The Platinum dRF Imaging System 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 radiology and diagnostic fluoroscopy examinations, conventional linear tomography and pediatrics 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, cranial, skeletal, thoracic, lung and urogenital tract examinations.

It may also be used in: lymphography, endoscopy, myelography, venography and arthrography.

The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed).

The Platinum dRF is not indicated for use in interventional radiology.

Device Description

The subject of this Special 510(k) application is the change to the imaging software system to the ADAM Imaging System. As the resources are now available, Apelem-DMS Group was able to develop their own Imaging System called the ADAM Imaging System. The ADAM Imaging System will now be developed by Apelem-DMS Group. The predicate device (K160301) had an Off the Shelf Software Imaging System called DUET DRF Imaging System which was developed by Thales.

The ADAM Imaging System is a digital image acquisition system to be used in conjunction with a detector during radiography or fluoroscopy X-ray examinations to acquire, display, process and export images according to DICOM protocol via a network connection.

The ADAM Imaging System software interfaces with an X-Ray detector to acquire raw pixel data and image processing algorithms which transform raw pixel data into images and image sequences to help medical professionals with viewing images to for patient diagnosis.

The Duet DRF requires the use of the THALES RF4343 FL detectors, whereas ADAM Imaging System requires the use of the VIEWORKS VIVIX-D 1717G detector. Both detectors employ the same state-of-the-art indirect conversion technology based on CsI scintillator and photo-diodes. The detector Vivix-D 1717G is connected to the x-ray system by cable. The integration with the PLATINUM dRF system has been established and appears adequate. The VIEWWORKS VIVIX-D 1717G detector is only compatible with the ADAM Imaging System.

The Duet DRF and ADAM Imaging System are designed to support general radiography (excluding mammography) and fluoroscopy imaging procedures.

The Apelem-DMS Group ADAM Imaging System is not a stand-alone device. It is integrated into the Platinum dRF Imaging System and 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 Group 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.

AI/ML Overview

The provided document is a 510(k) summary for the Platinum dRF Imaging System and does not contain detailed information about acceptance criteria or a study proving that the device meets those criteria. The document states that the new ADAM Imaging System component changes the internal imaging software and detector, but it does not include performance data or explicit acceptance criteria for image quality, diagnostic accuracy, or clinical effectiveness.

The submission focuses primarily on demonstrating substantial equivalence to a predicate device (K160301) by comparing technical specifications and highlighting that the proposed changes do not raise new questions of safety or effectiveness. It mentions compliance with various IEC and ISO standards related to medical electrical equipment, software, and risk management, which are general safety and performance standards rather than specific acceptance criteria for a diagnostic imaging study.

Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted from this document.

However, based on the available information, here's what can be inferred:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics for a diagnostic study. The document primarily focuses on demonstrating that the performance of the new detector (VIEWORKS VIVIX-D 1717G) is "similar enough" or "sufficient" compared to the predicate's detector.
Reported Device Performance: The document provides technical specifications of the new detector and compares them to the predicate's detector, implying these are the performance characteristics considered.

Metric	Acceptance Criteria (Implied)	Reported Device Performance (ADAM Imaging System Detector)	Reported Predicate Performance (DUET Imaging System Detector)	Comment
Scintillator	Same as predicate	CsI	CsI	Same
Pixel Pitch	Similar to predicate; smaller is generally better	140µm	148µm	ADAM Imaging System's detector has a smaller pixel pitch which means better detail detectability.
Pixel Matrix	Similar to predicate; larger is generally better	3072 x 3072 pixels	2874 x 2840 pixels	Adam Imaging System's detector has a larger pixel matrix which means a larger detection field.
Image Size	Same as predicate	17" x 17"	17" x 17"	Same
Grayscale	Same as predicate	16 bits	16 bit	Same
Resolution	Performance similar enough (>3%) for indicated procedures	3.5 linepairs/mm	3.4 linepairs/mm	The performance of both detectors are similar enough (>3%) for the procedures indicated.
Modulation Transfer Function (MTF)	Performance of both detectors sufficient for general radiographic procedures	MTF IEC 0.5 lp/mm: Minimal 78%, Typical 83% MTF IEC 1 lp/mm: Minimal 50%, Typical 55% MTF IEC 2 lp/mm: Minimal 20%, Typical 25% MTF IEC 3 lp/mm: Minimal 5%, Typical 10%	MTF IEC 0.5 lp/mm: Minimal 79%, Typical N/A MTF IEC 1 lp/mm: Minimal 55%, Typical 66% MTF IEC 2 lp/mm: Minimal 25%, Typical 35% MTF IEC 3 lp/mm: Minimal 10%, Typical 19%	Performance of both detectors are sufficient for general radiographic procedures. (Predicate listed MTF IEC Nyquist as 7% Minimal, 15% Typical)
Detective Quantum Efficiency (DQE)	DQE difference <5% considered equivalent, and small clinical significance (<10% variation) in required dose.	75%	78% (if shot noise only)60-65% (0.5 lp/mm)	Difference low enough to be considered equivalent; <10% variation in required dose, <5% DQE difference might be error margins.
Dimensions	Not increase, ideally smaller for easier installation	471 x 471 x 35 mm	500 x 490 x 45.5 mm	VIEWORKS detector is smaller than the predicate which will enable easier installation.
Weight	Differences with no impact	10 kg	9.1 kg	VIEWORKS detector is heavier than the predicate but as the difference is less than 1 kg there is no impact.

