This is a mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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 Description

This is a battery powered mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with Lithium batteries to supply both X-ray generator for X-ray exposures and motors for movements instead of the Sealed Lead Acid batteries of the predicate model. This system has been made lighter and therefore more maneuverable. Lithium batteries provide a much lower charging time and more autonomy in standby. The indication for use remains the same as the predicate. The x-ray generator has been adapted to the new power supply based on Lithium batteries. The same. The main features of this equipment are:
a) A solid and ergonomic design. Easy operation, safety and precision of all positioning movements relative to the position of the patient.
b) Standard electrical outlet operation with single-phase lines at 100 -- 240 V*. Automatic line voltage compensation.
c) Head-Assembly rotation in relation to its transversal axis (±180°) and horizontal axis (120°). Collimator rotation in relation to its vertical axis (±90°).
d) Controls for lock release of Rotating Column and Telescopic Arm.
e) Column rotation in relation to its vertical axis (±317°), telescopic and vertical motion of the Arm.
f) X-ray Handswitch for X-ray exposures and Collimator Light.
Infrared Remote X-ray Handswitch (optional) for X-ray exposures and Collimator Light. g)
h) Dosimetry (optional):
i) DAP reading with an Ion Chamber. i)
ii) Calculated DAP (eDAP).
i) Manual Collimation.
Tube protection circuitry prolongs Tube life and increases system performance. i)
Equipped with closed loop control of X-ray Tube current, kVp and filaments, which minimize k) potential errors and the need for readjustments.

There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser. The x-ray flat panel detectors (an integral part of a complete diagnostic system) are not part of the SM-IV device and must me provided separately by the user.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a mobile x-ray system (SM-IV) and focuses on demonstrating its substantial equivalence to a predicate device (PHOENIX, K212291). The assessment is primarily based on non-clinical testing and technical comparisons, and does not involve a study proving the device meets specific acceptance criteria related to diagnostic performance with human readers or AI.

Therefore, many of the requested details, such as those related to AI effectiveness, human reader studies, ground truth establishment for a test set, and sample sizes for diagnostic performance studies, are not applicable to this submission as it primarily concerns the safety and performance of the hardware itself, not its diagnostic accuracy in clinical use.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" in the sense of predefined thresholds for diagnostic accuracy (e.g., sensitivity, specificity, AUC) for an AI or human-in-the-loop system. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and compliance with safety standards.

The "performance" is largely described in terms of functional specifications and safety compliance, not diagnostic accuracy.

Characteristic	Predicate: K212291 PHOENIX (Reported Device Performance)	SM-IV (Reported Device Performance)	Acceptance Criteria (Implicit for Substantial Equivalence)
Indications for Use	Mobile diagnostic x-ray system for various body parts, adult/pediatric, not for mammography.	Same	Must be the same or very similar to the predicate.
Configuration	Mobile System with digital x-ray panel and image acquisition computer	Same, but no image acquisition software or hardware supplied.	Functionally equivalent as a mobile x-ray unit, with acceptable modifications.
X-ray Generator(s)	20, 32, 40 kW and 50 kW Monoblock generator; kV range: 40-150 kV; mA range: 10-630mA; mAs range: 0.1-500 mAs	Same	Equivalent X-ray generation capabilities.
Collimator	Ralco R108F	Same	Equivalent collimation and radiation control.
Touch screen control	Yes, 19"	19" or 21.5"	Acceptable range within control interface.
Motorized movement	Included	Same	Retention of mobility features.
Meets US Performance Standard	YES 21 CFR 1020.30	SAME	Compliance with regulatory performance standards.
Power Source	Universal power supply, from 100 V~ to 240 V~. 1 phase	SAME	Equivalent power delivery.
Type of Batteries	Sealed Lead batteries	Lithium batteries	Acceptable battery technology change if equivalent/improved safety and performance.
Standby autonomy	~11 hours	~17 hours	Improved or equivalent standby time.
Charging time	~8 hours	~4 hours	Improved or equivalent charging time.
Imaging Software	Konica-Minolta control software CS-7 (K151465 or K172793) OR Konica-Minolta control software Ultra.	Not Included	Acceptable change of responsibility to purchaser.
Digital detector Interface	Ethernet or Wi-Fi wireless	Not Applicable	Not applicable as detectors are not included.
Size	122 x 540 x 223 cm	122 x 540 x 222 cm	Substantially equivalent size.
Weight	520 kg	450 kg	Acceptable or improved weight.
Digital Detectors	AeroDR Series	Not Included	Not applicable as detectors are not included.

