(99 days)
Sedecal "NOVA FA DR System" is 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.
"NOVA FA DR System" refers to a full Digital Radiography system consisting of: NOVA: Automatic Ceiling Suspension NBS: Tilting Vertical Wall Stand system with CXDI Canon Detectors 401C / 401C Compact / 55C / 501C (Option 1) NET: Elevating Table with CXDI Canon Detector (same detectors as Wall Stand) (Option 2) Flexi DT: Mobile Elevating Table SEDECAL SHF Generator Series, output powers: 50 kW / 65 kW / 80 kW Toshiba Tube: maximum heat dissipation: 300 kHU / 400 kHU Ralco Collimator: Manual / Motorized
Here's a breakdown of the acceptance criteria and study information for the Sedecal "NOVA FA DR System" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes a modification to an existing X-ray system (K090279). The acceptance criterion for this modification is implicitly to demonstrate that the modified device is as safe and effective as the predicate device, with images of at least comparable quality.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| I. Non-Clinical Performance: | |
| - Electrical Safety (IEC 60601-1) | Demonstrated compliance with electrical safety standards. |
| - Electromagnetic Compatibility (IEC 60601-1-2) | Demonstrated compliance with electromagnetic compatibility standards. |
| - Software Integration Functionality | Unmodified software packages integrated and worked properly. |
| - Risk Analysis for Modifications/Integration | Performed for modifications, system integration, elevating table, generators, mobile table, overhead tube stand, and wall stand. |
| II. Clinical Performance (Image Quality): | |
| - Image quality comparable to predicate device | Images found to be of good quality, high resolution, and clinically acceptable. |
| - Image quality for various body structures | Demonstrated good quality for images of chest, skull, abdomen, and extremities. (Implicitly comparable to predicate given "clinically acceptable") |
| - Techniques comparable to predicate device | Techniques employed were comparable to those employed by the predicate panel. |
| III. Substantial Equivalence: | |
| - As safe as predicate | Demonstrated (via non-clinical and clinical tests) as safe as the predicate. |
| - As effective as predicate | Demonstrated (via non-clinical and clinical tests) as effective as the predicate. |
| - Performs as well as or better than predicate | Demonstrated (via non-clinical and clinical tests) performs as well as or better than the predicate. |
| - Materials and construction nearly identical to predicate | Stated that materials and construction methods are nearly identical to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "various human body structures (chest, skull, abdomen, extremities)" were acquired, but no number of cases or patients is provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study used "clinical images," implying prospective acquisition for the purpose of the study, but this is not explicitly confirmed. Given Sedecal is based in Spain, it's plausible the images were acquired there, but this is speculation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: One.
- Qualifications of Experts: "Board Certified Radiologist." No specific years of experience are mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: None explicitly mentioned. With only one radiologist, there was no need for adjudication for consensus.
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 MRMC or AI comparative effectiveness study was performed or mentioned. This submission is for a modification to a digital X-ray system, not an AI-powered diagnostic tool. The focus is on the imaging system itself, not on reader performance improvement with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a digital X-ray system, not an algorithm, and its performance inherently involves human operation and interpretation.
7. The Type of Ground Truth Used:
- Ground Truth Type: Expert opinion/evaluation by a Board Certified Radiologist. The "good quality, high resolution, and clinically acceptable" assessment served as the ground truth for image quality.
8. The Sample Size for the Training Set:
- Not applicable/Not mentioned. This document describes a 510(k) for a hardware modification and new detectors, not an AI/machine learning algorithm that requires a training set. The "testing" refers to verification and validation of the hardware performance, software integration, and image quality.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not mentioned. As above, there is no training set for an AI algorithm.
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MAR 2 1 2014
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Sedecal Special 510(k) Summary 510(k) Number K133782
- Submitter: SEDECAL SA C/ Pelava, 9 - 13, Pol. Ind. Río de Janeiro 28110 Algete. Madrid. España (Spain) Tel.- +34 91 6280544, Fax.- +34 91 6280574
Date Prepared: March 10, 2014 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager
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- Identification of the Device: Proprietary-Trade Name:) Sedecal "NOVA FA DR System" Classification Name: Stationary X-Ray System, Product Codes MQB and KPR Common/Usual Name: Digital Diagnostic X-Ray System; Regulation 21CFR892.1680
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- Equivalent legally marketed device: K090279, Sedecal Millennium Plus Digital Diagnostic X-Ray Systems.
