(130 days)
Not Found
No
The summary describes a standard fluoroscopic X-ray system and does not mention any AI or ML components or capabilities.
No.
The device is described as an X-ray system for imaging and diagnostic examinations, not for treating conditions.
No
The device is described as an X-ray system used for "general examinations" and "imaging", which are typically for visualization purposes. While imaging can assist in diagnosis, the device itself does not provide a diagnosis; it provides the images.
No
The device description explicitly lists hardware components such as an x-ray generator, tube housing, flat panel detector, monitors, procedure table, and an X-ray cabinet. This indicates it is a physical medical device system, not software-only.
Based on the provided information, the Dornier GENESIS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients." This describes a device used for imaging the human body directly, not for examining specimens taken from the body.
- Device Description: The description details an "Image Intensified Fluoroscopic X-ray System" with components like an x-ray generator, tube housing, flat panel detector, monitors, and procedure table. These are all components of a medical imaging system used for visualizing internal structures of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Dornier GENESIS is a medical imaging device used for in vivo (within the living body) imaging.
N/A
Intended Use / Indications for Use
"The Dornier Genesis 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
JAA
Device Description
"The Dornier GENESIS is an Image Intensified Fluoroscopic X-ray System (i.e., a solid state x-ray imager (flat panel/digital imager)). The GENESIS consists of the following components: an x-ray generator and tube housing, flat panel detector, 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic x-ray, radiography
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 GENISIS was tested per the following recognized testing standards: IEC 60601-1 (2005), IEC 60601-1-2 (2007), IEC 60601-1-3 (2008), IEC 60601-1-6 (2008), IEC 60601-2-7 (1998), IEC 60601-2-28 (2010), IEC 60601-2-54 (2009). The company completed all required nonclinical and clinical testing for the subject device per FDA's Guidance Document entitled Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (August 6, 1999). The GENESIS functioned as intended and the results observed were as expected. A concurrence study confirmed that the GENESIS has at least equivalent performance to the predicate Urotract.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dornier Urotract (K955019), Siemens Uroskop Omnia (K101491)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
| | | | 22768
JAN 1 8 2013
・・
510(k) SUMMARY
Dornier MedTech America, Inc.'s GENESIS
| 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: | December 18, 2012 |
| Device Trade Name(s): | GENESIS |
| Device Common Name /
Classification Name: | Image-intensified fluoroscopic x-ray system (Product Code: JAA) |
| Predicate Device(s): | Dornier Urotract (K955019)
Siemens Uroskop Omnia (K101491) |
| General Device
Description: | The Dornier GENESIS is an Image Intensified Fluoroscopic X-ray
System (i.e., a solid state x-ray imager (flat panel/digital imager)).
The GENESIS consists of the following components: an x-ray
generator and tube housing, flat panel detector, 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 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 and the predicate devices are substantially
equivalent. Based on the technological characteristics and overall
performance of the devices, Dornier believes that no significant
differences exist between the proposed product and the predicate
devices. |
| Performance Data | The GENISIS was tested per 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). |
| | In addition, per FDA's Guidance Document entitled Guidance for the
Submission of 510(k)s for Solid State X-ray Imaging Devices
(August 6, 1999), the company completed all required nonclinical
and clinical testing for the subject device. In all instances, the
GENESIS functioned as intended and the results observed were as
expected. With regard to the completed concurrence study, the
results confirm that the GENESIS has at least equivalent
performance to the predicate Urotract. |
| Substantial Equivalence | Based on the technological characteristics and overall performance
of the devices, Dornier believes that the GENESIS and the predicate
devices selected are substantially equivalent and that the
differences between the devices are minor and do not raise new
|
| | In sum, the GENESIS is as safe and effective as the identified
predicate devices. The GENESIS has the same intended
uses/indications for use and similar technological characteristics,
and principles of operation as its predicate device. The minor
technological differences between the GENESIS and its predicate
devices raise no new issues of safety or effectiveness.
Performance data demonstrate that the GENESIS is as safe and
effective as the identified predicate devices. Thus, the GENESIS is
substantially equivalent. |
1
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is oriented towards the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the left side of the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2013
Dornier MedTech America, Inc. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K122768
Trade/Device Name: GENESIS Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: January 2, 2013 Received: January 2, 2013
Dear Dr. Smith:
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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Sean M. Boyd -S
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K122768
Device Name: Dornier GENESIS
Indications For Use:
The Dornier GENESIS 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Sean M. Boyd -S
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sigm Off)
Division of Radiologii
Limits of In Vitro Diagnostics and Radiological Use
51060 K122768
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