(77 days)
CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
The CombiDiagnost R90 is a multi-functional remote controlled fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tilt- and heightadjustable patient support and a scan unit consisting of a tube and a flat panel detector, Pixium FE 4343F. The tabletop can be moved by a motor in the lateral direction and can be tilted +/- 90 degrees. The scan unit tilts with the table and can be moved in the longitudinal direction, relative to the table and to the patient. The fully integrated system is provided with a touch screen console, glass or metal x-ray tube(s) with collimator and high resolution displays. As a fully integrated system, the proposed CombiDiagnost R90 can be configured with a Philips generator, the flat panel detector Pixium FE 4343F, and the Philips Dynamic Eleva Image Chain acquisitionstation also provided with the currently marketed and reference device, Eleva Workspot with SkyFlow (Eleva Workspot). The proposed CombiDiagnost R90 uses the same workflow from the currently marketed and reference device, Eleva Workspot with SkyFlow. The only modification to the Eleva Workspot is integration with the Pixium FE 4343F detector.
The provided text is a 510(k) summary for the Philips CombiDiagnost R90, an X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic AI algorithm.
Therefore, much of the requested information regarding acceptance criteria for a diagnostic performance study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an AI algorithm is not applicable to this type of submission. This document describes a medical device, not a diagnostic AI.
However, I can extract the information related to the device's technical specifications and the non-clinical testing performed to show its safety and effectiveness.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria for diagnostic performance and corresponding reported performance values for the CombiDiagnost R90's imaging capabilities (e.g., sensitivity, specificity for a particular pathology). Instead, it presents a comparison of technological characteristics between the proposed device and its predicate, along with a statement that non-clinical tests met acceptance criteria.
Technological Characteristics Comparison (Proposed Device vs. Predicate Device)
| Feature | Primary Predicate Device: EasyDiagnost Eleva (K031535) | Proposed Device: CombiDiagnost R90 (K163210) | Discussion |
|---|---|---|---|
| Table Features | |||
| Working height | 83cm | 62 cm – 142 cm | Similar; the range of working height does not affect the safety or effectiveness of the device. |
| Table tilt movement | -20° to +90°Optional: -30° to +90°, -45° to +90°, -85° to +90° | -90° to +90° | Similar: The table tilt movement does not affect the safety or effectiveness of the device. |
| Table top suspension | Back and sides | Two sides suspensions | Similar: Two side table side suspension does not affect the safety or effectiveness of the device. |
| Table top material | Plastic laminate or carbon fiber | Same | Equivalent. |
| Table top movement | Lateral: -10 cm to + 9 cmLongitudinal: ± 83 cm | Same | Equivalent |
| Table top absorption | 0.7mm typical (@ 100kV, 2.7mm Al HVL) | Plastic, with Carbon fiber: 0.6mm Al @ 100kV, HVL = 3.6mm Al | Similar: Minor differences in the table top absorption does not affect the safety or effectiveness of the device. |
| Maximum patient weight | 180 kg | 284 kg (626 lbs) | The proposed CombiDiagnost R90 is able to hold more patient weight; this does not affect the safety or effectiveness of the device. |
| Lateral scan distance | 22 cm | 32 cm ± 16 cm | Similar: The range of lateral scan distances provided with the proposed CombiDiagnost R90 does not affect the safety or effectiveness of the device. |
| Lateral scan speed | Manual Movement | 5 cm/s, soft start and stopAuto centering | The automated lateral scan speed provided with the proposed CombiDiagnost R90 does not affect the safety or effectiveness of the device. |
| Longitudinal scan distance | 75 cm | 160 cm longitudinal, motorized | Similar: The extended longitudinal motorized scan distance of the proposed CombiDiagnost R90 does not affect the safety or effectiveness of the device. |
| Longitudinal scan speed | Manual Movement (Servo Support) | 3 cm - 20 cm / sec | Similar: The longitudinal scan speed provided with the proposed CombiDiagnost R90 does not affect the safety or effectiveness of the device |
| Table column angulation | N/A | -40° to +40° | The table angulation provided with the proposed CombiDiagnost R90 does not affect the safety or effectiveness of the device. |
