ORTHOVIEW

K032401 · Omsbar, Ltd. · LLZ · Aug 14, 2003 · Radiology

Device Facts

• Record ID: K032401
• Device Name: ORTHOVIEW
• Applicant: Omsbar, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence, 3rd-Party Reviewed

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K032401 · Aug 14, 2003	ORTHOVIEW	Omsbar, Ltd.	Retrospective clinical assessment (hand-scoring/traditional templating)	A retrospective comparison was conducted by healthcare professionals to evaluate the accuracy of the Orthoview digital templating system against traditional hand-scoring methods used in routine clinical practice.	Retrospective analysis; Clinical performance comparison; Prosthetic templating

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective comparative study	Patients requiring prosthetic device sizing	Traditional hand-scoring method using X-Ray film and acetate template overlays	Accuracy of prosthetic size determination

Indications for Use

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 devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

Device Story

Orthoview™ is a software application for orthopedic preoperative planning; operates on PC workstations either as a standalone application or integrated within a PACS environment. Input consists of digitized medical X-ray images (DICOM or other formats) from PACS or digitizers. The software allows surgeons to view, manipulate, and overlay digital prosthetic templates onto images. Key functions include image scaling, interactive template positioning, sizing, rotation, and mechanical linking of prosthetic components. Output is a templating plan stored in the patient's electronic record. The device assists surgeons in selecting the optimal prosthetic device for a patient, replacing traditional acetate template overlays on X-ray film. It does not perform image acquisition or storage; these are handled by the host system.

Clinical Evidence

Bench testing only. Retrospective comparison performed by healthcare professionals comparing traditional hand-scoring (acetate templates on X-ray film) versus Orthoview™ digital templating. Results confirmed Orthoview™ provides an accurate alternative to traditional methods.

Technological Characteristics

Software-based image processing system for PC workstations. Features include DICOM image viewing, digital prosthetic template overlay, automatic scaling, interactive positioning, sizing, rotation, and mechanical linking of components. Operates as a standalone application or integrated within a PACS workstation. No patient contact. No life-sustaining functions.

Indications for Use

Indicated for licensed healthcare professionals requiring access to medical images and prosthetic templates to plan surgical procedures and select prosthetic devices.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• eFilm Workstation (K020995)

Submission Summary (Full Text)

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K03 2401

# AUG 1 4 2003

## 510k Summary of Safety and Effectiveness

| Date of Submission | 9th June 2003 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and Address | Meridian Technique Ltd |
| | Pinewood |
| | Chineham Business Park |
| | Basingstoke |
| | Hampshire |
| | RG24 8AL |
| | Great Britain |
| Telephone | 011 44 1256 698007 |
| Fax | 011 44 1256 698233 |
| Official Correspondent<br>Name and Address | Mr Anthony Thorne<br>Omsbar Ltd<br>Unit 10 Harrier Park<br>Hawksworth<br>Southmead Industrial Estate<br>Didcot<br>Oxfordshire<br>OX11 7PL<br>Great Britain |
| Telephone | 011 44 1235 817758 |
| Fax | 011 44 1235 815183 |
| Classification Name | Image Processing System |
| Common Name | Picture Archiving and Communication (PACS)<br>System |
| Proprietary Name | Orthoview™ |
| Predicate Device | 510k reference K020995 |

Substantial equivalence is claimed between Orthoview™ and the templating, overlaying and image viewing elements only of:

> eFilm Workstation with Modules eFilm Medical inc 500 University Avenue Suite 300 Toronto Ontario - Canada M5G 1V7

| Meridian Technique Ltd<br>Orthoview™ 510k Notification | Section Number<br>5 | Total Pages in<br>Section<br>3 | Page Number in<br>Section<br>1 |
|--------------------------------------------------------|---------------------|--------------------------------|--------------------------------|
|--------------------------------------------------------|---------------------|--------------------------------|--------------------------------|

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Device Description - Orthoview™ is a software device that permits the orthopedic surgeon to pre-plan surgical procedures by permitting image viewing and manipulation and prosthetic template overlay within a PACS workstation or standalone environment.

