(203 days)
Not Found
No
The summary describes a light source accessory for surgical microscopes used for fluorescent visualization. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The performance studies focus on the physical and optical characteristics of the light source and a usability study comparing fluorescence levels.
No.
The device functions as an accessory that provides excitation light for visualizing gliomas, not for treating them.
No
The device is an accessory light source used to provide supplemental excitation light for fluorescent visualization during neurosurgery. Its function is to illuminate the surgical field with specific light wavelengths (white light and 405 nm light) to enable visualization of fluorescently-labeled suspected gliomas. It does not perform any diagnostic analysis, interpretation, or detection of disease itself, but rather aids in the visualization of structures already identified as suspicious using a fluorophore.
No
The device is a light source, which is a hardware component, and the summary describes hardware performance testing.
Based on the provided information, the Myriad SPECTRA Light Source 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.
- Myriad SPECTRA Light Source Function: The description clearly states that the Myriad SPECTRA Light Source is a light source used during neurosurgery to provide supplemental excitation light for fluorescent visualization of suspected gliomas. It is an accessory to a surgical microscope and works with a fluorophore.
- No Sample Analysis: The device does not analyze any samples taken from the patient's body. It is used directly on the surgical field to enhance visualization during a surgical procedure.
Therefore, the Myriad SPECTRA Light Source falls under the category of a surgical accessory or medical device used in vivo (within the living body) rather than in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore. The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
Product codes
QFX
Device Description
The Myriad SPECTRA Light Source used with the NICO Illumination Fiber and the NICO Delivery Sleeve delivers white light and 405 nm light to the surgical field when used with an appropriate surgical microscope and fluorophore. Surgical microscopes with the following characteristics are compatible with the Myriad SPECTRA Light Source:
- Includes an accessory used in fluorescent visualization of suspected grade III and IV ● gliomas during neurosurgery.
- The accessory enables viewing fluorescence of fluorophores with an excitation range ● between 380 nm - 430 nm and an observation band greater than 444 nm.
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
neurosurgery
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)
Illumination Characteristics Testing
- Test Method Summary: The following characteristics were measured for the Myriad SPECTRA Light Source: Irradiance, Beam Profile, Spectral Analysis
- Results: Passed. Key characteristics of light from the Myriad SPECTRA Light Source were successfully measured.
General Performance Testing
- Test Method Summary: General performance testing for the Myriad SPECTRA Light Source and Foot Pedal included the following: Physical Characteristics (weights, dimensions, etc.), Light Management, Operating Power, Noise. The collective purpose of these tests is to confirm proper functionality of the Myriad SPECTRA Light Source and Foot Pedal.
- Results: Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all acceptance criteria related to physical characteristics, light management, operating power and noise.
Environmental Testing
- Test Method Summary: Functionality of the Myriad SPECTRA Light Source and Foot Pedal was evaluated when subjected to ranges of altitude, humidity and temperature.
- Results: Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all acceptance criteria when subjected to various environmental conditions.
Software Verification and Validation
- Test Method Summary: Verification and validation consisted of both hardware/system testing and software testing. This included the ability to select desired wavelengths, switching between wavelengths, intensity of light output, LCD touchscreen brightness, ability to change brightness, and confirmation of system warnings. Regression testing was also conducted.
- Results: Passed. Software and/or hardware for Myriad SPECTRA Light Source and Foot Pedal satisfied all acceptance criteria. Additionally, regression testing was successfully completed.
Packaging Testing
- Test Method Summary: Packaged Myriad SPECTRA Light Sources and Foot Pedals were subjected to the ISTA 2A test procedure and were then evaluated visually and functionally.
- Results: Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all visual and functional acceptance criteria after being subjected to ISTA 2A test procedure.
Electrical Safety Testing
- Test Method Summary: Myriad SPECTRA Light Source and Foot Pedal were tested for electrical safety in accordance with IEC/UL/EN 60601-1, CAN/CSA C2.2 No. 601.1, and IEC/UL/EN 60601-1-2.