| Source image distance | 73cm - 103cm, 88cm - 118cm with Geomat in extended position | 113cm - 183cm | Similar: The source image distance provided with the proposed CombiDiagnost R90 does not affect the safety or effectiveness of the device. |
| Collimator | Square / rectangular plus Iris | Motorized automatic collimation | The motorized collimator provided with the proposed CombiDiagnost R90 does not affect the safety or effectiveness of the device. |
| Preparation time for exposure | 0.4 - 1.8 sec (depends on X-ray Tube and technique) | 1 sec (approximately) | Similar: The minor difference in the preparation time does not affect the safety or effectiveness of the device. |
| Grid | Parkable | Same | Equivalent: No effect on the safety or effectiveness of the device. |
| Auto Grid Selection | Yes | Same | Equivalent: No effect on the safety or effectiveness of the device. |
| Automatic pre-position of the table | No | Yes | The automatic pre-position of the table provided with the proposed CombiDiagnost R90 does not affect the safety or effectiveness of the device. |
| Picture archiving and communication system | Yes | Same | Equivalent: No effect on the safety or effectiveness of the device. |
| Image chain (fluoroscopy) | Philips Image Intensifier / CCD TV / Digital Imaging | Philips dynamic Eleva Image Chain | The proposed CombiDiagnost R90 includes the cleared Philips Eleva WorkSpot of the reference device (K153318) as part of the image chain. Therefore, no effect on the safety or effectiveness of the device |
| Detector | Image Intensifier 23 cm, 31 cm or 38 cm | Pixium FE 4343F (cleared via K080859 – Villa Sistemi Medicali S.p.A.) | No impact on the safety or effectiveness of the device. The detector data is from the reference device Philips Eleva WorkSpot (K153318) |
| Generator | Philips Velara RF 50kW, 65kW or 80kW | Philips Velara 65kW, optional 80 kW | Equivalent; The proposed CombiDiagnost R90 uses a Philips generator that operates in the same manner. |
| Tube | Philips SRO 2550 or SRM 2250 GS | Philips SRO 33100 ROT 380 or SRM 0608 ROT GS 505 | Equivalent; The proposed CombiDiagnost R90 uses Philips tubes that operate in the same manner. |
| System Control | Near by | Remote | The proposed CombiDiagnost R90 uses a remote system control. This does not affect the safety and effectiveness. |
| Indications for Use | The Philips EasyDiagnost Eleva intended use is for the following applications: As a multi-functional/ universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications. | CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography. | Equivalent; The Indications for Use for the proposed CombiDiagnost R90 is more general in nature. |
The study (non-clinical verification and validation tests as well as image quality testing) "demonstrate[d] that the proposed CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use." The acceptance criteria for these non-clinical tests are defined by the referenced international and FDA-recognized consensus standards.
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 as it is a 510(k) submission for an X-ray system, not a diagnostic AI algorithm. The "test set" here refers to the physical device undergoing non-clinical technical testing, not a dataset of patient images.
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 applicable as the document describes non-clinical technical testing of an X-ray system, not a diagnostic study requiring expert ground truth for image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #3.
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 done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the purpose of this 510(k) submission for an X-ray system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study of a diagnostic algorithm was not done. This document concerns an X-ray imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing of the CombiDiagnost R90, the "ground truth" would be established by engineering specifications and validated measurement equipment according to the referenced standards (e.g., IEC 62220-1 for detective quantum efficiency, IEC 60601 series for safety and performance). This is a technical ground truth, not a clinical one based on patient outcomes or expert reads.
8. The sample size for the training set
This information is not applicable as the device is an X-ray system, not an AI algorithm requiring a training set of images.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2017
Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Specialist North America Roentgenstrasse 24-26 Hamburg, 22335 GERMANY
Re: K163210 Trade/Device Name: CombiDiagnost R90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, KPR and MQB Dated: January 17, 2017 Received: January 25, 2017
Dear Ming Xiao:
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.