Intended Use - The Orthoview™ system is designed with the intention that licensed medical professionals can access digitised medical X-Ray images in DICOM or other formats obtained from a variety of modalities such as PACS systems, X-Ray digitisers etc.

This permits the review of such images and allows the overlay of digitised images of templates for prosthetic devices thereby providing an altemative to traditional means of optically viewing processed X-Ray films overlaid with the acetate templates of such prostheses supplied by the prosthetic manufacturer.

Orthoview™ provides the means of recording, storing and retrieving the templating process steps performed by the licensed medical professional when assessing the optimum prosthetic device for a particular patient.

The Orthoview™ system does not have any function such as image acquisition, image storage etc, this is the responsibility of the systems alongside which Orthoview™ operates. The Orthoview™ system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.

#### Assessment of Non-clinical Performance Data

The comparison of intended performance versus actual performance was carried out by experienced healthcare professionals using a retrospective technique of comparing the performance of 'templating' using a hand-scoring method versus the scoring achieved by Orthoview™

The hand-scoring carried out was the actual assessment and determination of prosthetic size using traditional templating methods using X-Ray film and template overlay versus the template size suggested by Orthoview™. The outcome of the comparison was that Orthoview™ provides an accurate alternative to traditional templating methods.

#### Conclusions of the non-clinical tests

Using a digital templating system such as Orthoview™™ avoids unnecessary hard copying and also provides other benefits such as the ability to save the templating outcome in the patients electronic record, the templates are never lost or damaged and are readily available anywhere on the PACS network.

Using Orthoview™ provides an alternative to traditional templating methods with similar accuracy and can be used to augment standard PACS functionality to provide the required orthopaedic preoperative planning functionality.

Meridian Technique Ltd
Orthoview™ 510k Notification

| Section Number | 5 |
|------------------------|---|
| Total Pages in Section | 3 |
| Page Number in Section | 2 |

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| Comparison of Technological Characteristics | | |
|------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate Device | Orthoview™ |
| Computer | PC Workstation. | PC compatible computer. |
| Availability of Device | Launched from within the<br>eFilm Workstation™ | Can be configured to be<br>launched from within a<br>workstation environment<br>or as a standalone PC<br>application. |
| Source of images | Receive digital images from<br>various sources. | Same. |
| Processing of Image | Scaling of image facility. | Same. |
| Superimposing digital<br>Prosthetic Templates | Permits Overlay of template. | Same. |
| | Permits automatic scaling. | Same. |
| | Interactive positioning of<br>Template. | Same. |
| | Interactive sizing of<br>template. | Same. |
| | Permits Template rotation. | Same. |
| | Permits mechanical linking<br>of prosthetic components. | Same. |
| | Provides templating support<br>from prosthetic<br>manufacturers. | Same. |
| Preoperative Planning | Permitted. | Same. |
| Patient Contact &<br>Control of Life<br>Sustaining Devices | None. | Same. |
| Human intervention<br>for interpretation of<br>images | Permits physician<br>intervention. | Requires physician<br>intervention. |

| Meridian Technique Ltd<br>Orthoview™ 510k Notification | Section Number | Total Pages in<br>Section | Page Number<br>Section |
|--------------------------------------------------------|----------------|---------------------------|------------------------|
| | 5 | 3 | 3 |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is an abstract image of an eagle's head and three lines representing the eagle's wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

Omsbar Ltd. % Ms. Pamela Gwynn Principal Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709

### Re: K032401

Trade/Device Name: Orthoview™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: July 16, 2003 Received: August 4, 2003

Dear Ms. Gwynn:

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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Ko 3 2401

#### Indications for Use

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 devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

*Prescription Use*

David A. Sezman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

| Meridian Technique Ltd<br>Orthoview™ 510k Notification | Section Number | Total Pages in<br>Section | Page Number in<br>Section |
|--------------------------------------------------------|----------------|---------------------------|---------------------------|
| 1 | 6 | 6 | |