(445 days)
Not Found
No
The device description focuses solely on optical filters and software for switching modes, with no mention of AI/ML algorithms for image analysis or decision support.
No.
The device is described as an accessory for a surgical microscope, intended for the fluorescent visualization of certain tissues, not for treating any condition.
Yes
The device is described as allowing "fluorescent visualization of suspected grade III and IV gliomas during neurosurgery" and "intraoperative viewing of malignant glioma tissue under fluorescence," which are diagnostic actions aimed at identifying or characterizing a medical condition.
No
The device is described as an accessory composed entirely of optical filters, which are hardware components. While it includes a software license for operation, the core functionality and physical form are hardware-based.
Based on the provided information, the BLUE 400 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- BLUE 400 Function: The BLUE 400 is an accessory for a surgical microscope. Its function is to provide specific optical filtering for the visualization of fluorescent agents during surgery on living tissue. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "fluorescent visualization of suspected grade III and IV gliomas during neurosurgery." This is an intraoperative imaging tool, not a diagnostic test performed on a sample outside the body.
Therefore, the BLUE 400 falls under the category of a medical device used for visualization during a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BLUE 400 is an accessory of the surgical microscope and allows 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 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.
Product codes
QFX
Device Description
The BLUE 400 is an accessory to the Zeiss surgical microscopes (OPMI PENTERO 800, OPMI PENTERO 900, and KINEVO 900), intended to allow intraoperative viewing of malignant glioma tissue under fluorescence. The BLUE 400 accessory is entirely composed of optical filters: the "Excitation" filter and the "Emission" filters. The Excitation filter is designed to filter all light wavelengths except 400 - 470 nanometers and is optimized to pass light between 400 - 410 nanometers. The Emission filters are designed to filter all light wavelengths except 430 - 800 nanometers and is optimized to pass light between 620 - 710 nanometers.
When installed in the surgical microscopes (class I), the BLUE 400 introduces optical filters to the illumination and viewing optical paths. The BLUE 400 includes installation of a software license that facilitates use of the accessory. After the SW license is installed, the user has the option to switch from the normal white light mode of the surgical microscope to the BLUE 400 mode.
The BLUE 400 accessory, when installed in the surgical microscopes, is intended to be used in conjunction with an approved optical imaging agent that is excited mainly in the wavelength range of 400 – 410 nanometers and fluoresces in the wavelength range of 620 - 710 nanometers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence
Anatomical Site
Not Found
Indicated Patient Age Range
BLUE 400 has not been evaluated to support the use of the device in a pediatric patient population.
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
Software verification testing was performed in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" to demonstrate that software is performing as intended. Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the defined specifications. The testing was completed for the predicate and subject device and the performance of the subject device was compared to the predicate. Special controls testing has also been performed and met the defined specifications with and without cover glass. All listed tests passed:
- Spectrum of the Illumination Source: 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.
- Maximum Power and Irradiance of the Illumination Source: 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.
- Irradiance Spectrum of the Excitation Light and Spectral Response of the Excitation Filter: 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.
- Maximum Excitation Power and Power Density: The maximum power (mW) and power density (mW/cm^2) of the excitation light was measured with a thermopile, at multiple different working distances (22.5 - 30 cm) and zoom settings, including the maximum and minimum zoom. The power density measurements of the subject device were compared to the predicate device.
- Optical Path Loss: 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.
- Spectrum of the Emission Filter: 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.
- Homogeneity of the Excitation Light at the Focal Point: 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.
- System Sensitivity: 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 three devices. The fluorescence signal in the eyepiece of the subject device was compared to the predicate device.
- Pre-Operative Phantom Test: This test was conducted to demonstrate that the ZEISS BLUE 400 test phantom is suitable for the pre-operative checks of the KINEVO 900 and OPMI PENTERO 900. 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.
- Spectrum of Camera Filter: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Leica FL400 (DEN180024)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4950 Diagnostic neurosurgical microscope filter.
