(15 days)
No
The summary describes standard image processing, visualization, and registration techniques, with no mention of AI or ML algorithms. The performance studies focus on geometric accuracy and volume calculation using phantoms, not on the performance of any AI/ML-driven analysis.
No.
Explanation: The device is intended for visualization, planning, and guidance of interventional procedures, not for direct therapeutic action on the patient.
No
The "Intended Use / Indications for Use" states that the software is for "2D and 3D visualization of ultrasound images of the prostate gland" and other features like "patient data management, multiplanar reconstruction, segmentation, image measurements, and 3-D registration." It explicitly states that "Images may not be used for diagnostic purposes." Therefore, it is a visualization and planning tool, not a diagnostic device.
No
The device description explicitly states that the software works with commercially available mechanical stepper and stabilizer assemblies, a PC-based workstation containing a video image converter, and commercially available ultrasound machines and probes. While the software is a key component, it relies on and interacts with specific hardware components for its intended use.
Based on the provided information, the BioJet software is likely considered an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The software is intended for use by physicians in a clinical or hospital setting for the visualization and analysis of ultrasound images of the prostate gland. While visualization is a key function, the software also includes features for planning and implementing image-guided interventional procedures like biopsies.
- Device Description: The description explicitly states that the software assists users in "planning and performing image-guided interventional procedures such as biopsies and the placement of instruments and markers." This goes beyond simple image display and moves into the realm of providing information used to guide medical procedures.
- Relationship to Biopsies: The software is designed to work with biopsy needles and guides, display needle trajectories, and assist in planning biopsy sites. Biopsies are a diagnostic procedure where tissue samples are taken for analysis, which is a core component of in vitro diagnostics.
- Image Analysis and Measurement: The software provides tools for image analysis, including segmentation, measurements (volume, length, angle), and registration. These analytical capabilities are used to derive information from the images that can inform diagnostic decisions or guide procedures.
- Comparison to Predicate Device: The predicate device listed (K081093; Eigen 3D-Imaging Workstation) is also a workstation for visualizing and analyzing medical images, often used in the context of procedures like biopsies. This further supports the classification of BioJet as a similar type of device.
While the software itself doesn't directly perform the in vitro diagnostic test (the analysis of the biopsy sample), it provides critical information and guidance that is integral to the diagnostic process. The software's function in planning and guiding biopsies, which are a key step in diagnosing prostate conditions, places it within the scope of devices that support in vitro diagnostic procedures.
Therefore, the BioJet software is likely classified as an IVD device because it provides information derived from medical images that is used to guide and support diagnostic procedures (biopsies).
N/A
Intended Use / Indications for Use
The BioJet software is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurements, and 3-D registration.
Product codes
LLZ
Device Description
The BioJet software is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image stack. The system has been designed to work with the clinicians' existing ultrasound machine and TRUS (TransRectal UltraSound) probe, commercially available needles, needle guides or needle gun combination. Additional software features include patient data management, multi-planar reconstruction, image measurements and 3-D image registration. BioJet works with commercially available mechanical stepper and stablizer assemblies that holds the ultrasound probe and tracks the probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The mechanical tracker is connected to a PC-based workstation containing a video image converter. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of BioJet. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, BioJet is able to reconstruct and display a 3-D rendered surface model of the prostate and to display the live image position within the prostate. Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3-D image stack and 3-D rendered surface model, and stored. Previously created 3-D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3-D model used for co-registration may be based on another series of ultrasound images or DICOM images. Finally, the physician may attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform biopsies. