(64 days)
Not Found
Not Found
No
The summary describes standard image processing techniques for CT brain perfusion analysis and does not mention AI, ML, or related concepts.
No
The device is intended for image analysis and visualization of blood flow, aiding in assessment, rather than directly treating or preventing a disease.
Yes
Explanation: The device "provides for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances." This function fits the definition of a diagnostic device as it aids in assessing a medical condition.
Yes
The device is described as a "software package" and an "add-on software feature" designed to run on standard PC hardware and within a cleared image management device. There is no mention of proprietary hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Ziostation's function: Ziostation and its CT Brain Perfusion option process and analyze medical images (specifically CT scans of the brain). They do not analyze biological specimens taken from the body.
- Intended Use: The intended use clearly states it's for "viewing, quantification, manipulation, printing, and management of medical images" and "post-processing based on dynamic CT images." This is image analysis, not in vitro testing.
Therefore, while it's a medical device used for diagnosis and assessment, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication:
The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion Option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
Product codes
LLZ
Device Description
CT Brain Perfusion for Ziostation is an add-on software feature designed to provide a color map of cerebral blood flow and pictorial illustration of perfusion-related parameters obtained on CT images of the brain. This software is designed to work within the currently cleared Ziostation image management device.
CT Brain Perfusion for Ziostation consists entirely of software. No materials are contained in this product.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Brain tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals
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)
All devices met the required specifications for the completed tests.
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.
Not Found
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
§ 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
ICOR30+Y
510(k) Summary
19 2008
This 510(k) summary is prepared in accordance with 21 CFR 807.92.
General Information
| Trade Name | CT Brain Perfusion for Ziostation |
|---|---|
| Common Name | Brain Perfusion Software Tool |
| Classification Name | System, Image Processing, Radiological (21 CFR § 892.2050 - LLZ) |
| Applicant: | Ziosoft, Inc. 2200 Bridge Parkway, Ste. 103 Redwood City, CA 94065 Tel 650-413-1300 Fax 650-596-7319 |
| Contact | Richard Ball Director, Regulatory and Quality Affairs |
Intended Use
Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication:
The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion Option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
Predicate Device
| . But the county of the re-count on the more of the may be and any and any and any and
.
and the first of the later to the belief to the below to the became of the later
Carlo Corporation Compressional Compressional Compressional Compressional Compressional Compressional Compressional Compressional Compressional Compressional Compressional Co
Carlo Career Comments
10 10 1 6 1 0 1 11
College College Court Collection Collins Collins Collins Collins Collins Collection Collins Collection Comers of Children Comparis | . Beach States . Collection Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Com
" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
Company of Children Company Concession Company of Children Company of Children Company of
. In the state and station in the minimals and designed and the comments of the former of the former of the former of the former of the form and the many of the form and the
A . The State Charles of Children and Children
.
. But and the state and any designed a many a matter and any and the may and the may be the may be the may be the may be the may be the may be the may be the may be the be
the concession of control of the finitial of the close of the close for finitiation for finit | all an an all of the became of the county of the county of the first and any a
. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| t | | |
Device Description
CT Brain Perfusion for Ziostation is an add-on software feature designed to provide a color map of cerebral blood flow and pictorial illustration of perfusion-related parameters obtained on CT images of the brain. This software is designed to work within the currently cleared Ziostation image management device.
1
Materials
.
CT Brain Perfusion for Ziostation consists entirely of software. No materials are contained in this product.
Testing Summary
1000
All devices met the required specifications for the completed tests.
:
Summary of Substantial Equivalence
CT Brain Perfusion for Ziostation is substantially equivalent in intended use and function to its predicate device.
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2008
Mr. Richard Ball Director, RA/QA ZioSoft, Inc. 2200 Bridge Parkway, Suite 103 REDWOOD CITY CA 94065
Re: K083084
Trade/Device Name: CT Brain Perfusion for Ziostation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 14, 2008 Received: October 16, 2008
Dear Mr. Ball:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
forque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ¥083084
Device Name: CT Brain Perfusion for Ziostation
Indications for Use:
Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication:
The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion for Ziostation option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusionrelated parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
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 Device Evaluation (ODE)
Hula Reima
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page _ of _