(28 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard x-ray system components and image processing software running on a Windows 7 platform, with no mention of AI/ML capabilities.
No.
The document describes the Dornier Genesis with Windows 7 as an "image intensified, fluoroscopic x-ray system" intended for imaging and diagnostic purposes, not for treating diseases or conditions.
No
The device is an image intensified, fluoroscopic x-ray system used for general examinations and imaging, not for diagnosing specific medical conditions.
No
The device description explicitly lists hardware components such as an x-ray generator, tube housing, image detector, monitors, procedure table, and an x-ray cabinet. While it includes software for image processing, it is an integral part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a fluoroscopic x-ray system used for imaging patients in vivo (within the living body) for diagnostic purposes. IVD devices are used to examine specimens in vitro (outside the living body), such as blood, urine, or tissue samples.
- Device Description: The device components are typical of an x-ray imaging system, not a device designed to analyze biological specimens.
- Input Imaging Modality: Fluoroscopic x-ray is an in vivo imaging modality.
- Anatomical Site: While not specifically limited, the mention of urology and gynecology further points to in vivo imaging of anatomical structures.
The device is clearly an imaging system used to visualize internal structures of the body, which falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JAA
Device Description
The Dornier Genesis with Windows 7 is an Image Intensified Fluoroscopic X-ray System. The Genesis with Windows 7 consists of the following components: an x-ray generator and tube housing image detector (flat panel or Image Intensifier), monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics and electronics for the imaging chain.
Mentions image processing
The only difference between the subject and predicate devices is that the image processing software will now use a Windows 7 platform versus Windows XP.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image intensified, fluoroscopic x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The device is in compliance with the following recognized 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.
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.
Dornier Genesis (K133434; K122768)
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.
Not Found
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
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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.
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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,
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
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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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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SPECIAL 510(k) SUMMARY
Dornier MedTech America, Inc.'s Genesis with Windows 7
| Submitter Name and
Address: | Dornier MedTech America, Inc.
1155 Roberts Blvd.
Kennesaw, GA 30144 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Hoffer
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
/ Classification Name: | Image Intensified Fluoroscopic X-ray System
(Product Code: JAA) |
| Classification: | 21 CFR § 892.1650 |
| Predicate Device(s): | Dornier Genesis (K133434; K122768) |
| General Device
Description: | The Dornier Genesis with Windows 7 is an Image Intensified
Fluoroscopic X-ray System. The Genesis with Windows 7 consists
of the following components: an x-ray generator and tube housing
image detector (flat panel or Image Intensifier), monitors and
procedure table. An X-ray cabinet contains system elements such
as the X-ray generator, power electronics and electronics for the
imaging chain. |
| Intended Use
/ Indications for 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. |
| Technological
Characteristics: | From a clinical perspective and comparing design specifications, the
Dornier Genesis with Windows 7 and the predicate devices are
substantially equivalent. The only difference between the subject
and predicate devices is that the image processing software will
now use a Windows 7 platform versus Windows XP. Based on the
technological characteristics and overall performance of the devices,
Dornier believes that no significant differences exist between the
proposed device and the predicate devices. |
| Performance Data | The device is in compliance with the following recognized
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. |
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