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The submission focuses on technical specifications of the components rather than a clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. No clinical or diagnostic performance study with expert adjudication is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication method is described as no clinical performance study is detailed.

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

This information is not applicable/not provided. The device is an imaging system (hardware and software for image acquisition and display), not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/not provided. The device is a complete imaging system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. The submission relies on technical specifications and compliance with standards, not on a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

This information is not provided. As no AI/machine learning component for diagnosis is indicated, a 'training set' in that context is not relevant to this submission. The software changes are for image acquisition, display, and processing.

9. How the ground truth for the training set was established

This information is not provided. See point 8.

Summary

{0}------------------------------------------------

January 22, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Apelem-DMS Group % Mr. Scott Blood Senior Regulatory Affairs Consultant MEDIcept, Inc. 200 Homer Avenue ASHLAND MA 01721

Re: K203010

Trade/Device Name: Platinum dRF Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA Dated: December 21, 2020 Received: December 28, 2020

Dear Mr. Blood:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203010

Device Name Platinum dRF Imaging System

Indications for Use (Describe)

It may also be used in: lymphography, endoscopy, myelography, venography and arthrography.

The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, while "CEPT" is in a cursive, purple font. Below the company name is the phrase "Trusted Solutions, Rapid Response" in a smaller font.

1. 510(K) SUMMARY K203010

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR ട്ല 807.92.

1.1. Submitter's Information

Name: Apelem-DMS Group Address: Parc Scientifique Georges Besse, 175 Allee Von Neumann, 30035 Nimes cedex 1 France

33 466 29 09 07 Phone:

Official FDA Contact:

MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 Scott Blood sblood@medicept.com 978-729-5978

Date Prepared: November 4th, 2020

1.2. Device Administrative Information

Trade Name:	Platinum dRF Imaging System
Device Name:	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Common Name:	System, X-Ray Fluoroscopic, Image-Intensified
Regulatory Class:	Class II per 21 CFR 892.1650
Product Code:	JAA- 21 CFR 892.1650, Image-intensified fluoroscopicx-ray system
Classification Panel:	Radiology

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, while the word "CEPT" is in a cursive, purple font. Below the company name is the phrase "Trusted Solutions, Rapid Response" in a smaller, gray font.

2. LEGALLY MARKETED PREDICATE DEVICE

The following is the identified predicate device:

The predicate referenced below has not been subject to a design-related recall.

Apelem-DMS Group Group – K160301–Platinum dRF Imaging System

Indications for Use: ●

Indications for Use for DMS Platinum dRF Imaging System:

The Platinum dRF Imaging System 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.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is a logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters. The word "CEPT" is in a stylized purple font. Below the words is the phrase "Trusted Solutions, Rapid Response" in a smaller font, with "Trusted Solutions" in gray and "Rapid Response" in purple.

3. DEVICE DESCRIPTION

The Duet DRF and ADAM Imaging System are designed to support general radiography (excluding mammography) and fluoroscopy imaging procedures.

3.1. Indications for Use (Proposed Device)

Indications for Use for DMS Platinum dRF Imaging System:

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, while "CEPT" is in a stylized purple font. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller font, with "Trusted Solutions" in purple and "Rapid Response" in gray.

It may also be used in: lymphography, endoscopy, myelography, venography and arthrography.

The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed).

The Platinum dRF is not indicated for use in interventional radiology.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for MEDICEPT. The first part of the logo, "MEDI", is in blue, while the second part, "CEPT", is in purple. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller font size.

SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION 4.

