0180 INTUITION, 0072 PRECISION

K140683 · Arcoma AB · KPR · Jun 3, 2014 · Radiology

Device Facts

• Record ID: K140683
• Device Name: 0180 INTUITION, 0072 PRECISION
• Applicant: Arcoma AB
• Product Code: KPR · Radiology
• Decision Date: Jun 3, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography

Device Story

Stationary digital X-ray system for clinical diagnostic imaging; utilizes digital X-ray panels and high-frequency generators to capture radiographic images. Features include ceiling tube suspension, motorized movements, auto-positioning, and an elevating 6-way table (550 lbs capacity). Operated by clinical staff in a hospital or clinic setting. System includes a tube-mounted 10" touch screen and a Windows-compatible workstation for image acquisition. Precision model supports automatic stitching for enhanced workflow. Output consists of digital radiographic images for physician review to support clinical decision-making. Benefits include improved ergonomic positioning, efficient patient throughput, and high-quality diagnostic imaging.

Clinical Evidence

Clinical images obtained in accordance with FDA Guidance Document on Solid State Imaging Devices. Evaluated by professional radiologists and determined to be of good diagnostic quality. No quantitative clinical metrics (sensitivity/specificity) reported; bench testing and software integration validation also performed.

Technological Characteristics

Stationary digital X-ray system; high-frequency generator (50, 65, 80 kW); digital receptor panels (Canon 401C, 70C wireless); motorized ceiling tube suspension and wall stand; 6-way elevating table. Connectivity via DICOM. Safety standards: UL/CSA listings, IEC 60601-1, IEC 60601-1-2. Software-based image acquisition on Windows workstation.

Indications for Use

Indicated for obtaining radiographic images of various portions of the human body in a clinical environment. Not intended for mammography. No specific age or gender restrictions.

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

• Arcoma Intuition (K073632)

Submission Summary (Full Text)

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JUN 0 3 2014

510(k) Summary, Device Modification, K14 0 68 3

- 1. Submitter: Arcoma AB Annavagen 1 SE-352 46 Vaxjo Sweden Phone: [phone] Contact/Prepared by: Mikael Larsson, CEO. Date prepared: 17 February 2014
- 2. Identification of the Device: 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems Classification Name: Stationary x-ray system Common/Usual Name: Stationary digital x-ray system Regulation Number: 21 CFR 892.1680 Product Codes: KPR and MQB
- 3. Predicate Device: Arcoma Intuition, K073632
- Modification Summary: (1) Newer versions of Canon digital panels will be supplied. (2) A 4. different brand of high frequency generator will be supplied. (3) The overhead tube crane has been motorized. (4) The wall stand now has motorized vertical movement.
- 5. A description of the device: This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are:
- Ceiling Tube Suspension a.
- Motorized Movements, Auto-Positioning ﻗ
- c. Tube Mounted 10" Touch Screen
- Elevating 6 Way Table Patient Load: 5501bs ರ.
- Single User Interface e.
- High Frequency Generator 。

This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.

- 6. These are stationary x-ray systems intended for obtaining radiographic Indications for use: images of various portions of the human body in a clinical environment. They are not intended for mammography.
- 7. The 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems have essentially the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device Arcoma Intuition, K073632. See the comparison table below. There are really only a few main differences: The digital panels, x-ray generator, and tube stands have been modified but have functionally identical capabilities. The proposed new digital x-ray panels each have their own 510(k) clearances.

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K140683
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| Characteristic | Arcoma Intuition, K073632 | 0180 Intuition 0072 Precision |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The 0170 Intuition is a stationary x-ray<br>system intended for obtaining<br>radiographic images of various portions<br>of the human body in a clinical<br>environment. The 0170 Intuition is not<br>intended for mammography | The 0180 Intuition and 0072 Precision are<br>stationary digital x-ray systems intended<br>for obtaining radiographic images of<br>various portions of the human body in a<br>clinical environment. They are not<br>intended for mammography |
| Digital Receptor<br>Panel | Canon 40C/G K031633 and<br>and Canon 50G K031447 | Canon 401C K103591<br>and Canon 70C wireless K102012 |
| Panel Resolution | Canon 40C/G<br>Imaging area 43 x 43 cm<br>Pixel Pitch 160 $\mu m$<br>Image matrix size 2,688 x 2,688 pixels<br>Canon 50G<br>Imaging area 35 x 43 cm.<br>Pixel Pitch 160 $\mu m$<br>Image matrix size 2,208 x 2,688 pixels | Canon 70C<br>Imaging area 35 X 43 cm<br>Pixel Pitch: 125 $\mu m$<br>Image matrix size: 2,800 x 3,408 Pixels<br>Canon 401C<br>Effective imaging area: 41.5 × 42.6 cm<br>Pixel pitch: 125 $\mu m$<br>Image matrix size: 3320 × 3408 pixels |
| Panel Connection | Wired | Wired or Wireless (WiFi) |
| DICOM | Yes | Yes |
| Tube Stand | Ceiling Mount | Same |
| Collimator | Siemens or Ralco | Siemens |
| Generator | EMD EPS 50, 65, 80 kW (High Frequency) | CPI, CMP 200 50, 65, 80 kW (High<br>Frequency) |
| Safety | UL Listings and IEC Standards IEC<br>60601-1 and IEC 60601-1-2, US<br>Performance Standards | UL/CSA Listings and IEC Standards IEC<br>60601-1 and IEC 60601-1-2, US<br>Performance Standards |
| Photo | Image: Arcoma Intuition, K073632 | Image: 0180 Intuition 0072 Precision |

- Description of non-clinical tests. The modified unit has undergone individual and system 8. performance tests, electrical safety and electromagnetic compatibility testing, as well as software integration validation and risk analysis. The unit meets IEC safety and EMC standards.
- 9. Description of clinical tests. Clinical images were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were evaluated by professional radiologist and found to be of good diagnostic quality.
- 10. Conclusions drawn: The nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending from its body.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3. 2014

Arcoma AB % Daniel Kamm, P.E. Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K140683

Trade/Device Name: 0180 Intuition and 0072 Precision Stationary Digital X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 29, 2014 Received: May 05, 2014

## 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 docs 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 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.

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Page 2 - Mr. Kamm

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdg.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.

for

Janine M Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

### 510{k) Number (if known) K140683

#### Device Name

0180 Intuition and 0072 Precision Digital Radiography Systems

#### Indications for Use (Describe)

These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography

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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)


FORM FDA 3881 (1/14)

PSL" Publiching Seri nees 1 2011 443-4740 H

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