(a)
Identification. A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and verify and validate filter specifications and functional characteristics, including the following:
(i) Spectrum and intensity of the illumination source;
(ii) Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope;
(iii) Excitation power and power density;
(iv) Optical path loss from illumination source to objective lens or microscope camera;
(v) Homogeneity of the excitation light at the focal plane;
(vi) Fluorescence detection sensitivity;
(vii) Verification of calibration or preoperative procedures; and
(viii) If camera-based, spectral sensitivity of the camera.
(2) Labeling must include:
(i) Identification of the filter characteristics in conjunction with a compatible surgical operating microscope, to include the following:
(A) Illumination spectrum and power density; and
(B) Excitation and emission filter spectra.
(ii) Instructions for calibration or preoperative checks to ensure device functionality prior to each use;
(iii) Instructions for use with compatible surgical operating microscopes, external light sources, and cameras;
(iv) A warning that the device should only be used with fluorophores approved for use within the specified spectral ranges; and
(v) A warning that the device is not a standalone diagnostic.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
July 22, 2022
Carl Zeiss Meditec AG % Maria Golovina Head of Regulatory Affairs - USA 5300 Central Parkway Dublin, California 94568
Re: K211346
Trade/Device Name: BLUE 400 Regulation Number: 21 CFR 882.4950 Regulation Name: Diagnostic Neurosurgical Microscope Filter Regulatory Class: Class II Product Code: QFX Dated: June 16, 2022 Received: June 21, 2022
Dear Maria Golovina:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
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 Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211346
Device Name BLUE 400
Indications for Use (Describe)
BLUE 400 is an accessory of the surgical microscope and allows 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 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
3
In accordance with 21 CFR 807.92 the 510(k) Summary for the BLUE 400 is provided below.
SUBMITTER 1.
| Applicant: | Carl Zeiss Meditec AG
Goeschwizer Strasse 51-52
D-07745 Jena
Germany |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Maria Golovina
Head of Regulatory Affairs - USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 216-1078 Phone (925) 557-4259 Fax
E-mail: maria.golovina@zeiss.com (preferred) |
| Secondary Correspondent | Chaitali Gawde
Senior Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 557-4202 Phone
E-mail: chaitali.gawde@zeiss.com |
| Date Prepared: | July 22, 2022 |
DEVICE 2.
Device Trade Name: BLUE 400 Classification: 21 CFR 882.4950 Diagnostic Neurosurgical Microscope Filter Regulatory Class: II Product Code: QFX
PREDICATE DEVICE 3.
Predicate Device: Leica FL400 (DEN180024) Classification: 21 CFR 882.4950 Diagnostic Neurosurgical Microscope Filter Regulatory Class: II Product Code: QFX
DEVICE DESCRIPTION 4.
The BLUE 400 is an accessory to the Zeiss surgical microscopes (OPMI PENTERO 800, OPMI PENTERO 900, and KINEVO 900), intended to allow intraoperative viewing of malignant glioma tissue under fluorescence. The BLUE 400 accessory is entirely composed of optical filters: the "Excitation" filter and the "Emission" filters. The Excitation filter is designed to filter all light wavelengths except 400 - 470 nanometers and is optimized to pass light between 400 - 410 nanometers. The Emission filters are designed to filter all light wavelengths except 430 - 800 nanometers and is optimized to pass light between 620 - 710 nanometers.
When installed in the surgical microscopes (class I), the BLUE 400 introduces optical filters to the illumination and viewing optical paths. The BLUE 400 includes installation of a software license that facilitates use of the accessory. After the SW license is installed, the user has the option to switch from the normal white light mode of the surgical microscope to the BLUE 400 mode.
4
510(k) Summary
The BLUE 400 accessory, when installed in the surgical microscopes, is intended to be used in conjunction with an approved optical imaging agent that is excited mainly in the wavelength range of 400 – 410 nanometers and fluoresces in the wavelength range of 620 - 710 nanometers.
INDICATIONS FOR USE ર.
BLUE 400 is an accessory of the surgical microscope and allows 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 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.
