(64 days)
No
The document describes a software program for motion correction in SPECT data, but there is no mention of AI, ML, or related terms, nor is there any description of training or test sets typically associated with ML development. The predicate devices also do not suggest AI/ML technology.
No
The device is described as software for correcting patient motion artifacts in SPECT data. It processes diagnostic imaging data and does not directly treat or prevent a disease or condition.
No
This device corrects motion artifacts in existing SPECT data. While it enhances the quality of images that clinicians use for diagnosis, the software itself does not interpret the data or provide a diagnosis of a patient's medical condition. Its function is to improve the input for diagnostic interpretation, not to perform the diagnosis itself.
Yes
The device is described as an "independent, standalone software application" and its function is solely focused on processing existing SPECT data. There is no mention of hardware components being part of the device itself.
Based on the provided information, the Cedars-Sinai Motion Correction (MoCo) software program is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of the MoCo software is to correct motion artifacts in SPECT data acquired directly from a patient using a gamma camera. This data is not a specimen derived from the body in the way that blood, urine, or tissue samples are.
- The device description and intended use clearly state it processes SPECT data. This is imaging data, not a biological sample.
- There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the MoCo software falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
90 KPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT data acquired on a nuclear medicine gamma camera system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
)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: cstewart@digirad.com
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
1
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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