(31 days)
The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.
The provided text describes a 510(k) summary for the SEDECAL URS LP/Millennium/RadPro X-ray Units with Detector. This submission appears to be for a combination device, integrating two previously cleared devices.
Based on the provided information, the 510(k) summary does not contain details about specific acceptance criteria or a study designed to prove the device meets those criteria in terms of clinical performance or detection accuracy. Instead, the summary focuses on demonstrating substantial equivalence to existing predicate devices.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria related to a performance study (e.g., sensitivity, specificity, accuracy) are mentioned. The "Performance Standard" in the Substantial Equivalence Chart refers to 21 CFR 1020.30, which is a regulatory performance standard for diagnostic X-ray systems and their major components, not a clinical performance metric. This standard typically covers aspects like radiation safety, image quality characteristics (e.g., resolution, contrast, noise), and operational parameters.
The reported device performance is implicitly covered by the "SAME" statements in the Substantial Equivalence Chart, indicating that the new device's characteristics are the same as the predicate devices in terms of energy source, digital resolution (160 x 160 microns pixel pitch, approximately 6 million pixels and 4,096 gray scale contrast), and relevant safety/performance standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical or performance test set data is provided. The evaluation was based on "bench, user, and standards testing" and a comparison of technical characteristics to predicate devices.
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 ground truth establishment by experts is mentioned, as there was no study involving medical image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned.
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
No such study was conducted or reported. This device is an X-ray unit, not an AI-powered diagnostic tool. The focus is on the hardware and its integration.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established, as the submission relies on demonstrating substantial equivalence of the hardware's technical characteristics and adherence to regulatory standards.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
Summary of Acceptance Criteria and Performance (Based on provided text):
Since the submission is a 510(k) for a combination device based on substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate devices and adherence to relevant regulatory standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: General purpose diagnostic X-ray unit | SAME as predicate devices. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. |
| Energy Source: 120V, 230/240V (50/60Hz) Line or Battery Power | SAME as predicate devices. Operates from 120 or 220 V 50-60~ AC. |
| User Interface: Software Driven Touch Panel LCD | SAME as predicate Canon CXDI-50G. The modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. |
| Maximum output: Models available from 30 kW to 64 kW | SAME as original units. |
| Tube mount: Fixed with respect to receptor, arm can rotate | Additional mounting options: Column mount, and ceiling mount options now available. (Note: This is a design difference, not a performance metric that requires a specific acceptance value, but rather a functional expansion compared to one predicate, while aligning with the general purpose of an X-ray unit). |
| Receptor mount: Fixed on same column as tube head | Wall mount and table mount now available. (Similar to tube mount, this is a design difference providing more flexibility). |
| Digital Resolution: 160 x 160 microns pixel pitch, with approximately 6 million pixels and 4,096 gray scale contrast | SAME as predicate Canon CXDI-50G. |
| Method of Control: Software Driven Touch Panel LCD | SAME as predicate Canon CXDI-50G. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. |
| Performance Standard: 21 CFR 1020.30 | Performs to SAME standard. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices. The units utilize high frequency inverters, and usual safety precautions regarding the use of x-rays must be observed. The company concludes that the new device is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering them substantially equivalent. (This implies compliance with the safety and performance aspects covered by the standard). |
| Electrical safety: UL 2601, IEC 60601-1 | Performs to SAME standards. |
In essence, the "study" demonstrating that the device meets acceptance criteria is the comparison to predicate devices and the assertion that "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." No specific details of these "bench, user, and standards testing" are provided in the 510(k) summary itself, but they would collectively serve to confirm that the combined device meets the functional and safety requirements established by regulatory standards and the performance of its cleared components.
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EXHIBIT 2 510(k) Summary
| SEDECAL SA --Pelaya 9- Poligono Industrial Rio DeJaneiro28110-AlgeteMadrid SpainTel (34) 91-628 0544/91-628 1592Fax (34) 91-628 0574(Foreign Manufacturer) | SEDECAL USA, Inc.2910 N. Arlington Heights Rd.Arlington Heights Illinois 60006Tel 847-394-6960Fax 847-394-6966(Initial Importer)Contact: Devan Moser |
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| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
October 13, 2004
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- Identification of the Device: Proprietary-Trade Name: URS LP/Millennium/RadPro X-ray Units with Detector Classification Name: Mobile X-ray system, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
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- Indications for Use (intended use) The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
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- Description of the Device: URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.
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- Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
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- Substantial Equivalence Chart, The Sedecal Portable X-ray Units with Detector
| Characteristic | Sedecal URSK012546 | Canon CXDI-50GDigitalRadiography,K031447 | URS LP/Millennium/RadPro X-ray Unitswith Detector(Combinationdevice) |
|---|---|---|---|
| Intended Use: | General purposediagnostic X-ray unit | SAME | SAME |
| Energy Source: | 120V,230/240V(50/60Hz)Line or Battery Power | 100V, 120V,230/240V(50/60Hz) | SAME (Combineddevice) |
| User Interface | Depends on ControlConsole optionchosen. Mainlydedicated touchcontrols | Software DrivenTouch Panel LCD | Software DrivenTouch Panel LCD |
| Maximum output | Depends on model ofgenerator chosen.Models available from30 kW to 64 kW | N/A | SAME as originalunits. |
| Tube mount | Fixed with respect toreceptor, arm canrotate. | Additional mountingoptions:Column mount, andceiling mount optionsnow available. | |
| Receptor mount | Fixed on samecolumn as tube head | N/A | Wall mount and tablemount now available |
| Digital Resolution | N/A | 160 x 160 micronspixel pitch, withapproximately 6million pixels and4,096 gray scalecontrast | SAME (Combineddevice) |
| Method of Control | Dedicated push buttonControls | Software DrivenTouch Panel LCD | Software DrivenTouch Panel LCD |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | UL 2601,IEC 60601-1 | SAME | SAME |
7. Conclusion
After analyzing bench, user, and standards testing data, it is the conclusion of Sedecal that the Sedecal Portable X-ray Units with Detector are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.
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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
SEDECAL SA % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
AUG 20 2013
Re: K042876
Trade/Device Name: URS LP/Millennium/RadPro X-Ray Units with Digital Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: October 13, 2004 Received: October 19, 2004
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of November 18, 2004.
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 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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Indications for Use
510(k) Number (if known):_
Device Name: URS LP/Millennium/RadPro X-Ray Units with Digital Detector
Indications For Use:
Indications for Use: The URS LP/Millennium/RadPro Radiographic Systems with Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Prescription Use X (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 Device Evaluation (ODE)
Nancy C. Brogdon
and Radiological Devic 510kl Nun
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§ 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.