SUBSTANTIAL EQUIVALENCE 6.
| Attribute | Subject Device
BLUE 400
K211346 | Predicate Device
Leica FL400
DEN180024 | Equivalency Analysis |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indications for use | BLUE 400 is an accessory of
the surgical microscope and
allows 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 Leica FL400 is a surgical microscope accessory filter set
for viewing fluorescence of
fluorophores comprising an
excitation filter for blue
spectral range 380 nm – 430
nm and an observation filter
comprising the long-wave
blue, green, yellow and red
spectrum in the spectral band
greater than 444 nm. | Similar |
| | The ZEISS BLUE 400 is a
surgical microscope accessory
used in fluorescent
visualization of suspected
grade III and IV gliomas
during neurosurgery. | The FL400 is a surgical
microscope accessory used in
fluorescent visualization of
suspected grade III or IV
gliomas during neurosurgery. | |
| Intended Use | Patients undergoing
neurological procedures. | Patients undergoing
neurological procedures. | Identical |
| Type of Component | Accessory to the
microscope (Filter) | Accessory to the microscope
(Filter) | Identical |
Table 1. Subject to Predicate Device Comparison Table - Indications for Use
5
| Attribute | Subject Device
K211346 | Predicate Device
DEN180024 | Equivalency
Analysis |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Device name | BLUE 400 | Leica FL400 | Different |
| Manufacturer | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena, Germany | Leica Microsystems
(Schweiz) AG | Different |
| Classification Product
Code | QFX | QFX | Identical |
| Regulation # | 21 CFR 882.4950 (Diagnostic
neurosurgical microscope
filter) | 21 CFR 882.4950
(Diagnostic neurosurgical
microscope filter) | Identical |
| Fluorescence
Excitation Spectral
Window | 400 nm - 430 nm | 380 – 430 nm | Equivalent for
fluorescence agent |
| Spectrum of the
Emission Filter | 430 - 800 nm | 300 – 1100 nm | Equivalent for
detecting the
fluorescence agent |
| Combination Device | No | No | Identical |
| 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 |
| Visualization of Real-
Time Images | Yes | Yes | Identical |
| Visualization on
Interface/Display | Yes | Yes | Identical |
| Light Specifications –
Type | White Light - Fluorescence | White Light – Fluorescence | Identical |
Table 2. Subject to Predicate Device Comparison Table - Technical Characteristics
7. SUMMARY OF STUDIES
Sterilization and Shelf Life
The device is provided non-sterile. Cleaning instructions are provided in the user users to follow the cleaning procedures of the surgical operating microscope that the BLUE 400 is installed in. 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 filter to work, it has to be installed onto a surgical microscope and a software license to the microscope has to be installed. Software verification testing was performed in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" to demonstrate that software is performing as intended.
6
510(k) Summary
Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the defined specifications.
The testing was completed for the predicate and subject device and the performance of the subject device was compared to the predicate.
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.
| Test | Test Method Summary | Results |
|---|---|---|
| Spectrum of the | ||
| Illumination Source | 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 | 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 | 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 | The maximum power (mW) and power density | |
| (mW/cm^2) of the excitation light was measured | ||
| with a thermopile, at multiple different working | ||
| distances (22.5 - 30 cm) 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 | 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 | The spectrum (350 nm - 1050 nm) of the emission | |
| filter when integrated in the surgical operating | Passed | |
| 510(k) Summary &text-align: left;">K211346 Page 7 of 7 | ||
| Test | Test Method Summary | Results |
| 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. | Passed | |
| Homogeneity of the | ||
| Excitation Light at the | ||
| Focal Point | 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 | 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 three devices. | Passed | |
| The fluorescence signal in the eyepiece of the | ||
| subject device was compared to the predicate | ||
| device. | ||
| Pre-Operative Phantom | ||
| Test | This test was conducted to demonstrate that the | |
| ZEISS BLUE 400 test phantom is suitable for the | ||
| pre-operative checks of the KINEVO 900 and | ||
| OPMI PENTERO 900. 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 Camera | ||
| Filter | 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 |
7
510(k) Summary
BLUE 400 has not been evaluated to support the use of the device in a pediatric patient population.
CONCLUSION 8.
The indications for use of the subject device, BLUE 400, are equivalent to the indications for use of the predicate device, Leica FL400. The technological characteristics and risk profile of the subject device are similar to the predicate device. Based on the similarities of the indications for use, technological characteristics, and the results of the non-clinical performance testing, the BLUE 400 filter is substantially equivalent to the legally marked predicate device, Leica FL400.