X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM by IMAGING DYNAMICS COMPANY LTD.

The X3C 1590 is intended for use by a qualified/trained doctor or lechnologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1590 (510k submission device) is not intended for mammography.

The 1590 Digital Radiographic System is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained day or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions.

Device Description

The X3C 1590 is a modification to Xplorer 1590 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1590 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1590 system is manufactured by Imaging Dynamics.

AI/ML Overview

The provided text is a 510(k) summary for the X3C 1590 Digital Radiographic System. It details a special 510(k) submission where a component (digital radiographic detector) of an existing device (Xplorer 1590) is replaced with a previously marketed device (X3C digital radiographic detector).

Based on the provided information, the device does not have specific acceptance criteria or a study demonstrating performance against those criteria in the typical sense of an AI/ML device or a device requiring new clinical performance data.

Here's a breakdown of why and what information is (or isn't) present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission focuses on substantial equivalence to a predicate device.
Reported Device Performance: The document states that the device has been evaluated for "performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety" and found to be "substantially equivalent to predicate device." No specific quantitative performance metrics are provided for the X3C 1590 system itself in this summary. The performance of the individual components (Xplorer 1590 system and X3C digital radiographic detector) must have been established in their respective prior 510(k) submissions (K062405 and K070079).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission explicitly states "Clinical tests: No clinical tests conducted." The evaluation relied on non-clinical tests and a comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical studies were conducted, so no ground truth was established by experts for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical studies were conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a digital radiographic system, not an AI/ML algorithm. No MRMC study was performed, nor is AI assistance mentioned.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth was established for this submission. The "ground truth" here is the established safety and effectiveness of the predicate device and the approved components.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML algorithm.

Summary of Acceptance:

The acceptance of the X3C 1590 Digital Radiographic System is based on demonstrating substantial equivalence to a legally marketed predicate device (Xplorer 1590 - K062405). The key "study" proving this is a non-clinical evaluation comparing the modified device to the predicate device, focusing on:

Non-clinical tests: Performance, biocompatibility, effectiveness, thermal, electrical, and mechanical safety.
Fundamental scientific technology: The submission asserts that replacing the detector does not alter the fundamental scientific technology.
Intended Use: The intended use remains the same as the predicate device.
Quality Systems: The manufacturer conforms to 21 CFR part 820, ISO 9001, and ISO 13485 quality systems.

The FDA's decision to grant 510(k) clearance (as evidenced by the letter in the document) indicates they agreed that the device is substantially equivalent and does not require new clinical data for market entry.

Summary

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K071409

Special 510k Submission X3C 1590 Digital Radiographic System

510k Summary

1. Submitter:	Imaging Dynamics Company LtdSuite 151, Pegasus Way NECalgary, AB,Canada T2E 8M5
Contact person:	Shirantha SamarappuliManager - Regulatory AffairsTel: 403 251 9939; Fax: 403 251 1771
Date Prepared:	May 14, 2007
2. Device Name:	X3C 1590 Digital Radiographic System,
3. Device Classification:	Class II, 892.1680 (KPR), 892.1630 (MQB),

1. Predicate Device: Xplorer 1590 Digital Radiographic System (K062405)
1. Device Description: The X3C 1590 is a modification to Xplorer 1590 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1590 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1590 system is manufactured by Imaging Dynamics.
1. Indications for Use: The X3C 1590 is intended for use by a qualified/trained doctor or lechnologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1590 (510k submission device) is not intended for mammography.
1. Comparison with predicate device: The X3C 1590 is substantially equivalent to the currently marketed Xplorer 1590. X3C 1590 device does not alter the fundamental scientific technology from Xplorer 1590 predicate device. The replacement of Xplorer 100 digital radiographic detector (K992955) with X3C digital radiographic detector (K070079) is the only significant change between the 2 devices. X3C 1590 has the same intended use as the predicate device.
- a. Non-clinical tests: The device has been evaluated for performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety and has been found to substantially equivalent to predicate device. The design and development process of the manufacturer conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems.
- Clinical tests: No clinical tests conducted. b.
- C. Conclusion: The device was evaluated against the predicate device (Xplorer 1590 -K042041) for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.

JUN - 8 2007

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company, Ltd. Suite 151, 2340 Pegasus Way NE CALGARY ALBERTA T2E 8M5 CANADA

AUG - 9 2013

Re: K071409 Trade/Device Name: X3C 1590 Digital Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: May 18, 2007 Received: May 21, 2007

Dear Ms. Samarappuli:

This letter corrects our substantially equivalent letter of June 8, 2007.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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1 - 2 · Indications for Use

1.1 Indications for Use

The U.S. Food and Drug Administration (FDA) requires the following statement to appear in this manual:

"The 1590 Digital Radiographic System is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained day or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions."

FDA 510(k) for X4C: K062405

FDA 510(k) for X3C Detector Head: K070079

FDA 510(k) for X3C: to be assigned by FDA

· The 1590 digital radiography system is not to be used for mammography.
The 1590 digital radiography system should only be operated in conjunction with specified medical x-ray equipment and by trained and licensed personnel.

WARNING! Only certified and properly trained, authorized personnel should be permitted to take x-ray exposures. No practical design can incorporate complete protection for personnel who do not follow proper safety precautions.

WARNING! The appropriate x-ray imaging exposure parameters should be consistent with established Federal and Provincial/State radiation protection protection procection procection processions and medical imaging standards in your institution.

Prescription Use

vision Sign-Off) vision of Reproductive, Abdominal, ar Radiological Devices 510(k) Number

Imaging Dynamics Company • PN: 902-0001-015 v1.0 • May 30, 2007

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.