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of BioJet during the biopsy. As the TRUS probe with attached needle guide or needle grid is maneuvered by the position and orientation of the probe is tracked. BioJet is able to add, display and edit plans for biopsy sites as well as an estimate of the probe position and needle trajectory relative to the 3-D image series and rendered surface model of the prostate. BioJet offers the physician additional 3 -D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The scientific concepts on which the BioJet Software is based is that organs such as the prostate can be visualized with a number of imaging modalities. All imaging modalities display the organs in a different way and deliver different information but they all display the same shape and size of the organ. Thus it is possible to co-register a previously acquired 3-D model of a prostate to live ultrasound images acquired with a commercially available endo-rectal probe. The BioJet Software provides two and 3 dimensional image review, manipulation, and analysis tools to assist users in planning and performing image-guided interventional procedures such as biopsies and the placement of instruments and markers. Supported imaging modalities include DICOM 3 images and 2D live video images received from commercially available ultrasound (US) machines. DICOM images are received from various commercially available imaging systems via a memory stick or a CD ROM. Live video US images are collected from the video output stream manually or triggered by a commercially available tracking stepper, i.e. a calibrated spatial positioning device. Non DICOM video images are - in contrary to DICOM images - not calibrated and must be scaled within the program based on scaling marks in the image and the known image spacing if collected manually. All know images from US devices include such scaling marks. The contrast and brightness display of the images can be changed manually by the user. Additionally, the user can zoom and pan the images and also change the image coloration for better visibility. The images in the image stack can be interpolated by linear interpolation to allow an image display at 1 mm intervals. This device provides the capability to overlay annotations on 2D medical image displays. These annotations may represent the position of instruments including but not limited to biopsy needles, imaging probes or other tracking devices. Additionally, the user can manually draw contours of structures (prostate, urethra, seminal vesicals, bladder, etc.) and regions of interest (ROI) into the images. The 3-D image stack can be further processed to perform volume estimations based on the manually drawn organ contours or ROIs drawn by a physician. Patient information, notes, and images may be stored unchanged - for future retrieval. In-plane length and angle measurements are available. The angle data pertains to the biopsy guidelines, biopsy cores, markers and instruments used. Thus only volume, length, and angle measurements are conducted. All images independant of the image format (JPEG, BMP, DICOM, PNG) are stored and displayed unchanged. JPEG images may have been created with lossy compression. For that reason the user is informed that JPEG images may have been created using a lossy compression. Images may not be used for diagnostic purposes. Live 2-D ultrasound images are used for example during biopsy or placement of instruments. As the TRUS probe with the attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked manually or by an attached tracked device. The ultrasound image contains the available device trajectories that are manually match to the trajectories in the program. Thus the complete biopsy procedure is controlled by the user by observing the live uttrasound images and matching the respective trajectories. The user may load image display test patterns into the program at any time for quality assessment using one of the allowed imaging modalities. These test patterns can be used, for example, to check the quality of image re-slicing, grayscale or color depiction, measurement precision or screen resolution and display. All data and images are stored in the patient file for later retrieveal. Image are always stored as unchanged originals. The files are CRC checksum protected zip files. When a checksum is received or read, the device performs a CRC on the data and compares the resulting check value with the received one. If the check values do not match, then the block contains a data error. Otherwise, the data is assumed to be error-free. CRCs are specifically designed to protect against common types of errors on communication channels, where they provide assurance of the integrity of messages delivered. The zip format uses a 32-bit CRC algorithm and includes two copies of the directory structure of the respective file to provide greater protection against data loss.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound machines, commercially available imaging systems (DICOM 3 images, 2D live video images)
Anatomical Site
prostate gland
Indicated Patient Age Range
men usually age 40 and older
Intended User / Care Setting
physicians in the clinic or hospital
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)
