(59 days)
Philips MammoDiagnost VU is a software workstation for viewing, manipulati reporting and communication of digital mammography images (DICOM "For Presentation" images) and other modality images. It interfaces to image storage, printing and CAD devices using DICOM or similar interface standards
Philips MammoDiagnost VU workstation software package is intended for viewing, manipulation, reporting and communication of digital mammography images (DICOM "For Presentation" images) as well as other modality images. It interfaces to mammography acquisition stations and image storage, printing and CAD devices using DICOM or similar interface standards. It uses and builds further on the Stentor iSite PACS v4.x software (Stentor is now a Philips owned company). Philips MammoDiagnost VU workstation software package runs on standard information technology hardware and software. The proprietary software in the Philips MammoDisonost VU workstation software package uses a standard Microsoft Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
The provided text is a 510(k) summary for the Philips MammoDiagnost VU, a Picture Archiving and Communication System (PACS) workstation software package for digital mammography images. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself as one would expect for a new AI/CAD device.
Therefore, the requested information, particularly regarding acceptance criteria and the study that proves the device meets the acceptance criteria, is not explicitly available in the provided document in the format requested. The document does not describe a clinical study of the Philips MammoDiagnost VU's diagnostic performance against specific metrics with human readers or as a standalone algorithm.
Instead, the summary establishes substantial equivalence based on:
- Intended Use: The MammoDiagnost VU shares the same intended use as predicate devices: viewing, manipulation, reporting, and communication of digital mammography images and other modality images, interfacing with standard imaging devices.
- System Description: It builds upon existing, cleared technology (Stentor iSite PACS v4.x) and uses standard components (Microsoft OS, TCP/IP, DICOM, HL7 protocols).
- General Safety and Effectiveness: Compliance with ISO 13485, 21 CFR Part 820, NEMA XR 22-2006, and NEMA PS 3.2 DICOM standards.
- No new indications for use or new potential hazards.
Since the device is a PACS workstation for viewing and managing images, and not a diagnostic AI algorithm that provides interpretations or detections, a typical "acceptance criteria" table for diagnostic performance (e.g., sensitivity, specificity, AUC) alongside "reported device performance" is not applicable here. The "performance" in this context is its ability to correctly display and manage images according to industry standards, which is assessed through engineering validation and adherence to regulatory standards rather than a clinical trial measuring diagnostic accuracy.
Therefore, many parts of your request about a diagnostic performance study cannot be answered from this document.
However, I can extract the following information based on what is available:
1. A table of acceptance criteria and the reported device performance
As explained above, this device is a PACS workstation. Its "performance" is primarily related to its functional capabilities and adherence to existing industry and regulatory standards for image display and management. The acceptance criteria relate to these functional and compliance aspects rather than diagnostic accuracy.
| Acceptance Criteria (Implied from document) | Reported Device Performance (Implied from document) |
|---|---|
| Functional Capabilities: | |
| - Viewing digital mammography images (DICOM "For Presentation" images) | - Intended for viewing digital mammography images. |
| - Manipulation of digital mammography images | - Intended for manipulation of digital mammography images. |
| - Reporting capabilities for digital mammography images | - Intended for reporting on digital mammography images. |
| - Communication of digital mammography images | - Intended for communication of digital mammography images. |
| - Interfacing with mammography acquisition stations | - Interfaces to mammography acquisition stations. |
| - Interfacing with image storage, printing, and CAD devices | - Interfaces to image storage, printing, and CAD devices. |
| - Support for DICOM standards | - DICOM support included (DICOM "For Presentation" images, DICOM protocols). |
| - Support for generic and mammography hanging protocols | - Generic and Mammography hanging protocols included. |
| - CAD overlays functionality | - CAD overlays functionality included. |
| - Double blind read workflow support | - Double blind read workflow functionality included. |
| - Automatic breast tissue alignment | - Automatic breast tissue alignment functionality included. |
| - Background suppression at inversion | - Background suppression at inversion functionality included. |
| Technical & Regulatory Compliance: | |
| - Operates on standard information technology hardware and software | - Runs on standard information technology hardware and software (Microsoft Operating System, standard user interface, TCP/IP, DICOM, HL7 protocols for communication). |
