(102 days)
No
The summary describes a conventional X-ray system with standard components and image processing capabilities, but there is no mention of AI or ML.
No
The device is described as an X-ray equipment used for taking diagnostic radiographic exposures, which falls under diagnostic imaging rather than therapy.
Yes
The device is explicitly stated as being intended "for taking diagnostic radiographic exposures."
No
The device description explicitly states it is "multifunctional fixed X-ray equipment consisting of Examination Table, Bucky Stand, Tube/Bucky Stand, X-ray Source Assembly (Tube/Collimator), High Voltage Generator plus Operating Panel, Conventional Image Receivers and, in specific version, Image System with Flat panel detector and Workstation". This clearly indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a radiographic X-ray equipment. Its purpose is to generate X-rays that pass through the patient's body to create images for diagnostic purposes. This is an in vivo (within the living body) diagnostic method, not an in vitro one.
- Intended Use: The intended use describes taking "diagnostic radiographic exposures" of various body parts. This aligns with the function of an X-ray machine, not an IVD.
- Device Components: The components listed (Examination Table, Bucky Stand, Tube/Bucky Stand, X-ray Source Assembly, High Voltage Generator, Image Receivers, Flat panel detector, Workstation) are all typical parts of an X-ray system.
Therefore, this device falls under the category of medical imaging equipment, specifically X-ray equipment, and is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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, 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.
Product codes
KPR, MQB
Device Description
Model difference: Apolo D includes a cleared digital x-ray receptor panel with one of two cleared software packages. Apolo S does not come with the digital x-ray receptor panel or software. This is a multifunctional fixed X-ray equipment consisting of Examination Table, Bucky Stand, Tube/Bucky Stand, X-ray Source Assembly (Tube/Collimator), High Voltage Generator plus Operating Panel, Conventional Image Receivers and, in specific version, Image System with Flat panel detector and Workstation for image acquisition, processing and visualization. The equipment was developed to perform radiographic examinations of patients in reclining, standing or sitting positions. Six possible tube head configurations are available: FLOOR TO CELLING TUBE STAND, FLOOR MOUNTED TUBE STAND, ROTARY U-ARM mount with integrated film/digital cassette mount, MANUAL CEILING-MOUNTED TELESCOPIC TUBE STAND, MOTORIZED CEILING-MOUNTED TELESCOPIC TUBE STAND, ROTARY STRAIGHT ARM mount with integrated film/digital cassette mount. The Apolo provides a complete x-ray system with generator, tube head, and collimator. The generator is made by us, VMI, whereas the tube head, collimator, and digital x-ray receptor panels/software are made by other manufacturers. Tube heads are typically Toshiba and collimators are typically Ralco. The Apolo D comes with digital x-ray receptor panels (see the comparison table below) while the Apolo S comes without digital x-ray receptor panels. This system employs without modification software Econsole cleared in K152172. This software has a Moderate level of concern. The reference detectors made by DRTECH can be used with anti-scatter grids.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, extremities, and other body parts; chest, abdomen
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Firmware was validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, 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. In addition, we reviewed the FDA guidance Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff and added a supplement to our user manual. We also reviewed and implemented the recommendations of other FDA source material at the Image Gently website (http://www.imagegently.org/) and the resources in FDA's Pediatric X-ray Imaging webpage (http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/Medicallmaging/ucm298899.html). The digital panel software employed was already reviewed by FDA in the reference submissions list, above. The labeling was reviewed in light of the FDA guidance document: Radio Frequency Wireless Technology in Medical Devices. Some of the available collimator models offer Class 2 line generator lasers as an optional aid to bucky alignment. All of the lasers meet the US Performance Standard for lasers, and corresponding product reports have been filed. Labeling is in accordance with the US Performance Standard. The predicate device has this laser option as well. This device complies with all applicable requirements of 21 CFR 1020.30, and 1020.31. The Apolo D / Apolo S Stationary X-Ray Units have been tested by 3rd party Nationally Recognized Testing Laboratories to be in compliance with the following International Standards: IEC 60601-1:2005 + AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; (19-4), IEC 60601-1-2:2010 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests (19-8: 2014), IEC 60601-1-3:2011 Medical Electrical Equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment; (12-269: 2013), IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability; (5-89), IEC 60601-1-9:2014 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirementally conscious design (NR), IEC 60601-2-28:2012 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (12-204), IEC 60601-2-54:2011 +2016 AM Medical electrical equipment - Part 2- 54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy; (12-296).
Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sedecal, K133782
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
December 1, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
VMI Tecnologias LTDA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K202388
Trade/Device Name: Apolo D / Apolo S Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MOB Dated: October 25, 2020 Received: October 28, 2020
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
1
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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202388
Device Name Apolo D / Apolo S
Indications for Use (Describe)
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, 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)
| \u2612 Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| \u2610 Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: 510(k) Number K202388 VMI Tecnologias LTDA Rua Prefeito Elizeu Alves Da Silva, 400 -Dist. Ind. Genesco Aparecido De Oliveira, Lagoa Santa, Minas Gerais, Brazil Date Prepared: November 13, 2020 Contact: Otavio Viegas Tel: (31) 3370-3750
-
- Identification of the Device: Trade/Device Name: Apolo D / Apolo S Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Codes: KPR, MQB. Common/Usual Name: Digital Stationary Diagnostic X-Ray System
-
- Equivalent legally marketed device: Sedecal, K133782 Trade/Device Name: NOVA FA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Codes: KPR, MQB. Common/Usual Name: Digital Stationary Diagnostic X-Ray System
-
- Indications for 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.
-
- Description of the Device: Model difference: Apolo D includes a cleared digital x-ray receptor panel with one of two cleared software packages. Apolo S does not come with the digital x-ray receptor panel or software. This is a multifunctional fixed X-ray equipment consisting of Examination Table, Bucky Stand, Tube/Bucky Stand, X-ray Source Assembly (Tube/Collimator), High Voltage Generator plus Operating Panel, Conventional Image Receivers and, in specific version, Image System with Flat panel detector and Workstation for image acquisition, processing and visualization. The equipment was developed to perform radiographic examinations of patients in reclining, standing or sitting positions. Six possible tube head configurations are available: FLOOR TO CELLING TUBE STAND, FLOOR MOUNTED TUBE STAND, ROTARY U-ARM mount with integrated film/digital cassette mount, MANUAL
4
CEILING-MOUNTED TELESCOPIC TUBE STAND, MOTORIZED CEILING-MOUNTED TELESCOPIC TUBE STAND, ROTARY STRAIGHT ARM mount with integrated film/digital cassette mount. The Apolo provides a complete x-ray system with generator, tube head, and collimator. The generator is made by us, VMI, whereas the tube head, collimator, and digital x-ray receptor panels/software are made by other manufacturers. Tube heads are typically Toshiba and collimators are typically Ralco. The Apolo D comes with digital x-ray receptor panels (see the comparison table below) while the Apolo S comes without digital x-ray receptor panels. This system employs without modification software Econsole cleared in K152172. This software has a Moderate level of concern. The reference detectors made by DRTECH can be used with anti-scatter grids.
| Characteristic | Predicate: Sedecal NOVA FA, K133782 | Apolo D / Apolo S |
|---|---|---|
| Indications | ||
| for 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 | SAME | |
| Configuration | Stationary System with digital x-ray panel and | |
| image acquisition computer | SAME | |
| Photo (Ceiling | ||
| Mount) | Image: Ceiling Mount | Image: Ceiling Mount |
| Functionally the same. | ||
| Wall mount straight arm and a "U" mount | ||
| tube head configurations are also available. | ||
| X-ray | ||
| Generator(s) | Output power: 50 kW, 65 kW, 80 kW. | |
| kV Range: from 40 kV to 150 kV, in 1 kV steps. | Output Power 50 or 64 kW | |
| kV Range: 40 to 150 kV-increments: 1 kv | ||
| mA Range: | ||
| mA Range: from 10 mA to 1000 mA (Depends | ||
| on the generator and X-ray tube model) | Small Focus 20 / 50 / 100 / 160 / 220 mA | |
| Large Focus 280 / 400 / 500 / 630 / 800 mA | ||
| Characteristic | Predicate: Sedecal NOVA FA, K133782 | Apolo D / Apolo S |
| Collimator | Ralco R225 ACS (Automatic Collimator) | |
| Ralco R225 (Manual Collimator) | Choice of Models | |
| Leadmec Collimator – LDM206 | ||
| Ralco Collimator - R104 | ||
| Ralco Collimator - R104/A | ||
| Ralco Collimator - R108 | ||
| All collimators meet the US Performance | ||
| Standard | ||
| Digital X-ray | ||
| Panel | ||
| Supplied | CXDI CANON Detector 401C/401G Compact | |
| (K103591). | ||
| CXDI CANON Detector 55C (K091436) | ||
| CXDI CANON Detector 501 C (K111682) | DRTECH EVS 4343: K162555 | |
| DRTECH EVS 3643: K151942 | ||
| Detector | ||
| Performance | For the CANON 501C: (Most recent model) | |
