(58 days)
Not Found
No
The document describes standard image processing, reconstruction, and fusion techniques common in nuclear medicine software. There is no mention of AI, ML, deep learning, or any related terms in the intended use, device description, or performance studies sections. The testing focuses on equivalence to predicate devices using traditional verification and validation methods.
No
This device is a software package for post-processing and quantification of medical images from various modalities. It is used by specialists to analyze data and display results in different formats, but it does not directly treat or prevent disease.
Yes
The device is indicated for "nuclear medicine image post-processing software for scinitigraphic and SPECT imaging" and "processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities." This post-processing and quantification of medical images for various anatomical sites indicates its use in aiding diagnosis.
Yes
The device description explicitly states "UniCam Evo is a software package" and details its functions related to processing, viewing, and transferring medical images. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, the UniCam Evo Software package is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- UniCam Evo's Function: The UniCam Evo Software processes and analyzes medical images obtained from nuclear medicine imaging modalities (scintigraphy, SPECT, CT, MR, PET, ultrasound). It does not interact with or analyze biological specimens.
- Intended Use: The intended use clearly states it's for "nuclear medicine image post-processing software" and "processing and quantification of planar and tomographic bone scintigraphy scans," etc. This is focused on image analysis, not laboratory testing of biological samples.
Therefore, UniCam Evo falls under the category of medical image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scinitigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities.
Product codes
LLZ
Device Description
UniCam Evo is a software package for processing planar, whole body, dynamic planar and SPECT nuclear medicine data sets. The UniCam Evo Software is used for digital images capture, pre-processing, saving, post-processing, multiplanar reconstruction, multimodal image fusion, multimodal image registration, 3D rendering, viewing, archiving and transferring between image viewing workstations. The UniCam Evo Software is intended for nuclear medicine specialists, nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills.
The software loads scintigraphic data sets in Dicom 3.0 format from the local database or queries the corresponding dicom data from a PACS archive. The operator may perform analysis on the data, ROI analysis, tomographic reconstruction, organ dependent procedure steps and the software displays the results in form of images, numerical data or curves. The operator may print the results, store as an image or dicom secondary capture. Reconstructed transversal, coronal and sagittal slices can be also stored in Dicom format.
The data to be processed can be transferred via the DICOM 3.0 Standard to another Nuclear Medicine Workstations of another Manufacturer or from a Gamma Camera / SPECT acquisition workstation.
The software runs under standard Windows operating systems, such as XP, 7, 8, 10, 11.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scintigraphic, SPECT, CT, MR, PET, ultrasound
Anatomical Site
bone, cerebrovascular, cardiovascular, renal, lung, gastrointestinal, liver, thyroid, parathyroid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nuclear medicine radiologists, or trained medicine technologists, nuclear medicine specialists / Office settings in clinic or hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The software has been extensively tested using verification and validation test protocols. An emphasis on early testing improves the quality and reliability of software prior to release. by comparing - for the selected test studies - the results from the current version with the results from reference values wherever possible the phantom studies are generated and the results from the program are validated with the expected values calculated in an independent way. The results of processing are validated (for a carefully selected series of studies) against the values from the published original reference. Each system integration / validation tests contain the following information: the test description, name of the tester, its signature, date of the test, software version number, steps required to perform the test, pass fail criteria for the test step and a checkbox for documenting the passes/failed step.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing summary: Verification and validation testing confirms that product specifications are met which are equivalent in design and technological characteristics as the predicate devices. The testing results support that the functional testing met for the acceptance of the device. The UniCam Evo Software passed all testing and supports the claims of substantial equivalence to the predicate devices. Summary of the performed tests: All performed tests passed and have met the acceptable test criteria. There were no test failures. Summary conclusion: The device has been designed, verified and validated complying with applicable safety standards for this type of medical equipment. Bench and clinical data demonstrate that processing methods, images and results are equivalent comparing to the predicate devices. No adverse effect has been detected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image contains 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.
April 13, 2023
Inter Medical Medizintechnik GmbH % Hans-Guenter Osiek Managing Director Daimlerstrasse 34-36 Luebbecke, D-32312 Germany
Re: K230393
Trade/Device Name: UniCam Evo Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: February 14, 2023 Received: February 14, 2023
Dear Hans-Guenter Osiek:
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
1
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 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 (OS) 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,
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230393
Device Name UniCam Evo Software
Indications for Use (Describe)
The UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scinitigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities.
The UniCam Evo Software is intended for nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills.
