(55 days)
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.
This is a capacitor assisted 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 a battery to supply the internal PC up to 3 hours without mains connection. This system has been made lighter and more maneuverable, such that battery assisted motorized movement is no longer necessary. The removal of the movement motorization and the required rechargeable batteries resulted in a much lighter system. The generator is also smaller resulting in further weight reduction. The indication for use remains the same as the predicate. The system uses a different xray generator than the one used by the predicate but both are monoblock x-ray generators (same type of generator). The collimator has been changed from the Ralco R108F to the Varex Optica 10. They are functionally identical, having just two manual controls. Although the available generator options have lower peak outputs, the full range of examinations can still be made.
The provided text describes a 510(k) submission for a mobile x-ray system (SM-V) and its substantial equivalence to a predicate device (PHOENIX). It does not include information about clinical studies with acceptance criteria for device performance in the context of diagnostic accuracy, sensitivity, specificity, or reader studies typical for AI/CAD devices.
The "study" referenced in the document is a comparison of the characteristics of the new device (SM-V) against a predicate device (PHOENIX) and compliance with international standards, along with non-clinical testing. This comparison is to establish "substantial equivalence," not to prove diagnostic performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested sections about clinical study details, such as sample sizes, ground truth establishment, expert adjudication, and MRMC studies, are not applicable or cannot be extracted from this document, as clinical testing was explicitly not required.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:
1. Table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are related to the technical specifications and adherence to international standards, comparing the new device (SM-V) against a predicate device (PHOENIX). There are no "performance" metrics in terms of diagnostic accuracy (e.g., sensitivity, specificity) for a clinical study in this document.
| Acceptance Criteria (Implied) | Reported Device Performance (SM-V) |
|---|---|
| Indications for Use: Same as predicate. | "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." (Same as Predicate) |
| Configuration: Similar to predicate. | Mobile System. "SAME but no image acquisition software is supplied." |
| X-ray Generator(s): Capable of full range of examinations. | 16, 20, 32 kW Monoblock generator. kV range: from 40 kV to 150 kV. mAs range: from 0.32 mAs to 200 mAs. "Although the peak power is lower, the full range of examinations from hand to chest can be effectively imaged." |
| Collimator: Functionally identical to predicate. | Varex Optica 10. "Controls are the same." (Predicate used Ralco R108F) |
| Touch screen control: Same as predicate. | Yes, 19". (SAME) |
| Motorized movement: Not included (a difference). | Not included. (Predicate included it) |
| Meets US Performance Standard: Compliance with 21 CFR 1020.30. | YES 21 CFR 1020.30. (SAME) |
| Power Source: Same as predicate. | Universal power supply, from 100 V~ to 240 V~. 1 phase. (SAME) |
| Imaging Software: Not included (a difference). | Not included. (Predicate included Konica-Minolta control software) |
| Panel Interface: Not applicable (a difference). | Not applicable. (Predicate had Ethernet or Wi-Fi wireless) |
| Size & Weight: Improved/reduced. | Size: 123 x 59 x 191 cm (including column) / 123 x 59 x 126 cm. "Smaller, more compact." (Predicate: 122 x 54 x 223 cm). Weights: 275kg. "Much lighter. Weight reduction due to elimination of motion motors and their heavy rechargeable batteries as well as using a smaller generator." (Predicate: 520 kg). |
| Digital Detectors: Not included (a difference). | Not included. (Predicate had AeroDR Series) |
| Compliance with International Standards: | IEC 60601-1:2005+A1:2012 (Edition 3.1), IEC 60601-1-2:2020 + A1:2020 (Edition 4.1), IEC 60601-1-3:2008+A1:2013 (Edition 2.1), IEC 60601-2-54:2009+A1:2015 + A2:2018 (Edition 1.2), IEC 60601-2-28:2017 (Edition 3.0), IEC 60601-1-6:2010 + A1:2013 (Edition 3.1), IEC 62304:2006 + A1:2015 (Edition 1.1). |
| Cybersecurity: Observed recommendations. | "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." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The document explicitly states, "Clinical testing was not required to establish substantial equivalence." The testing performed was non-clinical (bench testing and compliance with standards).
- Data Provenance: Not applicable, as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable.
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
- MRMC study: No, an MRMC study was not done. The device (SM-V) is a mobile diagnostic x-ray system, not an AI/CAD diagnostic aid. It explicitly states, "There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No, this is not an algorithm, but a hardware x-ray system. The document states, "There is no imaging hardware or software supplied with the unit."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable, as no clinical study with a diagnostic ground truth was conducted. The "truth" in this context is adherence to technical specifications and safety standards.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes an x-ray hardware system, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
In summary: The provided 510(k) submission focuses on demonstrating substantial equivalence for a mobile x-ray hardware system by comparing its technical specifications and compliance with standards to a predicate device. It explicitly states that no clinical testing was required to establish this equivalence. Therefore, inquiries related to diagnostic performance studies, AI algorithms, human reader improvement, and associated methodologies for clinical data are not addressed in this document.
