(25 days)
The O-Rad Radiographic System is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography.
The Q-Rad Radiographic System is general-purpose radiographic (X-ray) system used for acquiring radiographic images of various portions of the human body. The Q-Rad System consists of a combination of several components including various models of Xray generators and control panels or workstation computers, various models of patient support tables with integrated image receptor(s), wall-mounted image receptor/detector units for upright imaging, tube supports (ceiling-suspended or floor-mounted), and an Xray source and collimator (beam-limiting device). The Q-Rad System is available with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors: systems equipped with DR or CR modalities can also be configured to include a workstation computer that is fully integrated with the X-ray generator to allow communication of information such as image exposure factors directly from a connected RIS/PACS (radiology information system / picture archiving and communications system). The currently marketed Q-Rad System requires manual motion control for 3axis alignment of the X-ray source (tube) and the image receptor/detector located in the patient table or wall stand.
This Special 510(k): Device Modification is for the introduction of optional Auto-Tracker functionality to improve the ergonomics of the user - device interface of the currently marketed Q-Rad Radiographic System. The Auto-Tracker function provides optional automated, motorized vertical tracking of the X-ray tube to the image receptor. Q-Rad Systems with the Auto-Tracker option will have a motor added to the X-ray tube support, and position sensors incorporated into the image receptors/detectors located in the patient table and/or in the wall-mounted image receptor unit. The motor and image receptors are linked via a CANbus communication interface, which allows the X-ray tube to automatically align with the vertical position of the image receptor, which is still manually positioned by the operator. The automated tracking feature applies only to vertical positioning; the operator must still manually align the X-ray tube with the image receptor in the X- and Y-axes (longitudinal and lateral/transverse positioning). The addition of a motor to the X-ray tube support also enabled the addition of optional motorized vertical positioning of the X-ray tube using a "tube-up" or "tube-down" switch; this option is independent of the auto-tracking capability, and is offered as a convenience to the operator as an alternative to the fully manual tube up/down positioning on standard (non-Auto-Tracker) Q-Rad Systems. The standard O-Rad System without Auto-Tracker option will still be available, and the operator will have the option of disabling the Auto-Tracker function at any time if fully manual tube positioning is preferred.
The provided document is primarily a 510(k) clearance letter and a summary for a modified medical device, the "Q-Rad Radiographic System with Auto-Tracker Option." This type of document focuses on establishing substantial equivalence to a predicate device, rather than detailing the full acceptance criteria and specific studies in the way one might find for a novel AI/software medical device.
Based on the provided text, here's an attempt to answer your questions, highlighting where information is not available or not applicable in this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, specificity) and corresponding device performance for image diagnosis. This device is an X-ray system with an auto-tracking feature, not a diagnostic AI algorithm that provides diagnostic output.
However, the document lists the types of performance testing conducted:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Meets IEC 60601-1 |
| Safety & Performance (X-ray) | Meets IEC 60601-2-54 |
| Radiation Protection | Meets IEC 60601-1-3 |
| Usability | Meets IEC 60601-1-6 and IEC 62366 |
| EMC (Electromagnetic Compatibility) | Meets IEC 60601-1-2 |
| Software Verification & Validation | "Performs as intended" and "no unintended errors or failure modes have been introduced" |
| Design Requirements | "Meets all design requirements" |
| Intended Use | "Capable of fulfilling its intended use" |
2. Sample Size for the Test Set and Data Provenance
This document does not describe a "test set" in the context of data for an AI algorithm. The performance testing references standards for hardware and software functionality (e.g., electrical safety, EMC, software V&V), implying physical testing of the device rather than evaluation on a dataset of images or patient cases. Therefore, information about sample size (e.g., number of images, patients) and data provenance (country, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is an X-ray system with an auto-tracking feature, not a diagnostic algorithm requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method
This information is not applicable for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The device's primary modification is an "Auto-Tracker" feature to improve ergonomics and alignment of the X-ray tube and image receptor, not a diagnostic aid that would influence human readers' diagnostic accuracy. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described.
