(15 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard PACS functionalities like image display, manipulation, template overlay, and measurement tools, without mentioning any AI/ML-specific features or performance metrics.
No.
The device is intended for the manipulation, displaying, and distribution of medical images and assists in preoperative planning and post-operative follow-up. It does not exert a therapeutic effect on the patient.
No
The device is intended for the manipulation, displaying, and distribution of medical images, assisting orthopedic surgeons with preoperative planning and postoperative follow-up by overlaying prosthesis templates and providing measurement tools. It does not provide a medical diagnosis itself.
Yes
The device description explicitly states it "handles and displays various objects in a Picture Archive and Communication System (PACS) environment" and provides software tools for image manipulation and planning. There is no mention of accompanying hardware components being part of the submitted device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "manipulation, displaying, and distribution of medical images" and assists orthopedic surgeons with "preoperative planning and post-operative follow-up." This involves working with medical images, not analyzing biological samples or providing diagnostic information based on in vitro tests.
- Device Description: The description reinforces this by detailing features like overlaying prosthesis templates, repositioning tools, and measurement tools on radiological images. These are image processing and planning functions, not in vitro diagnostic procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is centered around image manipulation and planning based on those images.
N/A
Intended Use / Indications for Use
iPACS ORTHO™is intended for the manipulation, displaying, and distribution of medical images. It can show images from different modalities and interfaces to medical images. It one and printing devices using DICOM or similar interface standards.
The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Product codes
LLZ
Device Description
iPACS ORTHO™ 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
Typical users of this system are trained professionals, for example 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)
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
K04 1366
JUN - 8 2004
Image /page/0/Picture/2 description: The image shows the words "RealTime Image" stacked on top of each other. The word "RealTime" is on the top line, and the word "Image" is on the bottom line. There is a black square in the upper left corner of the image. The text is written in a simple, sans-serif font.
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 2, 2004
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Zvi Eintracht Real Time Image Inc. 1111 Bayhill Dr, San Bruno, CA94066, suite 290 Tel: 650.616.4671 Fax: 650.616.4680
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
Trade Name: Common Name: Device Classification: Name:
iPACS ORTHO™ Picture Archiving Communications System 892.2050 System, Image Processing
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)
iPACS ORTHO™ 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.
1
Image /page/1/Picture/0 description: The image shows a logo with a black square in the upper left corner. Below the square, the words "RealTime Image" are written in a simple, sans-serif font. The word "RealTime" is on the first line, and the word "Image" is on the second line.
Indications for Use: 21 CFR 807 92(a)(5)
iPACS ORTHO™is intended for the manipulation, displaying, and distribution of medical images. It can show images from different modalities and interfaces to medical images. It one 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.
Technological Characteristics: 21 CFR 807 92(a)(6)
iPACS ORTHO™ runs together with iPACS Prism on Windows 2000 or Windows If AOO ORTTTO - Fans togetherling upon system configuration).The device does Ar operating of any of any life sustaining devices. A nbysician, providing 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 iPACS ORTHO™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
iPACS ORTHO™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis 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 Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is black, and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2004
Real Time Image, Inc. % Mr. Ned Devine Official Correspondent Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49571 Re: K041366 Trade/Device Name: iPACS ORTHOTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: April 2, 2004 Received: May 24, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined the device is substantially equivalent (for the indications felerenced above and nave action legally marketed predicate devices marketed in interstate 101 use stated in the enclosers's 10 vegany the Medical Device Amendments, or to conninered phor to may 20, 1970, in accordance with the provisions of the Federal Food, Drug, devices may nave occh resulted in equire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, thanks of the Act include requirements for annual registration, listing of general controls provisions of 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 may be subject to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affect may be subject to save additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I DA 3 lossants of our device complies with other requirements of the Act that ITDA has made a decermination administered by other Federal agencies. You must comply of ally it call the Act's requirements, including, but not limited to: registration and listing (21 CFR Part with an the Ace 3 roquirements, more and manufacturing practice requirements as set forth in the 807), labornig (21 OFR Part 820); and if applicable, the electronic product quality Systems (QD) regular(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 ms letter will anow you to obgin hanteting of substantial equivalence of your device to a legally premarket notification. The PDF mailing sittems 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 specific advice for your de to 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 on the presses and e the regulation entitled, "Misbranding Other or of or premarket notification" (21CFR Part 807.97) you may obtain. Other general by receice to premarket neathed. Er the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1410146101613, 11:01:01:01:01:01 am its Internet address http://www.fda.gov/cdrh/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
41266
Image /page/4/Picture/1 description: The image shows a logo with a black square in the upper left corner. Below the square, the words "RealTime Image" are written in a simple, sans-serif font. The text is arranged in two lines, with "RealTime" on the first line and "Image" on the second line.
Indications for Use
510(k) Number (if known): Коч 1366
Device Name: iPACS ORTHO™
Indications For Use:
iPACS ORTHO™is intended for the manipulation, displaying, and distribution of if AOO ONYTIO fo Thenaba interent modalities and interfaces to medical intages. It can 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.
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)
Nancy C Brogdon
and Redintogical Devices 510(k) Number