Michael D.'Hara
For
Robert Ochs, Ph.D. 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) K163210
Device Name CombiDiagnost R90
Indications for Use (Describe)
CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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7. 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | January 26, 2017 | ||
|---|---|---|---|
| Manufacturer: | Philips Medical Systems DMC GmbHRoentgenstrasse 24-2622335 HamburgGERMANYEstablishment registration number: 3003768251 | ||
| Primary ContactPerson: | Ming XiaoRegulatory Affairs SpecialistNorth AmericaPhone: +49 40 5078-2306Fax: +49 40 5078-2425E-mail: ming.xiao@philips.com | ||
| Device Name: | CombiDiagnost R90 | ||
| Classification: | Classification Name: | Image-intensified fluoroscopic x-raysystem | |
| Classification Regulation: | 21CFR 892.1650 | ||
| Classification Panel: | 90 -- Radiology | ||
| Device Class: | Class II | ||
| Primary Product Code: | JAA | ||
| Secondary Product Codes: | KPR, MQB | ||
| Primary PredicateDevice: | Trade Name: | Philips EasyDiagnost Eleva | |
| Manufacturer: | Philips Medical Systems DMC | ||
| 510(k) Clearance: | K031535 – June 17, 2003 | ||
| Classification Name: | Image-intensified fluoroscopic x-raysystem; Stationary x-ray system; Spot-film device; Tilting Radiographic table | ||
| Classification Regulation: | 21CFR 892.1650; 21CFR 892.1680;21CFR 892.1670; 21CFR 892.1980 | ||
| Classification Panel: | Radiology | ||
| Device Class: | Class II | ||
| Product Codes: | JAA, KPR, IXL and IXR | ||
| Reference Device: | Trade Name: | Eleva Workspot with SkyFlow | |
| Manufacturer: | Philips Medical Systems | ||
| 510(k) Clearance: | K153318 – Dec 22, 2015 | ||
| Classification Name: | Stationary X-Ray System | ||
| Classification Regulation: | 21CFR 892.1680 | ||
| Classification Panel: | 90 -- Radiology | ||
| Device Class: | Class II | ||
| Product codes: | MQB, LLZ |
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Device The CombiDiagnost R90 is a multi-functional remote controlled Description: fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tilt- and heightadjustable patient support and a scan unit consisting of a tube and a flat panel detector, Pixium FE 4343F. The tabletop can be moved by a motor in the lateral direction and can be tilted +/- 90 degrees. The scan unit tilts with the table and can be moved in the longitudinal direction, relative to the table and to the patient. The fully integrated system is provided with a touch screen console, glass or metal x-ray tube(s) with collimator and high resolution displays. As a fully integrated system, the proposed CombiDiagnost R90 can be configured with a Philips generator, the flat panel detector Pixium FE 4343F, and the Philips Dynamic Eleva Image Chain acquisitionstation also provided with the currently marketed and reference device, Eleva Workspot with SkyFlow (Eleva Workspot). The proposed CombiDiagnost R90 uses the same workflow from the currently marketed and reference device, Eleva Workspot with SkyFlow. The only modification to the Eleva Workspot is integration with the Pixium FE 4343F detector.
Indications for CombiDiagnost R90 is a multi-functional general R/F system. It is Use: suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
Fundamental R90 is a multi-functional remote controlled CombiDiagnost Scientific fluoroscopy system in combination with high-end digital radiography Technology: consisting of a floor-mounted tilt- and height-adjustable patient -
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support and a scan unit consisting of a tube and a flat detector. It is designed for fluoroscopy examinations of the recumbent, standing or seated patient and also for lateral exposures. Fine positioning of the tube and collimator on the patient is easy to carry out using control grips and control buttons on table or tube user interfaces. It is quite convenient to be operated in hospitals. CombiDiagnost R90 is intended for use in generating radiographs of human anatomy by qualified/trained doctors or technicians. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Based on the information provided above, the CombiDiagnost R90 is considered substantially equivalent to the primary currently marketed and predicate device EasyDiagnost Eleva (K031535, June 17, 2003) in terms of fundamental scientific technology.