- Results: Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all applicable requirements related to electrical safety.
Biocompatibility
- Test Method Summary: The NICO Illumination Fiber and NICO Delivery Sleeve are used with the Myriad SPECTRA Light Source to deliver light to the desired area. These are external communicating devices with limited (≤ 24 hours) contact with tissue/bone, neural tissue and CSF. The biocompatibility evaluation of these components was completed in accordance with ISO 10993 and the FDA biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological valuation of medical devices - Part 1: Evaluation and testing within a risk management process""
- Results: Passed. Biocompatibility test results demonstrated that the NICO Illumination Fiber and NICO Delivery Sleeve meet the requirements from ISO 10993 and the FDA biocompatibility guidance.
Usability
- Test Method Summary: Usability activities were conducted for the Myriad SPECTRA Light Source and Foot Pedal in accordance with IEC 62366. A usability engineering report was completed and includes all required elements, including but not limited to a Use Specification, User Interface Specification, Task List and Use FMEA. A usability/comparison study was completed for fluorescence induced by the predicate (FL400) versus the predicate with the Myriad SPECTRA Light Source to demonstrate that the user could consistently and accurately rank the level of fluorescence.
- Results: Passed. All applicable usability activities were successfully completed for the Myriad SPECTRA Light Source and Foot Pedal. The usability/comparison study successfully demonstrated that he user can consistently and accurately rank the level of fluorescence when using the Myriad SPECTRA Light Source with a compatible surgical microscope.
Spectrum and intensity of the illumination source
- Test Method Summary: The spectrum and intensity of white light produced by the Myriad SPECTRA Light Source was measured and is included within the Illumination Characteristics Test Report.
- Results: Passed. The spectrum and intensity of white light produced by the Myriad SPECTRA Light Source were acceptable when compared to the predicate device.
Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope
- Test Method Summary: The Myriad SPECTRA Light Source uses LEDs rather than filtered Xenon to produce the desired spectral ranges of light. The spectrum of the excitation light was measured and is included within the Illumination Characteristics Test Report.
- Results: Passed. The spectrum of excitation light produced by the Myriad SPECTRA Light Source was acceptable when compared to the predicate device.
Excitation power and power density
- Test Method Summary: Maximum power density for the excitation light from the Myriad SPECTRA Light Source was measured and is included within the Illumination Characteristics Test Report.
- Results: Passed. The power density of the excitation light produced by the Myriad SPECTRA Light Source was acceptable when compared to the predicate device.
Optical path loss from illumination source to objective lens or microscope camera
- Test Method Summary: Not applicable - the Myriad SPECTRA Light Source is not a microscope and does not include an objective lens or camera.
- Results: N/A
Homogeneity of the excitation light at the focal plane
- Test Method Summary: Homogeneity of excitation light for the Myriad SPECTRA Light Source was assessed through beam profile measurements. Optical power was measured at various increments along the x and y axes of the light produced by the Myriad SPECTRA Light Source. The optical power measurements were then plotted to demonstrate the distribution of power. Results are included within the Illumination Characteristics Test Report.
- Results: Passed. Homogeneity of the excitation light at the focal plane produced by the Myriad SPECTRA Light Source was acceptable when compared to the predicate device.
Fluorescence detection sensitivity
- Test Method Summary: Not applicable – the Myriad SPECTRA Light Source is not a camera and does not have fluorescence detection capabilities.
- Results: N/A
Verification of calibration or pre-operative procedures
- Test Method Summary: The light output produced by the Myriad SPECTRA Light Source was tested to ensure its stability for a maximum number of hours. Results are included within the General Performance Test Report. Prior to each surgical case, the operator's manual instructs the end user to check the accumulated number of hours for light output from the Myriad SPECTRA Light Source to confirm that the maximum number of hours has not been exceeded.
