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.

AI/ML Overview

The Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems are intended for general diagnostic x-rays and compared for substantial equivalence to the Siemens Multix Fusion (K121513). The document does not provide a table of acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it relies on substantial equivalence to a predicate device and adherence to recognized industry standards for safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, resolution, dose). Instead, it states that "EMC, mechanical safety, and electrical safety were evaluated according to various FDA recognized consensus standards," and "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."

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

No specific test set or sample size for evaluating clinical performance is mentioned. The document states: "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."

The document also mentions: "We did collect and evaluate digital images using standardized phantoms." However, details on the sample size of these phantom images, their provenance, or how they relate to a "test set" are not provided.

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

Not applicable, as no clinical test set requiring expert-established ground truth is described. The device's substantial equivalence is based on physical and technological characteristics compared to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document focuses on substantial equivalence based on technical specifications and safety standards, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a digital radiography system, not an AI algorithm for image interpretation. Its performance is inherent in its ability to produce diagnostic x-ray images.

7. Type of Ground Truth Used:

The primary "ground truth" for the clearance is indirect:

Substantial equivalence to the predicate device (Siemens Multix Fusion K121513): This implies that the predicate device's established safety and effectiveness serve as the ground truth for the new device.
FDA-cleared imaging components: The digital panels and software (PaxScan 4343R and 4336R) used in the Amrad Systems were previously cleared by the FDA in K093066 and K130318. Their prior clearance acts as a form of ground truth for their performance.
Standardized phantoms: The document mentions evaluating "digital images using standardized phantoms." This type of testing uses known physical properties of the phantoms as ground truth for image quality measurements (e.g., spatial resolution, contrast-to-noise ratio), but no details of such measurements or acceptance criteria are provided.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware system, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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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

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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

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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)

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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510(k) Summary: Amrad Medical Digital Radiography Systems K153119

Company:	Summit Industries, LLC2901 W Lawrence Ave.Chicago, Illinois 60625 USAPhone 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.

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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, 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).

ComponentCategory	Component Description	Component Modeland Serial No.	Mfr,Location	AmradMedicalOTSSystem	AmradMedicalDFMTSSystem	AmradMedicalFRSSystem
Tubestand	Ceiling Mounted TubeSupport (OTS), manualmotion	J309 & ANA330-0915	SummitIndustries,USA	X
	Floor Mounted Tube Support(DFMTS)	J700 & BFA581-0914	SummitIndustries,USA		X
	Floor Rail mounted Tube Support(FRS)	SST-3001 &SST31405015	SYFM, So.Korea			X
RadiographicTable	Elevating 4-way Float TopTable includes reciprocatingbucky, cassette tray, X-raygrid & may include optionalAEC measuring detector(for use with OTS & DFMTSTubestands only)	S222 & 41108	SummitIndustries, USA	X	X
	Mobile Table(for use with FRS System only)	ST-1000 &ST11501005	SYFM, So.Korea			X
Wallstand	Wallstand withReciprocating Bucky,includes cassette tray, X-ray Grid & may include 1optional AEC radiationdetector (for floor to wallmounting)	J1000 (with B066FDA certified front panel)& 140806	SummitIndustries, USA	X	X
	Tilting, Motorized VerticalWallstand (Floor mounted)with Image Receptor forStationary Grid, includescassette tray (only if portableDR panel is used), X-ray Grid& may include 1 AECradiation detector	SST-3001 &SST31405015	SYFM, So.Korea& FDACertified bySummitIndustries,USA			X
X-rayGenerator	X-ray Generator, 80kW, HF,150kV, (AEC optional)	CMP200DR	CPI, Canada
	X-ray Generator, 65kW, HF,150kV, (AEC optional)	CMP200DR	CPI, Canada	Selectone	Selectone	Selectone
	X-ray Generator, 50kW, HF,150kV, (AEC optional)	CMP200DR &PD22626H 15	CPI, Canada
	X-ray Generator, 40kW, HF,150kV, (AEC optional)	CMP200DR	CPI, Canada
ComponentCategory	Component Description	Component Modeland Serial No.	Mfr,Location	AmradMedicalOTSSystem	AmradMedicalDFMTSSystem	AmradMedicalFRSSystem
	X-ray Generator, 40kW, HF,125kV, (AEC optional)	CMP200DR	CPI, Canada
X-ray BeamLimitingDevice	Manual Collimator with LEDlight source, laser alignmentlights & tape measure	CM-150-24-C-150kVp-01-LED &A03376 &A04056	Collimare,USA	X	X	X
DigitalImagingSystem	Complete Digital Imaging Systemincluding PC (w/Window OS, monitor, keyboard& mouse), Varian infiMed i5acquisition/image processingsoftware& either 1 or 2 of the followingPaxScan Flat Panel Detectors:4343R (fixed), 4336R (portable,tethered)	Varian InfiMed i5Digital ImagingSystem & i5DR-0714-0044 &U3-T2295244NS01Uses FDA cleared detectorsand software:PaxScan 4343R and 4336Rpanels and software clearedin K093066 as well as inK130318.	VarianMedicalSystems,USA	X	X	X
X-ray Tube	X-ray Tube, 300kHU, 0.6/1.2mmFS, 150kVp	RAD-14 &35727-T5	VarianMedicalSystems,USA	Selectone	Selectone	Selectone

