(154 days)
Not Found
No
The summary describes a fluorescence accessory for a surgical microscope that uses optical filters to visualize fluorescently labeled tissue. There is no mention of any computational analysis, learning, or decision-making processes that would indicate the use of AI or ML. The performance studies focus on optical and system parameters, not algorithmic performance.
No.
The device is an accessory to a surgical microscope used for fluorescence observation and visualization, not for direct therapeutic intervention. It aids in visualizing gliomas but does not treat them.
No
The device is an accessory to a surgical microscope that allows for the intraoperative viewing and visualization of malignant glioma tissue using fluorescence. It aids surgeons in identifying specified tissues but does not interpret or analyze patient data to provide a diagnosis.
No
The device is described as "fluorescence accessories to qualified surgical microscopes" and is comprised of "excitation (illumination) and emission (observation) filters". These are clearly hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The BLUE 400 and BLUE 400 S are accessories to a surgical microscope. Their function is to enhance the visualization of tissue during surgery by using fluorescence. They work by exciting a pre-administered optical imaging agent and observing the emitted light.
- No Specimen Examination: The device does not involve the collection or examination of specimens outside the body. The observation is happening directly on the tissue in situ during the surgical procedure.
- Intended Use: The intended use is for "fluorescent visualization of suspected grade III and IV gliomas during neurosurgery," which is a surgical aid, not a diagnostic test performed on a specimen.
Therefore, the BLUE 400 and BLUE 400 S fall under the category of surgical devices or accessories, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
BLUE 400 and BLUE 400 S are accessories to the surgical microscope and allow the fluorescence observation of fluorophores with an excitation peak between 400 nm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm.
The ZEISS BLUE 400 and BLUE 400 S are surgical microscope accessories used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.
Product codes (comma separated list FDA assigned to the subject device)
QFX
Device Description
The BLUE 400 and BLUE 400 S are fluorescence accessories to qualified surgical microscopes, intended to allow intraoperative viewing of malignant glioma tissue grade III and IV under fluorescence. The overall system is comprised of excitation (illumination) and emission (observation) filters to detect fluorescence and are optimized in conjunction with the drug to pass light between 620 – 710 nanometers. The BLUE 400 S filters allow the surgical microscope to produce excitation light in a wavelength range covering at least 400 - 410 nanometers that excites an approved optical imaging agent and enables the surgeon to observe the emitted fluorescent signal in the oculars or on a display. Fluorescence of marked brain tissue helps visualization of tissue associated with Grade III & IV glioma during neurosurgeries.
Compared to the blue visualization of the surrounding non-fluorescent tissue in the BLUE 400 image, BLUE 400 S is designed to visualize the surrounding nonfluorescent tissue more similar to white light impression, while tumor visualization of grade III and IV glioma remains consistent. With the visualization of non-fluorescent anatomy in an almost white light impression, BLUE 400 S is expected to allow PplX visualization with less frequent switching between fluorescence and white light imaging modes.
BLUE 400 and BLUE 400 S can be installed only into qualified ZEISS surgical microscopes. For these accessories to be used with a qualified ZEISS surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of BLUE 400 and BLUE 400 S.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Bench
Sterilization and Shelf Life
The device is provided non-sterile. Shelf-Life is not applicable.
Biocompatibility
The device does not have patient-contacting materials; therefore, a biocompatibility assessment is not needed for this device.
In order for BLUE 400 and BLUE 400 S to work, they must be installed onto a qualified ZEISS surgical microscope. A software license specific to BLUE 400 and BLUE 400 S must also be installed on the ZEISS microscope. Software verification testing (Documentation Level: Enhanced) has been performed in accordance with the FDA guidance document "Content of Premarket Submissions for Device Software Functions" to demonstrate that software is performing as intended. Cybersecurity concerns were addressed by providing cybersecurity documentation that included an assessment of the assets, threats, vulnerabilities, and controls in accordance with the FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. To ensure that the clinically relevant parameters for the Indications for Use of the fluorescence accessories are fulfilled, the following parameters/specifications were tested:
Brightness of the fluorescence ocular image: Measurement of the image brightness of the ZEISS fluorescence target at the ocular plane at a working distance of 250 mm. Results: Passed
Irradiance: Measurement of the excitation light density in the object plane. Results: Passed
Spatial resolution of the ocular image: Measurement of the spatial resolution with the spatial test target in white light mode. Results: Passed. @min. magnification + working distance 200mm, @max. magnification + working distance 200mm. Values may vary depending on different working distances.