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- Description of the Device: "NOVA FA DR System" refers to a full Digital Radiography system consisting of: NOVA: Automatic Ceiling Suspension NBS: Tilting Vertical Wall Stand system with CXDI Canon Detectors 401C / 401C Compact / 55C / 501C (Option 1) NET: Elevating Table with CXDI Canon Detector (same detectors as Wall Stand) (Option 2) Flexi DT: Mobile Elevating Table SEDECAL SHF Generator Series, output powers: 50 kW / 65 kW / 80 kW Toshiba Tube: maximum heat dissipation: 300 kHU / 400 kHU Ralco Collimator: Manual / Motorized
The new device represents a modification to our system shown in K090279. We have changed the originally supplied column suspension to a ceiling suspension and we are providing newer digital panel detectors. All of the panels have their own clearances: CXDI Canon Detector 401C / 401C Compact K103591 CXDI Canon Detector 55C / K091436 CXDI Canon Detector 501C K111682
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- Indications for Use (intended use) Sedecal "NOVA FA DR System" is 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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- Technological Characteristics: This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. Specifications are for all intents and purposes identical. This submission represents the combination of cleared and 510(k) exempt devices. The modifications are shown in the comparison table below.
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| Comparison Table | ||
|---|---|---|
| Characteristic | Predicate: K090279, Sedecal MillenniumPlus Digital Diagnostic X-Ray Systems. | Modified Device: Sedecal "NOVA FA DRSystem" |
| IndicationsStatement | Intended for use by a qualified/traineddoctor or technician on both adult andpediatric subjects for taking diagnosticradiographic exposures of the skull, spinalcolumn, chest, abdomen, extremities, andother body parts. Applications can beperformed with the patient sitting, standing,or lying in the prone or supine position. | Exactly the same but with the added FDArequested language: (Not for mammography). |
| Photo | Image: X-ray machine | Image: X-ray machine |
| Digital ReceptorPanel | Canon Model CXDI-50G (K060433) | CXDI Canon Detector 401C/401C Compact(K103591)CXDI Canon Detector 55C (K091436)CXDI Canon Detector 501C (K111682) |
| Panel Resolution | Pixel size 160 × 160 µmImage matrix size 2208 × 2688 pixelsNumber of pixels Approx. 5.9 million pixels | Pixel size 125 x 125 µm 3,320 x 3,408 pixels(11.3 megapixels) (401C) or160 x 160 microns2,208 x 2,688 pixels (approx. 5.9 million pixels)(55C) orPixel size 125 x 125 µm 2,800 x 3,408 Pixels(9.5 Megapixels) (501C) |
| Scintillator | GOS Gd2O2S:Tb | CsI (CsI: Tl) |
| Tube Mount | Column Suspension | Ceiling Suspension |
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- Discussion of the nonclinical tests in the premarket notification submission for a determination of substantial equivalence: We performed electrical safety (IEC 60601-1), electromagnetic compatibility testing, (IEC 60601-1-2), and software integration testing, Integration testing assured that the unmodified software packages we employed worked Risk analysis was performed for: the modifications, system integration, the together properly. elevating table, generators, mobile table, overhead tube stand, and the wall stand.
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- Discussion of the clinical testing performed: Clinical images of various human body structures (chest, skull, abdomen, extremities) were acquired and evaluated by a Board Certified Radiologist and found to be of good quality, high resolution, and clinically acceptable. Techniques employed were comparable to those employed by the predicate panel.
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- Conclusion. Based on the results of the nonclinical tests (that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed devices) we conclude that this new digital x-ray upgrade kit is safe and effective as the predicates identified in paragraph (3). Furthermore, the materials and construction methods are nearly identical to the predicate.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered in the image. The font is a serif font and the text is black.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
March 21, 2014
SEDECAL SA % Mr. Daniel Kamm. P.E. Principal Engineer 8870 Ravello Court NAPLES FL 34114
Re: K133782
Trade/Device Name: NOVA FA DR System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 14, 2014 Received: February 19, 2014
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 (sec 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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Page 2-Mr. Kamm
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
Janine M. Morris 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): K133782_____________________________________________________________________________________________________________________________________________
Device Name: Sedecal "NOVA FA DR System"
Indications For Use:
Sedecal "NOVA FA DR System" is 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K133782 510(k)
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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.