Who is the manufacturer of SPINEANALYER MODEL SAPOC?

Optasia Medical filed the 510(k) submission for SPINEANALYER MODEL SAPOC (K103475).

What is the FDA product code for SPINEANALYER MODEL SAPOC?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SPINEANALYER MODEL SAPOC?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SPINEANALYER MODEL SAPOC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPINEANALYER MODEL SAPOC

K103475 · Optasia Medical · LLZ · Jan 5, 2011 · Radiology

Device Facts

Record ID	K103475
Device Name	SPINEANALYER MODEL SAPOC
Applicant	Optasia Medical
Product Code	LLZ · Radiology
Decision Date	Jan 5, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Indications for Use

The Optasia Medical SpineAnalyzer™ is intended for the visualization or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant. Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment. The qualified medical practitioner may use the deformity ratios and deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.

Device Story

SpineAnalyzer is stand-alone software for PCs; processes lateral spine X-ray or DXA images. Clinician identifies vertebrae; software suggests vertebral body contours and 6-point morphometry markers. Clinician reviews and adjusts markers/contours; software calculates vertebral heights and deformity ratios (wedge, biconcavity, crush). Output includes annotated images, deformity percentages, and Genant-based deformity grades. Used by clinicians to assess vertebral deformities and incident fractures in patients with osteoporosis. Facilitates comparison of baseline and follow-up images to track condition progression. Supports clinical decision-making regarding therapeutic intervention.

Clinical Evidence

No clinical data, animal, or laboratory performance testing included. Equivalence established via descriptive comparison of technological characteristics and intended use.

Technological Characteristics

Stand-alone software for Windows XP Professional; requires Pentium IV-class processor, 1 GB RAM, 1024x768 display. Inputs: DICOM or TIFF images. Processing: 95-point contour detection, 6-point morphometry, height/ratio calculation. Connectivity: Standalone. Software: Windows-based application, .NET Framework 2.0.

Indications for Use

Indicated for visualization or quantitative assessment of vertebral body deformities (T4-L4) in adult patients at risk of osteoporotic fracture. Used by qualified medical practitioners to calculate deformity ratios and grades (Genant criteria) and record manual Genant Semi-Quantitative scores to assist in vertebral fracture diagnosis.

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

GE LUNAR Dual-energy Vertebral Assessment View Software (K023554)

Submission Summary (Full Text)