This modified device has the same indications for use and Summary of technological characteristics as the primary predicate device, technological Eleva. Comparisons of the technological characteristics: EasyDiagnost characteristics demonstrate the substantial equivalence to the primary predicate device.
| Primary Predicate Device:EasyDiagnost Eleva(K031535) | Proposed Device:CombiDiagnost R90(K163210) | Discussion | |
|---|---|---|---|
| Table Features | |||
| Working height(table top center tofloorplate) | 83cm | 62 cm – 142 cm | Similar; the range of workingheight does not affect thesafety or effectiveness of thedevice. |
| Table tiltmovement | -20° to +90°Optional:-30° to +90°-45° to +90°-85° to +90° | -90° to +90° | Similar: The table tiltmovement does not affect thesafety or effectiveness of thedevice. |
| Table topsuspension | Back and sides | Two sides suspensions | Similar: Two side table sidesuspension does not affect thesafety or effectiveness of thedevice. |
| Table top material | Plastic laminate or carbonfiber | Same | Equivalent. |
| Table topmovement | Lateral: -10 cm to + 9 cmLongitudinal: ± 83 cm | Same | Equivalent |
| Table topabsorption | 0.7mm typical (@ 100kV,2.7mm Al HVL) | Plastic, with Carbon fiber:0.6mm Al @ 100kV,HVL = 3.6mm Al | Similar: Minor differences inthe table top absorption doesnot affect the safety oreffectiveness of the device. |
| Maximum patientweight | 180 kg | 284 kg (626 lbs) | The proposed CombiDiagnostR90 is able to hold more |
| Primary Predicate Device:EasyDiagnost Eleva(K031535) | Proposed Device:CombiDiagnost R90(K163210) | Discussion | |
| patient weight; this does notaffect the safety or effective-ness of the device. | |||
| Lateral scandistance | 22 cm | 32 cm ± 16 cm | Similar: The range of lateralscan distances provided withthe proposed CombiDiagnostR90 does not affect the safetyor effectiveness of the device. |
| Lateral scan speed | Manual Movement | 5 cm/s, soft start and stopAuto centering | The automated lateral scanspeed provided with theproposed CombiDiagnost R90does not affect the safety oreffectiveness of the device. |
| Longitudinal scandistance | 75 cm | 160 cm longitudinal,motorized | Similar: The extendedlongitudinal motorized scandistance of the proposedCombiDiagnost R90 does notaffect the safety or effective-ness of the device. |
| Longitudinal scanspeed | Manual Movement (ServoSupport) | 3 cm - 20 cm / sec | Similar: The longitudinal scanspeed provided with theproposed CombiDiagnost R90does not affect the safety oreffectiveness of the device |
| Table columnangulation | N/A | -40° to +40° | The table angulation providedwith the proposedCombiDiagnost R90 does notaffect the safety or effective-ness of the device. |
| Source imagedistance | 73cm - 103cm,88cm - 118cm with Geomatin extended position | 113cm - 183cm | Similar: The source imagedistance provided with theproposed CombiDiagnost R90does not affect the safety oreffectiveness of the device. |
| Collimator | Square / rectangular plusIris | Motorized automaticcollimation | The motorized collimatorprovided with the proposedCombiDiagnost R90 does notaffect the safety oreffectiveness of the device. |
| Preparation timefor exposure | 0.4 - 1.8 sec (depends on X-ray Tube and technique) | 1 sec (approximately) | Similar: The minor differencein the preparation time doesnot affect the safety oreffectiveness of the device. |
| Grid | Parkable | Same | Equivalent: No effect on thesafety or effectiveness of thedevice. |
| Auto GridSelection | Yes | Same | Equivalent: No effect on thesafety or effectiveness of thedevice. |
| Automatic pre-position of thetable | No | Yes | The automatic pre-position ofthe table provided with theproposed CombiDiagnost R90does not affect the safety oreffectiveness of the device. |
| Primary Predicate Device:EasyDiagnost Eleva(K031535) | Proposed Device:CombiDiagnost R90(K163210) | Discussion | |
| Picture archivingandcommunicationsystem | Yes | Same | Equivalent: No effect on thesafety or effectiveness of thedevice. |
