CSBP-001A BODY ORGAN PERFUSION SYSTEM

K081482 · Toshiba America Medical Systems, In.C · JAK · Jun 11, 2008 · Radiology

Device Facts

• Record ID: K081482
• Device Name: CSBP-001A BODY ORGAN PERFUSION SYSTEM
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Jun 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The CSBP-001A is a non-invasive post processing package that can be used to evaluate perfusion of the organs, tissue, turnors and lesions; this type of application is useful in assisting in the diagnosis of disease and providing information for following treatment.

Device Story

CSBP-001A is post-processing software for dynamic CT images; inputs are dynamic image sets acquired post-contrast bolus injection. Software calculates numerical perfusion values—blood flow, blood volume, permeability—and generates perfusion maps; supports independent calculation of arterial/portal venous hepatic components. Used in clinical settings by radiologists/technicians to assist disease diagnosis and treatment monitoring. Output displayed as perfusion maps and time-density curves; aids clinicians in evaluating tissue/tumor perfusion status. Benefits include non-invasive quantitative assessment of organ/lesion perfusion.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Post-processing software package for dynamic CT data. Operates on reconstructed CT images. Provides quantitative perfusion analysis (blood flow, volume, permeability) and visual perfusion maps. No hardware components; software-only device.

Indications for Use

Indicated for evaluation of perfusion of organs, tissues, tumors, and lesions in patients undergoing dynamic CT imaging with contrast bolus. Supports calculation of blood flow, blood volume, permeability, and hepatic arterial/portal venous components.

Regulatory Classification

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.

Predicate Devices

• GE CT Perfusion 4 (k052839)
• Siemens Symgo Perfusion (k073373)
• Philips Brilliance CT (k060397)

Submission Summary (Full Text)

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Koriysz

## Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for CSBP-001A Body Organ Perfusion System

# 510(k) Summary

| Date: | May 12, 2008 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc.<br>JUN 11 2008 |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact:<br>[phone] | Paul Biggins, Regulatory Affairs Specialist, |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | CSBP-001A; Body Organ Perfusion System |
| Common Name: | Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1750, Pro. Code: 90JAK] |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard:<br>Standard | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment |
| Predicate Device(s): | GE CT Perfusion 4 (k052839)<br>Siemens Symgo Perfusion (k073373)<br>Philips Brilliance CT (k060397) |
| Reason For Submission | New Device |

## Description of this Device:

The CSBP-001A is post-processing software that does not affect the operation of the parent CT System. This software provides analysis tools that are used on a series of dynamic images (images collected over time) to provide numerical values related to tissue perfusion of organs, tumors lesions, etc. Additionally, this software will allow for the display of perfusion maps.

## Summary of Intended Uses:

The CSBP-001A is a non-invasive post processing package that can be used to evaluate perfusion of the organs, tissue, turnors and lesions; this type of application is useful in assisting in the diagnosis of disease and providing information for following treatment.

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## Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for CSBP-001A Body Organ Perfusion System

#### Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Bench test data is provided in the submission to provide evidence of the safety and effectiveness of this device.

### Substantial Equivalence:

This software package provides information to the user that is similar to that which is provided by the predicate devices. The information is obtained in a manner that is similar to the predicate devices, or in a manner that is a combination of the predicate devices. Additionally, the indications for use and intended uses are identical to the predicate devices. There are no new indications for use that are not already available in devices already marketed in the U.S.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2008

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1395 25th Street NW BUFFALO MN 55313

Re: K081482

Trade/Device Name: CSBP-001A, Body Organ Perfusion System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 27, 2008 Received: May 28, 2008

#### 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. Isting 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 madon outs not 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 CPR 100-1050.

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 logally marketed predicate device results in a classification for your device and this, perited 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 a to the of the following numbers, based on the regulation number at the top of this lotter.

| 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, release contact CDDF 3 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/02/6 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 Smy of Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrhindustry/suport/industry/suport/index.php?title=

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 CSBP-001A Body Organ Perfusion System

# Indications for Use

510(k) Number (if known):

Device Name: CSBP-001A, Body Organ Perfusion System

Indications for Use:

This software package has been designed to evaluate the perfusion of organs and turnors.

The software allows for the calculation of blood flow, blood volume and permeability from sets pf images reconstructed from dynamic CT data acquired after the injection of a contrast bolus.

The package also allows for the independent calculation of arterial and portal venous component of hepatic perfusion. It supports the evaluation of regions of interest and the visual inspection of time density curves.

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)

Page 1 of

Arni Mkhag

(Divisi Division of Reproductive, Abdominal and Radiological Devices 510(k) Number