GENESIS

K151485 · Dornier Medtech America, Inc. · JAA · Jun 30, 2015 · Radiology

Device Facts

• Record ID: K151485
• Device Name: GENESIS
• Applicant: Dornier Medtech America, Inc.
• Product Code: JAA · Radiology
• Decision Date: Jun 30, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Dornier Genesis with Windows 7 is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

Device Story

Dornier Genesis with Windows 7 is an image-intensified fluoroscopic X-ray system. System components include X-ray generator, tube housing, image detector (flat panel or image intensifier), monitors, and procedure table. X-ray cabinet houses generator, power electronics, and imaging chain electronics. Device used in clinical settings for urology, gynecology, endoscopic, and contrast examinations. Clinicians operate system to acquire radiographic/fluoroscopic images for diagnostic visualization. Primary modification from predicate is migration of image processing software platform from Windows XP to Windows 7. Output provides real-time or static imaging to assist clinical decision-making during procedures. Benefits include diagnostic visualization for various medical examinations.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-54, and NEMA PS 3.1-3.20. Risk analysis performed per ISO 14971.

Technological Characteristics

Image-intensified fluoroscopic X-ray system. Components: X-ray generator, tube housing, flat panel/image intensifier detector, monitors, procedure table. Connectivity: DICOM (NEMA PS 3.1-3.20). Software platform: Windows 7. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-7, 60601-2-28, 60601-2-54. Risk management: ISO 14971.

Indications for Use

Indicated for patients requiring general urological, gynecological, endoscopic, or contrast examinations, including radiography and fluoroscopy in horizontal or vertical positions.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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

• Dornier Genesis (K133434)
• Dornier Genesis (K122768)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

June 30, 2015

Dornier MedTech America, Inc. % Mr. John Hoffer Vice President, Quality/Regulatory/Clinical 1155 Roberts Blvd. KENNESAW GA 30144

Re: K151485

Trade/Device Name: Dornier Genesis with Windows 7 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: June 3, 2015 Received: June 4, 2015

Dear Mr. Hoffer:

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 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.

{1}------------------------------------------------

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,

Robert A Ocks

Robert Ochs. Ph.D. Acting 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) K151485

Device Name

Dornier Genesis with Windows 7

#### Indications for Use (Describe)

The Dornier Genesis with Windows 7 is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;"> </span><span style="margin-left:5px;">Prescription Use (Part 21 CFR 801 Subpart D)</span></div> |
| <div style="display:flex; align-items:center;"><span style="font-size:20px;"> </span><span style="margin-left:5px;">Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

### 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}------------------------------------------------

# SPECIAL 510(k) SUMMARY

### Dornier MedTech America, Inc.'s Genesis with Windows 7

| Submitter Name and<br>Address: | Dornier MedTech America, Inc.<br>1155 Roberts Blvd.<br>Kennesaw, GA 30144 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Hoffer<br>Vice President, Quality/Regulatory/Clinical |
| Phone Number: | 770-514-6163 |
| Fax Number: | 770-514-6291 |
| Date Prepared: | June 01, 2015 |
| Device Trade Name(s): | Genesis |
| Device Common Name<br>/ Classification Name: | Image Intensified Fluoroscopic X-ray System<br>(Product Code: JAA) |
| Classification: | 21 CFR § 892.1650 |
| Predicate Device(s): | Dornier Genesis (K133434; K122768) |
| General Device<br>Description: | The Dornier Genesis with Windows 7 is an Image Intensified<br>Fluoroscopic X-ray System. The Genesis with Windows 7 consists<br>of the following components: an x-ray generator and tube housing<br>image detector (flat panel or Image Intensifier), monitors and<br>procedure table. An X-ray cabinet contains system elements such<br>as the X-ray generator, power electronics and electronics for the<br>imaging chain. |
| Intended Use<br>/ Indications for Use: | The Dornier Genesis with Windows 7 is an image intensified,<br>fluoroscopic x-ray system that is intended for use in a wide field of<br>applications, including all general examinations in urology and<br>gynecology, as well as endoscopic and contrast examinations,<br>imaging with radiography and/or fluoroscopy on patients in either the<br>horizontal or vertical position. |
| Technological<br>Characteristics: | From a clinical perspective and comparing design specifications, the<br>Dornier Genesis with Windows 7 and the predicate devices are<br>substantially equivalent. The only difference between the subject<br>and predicate devices is that the image processing software will<br>now use a Windows 7 platform versus Windows XP. Based on the<br>technological characteristics and overall performance of the devices,<br>Dornier believes that no significant differences exist between the<br>proposed device and the predicate devices. |
| Performance Data | The device is in compliance with the following recognized<br>testing standards: |
| | • IEC 60601-1: Medical electrical equipment. Part 1: General requirements for safety (2005). |
| | • IEC 60601-1-2: Medical electrical equipment. Part 1-2: General requirements for safety; Electromagnetic compatibility-requirements and tests (2007). |
| | • IEC 60601-1-3: Medical electrical equipment. Part 1: General requirements for safety; general requirements for radiation protection in diagnostic X-ray equipment (2008). |
| | • IEC 60601-1-6: Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability (2008). |
| | • IEC 60601-2-7: Medical electrical equipment. Part 2-7: Particular requirements for the safety of high voltage generators of diagnostic X-ray generators (1998). |
| | • IEC 60601-2-28: Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (2010). |
| | • IEC 60601-2-54: Medical electrical equipment. Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (2009). |
| | • NEMA PS 3.1-3.20 - Digital imaging and Communications in Medicine (DICOM) Set |
| | In addition, a risk analysis was used to assess that the impact of the modifications was performed in compliance with ISO 14971. The results of the risk analysis demonstrated that there were no new risks or hazards present after any necessary mitigation was implemented. Design verification and validation tests were performed as a result of the risk analysis, and demonstrated that all units must meet final design requirements prior to release for sale. Labeling and packaging will also be verified prior to sale. |
| Substantial Equivalence | In summary, the Genesis with Windows 7 has the identical intended uses/indications for use and identical technological characteristics, and principles of operation as its predicate devices. The minor technological difference between the Genesis with Windows 7 and its predicate devices raises no new or different issues of safety or effectiveness. Thus, the Genesis with Windows 7 is substantially equivalent. |

{4}------------------------------------------------