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.

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.

AI/ML Overview

The provided text describes the Myriad SPECTRA Light Source, an accessory for fluorescent visualization of grade III or IV gliomas during neurosurgery. The submission focuses on demonstrating substantial equivalence to a predicate device (Leica FL400) through performance testing.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner for most tests. Instead, it lists various tests conducted and states that the device "Passed" them or that the results were "acceptable" compared to the predicate. The "acceptance criteria" are implied by the nature of the tests and the "Passed" results.

For the purpose of this summary, I will infer the acceptance criteria from the context of "Passed" or "acceptable when compared to the predicate device" results.

Test Category	Acceptance Criteria (Inferred)	Reported Device Performance
Illumination Characteristics Testing	• Irradiance measured successfully. • Beam Profile measured successfully. • Spectral Analysis measured successfully.	Passed. Key characteristics of light from the Myriad SPECTRA Light Source were successfully measured. (Details on specific values/ranges are not provided in this summary).
General Performance Testing	• Device and Foot Pedal satisfy acceptance criteria related to physical characteristics (e.g., weights, dimensions). • Light management functions properly. • Operating power is within acceptable limits. • Noise levels are within acceptable limits.	Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all acceptance criteria related to physical characteristics, light management, operating power and noise.
Environmental Testing	• Device and Foot Pedal function properly 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	• Hardware/system and software testing confirms ability to select desired wavelengths, switch between wavelengths, control light intensity, adjust LCD touchscreen brightness. • System warnings function correctly. • Regression testing completed successfully.	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	• Packaged devices visually and functionally acceptable after ISTA 2A test procedure (simulation of transport).	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	• Device and Foot Pedal meet electrical safety requirements of 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	• NICO Illumination Fiber and NICO Delivery Sleeve meet requirements of ISO 10993 and FDA biocompatibility guidance for external communicating devices with limited contact (≤ 24 hours).	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	• All applicable usability activities completed successfully in accordance with IEC 62366. • User can consistently and accurately rank the level of fluorescence when using the Myriad SPECTRA Light Source with a compatible surgical microscope (usability/comparison study).	Passed. All applicable usability activities were successfully completed for the Myriad SPECTRA Light Source and Foot Pedal. The usability/comparison study successfully demonstrated that the 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 illumination	• Spectrum and intensity of white light are acceptable when compared to the predicate device.	Passed. The spectrum and intensity of white light produced by the Myriad SPECTRA Light Source were acceptable when compared to the predicate device. (Details on what constitutes "acceptable" are not in this summary).
Spectrum of excitation light	• Spectrum of excitation light is acceptable when compared to the predicate device.	Passed. The spectrum of excitation light produced by the Myriad SPECTRA Light Source was acceptable when compared to the predicate device. (Details on what constitutes "acceptable" are not in this summary).
Excitation power and power density	• Power density of excitation light is acceptable when compared to the predicate device.	Passed. The power density of the excitation light produced by the Myriad SPECTRA Light Source was acceptable when compared to the predicate device. (Details on what constitutes "acceptable" are not in this summary).
Homogeneity of excitation light	• Homogeneity of excitation light at the focal plane is acceptable when compared to the predicate device.	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. (Details on what constitutes "acceptable" are not in this summary, but implied by beam profile measurements).
Verification of calibration	• Stability of light output is acceptable over a maximum number of hours.	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. (The specific "maximum number of hours" is not stated in this summary).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document provides very limited information regarding sample sizes for human-involved testing:

Usability/Comparison Study: This study involved a usability/comparison study where users "consistently and accurately rank[ed] the level of fluorescence." No specific sample size (number of users or cases) is mentioned.
Data Provenance: The document does not specify the country of origin of the data or whether any human user studies were retrospective or prospective. Given the nature of a 510(k) submission for a light source, most of the "testing" described is non-clinical (electrical, mechanical, optical properties) rather than clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For the usability/comparison study where users ranked the level of fluorescence, there is no mention of experts establishing a "ground truth" for the fluorescence levels themselves, nor are the qualifications of the users participating in this study mentioned. The study focused on the user's ability to consistently and accurately rank the level of fluorescence, implying a comparison rather than an absolute ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: There is no mention of an MRMC comparative effectiveness study in the provided text.
AI Assistance: The device described, Myriad SPECTRA Light Source, is a light source for surgical visualization, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device. The usability/comparison study simply assessed the user's ability to rank fluorescence levels when using the device with a compatible surgical microscope, comparing it implicitly to the predicate.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The Myriad SPECTRA Light Source is a hardware device (a light source) used in conjunction with a surgical microscope and a fluorophore for human visualization. It is not an algorithm, and therefore, a "standalone algorithm only" performance study is not applicable and was not done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests (illumination characteristics, general performance, environmental, electrical safety, etc.), the "ground truth" is based on established engineering specifications, industry standards (e.g., IEC/UL/EN 60601-1, ISO 10993), and comparisons to the predicate device's measured characteristics.

