(38 days)
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.
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.
The provided text is a 510(k) pre-market notification for the Toshiba America Medical Systems, Inc. CSNP-001A Neuro Package. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a regulatory submission for pre-market notification, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting raw performance data or a specific clinical study with acceptance criteria.
Therefore, many of the requested items cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not specify quantitative acceptance criteria or provide performance metrics of the device against such criteria. The focus is on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: The document does not describe a specific test set or clinical study with details on sample size, data provenance, or study design (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available: Since no specific test set or study is described, there's no information about experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Available: The document does not mention an MRMC comparative effectiveness study or the effect size of AI-assisted improvement for human readers. This device is described as "post processing software" that provides visual and numeric data to "assist in the assessment," rather than an AI system designed to improve human reader performance in a controlled study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available: The document describes the device as a "post processing package" that "allows the user to process dynamic volume sets" and, "when used by a trained physician, will assist in the assessment." This strongly implies a human-in-the-loop system, not a standalone, algorithm-only performance assessment. No such standalone study data is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: As no specific study or test set is described, the type of ground truth used is not mentioned.
8. The sample size for the training set
- Not Available: The document does not mention a training set or its sample size.
9. How the ground truth for the training set was established
- Not Available: No training set is mentioned, so how its ground truth was established is not applicable.
Summary of what is available from the document:
The regulatory submission primarily focuses on:
- Description of the Device: "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."
- Intended Uses: "application software that permits cerebral perfusion imaging based upon dynamic volume sets... 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."
- Technological Characteristics: "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: "designed and manufactured under the Quality System Regulations... in conformance with the applicable parts of the IEC 60601-1 international safety standard."
- Substantial Equivalence: Deemed substantially equivalent to the predicate device (CSCP-001A Cerebral Blood Perfusion Analysis Package) based on similar uses, applications, and providing visual and numeric data.
- Indications for Use: To perform brain perfusion studies, including whole brain studies, providing information such as TDC, CBF, CBV, MTT, TTP, and DLY for assessment of brain trauma or stroke.
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KC72693
Page 1 of 2
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 RegistrationNumber: | 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.
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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.
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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.
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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
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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)
Page 1 of __
ductive, Abdominal and Radiologic 510(k) Number
§ 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.