6. Standalone Performance Study
The document states, "Software verification and validation testing was performed to confirm that the modified device performs as intended, and that no unintended errors or failure modes have been introduced." This indicates that the software's functionality (including the auto-tracker) was tested in a standalone manner to ensure it met its design specifications. However, this is not a standalone diagnostic performance study as typically understood for AI algorithms.
7. Type of Ground Truth Used
For the functional and safety testing described (electrical safety, EMC, software V&V), the "ground truth" would be compliance with the respective international standards (IEC 60601 series, IEC 62366) and the device's original design specifications. This is not "expert consensus, pathology, or outcomes data" as would be used for a diagnostic algorithm.
8. Sample Size for the Training Set
This information is not applicable as the device is an X-ray system with an auto-tracking feature, not an AI algorithm that learns from a training set of data.
9. How Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
Summary of the Device and Study from the Document:
The device, "Q-Rad Radiographic System with Auto-Tracker Option," is a modified X-ray system. The modification introduces an optional Auto-Tracker functionality and motorized vertical positioning for the X-ray tube. This feature allows the X-ray tube to automatically align vertically with the image receptor (in the patient table or wall stand), improving ergonomics for the operator. The operator still manually aligns in the X and Y axes.
The study described is focused on demonstrating that these modifications do not compromise the safety or fundamental performance of the X-ray system and that the new features work as intended. This was achieved through:
- Risk Management: Per ISO 14971:2007, identifying and mitigating new risks.
- Design Controls: Adhering to 21 CFR 820.30 protocols.
- Performance Testing:
- Electrical safety (IEC 60601-1)
- X-ray system safety and performance (IEC 60601-2-54)
- Radiation protection (IEC 60601-1-3)
- Usability evaluation (IEC 60601-1-6 and IEC 62366)
- EMC testing (IEC 60601-1-2)
- Software verification and validation, confirming intended performance and absence of new errors or failure modes.
The conclusion is that the modified device is substantially equivalent to its predicate device (K011486) because its intended use and fundamental scientific technology remain the same, and the modifications have been verified through engineering and software testing to ensure safety and functionality.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Quantum Medical Imaging Division of Carestream % Pamela Papineau, RAC President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432
Re: K151924
Trade Name: Q-Rad Radiographic System with Auto-Tracker Option Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: July 8, 2015 Received: July 13, 2015
Dear Ms. Papineau:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Q-Rad Radiographic System with Auto-Tracker Option
Indications for Use (Describe)
The O-Rad Radiographic System is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography.
| 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 - Special 510(k) Summary
General Information
| Date Prepared: | July 8, 2015 |
|---|---|
| Owner's Name:Address: | Quantum Medical Imaging Division of Carestream2002-B Orville Drive NorthRonkonkoma, NY 11779 |
| Telephone Number: | 631-737-7237 |
| Fax Number:Contact Person: | 613-567-5074Mark Camirand |
| Subject Device Name:Trade Name:Common/Usual Name: | Q-Rad Radiographic System with Auto-Tracker OptionQ-Rad Radiographic System with Auto-Tracker OptionX-Ray System |
| Product Code: | KPR |
| Classification Name: | Stationary X-Ray System21 CFR 892.1680; Class II |
| Predicate Device Name: | Q-Rad Radiographic System |
| Trade Name: | Q-Rad Radiographic System |
| Common/Usual Name: | X-Ray System |
| Product Code: | KPR |
| Classification Name: | Stationary X-Ray System21 CFR 892.1680; Class II |
| Premarket Notification: | K011486; Quantum Medical Imaging Q-Rad RadiographicSystem (SE date June 20, 2001) |
Predicate Device Description
The Q-Rad Radiographic System is general-purpose radiographic (X-ray) system used for acquiring radiographic images of various portions of the human body. The Q-Rad System consists of a combination of several components including various models of Xray generators and control panels or workstation computers, various models of patient support tables with integrated image receptor(s), wall-mounted image receptor/detector units for upright imaging, tube supports (ceiling-suspended or floor-mounted), and an Xray source and collimator (beam-limiting device). The Q-Rad System is available with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors: systems equipped with DR or CR modalities can also be configured to include a workstation computer that is fully integrated with the X-ray generator to allow
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communication of information such as image exposure factors directly from a connected RIS/PACS (radiology information system / picture archiving and communications system). The currently marketed Q-Rad System requires manual motion control for 3axis alignment of the X-ray source (tube) and the image receptor/detector located in the patient table or wall stand.