Study that Proves the Device Meets Acceptance Criteria:

The study described is a non-clinical bench testing and technical comparison to demonstrate substantial equivalence, rather than a clinical study of diagnostic performance.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable in the context of diagnostic performance. The "test set" here refers to the physical SM-IV unit which underwent bench testing. The document states, "A system was assembled and found to be operating properly." This implies testing of a single or a few manufactured units for functional and safety compliance.
Data Provenance: Not applicable for diagnostic performance data. The device itself is manufactured by Sedecal SA in Madrid, Spain.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This submission does not involve establishing ground truth for diagnostic images or AI performance. The assessment is based on engineering and manufacturing standards.

4. Adjudication Method for the Test Set:

Not applicable. No diagnostic image interpretation requiring adjudication was performed.

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 study was not conducted because the device is a mobile x-ray system (hardware), not an AI-powered diagnostic software or a system intended to assist human readers in image interpretation. The device itself does not include imaging software or digital detectors.

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

No. This device is not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not applicable. Ground truth for diagnostic accuracy is not relevant to this submission. The "ground truth" for the device's performance is adherence to established engineering specifications and safety standards (e.g., IEC 60601 series).

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware system, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating that the SM-IV mobile x-ray system is substantially equivalent to a legally marketed predicate device (PHOENIX) primarily through technical comparison and non-clinical bench testing to ensure safety and effectiveness of the hardware. It does not involve any studies on diagnostic performance, AI capabilities, or human reader accuracy, as these components (imaging software and digital detectors) are explicitly stated as not included with the SM-IV device.

Summary

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August 21, 2023

Image /page/0/Picture/1 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.

Sedecal SA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

Re: K232185

Trade/Device Name: SM-IV Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: July 17, 2023 Received: July 24, 2023

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (see 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K232185

Device Name

SM-IV

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: 510(k) Number K232185

Image /page/3/Picture/1 description: The image is a logo for SEDECAL. The logo is a teal rectangle with rounded corners. Inside the rectangle is a white graphic of a person sitting at a desk, and the word "SEDECAL" in white letters.

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: August 4, 2023 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

1. Identification of the Device: Trade/Device Name: SM-IV Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL. Common/Usual Name: Mobile Diagnostic X-Ray System
1. Equivalent legally marketed device: K212291 Trade/Device Name: PHOENIX Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
1. Indications for Use: This is a mobile diagnostic x-ray system 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.
1. Description of the Device: This is a battery powered mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with Lithium batteries to supply both X-ray generator for X-ray exposures and motors for movements instead of the Sealed Lead Acid batteries of the predicate model. This system has been made lighter and therefore more maneuverable. Lithium batteries provide a much lower charging time and more autonomy in standby. The indication for use remains the same as the predicate. The x-ray generator has been adapted to the new power supply based on Lithium batteries. The same. The main features of this equipment are:
- a) A solid and ergonomic design. Easy operation, safety and precision of all positioning movements relative to the position of the patient.
- b) Standard electrical outlet operation with single-phase lines at 100 -- 240 V*. Automatic line voltage compensation.

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c) Head-Assembly rotation in relation to its transversal axis (±180°) and horizontal axis (120°). Collimator rotation in relation to its vertical axis (±90°).
d) Controls for lock release of Rotating Column and Telescopic Arm.
e) Column rotation in relation to its vertical axis (±317°), telescopic and vertical motion of the Arm.
f) X-ray Handswitch for X-ray exposures and Collimator Light.
Infrared Remote X-ray Handswitch (optional) for X-ray exposures and Collimator Light. g)
h) Dosimetry (optional):
- DAP reading with an Ion Chamber. i)
- ii) Calculated DAP (eDAP).
i) Manual Collimation.
Tube protection circuitry prolongs Tube life and increases system performance. i)
Equipped with closed loop control of X-ray Tube current, kVp and filaments, which minimize k) potential errors and the need for readjustments.