| - Developed under ISO 13485 and 21 CFR Part 820 compliant Quality System | - Software specified, validated, and tested under a registered ISO 13485 and 21 CFR Part 820 compliant Quality System. |
| - Complies with NEMA XR 22-2006 (Display & Workstation Quality Control) | - Complies with NEMA XR 22-2006 for manufacturers of displays and workstations labeled for final interpretation in full-field digital mammography. |
| - Complies with NEMA PS 3.2 DICOM set | - Complies with the NEMA PS 3.2 DICOM set. |
| - Instructions for use, cautions, and warnings provided for safe, effective use | - Device labeling contains instructions for use and necessary cautions/warnings for safe and effective use. (User responsibilities for display quality/environmental lighting also noted). |
| - Hardware components are "off the shelf" computer components | - Hardware components specified are all "off the shelf" computer components. |
| - Monitors used for interpretation in USA must be FDA cleared (≥5 Mpixel) | - Utilized with high-resolution monitors suitable for screening and diagnostic mammography; for USA, monitors must be FDA cleared offering at least 5 Mpixel resolution and meeting other FDA-reviewed technical specifications. |
| - No new indications for use compared to predicate devices | - The device does not introduce new indications for use compared to predicate devices. |
| - No new potential hazards compared to predicate devices | - The use of the device does not result in any new potential hazard compared to predicate devices. |
| - Device is substantially equivalent to predicate devices | - Philips Medical Systems considers the Philips MammoDiagnost VU to be substantially equivalent to Stentor (Philips) iSite PACS v 4.x (K063267), GE Seno Advantage (K033400), and Hologic SecurView DX (K062107). This equivalence was accepted by the FDA (K083740). |
Regarding the absence of other requested information:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical performance study on a test set is described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- No clinical performance study on a test set is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No clinical performance study on a test set is described.
- 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 is a PACS workstation, not an AI/CAD diagnostic device. No such comparative effectiveness study is described. The device facilitates a "Double blind read workflow," which is a feature of the workstation rather than a study outcome.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a PACS workstation, not a standalone diagnostic algorithm. No such study is described.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- No clinical performance study is described that would require ground truth for diagnostic accuracy.
- 8. The sample size for the training set
- This is a PACS workstation. There is no "training set" in the context of an AI algorithm learning diagnostic patterns.
- 9. How the ground truth for the training set was established
- Not applicable as there is no training set for an AI algorithm.
In summary, the provided 510(k) pertains to a medical imaging workstation rather than an AI-driven diagnostic tool. Therefore, the information typically associated with AI device performance studies (like test sets, ground truth, reader studies) is not present because it's not relevant for demonstrating the substantial equivalence of a PACS workstation. The device's "acceptance" is based on its functional design, adherence to established standards, and its similarity in intended use and technological principles to already cleared predicate devices.
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Philips Healthcare
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510(k) Summary
・・・・・・
Philips MammoDiagnost VU------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
විකාශය සිංහ මහතා විශ්වාදය විසින් පවත්වය පැවැත්වයි. ආශ්රිත
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. Sec. Saland . Sale and Controllar
| General Information | Bath : 1 : 1 : 143 : 13 : 26 : 26 : 26 : 26 : 26 : 26 : 26 : 20 : 26 : 26 : 20 : 20 : 26 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 202017/08/2018 |
|---|---|
| Company Name: | Philips Medical Systems North America Company. |
| Address: | 22100 Bothell Everett HighwayBothell Washington 98021-8431USA 39 000 000 000 000 000 000 000 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000001 M C = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = |
| Contact Person | Lynn. T. Harmer |
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| Prepared (date): | 2008 November 14 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 11993 11 11 165 11 |
| Manufacturing Site: | Philips Medical Systems Nederland B.V. J . JVeenpluis 4-6 2000 2 2 3 4 2 4 4 4 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 15684 PC Best (1) 300 Best Bearing Beach (1946) 1The Netherlands of the many of the comment of the free |
| Device Name: | Philips MammoDiagnost VU - 11 - 11 - 11 - 11 - 11 - 11 - 11 -1000 133 133 133 13 11 11 11 11 13 |
| Classification Name: | Picture Archiving and Communication SystemWE CLES IS OF IS IN DOS COME OF |
| Regulation number: | 11 VOIDU. 1191051. |
| Classification: | monr barberting Rei: 1975年: 1979年 1998年 1998 |
| ProCode: | 1:11 - 1. 1. 1. 1. 1.사람들 전 행: 上一篇: 家 |