Excitation wavelength (of the microscope): Excitation wavelength range of PpIX is covered by both options (400 nm to 410 nm). Results: Passed
Excitation filter: Check of optical filter specification of excitation filter. Results: Passed
Emission wavelength (of the microscope - ocular image): Design review via evaluation of component specifications or measurement of the spectrum at the ocular plane. Results: Passed
Emission wavelength (of the microscope - video image): Design review via evaluation of component specifications or measurement of the spectrum at the ocular plane. Results: Passed
Emission filter: Check of optical filter specification of emission filter. Results: Passed
Non-mirrored video image: Visual inspection with a corresponding test target in white light mode. Results: Passed
Non-rotated video image: Visual inspection with a corresponding test target in white light mode. Results: Passed
Non-deformed video image: Visual inspection of the geometric distortions of a test target with a circle in white light mode. Results: Passed
Centered video image: Visual inspection and measurement with a test target in white light mode. Results: Passed
Photometric resolution of video image: Grey value resolution test with a photometric resolution test target in white light mode. Results: Passed
Signal-to-noise ratio of the video image (sensitivity): Measurement of the signal-to-noise ratio of a video image of a fluorescent target at a given signal value (pixel value). Results: Passed
Latency of the video image: Measurement of the video latency in white light mode. Results: Passed
Spatial resolution of the video image: Measurement of the spatial resolution with the spatial test target in white light mode. Results: Passed
Spectrum of the Illumination Source (TS1): The irradiance spectrum (250 nm - 1020 nm, mW/cm^2) of the illumination source was measured and verified with a spectrometer. These measurements were assessed prior to application of the excitation filter module. Results: Passed
Maximum Power and Irradiance of the Illumination Source (TS2): The maximum output power and irradiance of illumination sources were measured and verified with a power meter at the end of the microscope light guide. These measurements were assessed prior to application of the excitation filter module. Results: Passed
Irradiance Spectrum of the Excitation Light and Spectral Response of the Excitation Filter (TS3): The irradiance spectrum (250 nm - 1020 nm) of the illumination light, following passage through the excitation filter module, was measured at a working distance of 30 cm with a spectrometer. The edges at 50% decrease of the blue excitation peak were calculated respectively. Results: Passed
Maximum Excitation Power and Power Density (TS4): The maximum power (mW) and power density (mW/cm^2) of the excitation light was measured with a thermopile, at multiple different working distances and zoom settings, including the maximum and minimum zoom. The power density measurements of the subject device were compared to the predicate device. Results: Passed
Optical Path Loss (TS5): To determine the overall detectable light output and the total losses in relation to device working distance and zoom setting, optical path loss was calculated by dividing the output signal measured at the microscope eyepiece (without emission filter) by the illumination signal measured with a spectrometer at the microscope focal plane for the same zoom setting. A reflection standard (white silicon remission disc) was used at a working distance of 35 cm. Results: Passed
Spectrum of the Emission Filter (TS6): The spectrum (350 nm – 1050 nm) of the emission filter when integrated in the surgical operating microscope was measured with a spectroradiometer to include all the coating and optics that affects the spectrum of the observation path. For this test the excitation filter was removed, and a reflection standard was used at the device focal plane with different zoom settings. To compare the light that passes the observation optics and emission filter, the 50% edge of the spectrum was calculated. Results: Passed
Homogeneity of the Excitation Light at the Focal Point (TS7): The reflected signal from a white sheet of paper positioned at 30 cm working distance was imaged by the surgical operating microscope camera and the intensity profile was calculated to demonstrate the homogeneity of the excitation light. Results: Passed
System Sensitivity (TS8): BLUE 400: As a diffusely reflecting and fluorescent disc the ZEISS BLUE 400 fluorescent target was used and positioned at a microscope working distance of 22.5 cm. The zoom setting was chosen to lead to the same image size of the target for all devices. The fluorescence signal in the eyepiece of the subject device was compared to the predicate device. BLUE 400 S: The fluorescence light portion of the ZEISS BLUE 400 fluorescence target, measured with BLUE 400 is scaled to and subtracted from the spectrum measured with BLUE 400 S. This results in the BLUE 400 S remission spectrum. The integral of the reconstructed fluorescence signal is divided by the integral of the reconstructed remission spectrum, corresponding to the ratio of fluorescence to emission light. Results: Passed