- Results: Passed. Stability of light output produced by the Myriad SPECTRA Light Source was determined to be acceptable over a maximum number of hours. Stability must be confirmed prior to each surgical case.
If camera-based, special sensitivity of the camera
- Test Method Summary: Not applicable – the Myriad SPECTRA Light Source is not camera-based.
- Results: N/A
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
§ 882.4950 Diagnostic neurosurgical microscope filter.
(a)
Identification. A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and verify and validate filter specifications and functional characteristics, including the following:
(i) Spectrum and intensity of the illumination source;
(ii) Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope;
(iii) Excitation power and power density;
(iv) Optical path loss from illumination source to objective lens or microscope camera;
(v) Homogeneity of the excitation light at the focal plane;
(vi) Fluorescence detection sensitivity;
(vii) Verification of calibration or preoperative procedures; and
(viii) If camera-based, spectral sensitivity of the camera.
(2) Labeling must include:
(i) Identification of the filter characteristics in conjunction with a compatible surgical operating microscope, to include the following:
(A) Illumination spectrum and power density; and
(B) Excitation and emission filter spectra.
(ii) Instructions for calibration or preoperative checks to ensure device functionality prior to each use;
(iii) Instructions for use with compatible surgical operating microscopes, external light sources, and cameras;
(iv) A warning that the device should only be used with fluorophores approved for use within the specified spectral ranges; and
(v) A warning that the device is not a standalone diagnostic.
0
March 14, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NICO Corporation Megan Becker Senior Regulatory Affairs Specialist 250 East 96th Street, Suite 125 Indianapolis, Indiana 46240
Re: K232567
Trade/Device Name: Myriad SPECTRA Light Source Regulation Number: 21 CFR 882.4950 Regulation Name: Diagnostic Neurosurgical Microscope Filter Regulatory Class: Class II Product Code: QFX Dated: November 3, 2023 Received: November 8, 2023
Dear Megan Becker:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature includes the name "Adam D. Pierce -S" on two lines on the left side of the image. On the right side of the image, the text "Digitally signed by Adam D. Pierce -S" is present, along with the date "2024.03.14" and the time "12:58:10 -04'00'".
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232567
Device Name Myriad SPECTRA Light Source
Indications for Use (Describe)
The Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore. The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
| 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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4
510(K) SUMMARY
Date Prepared: 11 March 2024
510(k) Number: K232567
| Submitter/Manufacturer | NICO Corporation
250 E. 96th Street, Suite 125
Indianapolis, IN 46240 | Technological Characteristic Comparison | Leica FL400
DEN180024 | Myriad SPECTRA Light Source
K232567 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Megan Becker
Sr. Regulatory Affairs Specialist
Office: 317.660.7118
Email: regulatory@niconeuro.com) | 510(k) # | DEN180024 | K232567 |
| Trade Name | Myriad SPECTRA Light Source | Regulation | §882.4950, QFX | §882.4950, QFX |
| Common/Usual Name | Diagnostic Neurosurgical Microscope Filter | Intended Use | Device intended for use during neurosurgery to
visualize fluorescence and enhance visualization of
tissue associated with a specific disease or condition. | SAME |
| Classification | 21 CFR 882.4950 (Class II) | Indications for Use | The Leica FL400 is a surgical microscope accessory
filter set for viewing fluorescence of fluorophores
comprising an excitation filter for blue spectral range
of 380nm - 430nm and an observation filter
comprising the long-wave blue, green, yellow and red
spectrum it the spectral band greater than 444nm.
