(137 days)
No
The document describes a standard radiographic system and image processing software, with no mention of AI or ML capabilities.
No
Explanation: The device is described as a diagnostic x-ray system intended to produce images for diagnosis, not for treatment.
Yes
The sections "Intended Use / Indications for Use" and "Device Description" explicitly state that the system is intended for "taking diagnostic x-rays" and to "produce diagnostic x-ray images of human anatomy." The images produced are "evaluated by a radiologist within the diagnostic process." This clearly indicates its role in diagnosis.
No
The device description explicitly lists hardware components such as a tube support, x-ray generator, x-ray tube, radiographic wall stand, and collimator, indicating it is a hardware system with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Description: The provided description clearly states that this device is a radiographic system that produces x-ray images of human anatomy. It is used to image the whole body of patients.
- Intended Use: The intended use is for taking diagnostic x-rays on patients.
- Mechanism: The device uses x-rays as the input imaging modality, which is a form of radiation used to create images of internal structures, not to analyze biological samples.
The device is a diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / 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, interventional, or fluoroscopy use.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
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 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.
Mentions image processing
Complete Digital Imaging System including PC (w/ Window OS, monitor, keyboard & mouse), Varian infiMed i5 acquisition/image processing software
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, chest, abdomen, and extremities, and may be used on pediatric 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.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained physician or technician; hospitals, clinics, and medical practices
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)
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 OTS, DFMTS, or FRS Digital Radiography Systems are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2016
Summit Industries LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K153119
Trade/Device Name: Amrad Medical OTS Digital Radiography System Amrad Medical DFMTS Digital Radiography System Amrad Medical FRS Digital Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: February 23, 2016 Received: February 26, 2016
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D.'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
2
Indications for Use
510(k) Number (if known) K153119
Device Name
System #1: Amrad Medical OTS Digital Radiography System System #2: Amrad Medical DFMTS Digital Radiography System System #3: Amrad Medical FRS 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)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary: Amrad Medical Digital Radiography Systems K153119
| Company: | Summit Industries, LLC
2901 W Lawrence Ave.
Chicago, Illinois 60625 USA
Phone 773-353-4024 Fax 773-588-3424 |
|----------------|----------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 7, 2016 |
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
1. General Information:
Establishment/Manufacturer/Location of Manufacturing Site: Summit Industries, LLC 2901 W Lawrence Ave. Chicago, Illinois 60625 USA Establishment Registration Number: 1450503
2. Contact Person: Tom Boon, President
3. Device Name and Classification
| Trade Names: | System #1: Amrad Medical OTS Digital Radiography System |
|---|---|
| System #2: Amrad Medical DFMTS Digital Radiography System | |
| System #3: Amrad Medical FRS Digital Radiography System | |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
4. Legally Marketed Predicate Device
| Trade Name: | Multix Fusion |
|---|---|
| 510(k) #: | K121513 |
| Clearance Date: | August 10, 2012 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
The Amrad Systems employ software and digital panels cleared by FDA: PaxScan 4343R and 4336R panels and software cleared in K093066 as well as in K130318.
4
-
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, 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 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).
| Component
Category | Component Description | Component Model
and Serial No. | Mfr,
Location | Amrad
Medical
OTS
System | Amrad
Medical
DFMTS
System | Amrad
Medical
FRS
System |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------|-------------------------------------|-----------------------------------|
| Tubestand | Ceiling Mounted Tube
Support (OTS), manual
motion | J309 & ANA330-0915 | Summit
Industries,
USA | X | | |
| | Floor Mounted Tube Support
(DFMTS) | J700 & BFA581-0914 | Summit
Industries,
USA | | X | |
| | Floor Rail mounted Tube Support
(FRS) | SST-3001 &
SST31405015 | SYFM, So.