Pre-Operative Phantom Test (TS9): This test was conducted to demonstrate that the ZEISS BLUE 400 test phantom is suitable for the pre-operative checks of a surgical microscope. The phantom has one fluorescent area and was imaged by the surgical microscope camera. The same test was repeated by observation through the microscope eyepiece. Results: Passed
Spectrum of the Camera Filter (TS10): The spectrum at the camera interface was measured with a spectroradiometer to demonstrate that camera filter can block near infrared and infrared leakage of excitation light to the camera. Results: Passed
Finally, special controls testing has also been performed and met the defined specifications. The following special controls testing has been conducted with and without cover glass: Not Found in provided text.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
June 28, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Carl Zeiss Meditec AG Chaitali Gawde Senior Regulatory Affairs Specialist 5300 Central Parkway Dublin, California 94588
Re: K240215
Trade/Device Name: BLUE 400; BLUE 400 S Regulation Number: 21 CFR 882.4950 Regulation Name: Diagnostic Neurosurgical Microscope Filter Regulatory Class: Class II Product Code: QFX Dated: January 25, 2024 Received: May 31, 2024
Dear Chaitali Gawde:
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 OS 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, Digitally signed by Adam D. Adam D. Pierce -S Date: 2024.06.28 Pierce -S 14:17:06 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240215
Device Name BLUE 400; BLUE 400 S
Indications for Use (Describe)
BLUE 400 and BLUE 400 S are accessories to the surgical microscope and allow the fluorescence observation of fluorophores with an excitation peak between 400 nm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm.
The ZEISS BLUE 400 and BLUE 400 S are surgical microscope accessories used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------ | --------------------------------------------- |
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4
In accordance with 21 CFR 807.92 the 510(k) Summary for the Fluorescence Accessories is provided below.
SUBMITTER 1.
| Applicant: | Carl Zeiss Meditec AG
Rudolf-Eber-Strasse 11D-73447
Oberkochen
Germany |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Chaitali Gawde
Senior Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(224) 300-3992 Phone
E-mail: chaitali.gawde@zeiss.com (preferred) |
| Secondary Correspondent | Paul Swift
Head of Regulatory and Clinical Affairs, Americas
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(817) 925-8507 Phone
E-mail: paul.swift@zeiss.com |
| Date Prepared: | June 27, 2024 |
5
2. DEVICE
| Device Trade Name: | BLUE 400; BLUE 400 S |
|---|---|
| Classification: | 21 CFR 882.4950 Diagnostic Neurosurgical Microscope Filter |
| Regulatory Class: | II |
| Product Code: | QFX |
3. LEGALLY MARKETED PREDICATE DEVICE
| Predicate Device Name: | BLUE 400 (K211346) |
|---|---|
| Classification: | 21 CFR 882.4950 Diagnostic Neurosurgical Microscope Filter |
| Regulatory Class: | II |
| Product Code: | QFX |
4. DEVICE DESCRIPTION SUMMARY
The BLUE 400 and BLUE 400 S are fluorescence accessories to qualified surgical microscopes, intended to allow intraoperative viewing of malignant glioma tissue grade III and IV under fluorescence. The overall system is comprised of excitation (illumination) and emission (observation) filters to detect fluorescence and are optimized in conjunction with the drug to pass light between 620 – 710 nanometers. The BLUE 400 S filters allow the surgical microscope to produce excitation light in a wavelength range covering at least 400 - 410 nanometers that excites an approved optical imaging agent and enables the surgeon to observe the emitted fluorescent signal in the oculars or on a display. Fluorescence of marked brain tissue helps visualization of tissue associated with Grade III & IV glioma during neurosurgeries.
Compared to the blue visualization of the surrounding non-fluorescent tissue in the BLUE 400 image, BLUE 400 S is designed to visualize the surrounding nonfluorescent tissue more similar to white light impression, while tumor visualization of grade III and IV glioma remains consistent. With the visualization of non-fluorescent anatomy in an almost white light impression, BLUE 400 S is expected to allow PplX visualization with less frequent switching between fluorescence and white light imaging modes.
BLUE 400 and BLUE 400 S can be installed only into qualified ZEISS surgical microscopes. For these accessories to be used with a qualified ZEISS surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of BLUE 400 and BLUE 400 S.
6
INDICATIONS FOR USE 5.
BLUE 400 and BLUE 400 S are accessories to the surgical microscope and allow the fluorescence observation of fluorophores with an excitation peak between 400 mm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm.
