AUTOSPECT

K090403 · Philips Medical Systems (Cleveland), Inc. · KPS · Mar 31, 2009 · Radiology

Device Facts

• Record ID: K090403
• Device Name: AUTOSPECT
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide enhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, providing enhanced reconstruction algorithms that include resolution recovery, scatter correction, noise compensation, and attenuation correction via application of a transmission dataset.

Device Story

AutoSPECT® is a software application for processing gamma camera emission data (cardiac, gated SPECT, MCD, non-cardiac SPECT). It automates manual image processing, motion correction, and reconstruction. Core algorithms include OSEM (Astonish SPECT), resolution recovery, scatter correction, noise compensation, and map-based attenuation correction. Used in clinical settings by healthcare providers to process DICOM 3.0 compatible datasets. The software offers automated (AutoAll, Auto Recon, Auto Reorient) and manual processing modes, including batch processing. Output images assist clinicians in diagnostic assessment of perfusion and tracer distribution. Benefits include improved diagnostic accuracy, image quality, and interpretive certainty, particularly for half-count imaging protocols.

Clinical Evidence

Multi-center evaluation of 297 patient images. Compared Astonish and Astonish-AC reconstruction techniques at half-count density against full-time back projection. Results: Astonish at half-count density showed equivalent diagnostic accuracy (sensitivity, specificity, normalcy) and better image quality for perfusion imaging. Astonish-AC showed improved diagnostic accuracy (specificity and normalcy) versus full-time back projection.

Technological Characteristics

Software-based image processing application. Operates on Microsoft Windows XP Professional. Compatible with DICOM 3.0 gamma camera datasets. Reconstruction algorithms: OSEM (Astonish SPECT), resolution recovery, scatter correction, noise compensation, and map-based attenuation correction. Hardware requirements: Intel x86/Pentium >1 GHz, 512 MB DRAM, 30 GB disk space, 1280x1024 display.

Indications for Use

Indicated for patients undergoing gamma camera emission imaging (cardiac, brain, or other SPECT datasets) to visualize 3D distribution of radiopharmaceutical tracers.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• AutoSPECT® (K042903)
• Cardius-1, -2, -3 and Cardius 1, 2, 3, XPO, 2020TC (with nSpeed) (K082368)

Submission Summary (Full Text)

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AutoSPECT® Special 510(k) (claim extension) Philips Medical Systems (Cleveland), Inc.

MAR 3 1 2009

K090403

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### A. SUBMITTED BY

Philips Medical Systems (Cleveland), Inc. 3860 N. First Street San Jose, CA 94135

Contact Person:

Robert Z. Phillips

Tel: [phone]

Fax: [phone]

Email: [e-mail]

#### DEVICE TRADE NAME B.

AutoSPECT® Trade Name: ﺮ Common Name: Gamma Camera Systems .

#### C. CLASSIFICATION(S) OF THE DEVICE

| Classification Name: | Emission Computed Tomography System, (21CFR 892.1200 |
|-----------------------|------------------------------------------------------|
| Classification Panel: | Radiology |
| Device Class: | 21CFR 892.1200, Class II |
| Product Code: | 90 KPS |
| Regulation Number: | 21 CFR 892.1200 |

#### D. DATE PREPARED

Date:

14 February 2009

# 00012

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#### PREDICATE DEVICE(S) E.

| Manufacturer | Product Name | 510(k) No. |
|---------------------------------------------------------------------------|----------------------------------------------------------------------|------------|
| Philips Medical Systems (Cleveland), Inc.<br>(formerly ADAC Laboratories) | AutoSPECT® | K042903 |
| Digirad Corporation (claim reference) | Cardius-1, -2`, -3 and Cardius 1, 2, 3,<br>XPO, 2020TC (with nSpeed) | K082368 |

#### INTENDED USE r.

AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide enhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, providing enhanced reconstruction algorithms that include resolution recovery, scatter correction, noise compensation, and attenuation correction via application of a transmission dataset.

NOTE: This submission is for an expansion of marketing claims and thus the intended use of this device is identical to that of the predicate device (AutoSPECT®).

#### G. DEVICE DESCRIPTION

AutoSPECT® is a software application that produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient via automatic or manual processing. One or more cardiac SPECT, gated SPECT, or MCD cardiac data sets may be processed automatically using AutoSPECT®. Additionally, one or more non-cardiac SPECT, or MCD data sets may be processed manually. AutoSPECT® contains basic data-processing algorithms that have been cleared previously; in addition to enhanced data reconstruction algorithms that include scatter correction, resolution recovery, map-based attenuation correction, and OSEM (Astonish SPECT) reconstruction.

