(34 days)
No
The summary describes a workstation and detector for digital radiography with image processing capabilities ("SkyFlow"), but there is no mention of AI or ML in the text. The performance studies focus on traditional software verification and validation, and image quality comparisons, not AI/ML specific metrics or training/test data.
No
The device is intended for acquiring, processing, storing, displaying, and exporting digital radiographic images, which are used for diagnosis, not therapy.
No
The device is described as a workstation used to acquire, process, store, display, and export digital radiographic images, but it does not perform any diagnostic analysis or interpretation on those images, nor does it make any diagnostic claims. Its function is to provide the means for image generation and handling, not to provide diagnoses.
No
The device description explicitly states it is a "workstation (computer keyboard, display, mouse), combined with a flat solid state X-ray detector," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire, process, store, display, and export digital radiographic images." This is related to medical imaging, not the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The device is described as a workstation and X-ray detector used to generate, process, and handle digital X-ray images. This aligns with medical imaging equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device is clearly a component of a radiographic system used for medical imaging.
N/A
Intended Use / Indications for Use
As a part of a radiographic system, the Philips Eleva Workspot with SkyFlow is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyFlow is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy. angiography and mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB, LLZ
Device Description
The Philips Eleva Workspot with SkyFlow is a workstation (computer keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data and to generate process and handle digital X-ray images. The Philips Eleva Workspot with SkyFlow will be used as a common software platform in the following currently marketed Philips X-ray systems:
Philips Digital Diagnost (K131483 – October 7, 2013), Philips MobileDiagnost (K111725 – July 19, 2011), Philips PCR Eleva (K093355– October 28, 2009), Philips EasyDiagnost Eleva (K031535 – September 6, 2006), and Philips BuckyDiagnost (K945278 – December 29, 1994).
As a part of a radiographic system, the Philips Eleva Workspot with SkyFlow is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyFlow is intended for clinical situations where practitioners deem necessary to remove the anti-scatter grid in critical care departments of hospitals (such as ICU and Emergency), where patients require portable radiographs. Whereas the Pre-Market Notification K140771 of the predicate device limited the indications for use of the SkyFlow option to bedside chest exams only, this Pre-Market Notification covers also other anatomical regions where scattered radiation might have an impact on image quality.
There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
practitioners / critical care departments of hospitals (such as ICU and Emergency)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical software verification and validation tests have been performed with regards to the intended use, technical claims, requirements specifications and risk management results. The non-clinical software verification and validation test results demonstrate that the Philips Eleva Workspot with SkyFlow complies with international and FDA-recognized consensus standards and meets the acceptance criteria and is adequate for its intended use. The image quality test results were equivalent or better with the modified SkyFlow function turned on than with this function turned off. The Philips Eleva Workspot with SkyFlow did not require clinical studies since 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K131483, K111725, K093355, K031535, K945278
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
0
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 a stylized image of a human figure, represented by three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2015
Philips Medical Systems Dmc Gmbh Ming Xiao Regulatory Affairs Specialist, North America Roentgenstrasse 24-26 Hamburg, 22335, DE
Re: K153318
Trade/Device Name: Philips Eleva Workspot With Skyflow Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB, LLZ Dated: November 13, 2015 Received: November 18, 2015
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oakes
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
6. Statement of Indication for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153318
R15510
Device Name Philips Eleva Workspot with SkyFlow
Indications for Use (Describe)
As a part of a radiographic system, the Philips Eleva Workspot with SkyFlow is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyFlow is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy. angiography and mammography.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Philips Eleva Workspot with SkyFlow Premarket Notification - Special 510(k)
- Page 22 of 69 -
3
Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out. The font is sans-serif and appears to be a custom typeface.
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. Preparation date of the initial summary is November 11th, 2015.
