Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,

K153119 · Summit Industries, LLC · KPR · Mar 14, 2016 · Radiology

Device Facts

• Record ID: K153119
• Device Name: Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,
• Applicant: Summit Industries, LLC
• Product Code: KPR · Radiology
• Decision Date: Mar 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 Story

Permanently-installed diagnostic x-ray systems for general purpose radiographic imaging; used in hospitals, clinics, and medical practices. System components include tube support (OTS, DFMTS, or FRS), x-ray generator, x-ray tube, radiographic wall stand, collimator, and FDA-cleared digital imaging system (Varian InfiMed i5 software and PaxScan flat panel detectors). Operated by qualified physicians or technicians. Device captures x-ray signals, converts them to digital images via flat panel detectors, and processes them through Varian InfiMed i5 software. Images displayed on PC monitor for radiologist evaluation to inform clinical decision-making and treatment planning. Benefits include high-quality diagnostic imaging for whole-body anatomy (skull, chest, abdomen, extremities) with patient positioning flexibility (sitting, standing, prone).

Clinical Evidence

Bench testing only. No clinical study performed. Safety and effectiveness supported by evaluation of EMC, mechanical, and electrical safety per FDA-recognized consensus standards. Digital imaging performance verified using standardized phantoms. Imaging components (detectors and software) previously cleared by FDA.

Technological Characteristics

Stationary x-ray system; components include ceiling/floor-mounted tube supports, elevating/mobile tables, high-frequency x-ray generators (40-80kW), and manual collimators. Digital imaging via Varian PaxScan 4343R/4336R flat panel detectors. Connectivity via PC-based workstation. System components bear UL or ETL certification. Software is Varian InfiMed i5.

Indications for Use

Indicated for diagnostic x-ray imaging of adult and pediatric patients. Contraindicated for mammography, interventional, or fluoroscopy use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Multix Fusion (K121513)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

| Company: | Summit Industries, LLC<br>2901 W Lawrence Ave.<br>Chicago, Illinois 60625 USA<br>Phone [phone] Fax [phone] |
|----------------|----------------------------------------------------------------------------------------------------------------------|
| 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}------------------------------------------------

5. 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.

6. 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<br>Category | Component Description | Component Model<br>and Serial No. | Mfr,<br>Location | Amrad<br>Medical<br>OTS<br>System | Amrad<br>Medical<br>DFMTS<br>System | Amrad<br>Medical<br>FRS<br>System |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------|-------------------------------------|-----------------------------------|
| Tubestand | Ceiling Mounted Tube<br>Support (OTS), manual<br>motion | J309 & ANA330-0915 | Summit<br>Industries,<br>USA | X | | |
| | Floor Mounted Tube Support<br>(DFMTS) | J700 & BFA581-0914 | Summit<br>Industries,<br>USA | | X | |
| | Floor Rail mounted Tube Support<br>(FRS) | SST-3001 &<br>SST31405015 | SYFM, So.<br>Korea | | | X |
| Radiographic<br>Table | Elevating 4-way Float Top<br>Table includes reciprocating<br>bucky, cassette tray, X-ray<br>grid & may include optional<br>AEC measuring detector<br>(for use with OTS & DFMTS<br>Tubestands only) | S222 & 41108 | Summit<br>Industries, USA | X | X | |
| | Mobile Table<br>(for use with FRS System only) | ST-1000 &<br>ST11501005 | SYFM, So.<br>Korea | | | X |
| Wallstand | Wallstand with<br>Reciprocating Bucky,<br>includes cassette tray, X-<br>ray Grid & may include 1<br>optional AEC radiation<br>detector (for floor to wall<br>mounting) | J1000 (with B066<br>FDA certified front panel)<br>& 140806 | Summit<br>Industries, USA | X | X | |
| | Tilting, Motorized Vertical<br>Wallstand (Floor mounted)<br>with Image Receptor for<br>Stationary Grid, includes<br>cassette tray (only if portable<br>DR panel is used), X-ray Grid<br>& may include 1 AEC<br>radiation detector | SST-3001 &<br>SST31405015 | SYFM, So.<br>Korea<br>& FDA<br>Certified by<br>Summit<br>Industries,<br>USA | | | X |
| X-ray<br>Generator | X-ray Generator, 80kW, HF,<br>150kV, (AEC optional) | CMP200DR | CPI, Canada | | | |
| | X-ray Generator, 65kW, HF,<br>150kV, (AEC optional) | CMP200DR | CPI, Canada | Select<br>one | Select<br>one | Select<br>one |
| | X-ray Generator, 50kW, HF,<br>150kV, (AEC optional) | CMP200DR &<br>PD22626H 15 | CPI, Canada | | | |
| | X-ray Generator, 40kW, HF,<br>150kV, (AEC optional) | CMP200DR | CPI, Canada | | | |
| Component<br>Category | Component Description | Component Model<br>and Serial No. | Mfr,<br>Location | Amrad<br>Medical<br>OTS<br>System | Amrad<br>Medical<br>DFMTS<br>System | Amrad<br>Medical<br>FRS<br>System |
| | X-ray Generator, 40kW, HF,<br>125kV, (AEC optional) | CMP200DR | CPI, Canada | | | |
| X-ray Beam<br>Limiting<br>Device | Manual Collimator with LED<br>light source, laser alignment<br>lights & tape measure | CM-150-24-C-<br>150kVp-01-LED &<br>A03376 &<br>A04056 | Collimare,<br>USA | X | X | X |
| Digital<br>Imaging<br>System | Complete Digital Imaging System<br>including PC (w/<br>Window OS, monitor, keyboard<br>& mouse), Varian infiMed i5<br>acquisition/image processing<br>software<br>& either 1 or 2 of the following<br>PaxScan Flat Panel Detectors:<br>4343R (fixed), 4336R (portable,<br>tethered) | Varian InfiMed i5<br>Digital Imaging<br>System & i5DR-0714-0044 &<br>U3-T2295244NS01<br>Uses FDA cleared detectors<br>and software:<br>PaxScan 4343R and 4336R<br>panels and software cleared<br>in K093066 as well as in<br>K130318. | Varian<br>Medical<br>Systems,<br>USA | X | X | X |
| X-ray Tube | X-ray Tube, 300kHU, 0.6/1.2mm<br>FS, 150kVp | RAD-14 &<br>35727-T5 | Varian<br>Medical<br>Systems,<br>USA | Select<br>one | Select<br>one | Select<br>one |

