(83 days)
Not Found
No
The document describes a standard PACS system for image viewing and storage, with no mention of AI, ML, or related concepts in the provided text.
No.
The device is described as a PACS system for reviewing, storing, and transferring medical images, which are functions related to diagnostics and information management rather than direct therapeutic intervention.
No
The device is described as a Picture Archiving and Communication System (PACS) that provides access to, storage of, and transfer of medical images and related data. Its intended use is for reviewing and storing images, not for making a diagnosis or providing diagnostic interpretations.
No
The description explicitly states the system includes "software installed on a computer configured with connections to image acquisition devices, image storage locations and the internet," indicating it is a system with both software and hardware components.
Based on the provided information, the Strykerware™ PACS System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Strykerware™ Function: The description clearly states that the Strykerware™ PACS System is designed to access, review, store, and transfer medical images from various modalities. It deals with images generated by imaging equipment (like X-ray, CT, MRI, etc.), not with analyzing biological specimens.
The system's purpose is to manage and display images for diagnostic and clinical purposes, which falls under the category of medical imaging systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The StrykerwareTM PACS System is a system designed to provide licensed medical professionals access to medical images. This product is intended to be used for reviewing and storing images from a variety of modalities. StrykerwareTM is the system with software installed on a computer configured with connections to image acquisition devices, image storage locations and the internet. The system facilitates the transferal of images between local and remote locations (including but not limited to a licensed medical professional's operating suite).
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The Strykerware™ PACS System is a medical system that is designed to allow access to medical images and related data for physicians and other licensed professionals. The system receives images and medical data from image acquisition devices or other PACS (Picture Archive and Communication System) networks. The system's software includes an integrated web-based viewing and storage archival applications. The Strykerware™ System allows for the transfer of medical images and data between locations such as but not limited to a physicians operating suite.
The intent of the Strykerware™ System is to allow an office-based practice to convert from a paper to paperless environment and to create a flow of medical images and information between the office and the operating suites of the physicians belonging to that practice.
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
licensed medical professionals, physicians and other licensed professionals, general surgeons, gynecologists, cardiac surgeons, plastic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
Office-based practice, physicians operating suite.
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): 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.
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).
0
K02 4159
MAR 1 0 2003
stryker
ENDOSCOPY
5900 Ontical Cour an Jose CA 9513 x (408) 754-2505
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
| Classification Name: | System, Image Processing |
|---|---|
| Common and Usual Name: | StrykerwareTM Office Portal/Media Archive |
Strykerware™ System Proprietary Name:
This 510(k) summary and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Strykerware™ PACS System is substantially equivalent in safety and efficacy as the currently marketed Remotelmage™ System and AMICAS Web/Intranet Image Server which were cleared under 510K#'s K994228 and K970064 respectively.
The Stryker Strykerware™ PACS System is a medical system that is designed to allow access to medical images and related data for physicians and other licensed professionals. The system receives images and medical data from image acquisition devices or other PACS (Picture Archive and Communication System) networks. The system's software includes an integrated web-based viewing and storage archival applications. The Strykerware™ System allows for the transfer of medical images and data between locations such as but not limited to a physicians operating suite.
The intent of the Strykerware™ System is to allow an office-based practice to convert from a paper to paperless environment and to create a flow of medical images and information between the office and the operating suites of the physicians belonging to that practice.
The Strykerware™ System conforms to the following voluntary standards: ACR/NEMA DICOM, ANSI/AAMI SW68 - "Medical device software - Software life cycle processes", and IEC 60601 -"Medical Electrical Equipment."
The technological differences between the Strykerware™ System and the predicate Remotelmage™ and AMICAS devices do not raise new issues of safety and efficacy of the predicate devices. Therefore, the Strykerware™ System is substantially equivalent to the currently marketed Remotelmage™ and AMICAS Web/Intranet Image Server.
Lee Rich
Jerry Dickerson Senior Project Engineer Stryker Endoscopy
Date: 12-13-02
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Evan Norton Product Manager Stryker Endoscopy 5900 Optical Court SAN JOSE CA 95138 Re: K024159
MAR 1 0 2003
Trade/Device Name: Strykerware PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 13, 2002 Received: December 17, 2002
Dear Mr. Norton:
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.
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); 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.
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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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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
3
December 12, 2002
KO2 4154 510(k) Number (if known):
Device Name
Indications for Use:
The Strykerware™ PACS System is a system designed to provide licensed medical professionals access to medical images. This product is intended to be used for reviewing and storing images from a variety of modalities. Strykerware™ is the system with software installed on a computer configured with connections to image acquisition devices, image storage locations and the internet. The system facilitates the transferal of images between local and remote locations (including but not limited to a licensed medical professional's operating suite). The users of Strykerware™ are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
510(k) Number
OR
Over-The-Counter-Use_
Marcye brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Dai
Stryker Endoscopy Strykerware™ PACS System SHUIKTSUOMISSION
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