	Proposed Device(This Submission):ADAM Imaging System integratedinto the DMS Platinum dRFImaging System	Predicate Device:(K160301)Duet Imaging System integratedinto the DMS Platinum dRFImaging System
FDA ProductCode	JAA	JAA
SingleUse/Reusable	Reusable	Same
Indications forUse	The Platinum dRF Imaging System isintended to be used as a universaldiagnostic imaging system forradiographic and fluoroscopic studies.Using a digital flat detector, it canperform a range of applicationsincluding: general radiology anddiagnostic fluoroscopy examinations,conventional linear tomography andpediatrics examinations.The Platinum dRF is a deviceintended to visualize anatomicalstructures by converting a pattern ofX-ray into a visible image. Thesystem has medical applicationsranging from, but not limited to,gastrointestinal, cranial, skeletal,thoracic, lung and urogenital tractexaminations.It may also be used in: lymphography,endoscopy, myelography, venographyand arthrography.The Platinum dRF may also be usedfor outpatient or emergency services,as well as for mobile transportexaminations (wheelchair and bed).The Platinum dRF is not indicated foruse in interventional radiology.	The Platinum dRF Imaging System isintended to be used as a universaldiagnostic imaging system forradiographic and fluoroscopic studies.Using a digital flat detector, it canperform a range of applicationsincluding general R/F, diagnosticfluoroscopy, conventional lineartomography, angiography andpediatric examinations.The Platinum dRF is a deviceintended to visualize anatomicalstructures by converting a pattern ofX-ray into a visible image. Thesystem has medical applicationsranging from but not limited togastrointestinal examinations, cranial,skeletal, thoracic and lung exposuresas well as examination of theurogenital tract.The units may also be used inlymphography, endoscopy,myelography, venography, pediatrics,arthrography, digital angiography anddigital subtraction angiography(DSA).The Platinum dRF may be used foroutpatient and emergency treatment,
	Proposed Device(This Submission):ADAM Imaging System integratedinto the DMS Platinum dRFImaging System	Predicate Device:(K160301)Duet Imaging System integratedinto the DMS Platinum dRFImaging System
		as well as for mobile transport(wheelchair and bed) examinations.The Platinum dRF is not indicated foruse in interventional radiology.
Use Environment	Hospital or clinical setting by alicensed doctor, orthopedicsurgeon, radiologist, radiologicaltechnician, or technicianauthorized by the manufacturer	Same
Patient Contact	The patient does not come intodirect contact with the ADAMImaging System component or theDetector. The patient comes incontact with the examination tableonly.	Same
Flat Detector	VIEWORKS VIVX-D 1717G	RF4343 FL
Frame Rate	12f/sec (RAD)18f/sec fluoroscopy (large field),No change	Same
Image Specifications	No Change	Same
Lead Shield	Included	Same
Platinumexaminationremote controltable	No change	Same
Imaging SystemComponent	ADAM Imaging System	Duet DRF Imaging System
	Proposed Device(This Submission):ADAM Imaging System integratedinto the DMS Platinum dRFImaging System	Predicate Device:(K160301)Duet Imaging System integratedinto the DMS Platinum dRFImaging System
Control Panelwith SystemControllerSoftware	No change	Same
Electrical Panel	No change	Same
Platinum Software	No change	Same

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for MEDICEPT. The first part of the logo, "MEDI", is in blue, while the second part, "CEPT", is in purple. Below the logo is the text "Trusted Solutions, Rapid Response", with "Trusted Solutions" in purple and "Rapid Response" in gray.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, while "CEPT" is in a stylized, cursive, purple font. Below the logo, the words "Trusted Solutions, Rapid Response" are written in a smaller font, with "Trusted Solutions" in purple and "Rapid Response" in gray.

The technological characteristics of the Detector are summarized in the table below:

DetectorInformation	Proposed: ADAM ImagingSystem Detector Information	Predicate: Duet ImagingSystem DetectorInformation (K160301)	Comment
Manufacturerof detector	VIEWORKS	THALES	Differentmanufacturersbut similartechnology
Model Name	VIVIX-D 1717G	PIXIUM RF 4343 FL	Differentmanufacturersbut similartechnology
Scintillator	CsI	CsI	Same
Pixel Pitch	140µm	148µm	ADAMImagingSystem'sdetector has asmaller pixelpitch whichmeans betterdetaildetectability

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDICEPT" is written in a combination of blue and purple colors. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller font size.