The BioJet has been designed to comply with the applicable software standards: IEC 62304:2006, IEC 62366:2007, IEC 60601-1-4:1999, ISO 14971:2007, DICOM (NEMA PS 3.1 3.18), ISO / IEC 15444-1:2005 + Technical Corrigendum 1:2007, HIPAA (45 CFR Parts 160 and 164 as far as applicable). All product and engineering specifications were verified and validated. Test phantoms incorporating simulated prostates were used to verify system performance through verification, validation and benchmarking. Performance tests include tests on ultrasound phantoms that the biopsy guidelines in transverse and longitudinal section are precisely aligned with the biopsy guidelines on the ultrasound images. It was also demonstrated that the contours of the longitudinal display calculated from the transverse contour drawing fit onto the actual longitudinal contours of the phantom. Volume tests proved that the calculated volume is within an error of less than 3% equal to the volume displayed by the shelf commercially available ultrasound device used. The temporal resolution the biopsy needles depends only on the video frequency of ultrasound machine used which is the standard NTSC video signal. All graphics functions are accessible in real-time, i.e. the user cannot detect any time delay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume tests proved that the calculated volume is within an error of less than 3% equal to the volume displayed by the shelf commercially available ultrasound device used.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
SECTION 5
22329
AUG 16 2012
510(k) SUMMARY
(As required by 21 CFR 807.92)
5.1. Submitted by
Jet Soft SRL
Str. Anasttasie Panu Nr. 6 031164 Bucharest Romania
Contact Person
Dr. Peter-M. Klews Regulatory affairs Phone: +49 4133 51 01 85 Fax: +49 4133 51 01 85 E-mail: peter@jetsoftware.eu
Date Initial Summary prepared
June 26th, 2012
5.2. Name of the Device
Proprietary Name: BioJet Common / Usual name: Medical Imaging Processing Software System Regulation Description: Picture Archiving and Communications System (21 CFR 892.2050) Classification: Class II Classification Product Code: System, Image Processing, Radiological Product Code: LLZ
5.3. Substantial Equivalence
Predicate Device:
| Device Name | Eigen 3D-Imaging Workstation |
|---|---|
| Manufacturer | Eigen LLC |
| 510k Number | K081093 |
| Decision Date | May 1st, 2008 |
| Decision | Substantially Equivalent |
5.4. Device Description and Summery of Technological Characteristics, Scientific Concepts
The BioJet software is designed to display the 2-D live video received from commercially available . ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image stack. The system has been designed to work with the clinicians' existing ultrasound machine and TRUS (TransRectal UltraSound)
1
SECTION 5
510(k) SUMMARY
probe, commercially available needles, needle guides or needle gun combination. Additional software features include patient data management, multi-planar reconstruction, image measurements and 3-D image registration.
BioJet works with commercially available mechanical stepper and stablizer assemblies that holds the ultrasound probe and tracks the probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The mechanical tracker is connected to a PC-based workstation containing a video image converter. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of BioJet. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, BioJet is able to reconstruct and display a 3-D rendered surface model of the prostate and to display the live image position within the prostate.
Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3-D image stack and 3-D rendered surface model, and stored. Previously created 3-D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3-D model used for co-registration may be based on another series of ultrasound images or DICOM images.
Finally, the physician may attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform biopsies. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of BioJet during the biopsy. As the TRUS probe with attached needle guide or needle grid is maneuvered by the position and orientation of the probe is tracked. BioJet is able to add, display and edit plans for biopsy sites as well as an estimate of the probe position and needle trajectory relative to the 3-D image series and rendered surface model of the prostate. BioJet offers the physician additional 3 -D information for assessing prostate abnormalities, planning and implementing biopsy procedures.
The scientific concepts on which the BioJet Software is based is that organs such as the prostate can be visualized with a number of imaging modalities. All imaging modalities display the organs in a different way and deliver different information but they all display the same shape and size of the organ. Thus it is possible to co-register a a previously acquired 3-D model of a prostate to live ultrasound images acquired with a commercially available endo-rectal probe.
The BioJet Software provides two and 3 dimensional image review, manipulation, and analysis tools to assist users in planning and performing image-guided interventional procedures such as biopsies and the placement of instruments and markers. Supported imaging modalities include DICOM 3 images and 2D live video images received from commercially available ultrasound (US) machines. DICOM images are received from various commercially available imaging systems via a memory stick or a CD ROM. Live video US images are collected from the video output stream manually or triggered by a commercially available tracking stepper, i.e. a calibrated spatial positioning device. Non DICOM video images are - in contrary to DICOM images - not calibrated and must be scaled within the program based on scaling marks in the image and the known image spacing if collected manually. All know images from US devices include such scaling marks.
