CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005

K023110 · Digirad Corp. · KPS · Nov 22, 2002 · Radiology

Device Facts

• Record ID: K023110
• Device Name: CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
• Applicant: Digirad Corp.
• Product Code: KPS · Radiology
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Cedars-Sinai Motion Correction (MoCo) software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.

Device Story

Standalone software application; corrects motion artifacts in gated/ungated SPECT projection datasets. Inputs: SPECT projection data from gamma camera systems. Processing: automatic or manual correction of motion artifacts. Output: corrected SPECT image data. Used in clinical settings; operated by nuclear medicine technologists or physicians. Healthcare providers use corrected images to improve diagnostic quality of myocardial perfusion SPECT imaging. Benefits: reduces motion-induced artifacts, potentially improving diagnostic accuracy.

Clinical Evidence

Bench testing only. Functionality tests conducted to verify software performance against specifications; all tests passed with results matching expected outcomes.

Technological Characteristics

Standalone software application; PC architecture; Windows operating system; PC X windows server software. Algorithm performs motion correction on SPECT projection datasets.

Indications for Use

Indicated for correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.

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

• Cedars-Sinai BPGS and MoCo (K010509)
• QPS/BPGS/MoCo Processing Applications (K003264)

Reference Devices

• Mirage software (K972886)

Submission Summary (Full Text)

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)023110

# Identification:

### Date of Application:

September 18 , 2002

NOV 22 2002

# Applicant's and Name and Address:

Corey Stewart Quality Assurance Manager Digirad Corporation 9350 Trade Place San Diego, CA 92126

# Telephone and Fax Numbers of the Applicant

Telephone: (858) 537 – 2118 Fax: (858) 549 - 9789 Email: [e-mail]

# Signature

Cory Stuart

Date 9/18/02

# Device name and classification

# Classification Code:

90 KPS

### Panel Identification:

Radiology

### Proprietary Name:

Cedars-Sinai Motion Correction (MoCo) Software

# Common Name:

Gamma Camera System

# Classification Name: System, Emission Computed Tomography

# Classification Class:

Class II Product

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# Substantial Equivalence

#### Predicate devices

| | GE/SMV | ELGEMS Ltd. |
|---------------|------------|---------------|
| | Cedars- | QPS/BPGS/MoCo |
| | Sinai BPGS | Processing |
| | and MoCo | Applications |
| Product Code | 90 KPS | 90 KPS |
| 510(k) Number | K010509 | K003264 |

### Device Description

The MoCo program is an independent, standalone software application developed by Cedars-Sinai Medical Center for the automatic and manual correction of SPECT acquisition motion artifacts from gated and ungated projection datasets. MoCo is the most popular motion correction application in the field of nuclear myocardial perfusion SPECT imaging. The software has the same indication for use and function as the Motion Correction function module of Mirage software (Segami Corporation, K972886), which is currently being used on Digirad 2020tc SPECT Imaging systems.

### Intended Use

The Cedars-Sinai Motion Correction (MoCo) software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.

## Testing

Functionality tests were conducted to demonstrate that the MoCo software application functioned as per its specifications. All tests passed with the actual results substantially matching the expected results.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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NOV. 22. 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Corey Stewart Quality Assurance Manager DIGIRAD CORPORATION 3950 Trade Place SAN DIEGO CA 92126

Re: K023110

Trade/Device Name: Cedars-Sinai Motion Correction (MoCo) Software, Model 111005 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system

Regulatory Class: II Product Code: 90 KPS Dated: September 18, 2002 Received: September 19, 2002

Dear Mr. Stewart:

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. Iisting 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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Page 2

This letter will allow you to begin marketing your device as described in your 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:

| 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" (21 CFR Part 807.97). 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,

Vernie 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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Digirad Corporation, Traditional 510(k) Submission Cedars-Sinai Motion Correction (MoCo) Software Program

### APPENDIX I. INDICATIONS FOR USE STATEMEN

02311 510(k) Number (if known): K_

Device Name:

Cedars-Sinai Motion Correction (MoCo) Software Program on computer systems with a PC architecture, the Windows operating system and a PC X windows server software.

Indications For Use:

The Cedars-Sinai Motion Correction (MoCo) software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use \$\underline{\checkmark}\$

Daniel A. Deegan

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

09/18/2002