The software loads scintigraphic data sets in Dicom format from the local database or queries the corresponding dicom data from a PACS archive. The operator may perform analysis on the data, ROI analysis, tomographic reconstruction, organ dependent procedure steps and the software displays the results in form of images, numerical data or curves. The operator may print the results, store as an image or dicom secondary capture. Reconstructed transversal, coronal and sagittal slices can be also stored in Dicom 3.0 format.
| 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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3
Image /page/3/Picture/1 description: The image shows the words "Inter Medical" in white font on a blue background. The words are written in a bold, sans-serif font. The text appears to be a logo or branding for a medical company. The background is a solid, dark blue color.
Inter Medical Medizintechnik GmbH Daimlerstr. 34-36 D-32312 Luebbecke Phone +49 ( 57 41) 23 59-16 Fax +49 ( 57 41) 23 59-10 Contact: Mr. H-G. Osiek E Mail Osiek@Intmed.de www.IntMed.de
510(k) Summary
| 510(k) Submitter's Name: | InterMedical Medizintechnik GmbH
Daimlerstrasse 34-36
D-32312 Luebbecke
Germany |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hans Guenter Osiek
Tel: 00495741 2359-0
Fax: 00495741 2359-10
Email: osiek@intmed.de |
| US Agent: | William J. Carroll, Eclipse Systems Inc.
422 Briarwood Drive,
Guildford, CT 06437
USA |
| US Agent Contact: | William J. Carroll, Managing Director
Eclipse Systems Inc.
14 Commercial st., Unit B
Branford, Connecticut, 06405, USA
Phone: 1- (203) 4830665
Fax: 1-(203) 4830669
Email:wcarroll@eclipsesys.com |
| Establishment Registration Number: | |
| Date Prepared: | 17 July 2022 |
Device Name: Trade name: Common Name: Regulatory Class:
UniCam Evo Software Evo Software ll
510(k) Summary 5 - 1
4
Image /page/4/Picture/0 description: The image features the words "Inter Medical" in a bold, sans-serif font. The text is white and is set against a solid blue background. The words are stacked on a single line and are centered in the image.
Inter Medical Medizintechnik GmbH Daimlerstr. 34-36 D-32312 Luebbecke Phone +49 ( 57 41) 23 59-16 Fax +49 ( 57 41) 23 59-10 Contact: Mr. H-G. Osiek E Mail Osiek@Intmed.de www.IntMed.de
Classification Name:
Panel: Product Code: 21CFR 892.2050, Medical image management and processing system Radiology Devices LLZ
Identification of Predicate Device(s):
| Manufacturer | Device name | 510(k) Number |
|---|---|---|
| PHILIPS MEDICAL | ||
| SYSTEMS (CLEVELAND), | ||
| INC. 595 MINER RD. | ODYSSEY LX, MODEL 211320 | K003437 |
| CONVERGENT IMAGING | ||
| SOLUTIONS | ||
| 49 FIRST AVE. SUITE B | ||
| OTTAWA, ONTARIO, CA | ||
| K1S 2G1 | UniSyn Image Fusion | K081987 |
Device Description:
UniCam Evo is a software package for processing planar, whole body, dynamic planar and SPECT nuclear medicine data sets. The UniCam Evo Software is used for digital images capture, pre-processing, saving, post-processing, multiplanar reconstruction, multimodal image fusion, multimodal image registration, 3D rendering, viewing, archiving and transferring between image viewing workstations. The UniCam Evo Software is intended for nuclear medicine specialists, nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills.
The software loads scintigraphic data sets in Dicom 3.0 format from the local database or queries the corresponding dicom data from a PACS archive. The operator may perform analysis on the data, ROI analysis, tomographic reconstruction, organ dependent procedure steps and the software displays the results in form of images, numerical data or curves. The operator may print the results, store as an image or dicom secondary capture. Reconstructed transversal, coronal and sagittal slices can be also stored in Dicom format.
The data to be processed can be transferred via the DICOM 3.0 Standard to another Nuclear Medicine Workstations of another Manufacturer or from a Gamma Camera / SPECT acquisition workstation.
The software runs under standard Windows operating systems, such as XP, 7, 8, 10, 11. The basic operation principle of the processing program is displayed as flowchart below:
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Image /page/5/Picture/0 description: The image features the words "Inter Medical" in a bold, sans-serif font. The text is white and stands out against a solid blue background. The words are arranged on a single line, with "Inter" positioned to the left of "Medical."
