(19 days)
Not Found
No
The description focuses on image processing, scaling, templating, and reporting, which are standard functionalities for surgical planning software and do not inherently require AI/ML. There is no mention of AI, ML, or related concepts like deep learning or neural networks.
No.
Orthoview™ is a software that assists healthcare professionals in planning surgical procedures by allowing them to access, process, and overlay medical images with templates for prosthetic and fixation devices. It does not directly treat or diagnose a medical condition.
No
The device is intended for surgical planning and templating using medical images, not for diagnosing medical conditions. Its purpose is to help choose prosthetic and fixation devices, which is a planning function, not a diagnostic one.
Yes
The device description explicitly states it is downloaded from the internet and receives digital images, and its functionality is described purely in terms of software operations (processing, scaling, overlaying, printing, archiving). There is no mention of accompanying hardware components provided by the manufacturer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Orthoview™ processes medical images (X-Ray images), not biological specimens like blood, urine, or tissue.
- The purpose of an IVD is to provide information about a physiological or pathological state. Orthoview™ is used for surgical planning by overlaying templates on images to choose prosthetic/fixation devices. While this information is used in a medical context, it's not directly diagnosing or monitoring a patient's condition through the analysis of biological samples.
The device description and intended use align with a medical image processing and surgical planning software, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Orthoview™ intended use is to enable a suitably licensed and qualified healthcare professional access to medical images with the intention of using such images, in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are included to extend the range of functionality available to the healthcare professional.
Orthoview™ is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are provided to extend the range of functionality available to the healthcare professional.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Orthoview™ is intended to provide the following for the Operator (a suitably qualified and trained healthcare professional):
- To be downloaded from the Internet and to be unlocked using a Meridian . Technique Ltd provided key.
- . Grant access rights only to authorized users (via PC password system).
- . Receive X-Ray images in a digital format from third party X-Ray machines/ X-Ray digitisers or PACS systems.
- Process such images securely with respect to patient confidentiality, patient . identification and image integrity.
- . Allow the image to be retrieved for processing as follows:
- Scaling of the image. o
- Selection of appropriate prosthetic and fixing device manufacturer and size range templates.
- O Overlaying the template on the image and permitting selection of appropriate size of prosthetic/fixing.
- o Provide additional functionality in the form of Trauma and Osteotomy modules
- Print and archive appropriate reports.
- Receive and store templates for prostheses and fixations supplied by ̇ Meridian Technique Ltd for particular manufacturer's range of products.
- o Provide traceability of operator, date and decisions made.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray images in a digital format from third party X-Ray machines/ X-Ray digitisers or PACS systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Suitably licensed and qualified healthcare professional
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)
Risk analysis indicates that Orthoview™ is identical to the predicate device in the patient environment. Orthoview™ uses similar materials and constructional principles to the predicate device. Due to this similarity, clinical testing of Orthoview ™ is considered unnecessary.
Orthoview ™ processes data in the form of Images collected in the patient environment after the event of actual collection. This non-patient contact processing is described exactly in terms of its software functions and associated Wizards and Templates. It is therefore feasible to verify and validate the functionality of Orthoview ™ outside of the clinical environment. This is the method which has been adopted.
Conclusions of the Non-clinical Tests
Verification and Validation of Orthoview ™ indicates that the requirements for intended use and associated performance characteristics are satisfied. In particular, the following functions have been tested and confirmed as operating according to specified requirements.
- . Patient and Procedure Selection
- . Image Scaling
- . Procedure Planning
- . Templating and Trauma (Fracture) reduction
- Osteotomy and alleviation of congenital deformity .
- Committing and Saving operating session Data .
