3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH

K030450 · J. Morita USA, Inc. · JAK · May 6, 2003 · Radiology

Device Facts

• Record ID: K030450
• Device Name: 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
• Applicant: J. Morita USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: May 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The 3D Accu-I-tomo is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three-dimensional images. The device can also be used for fluoroscopy during surgery, mostly for ENT and TMJ applications and mostly with a contrast medium. The device is operated and used by physicians, dentists, and x-ray technologists.

Device Story

3D Accu-I-tomo is a cone beam x-ray CT system for head/neck imaging. Input: 360-degree rotational x-ray sequence. Operation: C-arm assembly with x-ray head and image intensifier; system reconstructs 3D matrix from volume data. Output: 2D and 3D images for diagnostic support; fluoroscopic moving/still images for surgery. Used in clinical settings by physicians, dentists, and technologists. System includes Windows-based PC with '3DXD' driver and '3DX Integrated Information System' software. Healthcare providers use images for pre/post-surgical diagnosis and intraoperative guidance. Benefits include high-resolution imaging with lower radiation than conventional CT.

Clinical Evidence

Bench testing only. Evidence includes software validation report (firmware, driver, and application software), hazard analysis, and system/software requirements verification. Device passed image quality testing and complied with electrical, mechanical, and thermal safety standards (UL2601-1, IEC 60601-1). Biocompatibility of patient-contacting materials (head/chin band, cushions, etc.) confirmed via predicate comparison and established use in medical applications.

Technological Characteristics

Cone beam x-ray CT system. Components: C-arm assembly, x-ray head, image intensifier, beam-limiting device. Materials: Biocompatible plastics for patient-contacting surfaces. Connectivity: Windows-based PC (standalone or networked server/client). Software: 3DXD driver and 3DX Integrated Information System. Safety: Complies with UL2601-1, IEC 60601-1, and 21 CFR Subchapter J. Operation: CT mode (3D reconstruction) and Fluoroscopic mode (moving/still images).

Indications for Use

Indicated for diagnostic support via x-ray imaging of head and neck areas, including ENT and dentomaxillofacial regions. Supports 3D volume reconstruction and 2D viewing, plus intraoperative fluoroscopy (often with contrast) for ENT and TMJ applications. For use by physicians, dentists, and x-ray technologists.

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

• Siremobil C02 (K973598)
• Siremobil Iso-C 3D Imaging Option (K003266)
• NewTom Model QR-DVT 9000 (K003787)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

# J. Morita Manufacturing Corporation 3D Accu-I-tomo XYZ Slice View Tomograph

#### Name of Device and Name/Address of Sponsor

Trade or Proprietary Name: 3D Accu-I-tomo XYZ Slice View Tomograph Common Name: Cone beam x-ray CT Classification Name: computed tomography x-ray system Product Code: JAK

J. Morita Manufacturing Corporation 680 Higashihama Minami-cho, Fushimi-ku Kyoto 612-8533 Japan Telephone: [phone] 011-81-75-605-2350 Facsimile: Date Prepared: January 20, 2003

### Intended Use

The 3D Accu-I-tomo is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing twodimensional views of this volume, displaying both two- and three-dimensional images. The device can also be used for fluoroscopy during surgery, mostly for ENT and TMJ applications and mostly with a contrast medium. The device is operated and used by physicians, dentists, and x-ray technologists.

## Technological Characteristics and Substantial Equivalence

The C-arm assembly is mounted to the support column, which has an x-ray control panel for loading factors, an emergency stop switch, and a remote control for patient positioning. The C-arm assembly includes an image intensifier and an x-ray head with a beam-limiting device. The control box, which includes operational lights and an x-ray emission button, is typically placed in a separate room from the rest of the system. The patient chair includes an armrest and a headrest to fix the patient's head during the x-ray emission. An optional headrest for ENT applications is available which can be replaced with the headrest for dental applications.

A Windows-based personal computer is connected to the 3D Accu-I-tomo, on which is installed "3DXD" driver software and "3DX Integrated Information System" application software. For the network environment, "3DXD" driver software and "3DX Integrated Information System" are installed in the server computer and "3DX Integrated Information System" is installed in the client computer. The Windows-based personal computer is not manufactured by J. Morita Manufacturing Corp.

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The 3D Accu-I-tomo operates in either CT mode or Fluoroscopic mode. In CT mode, it generates three-dimensional images that make possible precise diagnosis of the head and neck areas. It produces high resolution images and uses less x-radiation in comparison with conventional computed tomography x-ray systems. Fluoroscopy is available using the same x-ray head and image intensifier that are used for the CT mode. Fluoroscopy is mainly used with a contrast medium for ENT applications and surgery of the TM Joint. The same device can provide three-dimensional images and fluoroscopy. Both two- and three-dimensional images are taken for diagnosis before and after surgery. The fluoroscopic setting has three modes: a fluoroscopic moving image mode, a still image mode, and a testing mode. In the testing mode, it can take but not save a moving image.

The 3D Accu-I-tomo is substantially equivalent to the (i) Siemens Medical Systems' Siremobil C02 (K#973598), (ii), Siemens Siremobil Iso-C 3D Imaging Option (K#003266), and (iii) NIM s.r.l.'s NewTom Model QR-DVT 9000 (K#003787). The 3D Accu-I-tomo has similar general intended uses, principles of operation, and technological characteristics as the previously cleared predicate devices. Although there are minor difference in the characteristics of the 3D Accu-I-tomo and the predicate devices, these differences do not raise new questions of safety or efficacy.

The software used in the 3D Accu-I-tomo has been successfully validated by J. Morita Manufacturing Corp. The software validation report describes: the development process for the device's firmware; and driver software and application software installed in Windows-based personal computer; the software change control and code revision procedures; the system and software requirements; the software handling and storage procedures; a hazard analysis; and a software/firmware certification that the company followed the above-described procedures and policies.

The 3D Accu-I-tomo was tested to ensure compliance with UL2601-1 and IEC 60601-1, and its collateral standards, and it complied with the applicable requirements. The 3D Accu-I-tomo will be tested and will comply with the applicable requirements of 21 CFR Subchapter J prior to marketing. The 3D Accu-I-tomo also passed the image quality testing.

The 3D Accu-I-tomo complies with the applicable thermal, mechanical, and electrical safety requirements of UL2601-1, IEC 60601-1, and its collateral standards and will comply with the applicable requirements of 21 CFR Subchapter J prior to marketing.

The 3D Accu-I-tomo uses biocompatible plastics on all body contacting surfaces. such as the head/chin band, headrest cushion, headrest support, side head support, subnasal point rest and ear piece, etc. Such plastics have been used in predicate devices or widely used in other medical applications in which the plastic is in contact with the patient's body.

40139551.doc

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

MAY 0 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

J. Morita Manufacturing Corporation % Mr. Keith A. Barritt Fish & Richardson, P.C. 1425 K Street, N. W. 11" Floor WASHINGTON DC 20005

Re: K030450 Trade/Device Name: 3D Accu-I-tomo XYZ Slice View Tomograph Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 10, 2003 Received: February 11, 2003

Dear Mr. Barritt:

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. Iisting 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 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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,

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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510(k) Number (if known): Device Name: 3D Accu-I-tomo XYZ Slice View Tomograph Indications For Use: Κοζο 450

> The 3D Accu-I-tomo is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and threedimensional images. The device can also be used for fluoroscopy during surgery, mostly for ENT and TMJ applications and mostly with a contrast medium. The device is operated and used by physicians, dentists, and x-ray technologists.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over-The-Counter Use

(Per 21 CFR 801.109)

40139586.doc

David A. Larson

Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number