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 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.

AI/ML Overview

This document (K181834) describes a 510(k) premarket notification for the Ultimax-i, DREX-UI80, V1.60, an image-intensified fluoroscopic x-ray system. The submission concerns a modification to a previously cleared device (K170832) by adding a wireless general radiography solid-state x-ray detector (TFP-1417W).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria or quantitative performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device after a modification. The acceptance criteria appear to be implicit in the regulatory standards and the demonstration that the modification does not negatively impact the system's performance or intended use.

The relevant statement is:
"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."

Given the information, an inferred "acceptance criteria" and "reported performance" table would look like this, though it's the lack of specific numbers that is notable:

Acceptance Criteria (Inferred)	Reported Device Performance (as stated)
Performance of modified system is equal to or better than the predicate system (K170832).	Integration test data demonstrates that the system modifications result in performance that is equal to or better than the predicate system.
Compliance with applicable IEC 60601 standards and Federal Diagnostic X-ray Equipment Standard.	Testing conducted in accordance with applicable IEC standards. Device conforms to 21 CFR Subchapter J.
All known risks mitigated to an acceptable level.	Design controls included risk management, and all known risks were mitigated to an acceptable level.
Indications for Use and Intended Use remain unchanged.	The introduction of the portable x-ray detector does not change the operational capabilities, intended use, or indications for use.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample size used for the integration test data. It broadly states "integration test data."
Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions that the manufacturing site is Canon Medical Systems Corporation in Tochigi-ken, Japan.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The study described is not a clinical study involving experts establishing ground truth for diagnostic accuracy, but rather an engineering and integration test to demonstrate equivalence after a hardware modification.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. There is no mention of a human-read test set requiring adjudication in this technical submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

No, an MRMC comparative effectiveness study was not done as described in this submission. This is a technical modification submission, not a human reader performance study. The focus is on the device's technical performance and safety, not on how human readers interact with or improve using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable in the context of an x-ray imaging system being developed. The "device" itself is the imaging system (hardware and associated software), not an AI algorithm that produces an output for interpretation. The software version (V1.6) remained unchanged from the predicate device and thus no new software performance testing was required beyond integration.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., pathology, outcomes data) is not explicitly stated or relevant to the type of testing described. The "truth" here is the technical performance of the system against established engineering and safety standards, as well as its functional equivalence to the predicate. This would have been established through phantom measurements, quality assurance checks, and functional testing to ensure image quality, dose, and system operation were maintained or improved.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is an x-ray imaging system, not an AI algorithm that requires a training set for model development. The software was already developed and its version (1.6) was not changed as part of this submission.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/not provided for the same reasons as point 8.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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)
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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)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

1. DATE PREPARED July 6, 2018

8. DEVICE NAME

Ultimax-i, DREX-UI80, V1.60

1. TRADE NAME Ultimax-i, DREX-UI80, V1.60

10. CLASSIFICATION NAME

2441 Michelle Drive, Tustin, CA 92780 (714) 730-5000 Fax: (714) 730-1310 pbiggins@us.medical.canon

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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 UI80Version 1.60	Ultimax-I, DREX UI80Version 1.60	DelWorks DR System
Manufacturer	Canon MedicalSystems Corporation	Canon MedicalSystems Corporation	Del Medical
510(k) Number	TBD	K170832	K140825
Clearance Date		July 21, 2017	July 17, 2014
Regulation Number(classification code)	21 CFR § 892.1650(Class II)	21 CFR § 892.1650(Class II)	21 CFR § 892.1650(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

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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.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
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.(b)
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.