The ZEISS BLUE 400 and BLUE 400 S are surgical microscope accessories used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.
SUBSTANTIAL EQUIVALENCE 6.
Table 1. Subject to Predicate Device Comparison Table – Indications for Use
| Attribute | Subject Device | Predicate Device | Equivalence | Justification |
|---|---|---|---|---|
| BLUE 400 / BLUE 400 S | BLUE 400 | statement | of equivalency | |
| (K240215) | (K211346) | |||
| Indications for | ||||
| Use | BLUE 400 and BLUE 400 | |||
| S are accessories to the | ||||
| surgical microscope and | ||||
| allow the fluorescence | ||||
| observation of | ||||
| fluorophores with an | ||||
| excitation peak between | ||||
| 400 nm and 410 nm and | ||||
| the fluorescence emission | ||||
| observation comprising the | ||||
| spectrum in a spectral band | ||||
| of 620 - 710 nm. | ||||
| The ZEISS BLUE 400 and | ||||
| BLUE 400 S are surgical | ||||
| microscope accessories | ||||
| used in fluorescent | ||||
| visualization of suspected | ||||
| grade III and IV gliomas | ||||
| during neurosurgery. | BLUE 400 is a surgical | |||
| microscope accessory filter | ||||
| for viewing fluorescence | ||||
| of fluorophores with an | ||||
| excitation peak between | ||||
| 400 nm and 410 nm and | ||||
| the fluorescence emission | ||||
| observation comprising the | ||||
| spectrum in a spectral band | ||||
| of 620 - 710 nm. | ||||
| The ZEISS BLUE 400 is a | ||||
| surgical microscope | ||||
| accessory used in | ||||
| fluorescent visualization of | ||||
| suspected grade III and IV | ||||
| gliomas during | ||||
| neurosurgery. | Equivalent | Updated to | ||
| include BLUE | ||||
| 400 S. | ||||
| Patient | ||||
| Population | Patients undergoing | |||
| neurological procedures | ||||
| who already have been | ||||
| diagnosed with grade III & | ||||
| IV glioma with the aid of | ||||
| further diagnostic | ||||
| procedures. | Patients undergoing | |||
| neurological procedures. | Equivalent | The patient | ||
| population | ||||
| remains the | ||||
| same, it is only | ||||
| described in | ||||
| more detail. | ||||
| Configuration/R | ||||
| elationship to the | ||||
| device | BLUE 400 consists of a | |||
| HW module (specific | ||||
| filters). | ||||
| BLUE 400 S consists of a | ||||
| HW module (specific | ||||
| filters). | BLUE 400 consists of a | |||
| HW module (specific | ||||
| filters). | Identical | N/A | ||
| Attribute | Subject Device | |||
| BLUE 400 / BLUE 400 S | ||||
| (K240215) | Predicate Device | |||
| BLUE 400 | ||||
| (K211346) | Equivalence | |||
| statement | Justification | |||
| of equivalency | ||||
| Manufacturer | Carl Zeiss Meditec AG | |||
| Goeschwitzer Strasse 51-52 | ||||
| D-07745 Jena Germany | Carl Zeiss Meditec AG | |||
| Goeschwitzer Strasse 51-52 | ||||
| D-07745 Jena Germany | Identical | N/A | ||
| Classification | ||||
| Product Code | QFX | QFX | Identical | N/A |
| Regulation | ||||
| Number | 882.4950 (Diagnostic | |||
| neurosurgical microscope | ||||
| filter) | 882.4950 (Diagnostic | |||
| neurosurgical microscope | ||||
| filter) | Identical | N/A | ||
| Review Panel | Neurology | Neurology | Identical | N/A |
| Fluorescence | ||||
| Excitation | BLUE 400: | |||
| 400 nm to 430 nm (50% | ||||
| edges) | ||||
| BLUE 400 S: | ||||
| 398 nm to 457 nm (50% | ||||
| edges) | 400 nm to 430 nm (50% | |||
| edges) | Equivalent | Excitation | ||
| wavelength | ||||
| range of PpIX | ||||
| is covered by | ||||
| both options | ||||
| (400 nm to 410 | ||||
| nm) | ||||
| Fluorescence | ||||
| Detection | BLUE 400: |
450 nm (50% edge)
BLUE 400 S:
540 nm to 728 nm (50%
edges) | > 450 nm (50% edge) | Equivalent | Fluorescence
light of PpIX
between 620
nm and 710
nm is covered
by both
options. |
| Fluorescence
Agent | 5-Aminolevulinic acid
hydrochloride (5-ALA HCl)
Gleolan | 5-Aminolevulinic acid
hydrochloride (5-ALA HCl)
Gleolan | Identical | N/A |
| Combination
Device | No | No | Identical | N/A |
| Visualization
Result | Fluorescent image of
distribution of the
accumulated protoporphyrin
IX (PpIX) in malignant
tissue during operation | Fluorescent image of
distribution of the
accumulated protoporphyrin
IX (PpIX) in malignant
tissue during operation | Identical | N/A |
| Visualization
of Real Time
Images | Yes | Yes | Identical | N/A |
| Visualization
on Interface/
Display | Yes | Yes | Identical | N/A |
| Light
Specifications -
Type | White Light – Fluorescence | White Light – Fluorescence | Identical | N/A |
| Attribute | Subject Device
BLUE 400 / BLUE 400 S
(K240215) | Predicate Device
