(101 days)
These Portable Diagnostic Radiographic Systems 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. (Not for mammography).
DRAGON X SPSL4HC and DRAGON X SPSL8HC are mobile x-ray units that cover all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These line operated units combine stand-alone feature for exposures for ease in imaging. Two different models of digital image acquisition panels are offered: FDX3543RP and FDX3543RPW. Both of the Toshiba panels and the associated software have been previously cleared by FDA (K130883). Integration with the portable system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed.
This document describes the Predicate Device Summary and not a study to prove that the device meets acceptance criteria. The requested information cannot be extracted from the provided text.
Here is a breakdown of why this information cannot be extracted from the provided text:
- No Acceptance Criteria or Performance Data: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a pre-defined set of acceptance criteria for the new device's performance, nor does it present data showing the new device's performance against such criteria.
- No Clinical Study Design Details: The document explicitly states "Summary of Clinical Testing: Not required because the proposed digital panels have prior FDA clearance." This means no new clinical study was conducted for this 510(k) submission to assess the device's clinical performance. Therefore, details like sample size, data provenance, expert qualifications, ground truth establishment, MRMC study results, or standalone performance are not present.
- Focus on Substantial Equivalence: The primary objective of this 510(k) is to demonstrate that the DRAGON X SPSL4HC and DRAGON X SPSL8HC are substantially equivalent to the predicate device (Sedecal Digital Portable X-ray Units: SPSLW4 and SPSLW8). This is achieved by comparing characteristics like intended use, configuration, performance standards, generator, collimator, and power source, and noting that the only key difference is the manufacturer of the digital panel and accompanying software, which themselves have prior FDA clearance (K130883).
- Bench and Lab Testing Summary: While Section 7 mentions "Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. A risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hipot testing, generator testing, including generator controls (voltage, current, timing), and image acquisition," these are general statements about compliance with regulatory standards and functional checks, not a detailed study with specific acceptance criteria and quantitative results for clinical or algorithmic performance as requested.
In summary, this document is a regulatory submission demonstrating substantial equivalence, not a research paper detailing a study of acceptance criteria and device performance.
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January 26, 2018
SEDECAL S.A. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K173299
Trade/Device Name: DRAGON X SPSL4HC; DRAGON X SPSL8HC Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB Dated: October 9, 2017 Received: October 17, 2017
Dear Mr. Kamm:
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 (OS) 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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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.
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,
Michael D. O'Hara For
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) K173299
Device Name DRAGON X SPSL4HC; DRAGON X SPSL8HC
Indications for Use (Describe)
These Portable Diagnostic Radiographic Systems 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. (Not for mammography).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary 510(k) Number K173299 SEDECAL SA C/ Pelaya, 9 - 13, Pol. Ind. Río de Janeiro 28110 Algete, Madrid, España (Spain) Tel.- +34 91 6280544 Fax.- +34 91 6280574 Date Prepared: October 9, 2017 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager
1. Identification of the Device:
Trade/Device Names: DRAGON X SPSL4HC; DRAGON X SPSL8HC Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System
2. Equivalent legally marketed device: K121410
Trade/Device Name: Sedecal Digital Portable X-ray Units: SPSLW4 and SPSLW8 ("Dragon LW") Manufacturer: Sedecal SA Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System
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- Indications for Use (intended use) These Portable Diagnostic Radiographic Systems 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, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
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- Description of the Device: DRAGON X SPSL4HC and DRAGON X SPSL8HC are mobile x-ray units that cover all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These line operated units combine stand-alone feature for exposures for ease in imaging. Two different models of digital image acquisition panels are offered: FDX3543RP and FDX3543RPW. Both of the Toshiba panels and the associated software have been previously cleared by FDA (K130883). Integration with the portable system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed. The key differences between the modified device and the predicate device are as follows: Manufacturer of the digital panel and the accompanying software. We have updated the User Manuals to reflect the changes made to the device.
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- Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, and risk management evaluations indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified.
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6. Substantial Equivalence Chart
| Characteristic | Sedecal Digital Portable X-ray Units:SPSLW4 and SPSLW8 ("Dragon LW")K121410 | SEDECAL DRAGON X SPSL4HC; DRAGONX SPSL8HC K173299 |
|---|---|---|
| Intended Use: | These Portable Diagnostic RadiographicSystems are intended for use by aqualified/trained doctor or technicianon both adult and pediatric subjects fortaking diagnostic radiographicexposures of the skull, spinal column,chest, abdomen, extremities, and otherbody parts. Applications can beperformed with the patient sitting,standing, or lying in the prone or supineposition. (Not for mammography). | SAME |
| Configuration | Line operated portable | SAME |
| PerformanceStandard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal | SAME |
| Generatorpower level | Two available power levels:4 KW, 8 KW | SAME |
| Collimator | Ralco R72S (K030487) | SAME |
| Imageacquisition | Canon CXDI-501, CXDI-70C, orCXDI-80C. | Toshiba FDX3543RP and FDX3543RPWas cleared in K130883 |
| Digital PanelSpecifications | CXDI-501: 125 μ, 2800 x 3408 pixelsCXDI-70C: 125 μ, 2800 x 3408 pixelsCXDI-80C: 125 μ, 2192 x 2800 pixels | FDX3543RP: 143 μ 2448 × 2984 pixelsFDX3543RPW: 140 μ, 2466 × 3040 pixelscleared in K130883 |
| Software | Canon | eCom software as cleared in K130883 |
| Connection | Ethernet or Wi-Fi | SAME |
| DICOM | YES | YES |
| Power Source | AC Line | SAME |
| Electricalsafety and EMC | Electrical Safety per IEC-60601. ULlisted; EMC per IEC-60601-1-2;IEC 60601-1-3 Radiation protection indiagnostic X-ray equipmentIEC 60601-2-54 Particular RequirementsFor The Basic Safety And EssentialPerformance Of X-Ray Equipment forRadiography and Radioscopy | SAME |
| Characteristic | Sedecal Digital Portable X-ray Units:SPSLW4 and SPSLW8 ("Dragon LW")K121410 | SEDECAL DRAGON X SPSL4HC; DRAGONX SPSL8HC K173299 |
| Standards(Other thanElectrical andEMC) | Wi-Fi 802.11b/g and:FCC Rules and Regulations 47 CFRChapter I Part 15 Subpart B; Part 18Subpart C ICES-003 ISSUE 5 (2012) &ICES-001 ISSUE 4 (2014) & ANSI C63.4-2009. | SAME |
| Photos | Image: Sedecal Digital Portable X-ray Unit SPSLW4 and SPSLW8 | Image: SEDECAL DRAGON X SPSL4HC |
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- Summary of Laboratory Testing and Bench Testing: Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. A risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hipot testing, generator testing, including generator controls (voltage, current, timing), and image acquisition.
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- Summary of Clinical Testing: Not required because the proposed digital panels have prior FDA clearance.
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- Conclusion After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Sedecal SA that the modified Sedecal Portable X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.