(15 days)
IMPAX® OT3000 Orthopedic Workstation, Sectra Orthopedic Package
Not Found
No
The description focuses on standard image manipulation and measurement tools, explicitly comparing them to conventional manual methods. There is no mention of AI, ML, or related concepts.
No
Explanation: The device is a software suite for planning and evaluating orthopaedic procedures using medical images. It does not directly treat or diagnose patients.
No
The device is described as software applications assisting medical professionals in planning and evaluating orthopedic procedures using medical images. It views, manipulates, measures, and simulates treatments, essentially providing digital alternatives to traditional tools (calipers, transparent sheets) for image post-processing and surgical planning. It does not provide a medical diagnosis of a disease or condition.
Yes
The device is described as a "suite of software applications" that runs on standard PC components and operating systems. It provides digital tools for image manipulation and planning, explicitly replacing conventional physical tools. There is no mention of proprietary hardware or hardware components included with the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Philips Orthopaedic Applications software is designed to process and manipulate medical images (like X-rays, CT scans, etc.) for surgical planning and evaluation. It works with images of the body, not with samples taken from the body.
- Intended Use: The intended use clearly states its purpose is to assist medical professionals in planning and evaluating orthopaedic procedures using medical images. This is a diagnostic imaging and planning tool, not a test performed on biological samples.
Therefore, this device falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Philips Orthopaedic Applications is a suite of software applications designed to assist medical professionals such as Orthopaedic surgeons, physicians and radiologists in planning and evaluating Orthopaedic procedures using medical images.
The applications are intended to view and manipulate 2D and 3D medical images; to calibrate and make length, angle and area measurements on such images; to represent and manipulate surgical planning templates overlaid on such images; to plan and simulate the effect of treatments by transforming such images; and to print and store the results of these measurements and simulations.
Product codes
90 LLZ
Device Description
The Philips Orthopaedic Applications software runs on "off the shelt" standard PC components using a Microsoft Operating System. It can be used as stand-alone SW applications or as a Plug-in on advanced image processing workstations or review workstations (PACS).
These applications provide digital alternatives for the tools medical specialists are used to work with when using conventional images printed on film: callipers, pencil, transparent sheets, scissors and tape. The software tools transform these conventional tools for working with digital images on a computer display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals such as Orthopaedic surgeons, physicians and radiologists
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Agfa Corporation: IMPAX® OT3000 Orthopedic Workstation, Sectra Imtec AB: Sectra Orthopedic Package
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
NOV - 2 2004
PHILIPS
Philips Medical Systems
510(k) Summary
Philips Orthopaedic Applications
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
General Information I
| Company Name: | Philips Medical Systems North America Company | |
|---|---|---|
| Address: | 22100 Bothell Everett Highway | |
| Bothell Washington 98021-8431 | ||
| USA | ||
| Contact Person | Lynn T. Harmer | |
| Telephone Number: | 425-478-7312 | |
| Prepared (date): | September 24, 2004 | |
| Device Name: | Philips Orthopaedic Applications | |
| Classification Name: | Image Processing System | |
| Regulation number | 892.2050 | |
| Classification: | Class: II | |
| ProCode: | 90 LLZ | |
| Common/Usual Name: | Workstation | |
| Predicate Devices: | Agfa Corporation: IMPAX® OT3000 Orthopedic Workstation | |
| Sectra Imtec AB: Sectra Orthopedic Package |
1
Information Supporting Substantial Equivalence Determination II
System Description:
The Philips Orthopaedic Applications software runs on "off the shelt" standard PC components using a Microsoft Operating System. It can be used as stand-alone SW applications or as a Plug-in on advanced image processing workstations or review workstations (PACS).
These applications provide digital alternatives for the tools medical specialists are used to work with when using conventional images printed on film: callipers, pencil, transparent sheets, scissors and tape. The software tools transform these conventional tools for working with digital images on a computer display.
Intended Use:
Philips Orthopaedic Applications is a suite of software applications designed to assist medical professionals such as Orthopaedic surgeons, physicians and radiologists in planning and evaluating Orthopaedic procedures using medical images.
The applications are intended to view and manipulate 2D and 3D medical images; to calibrate and make length, angle and area measurements on such images; to represent and manipulate surgical planning templates overlaid on such images; to plan and simulate the effect of treatments by transforming such images; and to print and store the results of these measurements and simulations.
The software packages are designed to run on standard PC hardware ("off the shelf" standard computer components) and are available as stand-alone applications or as plug-ins for specified advanced image processing workstations or review workstations (PACS).
General Safety and Effectiveness:
The Orthopaedic Applications complies with ACR/NEMA DICOM digital imaging communication standard.
Conclusion:
The Philips Orthopaedic Applications 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 Orthopaedic Applications to be substantially equivalent to the Agfa IMPAX® OT3000 Orthopedic Workstation (K040334) and the Sectra Orthopedic Package (K031590).
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines extending from its head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2004
· Philips Medical Systems North America Company % Ms. Melissa J. DeGuia Associate Project Engineer/ Program Reviewer 'Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
Re: K042867
Trade/Device Name: Philips Orthopaedic Applications Regulation Number: 21 CFR 892.2050 . Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: October 15, 2004 Received: October 18, 2004
'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 reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
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 (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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
8042867 Unknown_ 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Philips Orthopaedic Applications Device Name:
Indications for Use:
Philips Orthopaedic Applications is a suite of software applications designed to assist medical professionals such as orthopaedic surgeons, physicians and radiologists in planning and evaluating orthopaedic procedures using medical images.
The applications are intended to view and manipulate 2D and 3D medical images; to calibrate and make length, angle and area measurements on such images; to represent and manipulate surgical planning templates overlaid on such images; to plan and simulate the effect of treatments by transforming such images; and to print and store the results of these measurements and simulations.
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)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042867