CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)

K022050 · Toshiba America Medical Systems, In.C · JAK · Jul 9, 2002 · Radiology

Device Facts

• Record ID: K022050
• Device Name: CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Jul 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.

Device Story

CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner (TSX-101A) upgrades existing CT systems to collect sixteen axial slices per rotation. System utilizes multiple solid-state detectors to acquire high-resolution slices while increasing speed to minimize anatomical motion artifacts. Input consists of X-ray transmission data generated by high-frequency X-ray controllers; data is processed by computer to reconstruct 2D and 3D black and white images. Used in clinical settings by trained operators; images are stored electronically or filmed for physician review. Output supports clinical diagnosis of tumors, trauma, lesions, and musculoskeletal degeneration. Benefits include improved image resolution and reduced motion artifacts during scanning.

Clinical Evidence

No clinical data provided; bench testing only. Device performance is supported by compliance with 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard) and IEC-60601 safety standards.

Technological Characteristics

System utilizes high-frequency X-ray controllers and solid-state detectors. Produces 2D and 3D black and white images. Complies with 21 CFR 1020.30, 1020.33, and IEC-60601. Upgrade increases slice acquisition to 16 slices per rotation.

Indications for Use

Indicated for whole body X-ray imaging using Computerized Tomography, including axial, volumetric (helical), and CT fluoroscopy for patients requiring diagnostic imaging of head, spine, extremities, and internal organs.

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

• CGS-30A Multislice Upgrade kit for the Aquilion CT (K020385)

Submission Summary (Full Text)

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Jul 9 2002

# 510(k) Summary

# ×022056

| Date: | June 5, 2002 |
|---------------------------------------|--------------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Manager, [phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner<br>TSX-101A(Aquilion Advance Multi) |
| 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: | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment Standard |
| Predicate Device(s): | CGS-30A Multislice Upgrade kit for the Aquilion CT |
| Reason For Submission | Modification of cleared device |

## · Description of this Device:

The Multislice kit is an upgrade to previously cleared CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner [K020385]. This upgrade will allow for the collection of sixteen axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high-resolution slices while maintaining the speed required to reduce anatomical motion artifacts.

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### Summary of Intended Uses:

This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.

#### Technological Characteristics:

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This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these systems employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. This device produces two dimensional and three dimensional, black and white images that can be filmed or electronically stored for future review.

### 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, Multislice CT, CGS-31A, is substantially equivalent to the CGS-30A upgrade kit for Aquilion CT scanner. The major difference is the number of slices being collected in a single rotation.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.

Toshiba America Medical Systems, Inc. Re: K022050 % Mr. Mark Job Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Trade/Device Name: CGS-31A Multislice Upgrade kit for Aquilion CT Scanner Model TSX-101A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: June 21, 2002 Received: June 24, 2002

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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Henry 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Multislice Upgrade kit (CGS-31A) for the Aquilion CT Scanner TSX-101A Device Name:

Indications for Use:

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------------|----------|
| (Division Sign-Off) | David G. |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K022050 |

Prescription Use ____________ OR ____________ Over-The-Counter Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

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