Ultimax-i, DREX-UI80 (V1.60)

K181834 · Canon Medical Systems Corporation · OWB · Jul 19, 2018 · Radiology

Device Facts

• Record ID: K181834
• Device Name: Ultimax-i, DREX-UI80 (V1.60)
• Applicant: Canon Medical Systems Corporation
• Product Code: OWB · Radiology
• Decision Date: Jul 19, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Ultimax-i multipurpose digital X-ray system is designed for gastrointestinal studies, general radiography, and fluoroscopy. The Ultimax-i system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast enhanced studies, nonvascular contrast-enhanced studies, support of vascular IVR, and general radiography. Note: This system is not intended for cardiovascular contrast studies or interventional radiology procedures for the cardiac or cerebral blood vessels.

Device Story

Fixed C-arm fluoroscopic X-ray system; includes X-ray tube, beam limiter, digital flat panel detector (FPD), wireless FPD, tilting patient table, 80kW generator, and overhead tube support. Used in clinical settings for radiographic and fluoroscopic imaging. Operates by capturing X-ray projections transformed into digital images via FPD; images displayed for clinician review to support diagnostic and interventional procedures. Modification adds TFP-1417W wireless detector for increased flexibility in table bucky, wall stand, or portable exams. System provides real-time visualization for clinicians to guide procedures and assess anatomy, benefiting patients through diagnostic imaging and minimally invasive support.

Clinical Evidence

Bench testing only. Integration test data demonstrates system performance with the new wireless detector is equal to or better than the predicate system. Conformance to IEC standards (60601-1, 60601-2-54, 60601-2-43, 60601-2-28) and FDA guidance for solid-state X-ray imaging devices.

Technological Characteristics

Fixed C-arm fluoroscopic system; 80kW X-ray generator; digital flat panel detector (FPD) and wireless FPD. Conforms to IEC 60601-1, IEC 60601-2-54, IEC 60601-2-43, IEC 60601-2-28, and 21 CFR Subchapter J. Connectivity includes wireless detector integration. Software version 1.60 remains unchanged from predicate.

Indications for Use

Indicated for gastrointestinal, vascular, and general radiographic and fluoroscopic studies, including contrast-enhanced and endoscopic support. Not for cardiac/cerebral vascular interventional procedures or mammography.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Ultimax-i, DREX-UI80, V1.31 (K170832)

Reference Devices

• DelWorks DR System (K140825)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 19, 2018

Canon Medical Systems Corporation % Mr. Paul Biggins Senior Director Regulatory Affairs Canon Medical Systems, U.S., Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K181834

Trade/Device Name: Ultimax-i, DREX-UI80, V1.60 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: July 6, 2018 Received: July 10, 2018

Dear Mr. Biggins:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hsb 2. Nils

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) k181834

Device Name

Ultimax-i, DREX-UI80, V1.60

#### Indications for Use (Describe)

The Ultimax-i multipurpose digital X-ray system is designed for gastrointestinal studies, general radiography, and fluoroscopy.

The Ultimax-i system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast enhanced studies, nonvascular contrast-enhanced studies, support of vascular IVR, and general radiography.

Note: This system is not intended for cardiovascular contrast studies or interventional radiology procedures for the cardiac or cerebral blood vessels.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is stacked on top of the word "MEDICAL". Both words are in a bold, sans-serif font and are colored red.

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92

## 1. CLASSIFICATION and DEVICE NAME

| Classification Name | Image Intensified Fluoroscopic X-Ray System |
|------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR § 892.1650 (Class II) |
| Product Code | OWB - Interventional Fluoroscopic X-ray System (Primary)<br>JAA - Image-Intensified Fluoroscopic X-Ray System (Secondary) |
| Trade Proprietary Name | Ultimax-i |
| Model Number | DREX-U180 |

#### 2. SUBMITTER'S NAME

Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

## 3. OFFICIAL CORRESPONDENT

Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance

## 4. CONTACT PERSON, U.S. AGENT and ADDRESS

Official Correspondent/U.S. Agent Paul Biggins Senior Director Regulatory Affairs Canon Medical Systems USA, Inc.

## 5. MANUFACTURING SITE

Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

## 6. ESTABLISHMENT REGISTRATION 9614698

- 7. DATE PREPARED July 6, 2018
## 8. DEVICE NAME

Ultimax-i, DREX-UI80, V1.60

- 9. TRADE NAME Ultimax-i, DREX-UI80, V1.60
## 10. CLASSIFICATION NAME

2441 Michelle Drive, Tustin, CA 92780 [phone] Fax: [phone] [e-mail]

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Image /page/4/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is in a bold, sans-serif font and is stacked on top of the word "MEDICAL", which is also in a bold, sans-serif font. Both words are in red color. The logo is simple and modern, and it is likely used to represent the company's brand.