DetectorInformation	Proposed: ADAM ImagingSystem Detector Information	Predicate: Duet ImagingSystem DetectorInformation (K160301)	Comment
Pixel Matrix	3072 x 3072 pixels	2874 x 2840 pixels	AdamImagingSystem'sdetector has alarger pixelmatrix whichmeans alargerdetectionfield.
Image Size	17" x 17"	17" x 17"	Same
Grayscale	16 bits	16 bit	Same
Resolution	3.5 linepairs/mm	3.4 linepairs/mm	Theperformanceof bothdetectors aresimilarenough(>3%) for theproceduresindicated
ModulationTransferFunction(MTF)	MTF IEC0.5 lp/mmMTF IEC1 lp/mmMTF IEC2 lp/mmMTF IEC3 lp/mmMTF IECNyquist	Minimal Typical 78 % 83 % 50 % 55 % 20 % 25 % 5 % 10 % - -				Minimal Typical 79%	MTF IEC0.5 lp/mmMTF IEC1 lp/mmMTF IEC2 lp/mmMTF IEC3 lp/mmMTF IECNyquist	Minimal Typical 55% 66% 25 % 35 % 10 % 19 % 7 % 15 %		Performanceof bothdetectors aresufficient forgeneralradiographicprocedures.
DetectiveQuantumEfficiency(DQE)	75%	Minimal Typical DQE0.5 lp/mm Minimal Typical 60 % 65 %		78%	Minimal Typical DQE0 lp/mm Minimal Typical 65 % 73 %				See Notesbelow.

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for MediCept. The logo has the word "MEDI" in blue and the word "CEPT" in purple. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller font size.

DetectorInformation	Proposed: ADAM ImagingSystem Detector Information	Predicate: Duet ImagingSystem DetectorInformation (K160301)	Comment
Dimensions	471 x 471 x 35 mm	500 x 490 x 45.5 mm	VIEWORKSdetector issmaller thanthe predicatewhich willenable easierinstallation.
Weight	10 kg	9.1kg	VIEWORKSdetector isheavier thanthe predicatebut as thedifference isless than 1 kgthere is noimpact.

Notes:

Differences in Detective Quantum Efficiency (DQE):

The predicate device has a DQE of 78% if the shot noise was the only cause to be taken into account, i.e. the proportion of photons that are detected. This is close to the value found for the subject device detector (75%). The difference between the two detector DQE values is low enough to be considered equivalent because:

1. The difference in the required dose to obtain a given image quality is small enough (ratio of 78% to 75%) not to have any clinical significance (<10% of variation)
1. The evaluation of DQE, which combines information about the signal and the noise, has error margins: no definitive conclusion can be given if the difference is <5%
The DQE value can vary somewhat between different units of the same model, specially 3. from a small difference in the scintillator thickness. This can be seen from the predicate device detector specification, which indicates 5% of difference between the "minimal" and "typical" values of the DQE.

The image below shows the design of the proposed (Apelem) and predicate (Thales) Imaging Systems.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in bold, dark blue letters, while "CEPT" is in a lighter purple color with a swoosh effect. Below the logo, the words "Trusted Solutions, Rapid Response" are written in a smaller font, with "Trusted Solutions" in purple and "Rapid Response" in gray.

Manufacturers	APELEM	THALES
Design	Image: APELEM monitor and computer	Image: THALES monitor and computer

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, and the word "CEPT" is in a cursive, purple font. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller, purple font.

COMPLIANCE WITH DESIGN CONTROLS 5.

The results of assessment under Design Controls supports that the Apelem-DMS Group Platinum dRF Imaging System integrated with the ADAM Imaging System component is substantially equivalent to the predicate device. There are no new causes of risk or no new cause of existing risk, therefore the change does not raise different issues of safety or effectiveness.

Compliance with Standards 5.1.

The Platinum dRF Imaging System with the ADAM Imaging System component and VIEWORKS detector comply with the following standards:

1. IEC 60601-1:2005/A1:2012 Medical Electrical Equipment: General Requirements for basic safety and essential performance
1. IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
1. IEC 60601-1-3:2008+A1:2013 Medical electrical equipment part 1-3: general requirements for basic safety and essential performance - collateral standard: radiation protection in diagnostic x-ray equipment.
1. 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
1. EN ISO 14971:2012 Application of Risk Management to Medical Devices
1. IEC 62304:2006 Medical Device Software Software life cycle processes
1. EN 1041:2008 Information supplied by the manufacturer of Medical devices
EN ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, 8. labelling and information to be supplied - Part 1: General requirements.

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in blue, and the word "CEPT" is in purple. Underneath the logo is the text "Trusted Solutions, Rapid Response" in a smaller font.

CONCLUSION 6.

The Apelem-DMS Group Platinum dRF Imaging System integrated with the ADAM Imaging System has the same intended use, technology, materials, and uses the same components as the predicate device except for the ADAM Imaging System component and VIEWORKS Detector. The changes to the proposed device have little to no impact on the safety or performance device (i.e. image quality) and no additional questions regarding safety or effectiveness have been raised. The fundamental scientific technology of the proposed device included in this submission remains unchanged from the legally marketed predicate device. Therefore, the proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.