| DQE 60% at 0 lp/mm | ||
| MTF 35 % at 2 cy/mm | EVS 4343: | |
| DQE 52 % at 1.0 lp/mm | ||
| MTF 36.6 % at 2.0 lp/mm | ||
| EVS 3643: | ||
| DQE 50 % at 1.0 lp/mm | ||
| MTF 35 % at 2.0 lp/mm | ||
| (Comparable results because the CANON MTF was taken | ||
| at 0 lp/mm) | ||
| Detector | ||
| Resolutions | 3,320 x 3,408 | |
| 2,208 x 2,688 | ||
| 2,800 x 3,408 | 3,072 x 3072 (EVS 4343) | |
| 2,560 x 3072 (EVS 3643) | ||
| Comparable resolutions | ||
| Pixel size | 125 μ | |
| 160 μ | ||
| 125 μ | All 140 μ | |
| Software | Canon control software CXDI-NE | ECONSOLE Software for DRTECH Detectors. |
| K152172 | ||
| Panel | ||
| Interface | Ethernet or Wi-Fi wireless | SAME |
| DAP | Typically not provided | Always provided with digital and CR equipped |
| systems (VacuDAP) | ||
| Meets US | ||
| Performance | ||
| Standard | 21 CFR 1020.30 Diagnostic x-ray systems and | |
| their major components. | ||
| 21 CFR 1020.31 Radiographic equipment. | SAME | |
| Power Source | AC Line Only | SAME |
6) Substantial Equivalence Chart
5
7) 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 devices are as safe and effective as the predicate device. Proper system operation is fully verified upon installation. We verified that this new combination of components worked properly and produced diagnostic quality images. Regarding the power level of the generator compared to the predicate: Our maximum power level is 20% lower than the maximum predicate model, however the power offered is more than sufficient to perform chest and other demanding imaging. The proposed device can perform the same range of exams that the predicate can perform. The OEM manufacturer
6
of the predicate device offers 50 kW, 65 kW, 80 kW versions of the same device. This system employs without modification software ECONSOLE cleared in K152172. This software has a Moderate level of concern.
-
- Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Firmware was validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, 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. In addition, we reviewed the FDA guidance Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff and added a supplement to our user manual. We also reviewed and implemented the recommendations of other FDA source material at the Image Gently website (http://www.imagegently.org/) and the resources in FDA's Pediatric X-ray Imaging webpage (http://www.fda.gov/Radiation-
EmittingProducts/RadiationEmittingProductsandProcedures/Medicallmaging/ucm298899.html
- Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Firmware was validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, 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. In addition, we reviewed the FDA guidance Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff and added a supplement to our user manual. We also reviewed and implemented the recommendations of other FDA source material at the Image Gently website (http://www.imagegently.org/) and the resources in FDA's Pediatric X-ray Imaging webpage (http://www.fda.gov/Radiation-
The digital panel software employed was already reviewed by FDA in the reference submissions list, above. The labeling was reviewed in light of the FDA guidance document: Radio Frequency Wireless Technology in Medical Devices.
Some of the available collimator models offer Class 2 line generator lasers as an optional aid to bucky alignment. All of the lasers meet the US Performance Standard for lasers, and corresponding product reports have been filed. Labeling is in accordance with the US Performance Standard. The predicate device has this laser option as well.
This device complies with all applicable requirements of 21 CFR 1020.30, and 1020.31
The Apolo D / Apolo S Stationary X-Ray Units have been tested by 3rd party Nationally Recognized Testing Laboratories to be in compliance with the following International Standards:
IEC 60601-1:2005 + AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; (19-4)
IEC 60601-1-2:2010 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests (19-8: 2014)
IEC 60601-1-3:2011 Medical Electrical Equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment; (12-269: 2013)
IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability; (5-89)
IEC 60601-1-9:2014 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirementally conscious design (NR)
7
IEC 60601-2-28:2012 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (12-204)
IEC 60601-2-54:2011 +2016 AM Medical electrical equipment - Part 2- 54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy; (12-296)
-
- Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
-
- Conclusion: After analyzing bench and clinical tests, it is the conclusion of VMI Tecnologias LTDA that the new Apolo D / Apolo S Digital Diagnostic Stationary X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.