Korea | | | X |
| Radiographic
Table | Elevating 4-way Float Top
Table includes reciprocating
bucky, cassette tray, X-ray
grid & may include optional
AEC measuring detector
(for use with OTS & DFMTS
Tubestands only) | S222 & 41108 | Summit
Industries, USA | X | X | |
| | Mobile Table
(for use with FRS System only) | ST-1000 &
ST11501005 | SYFM, So.
Korea | | | X |
| Wallstand | Wallstand with
Reciprocating Bucky,
includes cassette tray, X-
ray Grid & may include 1
optional AEC radiation
detector (for floor to wall
mounting) | J1000 (with B066
FDA certified front panel)
& 140806 | Summit
Industries, USA | X | X | |
| | Tilting, Motorized Vertical
Wallstand (Floor mounted)
with Image Receptor for
Stationary Grid, includes
cassette tray (only if portable
DR panel is used), X-ray Grid
& may include 1 AEC
radiation detector | SST-3001 &
SST31405015 | SYFM, So.
Korea
& FDA
Certified by
Summit
Industries,
USA | | | X |
| X-ray
Generator | X-ray Generator, 80kW, HF,
150kV, (AEC optional) | CMP200DR | CPI, Canada | | | |
| | X-ray Generator, 65kW, HF,
150kV, (AEC optional) | CMP200DR | CPI, Canada | Select
one | Select
one | Select
one |
| | X-ray Generator, 50kW, HF,
150kV, (AEC optional) | CMP200DR &
PD22626H 15 | CPI, Canada | | | |
| | X-ray Generator, 40kW, HF,
150kV, (AEC optional) | CMP200DR | CPI, Canada | | | |
| Component
Category | Component Description | Component Model
and Serial No. | Mfr,
Location | Amrad
Medical
OTS
System | Amrad
Medical
DFMTS
System | Amrad
Medical
FRS
System |
| | X-ray Generator, 40kW, HF,
125kV, (AEC optional) | CMP200DR | CPI, Canada | | | |
| X-ray Beam
Limiting
Device | Manual Collimator with LED
light source, laser alignment
lights & tape measure | CM-150-24-C-
150kVp-01-LED &
A03376 &
A04056 | Collimare,
USA | X | X | X |
| Digital
Imaging
System | Complete Digital Imaging System
including PC (w/
Window OS, monitor, keyboard
& mouse), Varian infiMed i5
acquisition/image processing
software
& either 1 or 2 of the following
PaxScan Flat Panel Detectors:
4343R (fixed), 4336R (portable,
tethered) | Varian InfiMed i5
Digital Imaging
System & i5DR-0714-0044 &
U3-T2295244NS01
Uses FDA cleared detectors
and software:
PaxScan 4343R and 4336R
panels and software cleared
in K093066 as well as in
K130318. | Varian
Medical
Systems,
USA | X | X | X |
| X-ray Tube | X-ray Tube, 300kHU, 0.6/1.2mm
FS, 150kVp | RAD-14 &
35727-T5 | Varian
Medical
Systems,
USA | Select
one | Select
one | Select
one |
Table 1. Components used
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- Substantial Equivalence: The Amrad Medical Systems (3 models) are substantially equivalent to the commercially available Siemens Multix Fusion (K121513) radiographic x-ray system with similar indications for use. The Multix Fusion was described in premarket notification K121513 which received FDA Clearance on August 10, 2012
| Classification Name: | Stationary X-Ray System |
|---|---|
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | 90 KPR |
Table 2: Subject and Predicate Device Comparable Properties
| Comparable | Predicate Device: Siemens Multix | Amrad Medical OTS, DFMTS, or FRS | Comparison |
|---|---|---|---|
| Properties | Fusion K12113 | Digital Radiography Systems | Results |
| Indications for | |||
| use | The Multix Fusion is a radiographic system | ||
| used in hospitals, clinics, and medical | |||
| practices. Multix Fusion enables | |||
| radiographic exposures of the whole body | |||
| including: skull, chest, abdomen, and | |||
| extremities and may be used on pediatric, | |||
| adult, and bariatric patients. It can also be | |||
| used for intravenous, small interventions | |||
| (like biopsy, punctures, etc.) and emergency | |||
