(53 days)
These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
The Amrad Systems are permanently-installed diagnostic x-ray systems for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. They are intended to produce diagnostic x-ray images of human anatomy. The Amrad Systems enable radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography. The Amrad Systems typically include a tube support, x-ray generator, x-ray tube, radiographic wall stand, and collimator. An FDA cleared digital imaging system is included.
The provided text describes a 510(k) premarket notification for Amrad Medical Digital Radiography Systems, asserting their substantial equivalence to a legally marketed predicate device. This submission does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would.
Instead, the submission focuses on demonstrating that the new devices are functionally equivalent and technologically similar to a previously cleared predicate device, and that their individual components (like the digital panels) have already received FDA clearance. Therefore, the following information, typically found in AI/ML performance studies, is largely not applicable or not provided in this document.
However, I can extract the acceptance criteria (or rather, the basis for substantial equivalence) and what performance was reported in relation to the submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Basis for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use: Same as predicate device. | Identical: "These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use." |
| Technological Characteristics: Functionally identical and technologically similar in design and composition. | Similar Functionality: - Tube crane/stand: Similar Functionality (Predicate has overhead, new devices have U-Arm, Floor Stand, or Wall/Floor Stand). - Wall stand: Same (manual or motorized). - Table: Same or Similar Functionality. - X-ray tube: Similar Functionality (150 kVp 0.6/1.2mm focal spots). - Collimator: Similar Functionality (Ralco R221 or R225 vs. Collimare). - X-ray Generator: Identical Functionality (40, 50, 65, or 80 kW models). - Wireless detector: Greater convenience (new device includes Cleared Wi-Fi, predicate does not explicitly mention). - Fixed detector: Similar Functionality (new device uses THALES/CMT K162224 ArtPix Mobile EZ2GO using Pixium Portable 3543 EZ and 2430 EZ Wireless Detectors; predicate uses Varian PaxScan 4343R and 4336R panels cleared in K093066 and K130318). - Conventional film/screen systems or CR cassettes: Similar Functionality (both can still be used). - Operator console: Similar Functionality ("Same"). - Power Source: Same (AC LINE). |
| Safety: Device must adhere to recognized safety standards (EMC, mechanical, electrical). | Mitigated Risks: EMC, mechanical safety, and electrical safety were evaluated according to various FDA-recognized consensus standards. Identified risks were mitigated. All components bear UL or ETL certification labels. |
| Imaging Performance: Imaging components previously cleared by FDA. | Phantoms Used: "We did collect and evaluate digital images using standardized phantoms." Clinical study not required because imaging components already received FDA clearance. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This submission doesn't describe a performance study with a test set in the context of AI/ML evaluation. It uses phantoms for image evaluation.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment for a diagnostic study is not described.
4. Adjudication method for the test set:
- 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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a general radiography system, not an AI-powered diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a radiographic system, not an algorithm. The software and digital panels are part of the system and were previously cleared by FDA.
7. The type of ground truth used:
- Not explicitly defined in the context of a diagnostic dataset. The "ground truth" for the submission's purpose is related to compliance with safety standards and the performance of previously cleared imaging components, evaluated via:
- Comparison to a predicate device's established performance.
- Evaluation of digital images using standardized phantoms.
8. The sample size for the training set:
- Not applicable. This document does not describe the development or training of an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 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 acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.
February 9, 2018
Summit Industries LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. Naples, Florida 34114
Re: K173823
Trade/Device Name: Amrad Medical AAU Digital Radiography System: Amrad Medical AAU Plus Digital Radiography System: Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MQB Dated: December 13, 2017 Received: December 18, 2017
Dear Daniel 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. 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 and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173823
Device Name
System #1: Amrad Medical AAU Digital Radiography System; System #2: Amrad Medical AAU Plus Digital Radiography System System #3: Amrad Medical DFMT Digital Radiography System: #4: Amrad Medical FMT Digital Radiography System
Indications for Use (Describe)
These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
| 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: Amrad Medical Digital Radiography Systems K173823
| Company: | Summit Industries, LLC7555 North Caldwell Avenue,Niles, Illinois 60714 USAPhone 773-353-4024 Fax 773-588-3424Establishment Registration Number: 145050 |
|---|---|
| Date Prepared: | November 13, 2017 |
| Contact Person: | Tom Boon, President |
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
1. Device Name and Classification
| Trade Names: | System #1: Amrad Medical AAU Digital Radiography SystemSystem #2: Amrad Medical AAU Plus Digital Radiography SystemSystem #3: Amrad Medical DFMT Digital Radiography SystemSystem #4: Amrad Medical FMT Digital Radiography System |
|---|---|
| Regulation Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
2. Legally Marketed Predicate Device
| Trade Names: | System #1: Amrad Medical OTS Digital Radiography SystemSystem #2: Amrad Medical DFMTS Digital Radiography SystemSystem #3: Amrad Medical FRS Digital Radiography System |
|---|---|
| 510(k) #: | K153119 |
| Regulation Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
- Reference Device (Imaging System) The Amrad Systems employ software and digital panels cleared by FDA: THALES/ CMT Medical Technologies Ltd. ArtPix Mobile EZ2GO using Pixium Portable 3543 EZ and 2430 EZ Wireless Detectors
| 510(k) #: | K162224 |
|---|---|
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| Subsequent Product Code: | MQB - solid-state X-Ray imager (flat panel / digital imager) |
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-
Indications for Use: These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.