BLUE 400
(K211346) | Equivalence
statement | Justification
of equivalency |
| Light
Specifications -
Light Source | Non-laser light source -
Minimum Irradiance must
be met (Brightness Ocular
Image: $\geq$ 92 nW,
Measured at a working
distance of 250 mm) | 300 Watt Xenon | Equivalent | Replaced by
irradiance
required for
acceptable
illumination |
7
Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics
8
7. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY OF STUDIES
Sterilization and Shelf Life
The device is provided non-sterile. Shelf-Life is not applicable.
Biocompatibility
The device does not have patient-contacting materials; therefore, a biocompatibility assessment is not needed for this device.
Performance Testing - Bench
In order for BLUE 400 and BLUE 400 S to work, they must be installed onto a qualified ZEISS surgical microscope. A software license specific to BLUE 400 and BLUE 400 S must also be installed on the ZEISS microscope. Software verification testing (Documentation Level: Enhanced) has been performed in accordance with the FDA guidance document "Content of Premarket Submissions for Device Software Functions" to demonstrate that software is performing as intended. Cybersecurity concerns were addressed by providing cybersecurity documentation that included an assessment of the assets, threats, vulnerabilities, and controls in accordance with the FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. To ensure that the clinically relevant parameters for the Indications for Use of the fluorescence accessories are fulfilled, the following parameters/specifications were tested:
| Test | Test Method | Results |
|---|---|---|
| Brightness of the fluorescence | ||
| ocular image | Measurement of the image brightness of the ZEISS | |
| fluorescence target at the ocular plane at a working | ||
| distance of 250 mm. | Passed | |
| Irradiance | Measurement of the excitation light density in the | |
| object plane. | Passed | |
| Test | Test Method | Results |
| Spatial resolution of the ocular image | Measurement of the spatial resolution with the spatial test target in white light mode. | Passed |
| @min. magnification + working distance 200mm | ||
| @max. magnification + working distance 200mm | ||
| Values may vary depending on different working distances. | ||
| Excitation wavelength (of the microscope) | Excitation wavelength range of PpIX is covered by both options (400 nm to 410 nm). | Passed |
| Excitation filter | Check of optical filter specification of excitation filter | Passed |
| Emission wavelength (of the microscope - ocular image) | Design review via evaluation of component specifications or measurement of the spectrum at the ocular plane. | Passed |
| Emission wavelength (of the microscope - video image) | Design review via evaluation of component specifications or measurement of the spectrum at the ocular plane. | Passed |
| Emission filter | Check of optical filter specification of emission filter | Passed |
| Non-mirrored video image | Visual inspection with a corresponding test target in white light mode. | Passed |
| Non-rotated video image | Visual inspection with a corresponding test target in white light mode. | Passed |
| Non-deformed video image | Visual inspection of the geometric distortions of a test target with a circle in white light mode | Passed |
| Centered video image | Visual inspection and measurement with a test target in white light mode. | Passed |
| Photometric resolution of video image | Grey value resolution test with a photometric resolution test target in white light mode. | Passed |
| Signal-to-noise ratio of the video image (sensitivity) | Measurement of the signal-to-noise ratio of a video image of a fluorescent target at a given signal value (pixel value). | Passed |
| Latency of the video image | Measurement of the video latency in white light mode. | Passed |
| Spatial resolution of the video image | Measurement of the spatial resolution with the spatial test target in white light mode. | Passed |
| Test | Test Method | Results |
| Spectrum of the Illumination | ||
| Source (TS1) | The irradiance spectrum (250 nm - 1020 nm, $mW/cm^2$ | |
| of the illumination source was measured and verified | ||
| with a spectrometer. These measurements were | ||
| assessed prior to application of the excitation filter | ||
| module. | Passed | |
| Maximum | ||
| Power | ||
| and | ||
| Irradiance of the Illumination | ||
| Source (TS2) | The maximum output power and irradiance of | |
| illumination sources were measured and verified with a | ||