- . Compilation and Printing of associated Reports
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
KO63327
510k Summary of Safety and Effectiveness
| Date of Submission | 1st June 2006. |
|---|---|
| Submitter Name and Address | Meridian Technique Ltd |
| 2 Venture Road | |
| Chilworth Science Park | |
| Southampton | |
| Hampshire | |
| SO16 7NP | |
| Great Britain | |
| Telephone | 011 44 2380 762 500 |
| Fax | 011 44 2380 762 550 |
| Official Correspondent Name and Address | Mr Anthony Thorne |
| Omsbar Ltd | |
| Unit 7 Building T2 | |
| Area 200 | |
| Milton Park | |
| Abingdon | |
| OX14 4TA | |
| Great Britain | |
| Telephone | 011 44 1235 820 401 |
| Fax | 011 44 1235 820 401 |
| Classification and Name | Class II - Picture Archiving and Communications (PACS) System |
| Common Name | PACS System |
| Proprietary Name | Orthoview™ |
| Predicate Device | 510k references K042816 and K032401 |
| Substantial equivalence is claimed between Orthoview™ and : | |
| Manufacturer | Orthocrat Ltd |
| Tradename | TraumaCAD |
Meridian Technique Ltd
Orthoview™ Manufacturer Tradename
,
1
Device Description -
Orthoview™ is intended to provide the following for the Operator (a suitably qualified and trained healthcare professional):
- To be downloaded from the Internet and to be unlocked using a Meridian . Technique Ltd provided key.
- . Grant access rights only to authorized users (via PC password system).
- . Receive X-Ray images in a digital format from third party X-Ray machines/ X-Ray digitisers or PACS systems.
- Process such images securely with respect to patient confidentiality, patient . identification and image integrity.
- . Allow the image to be retrieved for processing as follows:
- Scaling of the image. o
- Selection of appropriate prosthetic and fixing device manufacturer and ୍ size range templates.
- O Overlaying the template on the image and permitting selection of appropriate size of prosthetic/fixing.
- o Provide additional functionality in the form of Trauma and Osteotomy modules
- Print and archive appropriate reports. ୍
- Receive and store templates for prostheses and fixations supplied by ் Meridian Technique Ltd for particular manufacturer's range of products.
- o Provide traceability of operator, date and decisions made.
Intended Use -
Orthoview™ intended use is to enable a suitably licensed and qualified healthcare professional access to medical images with the intention of using such images, in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are included to extend the range of functionality available to the healthcare professional.
2
Assessment of Clinical and Non-clinical Performance Data
Risk analysis indicates that Orthoview™ is identical to the predicate device in the patient environment. Orthoview™ uses similar materials and constructional principles to the predicate device. Due to this similarity, clinical testing of Orthoview ™ is considered unnecessary.
Orthoview ™ processes data in the form of Images collected in the patient environment after the event of actual collection. This non-patient contact processing is described exactly in terms of its software functions and associated Wizards and Templates. It is therefore feasible to verify and validate the functionality of Orthoview ™ outside of the clinical environment. This is the method which has been adopted.
Conclusions of the Non-clinical Tests
Verification and Validation of Orthoview ™ indicates that the requirements for intended use and associated performance characteristics are satisfied. In particular, the following functions have been tested and confirmed as operating according to specified requirements.
- . Patient and Procedure Selection
- . Image Scaling
- . Procedure Planning
- . Templating and Trauma (Fracture) reduction
- Osteotomy and alleviation of congenital deformity .
- Committing and Saving operating session Data .
- . Compilation and Printing of associated Reports
3
| Comparison of Technological Characteristics | |||
|---|---|---|---|
| Characteristic | Orthoview™ | Predicate Device | |
| Computer | Personal Computer or | ||
| Workstation/Server | Same | ||
| Availability of | |||
| Device | Is used for planning | ||
| orthopedic procedures using | |||
| templates and wizards in the | |||
| areas of Prosthetic | |||
| placement, Trauma and | |||
| Osteotomy | Same | ||
| Means of | |||
| collecting data | Obtained from pre-obtained | ||
| digital images via PACS | |||
| system | Same | ||
| Processing of | |||
| data | The software processes data | ||
| to provide prosthetic and | |||
| fixing template, trauma and | |||
| osteotomy overlay and | |||
| placement | Same | ||
| Patient Contact | No intentional patient | ||
| contact | Same | ||
| Control of Life | |||
| Sustaining | |||
| Devices | None | Same. | |
| Human | |||
| intervention for | Requires physician | ||
| intervention. | Same. |
and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con
4
Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Merdian Technique, Ltd. % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
NOV 2 2 2006
Re: K063327
Trade/Device Name: Orthoview™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 2, 2006 Received: November 3, 2006
Dear Mr. Devine:
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 (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.
Image /page/4/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center, and "Centennial" at the bottom. There are three dots below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration of the organization "PA" from 1906 to 2006.
diana Public .
5
Page 2 -
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name:
Orthoview™
Orthoview™ is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are provided to extend the range of functionality available to the healthcare professional.
1063327
AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of of 1
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________