SEDECAL

K103522 · Sedecal., Sa. · IZL · Jan 26, 2011 · Radiology

Device Facts

• Record ID: K103522
• Device Name: SEDECAL
• Applicant: Sedecal., Sa.
• Product Code: IZL · Radiology
• Decision Date: Jan 26, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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)

Device Story

Portable diagnostic X-ray system; generates radiographic exposures for diagnostic imaging. Components: control panel, power module, high-voltage tank (transformer/X-ray tube), collimator, handswitch, mobile column with articulated arm, and cassette basket. Operated by qualified doctors or technicians in clinical settings. Device transforms electrical energy into X-ray beams to capture images of anatomy. Output used by clinicians to visualize internal structures for diagnostic decision-making. Benefits include mobile, point-of-care diagnostic capability for various body parts.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness demonstrated via electrical safety, electromagnetic compatibility, and performance testing per IEC standards.

Technological Characteristics

Mobile X-ray system; high-voltage transformer/filament transformer/X-ray tube assembly. Energy source: electrical. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-3, IEC 60601-2-7. Form factor: mobile column with articulated arm.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of skull, spine, chest, abdomen, and extremities. Patient may be sitting, standing, or lying (prone/supine). Contraindicated for mammography.

Regulatory Classification

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.

Predicate Devices

• Sedecal Models SP-HF-2.8 and SP-HF-4.0 (K020436)

Submission Summary (Full Text)

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### 510(k) Summary

# 510(k) Number K103 S-22

JAN 2 6 2011

#### l. Submitter:

SEDECAL SA C/ Pelaya, 9 - 13 Pol. Ind. Río de Janeiro 28110 Algete, Madrid, España (Spain) Tel .- [phone] Fax.- [phone] Date Prepared: October 27, 2010 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

- 2. Identification of the Device: Proprietary-Trade Name: Sedecal SPL-HF-4.0 (and SPL-HF-2.0) Classification Name: Mobile x-ray system, Product Code IZL Common/Usual Name: Mobile Diagnostic X-Ray System
- 3. Equivalent legally marketed device: K020436 Sedecal Models SP-HF-2.8 and SP-HF-4.0
- 4. Description of the Device: The Sedecal SPL-HF-4.0 portable x-ray generator consists of: X-ray Unit with: Control Panel with controls and displays for radiographic operations; Power Module containing control and power components; HV Tank that comprises the High Voltage Transformer, the Filament Transformer and the X-ray Tube; and a Collimator with controls to limit the X-ray beam; a Handswitch and a Mobile Column with an Articulated Arm and a Cassette Basket.
- 5. Indications for Use (intended use) 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)
- 6. Technological Characteristics: This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. Specifications are nearly identical. This submission represents an updated design of our previous model in K020436.
- 7. 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), software validation testing, and testing to IEC 60601-1-3 and IEC 60601-2-7.
- 8. 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 sare, as ofted this modified x-ray system is safe and effective as the predicate identified in paragraph (3). Furthermore, the materials and construction methods are nearly identical to the predicate.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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. Principal Consultant Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

JAN 2 6 2011

Re: K103522

Trade/Device Name: Sedecal SPL-HF-4.0 (and SPL-HF-2.0) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: November 24, 2010 Received: December 1, 2010

#### 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 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

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Postel

Mary Pastel, ScD. 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): K1035 22

Device Name: Sedecal SPL-HF-4.0 (and SPL-HF-2.0)

Indications For Use:

This Portable Diagnostic Radiographic 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 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In-vitro Diagnostics (OIVD)

Office of In Vitro Diagnostic Devices
(Division Sign-Off)
Division of Radiological Devices
Device Evaluation and Safe

510K K103522

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