Date 21
2
SECTION 5
510(k) SUMMARY
The contrast and brightness display of the images can be changed manually by the user. Additionally, the user can zoom and pan the images and also change the image coloration for better visibility. The images in the image stack can be interpolated by linear interpolation to allow an image display at 1 mm intervals.
This device provides the capability to overlay annotations on 2D medical image displays. These annotations may represent the position of instruments including but not limited to biopsy needles, imaging probes or other tracking devices. Additionally, the user can manually draw contours of structures (prostate, urethra, seminal vesicals, bladder, etc.) and regions of interest (ROI) into the images.
The 3-D image stack can be further processed to perform volume estimations based on the manually drawn organ contours or ROIs drawn by a physician. Patient information, notes, and images may be stored unchanged - for future retrieval. In-plane length and angle measurements are available. The angle data pertains to the biopsy guidelines, biopsy cores, markers and instruments used. Thus only volume, length, and angle measurements are conducted. All images independant of the image format (JPEG, BMP, DICOM, PNG) are stored and displayed unchanged. JPEG images may have been created with lossy compression. For that reason the user is informed that JPEG images may have been created using a lossy compression. Images may not be used for diagnostic purposes.
Live 2-D ultrasound images are used for example during biopsy or placement of instruments. As the TRUS probe with the attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked manually or by an attached tracked device. The ultrasound image contains the available device trajectories that are manually match to the trajectories in the program. Thus the complete biopsy procedure is controlled by the user by observing the live uttrasound images and matching the respective trajectories.
The user may load image display test patterns into the program at any time for quality assessment using one of the allowed imaging modalities. These test patterns can be used, for example, to check the quality of image re-slicing, grayscale or color depiction, measurement precision or screen resolution and display.
All data and images are stored in the patient file for later retrieveal. Image are always stored as unchanged originals. The files are CRC checksum protected zip files. When a checksum is received or read, the device performs a CRC on the data and compares the resulting check value with the received one. If the check values do not match, then the block contains a data error. Otherwise, the data is assumed to be error-free. CRCs are specifically designed to protect against common types of errors on communication channels, where they provide assurance of the integrity of messages delivered. The zip format uses a 32-bit CRC algorithm and includes two copies of the directory structure of the respective file to provide greater protection against data loss.
5.5. Intended use
The BioJet software is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurements, and 3-D registration.
-n-nn
3
The intended use is the same as that of the predicate device mentioned in paragraph 5.3.
The BioJet Software provides two and 3 dimensional image review, manipulation, and analysis tools to assist users in planning and performing image-guided interventional procedures such as biopsies and the placement of instruments and markers. The patient population for which the device is intended are men usually age 40 and older that are suspected of having or actually have prostate disorders such as BPH, prostate cancer or other prostate problems.
5.6. Substantial Equivalence
In summary BioJet utilizes the same technological characteristic as the predicate device. Both:
- are PC based software applications that provide 2D and 3D medical image acquisition including ultrasound video image acquisition and visualization of the prostate gland
- use Windows operating systems -
- allow co-registration of live ultrasound images to previously created 3-D image sets based on previously collected live ultrasound image sets or DICOM images sets
- include image enhancements such as contrast and brightness, zoom and pan capabilities -
- provide patient and clinical data management features. ・
- deal with live ultrasound images received from commercially available imaging devices. -
- use graphic overlays to define segmentations -
- calibrate ultrasound video images -
- run on a Windows operating system
- = create a report
- allow for image measurements such as volume, length, and angle measurements ।
- allow multi-planar reformatting
- allow manual planning of instrument positioning including biopsy needle placement and planning -
- allow the user to plan and mark the reached positions of the biopsies and instruments -
- do not steer or in anyway control the positioning of the instruments used or of any treatment process what so ever
- are only intended for use on the prostate gland
The devices differ in a few features. These do not raise any safety or effectiveness concerns. These are:
- The predicte device uses a propriatary mechanical positioning device and BioJet uses a standard off the shelf mechanical positioning device
- BioJet TRUS contours cannot be automatically elastically deformed (non-rigid registration) to align with an MR image ·
- BioJet does not allow the recoding of video sequences
- BioJet also allows the user to mark the position of markers placed into the prostate.