-
Device Description: The Amrad Systems are permanently-installed diagnostic x-ray systems for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. They are intended to produce diagnostic x-ray images of human anatomy. The Amrad Systems enable radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography. The Amrad Systems typically include a tube support, x-ray generator, x-ray tube, radiographic wall stand, and collimator. An FDA cleared digital imaging system is included. Below are the specific components in various configurations to form a radiographic system used for general purpose radiographic imaging (see Table 1).
| ComponentCategory | Component Description | ComponentModel. | Mfr./Location | AmradMedicalAAUSystem | AmradMedicalAAUPlusSystem | AmradMedicalDFMTSystem | AmradMedicalFMTSystem |
|---|---|---|---|---|---|---|---|
| Tubestand | Floor Rail mounted TubeSupport | J700 / J700D | Summit USA | X | X | ||
| Wallstand | Tilting, Rotational VerticalWallstand (Floor to wallmounted) with Receptorfor Bucky or grid cabinetincludes cassette tray, X-ray Grid & may include 1optional AEC radiationdetector | "Millennium"TWBS-TILT | SedecalSpain | X | X | ||
| Wallstand with Bucky orgrid cabinet, includescassette tray, X-ray grid &may include 1 optionalAEC radiation detector(for floor to wallmounting) | J1000 | Summit USA | X | X | |||
| CombinationTubestand/Cassette Holder("C-Arm") | Floor Mounted to wallmounted U-Arm withmotorized vertical,rotational and SIDmovement with receptor forBucky or grid cabinet,includes cassette tray,removable X-ray grid & mayinclude 1 optional AECradiation detector | X Plus LP PLUS | Sedecal Spain | X | X |
| Table 1. Components used Note: X = Included | |
|---|---|
| ----------------------------------------------- | -- |
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| ComponentCategory | Component Description | ComponentModel. | Mfr ,/Location | AmradMedicalAAUSystem | AmradMedicalAAUPlusSystem | AmradMedicalDFMTSystem | AmradMedicalFMTSystem |
|---|---|---|---|---|---|---|---|
| RadiographicTable | Elevating 4-way FloatTop Table And Non-elevating 4 way FloatTop TableIncludes ReciprocatingBucky or Grid Cabinet,cassette tray, X-Ray Grid& may include optionalAEC radiation detector | S222 - ElevatingS223 - Non-elevating | Summit USA | X | X | ||
| RadiographicTable | Mobile Table | ST-1000 | SYFM Korea | X | X | ||
| X-ray Generator, 80kW, HF,150kV, (AEC optional) | SHFR 800 | Sedecal, Spain | |||||
| X-rayGenerator | X-ray Generator, 65kW, HF,150kV, (AEC optional) | SHFR 600 | Sedecal, Spain | Selectone | Selectone | Selectone | Selectone |
| X-ray Generator, 50kW, HF,150kV, (AEC optional) | SHFR 500 | Sedecal, Spain | |||||
| X-ray Generator, 40kW, HF,150kV, (AEC optional) | SHFR 400 | Sedecal, Spain | |||||
| X-ray BeamLimitingDevice | Manual Collimator withLED light source, laseralignment lights & tapemeasure | R 221 orR225 | Ralco Italy | X | X | X | X |
| DigitalImagingSystem | Complete Digital ImagingSystem includingTablet PC (w/Window OS, monitor,keyboard & mouse), THALES/CMT Medical TechnologiesLtd. K162224ArtPix Mobile EZ2GOusing Pixium Portable3543 EZ and 2430 EZWireless Detectors | Pixium Portable 3543 EZand 2430 EZ WirelessDetectors | Thales/CMTMedical,France/Israel | X | X | X | X |
| X-ray Tube | Toshiba X-ray Tubes,various models | E7242x.E7252X.E7254x.E7255X.E7869X. | ToshibaElectronTubes &Devices Co.Ltd. | Selectone | Selectone | Selectone | Selectone |
- Substantial Equivalence: The Amrad Medical Systems (4 models) are substantially equivalent to the commercially available Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119 radiographic xray system with identical indications for use. The similarities and differences are shown in Table 2, below.