The FL400 is a surgical microscope accessory used in
fluorescent visualization of suspected grade III or
grade IV gliomas during neurosurgery. | The Myriad SPECTRA Light Source is an accessory
to the Myriad System and delivers white light as
well as excitation light for blue spectral range of
399 - 411 nm for use with an appropriate surgical
microscope and fluorophore
The Myriad SPECTRA Light Source is used to
provide supplemental excitation light for fluorescent
visualization of suspected grade III or IV gliomas
during neurosurgery. |
| Product Code | QFX | Type of
Component | Accessory to a surgical microscope (microscope filter
enabling excitation and emission) | Accessory to a surgical microscope (light source
enabling excitation)
Accessory to a tissue resection system (tool-
mounted light) |
| Predicate Device | DEN180024, Leica FL400 | Fundamental
Technology | Consists of an excitation filter module and an
emission filter module that are inserted into the
optical beam path of a Xenon surgical microscope.
Excitation filter module creates light that causes
fluorescence of tissue containing an approved
fluorophore. Emission filter module enhances
fluorescence observed through microscope for
visualization of fluorophore in neurosurgical field. | Consists of a high output LED light source that
outputs either white light for general illumination or
excitation light that causes fluorescence of tissue
containing an approved fluorophore.
Does not include an emissions filter or camera for
detection of fluorescence. Must be used with an
existing observation device (e.g., surgical
microscope) intended for visualization of suspected
grade III and IV gliomas during neurosurgery. |
| Principles of Use | Filtered light is delivered from and received by the
microscope which is ~30 cm above the surgical field.
FL400 is toggled on/off to deliver either white light or
excitation light. Toggling is controlled by the end user
of the microscope within the sterile field by using one
of several configurable buttons/switches on the
microscope. Intensity and other light characteristics
are also controlled by the end user on the microscope. | Light source delivers light to surgical field through a
fiber optic cable that is attached to Myriad resection
handpiece tool. 405 nm light is toggled on/off to
deliver either white light or excitation light.
Toggling is controlled by the end user of the light
source either within the sterile field using a foot
pedal or outside the sterile field using the touch
screen on the light source. Light intensity is
controlled by the end user outside the sterile field
using the touch screen on the light source. | | |
| Fluorescence
Excitation Spectral
Window | 380 nm – 430 nm | 405 nm center wavelength plus/minus 6 nm
(399 nm - 411 nm) | | |
Device Description
The Myriad SPECTRA Light Source used with the NICO Illumination Fiber and the NICO Delivery Sleeve delivers white light and 405 nm light to the surgical field when used with an appropriate surgical microscope and fluorophore. Surgical microscopes with the following characteristics are compatible with the Myriad SPECTRA Light Source:
- Includes an accessory used in fluorescent visualization of suspected grade III and IV ● gliomas during neurosurgery.
- The accessory enables viewing fluorescence of fluorophores with an excitation range ● between 380 nm - 430 nm and an observation band greater than 444 nm.
Indication for Use
The Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore.
The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
Comparison to Predicate
The Myriad SPECTRA Light Source is substantially equivalent to the Leica's FL400 (DEN180024). The subject device and the predicate device both enable the delivery of excitation light for visualization of suspected grade III and IV gliomas. The subject device is a new light
5
source with multiple outputs (white light and 405 nm light). This device and its capabilities, when evaluated individually or collectively, do not raise new questions of safety or effectiveness.
Technological Characteristics
The following table compares the subject device and predicate device.
Technological Characteristic Comparison
6
The Myriad SPECTRA Light Source has similar principles of use and fundamental technology as the predicate. The technological and design differences do not raise new questions of safety or effectiveness and where applicable the nonclinical testing provides adequate means to assess the effects of the subject device as compared to the predicate.