For the usability/comparison study, the "ground truth" for fluorescence levels is not explicitly defined as expert consensus or pathology. The study assesses the user's ability to consistently and accurately rank fluorescence, implying that the relative levels of fluorescence in the tested scenarios served as a de facto ground truth for comparative purposes.

8. The sample size for the training set

The device is a hardware light source, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable to this device.

9. How the ground truth for the training set was established

As the device does not involve a training set for machine learning, this question is not applicable.

Summary

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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).

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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

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Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232567

Device Name Myriad SPECTRA Light Source

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

Date Prepared: 11 March 2024

510(k) Number: K232567

Submitter/Manufacturer	NICO Corporation250 E. 96th Street, Suite 125Indianapolis, IN 46240	Technological Characteristic Comparison	Leica FL400DEN180024	Myriad SPECTRA Light SourceK232567
Primary Contact:	Megan BeckerSr. Regulatory Affairs SpecialistOffice: 317.660.7118Email: 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 tovisualize fluorescence and enhance visualization oftissue 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 accessoryfilter set for viewing fluorescence of fluorophorescomprising an excitation filter for blue spectral rangeof 380nm - 430nm and an observation filtercomprising the long-wave blue, green, yellow and redspectrum it the spectral band greater than 444nm.The FL400 is a surgical microscope accessory used influorescent visualization of suspected grade III orgrade IV gliomas during neurosurgery.	The Myriad SPECTRA Light Source is an accessoryto the Myriad System and delivers white light aswell as excitation light for blue spectral range of399 - 411 nm for use with an appropriate surgicalmicroscope and fluorophoreThe Myriad SPECTRA Light Source is used toprovide supplemental excitation light for fluorescentvisualization of suspected grade III or IV gliomasduring neurosurgery.
Product Code	QFX	Type ofComponent	Accessory to a surgical microscope (microscope filterenabling excitation and emission)	Accessory to a surgical microscope (light sourceenabling excitation)Accessory to a tissue resection system (tool-mounted light)
Predicate Device	DEN180024, Leica FL400	FundamentalTechnology	Consists of an excitation filter module and anemission filter module that are inserted into theoptical beam path of a Xenon surgical microscope.Excitation filter module creates light that causesfluorescence of tissue containing an approvedfluorophore. Emission filter module enhancesfluorescence observed through microscope forvisualization of fluorophore in neurosurgical field.	Consists of a high output LED light source thatoutputs either white light for general illumination orexcitation light that causes fluorescence of tissuecontaining an approved fluorophore.Does not include an emissions filter or camera fordetection of fluorescence. Must be used with anexisting observation device (e.g., surgicalmicroscope) intended for visualization of suspectedgrade III and IV gliomas during neurosurgery.
Principles of Use	Filtered light is delivered from and received by themicroscope which is ~30 cm above the surgical field.FL400 is toggled on/off to deliver either white light orexcitation light. Toggling is controlled by the end userof the microscope within the sterile field by using oneof several configurable buttons/switches on themicroscope. Intensity and other light characteristicsare also controlled by the end user on the microscope.	Light source delivers light to surgical field through afiber optic cable that is attached to Myriad resectionhandpiece tool. 405 nm light is toggled on/off todeliver either white light or excitation light.Toggling is controlled by the end user of the lightsource either within the sterile field using a footpedal or outside the sterile field using the touchscreen on the light source. Light intensity iscontrolled by the end user outside the sterile fieldusing the touch screen on the light source.
FluorescenceExcitation SpectralWindow	380 nm – 430 nm	405 nm center wavelength plus/minus 6 nm(399 nm - 411 nm)

Device Description

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 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

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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

