(22 days)
This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest, abdomen, and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.
The RADREX-i is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals shich can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto stitching function.
The provided documents do not contain a detailed study report with quantitative acceptance criteria and device performance metrics in the format requested. The submission is a 510(k) for a modification (Special 510(k)) to an already cleared device, primarily adding new flat panel detectors.
Therefore, many of the requested elements (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance with specific metrics like sensitivity/specificity) are not present in the provided text.
Specifically, the document states:
- "Image Quality metrics utilizing phantoms are provided in this submission." (Section 18. TESTING)
- "Safety and effectiveness have been verified via risk management and application of design controls to the modifications." (Section 19. CONCLUSION)
These statements indicate that testing was performed, but the specific results and methodology are not detailed in the provided summary. The submission focuses on demonstrating substantial equivalence to a predicate device, and for modifications like this, a detailed clinical study with human readers might not have been deemed necessary by the submitter or requested by the FDA if phantom testing and engineering verification were sufficient to establish equivalence for the new components.
Given the available information, here's what can be extracted, with explicit notes for missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (if available) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Image Quality (Phantoms) | (Not specified) | (Not specified) | Provided in submission (specific values not detailed) |
| Safety | Compliance | 21 CFR § 820, ISO 13485, IEC60601-1, IEC 60601-2-32, IEC60601-2-28, 21 CFR §1020 | Device is designed and manufactured in conformance with these standards. |
| Effectiveness | (Not specified) | (Not specified) | Verified via risk management and design controls. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document primarily refers to "Image Quality metrics utilizing phantoms," implying phantom-based testing rather than a clinical human-subject test set.
- Data Provenance: Not specified. Based on phantom testing, geographic origin is not relevant. The testing would be considered prospective for the device modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for phantom-based image quality metrics is typically established by physical measurements or known characteristics of the phantom, not by expert consensus on clinical images.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as detailed multi-reader clinical testing with human subjects is not described for the test set.
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:
- MRMC Study: No. This submission does not describe an AI device or an MRMC study comparing human readers with and without AI assistance. The device is a general radiography system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Test: Not applicable. The device is an imaging system, not an algorithm, and its performance is assessed via image quality and safety standards for the hardware/software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the "Image Quality metrics utilizing phantoms," the ground truth would be based on the known, reproducible properties of the phantom and objective physical measurements (e.g., spatial resolution, contrast-to-noise ratio, MTF, DQE). If any limited subjective evaluation was done, it is not described.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This is not an AI/ML device that requires a training set of data in the conventional sense. The "base software" is stated to remain unchanged, implying previous development and validation.
9. How the ground truth for the training set was established:
- Ground Truth (Training Set): Not applicable. See point 8.
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) RADREX-i (DRAD-3000E), V4.00
OCT
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510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
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- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
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- ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
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- ESTABLISHMENT REGISTRATION: 2020563
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- CONTACT PERSON: Charlemagne Chua Manager, Regulatory Affairs (714) 730-5000
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- Date Prepared: September 13, 2012
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- TRADE NAME(S): RADREX-i, Model No, DRAD-3000E
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- COMMON NAME: Solid State X-ray Imager (Flat Panel/Digital Imager)
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- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1650)
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- PRODUCT CODE / DESCRIPTION: MQB - Solid State X-ray Imager (Flat Panel/Digital Imager)
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- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
12. REASON FOR SUBMISSION:
Modification of a cleared device
SEP 2012
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13. SUBMISSION TYPE:
Special 510(k)
14. DEVICE DESCRIPTION: '
The RADREX-i is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals shich can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto stitching function.
15. SUMMARY OF INTENDED USES:
This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
16. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the RADREX-i (DRAD-3000E) SW v3.00, K083503, marketed by Toshiba America Medical Systems. The RADREX-i (DRAD-3000E) SW v4.00 includes modifications to the cleared device which adds a new wireless flat panel detector (TFP-4336W. 14 in. x 17 in.) and a new wired flat panel detector (TFP-4343A. 17 in x 17in). The basic system configuration. method of operation, base software and manufacturing process remain unchanged from the cleared device.
17. SAFETY:
The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards and its collateral standards: IEC 60601-2-32 and IEC60601-2-28. 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.
18. TESTING
Image Quality metrics utilizing phantoms are provided in this submission. Additionally, 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.
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19. CONCLUSION
The modifications incorporated into the RADREX-i (DRAD-3000E) SW v4.00, do not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ост
9.202
Toshiba Medical Systems Corporation % Ms. Charlemange Chua Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K122842
Trade/Device Name: RADREX-I (DRAD-3000E, SW v4.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: September 14, 2012 Received: September 17, 2012
Dear Ms. Chua:
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 requirences as begin marketing your device as described in your Section 510(k) premarket whichotion. The FDA finding of substantial equivalence of your device to a legally marketed nothicate 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 11 you don't be 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,
Michael D'Ortenzio
Janine M. Morris 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):
Device Name:
RADREX-i (DRAD-3000E), SW v4.0
Indications for Use:
This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest, abdomen, and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Davice Evaluation and Safety
510K K122842
Page 1 of
§ 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.