Performance Testing
The performance of the Myriad SPECTRA Light Source was compared to the predicate device as part of performance testing to support substantial equivalence to the predicate device. The tests summarized in the table below were successfully completed to demonstrate that the Myriad SPECTRA Light Source met all applicable design and performance requirements and supports a determination of substantial equivalence.
| Test | Test Method Summary | Results |
|---|---|---|
| Illumination | ||
| Characteristics Testing | The following characteristics were | |
| measured for the Myriad SPECTRA | ||
| Light Source: | ||
| • Irradiance | ||
| • Beam Profile | ||
| • Spectral Analysis | Passed. Key characteristics of light | |
| from the Myriad SPECTRA Light | ||
| Source were successfully measured. | ||
| General Performance | ||
| Testing | General performance testing for the | |
| Myriad SPECTRA Light Source and Foot | ||
| Pedal included the following: | ||
| • Physical Characteristics (weights, | ||
| dimensions, etc.) | ||
| • Light Management | ||
| • Operating Power | ||
| • Noise | ||
| The collective purpose of these tests is to | ||
| confirm proper functionality of the | ||
| Myriad SPECTRA Light Source and Foot | ||
| Pedal. | Passed. Myriad SPECTRA Light | |
| Source and Foot Pedal satisfied all | ||
| acceptance criteria related to physical | ||
| characteristics, light management, | ||
| operating power and noise. | ||
| Environmental Testing | Functionality of the Myriad SPECTRA | |
| Light Source and Foot Pedal was | ||
| evaluated when subjected to ranges of | ||
| altitude, humidity and temperature. | Passed. Myriad SPECTRA Light | |
| Source and Foot Pedal satisfied all | ||
| acceptance criteria when subjected to | ||
| various environmental conditions. | ||
| Software Verification and | ||
| Validation | Verification and validation consisted of | |
| both hardware/system testing and | ||
| software testing. This included the ability | ||
| to select desired wavelengths, switching | ||
| between wavelengths, intensity of light | ||
| output, LCD touchscreen brightness, | ||
| ability to change brightness, and | Passed. Software and/or hardware for | |
| Myriad SPECTRA Light Source and | ||
| Foot Pedal satisfied all acceptance | ||
| criteria. Additionally, regression testing | ||
| was successfully completed. | ||
| Test | Test Method Summary | Results |
| confirmation of system warnings. | ||
| Regression testing was also conducted. | ||
| Packaging Testing | Packaged Myriad SPECTRA Light | |
| Sources and Foot Pedals were subjected | ||
| to the ISTA 2A test procedure and were | ||
| then evaluated visually and functionally. | Passed. Myriad SPECTRA Light | |
| Source and Foot Pedal satisfied all | ||
| visual and functional acceptance | ||
| criteria after being subjected to ISTA | ||
| 2A test procedure. | ||
| Electrical Safety Testing | Myriad SPECTRA Light Source and Foot | |
| Pedal were tested for electrical safety in | ||
| accordance with IEC/UL/EN 60601-1, | ||
| CAN/CSA C2.2 No. 601.1, and | ||
| IEC/UL/EN 60601-1-2. | Passed. Myriad SPECTRA Light | |
| Source and Foot Pedal satisfied all | ||
| applicable requirements related to | ||
| electrical safety. | ||
| Biocompatibility | The NICO Illumination Fiber and NICO | |
| Delivery Sleeve are used with the Myriad | ||
| SPECTRA Light Source to deliver light | ||
| to the desired area. These are external | ||
| communicating devices with limited (≤ | ||
| 24 hours) contact with tissue/bone, neural | ||
| tissue and CSF. The biocompatibility | ||
| evaluation of these components was | ||
| completed in accordance with ISO 10993 | ||
| and the FDA biocompatibility guidance | ||
| "Use of International Standard ISO | ||
| 10993-1, "Biological valuation of | ||
| medical devices - Part 1: Evaluation and | ||
| testing within a risk | ||
| management process"" | Passed. Biocompatibility test results | |
| demonstrated that the NICO | ||
| Illumination Fiber and NICO Delivery | ||
| Sleeve meet the requirements from ISO | ||
| 10993 and the FDA biocompatibility | ||
| guidance. | ||
| Usability | Usability activities were conducted for | |
| the Myriad SPECTRA Light Source and | ||
| Foot Pedal in accordance with IEC |
- A usability engineering report was
completed and includes all required
elements, including but not limited to a
Use Specification, User Interface
Specification, Task List and Use FMEA. | Passed. All applicable usability
