PLATINUM DRF IMAGING SYSTEM

{0}------------------------------------------------ # DEC 1 2 2013 K131766 Page 1 of 4 ### Traditional 510(k) Summary as required by 21 CFR 807.92(a) | A) Submitted by: | APELEM- DMS GROUP | |------------------|--------------------------------------------| | | Parc Scientifique Georges Besse | | | 175 Allée Von Neumann. 30035 Nîmes cedex 1 | | | France | | | Phone : +33 (0)4 67 50 49 00 | | | Fax : +33 (0)4 67 50 40 09 | Sharyn Orton. Ph.D. Contact: MEDIcept. Inc. 200 Homer Ave. Ashland. MA 01721 | B) Date Prepared: | October 24. 2013 | |-------------------------------|-----------------------------------------------| | C) Common Name: | System, X-Ray Fluoroscopic. Image-Intensified | | Proprietary Name: | Platinum dRF Imaging System | | Device Regulations and Class: | 21 CFR 892.1650. Class II | | Product Code: | JAA | | Classification Panel: | Radiology | | C) Predicates: | K062623 Siemens AXIOM Luminos dRF | D) Device Description: The Apelem-DMS Platinum dRF Imaging System (*Platinum*) is not a stand-alone device, but functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator. X-ray tube and software imaging packages), that are installed with a Apelem-DMS manufactured radiological examination table, control panel with system controller software. and electrical panel. The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography. This device allows for treatment on the whole body, using all angles. It allows the user dynamic acquisition for the whole body, to target the zones to analyze, and to be able to track contrast media. {1}------------------------------------------------ E) Intended Use/Indication for Use: The Platinum dRF Imaging Svstem is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy. conventional linear tomography, angiography and pediatric examinations. The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA). The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations. The Platinum dRF is not indicated for use in interventional radiology. F) Comparison to Predicate Device(s): | | Platinum dRF Imaging System | Siemens AXIOM Luminos dRF<br>K062623 | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Product code | JAA | JAA, OWB. OXO | | Components | | | | Flat detector | Trixell Pixium RF 4343<br>(K080859) | Trixell Pixium RF 4343 | | Collimator | RALCO R225 ACS<br>(K091517) | Self manufactured | | Type | Motorized, remote controlled, with<br>± 45° manual rotation according to<br>a vertical axis. automatic lighting<br>on, including positioning camera | Motorized up to a maximum of ±<br>45°. detent at 0° | | Field coverage | min 4X4 and max 48X48 at<br>100 cm source to image distance | min/max not reported | | Generator | CMT Indico 100 Series | Self manufactured | | Power | 50-80 kW | 65 kW or 80 kW (optional) | | AEC Interface | 4 ionization chambers max (solid<br>state ionization 3 fields) | Not available | | X-ray tube | Varian 600 kHU tubes RAD92 and<br>G292: 400 kHU tube RAD60 | Self manufactured | | Use with X-ray<br>ceiling tube | Yes | Yes | | X-ray Grid | Smit Röntgen | Self manufactured | | Tube motorized<br>rotation | +180°/-180° | +180/-90° | {2}------------------------------------------------ | | Platinum dRF Imaging System | Siemens AXIOM Luminos dRF<br>K062623 | |------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | Oblique | 45°/-45° motorized adjustment of | 40°/-40°: motorized adjustment of | | projections | the height of the rotation axis from | the height of the rotation axis from | | | 10 to 450 mm above the table (to | 10 to 300 mm above the table (to | | | correct object parallax) | correct object parallax) | | | The angle is displayed on both the | The angle is displayed on both the | | | control console and on the table's | control console and on the table's | | | control panel | control panel | | Distance between | 6.2 cm | 7 cm | | table-top and | | | | detector<br>Anti-diffusion | Oscillating: ratio 10:1, 12:1 / | Fixed : ratio 15:1. 80 lignes/cm, f0 | | grid | 401:cm - 60 1:cm / Multifocus 140 | = 125 cm, easy ejection from the | | | cm for exams in the range of 110 to | front of the table | | | 180 cm : easy ejection from the | | | | front of the table | | | Movement of the | Max 158 cm (remotely), | Max 113 cm (remotely). | | AB selector | adjustments by increments up to 6 | adjustments by increments up to 7 | | | cm/sec | cm/sec : PERISTEPPING step to | | | | step movements of 25 cm each | | Compression | 0-160 N with a compression | 5-155N | | cone | indication above 3 kg | | | Imaging Software | CMT Thales Duet | Flurospot COMPACT digital | | | (K103028) | imaging system | | Image resolution | 3.4 lp/mm | 3.4 lp/mm | | Speed | 12 f/s (RAD) | 8 f/s (RAD) | | | 18 f/sec for fluoroscopy (large | 15 f/s for fluoroscopy | | | field) | | | Dose Reduction | Yes | Yes | | DICOM | Yes | Yes | | DAP measuring | 0.1 - 99 999 999 µGy.m2 | Not available | | range | | | | Pulse frequency | 15, 7.5 and 3 pulsed per sec | 15, 10, 7.5 and 3 pulsed per sec | | | Platinum dRF Imaging System | Siemens AXIOM Luminos dRF<br>K062623 | | Table<br>specifications | | | | Table Tilting | +90°/-90° | +90°/-45° or +90°/-90° (optional) | | | Variable tilting up to 10°/sec | Two speeds about 3°/sec and<br>6°/sec. | | | | Time for complete tilt +90° to 0° :<br>17 sec | | | Automatic stop in the 0° position is<br>possible / angle indication on the<br>remote control panel as well as the<br>panel on the front of the table. | Automatic stop in the 0° position<br>is possible / angle indication on<br>the remote control panel as well as<br>the panel on the front of the table. | | Table top height | 50 cm to 130 cm continuously<br>adjustable, about 4 cm/sec | 50 cm to 100 cm continuously<br>adjustable. about 4 cm/sec | | | 48 cm - 128 cm with the base plate | 48 cm - 98 cm with the base plate<br>not encrusted in the floor | | Table top | 240 x 85 cm / radio transparent<br>field: 283 x 65 cm / surface<br>inalterable / sliding rail system | 210 X 80 cm / radio transparent<br>field : 193 x 53.5 cm / surface<br>inalterable / sliding rail system | | | Equivalent attenuation value :<br><0.70 mm (+/- 0.1 Al à 100 kV/3.7<br>mm Al HVL | Equivalent attenuation value : 0.65<br>mm (+/- 0.1 Al à 100 kV/3.7 mm<br>AI HVL | | Movement | Laterally; longitudinally<br>5 way movement: 8 way movement<br>including Z-motion and tilt motion | Laterally; longitudinally<br>8-way movement | | Weight tolerance | 265 kg with no restrictions | 230 kg | | Longitudinal<br>movement of the<br>table top<br>(optional) | 150 cm (±75 cm) | 160cm (±80 cm) | | Transversal<br>movement of the<br>table top | 35 cm (±17.5 cm) speed around 6<br>cm/sec | 35 cm (±17.5 cm) speed around<br>4.5 cm/sec | | Patient coverage | 201 cm with 2 way<br>283 cm with 4 way | Not available | | Focal distance | 110 - 180 cm | 115 - 150 cm | | Measuring<br>detector/focal<br>point | 50 cm | Not available | {3}------------------------------------------------ {4}------------------------------------------------ #### Substantial Equivalence Discussion The Platinum dRF Imaging System has a similar intended use, the same technology, and uses identical or the same general components as the predicate device. Components and/or component specifications are nearly identical between the Platinum and predicate device. Compared to the predicate device, the Platinum has larger table specifications, larger rotation ability, and greater movement of the AB selector. These differences are designed to allow for larger, taller patients to be examined and for the examinations themselves to conduct. This ability has no impact on the imaging functionality of the device, and does not raise new or different issues of safety or effectiveness. All of the features of the Platinum dRF Imaging System are substantially equivalent to the similar features of the predicate device. #### Performance The Platinum is not a stand-alone device, but functions as a platform for FDA cleared or registered components. The Platinum is manufactured with FDA cleared/registered commercially available imaging components. Data as required in the appropriate sections of 21 CFR 1020 have been generated by the appropriate component manufacturer, and included in their manuals. Data generated by Apelem-DMS is limited to that required in CFR 1020.31(e)(1). No additional special imaging performance testing was conducted. Electrical/EMC testing was successfully conducted per the standards listed below. ### Software The system integration and interconnection software was developed. tested and documented in compliance with FDA Guidance "General Principles of Software Validation: Final Guidance for Industry and FDA Staff". January 2002. ### Conformity to Standards and 21 CFR 1020.30 The Platinum complies with: - IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment -. Part 1: General requirements for basic safety and essential performance . - IEC 60601-1-3:2008 Medical electrical equipment Part 1-3: General requirements for . basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment - IEC 60601-1-6 :2010 Medical electrical equipment Part 1-6: General requirements for . basic safety and essential performance - Collateral standard: Usability - IEC 62366: 2007 Medical devices -- Application of usability engineering to medical . devices - IEC 60601-2-54:2009 Medical electrical equipment Part 2-54: Particular requirements . for the basic safety and essential performance of X-ray equipment for radiography and radioscopy {5}------------------------------------------------ K131766 Page 6 of 6 - 1EC 60601-1-2: 2007 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - NEMA XR7-1995 (R2000) High Voltage X-ray Cable Assemblies and Receptacles (for . the Claymount X-ray Cables) - NEMA PS 3.1-3.20 (2011) Digital Imaging and Communications in Medicine � (DICOM) Set - 21 CFR 1020.30. 1020.31 and 1020.32 as applicable . ### Conclusion The Apelem-DMS Platinum dRF Imaging System features are substantially equivalent to the similar features of the Siemens AXIOM Luminos predicate device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure embracing a globe or sphere. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 12, 2013 Apelem-DMS Group % Sharyn Orton, Ph.D. Senior Consultant MEDIcept, Inc. 200 Homer Avenue ASHLAND MA 01721 Re: K131766 Trade/Device Name: Platinum dRF Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: October 25, 2013 Received: October 30, 2013 Dear Dr. Orton: 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. Iisting 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. {7}------------------------------------------------ Page 2 - Dr. Sharyn Orton If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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/McdicalDevices/Safetv/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/ResourcesforYou/Industry/default.hum. Sincerely yours. Smh.7) Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health for Enclosure {8}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K 131766 ## Device Name Platinum dRF Imaging System #### Indications for Use (Describe) The Plainum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic sudies. Using a digital flat detector. it cange of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations. The Plainum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointesinal examinations, cranial, shoracic and lung exposures as well as examination of the units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA). The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations. The Platinum dRF is not indicated for use in interventional radiology. 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) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) FORM FDA 3881 (9/13) PSU Publishing Services ( 1/2) : 443-6741 {9}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### 'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.' The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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