(9 days)
Not Found
No
The summary describes image analysis software for calculating and visualizing perfusion parameters from CT images. There is no mention of AI, ML, or related concepts like training data or performance metrics typically associated with AI/ML devices. The description focuses on standard image processing and calculation techniques.
No.
The device is described as an image analysis software package that assists physicians in assessing cerebral perfusion disturbances by processing CT images, but it does not directly treat or provide therapy to patients.
Yes.
The device's Intended Use states that it "will assist in the assessment of the type and extent of cerebral perfusion disturbances," which indicates a diagnostic purpose.
Yes
The device is described as "application software" and "image analysis software package" that is applied to existing CT scanners for post-processing. It does not include or control any hardware components of the CT system.
Based on the provided information, this 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.
- Device Function: The Cerebral Blood Perfusion Package is an image analysis software that processes dynamic CT images acquired from a patient. It analyzes the images to provide information about blood flow and perfusion parameters within the brain.
- No Sample Analysis: The device does not analyze biological samples taken from the patient. It works directly with medical images.
Therefore, while it is a medical device used for diagnostic purposes, its function falls under the category of medical imaging software rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Cerebral Blood Perfusion Package is an application software that permits cerebral perfusion imaging based upon dynamic CT images that are acquired after the injection of contrast. The software allows for visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR -CBP residual difference SD map) from a set of dynamic images. This package when used by a trained physician will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The CSCP-001A is an image analysis software package, that will be applied to the Toshiba TSX-101A (Aquilion) and TSX-021A (Asteion) CT schanners, that allows the user to process dynamic scan image data that are acquired in conjunction with a contrast bolus. The package allows visualization of the data in image map formats. Additionally, the package allows the display of numeric data via the image analysis software that is integral to the package. The software is post processing and does not control the x-ray features of the system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Not Found
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.
General Electric Perfusion CT 2 [K010042], Siemens Perfusion CT [K982536]
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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K013214
Page 1 of 2
OCT = 5 2001
510(k) Summary
| Date: | September 15, 2001 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Tustin, CA 92781-2068 | |
| Submitter's Contact: | |
| (714)730-5000 | Paul Biggins, Regulatory Affairs Specialist, |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | Cerebral Blood Flow Analysis System |
| (CBP), Model Number CSCP-001A | |
| Common Name: | Scanner, Computed Tomography, X-Ray |
| [Fed. Reg. No. 892.1750, Pro. Code: | |
| 90JAK] | |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard: | 21 CFR Subchapter J, |
| Federal Diagnostic X-ray Equipment | |
| Standard | |
| Predicate Device(s): | General Electric Perfusion CT 2 [K010042] |
| Siemens Perfusion CT [K982536] | |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The CSCP-001A is an image analysis software package, that will be applied to the Toshiba TSX-101A (Aquilion) and TSX-021A (Asteion) CT schanners, that allows the user to process dynamic scan image data that are acquired in conjunction with a contrast bolus. The package allows visualization of the data in image map formats. Additionally, the package allows the display of numeric data via the image analysis software that is integral to the package. The software is post processing and does not control the x-ray features of the system.
Summary of Intended Uses:
The Cerebral Blood Perfusion Package is an application software that permits cerebral perfusion imaging based upon dynamic CT images that are acquired after the injection of contrast. The software allows for visualization of apparent blood
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K013214
Page 2 of 2
flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR -CBP residual difference SD map) from a set of dynamic images. This package when used by a trained physician will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance.
Technological Characteristics:
This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results. Both this and the predicate devices are used as post-processing software to images collected by the parent CT Scanner.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards.
Substantial Equivalence:
Based upon the above considerations TAMS believes that this upgrade package, Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A is substantially equivalent to the predicate devices. This package and the predicate devices are all post-processing and provide the same features of visualization and numeric data. Additionally this package and the predicate devices have the same indications for use.
2
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 stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 5 2001
Toshiba America Medical Systems, Inc. Re: K013214 % Mr. Mark Job TUV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
e: K013214
Trade/Device Name: Cerebral Blood Flow Analysis Syster (CBP), Model Number CSCP-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: September 15, 2001 Received: September 26, 2001
Dear Mr. Job:
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 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 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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
510(k) Number (if known):
Device Name: Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-00TA
Indications for Use:
1
The Cerebral Blood Perfusion Package is an application software that permits cerebral perfusion imaging based upon dynamic CT images that are acquired after the injection of contrast. The software allows for visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR -CBP residual difference SD map) from a set of dynamic images. This package when used by a trained physician will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance.
Carolyn Y Neubnel
(Division Sign-Off)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K013214
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
OR
Over-The-Counter Use
SKIF