Characteristic	Predicate: K212291 PHOENIX	SM-IV
Indicationsfor Use:	This is a digital mobile diagnostic x-ray systemintended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body parts.Applications can be performed with the patientsitting, standing, or lying in the prone or supineposition. Not for mammography	This is a mobile diagnostic x-ray systemintended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in the proneor supine position. Not for mammography.(Same)
Configuration	Mobile System with digital x-ray panel andimage acquisition computer	SAME but no image acquisition software orhardware s supplied.
X-rayGenerator(s)	20, 32, 40 kW and 50 kW Monoblock generatorkV range: from 40 kV to 150 kVmA range: 10 mA – 630mAmAs range: from 0.1 mAs to 500 mAs	20, 32, 40 kW and 50 kW MonoblockgeneratorkV range: from 40 kV to 150 kVmA range: 10 mA – 630mAmAs range: from 0.1 mAs to 500 mAs(Same)
Collimator	Ralco R108F	Same
Characteristic	Predicate: K212291 PHOENIX	SM-IV
Photos	Image: K212291 PHOENIX	Image: SM-IV
Touch screencontrol	Yes, 19"	19" or 21'5"
Motorizedmovement	Included	SAME
Meets USPerformanceStandard	YES 21 CFR 1020.30	SAME
Power Source	Universal power supply, from 100 V~ to 240V~. 1 phase	SAME
Type ofBatteries	Sealed Lead batteries	Lithium batteries
Standbyautonomy	The Mobile Unit in Stand-Alone (disconnectedfrom the mains) will be 100% discharged fromfull charge in approximately: 11 hours	The Mobile Unit in Stand-Alone (disconnectedfrom the mains) will be 100% dischargedfrom full charge in approximately: 17 hours .
Charging time	The required time for the Batteries to be 100%charged is approximately: 8 hours.	The required time for the Battery to be 100%charged is approximately: 4 hours.
ImagingSoftware	Konica-Minolta control software CS-7(K151465 or K172793) OR Konica-Minoltacontrol software Ultra.	Not included
Digital detectorInterface	Ethernet or Wi-Fi wireless	Not applicable
Size	122 x 540 x 223 cm	122 x 540 x 222 cm
Weight	520 kg	450 kg.
DigitalDetectors	AeroDR Series	Not included.

5) Substantial Equivalence Chart

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1. The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new device is as safe and effective as the predicate device. Here is a summary of the changes we made to the device: The battery technology has changed from sealed lead acid to lithium and the digital imaging components have been removed to allow for various other previously cleared digital receptor panels to be installed by trained service technicians.
1. Summary of non-clinical testing: A system was assembled and tound to be operating properly. Firmware was essentially unchanged except a small adaptation required by lithium batteries. Because the system has an Ethernet interface, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. The internal computer is available for the installation of user supplied imaging software.

The SM-IV Battery Mobile X-Ray Unit has been tested to be in compliance with the following International Standards:

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION FDA #19-49 IEC 60601-1-2:2020 + A1:2020 (Edition 4.1) FDA #19-36 IEC TR 60601-4-2 (Edition 1.0 2016-05) FDA #19-19 IEC 60601-1-3:2008+A1:2013 + A2: 2021(Edition 2.1) FDA 12-336 IEC 60601-2-54:2009+A1:2015 + A2:2018 (Edition 1.2) FDA 12-317 IEC 60601-2-28:2017 (Edition 3.0) FDA 12-309 IEC 60601-1-6:2010 + A1:2013 + A2: 2020 (Edition 3.2) FDA 5-132 IEC 62304:2006 + A1:2015 (Edition 1.1) FDA 13-79

1. Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
1. Conclusion: After analyzing bench and non-clinical tests, it is the conclusion of Sedecal SA. that the SM-IV Diagnostic Mobile X-Ray System is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.