| Common/Usual Name: | PACS Workstation 1 1 1 1 1 1 2 0 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -objection in other than the more and captive and portugal por |
| Predicate Devices: | ೆ ಇವರ ಇದೆ.Stentor Inc. (now Philips Healthcare Inc.), ArentoiSite PACS v 4.x 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
| General Electric Medical Systems of Childer Systems andSeno-Advantage of Santa Childer of Children Charless Pick,Hologio Inc. Spino Led oct 100 and the formatioiləyə dəmə, mətbə ySecurView DX | |
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| ਪ੍ਰਾਫ਼ ਕੀਕੀ ਨਾਮਾਕੀ ਮੰਗਰ能 |
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Information Supporting Substantial Equivalence Determination II
System Description:
Philips MammoDiagnost VU workstation software package is intended for viewing, manipulation, reporting and communication of digital mammography images (DICOM "For Presentation" images) as well as other modality images. It interfaces to mammography acquisition stations and image storage, printing and CAD devices using DICOM or similar interface standards. It uses and builds further on the Stentor iSite PACS v4.x software (Stentor is now a Philips owned company).
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Philips MammoDiamore VII includes and Sun Marc
Philips MammoDiagnost VU workstation software package runs on standard information technology hardware and software. The proprietary software in the Philips MammoDisonost VU workstation software package uses a standard Microsoft Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Intended Use:
Philips MammoDiagnost VU workstation software package is intended for viewing, manipulation, reporting and communication of digital mammography images (DICOM "For Presentation" images) as well as other modality images. It interfaces to mammography acquisition stations and image storage, printing and CAD devices using DICOM or similar interface standards.
Philips MammoDiagnost VU is used with high-resolution monitors suitable for screening and diagnostic mammography, for use in the USA these monitors must be FDA cleared. It is used by trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
General Safety and Effectiveness:
The MammoDiagnost VU software is specified, validated and tested under a registered ISO 13485 and 21 CFR Part 820 compliant Quality System.
The MammoDiagnost VU complies with the NEMA XR 22-2006, ("Quality Control Manual" Template for Manufactures of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography) and to the NEMA PS 3.2 DICOM set
The device labelling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. It is the user's responsibility to ensure that display quality, environmental lighting and other possible distractions are consistent with the clinical environment. lunakes (1917) .
The hardware components specified are all "off the shelf" computer components.
Conclusion:
The Philips MammoDiagnost VU does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Philips MammoDiagnost VU to be substantially equivalent to the Stentor (Philips) iSite PACS v 4.x (K063267), the GE, Seno Advantage (K033400) and the Hologic, Secur View DX (K062107)
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems Nederland BV % Ms. Melissa J. DeGuia Senior Project Engineer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
Re: K083740
Trade/Device Name: Philips MammoDiagnost VU Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 2, 2009 Received: February 3, 2009
Dear Ms. DeGuia:
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.
FEB 1 3 2009
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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.
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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; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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ications for
510(K) Number (if known): K083740
Device Name:
Philips MammoDiagnost VU
1 2019 30 33
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Indications for Use:
Philips MammoDiagnost VU is a software workstation for viewing, manipulati reporting and communication of digital mammography images (DICOM "For Presentation" images) and other modality images. It interfaces to image storage, printing and CAD devices using DICOM or similar interface standards
The functional components include
- · DICOM support
- Generic hanging protocols
- · Mammography hanging protoce
- CAD overlays
- Double blind read workflow
- Automatic breast tissue alignment
- Background suppression at inversion
Philips MammoDiagnost VU software nuns on standard information technology hardware and software. The proprietary software in the MammoDiagnost VU product uses a standard Microsoft Operating System and user interface. Communication and data exchange are done using standard TCPMP, DICQMand HL7 protocols
14-401-02-2015 11 13:15:53:33 In the USA, mammographic images may only be interpreted using FDA cleared monitors that offer at least 5 Mpixel resolution and meet other technical specifications reviewed and accepted by FDA.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) िस्तारिए 14 (Division (Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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).