{0}------------------------------------------------ K163475 P. Center for Devices and Radiological Health 11/17/2010 JAN - 5 2011 Optasia Medical Haw Bank House, High Street Cheadle Cheshire, SK8 1AL United Kingdom Telephone: 011 44 161 4917860 Fax: 011 44 161 4917879 Optasia Medical THE SCIENCE OF IMAGE UNDERSTANDING # 510(k) Summary As required by 21 CFR 807.92(c) #### Owner's Name Optasia Medical Haw Bank House High Street Cheadle Cheshire SK8 1AL United Kingdom Tel: Fax: Contact Person: e-mail : 011 44 161 4917860 011 44 161 4917879 Anthony Holmes anthony .holmes@optasiamedical.com # Date this Summary was Prepared November 17, 2010 ### Classification name Classification name: Requlation: Product Code: Requlatory Class: Picture archiving and communications system 21 CFR 892.2050 LLZ II # Common/Usual Name Spine Analysis Software # Proprietary Name SpineAnalyzer #### 5 510(k) Summary Page 5-2 {1}------------------------------------------------ 11/17/2010 JAN - 5 2011 ## Establishment Registration Number The SpineAnalyzer was manufactured by: Optasia Medical Limited Haw Bank House High Street Cheadle Cheshire SK8 1AL United Kingdom Establishment Registration Number: "to be applied for" ## Substantial Equivalence Optasia Medical believes that its SpineAnalyzer is substantially equivalent in design, use and materials to the GE LUNAR Dual-energy Vertebral Assessment View Software, K023554. ## Description of Product The Optasia Medical SpineAnalyzer is a stand-alone software package which can be installed and used on any "personal computer" meeting the minimum specification requirements defined in Tab 16, section 16.6. SpineAnalyzer is designed with context sensitive menus to guide the qualified medical practitioner through the vertebral assessment workflow of lateral spine xpractionel images from patients at risk of, or suffering from, osteoporosis. The SpineAnalyzer allows visualization of the spine from lateral spine x-ray or DXA images, and hence identification of vertebral deformities. The SpineAnalyzer can then suggest points that represent the vertebral bodies in the image using a "6-point morphometry" protocol, for the vertebrae the image asing a - These points are then reviewed by a suitably qualified beedical practitioner who can adjust them using his/her clinical expertise to medical practicity. The spine in the spine in the region of interest. A set of "tools" are provided within the SpineAnalyzer software to allow the A set of "tools" and peasure features on the digital image of cimical Specialist to announce es" which are derived from heights or ratios of spiric us "derormism" (1) in ther tools are provided to allow the neights of the vertebral boxed; allowing the physician to compare these measurements to be reported) measurements against those made on previous occasions and hence infer 5 510(k) Summary Page 5-3 {2}------------------------------------------------ $$\begin{array}{cccc} \text{15:} & \mathbf{5} - & \mathbf{N} \mathbf{\hat{k}} \\ \hline \end{array}$$ 11/17/2010 improvement or deterioration in the condition of the area of interest of the spine. The Optasia Medical SpineAnalyzer guides the qualified medical practitioner's workflow in the objective assessment of the vertebrae T4 through L4 captured in the image. In osteoporosis, a vertebral deformity may indicate an osteoporotic fracture. A qualified medical practitioner can use the information provided by SpineAnalyzer, together with other clinical information, to make a diagnosis. In patients who have been diagnosed with osteoporosis, a change in vertebral deformity over time may indicate an incident vertebral fracture. SpineAnalyzer facilitates the comparison of baseline and follow-up spine xray or DXA images which the qualified medical practitioner, together with other clinical information, can use to diagnose incident vertebral fracture. The intended use of SpineAnalyzer™ is to facilitate the visual or quantitative assessment of vertebral body deformities in lateral DXA or digital/digitized X-ray images. The indications for use are defined as: - The Optasia Medical SpineAnalyzer™ is intended for the visualization . or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant . Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment. - The qualified medical practitioner may use the deformity ratios and . deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated. * H K, et al. Vertebral Fracture Assessment Using a Semiquantitative Technique. Journal of Bone and Mineral Research. 8(9), pp1137-1148, 1993. The Optasia Medical SpineAnalyzer will be delivered on a CD-ROM together with documentation containing operation manual, user installation instructions and release notes. The CD-ROM will auto-run an application installer and will contain the following files: 5 510(k) Summary {3}------------------------------------------------ ### 11/17/2010 - An installer program which utilizes the "Windows Installer" on the . target system. - A separate PDF (Portable Document Format) document which contains . user installation instructions and release notes. - A separate PDF file containing the operation manual. . - Additional system files associated with auto-run installation. . The Optasia Medical SpineAnalyzer software does not contain any integrated "help" function. The user is guided through the workflow by a contextsensitive menu system available from a right-button mouse click at each stage. # Technological Comparison to Predicate Devices The table below provides a comparison of the SpineAnalyzer device and the predicate device. These differences raise no new types of safety or effectiveness questions. | Feature | Optasia Medical SpineAnalyzer | GE Lunar Dual-energy Vertebral Assessment View Software K023554 | |------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Minimum Specification (Hardware) | Pentium IV-class processor with 1 GB RAM 1024 x 768 color display resolution | Greater than 900Mhz Pentium 512 MB RAM Greater than 10GB hard disk 17" SVGA monitor (1024x768x32-bit color) ZIP 250 drive CD ROM Audio capable with speakers Modem Fast Serial I/O board (GE MEDICAL SYSTEMS part number 7151) - Prodigy only | | Platform Software Requirements | Windows XP Professional with SP2 .NET Framework 2.0 PDF Reader | Windows® XP Professional operating system Internet Explorer version 5.0 | | Image Retrieval | Can load images from DICOM files and in TIFF format | Works only with images generated on GE Lunar scanners. | | Image Manipulation | Basic manipulations supported are brightness, contrast, histogram equalization, invert, pan, zoom | Basic manipulations supported are brightness, contrast, clearview (edge enhancement), pan, zoom | | Image Annotation | Software overlays relevant annotation data for clinician review, including vertebral outlines, 6- point morphometry markers and height markers | Software overlays relevant annotation data for clinician review, including vertebral outlines and 6-point morphometry markers. Heights are calculated but not annotated on the image | | Patient contact & control of life sustaining devices | No contact or control | No contact or control | | Image