The AutoSPECT® software option may be used on images from a gamma camera system that are DICOM 3.0 compatible. The following data sets may be used:

Cardiac, brain, or other (bone, liver, etc.) SPECT datasets .

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- Gated SPECT datasets .
- . Vantage SPECT datasets
- SPECT-CT datasets ●
- Total Body SPECT datasets .
- MCD and MCD-AC datasets .

AutoSPECT® provides the user three options for automatically processing cardiac datasets: AutoAll, ' > Auto Recon, and Auto Reorient. Each option is described in greater detail in the Software Description section, Section 4.

AutoSPECT® also allows the user to process non-cardiac SPECT and MCD datasets. In this case, the operator manually positions the reconstruction limit lines to reconstruct transverse data sets. If necessary, the data set can be reoriented manually by positioning the azimuth, elevation, and twist lines to the desired locations.

In addition, the capability of processing groups of SPECT data sets in a batch mode fashion is provided. Once the operator has selected the datasets and determined the processing method, AutoSPECT® processes the first dataset, followed by all remaining datasets without further interaction from the user.

AutoSPECT® application runs on Microsoft Windows XP Professional environment. The minimum hardware requirements are listed:

- . Intel x86/Pentium class processor > 1 GHz ;
- Graphics capability must meet or exceed 1280x1024 pixels with 32 bit pixel depth; .
- 30 GB of disk space (minimum); .
- 512 MB of DRAM (minimum); .
- . 10/100 BaseTX Ethernet interface;
- Port capable of supporting a dongle; .
- . CD drive- capable of reading and writing;
- . 56 Kbps modem (minimum)

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#### TECHNOLOGICAL COMPARISON (DESCRIPTION OF CHANGES) H.

AutoSPECT® (claim extension) and the predicate (AutoSPECT®), have identical indications for use and use the same methods for motion correction, reconstruction, and display of images. AutoSPECT® (claim extension) like the predicate device also has the tools for automated and manual processing of images. AutoSPECT® (claim extension) provides the same enhanced data reconstruction algorithms that include scatter correction, recovery, map-based attenuation correction, and OSEM (Astonish) reconstruction as the predicate. The purpose of this submission is to support the expansion of claims relative to half-count imaging (using Astonish -AC). The functionality to support these claims has already been cleared, but not highlighted given that the present supporting data had not yet been obtained.

#### CONCLUSION l.

AutoSPECT® (claim extension) is substantially equivalent to the predicate device, AutoSPECT®, based on an identical intended use and technology. Additionally, analysis was performed (provided in Section 3) on previously scanned images via multi-center evaluations utilizing data from 297 patient images acquired using Philips' imaging systems and AutoSPECT® (with Astonish & Astonish AC). These studies concluded that count data processed with the previously cleared reconstruction technique, Astonish (previously cleared in AutoSPECT®), at half count density (e.g., full-time scan, half dose / half-time scan, full dose), produced equivalent diagnostic accuracy (equivalent sensitivity, specificity, and normalcy), better image quality for perfusion imaging, and improved equivalent interpretive certainty versus full-time back projection. Additionally, these studies concluded that count data processed with Astonish-AC (Astonish + Attenuation Correction) produced improved diagnostic accuracy (improved specificity and normalcy) versus full-time back projection.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

## MAR 3 1 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems (Cleveland), Inc. % Mr. Robert Z. Phillips Sr. Dir. Quality, Regulatory, and Sustainability Philips Medical Systems 595 Miner Road CLEVELAND OH 44143

Re: K090403

Trade/Device Name: AutoSPECT® Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: February 14, 2009 Received: February 17, 2009

### Dear Mr. Phillips:

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 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.

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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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDXH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. Youmay obtain other general information on your responsibilities under the Act from the Division of Small Manufactures. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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### INDICATIONS FOR USE

510(k) Number (if known): K090403

Device Name: AutoSPECT®

Indications for Use:

AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide enhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, providing enhanced reconstruction algorithms that include resolution recovery, scatter correction, noise compensation, and attenuation correction via application of a transmission dataset.

Prescription Use __

AND/OR

Over-The-Counter 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

Helene

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