(28 days)
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.
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.
The provided text describes a Special 510(k) Summary for the Dornier Genesis with Windows 7, an image-intensified fluoroscopic x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance studies in the way you've outlined for an AI/device performance study.
Here's an analysis based on the information provided, highlighting what is and is not present concerning your request:
The core of this document is a 510(k) submission seeking clearance for a modification to an existing medical device. The primary "study" proving the device meets its acceptance criteria is the demonstration of substantial equivalence to a legally marketed predicate device. The acceptance criteria for this type of submission are typically adherence to recognized standards and a demonstration that the changes do not introduce new safety or effectiveness issues.
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) is provided, nor is there reported device performance in those terms. The "acceptance criteria" here are broad regulatory compliance and substantial equivalence to a predicate device.
The "performance data" section lists recognized testing standards that Dornier MedTech America, Inc. states the device complies with:
| Acceptance Criteria (Implied) | Reported Device Performance (Compliance) |
|---|---|
| Safety (General) | IEC 60601-1: Medical electrical equipment. Part 1: General requirements for safety (2005). |
| Electromagnetic Compatibility | IEC 60601-1-2: Medical electrical equipment. Part 1-2: General requirements for safety; Electromagnetic compatibility-requirements and tests (2007). |
| Radiation Protection (Diagnostic X-ray) | IEC 60601-1-3: Medical electrical equipment. Part 1: General requirements for safety; general requirements for radiation protection in diagnostic X-ray equipment (2008). |
| Usability | IEC 60601-1-6: Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability (2008). |
| Safety (High Voltage Generators) | 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). |
| Safety (X-ray Source & Tube Assemblies) | 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). |
| Safety & Performance (Radiography/Radioscopy) | 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). |
| Digital Imaging and Communications | NEMA PS 3.1-3.20 - Digital imaging and Communications in Medicine (DICOM) Set |
| Risk Management | ISO 14971 (Risk analysis performed, no new risks or hazards after mitigation) |
| Design Verification & Validation | Design verification and validation tests performed to meet final design requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes compliance with standards and risk analysis, not a clinical performance study with a specific test set of patient data. The modification is primarily a software platform upgrade (Windows XP to Windows 7), implying that the core imaging hardware's performance characteristics are considered unchanged.
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. As there's no mention of a clinical test set for diagnostic performance, there's no discussion of ground truth establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
An MRMC study was not mentioned or indicated. The device is an imaging system, not an AI-assisted diagnostic tool in the typical sense of generating interpretations or assisting human readers with diagnostic tasks. The change is an operating system upgrade.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm is not mentioned or indicated. This is not an algorithmic diagnostic device, but rather an imaging system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Ground truth for diagnostic performance is not applicable in the context of this 510(k) summary, as it's not a diagnostic algorithm undergoing validation of its diagnostic accuracy. The ground truth for the engineering tests mentioned would be the specified requirements of the standards (e.g., specific measurement readings, functional tests).
8. The sample size for the training set
This information is not provided. This device is not an AI/machine learning product that requires a training set for model development.
9. How the ground truth for the training set was established
This information is not provided. This is not applicable to the device described.
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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 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: | 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 DeviceDescription: | The Dornier Genesis with Windows 7 is an Image IntensifiedFluoroscopic X-ray System. The Genesis with Windows 7 consistsof the following components: an x-ray generator and tube housingimage detector (flat panel or Image Intensifier), 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 with Windows 7 is an image intensified,fluoroscopic x-ray system that is intended for use in a wide field ofapplications, including all general examinations in urology andgynecology, as well as endoscopic and contrast examinations,imaging with radiography and/or fluoroscopy on patients in either thehorizontal or vertical position. |
| TechnologicalCharacteristics: | From a clinical perspective and comparing design specifications, theDornier Genesis with Windows 7 and the predicate devices aresubstantially equivalent. The only difference between the subjectand predicate devices is that the image processing software willnow use a Windows 7 platform versus Windows XP. Based on thetechnological characteristics and overall performance of the devices,Dornier believes that no significant differences exist between theproposed device and the predicate devices. |
| Performance Data | The device is in compliance with the following recognizedtesting 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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§ 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.