Indications for Use
The Q-Rad Radiographic System is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography. The indications for use of the modified Q-Rad Radiographic System with Auto-Tracker option remain identical to those of the currently marketed "standard" Q-Rad System.
Device Modifications
This Special 510(k): Device Modification is for the introduction of optional Auto-Tracker functionality to improve the ergonomics of the user - device interface of the currently marketed Q-Rad Radiographic System. The Auto-Tracker function provides optional automated, motorized vertical tracking of the X-ray tube to the image receptor. Q-Rad Systems with the Auto-Tracker option will have a motor added to the X-ray tube support, and position sensors incorporated into the image receptors/detectors located in the patient table and/or in the wall-mounted image receptor unit. The motor and image receptors are linked via a CANbus communication interface, which allows the X-ray tube to automatically align with the vertical position of the image receptor, which is still manually positioned by the operator. The automated tracking feature applies only to vertical positioning; the operator must still manually align the X-ray tube with the image receptor in the X- and Y-axes (longitudinal and lateral/transverse positioning). The addition of a motor to the X-ray tube support also enabled the addition of optional motorized vertical positioning of the X-ray tube using a "tube-up" or "tube-down" switch; this option is independent of the auto-tracking capability, and is offered as a convenience to the operator as an alternative to the fully manual tube up/down positioning on standard (non-Auto-Tracker) Q-Rad Systems. The standard O-Rad System without Auto-Tracker option will still be available, and the operator will have the option of disabling the Auto-Tracker function at any time if fully manual tube positioning is preferred.
The changes described in this Special 510(k) are limited to the addition of the optional Auto-Tracker functionality and motorized vertical X-ray tube positioning. There are no other changes to the device specifications and performance. The intended use and
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indications for use remain unchanged. The same fundamental scientific technology for X-ray imaging is present in the "standard" Q-Rad System cleared in K011486 and in the Q-Rad Systems with optional Auto-Tracker functionality.
Risk Management
Risk management for the modified device has been performed and documented in accordance with ISO 14971:2007. Risk analysis has been performed for the modified device to identify any new risks associated with the new functionality. Any new risks have been thoroughly documented and appropriate risk reductions have been applied. Verification and validation testing has been performed to confirm that the device modifications have been thoroughly evaluated to ensure that design outputs meet design inputs, and that all risk mitigations are effective in achieving their intended effect. Riskbenefit analysis has been performed to establish that all residual risks for the modified device have been reduced as far as possible, and are outweighed by expected benefits. The outputs of the risk management process were utilized to ensure that appropriate performance testing and software V&V requirements have been identified to ensure that the modified device meets design specifications and is free from unacceptable risk.
Design Controls and Performance Testing
The proposed modification to add optional Auto-Tracker functionality to the currently marketed Q-Rad Radiographic System has been fully documented via a design control system that is compliant with 21 CFR 820.30. The modified design has been verified and validated in accordance with documented protocols and procedures which include predetermined acceptance criteria. Performance testing includes the following: electrical safety testing per IEC 60601-1, safety and performance evaluation for X-ray systems per IEC 60601-2-54, radiation protection for X-ray systems per IEC 60601-1-3, usability evaluation per IEC 60601-1-6 and IEC 62366, and EMC testing per IEC 60601-1-2. Software verification and validation testing was performed to confirm that the modified device performs as intended, and that no unintended errors or failure modes have been introduced. Testing has demonstrated that the Q-Rad Radiographic System with Auto-Tracker option meets all design requirements, performs as intended, and is capable of fulfilling its intended use.
Conclusion
The modified device (Quantum Medical Imaging Q-Rad Radiographic System with Auto-Tracker Option) is substantially equivalent to the predicate Quantum Medical Imaging O-Rad Radiographic System cleared in K011486.
N/A