| Manufacturer: | Philips Medical Systems DMC GmbH
Roentgenstrasse 24-26
22335 Hamburg
GERMANY
Establishment registration number: 3003768251 | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Contact Person: | Ming Xiao
Regulatory Affairs Specialist, North America
Phone: +49 40 5078-2306
Fax: +49 40 5078-2425
E-mail: ming.xiao@philips.com | |
| Device Name: | Philips Eleva Workspot with SkyFlow | |
| Classification (primary): | Classification Name: | Stationary x-ray system |
| | Classification Regulation: | 21 CFR 892.1680 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product code: | MQB (Solid State X-Ray Imager) |
| Subsequent Product Code : | Classification Name: | Picture archiving and communications
system |
| | Classification Regulation: | 21 CFR 892.2050 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product code: | LLZ (system, image processing) |
| Predicate Device: | Trade Name: | Philips Eleva Workspot |
| | Manufacturer: | Philips Medical Systems DMC GmbH |
| | 510(k) Clearance: | K140771 – March 21, 2014 |
| Classification Name: | Picture archiving and communications system | |
| Classification Regulation: | 21 CFR 892.1680 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product code: | MQB (Solid State X-Ray Imager) | |
| Subsequent Product Code: | LLZ (system, image processing) | |
| Device description: | The Philips Eleva Workspot with SkyFlow is a workstation (computer keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data and to generate process and handle digital X-ray images. The Philips Eleva Workspot with SkyFlow will be used as a common software platform in the following currently marketed Philips X-ray systems:
Philips Digital Diagnost (K131483 – October 7, 2013), Philips MobileDiagnost (K111725 – July 19, 2011), Philips PCR Eleva (K093355– October 28, 2009), Philips EasyDiagnost Eleva (K031535 – September 6, 2006), and Philips BuckyDiagnost (K945278 – December 29, 1994). | |
| | As a part of a radiographic system, the Philips Eleva Workspot with SkyFlow is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyFlow is intended for clinical situations where practitioners deem necessary to remove the anti-scatter grid in critical care departments of hospitals (such as ICU and Emergency), where patients require portable radiographs. Whereas the Pre-Market Notification K140771 of the predicate device limited the indications for use of the SkyFlow option to bedside chest exams only, this Pre-Market Notification covers also other anatomical regions where scattered radiation might have an impact on image quality. | |
| | There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software. | |
| Indications for Use: | The Indication for Use of the Philips Eleva Workspot with SkyFlow is identical to that of the currently marketed and predicate device, Philips Eleva Workspot K140771 – March 21, 2015, and is as follows:
As a part of a radiographic system, the Philips Eleva Workspot with SkyFlow is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyFlow is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography. | |
| Fundamental Scientific Technology: | The Philips Eleva Workspot with SkyFlow employs the same basic construction and fundamental scientific technology as provided with the currently marketed and predicate device, Philips Eleva Workspot K140771 - March 21, 2015, with regards to the functionality of the following: image receptor type, image processor, automatic image processing, manual image processing, advanced image processing, image export (interfaces), X-ray generator integration and the use of standard monitors.
Based on the information provided above, the Philips Eleva Workspot with SkyFlow is considered substantially equivalent to the currently marketed and predicate device, Philips Eleva Workspot K140771 – March 21, 2015, in terms of fundamental scientific technology. | |
| Summary of Non-Clinical Performance Data: | The Philips Eleva Workspot with SkyFlow complies with the following international and FDA-recognized consensus standards:
IEC 62304 Medical device software – Software life cycle processes (2006) IEC 62366-1 Edition 1.0 2015-02, Medical Device – Part 1: Application of usability engineering to medical devices (2015) ISO 14971 Application of risk management to medical devices (2007) Non-clinical software verification and validation tests have been performed with regards to the intended use, technical claims, requirements specifications and risk management results.
The non-clinical software verification and validation test results demonstrate that the Philips Eleva Workspot with SkyFlow complies with international and FDA-recognized consensus standards and meets the acceptance criteria and is adequate for its intended use. Therefore, the Philips Eleva Workspot with SkyFlow is substantially equivalent to the | |
Philips Eleva Workspot with SkyFlow Premarket Notification – Special 510(k)
- Page 23 of 69 -
4
Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
Philips Eleva Workspot with SkyFlow Premarket Notification – Special 510(k)
- Page 24 of 69 -
5
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue text stand out. The logo is simple and modern.
Philips Eleva Workspot with SkyFlow Premarket Notification – Special 510(k)
- Page 25 of 69 -
6
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out.
| currently marketed device, Philips Eleva Workspot K140771 – March 21, |
|---|
| 2015, in terms of safety and effectiveness. |
The image quality test results were equivalent or better with the modified SkyFlow function turned on than with this function turned off.
Summary of The Philips Eleva Workspot with SkyFlow did not require clinical studies Clinical Data: since 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. ●
Summary of Substantial Equivalence Conclusion:
The Philips Eleva Workspot with SkyFlow is substantially equivalent to the currently marketed and predicate device, Philips Eleva Workspot, K140771 - March 21, 2014 in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with nonclinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 62304, IEC 62366 and ISO 14971. The results of these tests demonstrate that Philips Eleva Workspot with SkyFlow met the acceptance criteria and is adequate for this intended use.