Who is the manufacturer of Myriad SPECTRA Light Source?

Nico Corporation filed the 510(k) submission for Myriad SPECTRA Light Source (K232567).

What is the FDA product code for Myriad SPECTRA Light Source?

QFX. It is classified under 21 CFR 882.4950 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Myriad SPECTRA Light Source?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Myriad SPECTRA Light Source?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Myriad SPECTRA Light Source

K232567 · Nico Corporation · QFX · Mar 14, 2024 · Neurology

Device Facts

Record ID	K232567
Device Name	Myriad SPECTRA Light Source
Applicant	Nico Corporation
Product Code	QFX · Neurology
Decision Date	Mar 14, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4950
Device Class	Class 2

Intended 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.

Device Story

Myriad SPECTRA Light Source is an accessory to the Myriad System; delivers white light and 405 nm excitation light to surgical field via fiber optic cable attached to Myriad resection handpiece. Used with surgical microscope and fluorophore to visualize suspected grade III/IV gliomas. Operated by physician/surgeon in OR; toggling between white/excitation light controlled via foot pedal (sterile field) or touchscreen (non-sterile). Provides supplemental excitation light to enable fluorescence visualization; does not include emission filters or camera. Output intensity/wavelength selection managed by user. Benefits patient by enhancing visualization of tumor tissue during resection.

Clinical Evidence

Bench testing only. Includes illumination characteristics (irradiance, beam profile, spectral analysis), general performance, environmental, electrical safety (IEC/UL/EN 60601-1), and biocompatibility (ISO 10993). Usability/comparison study demonstrated users could consistently and accurately rank fluorescence levels using the subject device compared to the predicate.

Technological Characteristics

High-output LED light source; 405 nm center wavelength (399-411 nm). Fiber optic delivery to resection handpiece. Compatible with surgical microscopes supporting 380-430 nm excitation and >444 nm observation. Electrical safety per IEC/UL/EN 60601-1 and 60601-1-2. Biocompatibility per ISO 10993. Usability per IEC 62366.

Indications for Use

Indicated for supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery in patients undergoing such procedures.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the diagnostic neurosurgical microscope filter is subject to the following special controls: - (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; - Spectrum of the excitation and emission filter modules when integrated in the (ii) 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 pre-operative procedures; and - (viii)If camera-based, spectral sensitivity of the camera. - (2) Labeling must include: - Identification of the filter characteristics in conjunction with a compatible surgical (i) operating microscope, to include the following: - (A) Illumination spectrum and power density; and - (B) Excitation and emission filter spectra. - (ii) Instructions for calibration or pre-operative 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 - A warning that the device is not a standalone diagnostic. (v)

*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.

Predicate Devices

Leica FL400 (DEN180024)

Related Devices

K240215 — BLUE 400; BLUE 400 S · Carl Zeiss Meditec, AG · Jun 28, 2024
K251286 — Affirm 400 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jan 21, 2026
K211346 — BLUE 400 · Carl Zeiss Meditec, AG · Jul 22, 2022
DEN180024 — Leica FL400 · Leica Microsystems (Schweiz) AG · Mar 28, 2019

Submission Summary (Full Text)

{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) | |-------------------------------------------------------------------------------------------------| | <div>☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | | <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 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. | 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 | {7}------------------------------------------------ {8}------------------------------------------------ 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. {9}------------------------------------------------ # 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.