| Image chain(fluoroscopy) | Philips Image Intensifier /CCD TV / Digital Imaging | Philips dynamic ElevaImage Chain | The proposedCombiDiagnost R90 includesthe cleared Philips ElevaWorkSpot of the referencedevice (K153318) as part ofthe image chain. Therefore,no effect on the safety oreffectiveness of the device |
| Detector | Image Intensifier 23 cm, 31cm or 38 cm | Pixium FE 4343F (clearedvia K080859 – VillaSistemi Medicali S.p.A.) | No impact on the safety oreffectiveness of the device.The detector data is from thereference device PhilipsEleva WorkSpot (K153318) |
| Generator | Philips Velara RF 50kW,65kW or 80kW | Philips Velara 65kW,optional 80 kW | Equivalent; The proposedCombiDiagnost R90 uses aPhilips generator thatoperates in the same manner. |
| Tube | Philips SRO 2550 or SRM2250 GS | Philips SRO 33100 ROT380 or SRM 0608 ROTGS 505 | Equivalent; The proposedCombiDiagnost R90 usesPhilips tubes that operate inthe same manner. |
| System Control | Near by | Remote | The proposedCombiDiagnost R90 uses aremote system control. Thisdoes not affect the safety andeffectiveness. |
| Indications forUse | The Philips EasyDiagnostEleva intended use is for thefollowing applications: As amulti-functional/ universalsystem, general R/F, Fluoro-scopy, Radiography andAngiography can beperformed along withpediatric examinations andsome more specializedinterventional applications. | CombiDiagnost R90 is amulti-functional generalR/F system. It is suitablefor all routine radiographyand fluoroscopy exams,including specialist areaslike angiography orpediatric work, excludingmammography. | Equivalent; The Indicationsfor Use for the proposedCombiDiagnost R90 is moregeneral in nature. |
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This 510(k) premarket notification contains technical documentation Summary of Non-Clinical which includes non-clinical verification and validation tests as well as image quality testing. Tests were performed on the proposed Data: CombiDiagnost R90 according to the following international and FDArecognized consensus standards:
- ISO 14971, Medical devices. Application of risk management to . medical devices
- · IEC 60601-1, Medical electrical equipment. General
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requirements for safety. Collateral standard. Safety requirements for medical electrical systems
- . IEC 60601-1-2. Medical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
- 60601-1-3. Medical equipment. IEC General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
- 60601-2-54, Medical electrical equipment. IEC Particular requirements for the basic safety and essential performance of Xray equipment for radiography and radioscopy
- . IEC 62220-1. Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
- IEC 62304, Medical device software. Software life-cycle ● processes
The test results demonstrate that the proposed CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use.
Based upon the same intended use, similar technology, software functionalities, same product configuration and administration, and similarity of materials, it can be concluded the proposed CombiDiagnost R90 is substantially equivalent to the primary predicate device EasyDiagnost Eleva, in terms of intended use, design characteristics, and safety and effectiveness.
Summary of The proposed CombiDiagnost R90 did not require a clinical study since Clinical Data: substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes:
- . Design features;
- Indication for use;
- . Fundamental scientific technology;
- Non-clinical performance testing including validation; and ●
- . Safety and effectiveness.
Substantial comparison of technological characteristics, non-clinical The Equivalence performance data, safety testing, software validation, and clinical image Conclusion: concurrence data demonstrates that the device is as safe and effective as the predicate device. Philips Medical Systems concludes that the proposed CombiDiagnost R90 is substantially equivalent to the legally marketed primary predicate device, EasyDiagnost Eleva.
§ 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.