It total the main differences relate to omitting automatic functions and add-ons that in our case must be done manually and to the use of a standard positioning device used for may years in therapy options such as
4
LDR/HDR brachytherapy instead of a specially produced device. These differences do not create any additional safety issues.
Summary of Testing and Performance data
The BioJet has been designed to comply with the applicable software standards:
- IEC 62304:2006,
- IEC 62366:2007,
- IEC 60601-1-4:1999
- ISO 14971:2007,
- DICOM (NEMA PS 3.1 3.18)
- ISO / IEC 15444-1:2005 + Technical Corrigendum 1:2007
- HIPAA (45 CFR Parts 160 and 164 as far as applicable)
All: product and engineering specifications were verified and validated. Test phantoms incorporating simulated prostates were used to verify system performance through verification, validation and benchmarking. Performance tests include tests on ultrasound phantoms that the biopsy guidelines in transverse and longitudinal section are precisely aligned with the biopsy guidelines on the ultrasound images. It was also demonstrated that the contours of the longitudinal display calculated from the transverse contour drawing fit onto the actual longitudinal contours of the phantom. Volume tests proved that the calculated volume is within an error of less than 3% equal to the volume displayed by the shelf commercially available ultrasound device used. The temporal resolution the biopsy needles depends only on the video frequency of ultrasound machine used which is the standard NTSC video signal. All graphics functions are accessible in real-time, i.e. the user cannot detect any time delay.
As such BioJet is as safe and effective as the predicate device and is substantially equivalent to the predicate device.
Conclusions
The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of BioJet with those of the predicate device demonstrate that BioJet is substantially equivalent to the existing product in the market today.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 6 2012
Jet Soft SRL % Mr. Olaf Teichert Responsible Third Party Official (510)k TPR Program Manager TUV SUD America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K122329
Trade/Device Name: BioJet Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 9, 2010 Received: August 1, 2012
Dear Mr. Teichert:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use slated in the Closure) to regarry manager and the Medical Device Ameral Food Fred Conimeter prior to hay 20, 1978, the eccordance with the provisions of the Federactive (DMA) 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. The Act. The 1 ou may, utcretore, tharket the 2012 to the Act include requirements for annual registration, listing of general controls provisions of are feel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such in title 21 IT your device is classified (600 a00 regulations affecting your device can be found in Title 21, adultional controls. Existing mayor regulation of 895. In addition, FDA may publish further Sode of I odoral concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that i Dri 3 issuanted or or device complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a determination that your were by other Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to special of Comply with an the Fee 3104 ERR Parts 801 and 809); medical device reporting (reporting of
6
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse events) (21 er it occa), and gion (21 CFR Part 820). This letter requirements as set form in the quality of steen (Q-7) vour Section 510(k) prematked will allow you to begin marketing your active a coaches of your device to a legally marketed nothication. The FDA indulig of substantial equice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice for your device of our ideoning reguluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference of educations of educations of educations of educations of educations of educations of educations o 5450. Also, please note the regulation officials. "Firstelling the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDR regulation (21 CFR Pat 605), prodo go go default.htm for the CDRH's Office
Ifttp://www.raa.good.diometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Y ou may obtain other geleral imonmational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
INDICATION FOR USE FORM
510(k) Number (if known):
Device Name: BioJet
Indication For Use:
The BioJet software is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization The Bloce sollware is intended to be used by prysioland in the olines not prospect of the progetent a of ultrasound imaged of the procees gan image measurements, and 3-D registration.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (O!VD)
hal D. R.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_