(35 days)
These Digital 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 skall, 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.
These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.
The provided document is a 510(k) summary for the Sedecal Millennium Plus Digital Diagnostic X-Ray System. It states that the new device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study as requested.
The document primarily focuses on establishing substantial equivalence by comparing the new device's characteristics and intended use to those of its predicate devices (Sedecal Millennium Digital K042876 and Sedecal X Plus LP Plus K062335) and by stating that it passes bench and test laboratory evaluations to applicable standards (21 CFR 1020.30 and IEC 60601).
Therefore, I cannot provide the requested table and detailed information based on the content of this document. The document explicitly states:
"The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."
and
"After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Sedecal Inc that the Scdecal Millennium Plus Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."
This indicates that general safety and effectiveness testing was conducted, but the specific details of the acceptance criteria, study design, performance metrics, sample sizes, ground truth, or expert involvement are not disclosed in this 510(k) summary.
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MAR 1 1 2009
510(k) Summarv 510(k) Number K09 Sedecal, Inc. 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: January 30, 2009 Mª Luisa Gómez de Agüero, Quality and Regulatory Manager Contact:
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- Identification of the Device: Proprietary-Trade Name: Sedecal Millennium Plus Digital Diagnostic X-Ray System Classification Name: Stationary x-ray system, Product Code 90 KPR and Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital Stationary Diagnostic X-Ray System
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- Indications for Use (intended use) These Digital 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 skall, 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: These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.
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- Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices.
Image /page/0/Picture/8 description: The image shows a piece of equipment with the words "Millennium Digital, K042876" at the top. The equipment has a table-like surface with a box underneath. Above the table, there is a device with a screen that has multiple dots on it.
Sedecal X Plus LP Plus K062335
Image /page/0/Picture/10 description: The image shows a piece of medical equipment, specifically an X-ray machine. The machine consists of a table on wheels, a large vertical support structure, and an arm that extends over the table. The X-ray machine is designed to allow medical professionals to take X-ray images of patients.
Sedecal Millennium Plus Digital
Image /page/0/Picture/12 description: The image shows an X-ray machine in a medical setting. The machine has a large, rectangular table with a movable X-ray source positioned above it. The X-ray source is attached to a vertical support structure, and there is a control panel or display screen nearby. The room appears to be a dedicated X-ray room, with the necessary equipment for medical imaging.
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| Characteristic | Sedecal Millennium LPDigital, K042876 | Sedecal X Plus LP Plus,K062335. | Sedecal Millennium PlusDigital |
|---|---|---|---|
| Intended Use: | Intended for use by aqualified/trained doctoror technician on bothadult and pediatricsubjects for takingdiagnostic radiographicexposures of the skull,spinal column, chest,abdomen, extremities,and other body parts.Applications can beperformed with thepatient sitting, standing,or lying in the prone orsupine position. | SAME | SAME |
| Configuration | U-Arm, column mount,or Ceiling Suspension | U-Arm mount only | Column mount |
| Positioningcontrols | Standard | Enhanced | Enhanced, same as X PlusLP Plus |
| PerformanceStandard | 21 CFR 1020.30 | SAME | SAME |
| Generator | High frequency madeby Sedecal | SAME | SAME |
| Collimator | Manual, Ralco | Manual, Ralco | Manual (Ralco) orAutomatic (Huestis) |
| Image acquisition | Digital CANON 50G | Film | CANON panels, multiplemodels: 50C, 50G, 40C &40G |
| Electrical safety | Electrical Safety perIEC 60601, UL listed | SAME | SAME |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Sedecal Inc that the Scdecal Millennium Plus Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a bird-like shape. The emblem is composed of three curved lines that converge to create a sense of movement or flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2009
Sedecal SA % Daniel Kamm, P.E. Principal Consultant Kamm & Associates 333 Milford Rd. DEERFIELD IL 60015
Re: K090279
Trade/Device Name: Sedecal Millennium Plus Digital Diagnostic X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: February 1, 2009
Received: February 9, 2009
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morri Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use 510(k) Number (if known): K090279
Device Name: Sedecal Millennium Plus Digital Diagnostic X-Ray Systems
Indications For Use:
These Digital 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.
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)
Hulo Remen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
§ 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.