(29 days)
Indications for Use: Sedecal Portable X-Ray 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.
SPS-HF-4.0-D Portable X-ray Unit with Detector is a portable unit which operate from 120 V 50-60~ AC. The unit utilizes a high frequency inverter mounted to a tripod or support arm. 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 provided text describes a 510(k) summary for the SEDECAL SPS-HF-4.0-D Portable X-ray Units with Detector. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria are not directly applicable or explicitly detailed in the provided document, as the submission relies on the established safety and effectiveness of the predicate devices.
However, I can extract the relevant information where available and note when the information is not present or not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets for metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices in terms of intended use, safety, and effectiveness.
The "reported device performance" is a comparison of characteristics to the predicate devices.
| Characteristic | Intended Use | Size | Weight | Energy Source | User Interface | Exposure Times | Ma. (Current) | KvP (Voltage) | Resolution | Method of Control | Performance Standard | Electrical Safety |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acceptance Criteria (Implied) | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | SAME as predicates | SAME as predicates |
| SEDECAL SPS-HF-4.0-D Performance | Portable general purpose diagnostic X-ray unit | Same (Combined device) (A stand has been added) | 207 lb. (Combined device) | Same (Combined device) | Same (Combined device) - Combines predicates' UI and Canon's touch screen | Same (Combined device) | Same (Combined device) (5-100 Ma.) | Same (Combined device) (40-115 KvP) | Same (Combined device) (160x160 micron pixel, 6M pixels, 4096 gray scale) | Same as CANON. Or original Dedicated Touch Panel | 21 CFR 1020.30 | UL 2601, IEC 60601-1 |
Note: The term "SAME" in the table for "reported device performance" refers to being the same as or comparable to the predicate devices, which is the basis for substantial equivalence. The specific resolution is from the Canon CXDI-50G predicate, which the combined device utilizes.
Study Details (Based on the provided document)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document 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, it is the conclusion of Sedecal that the Sedecal Portable X-ray Units with Detector are as safe and effective as the predicate devices..."
- No specific sample size for a "test set" from a clinical performance study is mentioned. The "tests" refer to bench testing, user testing (which might involve testing the combined user interface and functionality), and compliance with standards.
- Data provenance is not specified. These are likely internal company tests.
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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 / Not specified. This document is not a clinical study report that establishes ground truth for a test set based on expert review. It's a 510(k) summary focused on substantial equivalence.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. As no clinical "test set" requiring ground truth establishment or adjudication is described, this information is not present.
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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. This is not an AI-assisted device, and no MRMC study is mentioned. This is a submission for a combined X-ray unit (hardware and controlling software).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device with associated control software, not an algorithm being tested in a standalone capacity. Its performance is intrinsically linked to its intended use by a human operator.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not specified. The validation focuses on comparison of technical specifications and compliance with safety standards rather than diagnostic ground truth in a clinical performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
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The sample size for the training set
- Not applicable. This submission describes a medical device (X-ray unit), not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established
- Not applicable. As there is no training set for a machine learning algorithm, this question is not relevant.
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SEP 2 9 2004
K042361
Page 1 of 2
EXHIBIT 2 510(k) Summary
| SEDECAL SA | SEDECAL USA, Inc. |
|---|---|
| Pelaya 9- Poligono Industrial Rio De | 2910 N. Arlington Heights Rd. |
| Janeiro | Arlington Heights Illinois 60006 |
| 28110 -Algete | Tel 847-394-6960 |
| Madrid Spain | Fax 847-394-6966 |
| Tel (34) 91-628 0544/91-628 1592 | (Initial Importer) |
| Fax (34) 91-628 0574 | Contact: Devan Moser |
| (Foreign Manufacturer) |
August 24, 2004
-
- Identification of the Device: Proprietary-Trade Name: SPS-HF-4.0-D Portable X-ray Units with Detector Classification Name: Mobile X-ray system, Product Codes 90 IZL and MQB Common/Usual Name: Portable general purpose diagnostic X-ray Unit.
-
- Indications for Use (intended use) The Sedecal Portable X-ray 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.
-
- Description of the Device: SPS-HF-4.0-D Portable X-ray Unit with Detector is a portable unit which operate from 120 V 50-60~ AC. The unit utilizes a high frequency inverter mounted to a tripod or support arm. 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.
-
- 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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K042361
Page 2 of 2
| Characteristic | Model SP-HF-4.0K020435 | Canon CXDI-50GDigitalRadiography,K031447 | Sedecal SPS-HF-4.0-D Portable X-ray Units withDetector(Combinationdevice) |
|---|---|---|---|
| Intended Use: | Potable generalpurpose diagnostic X-ray unit | SAME | SAME |
| Size | 8.7 H x 10.4" W x16.5" D | Imaging Area 14 x 17 | SAME (Combineddevice) (A stand hasbeen added) |
| Weight | 33 lb | 10.6 lb | 207 lb. |
| Energy Source: | 90 to 285 VAC (50-60Hz) | 100V, 120V,230/240V(50/60Hz) | SAME (Combineddevice) |
| User Interface | Up-Downpushbuttons for kVpand mAs. kVpadjustable in 1 kVpsteps | Software DrivenTouch Panel LCD | SAME (Combineddevice) |
| Exposure times | 0.001-10 sec 41 steps | N/A | SAME (Combineddevice) |
| Ma. | 5, 6.4, 8, 10, 12.5, 16,20, 25, 32, 40, 50, 64,80, 100 | N/A | SAME (Combineddevice) |
| KvP | 40 to 115 in 1 kVpsteps | N/A | SAME (Combineddevice) |
| Resolution | N/A | 160 x 160 micronspixel pitch, withapproximately 6million pixels and4,096 gray scalecontrast | SAME (Combineddevice) |
| Method of Control | Dedicated TouchPanel | Software DrivenTouch Panel LCD | SAME as CANON.Or original DedicatedTouch Panel |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | UL 2601, IEC 60601-1 | SAME | SAME |
Substantial Equivalence Chart, The Sedecal Portable X-ray Units with Detector 6
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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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of two parts: 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 written in a 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, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
AUG 2 3 2013
Re: K042361
Trade/Device Name: Sedecal SPS-HF-4.0-D Portable X-Ray Units with Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and IZL Dated: August 30. 2004 Received: September 2, 2004
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of September 29, 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 aboye) 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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Page 2
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
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: Sedecal SPS-HF-4.0-D Portable X-Ray Units with Detector
Indications For Use:
Indications for Use: Sedecal Portable X-Ray Units with Detector are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
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)
Daniel B. Bergman
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Page i of 1
Page 8 of 487
§ 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.