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 foruse	The Multix Fusion is a radiographic systemused in hospitals, clinics, and medicalpractices. Multix Fusion enablesradiographic exposures of the whole bodyincluding: skull, chest, abdomen, andextremities and may be used on pediatric,adult, and bariatric patients. It can also beused for intravenous, small interventions(like biopsy, punctures, etc.) and emergency(trauma, critically ill) applications.Exposures may be taken with the patientsitting, standing, or in the prone position.The Multix Fusion system is not meant formammography. The Multix Fusion uses amobile (wired) or portable (wireless) digitaldetector for generating diagnostic imagesby converting x-rays into electronic signals.The Multix Fusion is also designed to beused with conventional film/screen orComputed Radiography (CR) cassettes.	These radiographic systems are intendedfor use by a qualified/trained physician ortechnician on both adult and pediatricsubjects for taking diagnostic x-rays. Notfor mammography, angiography,interventional, or fluoroscopy use.	Equivalent
ComparableProperties	Predicate Device: Siemens MultixFusion K12113	Amrad Medical OTS, DFMTS, or FRSDigital Radiography Systems	ComparisonResults
Tubecrane/Tubestand	Overhead tube crane with manual orautomated x-ray tube assemblymovement.	Equivalent model: OTS	SimilarFunctionality
Wall stand	Manual vertical movable wall stand,tiltable tray.	Manual or Motorized	SimilarFunctionality
Table	Free-floating and height-adjustable,maximum patient weight 660 lbs.,working table height 20-5/16 inch to37-5/8 inch.	Elevating 4-way Float Top Tableincludes reciprocating bucky, cassettetray, X-ray grid & may includeoptional AEC measuring detector (foruse with OTS & DFMTS Tubestandsonly) or: Mobile Table (for use withFRS System only)	Same orSimilarFunctionality
X-ray tube	150 kVp, 0.6 mm & 1 mm focal spots.	150 kVp 0.6/1.2mm focal spots	SimilarFunctionality
Collimator	Siemens.	Collimare	SimilarFunctionality
X-rayGenerator	55, 65, or 80 kW	40, 50, 65, or 80 kW	SimilarFunctionality
Wirelessdetector	14" x 17"	Not applicable	Notapplicable
Fixed detector	14" x 17" or 17" x 17"	SAME. Uses FDA cleared detectorsand software:PaxScan 4343R and 4336R panels andsoftware cleared in K093066 as wellas in K130318.	SimilarFunctionality
Conventionalfilm/screensystems or CRcassettes	Film/Screen or CR Cassettes.	Comes with FDA cleared digital x-raypanels. Conventional film and CRcassettes can still be used.	SimilarFunctionality
Operatorconsole	GUI-based	Same	SimilarFunctionality
Photos	Image: Siemens Multix Fusion K12113	Image: Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems	Similarity isobvious.
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.

Regulation Number and Section

§ 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.