
(S&E). |
| Modes of
Action | LaserShot M - Fixed
laser system where the
user moves the sample
to the target area.
NaviLase - Operates in
fixed (similar to
LaserShot M) and
dynamic modes. The
dynamic mode allows
the user to move the
laser target to the
sample within the field
of view on the display
screen. | Fixed mode and active
mode. Active mode
allows the user to move
the laser within the field
of view. | Same |
| Laser Details | 1.48 µm diode laser
Class 1M laser | 1.48 µm diode laser
Class 1 laser | Different: The class of
lasers are different.
This difference does
not raise different
questions of S&E. |
| Energy
delivered | 140 mW and 200 mW | 400 mW | Different: The subject
device has a lower
energy output. This
difference does not
raise different
questions of S&E. |
| Maximum
Pulse Length | 10 ms | 2ms | Different: The subject
device has a longer
maximum pulse length
than the predicate
device. This difference
does not raise different
questions of S&E. |
| Multi-Pulse
Mode | Yes - NaviLase
dynamic mode allows
user to ablate a series
of holes along a set,
pre-determined path. | Yes - active version
allows user to ablate a
series of holes along a
set, pre-determined path. | Same |
| Hole Size
Indicator | Yes | Yes | Same |
| Laser firing
mechanism | Mouse or foot pedal | Mouse or foot pedal | Same |
| Microscope
Compatibility: | Compatible with various
models of inverted
microscopes | Compatible with various
models of inverted
microscopes | Same |
| Hole Size
Indication: | 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
6
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.