(17 days)
The Sedecal Mobile 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.
Sedecal Mobile X-ray Units with Digital Detector arc mobile units which operate from 120 or 220 V 50-60~ AC or batteries. The units utilize high frequency inverters. The usual safety precautions regarding the use of xrays 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 provided text describes a 510(k) summary for the Sedecal Mobile X-Ray Units with Digital Detector. This regulatory submission primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than an independent study to prove the device meets specific performance acceptance criteria in the same way a de novo or PMA submission might.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, expert involvement, and ground truth for a performance claims study is largely not applicable in this context.
Here's an breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not present explicit acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting specific pathologies) because it's a substantial equivalence submission. Instead, the "acceptance criteria" are implied by demonstrating equivalence in technical specifications and intended use to existing, cleared devices.
The table provided is a comparison to predicate devices for various technical characteristics, not performance metrics against acceptance criteria.
| Characteristic | Predicate Device (K012663) | Predicate Device (K031447) | New Device (Combination) | Reported Performance (for new device) |
|---|---|---|---|---|
| Intended Use: | Mobile general purpose diagnostic X-ray unit | SAME | SAME | SAME as predicate devices |
| Size | (Not specified for X-ray unit) | Imaging Area 14 x 17 | SAME (Combined device) (A stand has been added) | Imaging Area 14 x 17 (Digital Detector) |
| Weight (battery version) | 1045 lb | 10.6 lb | 964 lb. | 964 lb. (Combined device) |
| Energy Source: | 90 to 285 VAC (50-60 Hz) or Batteries | 100V, 120V, 230/240V(50/60Hz) | SAME (Combined device) | SAME as predicate devices |
| User Interface | Up-Down pushbuttons for kVp and mAs. KVp adjustable in 1 kVp steps | Software Driven Touch Panel LCD | Software Driven Touch Panel LCD (Combined device) | Software Driven Touch Panel LCD |
| Power | 20 or 30 kW | N/A | Models up to 50 kW | Up to 50 kW |
| Exposure times | 0.001 - 8 SECONDS $\pm$ (1%+0.1 MS) | N/A | SAME (Combined device) | SAME as predicate device (K012663) |
| Ma. | 10, 12.5, ..., 320 (400, 500 on 30kw unit) $\pm$ (5%+0.1 MA) | N/A | SAME (Combined device) | SAME as predicate device (K012663) |
| kVp | 40 to 150 in 1 kVp steps (30 kw unit) | N/A | SAME (Combined device) | SAME as predicate device (K012663) |
| Resolution | N/A | 160 x 160 microns pixel pitch, with approximately 6 million pixels and 4,096 gray scale contrast | SAME (Combined device) | 160 x 160 microns pixel pitch, 6 million pixels, 4,096 gray scale |
| Method of Control | Dedicated Touch Panel | Software Driven Touch Panel LCD | SAME as CANON. Or original Dedicated Touch Panel | Software Driven Touch Panel LCD or original Dedicated Touch Panel |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME | Compliance with 21 CFR 1020.30 |
| Electrical safety: | IEC 60601-1 | SAME | SAME | Compliance with IEC 60601-1 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text states: "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench, user, and standards testing data...".
- Sample Size for Test Set: Not specified. This typically refers to a clinical dataset for performance evaluation, which wasn't the primary focus of this 510(k). The "user testing" likely refers to functional testing, not a clinical study with a defined patient sample.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified. Given the nature of a 510(k) for device combination, clinical studies are often not required if substantial equivalence can be demonstrated through technical comparison and bench testing.
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. The submission does not detail any clinical study where ground truth for diagnostic features would need to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No clinical study with adjudicated ground truth is described.
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 is an X-ray imaging system, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is an X-ray imaging system, not an algorithm, so standalone performance is not relevant in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. As no clinical diagnostic performance study is described, the concept of "ground truth" for diagnostic findings is not addressed in this submission. The "ground truth" for the technical specifications (e.g., power output, exposure times) would be established by direct measurement during bench testing.
8. The sample size for the training set
Not Applicable. This is an X-ray imaging system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set mentioned.
{0}------------------------------------------------
Koysaooz
NOV 1 8 2004
| 510(k) Summary | ||||
|---|---|---|---|---|
| SEDECAL SAPelaya 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 |
EXHIBIT 2
October 22, 2004
-
- Identification of the Device: Proprietary-Trade Name: Sedecal Mobile Radiographic Systems with Digital Detector Classification Name: Mobile X-ray system, Product Codes Product Code 90 IZL and MOB Common/Usual Name: General purpose mobile diagnostic X-ray Unit.
-
- Indications for Use (intended use) The Sedecal Mobile 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.
-
- Description of the Device: Sedecal Mobile X-ray Units with Digital Detector arc mobile units which operate from 120 or 220 V 50-60~ AC or batteries. The units utilize high frequency inverters. The usual safety precautions regarding the use of xrays 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.
-
- 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.
{1}------------------------------------------------
| Characteristic | Model MobileK012663 (Twomodels) | Canon CXDI-50GDigitalRadiography,K031447 | Sedecal Mobile X-ray Units with Detector(Combinationdevice) |
|---|---|---|---|
| Intended Use: | Mobile general purposediagnostic X-ray unit | SAME | SAME |
| Size | Imaging Area 14 x 17 | SAME (Combineddevice) (A stand hasbeen added) | |
| Weight (battery version) | 1045 lb | 10.6 lb | 964 lb. |
| Energy Source: | 90 to 285 VAC (50-60Hz) or Batteries | 100V, 120V,230/240V(50/60Hz) | SAME (Combineddevice) |
| User Interface | Up-Down pushbuttonsfor kVp and mAs. KVpadjustable in I kVpsteps | Software Driven TouchPanel LCD | Software Driven TouchPanel LCD (Combineddevice) |
| Power | 20 or 30 kW | N/A | Models up to 50 kW |
| Exposure times | 0.001 - 8 SECONDS$\pm$ (1%+0.1 MS) | N/A | SAME (Combineddevice) |
| Ma. | 10, 12.5, 16, 20, 25, 32,40, 10, 12.5, 16, 20, 25,32, 40, 50, 64, 80, 100,125, 160, 50, 64, 80,100, 125, 160, 200, 250,320 200, (400, and 500on 30 kw unit)$\pm$ (5%+0.1 MA) | N/A | SAME (Combineddevice) |
| kVp | 40 to 150 in 1 kVp steps(30 kw unit) | N/A | SAME (Combineddevice) |
| Resolution | N/A | 160 x 160 microns pixelpitch, withapproximately 6 millionpixels and 4,096 grayscale contrast | SAME (Combineddevice) |
| Method of Control | Dedicated Touch Panel | Software Driven TouchPanel LCD | SAME as CANON. Ororiginal DedicatedTouch Panel |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | IEC 60601-1 | SAME | SAME |
6. Substantial Equivalence Chart, The Sedecal Portable X-ray Units with Detector
7. Conclusion
After analyzing bench, user, and standards testing data, it is the conclusion of Sedecal that the Sedecal Mobile X-ray Units with Digital 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.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEDECAL SA % Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
AUG 23 2013
Re: K043002
Trade/Device Name: Sedecal Mobile X-Ray Units with Digital Detector Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: October 27, 2004 Received: November 1, 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 (reporting of
{3}------------------------------------------------
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. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Sedecal Mobile X-Ray Units with Digital Detector
Indications For Use:
The Sedecal Mobile 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)
David A. Bergman
Page I of 1
(Division Sign-Off) Division of Reproductive, Ab and Radinlogical Devices 5 1()(k) Number
§ 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.