| power meter at the end of the microscope light guide. | ||
| These measurements were assessed prior to application | ||
| of the excitation filter module. | Passed | |
| Irradiance Spectrum of the | ||
| Excitation Light and Spectral | ||
| Response of the Excitation | ||
| Filter (TS3) | The irradiance spectrum (250 nm - 1020 nm) of the | |
| illumination light, following passage through the | ||
| excitation filter module, was measured at a working | ||
| distance of 30 cm with a spectrometer. The edges at | ||
| 50% decrease of the blue excitation peak were | ||
| calculated respectively. | Passed | |
| Maximum Excitation Power | ||
| and Power Density (TS4) | The maximum power (mW) and power density | |
| (mW/cm²) of the excitation light was measured with a | ||
| thermopile, at multiple different working distances and | ||
| zoom settings, including the maximum and minimum | ||
| zoom. | ||
| The power density measurements of the subject device were compared to the predicate device. | Passed | |
| Optical Path Loss (TS5) | To determine the overall detectable light output and the | |
| total losses in relation to device working distance and | ||
| zoom setting, optical path loss was calculated by | ||
| dividing the output signal measured at the microscope | ||
| eyepiece (without emission filter) by the illumination | ||
| signal measured with a spectrometer at the microscope | ||
| focal plane for the same zoom setting. A reflection | ||
| standard (white silicon remission disc) was used at a | ||
| working distance of 35 cm. | Passed | |
| Spectrum of the Emission Filter | ||
| (TS6) | The spectrum (350 nm – 1050 nm) of the emission filter | |
| when integrated in the surgical operating microscope | ||
| was measured with a spectroradiometer to include all | ||
| the coating and optics that affects the spectrum of the observation path. For this test the excitation filter was | Passed | |
| Test | Test Method | Results |
| removed, and a reflection standard was used at the device focal plane with different zoom settings. To compare the light that passes the observation optics and emission filter, the 50% edge of the spectrum was calculated. | ||
| Homogeneity of the Excitation | ||
| Light at the Focal Point (TS7) | The reflected signal from a white sheet of paper positioned at 30 cm working distance was imaged by the surgical operating microscope camera and the intensity profile was calculated to demonstrate the homogeneity of the excitation light. | Passed |
| System Sensitivity (TS8) | BLUE 400: As a diffusely reflecting and fluorescent disc the ZEISS BLUE 400 fluorescent target was used and positioned at a microscope working distance of 22.5 cm. The zoom setting was chosen to lead to the same image size of the target for all devices. |
The fluorescence signal in the eyepiece of the subject device was compared to the predicate device.
BLUE 400 S: The fluorescence light portion of the ZEISS BLUE 400 fluorescence target, measured with BLUE 400 is scaled to and subtracted from the spectrum measured with BLUE 400 S. This results in the BLUE 400 S remission spectrum. The integral of the reconstructed fluorescence signal is divided by the integral of the reconstructed remission spectrum, corresponding to the ratio of fluorescence to emission light. | Passed |
| Pre-Operative Phantom Test
(TS9) | This test was conducted to demonstrate that the ZEISS BLUE 400 test phantom is suitable for the pre-operative checks of a surgical microscope. The phantom has one fluorescent area and was imaged by the surgical microscope camera. The same test was repeated by observation through the microscope eyepiece. | Passed |
| Spectrum of the Camera Filter
(TS10) | The spectrum at the camera interface was measured with a spectroradiometer to demonstrate that camera filter can block near infrared and infrared leakage of excitation light to the camera. | Passed |
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Finally, special controls testing has also been performed and met the defined specifications. The following special controls testing has been conducted with and without cover glass:
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CONCLUSION 8.
Based on the similarities of the intended use/indications for use, device design, principles of operation, technological characteristics and the results of the non-clinical performance testing, the subject device, BLUE 400 and BLUE 400 S, is substantially equivalent to the legally marketed predicate device.