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November 21, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
SEDECAL SA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K222951
Trade/Device Name: SM-V Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: September 20, 2022 Received: September 27, 2022
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
2022.11.21
Lu Jiang 14:55:12 -05'00'
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
510(k) Number (if known) K222951
Device Name SM-V.
Indications for Use (Describe)
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.
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 K222951
Image /page/3/Picture/1 description: The image is a logo for SEDECAL. The logo is a teal rounded rectangle with a white border. Inside the rectangle is a white icon of a desk with a lamp on top, followed by the word "SEDECAL" in white, sans-serif font.
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: October 12, 2022 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager
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- Identification of the Device: Trade/Device Name: SM-V 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
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- 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
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- 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.
-
- Description of the Device: This is a capacitor assisted 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 a battery to supply the internal PC up to 3 hours without mains connection. This system has been made lighter and more maneuverable, such that battery assisted motorized movement is no longer necessary. The removal of the movement motorization and the required rechargeable batteries resulted in a much lighter system. The generator is also smaller resulting in further weight reduction. The indication for use remains the same as the predicate. The system uses a different xray generator than the one used by the predicate but both are monoblock x-ray generators (same type of generator). The collimator has been changed from the Ralco R108F to the Varex Optica 10. They are functionally identical, having just two manual controls. Although the available generator
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options have lower peak outputs, the full range of examinations can still be made. The main features of this equipment are:
- a) A solid and ergonomic design. Easy operation, security 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 (+90°, --30°). 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.
- Two Point control by selecting kVp and mAs. t)
- g) X-ray Handswitch for X-ray exposures and Collimator Light.
- h) Infrared Remote X-ray Handswitch (optional) for X-ray exposures and Collimator Light.
- i) Dosimetry (optional):
- i) DAP reading with an Ion Chamber.
- ii) Calculated DAP (eDAP).
- j) Manual Collimation.
- k) 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 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.
| Characteristic | Predicate: K212291 PHOENIX | SM-V |
|---|---|---|
| Indications forUse: | 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 thepatient sitting, standing, or lying in the proneor supine position. 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 issupplied. |
| X-rayGenerator(s) | 20, 32, 40 kW and 50 kW MonoblockgeneratorkV range: from 40 kV to 150 kVmAs range: from 0.1 mAs to 500 mAs | 16, 20, 32 kW Monoblock generatorkV range: from 40 kV to 150 kVmAs range: from 0.32 mAs to 200 mAsAlthough the peak power is lower, the fullrange of examinations from hand to chest canbe effectively imaged. |
| Collimator | Ralco R108F | Varex Optica 10. Controls are the same. |
| Characteristic | Predicate: K212291 PHOENIX | SM-V |
| Photos | Image: K212291 PHOENIX | Image: SM-V |
| Touch screencontrol | Yes, 19" | SAME |
| Motorizedmovement | Included | Not included |
| Meets USPerformanceStandard | YES 21 CFR 1020.30 | SAME |
| Power Source | Universal power supply, from 100 V~ to 240V~. 1 phase | SAME |
| ImagingSoftware | Konica-Minolta control software CS-7(K151465 or K172793) OR Konica-Minoltacontrol software Ultra. | Not included |
| Panel Interface | Ethernet or Wi-Fi wireless | Not applicable |
| Size | 122 x 54 x 223 cm | 123 x 59 x 191 cm (including column) /123 x 59 x 126 cm. Smaller, more compact. |
| Weight | 520 kg | 275kg Much lighter. Weight reduction due toelimination of motion motors and their heavyrechargeable batteries as well as using asmaller generator. |
| DigitalDetectors | AeroDR Series | Not included. |
5) Substantial Equivalence Chart
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- The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. 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: We removed the imaging system hardware and software, and we removed the motorized motion system, including motors and rechargeable batteries.
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-
- Summary of non-clinical testing: A system was assembled and found to be operating properly. Firmware was essentially unchanged except for new technique stations. 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-V Battery Mobile X-Ray Unit has been tested to be in compliance with the following International Standards:
- Summary of non-clinical testing: A system was assembled and found to be operating properly. Firmware was essentially unchanged except for new technique stations. 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.
IEC 60601-1:2005+A1:2012 (Edition 3.1) IEC 60601-1-2:2020 + A1:2020 (Edition 4.1) IEC 60601-1-3:2008+A1:2013 (Edition 2.1) IEC 60601-2-54:2009+A1:2015 + A2:2018 (Edition 1.2) IEC 60601-2-28:2017 (Edition 3.0) IEC 60601-1-6:2010 + A1:2013 (Edition 3.1) IEC 62304:2006 + A1:2015 (Edition 1.1)
-
- Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
-
- Conclusion: After analyzing bench and non-clinical tests, it is the conclusion of Sedecal SA. that the SM-V 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.
§ 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.