Inter Medical Medizintechnik GmbH Daimlerstr. 34-36 D-32312 | uebbecke Phone +49 ( 57 41) 23 59-16 Fax +49 ( 57 41) 23 59-10 Contact: Mr. H-G. Osiek F Mail Osiek@Intmed.de www.IntMed.de
Intended Use Statement:
The UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scintigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid, parathyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities.
The UniCam Evo Software is intended for nuclear medicine specialists, nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills.
The software loads scintigraphic data sets in Dicom format from the local database or queries the corresponding dicom data from a PACS archive. The operator may perform analysis on the data, ROI analysis, tomographic reconstruction, organ dependent procedure steps and the software displays the results in form of images, numerical data or curves. The operator may print the results, store as an image or dicom secondary capture. Reconstructed transversal, coronal and sagittal slices can be also stored in Dicom 3.0 format.
Predicate Device Comparison
The primary legally marketed device is the ODYSSEY LX, MODEL 211320 (K003437) and the second predicate device is the UniSyn Image Fusion (K081987) Software. The intended use of the device and the predicate devices are similar and the device under subject combines features from both predicate devices. The combined features are quantitative analysis of nuclear medicine data processing, reporting, displaying images in Dicom format, ROI analysis from predicate device 1, and multimodal image fusion, multimodal image registration, displaying, storing images in Dicom format from predicate device 2.
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Image /page/6/Picture/0 description: The image shows the words "Inter Medical" in white font on a blue background. The words are in a bold, sans-serif font. The text is centered in the image. The background is a solid blue color.
Inter Medical Medizintechnik GmbH Daimlerstr. 34-36 D-32312 Luebbecke Phone +49 ( 57 41) 23 59-16
E Mail Osiek@Intmed.de www.IntMed.de
Device Comparison Chart:
| Description | Subject device | Primary Predicate device | Predicate device 2 | Significant difference |
|---|---|---|---|---|
| Device name and | ||||
| 510k number | UniCam Evo Software | ODYSSEY | ||
| LX, MODEL 211320 | ||||
| (K003437) | UniSyn Image Fusion | |||
| (K081987) | ||||
| Intended use/Indications | ||||
| for use | The UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scintigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid, parathyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities. |
The UniCam Evo Software is intended for nuclear medicine specialists, nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills. | The Philips Medical Systems ODYSSEY LX computer workstation performs acquisition, processing, display, archiving, printing and networking of Nuclear Medicine data. | UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | Similar |
| | The software loads
scintigraphic data sets in
Dicom format from the local
database or queries the
corresponding dicom data
from a PACS archive. The
operator may perform
analysis on the data, ROI
analysis, tomographic
reconstruction, organ
dependent procedure steps
and the software displays
the results in form of
images, numerical data or
curves. The operator may
print the results, store as an
image or dicom secondary
capture. Reconstructed
transversal, coronal and
sagittal slices can be also
stored in Dicom 3.0 format. | | | www.IntMed.de |
| Device | | | | |
| Where to use | Office settings in clinic or
hospital | Office
settings in
clinic or
hospital | Office settings in
clinic or hospital | No significant
difference |
| Stand-alone
Software | yes | yes | yes | No significant
difference |
| Web application | no | no | no | No significant
difference |
| Mobile medical
app | no | no | no | No significant
difference |
| Operating system | Windows 7 64 bit or later | Linux | Microsoft Windows
XP and later | Odyssey LX and UniSyn
operate on different
operating system, for
further details see
Explanation A) below |
| User interface | Graphical User Interface | Graphical
User
Interface | Graphical User
Interface | No significant
difference |
| Nuclear Medicine
data
quantification
algorithms | yes | yes | yes | No significant
difference |
| SNMMI and
EANM Procedure
Standards and
Guidelines | | | | www.IntMed.de |
| ROI drawing,
reporting, 3D
rendering,
Multiplanar
reconstruction,
Study
comparison | yes | yes | yes | No significant
difference |
| Planar Nuclear Medicine Scintigraphy Processing features | | | | |
| Thyroid uptake,
Parathyroid
suppression,
Bone two and
three phase,
Brain
scintigraphy,
Renal
scintigraphy,
Lung planar,
Multiple gated
cardiac blood
pool imaging,
First-pass
radionuclide
ventriculography,
HIDA, Gallbladder
ejection fraction
calculation,
Gastric emptying,
Sentinel node,
Esophageal
transit, Salivary
Gland | yes | yes | Not specified | Primary Predicate
device:
No significant
difference
Predicate device 2 is
not intended for the
full spectrum of
scintigraphic image
processing. |
| SPECT processing features | | | | |
| Lung, bone, brain
perfusion,
myocardial
perfusion | yes | yes | Not specified | Primary Predicate
device:
No significant
difference
Predicate device 2 is
not intended for the
full spectrum of |
| | | | | www.IntiMed.de |
| | | | | scintigraphic image
processing. |
| Multimodal image fusion | | | | |
| Image fusion /
overlay display,
Opacity control,
Image
registration | yes | Not
specified | yes | Primary Predicate
device: is not intended
for multimodal image
fusion.
