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.

Device Description

These digital diagnostic x-ray systems consist of a tubehead/collimator assembly mounted on a U-Arm, along with a generator, generator control, and an x-ray 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.

AI/ML Overview

The provided 510(k) summary for the Sedecal X-Plus LP Plus Digital Diagnostic X-Ray System (K090238) does not contain the information requested regarding acceptance criteria and a specific study proving the device meets those criteria, as you would typically expect for performance data of AI/CADe devices.

This submission is for a traditional X-ray system, and the approval is based on substantial equivalence to predicate devices, rather than a performance study with defined acceptance criteria for diagnostic accuracy.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: For this type of device, the acceptance criteria are generally related to demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and effectiveness through comparison of technical characteristics and adherence to relevant performance standards.
Reported Device Performance: The document states, "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."

Acceptance Criteria Category	Reported Device Performance
Intended Use	Met: Same intended use as predicate devices: diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts for adult and pediatric subjects, in various patient positions.
Configuration	Met: Similar configuration (U-Arm mount only) to predicate K062335. Differs from K042876 (U-Arm or Ceiling Suspension) but is considered a minor technological difference not impacting safety/effectiveness.
Positioning Controls	Met: "Enhanced, same as X Plus LP Plus" (predicate K062335), an improvement over K042876's "Standard" but still within the scope of safe and effective operation for an X-ray system.
Performance Standard	Met: Adheres to 21 CFR 1020.30 (Performance standards for ionizing radiation emitting products - radiographic equipment). This is a statutory requirement for all such devices.
Generator	Met: High frequency made by Sedecal, same as both predicate devices.
Collimator	Met: Manual (Ralco) or Automatic (Huestis). Offers an automatic option, which is an enhancement over the manual-only collimators of the predicate devices but is a common and accepted component in X-ray systems.
Image Acquisition	Met: Utilizes CANON panels (multiple models: 50C, 50G, 40C & 40G). This is a key technological difference from predicate K062335 (Film) and an update from K042876 (Digital CANON 50G). The use of cleared Canon digital panels (referenced by K numbers K060433, K031633, K031447, K023750) demonstrates their established safety and effectiveness.
Electrical Safety	Met: Adheres to IEC-60601 UL listed. This is a standard safety requirement for medical electrical equipment.
Overall Conclusion	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The approval is based on "bench and test laboratory" results and comparison of specifications, not a clinical test set with patient data for diagnostic accuracy assessment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable/provided. No clinical reader study or ground truth establishment relevant to diagnostic accuracy is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided.

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, an MRMC comparative effectiveness study was not done. This device is a digital X-ray system, not an AI or CADe device designed to assist human readers or provide diagnostic interpretations.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone performance study was not done. This is an imaging acquisition device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for this submission revolves around engineering performance verified by "bench and external laboratory testing to applicable standards" (e.g., 21 CFR 1020.30, IEC-60601) to demonstrate the device functions as intended and is safe. It's not about diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This isn't an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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K090238

FEB 2 7 2009

510(k) Summary 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 20, 2009

Mª Luisa Gómez de Agüero, Quality and Regulatory Manager Contact:

1. Identification of the Device: Proprietary-Trade Name: Sedecal X-Plus LP 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
1. Equivalent legally marketed device: Sedecal URS LP Digital K042876 and Sedecal X Plus LP Plus, K062335. Digital panels: Canon, K060433 (50C); K031633 (40C); K031447 (50G); K023750 (40G).
1. 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 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.
1. Description of the Device: These digital diagnostic x-ray systems consist of a tubehead/collimator assembly mounted on a U-Arm, along with a generator, generator control, and an x-ray 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.
1. 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/Figure/9 description: The image shows three different medical imaging systems. The first system is labeled "URS LP Digital, K042876". The second system is labeled "Sedecal X Plus LP Plus K062335". The third system is labeled "Sedecal X Plus LP Plus Digital".

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Characteristic	Sedecal URS LPDigital, K042876	Sedecal X Plus LP Plus,K062335.	Sedecal X-Plus LP 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 mount orCeiling Suspension	U-Arm mount only	U-Arm mount only
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 Sedecal X-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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a descending order.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB & 7 2009

Sedecal SA % Mr. Daniel Kamm, P. E. Principal Consultant Kamm & Associates 333 Milford Road DEERFIELD IL 60015

Re: K090238

Trade/Device Name: Sedecal X-Plus LP 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: January 30, 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

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 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (240) 276-0115 (Obstetrics/Gynecology) (240) 276-0115 (Radiology) (240) 276-0120 (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. Morris cting 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): K09D238 8 8

Device Name: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems

Indications For Use:

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)

Hulb Reima

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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Regulation Number and Section

§ 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.