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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
IlluminationCharacteristics Testing	The following characteristics weremeasured for the Myriad SPECTRALight Source:• Irradiance• Beam Profile• Spectral Analysis	Passed. Key characteristics of lightfrom the Myriad SPECTRA LightSource were successfully measured.
General PerformanceTesting	General performance testing for theMyriad SPECTRA Light Source and FootPedal included the following:• Physical Characteristics (weights,dimensions, etc.)• Light Management• Operating Power• NoiseThe collective purpose of these tests is toconfirm proper functionality of theMyriad SPECTRA Light Source and FootPedal.	Passed. Myriad SPECTRA LightSource and Foot Pedal satisfied allacceptance criteria related to physicalcharacteristics, light management,operating power and noise.
Environmental Testing	Functionality of the Myriad SPECTRALight Source and Foot Pedal wasevaluated when subjected to ranges ofaltitude, humidity and temperature.	Passed. Myriad SPECTRA LightSource and Foot Pedal satisfied allacceptance criteria when subjected tovarious environmental conditions.
Software Verification andValidation	Verification and validation consisted ofboth hardware/system testing andsoftware testing. This included the abilityto select desired wavelengths, switchingbetween wavelengths, intensity of lightoutput, LCD touchscreen brightness,ability to change brightness, and	Passed. Software and/or hardware forMyriad SPECTRA Light Source andFoot Pedal satisfied all acceptancecriteria. Additionally, regression testingwas successfully completed.
Test	Test Method Summary	Results
	confirmation of system warnings.Regression testing was also conducted.
Packaging Testing	Packaged Myriad SPECTRA LightSources and Foot Pedals were subjectedto the ISTA 2A test procedure and werethen evaluated visually and functionally.	Passed. Myriad SPECTRA LightSource and Foot Pedal satisfied allvisual and functional acceptancecriteria after being subjected to ISTA2A test procedure.
Electrical Safety Testing	Myriad SPECTRA Light Source and FootPedal were tested for electrical safety inaccordance with IEC/UL/EN 60601-1,CAN/CSA C2.2 No. 601.1, andIEC/UL/EN 60601-1-2.	Passed. Myriad SPECTRA LightSource and Foot Pedal satisfied allapplicable requirements related toelectrical safety.
Biocompatibility	The NICO Illumination Fiber and NICODelivery Sleeve are used with the MyriadSPECTRA Light Source to deliver lightto the desired area. These are externalcommunicating devices with limited (≤24 hours) contact with tissue/bone, neuraltissue and CSF. The biocompatibilityevaluation of these components wascompleted in accordance with ISO 10993and the FDA biocompatibility guidance"Use of International Standard ISO10993-1, "Biological valuation ofmedical devices - Part 1: Evaluation andtesting within a riskmanagement process""	Passed. Biocompatibility test resultsdemonstrated that the NICOIllumination Fiber and NICO DeliverySleeve meet the requirements from ISO10993 and the FDA biocompatibilityguidance.
Usability	Usability activities were conducted forthe Myriad SPECTRA Light Source andFoot Pedal in accordance with IEC62366. A usability engineering report wascompleted and includes all requiredelements, including but not limited to aUse Specification, User InterfaceSpecification, Task List and Use FMEA.	Passed. All applicable usabilityactivities were successfully completedfor the Myriad SPECTRA Light Sourceand Foot Pedal.
	A usability/comparison study wascompleted for fluorescence induced bythe predicate (FL400) versus the predicatewith the Myriad SPECTRA Light Sourceto demonstrate that the user couldconsistently and accurately rank the levelof fluorescence.	Passed. The usability/comparison studysuccessfully demonstrated that he usercan consistently and accurately rank thelevel of fluorescence when using theMyriad SPECTRA Light Source with acompatible surgical microscope.
Control	Test Method Summary	Results
Spectrum and intensity ofthe illumination source	The spectrum and intensity of white lightproduced by the Myriad SPECTRA LightSource was measured and is includedwithin the Illumination CharacteristicsTest Report.	Passed. The spectrum and intensity ofwhite light produced by the MyriadSPECTRA Light Source wereacceptable when compared to thepredicate device.
Spectrum of the excitationand emission filtermodules when integratedin the surgical operatingmicroscope	The Myriad SPECTRA Light Source usesLEDs rather than filtered Xenon toproduce the desired spectral ranges oflight. The spectrum of the excitation lightwas measured and is included within the	Passed. The spectrum of excitationlight produced by the MyriadSPECTRA Light Source wasacceptable when compared to thepredicate device.
Excitation power andpower density	Illumination Characteristics Test Report.Maximum power density for theexcitation light from the MyriadSPECTRA Light Source was measuredand is included within the IlluminationCharacteristics Test Report.	Passed. The power density of theexcitation light produced by the MyriadSPECTRA Light Source wasacceptable when compared to thepredicate device.
Optical path loss fromillumination source toobjective lens ormicroscope camera	Not applicable - the Myriad SPECTRALight Source is not a microscope anddoes not include an objective lens orcamera.	N/A
Homogeneity of theexcitation light at thefocal plane	Homogeneity of excitation light for theMyriad SPECTRA Light Source wasassessed through beam profilemeasurements. Optical power wasmeasured at various increments along thex and y axes of the light produced by theMyriad SPECTRA Light Source. Theoptical power measurements were thenplotted to demonstrate the distribution ofpower. Results are included within theIllumination Characteristics Test Report.	Passed. Homogeneity of the excitationlight at the focal plane produced by theMyriad SPECTRA Light Source wasacceptable when compared to thepredicate device.
Fluorescence detectionsensitivity	Not applicable – the Myriad SPECTRALight Source is not a camera and does nothave fluorescence detection capabilities.	N/A
Verification of calibrationor pre-operativeprocedures	The light output produced by the MyriadSPECTRA Light Source was tested toensure its stability for a maximumnumber of hours. Results are includedwithin the General Performance TestReport.	Passed. Stability of light outputproduced by the Myriad SPECTRALight Source was determined to beacceptable over a maximum number ofhours. Stability must be confirmedprior to each surgical case.
Control	Test Method Summary	Results
	Prior to each surgical case, the operator'smanual instructs the end user to check theaccumulated number of hours for lightoutput from the Myriad SPECTRA LightSource to confirm that the maximumnumber of hours has not been exceeded.
If camera-based, specialsensitivity of the camera	Not applicable – the Myriad SPECTRALight 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.

Regulation Number and Section

§ 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.