Predicate device 2:
No significant
difference |
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Image /page/7/Picture/0 description: The image shows the words "Inter Medical" in white font on a blue background. The words are bolded and sans-serif. The words are centered in the image.
Inter Medical Medizintechnik GmbH Daimlerstr. 34-36 D-32312 Luebbecke Phone +49 ( 57 41) 23 59-16
www.lntMed.de
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Image /page/8/Picture/0 description: The image shows the words "Inter Medical" in white font on a blue background. The words are bolded and sans-serif. The words are centered in the image.
9
Image /page/9/Picture/0 description: The image shows the words "Inter Medical" in white font on a blue background. The words are bolded and sans-serif. The words are stacked on top of each other, with "Inter" on the top and "Medical" on the bottom.
Explanation A) The technological characteristics between the UniCam Evo Software and Odyssey LX are different, as the software operates on different operating system. Although Odyssey LX runs under a different operating system with another graphical user interface, both devices are image-processing programs, the different operating systems, do not limit the functionality of the software.
The Unicam Evo Software and the predicate devices are software product that run on PCbased workstations. Image data is input to the devices and used to generate 2D and 3D views, perform image processing, quantitative processing, image fusion and co-registration. Like the two predicate devices, the software has image processing, quantitative analysis, Region Of Interest drawing and image registration abilities, fusion of images from different-modalities, image storage and retrieval, as well as patient information management functions. The UniCam Evo and UniSyn Image Fusion are software products that accept multiple image data types including magnetic resonance, computed tomography, single photon emission computed tomography, or positron emission tomography. Odyssey LX accepts only nuclear medicine, namely, planar and SPECT scintigraphic data sets. The UniCam Evo Software and the predicate devices are capable to display, load, process and store image data in Dicom format.
Nonclinical testing summary
Verification and validation testing confirms that product specifications are met which are equivalent in design and technological characteristics as the predicate devices. The testing results support that the functional testing met for the acceptance of the device. The UniCam Evo Software passed all testing and supports the claims of substantial equivalence to the predicate devices.
The software has been extensively tested using verification and validation test protocols. An emphasis on early testing improves the quality and reliability of software prior to release.
510(k) Summary 5 - 7
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Image /page/10/Picture/0 description: The image shows the words "Inter Medical" in white font on a blue background. The words are written in a bold, sans-serif font. The words are centered in the image and take up most of the space. The blue background is a solid color and there are no other objects or details in the image.
Inter Medical Medizintechnik GmbH Daimlerstr. 34-36 Phone +49 ( 57 41) 23 59-16 F Mail Osiek@Intmed.de www.IntMed.de
by comparing - for the selected test studies - the results from the current version with the results from reference values wherever possible the phantom studies are generated and the results from the program are validated with the expected values calculated in an independent way. The results of processing are validated (for a carefully selected series of studies) against the values from the published original reference.
The carried out tests are finally being evaluated and released in an all-embracing risk analysis. The results of the software tests are part of the evaluation of the remaining risks (see Device hazard analysis).
During a review it was checked, if all specifications were implemented in the software as descript in the specification and matches to the requirements.
Each system integration / validation tests contain the following information: the test description, name of the tester, its signature, date of the test, software version number, steps required to perform the test, pass fail criteria for the test step and a checkbox for documenting the passes/failed step.
Summary of the performed tests:
All performed tests passed and have met the acceptable test criteria. There were no test failures.
Summary conclusion:
The device has been designed, verified and validated complying with applicable safety standards for this type of medical equipment. Bench and clinical data demonstrate that processing methods, images and results are equivalent comparing to the predicate devices. No adverse effect has been detected.
Before placing the system on the market and use on human beings, Inter Medical has reviewed all known information and carried out a risk analysis for the software. The comparison table between UniCam Evo Software to predicate devices showed the close similarities and therefore we concluded that it is substantially equivalent to the legally marketed device.