Image-Intensified Fluoroscopic X-Ray System

### 11. CLASSIFICATION PANEL

Radiology

## 12. DEVICE CLASSIFICATION

Class II (Per 21 CFR § 892.1650)

## 13. PRODUCT CODE / DESCRIPTION

OWB - Interventional Fluoroscopic X-ray System (Primary) JAA - Image Intensified Fluoroscopic X-Ray System (Secondary)

#### 14. PERFORMANCE STANDARD

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].

#### 15. PREDICATE DEVICE

Ultimax-i, DREX-UI80, V1.31 (K170832)

### Reference Predicate DelWorks DR System (K140825

| System | Subject | Primary Predicate | Reference Predicate |
|--------------------------------------------|--------------------------------------|--------------------------------------|---------------------------------|
| | Ultimax-I, DREX UI80<br>Version 1.60 | Ultimax-I, DREX UI80<br>Version 1.60 | DelWorks DR System |
| Manufacturer | Canon Medical<br>Systems Corporation | Canon Medical<br>Systems Corporation | Del Medical |
| 510(k) Number | TBD | K170832 | K140825 |
| Clearance Date | | July 21, 2017 | July 17, 2014 |
| Regulation Number<br>(classification code) | 21 CFR § 892.1650<br>(Class II) | 21 CFR § 892.1650<br>(Class II) | 21 CFR § 892.1650<br>(Class II) |
| Product Code | OWB/JAA | OWB/JAA | KPR/MQB |

#### 16. REASON FOR SUBMISSION

Modification of a cleared device

## 17. SUBMISSION TYPE

Special 510(k)

## 18. DEVICE DESCRIPTION

Ultimax-i, DREX-UI80, is a fixed C-arm fluoroscopic device intended to provide radiographic and fluoroscopic images in a variety of studies. The unit consists of a C-arm with X-ray tube, beam limiter and digital flat panel detector (FPD), a wireless flat panel detector, a patient table that can tilt in both directions, an 80kW X-ray generator, an overhead tube support assembly, an image processor and both remote and table side control.

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Image /page/5/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in large, bold, red letters on the top line. Below it, the word "MEDICAL" is written in a similar font, also in red. The logo is simple and clean, with a focus on the company name.

## 19. INDICATIONS FOR USE

The Ultimax-i multipurpose digital X-ray system is designed for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy.

The Ultimax-i system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies, support of vascular IVR, and general radiography.

Note: This system is not intended for cardiovascular contrast studies or interventional radiology procedures for the cardiac or cerebral blood vessels. This system is not intended for mammography studies in the US.

## 20. SUMMARY OF CHANGE(S)

This submission is to report modifications made to the Ultimax-i system consisting of the addition of the TFP-1417W wireless general radiography solid state x-ray detector. This detector allows for one detector to be used in the table bucky, the wall stand and other x-ray exams outside of a standard holder. This detector was cleared under the reference predicate via K140825. The software remains unchanged from the predicate device submission K170832.

## 21. SAFETY

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards, its collateral standards and particular standards; IEC 60601-2-54, IEC60601-2-43 and IEC 60601-2-28. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report. Additionally, this device meets the applicable requirements of the Food and Drug Administration Guidance Document "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, September 1, 2016"

## LIST OF APPLICABLE STANDARDS

- IEC60601-1:2005 ●
- IEC60601-1-2:2007 .
- IEC60602-1-3: 2008
- . IEC60601-1-6: 2010
- IEC60601-2-28: 2010
- IEC60601-2-43:2010
- . IEC60601-2-54:2009
- IEC62304:2006
- IEC62366:2007
- IEC60825-1:2007
- IEC60627:2001 ●

- IEC62494-1:2008

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## 22. TESTING

This submission contains integration test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems. Software testing was not conducted as the software version 1.6 was not changed. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.

## 23. SUBSTANTIAL EQUIVALENCE

This device is substantially equivalent to the Ultimax-i, DREX-UI80, V1.60, in that the introduction of the portable x-ray detector does not change the operational capabilities of the system, the intended use of the system and the indications for use.

## 24. CONCLUSION

The subject device is substantially equivalent to the Ultimax-i, DREX-U180, V1.60 which was cleared via Pre-Market Notification 510(k), K170832. The Ultimax-i, DREX-UI80, V1.60, incorporates a modification to the cleared device in the addition of a wireless general radiography x-ray solid state detector. The change to this device do not alter the indications for use or the intended uses associated with the previously cleared device, as described in the labeling. It is the contention of Canon Medical Systems Corporation that all new safety issues have been addressed in the design of this change and that adequate evidence of this is presented with this submission.