activities were successfully completed
for the Myriad SPECTRA Light Source
and Foot Pedal. |
| | A usability/comparison study was
completed for fluorescence induced by
the predicate (FL400) versus the predicate
with the Myriad SPECTRA Light Source
to demonstrate that the user could
consistently and accurately rank the level
of fluorescence. | Passed. The usability/comparison study
successfully demonstrated that he user
can consistently and accurately rank the
level of fluorescence when using the
Myriad SPECTRA Light Source with a
compatible surgical microscope. |
| Control | Test Method Summary | Results |
| Spectrum and intensity of
the illumination source | The spectrum and intensity of white light
produced by the Myriad SPECTRA Light
Source was measured and is included
within the Illumination Characteristics
Test Report. | Passed. The spectrum and intensity of
white light produced by the Myriad
SPECTRA Light Source were
acceptable when compared to the
predicate device. |
| Spectrum of the excitation
and emission filter
modules when integrated
in the surgical operating
microscope | The Myriad SPECTRA Light Source uses
LEDs rather than filtered Xenon to
produce the desired spectral ranges of
light. The spectrum of the excitation light
was measured and is included within the | Passed. The spectrum of excitation
light produced by the Myriad
SPECTRA Light Source was
acceptable when compared to the
predicate device. |
| Excitation power and
power density | Illumination Characteristics Test Report.
Maximum power density for the
excitation light from the Myriad
SPECTRA Light Source was measured
and is included within the Illumination
Characteristics Test Report. | Passed. The power density of the
excitation light produced by the Myriad
SPECTRA Light Source was
acceptable when compared to the
predicate device. |
| Optical path loss from
illumination source to
objective lens or
microscope camera | Not applicable - the Myriad SPECTRA
Light Source is not a microscope and
does not include an objective lens or
camera. | N/A |
| Homogeneity of the
excitation light at the
focal plane | Homogeneity of excitation light for the
Myriad SPECTRA Light Source was
assessed through beam profile
measurements. Optical power was
measured at various increments along the
x and y axes of the light produced by the
Myriad SPECTRA Light Source. The
optical power measurements were then
plotted to demonstrate the distribution of
power. Results are included within the
Illumination Characteristics Test Report. | Passed. Homogeneity of the excitation
light at the focal plane produced by the
Myriad SPECTRA Light Source was
acceptable when compared to the
predicate device. |
| Fluorescence detection
sensitivity | Not applicable – the Myriad SPECTRA
Light Source is not a camera and does not
have fluorescence detection capabilities. | N/A |
| Verification of calibration
or pre-operative
procedures | The light output produced by the Myriad
SPECTRA Light Source was tested to
ensure its stability for a maximum
number of hours. Results are included
within the General Performance Test
Report. | Passed. Stability of light output
produced by the Myriad SPECTRA
Light Source was determined to be
acceptable over a maximum number of
hours. Stability must be confirmed
prior to each surgical case. |
| Control | Test Method Summary | Results |
| | Prior to each surgical case, the operator's
manual instructs the end user to check the
accumulated number of hours for light
output from the Myriad SPECTRA Light
Source to confirm that the maximum
number of hours has not been exceeded. | |
| If camera-based, special
sensitivity of the camera | Not applicable – the Myriad SPECTRA
Light Source is not camera-based. | N/A |
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Additionally, the Myriad SPECTRA Light Source is subject to special controls per 21 CFR 882.4950. Performance testing was completed to comply with all applicable special controls. A summary of these controls and related testing is outlined in the table below.
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Conclusion
The subject device and the predicate device are equivalent in terms of intended use and technological considerations. Risk assessments and performance testing have demonstrated that the design differences between the subject and the predicate device do not raise different questions of safety or effectiveness. Therefore, the Myriad SPECTRA Light Source is substantially equivalent to the legally marketed predicate device Leica FL400.