| (trauma, critically ill) applications. | |||
| Exposures may be taken with the patient | |||
| sitting, standing, or in the prone position. | |||
| The Multix Fusion system is not meant for | |||
| mammography. The Multix Fusion uses a | |||
| mobile (wired) or portable (wireless) digital | |||
| detector for generating diagnostic images | |||
| by converting x-rays into electronic signals. | |||
| The Multix Fusion is also designed to be | |||
| used with conventional film/screen or | |||
| Computed Radiography (CR) cassettes. | 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. | Equivalent | ||
| Comparable | |||
| Properties | Predicate Device: Siemens Multix | ||
| Fusion K12113 | Amrad Medical OTS, DFMTS, or FRS | ||
| Digital Radiography Systems | Comparison | ||
| Results | |||
| Tube | |||
| crane/Tube | |||
| stand | Overhead tube crane with manual or | ||
| automated x-ray tube assembly | |||
| movement. | Equivalent model: OTS | Similar | |
| Functionality | |||
| Wall stand | Manual vertical movable wall stand, | ||
| tiltable tray. | Manual or Motorized | Similar | |
| Functionality | |||
| Table | Free-floating and height-adjustable, | ||
| maximum patient weight 660 lbs., | |||
| working table height 20-5/16 inch to | |||
| 37-5/8 inch. | Elevating 4-way Float Top Table | ||
| includes reciprocating bucky, cassette | |||
| tray, X-ray grid & may include | |||
| optional AEC measuring detector (for | |||
| use with OTS & DFMTS Tubestands | |||
| only) or: Mobile Table (for use with | |||
| FRS System only) | Same or | ||
| Similar | |||
| Functionality | |||
| X-ray tube | 150 kVp, 0.6 mm & 1 mm focal spots. | 150 kVp 0.6/1.2mm focal spots | Similar |
| Functionality | |||
| Collimator | Siemens. | Collimare | Similar |
| Functionality | |||
| X-ray | |||
| Generator | 55, 65, or 80 kW | 40, 50, 65, or 80 kW | Similar |
| Functionality | |||
| Wireless | |||
| detector | 14" x 17" | Not applicable | Not |
| applicable | |||
| Fixed detector | 14" x 17" or 17" x 17" | SAME. Uses FDA cleared detectors | |
| and software: | |||
| PaxScan 4343R and 4336R panels and | |||
| software cleared in K093066 as well | |||
| as in K130318. | Similar | ||
| Functionality | |||
| Conventional | |||
| film/screen | |||
| systems or CR | |||
| cassettes | Film/Screen or CR Cassettes. | Comes with FDA cleared digital x-ray | |
| panels. Conventional film and CR | |||
| cassettes can still be used. | Similar | ||
| Functionality | |||
| Operator | |||
| console | GUI-based | Same | Similar |
| Functionality | |||
| Photos | Image: Siemens Multix Fusion K12113 | Image: Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems | Similarity is |
| obvious. | |||
| Power Source | AC LINE | SAME | Same. |
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Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device: In all important respects the Amrad Systems are functionally identical and technologically similar in design and composition to the Multix Fusion System.
-
Performance Testing. EMC, mechanical safety, and electrical safety were evaluated according to various FDArecognized 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 OTS, DFMTS, or FRS Digital Radiography Systems are health care professionals familiar with and responsible for the xray examinations being performed. To minimize electrical, 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 Multix Fusion. It uses components similar to those cleared for the Multix Fusion (e.g. tube crane/tube stand, wall stand, table, x-ray tube, collimator, x-ray generator, operator console). Summit Industries LLC's opinion that the proposed systems are substantially equivalent to the cleared predicate device, the Multix Fusion.