STEREOS WORKSTATION

K080529 · Biospace Med · LLZ · Aug 29, 2008 · Radiology

Device Facts

• Record ID: K080529
• Device Name: STEREOS WORKSTATION
• Applicant: Biospace Med
• Product Code: LLZ · Radiology
• Decision Date: Aug 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Pediatric

Intended Use

The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance, transfer, display, storage, and digital processing of 2D x-ray images of the musculoskeletal system including interactive 2D measurement tools. When using 2D X-ray images obtained with the Biospace EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of scollosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 16 vears and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities

Device Story

sterEOS Workstation functions as a PACS for musculoskeletal 2D X-ray images; enables acceptance, transfer, display, storage, and digital processing. When paired with Biospace EOS System (K071546) images, provides interactive 3D measurement tools for spinal deformity and scoliosis analysis. Operates on off-the-shelf hardware using Windows XP. Clinicians use interactive tools to analyze bone structures based on a pre-existing model derived from 175 patient datasets and dry vertebrae. Output assists physicians in evaluating spinal alignment and deformities. Intended for clinical use in radiology and orthopedic settings. Does not assess individual vertebral abnormalities or patients with Cobb's angle > 50 degrees.

Clinical Evidence

Comparative study conducted in a clinical setting to validate 3D reconstruction software and accuracy of clinical parameters calculated in 3D space. Results demonstrated equivalent performance to predicate devices.

Technological Characteristics

Supports DICOM 3.0 images. Runs on off-the-shelf hardware with Windows XP operating system. Features interactive 2D and 3D measurement tools. User interface follows standard clinical workflow patterns.

Indications for Use

Indicated for musculoskeletal radiology and orthopedics in pediatric (≥16 years) and adult populations. Used for PACS functions (transfer, display, storage, processing) of 2D X-ray images. 3D measurement tools are indicated for analysis of scoliosis and spinal deformities. Contraindicated for patients with Cobb's angle > 50 degrees and for assessment of individual vertebral abnormalities.

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

• Syngo Multimodality Workstation from Siemens Medical Systems, Inc. (K010938)
• Agfa Orthopedic Software for Impax Workstations (K071972)

Reference Devices

• Biospace EOS System (K071546)

Submission Summary (Full Text)

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K080529
Page 1 of 2

### 510(k) Summary

#### Biospace med's sterEOS Workstation

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

AUG 2 9 2008

Biospace med 10 rue Mercoeur PARIS F-75011 FRANCE

Phone: [phone] Facsimile: [phone]

Contact Person: Karine Chevrie

Date Prepared: August 21, 2008

### Trade Name:

sterEOS Workstation

### Common or Usual Name:

sterEOS Workstation for the EOS

#### Classification:

21 CFR 892.2050; radiological image processing system

#### Product Code:

LLZ

### Predicate Devices:

- Syngo Multimodality Workstation from Siemens Medical Systems, Inc. (K010938) ー
- -Agfa Orthopedic Software for Impax Workstations (K071972)

### Device Description:

The SterEOS Workstation is a general picture archiving and communications storage system for acceptance, transfer, display, storage, and digital processing of 2D x-ray images of the musculoskeletal system, including interactive 2D measurement tools.

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K08052°
Page 2 of 2

When used with 2D X-ray images obtained with the Biospace EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of scoliosis and related disorders and deformities of the spine.

### Indications for Use:

The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthonedics in both pediatic and adult populations as a general PACS device for acceptance, transfer, display, storage, and digital processing of 2D x-ray images of the musculoskeletal system including interactive 2D measurement tools.

When using 2D X-ray images obtained with the Biospace EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of scollosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 16 vears and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities

### Technological Characteristics:

The sterEOS Workstation supports DICOM 3.0 formatted images. The Workstation is based on the Windows XP operating system and runs on off-the-shelf hardware. The sterEOS Workstation user interface follows typical clinical workflow patterns to process, review, and analyze digital images.

### Performance Data:

A comparative study was conducted in a clinical setting to demonstrate accuracy of clinical parameters calculated in the 3D space. The results of this study validate the 3D reconstruction software and demonstrate the equivalent performance of the device.

#### Substantial Equivalence:

The sterEOS Workstation, when used as a general picture archiving and communications storage system, including the interactive 2D measurement tools, and when used with 2D X-ray images obtained with the Biospace EOS System (K071546), is as safe and effective as the Siemens Syngo Multimodality Workstation and the Agfa Orthopedic Software for Impax Workstation. The sterEOS Workstation, when used as a general PACS and with the 3D measurement tools available for use with the 2D X-ray images from the EOS System, has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the sterEOS Workstation and its predicate devices raise no new questions of safety or effectiveness. Thus, the sterEOS Workstation is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars extending from its head, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

/AUG 2 9 2008

Biospace Med Incorporated % John J. Smith, M.D., J.D., Partner Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, N.W. WASHINGTON DC 20004

Re: K080529

Trade/Device Name: stereos Workstation Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: August 21, 2008 Received: August 21, 2008

### Dear Dr. Smith:

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/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is written in cursive. Three stars are below the word "Centennial". The logo is surrounded by a circular border with text and star shapes.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliary, prome of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRF's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/1276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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### Indications for Use Statement

## 510(k) Number (if known): K080529

#### Device Name: sterEOS Workstation

The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance, transfer, display, storage, and digital processing of 2D x-ray images of the musculoskeletal system including interactive 2D measurement tools.

When using 2D X-ray images obtained with the Biospace EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of scollosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 16 vears and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arnal M. Whang

and Radiological Devic 510(k) Number