(130 days)
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.
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.
The provided text describes the 510(k) summary for the Dornier GENESIS, an Image Intensified Fluoroscopic X-ray System. The documentation focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets them as would be found for an Artificial Intelligence/Machine Learning (AI/ML) device.
Here's an analysis based on the provided text, addressing the requested points. It's important to note that many of these points are not applicable or cannot be fully answered given the nature of the document (a 510(k) for a conventional medical imaging device, not an AI/ML device).
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific quantitative acceptance criteria or detailed reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it states that the GENESIS was tested against recognized testing standards for medical electrical equipment and X-ray systems.
| Acceptance Criteria (Based on standards compliance and stated equivalence) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (General safety) | Device functioned as intended. |
| Compliance with IEC 60601-1-2 (EMC) | Device functioned as intended. |
| Compliance with IEC 60601-1-3 (Radiation protection for diagnostic X-ray) | Device functioned as intended. |
| Compliance with IEC 60601-1-6 (Usability) | Device functioned as intended. |
| Compliance with IEC 60601-2-7 (Safety of high voltage generators) | Device functioned as intended. |
| Compliance with IEC 60601-2-28 (Safety of X-ray source assemblies) | Device functioned as intended. |
| Compliance with IEC 60601-2-54 (Safety and performance of X-ray equipment) | Device functioned as intended. |
| Compliance with FDA Guidance for Solid State X-ray Imaging Devices | All required nonclinical and clinical testing completed; results were as expected. |
| Equivalent performance to predicate Urotract | Concurrence study confirmed the GENESIS has at least equivalent performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "concurrence study" but does not provide details on the sample size used (number of patients or images). It also does not specify the data provenance (country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The nature of the device (a fluoroscopic x-ray system) suggests that evaluation would likely involve assessments of image quality and functionality by subject matter experts, but details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the test set in the concurrence study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, particularly one measuring improvement with AI assistance, is not applicable to this device. The Dornier GENESIS is an X-ray imaging system, not an AI/ML diagnostic software. The "concurrence study" mentioned would have focused on comparing the performance of the GENESIS device itself against a predicate device, not on how human readers perform with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable as the Dornier GENESIS is an imaging hardware system, not an algorithm or software that operates in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the "concurrence study." Given it's an imaging device, ground truth would likely be established through a combination of clinical assessment, potentially comparison to higher-fidelity imaging, or follow-up outcomes, but no specifics are provided.
8. The sample size for the training set
This is not applicable. The Dornier GENESIS is an X-ray imaging system, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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JAN 1 8 2013
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510(k) SUMMARY
Dornier MedTech America, Inc.'s GENESIS
| Submitter Name andAddress: | Dornier MedTech America, Inc.1155 Roberts Blvd.Kennesaw, GA 30144 |
|---|---|
| Contact Person: | John HofferVice 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 DeviceDescription: | The Dornier GENESIS is an Image Intensified Fluoroscopic X-raySystem (i.e., a solid state x-ray imager (flat panel/digital imager)).The GENESIS consists of the following components: an x-raygenerator and tube housing, flat panel detector, monitors andprocedure table. An X-ray cabinet contains system elements suchas the X-ray generator, power electronics and electronics for theimaging chain. |
| Intended Use /Indications for Use: | The Dornier Genesis is an image intensified, fluoroscopic x-raysystem that is intended for use in a wide field of applications,including all general examinations in urology and gynecology, aswell as endoscopic and contrast examinations, imaging withradiography and/or fluoroscopy on patients in either the horizontal orvertical position. |
| TechnologicalCharacteristics: | From a clinical perspective and comparing design specifications, theDornier GENESIS and the predicate devices are substantiallyequivalent. Based on the technological characteristics and overallperformance of the devices, Dornier believes that no significantdifferences exist between the proposed product and the predicatedevices. |
| Performance Data | The GENISIS was tested per the following recognized testingstandards:IEC 60601-1: Medical electrical equipment. Part 1: Generalrequirements for safety (2005). IEC 60601-1-2: Medical electrical equipment. Part 1-2:General requirements for safety; Electromagneticcompatibility-requirements and tests (2007). IEC 60601-1-3: Medical electrical equipment. Part 1:General requirements for safety; general requirements forradiation protection in diagnostic X-ray equipment (2008). IEC 60601-1-6: Medical electrical equipment. Part 1-6:General requirements for basic safety and essentialperformance -Collateral standard: Usability (2008). IEC 60601-2-7: Medical electrical equipment. Part 2-7:Particular requirements for the safety of high voltagegenerators of diagnostic X-ray generators (1998). IEC 60601-2-28: Medical electrical equipment. Part 2:Particular requirements for the safety of X-ray sourceassemblies 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 essentialperformance of X-ray equipment for radiography andradioscopy (2009). |
| In addition, per FDA's Guidance Document entitled Guidance for theSubmission of 510(k)s for Solid State X-ray Imaging Devices(August 6, 1999), the company completed all required nonclinicaland clinical testing for the subject device. In all instances, theGENESIS functioned as intended and the results observed were asexpected. With regard to the completed concurrence study, theresults confirm that the GENESIS has at least equivalentperformance to the predicate Urotract. | |
| Substantial Equivalence | Based on the technological characteristics and overall performanceof the devices, Dornier believes that the GENESIS and the predicatedevices selected are substantially equivalent and that thedifferences between the devices are minor and do not raise new |
| In sum, the GENESIS is as safe and effective as the identifiedpredicate devices. The GENESIS has the same intendeduses/indications for use and similar technological characteristics,and principles of operation as its predicate device. The minortechnological differences between the GENESIS and its predicatedevices raise no new issues of safety or effectiveness.Performance data demonstrate that the GENESIS is as safe andeffective as the identified predicate devices. Thus, the GENESIS issubstantially equivalent. |
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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.
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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
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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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§ 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.