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| ComparableProperties | SubjectAmrad Medical OTS, DFMTS, or FRS DigitalRadiography Systems K153119 | Amrad Medical AAU, AAU Plus,DFMT, or FMT Digital RadiographySystems K173823 | ComparisonResults |
|---|---|---|---|
| Indications foruse | These radiographic systems are intended foruse by a qualified/trained physician ortechnician on both adult and pediatric subjectsfor taking diagnostic x-rays. Not formammography, angiography, interventional, orfluoroscopy use. | These radiographic systems areintended for use by a qualified/trainedphysician or technician on both adultand pediatric subjects for takingdiagnostic x-rays. Not formammography, angiography,interventional, or fluoroscopy use. | Identical |
| Tubecrane/Tubestand | Overhead tube crane: OTS | No Overhead tube crane. Only U-Arm, Floor Stand, or Wall/FloorStand available | SimilarFunctionality |
| Wall stand | Manual or Motorized | Manual or Motorized | SAME |
| Table | Elevating 4-way Float Top Table includesreciprocating bucky, cassette tray, X-raygrid & may include optional AECmeasuring detector (for use with OTS &DFMTS Tubestands only) or: Mobile Table(for use with FRS System only) | Elevating 4-way Float Top Tableincludes reciprocating bucky,cassette tray, X-ray grid & mayinclude optional AEC measuringdetector (for use with DFMT & FMTTubestands only) or: Mobile Table(for use with AAU and AAU Plus) | Same orSimilarFunctionality |
| X-ray tube | 150 kVp 0.6/1.2mm focal spots | 150 kVp 0.6/1.2mm focal spots | SimilarFunctionality |
| Collimator | Collimare | Ralco R221 or R225 | SimilarFunctionality |
| X-rayGenerator | CPI Models: 40, 50, 65, or 80 kW | Sedecal Models: 40, 50, 65, or 80kW | IdenticalFunctionality |
| Wirelessdetector | Not applicable | Yes, Cleared Wi-Fi | Greaterconvenience |
| Fixed detector | Uses FDA cleared detectors and software:VARIANPaxScan 4343R and 4336R panels andsoftware cleared in K093066 as well as inK130318. | Uses FDA cleared detectors andsoftware: THALES/ CMT MedicalTechnologies Ltd. K162224ArtPix Mobile EZ2GO using PixiumPortable 3543 EZ and 2430 EZWireless Detectors | SimilarFunctionality |
| Conventionalfilm/screensystems or CRcassettes | Comes with FDA cleared digital x-raypanels. Conventional film and CRcassettes can still be used. | Comes with FDA cleared digital x-ray panels. Conventional film andCR cassettes can still be used. | SimilarFunctionality |
| Operatorconsole | Provided | Same | SimilarFunctionality |
| ComparableProperties | Amrad Medical OTS, DFMTS, or FRS DigitalRadiography Systems K153119 | Amrad Medical AAU, AAU Plus,DFMT, or FMT Digital RadiographySystems K173823 | ComparisonResults |
| Photos | Image: Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119 | Image: Amrad Medical AAU, AAU Plus, DFMT, or FMT Digital Radiography Systems K173823 | SimilarFunctionalityCustomerpreference isthe onlydifference. |
| Power Source | AC LINE | SAME | Same. |
Table 2: Subject and Predicate Device Comparable Properties
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-
Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device: As can be seen from the table above, the devices are functionally identical in that they can perform the same kinds of x-ray imaging, but they are different in the mechanical aspects. For example the tube head/collimator combination is celling mounted in the predicate whereas the same components are floor mounted in the modified system. In the predicate system, Varian digital panels are employed whereas in the modified system Thales/CMT digital panels are employed. The panels were all previously cleared by FDA in both systems. In all important respects the Amrad Systems are functionally identical and technologically similar in design and composition to the Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119.
-
Performance Testing. EMC, mechanical safety, and electrical safety were evaluated according to various FDA-recognized consensus standards. In conclusion, the identified risk of EMC, mechanical, and electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. Clinical testing is not required for a determination of substantial equivalence because the imaging components supplied have already received FDA clearance. Furthermore, the intended operators of the Amrad Medical AAU, AAU Plus, DFMT, or FMT Digital Radiography Systems are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Summit Industries LLC adheres to recognized and established industry practice, and all equipment is subject to final performance testing. All components bear the UL or ETL certification labels.
-
Clinical Evaluation: Since the digital x-ray panels and software had previously received FDA clearance, a clinical study as required by the FDA guidance document was not required. We did collect and evaluate digital images using standardized phantoms.
10. Conclusion as to Substantial Equivalence
The Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems are intended for the same use as the Amrad predicate. It uses components similar to those cleared for the Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119 (e.g. tube stand, wall stand, table, x-ray tube, collimator, x-ray generator, operator console). Summit Industries LC's opinion that the proposed systems are substantially equivalent to the cleared predicate device, the Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119.
§ 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.