(38 days)
Not Found
Not Found
No
The summary describes standard image processing and analysis techniques for calculating perfusion parameters, with no mention of AI or ML.
No.
The device is a post-processing package that analyzes data for assessment of brain trauma or stroke; it does not directly treat or prevent a disease or condition.
Yes
Explanation: The device provides "information that can then be measured and analyzed in the assessment of brain trauma or stroke," which directly relates to diagnosing medical conditions.
Yes
The device description explicitly states it is a "post processing package" and "software," and the intended use describes processing data acquired on a time sequential basis, which is characteristic of software analysis of existing medical imaging data. There is no mention of hardware components being part of the device itself.
Based on the provided information, the CSNP-001A is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (in vitro). The CSNP-001A processes imaging data acquired from the human body (in vivo).
- The intended use describes processing imaging data. The device takes "data that is acquired on a time sequential basis" and performs "brain perfusion studies." This is consistent with processing medical images, not analyzing biological samples.
- The device description mentions image processing. It explicitly states it's a "post processing package" that processes "dynamic volume sets" and provides "visualization of the data in image map format" and "numeric data via image analysis software."
- The output is imaging-based information. The outputs listed (TDC, CBF, CBV, MTT, TTP, DLY) are all parameters derived from the analysis of imaging data, not from the analysis of biological samples like blood or urine.
Therefore, the CSNP-001A falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CSNP-001A is a post processing package that has the capability to perform brain perfusion studies to include whole brain studies, when used by a trained physician, by using data that is acquired on a time sequential basis. This package provides the physician with the following information that can then be measured and analyzed in the assessment of brain trauma or stroke:
TDC (time density curve)
CBF: Blood flow in the capillary vessels of the cerebral tissues.
CBV: Blood volume in the capillary vessels of the cerebral tissues.
MTT: Mean transit time of blood in the capillary vessels f the cerebral vessels.
TTP: Time to peak of the TDCs.
DLY: Delay of each voxel curve from the arterial curves.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
This device is a post processing package that allows the user to process dynamic volume sets using a Time Density Curve. The package allows visualization of the data in image map format. Additionally, the software provides numeric data via image analysis software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cerebral, 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.
CSCP-001A Cerebral Bloop Perfusion Analysis Package
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.
0
KC72693
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; CSNP-001A Neuro Package
510(k) Summary
| Date: | September 20, 2007 | NOV - 1 2007 |
|---|---|---|
| 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: | Paul Biggins, Director Regulatory Affairs | |
| (714)730-5000 | ||
| Establishment Registration | ||
| Number: | 2020563 | |
| Device Proprietary Name: | CSNP-001A Neuro Package | |
| 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): | CSCP-001A Cerebral Bloop Perfusion Analysis Package | |
| Reason For Submission | New device |
Description of this Device:
This device is a post processing package that allows the user to process dynamic volume sets using a Time Density Curve. The package allows visualization of the data in image map format. Additionally, the software provides numeric data via image analysis software.
Summary of Intended Uses:
This device is application software that permits cerebral perfusion imaging based upon dynamic volume sets. The software allows for visualization of apparent blood flow in the brain tissue and pictorially illustrates perfusion parameters (CBP - cerebral blood perfusion, CBV - cerebral blood volume, MTT - mean time to transit, TTP - time to peak of the time density curve, and DLY - delay of each voxel curve from the arterial curve). This device, 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.
1
Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; CSNP-001A Neuro Package
Technological Characteristics:
This device is similar to the predicate device in uses and applications. The primary difference is in the method used to obtain final results. Both devices are post processing software packages.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Additionally this device is in conformance with the applicable parts of the IEC 60601-1 international safety standard.
Substantial Equivalence:
Based upon the above considerations TAMS believes that this device, CSNP-001A Neuro Package, is substantially equivalent to the predicate device and other devices already marketed in the US. This device and other similar marketed devices are post processing software that provide visual and numeric data. Additionally, this device has the same indications of previously marketed devices.
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 stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that converge to form the shape of a person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Toshiba America Medical Systems. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 24th Street NW BUFFALO MN 55313
NOV - 1 2007
Re: K072693
Trade/Device Name: CSNP-001A, NeuroPackage Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK and LLZ Dated: October 22, 2007 Received: October 23, 2007
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 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
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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 yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for CSNP-001A Neuro Package
Indications for Use
510(k) Number (if known):
072693
Device Name: CSNP-001A, NeuroPackage
Indications for Use:
The CSNP-001A is a post processing package that has the capability to perform brain perfusion studies to include whole brain studies, when used by a trained physician, by using data that is acquired on a time sequential basis. This package provides the physician with the following information that can then be measured and analyzed in the assessment of brain trauma or stroke:
TDC (time density curve)
CBF: Blood flow in the capillary vessels of the cerebral tissues.
CBV: Blood volume in the capillary vessels of the cerebral tissues.
MTT: Mean transit time of blood in the capillary vessels f the cerebral vessels.
TTP: Time to peak of the TDCs.
DLY: Delay of each voxel curve from the arterial curves.
Prescription Use X (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)
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ductive, Abdominal and Radiologic 510(k) Number