Interpretation | Manual by Clinician, captured as free text "Impression" narrative on report | Manual by Clinician, captured as free text "Comments" narrative on report | | Feature | Optasia Medical SpineAnalyzer | GE Lunar Dual-energy Vertebral Assessment View Software K023554 | | Target Anatomy | Spine (Lateral) T4-L4 | Spine (Lateral & AP) T4-L4 | | Modality | DXA, and digital or digitized X-ray | DXA, SXA | | Label Vertebral Levels | Clinician manually labels vertebra | Clinician manually labels vertebra | | Automated annotation | Physician clicks approximate center of vertebrae of interest; software returns suggested vertebral body contour and 6-point morphometry placements | Physician clicks approximate center of vertebrae of interest; software returns suggested vertebral body contour and 6- point morphometry placements | | Vertebral Body Contour Display | 95-point, full contour capturing endplate projections, anterior and posterior extent of vertebral body. Used to suggest 6-point placements. Displayed but not shown on the report. | Vertebra "ROI" (region of interest) defined by region enclosed by vertebral "bone edges". Displayed and shown on the report | | Vertebral Body Contour Placement | Clinician interactively adjusts contour components; suggested 6-point placements updated accordingly (unless 6-point placements have been directly edited) | Clinician interactively adjusts contour by moving 6-points | | 6-pt Morphometry Placement | Initial placement derived from contour. Clinician manually adjusts point placements | Initial placement derived from contour. Clinician manually adjusts point placements | | Vertebral Heights (anterior, mid and posterior) | Device computes heights from morphometry points (in pixels). | Device computes heights from morphometry points (in cm). | | Height ratio: Wedge | Device calculates Ha/Hp, which is same as method 2 in Black951. Reported as deformity percentage (see below) | Device calculates Ha/Hp, which is same as method 2 in Black95. Reported as deformity ratio percentage (see below) | | Height ratio: Biconcavity | Device calculates Hm/Hp, which is same as method 2 in Black95 paper. Reported as deformity percentage (see below) | Device calculates Hm/Hp, which is same as method 2 in Black95 paper. Reported as deformity ratio percentage (see below) | | Height ratio: Crush | Device calculates ratio according to method 2 of Black95 paper. See labeling comparison below for algorithmic details. Reported as deformity percentage (see below) | Device calculates ratio of vertebral posterior height to average height of L2-L4 vertebrae in same image. Reported as deformity percentage (see below) | | Deformity Percentage | Calculated as 1-height ratio and expressed as percentage, as in Genant932 paper e.g. a ratio of 0.75 is a 25% deformity | Calculated as height ratio and expressed as percentage e.g. a ratio of 0.75 is a 75% deformity ratio | | Deformity Grade | Calculated from deformity percentages using the Genant height reduction thresholds i.e. normal <20%, mild <25%, moderate <40%, severe >=40%. Thresholds cannot be altered | Calculated from deformity percentages using Z-scores (number of SDs from mean of normative data) i.e. normal <2sd, mild <3sd, moderate <4sd, severe >=4sd. Thresholds cannot be altered. | | Deformity Grade Color | Deformity grades are color-coded based upon their values, to draw the eye. Mild - yellow, moderate - orange, severe - red. | Deformity grades are color-coded based upon their values, to draw the eye. Mild - white, moderate - half-red/half-white, severe - red. | | Feature | Optasia Medical SpineAnalyzer | GE Lunar Dual-energy Vertebral Assessment View Software K023554 | | Genant SQ score | Device allows clinician to capture manual score of mild, moderate or severe wedge, biconcave or crush deformity, or explicitly score vertebra as normal. Manual score is recorded separately from score derived from quantitative morphometry. | Device allows clinician to capture manual score of mild, moderate or severe wedge, biconcave or crush deformity, or implicitly score vertebra as normal. Manual score replaces score derived from quantitative morphometry. | | Report generation | Yes - includes annotated images, deformity percentages, deformity classifications and manual Genant SQ scores | Yes - includes annotated images, deformity percentages, deformity classifications and manual Genant SQ scores | {4}------------------------------------------------ #### JAN - 5 2011 11/17/2010 1 Black D M, Palermo L, Nevitt M C, Genant H K, Epstein R, San Valentin R, Cummings S R Compatison of S Black D M, L alching prevalent vertebral deformities: the Study of Osteoporotic Fractures. J Bone Miner Res. 10(6): 890-902. 1995. 2 Genant H K, et al. Vertebral Fracture Assessment Using a Semiquantitative Technique. Journal of Bone and Mineral Research. 8(9): 1137-1148. 1993. {5}------------------------------------------------ JAN - 5 2011 11/17/2010 # Performance Testing No performance data (laboratory, animal or clinical) is included. ## Conclusion Optasia Medical believes the SpineAnalyzer is substantially equivalent to the predicate device on the basis of intended use and technological characteristics. Further that the descriptive characteristics contained in the PreMarket Notification are sufficient to assess equivalence without comparison of performance data (laboratory, animal or clinical). {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002 Mr. Anthony Holmes Vice President of Technical Services Optasia Medical Haw Bank House, High Street Cheadle, Cheshire, SK8 1AL UNITED KINGDOM JAN - 5 2011 Re: K103475 Trade/Device Name: SpineAnalyzer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: November 17, 2010 Received: November 24, 2010 Dear Mr. Holmes: 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of {7}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, signature David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ 11/17/2010 ## Indications for Use | 510(k) Number (if known): | K163475 | |---------------------------|---------| |---------------------------|---------| Device Name: SpineAnalyzer SpineAnalyzer JAN - 5 2011 JAN - 5 2C .. Indications for Use: The Optasia Medical SpineAnalyzer™ is intended for the visualization or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant . Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment. The qualified medical practitioner may use the deformity ratios and deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated. †Genant H K, et al. Vertebral Fracture Assessment Using a Semiquantitative Technique. Journal of Bone and Mineral Research. 8(9), pp1137-1148, 1993. Prescription Use _ X _ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 _ (Posted November 13, 2003) Michael D'O'hm (Division Sign-Off) 510K. Office of In Vitro Diagnosti Indications for Use Statement ব Page 4-2

SPINEANALYER MODEL SAPOC

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Device Story

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Special Controls

Predicate Devices

Submission Summary (Full Text)

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