Table 1. Components used

{5}------------------------------------------------

6. 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<br>use | The Multix Fusion is a radiographic system<br>used in hospitals, clinics, and medical<br>practices. Multix Fusion enables<br>radiographic exposures of the whole body<br>including: skull, chest, abdomen, and<br>extremities and may be used on pediatric,<br>adult, and bariatric patients. It can also be<br>used for intravenous, small interventions<br>(like biopsy, punctures, etc.) and emergency<br>(trauma, critically ill) applications.<br>Exposures may be taken with the patient<br>sitting, standing, or in the prone position.<br>The Multix Fusion system is not meant for<br>mammography. The Multix Fusion uses a<br>mobile (wired) or portable (wireless) digital<br>detector for generating diagnostic images<br>by converting x-rays into electronic signals.<br>The Multix Fusion is also designed to be<br>used with conventional film/screen or<br>Computed Radiography (CR) cassettes. | These radiographic systems are intended<br>for use by a qualified/trained physician or<br>technician on both adult and pediatric<br>subjects for taking diagnostic x-rays. Not<br>for mammography, angiography,<br>interventional, or fluoroscopy use. | Equivalent |
| Comparable<br>Properties | Predicate Device: Siemens Multix<br>Fusion K12113 | Amrad Medical OTS, DFMTS, or FRS<br>Digital Radiography Systems | Comparison<br>Results |
| Tube<br>crane/Tube<br>stand | Overhead tube crane with manual or<br>automated x-ray tube assembly<br>movement. | Equivalent model: OTS | Similar<br>Functionality |
| Wall stand | Manual vertical movable wall stand,<br>tiltable tray. | Manual or Motorized | Similar<br>Functionality |
| Table | Free-floating and height-adjustable,<br>maximum patient weight 660 lbs.,<br>working table height 20-5/16 inch to<br>37-5/8 inch. | Elevating 4-way Float Top Table<br>includes reciprocating bucky, cassette<br>tray, X-ray grid & may include<br>optional AEC measuring detector (for<br>use with OTS & DFMTS Tubestands<br>only) or: Mobile Table (for use with<br>FRS System only) | Same or<br>Similar<br>Functionality |
| X-ray tube | 150 kVp, 0.6 mm & 1 mm focal spots. | 150 kVp 0.6/1.2mm focal spots | Similar<br>Functionality |
| Collimator | Siemens. | Collimare | Similar<br>Functionality |
| X-ray<br>Generator | 55, 65, or 80 kW | 40, 50, 65, or 80 kW | Similar<br>Functionality |
| Wireless<br>detector | 14" x 17" | Not applicable | Not<br>applicable |
| Fixed detector | 14" x 17" or 17" x 17" | SAME. Uses FDA cleared detectors<br>and software:<br>PaxScan 4343R and 4336R panels and<br>software cleared in K093066 as well<br>as in K130318. | Similar<br>Functionality |
| Conventional<br>film/screen<br>systems or CR<br>cassettes | Film/Screen or CR Cassettes. | Comes with FDA cleared digital x-ray<br>panels. Conventional film and CR<br>cassettes can still be used. | Similar<br>Functionality |
| Operator<br>console | GUI-based | Same | Similar<br>Functionality |
| Photos | Image: Siemens Multix Fusion K12113 | Image: Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems | Similarity is<br>obvious. |
| Power Source | AC LINE | SAME | Same. |

{6}------------------------------------------------

{7}------------------------------------------------

7. 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.

8. 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.

9. 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.