(14 days)
Not Found
No
The summary describes standard image manipulation and display tools for orthopedic planning, with no mention of AI, ML, or related concepts.
No
The device is intended for manipulation and display of medical images to assist orthopedic surgeons in preoperative planning and post-operative follow-up, which are diagnostic and assistive functions, not therapeutic.
No
The device is intended for the manipulation and displaying of medical images, assisting orthopedic surgeons with preoperative planning and post-operative follow-up by overlaying prosthesis templates and performing measurements. It does not provide a medical diagnosis itself.
Unknown
The summary describes a software system for image manipulation and display in a PACS environment, specifically for orthopedic planning. While it focuses on software functionalities (overlaying templates, measurements), it doesn't explicitly state that it is only software and includes no dedicated hardware components or relies solely on off-the-shelf computing platforms without any specialized hardware. The description of interfacing with "various image storage and printing devices" using DICOM suggests it interacts with hardware, but it's unclear if the device itself includes any hardware beyond a standard computer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary function described is the manipulation and display of medical images for preoperative planning and post-operative follow-up in orthopedics. This involves working with images already acquired from the patient, not analyzing samples taken from the patient (like blood, urine, tissue, etc.).
- Device Description: The description focuses on handling and displaying images, overlaying templates, and making measurements on the images. This is consistent with image processing and viewing, not in vitro analysis.
- Lack of IVD-Specific Information: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device operates on medical images, which are a different type of data.
N/A
Intended Use / Indications for Use
The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
STARPACS ™ Orthopedics System handles and displays various objects in a Picture Archive and Communication System (PACS) environment and is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device is used to overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images.
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
orthopedic 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): 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
JUN 2 1 2004
Image /page/0/Picture/1 description: The image shows the text "K041500" at the top, followed by a black rectangle with the word "INFINITT" in white letters. The text "K041500" appears to be a code or identifier. The word "INFINITT" is prominently displayed, suggesting it is a brand name or product name.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: April 28, 2004
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Samuel Choi, Director INFINITT CO.,LTD Taesuk Bldg. 9F, 275-5 Yangjae-Dong Seocho-Gu, Seoul, South Korea 137-943 Fax: 82-2-2194-1696 Email: switch@infinitt.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) STARPACS ™ Orthopedics System Trade Name: Picture Archiving Communications System Common Name: 892.2050 Device Classification: System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K031590 |
| Regulation Number | 892.2050 Class II |
| Device Name | Sectra orthopedic package |
| Applicant | sectra-imtec ab |
| Product Code | LLZ |
| Decision Date | 10/02/2003 |
| Decision | Substantially equivalent (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |
| Type | Traditional |
Device Description: 21 CFR 807 92(a)(4)
STARPACS ™ Orthopedics System handles and displays various objects in a Picture Archive and Communication System (PACS) environment and is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device is used to overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images.
Indications for Use: 21 CFR 807 92(a)(5)
battons for ous in of the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
1
Image /page/1/Picture/0 description: The image shows the word "INFINITT" in white letters against a black background. The letters are blocky and sans-serif. The word is centered in the image and takes up most of the space. The image is simple and high contrast.
The device assists orthopedic surgeons when doing preoperative planning and post-The device assists of this system are trained professionals, for operative form of one surgeons, physicians, and radiologists.
Technological Characteristics: 21 CFR 807 92(a)(6)
STARPACS Orthopedics™ system is a software product that assists orthopedic surgeons STARPACS Onlinopedics - System is a sommer proative follow-up. It is a module that is used for when doing preoperative planning and people of a problem on images that are handled and displayed displaying and treming intern (K031013) Workstation. STARPACS ™ Orthopedics System by the STAN AGS - Oystem (1001818) vention systems, (depending upon system runs on Windows 2000 or Pintsont the patient, nor does it control any life sustaining Comiguration). This droviding ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for STARPACS Orthopedics™ system contains adequate The STO(K) FTe-Market Notinoution for CDRH to determine substantial equivalence to the predicate device.
STARPACS Orthopedics™ system has been and will be manufactured in accordance with STANT ACC Online and one of the enclosed voluntary standard survey. The submission the volumary standardo lieted in anolysis and the "Level of Concern for potential hazards have been classified as "minor".
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2004
Infinitt Co., Ltd. % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K041500 Trade/Device Name: STARPACS Orthopedics™ System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ
Dated: June 4, 2004 Received: June 7, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE nave reviewed your beceibled the device is substantially equivalent (for the indications felerenced above unders develo legally marketed predicate devices marketed in interstate for use stated in the encreativent of to togens .
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered phos to May 20, 1777) 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). allu Costictle 71ct (71ct) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mances of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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 If your device is classinod (600 as 010). Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affecti may be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may oc round in the 000 acements 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 that I DA has made a decermination administered by other Federal agencies. You must comply or any I-cocrar statures and regalanceding, but not limited to: registration and listing (21 CFR Part whill an the Act 3 requirements, metading, one manufacturing practice requirements as set forth in the 807), laocimig (21 CFR Part 820); and if applicable, the electronic product quality Systems (QD) rogential (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) I his iciter will anow you to ogm haring of substantial equivalence of your device to a legally prematication. The Presults 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 If you desire spoolite 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 Additionally, for questions 01 13 1-4639. Also, please note the regulation entitled, "Misbranding Other of Comphance at (301) 97 - 100 (21 Part 807.97) you may obtain. Other general by receibod to promative to promation the Act may be obtained from the Division of Small mormation on your responsible Consumer Assistance at its toll-free number (800) 638-2041 or Mandractors, International address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
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
510(k) Number (if known):
Device Name: STARPACS Orthopedics™
Indications For Use:
The device is intended for the manipulation and displaying of medical images. It The device is intended for the manipalities and interfaces to various image Can show images from different model or similar interface standards.
The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
Prescription Use -(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (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)
Daniel B. Szyfman
510kl 1