(78 days)
No
The description mentions "algorithms developed by Digirad" and compares the software to a predicate device using similar "algorithms" for motion correction. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models. The focus is on algorithmic correction of motion artifacts.
No
The device is a software program designed to correct motion artifacts in SPECT data. It does not treat or prevent a disease or condition.
No
The device corrects artifacts in SPECT data. It does not provide a diagnosis or aid in making a diagnosis. Its function is to improve the quality of imaging data.
Yes
The device description explicitly states that STASYS is a "software application" and describes its function as correcting motion artifacts in SPECT data using "algorithms." There is no mention of any accompanying hardware components being part of the device itself. While it operates on data acquired from a gamma camera system, the device being submitted for 510(k) is the software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to correct motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system. This is a process applied to medical imaging data, not a test performed on biological samples (like blood, urine, or tissue) to diagnose or monitor a disease or condition.
- Device Description: The description clearly states it's a software application for correcting motion artifacts in SPECT projection datasets. It processes image data, not biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body. This software operates on image data acquired in vivo (within the body) and is used to improve the quality of that image data for interpretation by a healthcare professional.
N/A
Intended Use / Indications for Use
The STASYS Motion Correction software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
Product codes
KPS
Device Description
STASYS™ is a software application developed by Digirad for the correction of SPECT acquisition motion artifacts from gated and non-gated projection datasets. When the program is activated, STASYS uses algorithms developed by Digirad to minimize motion error metrics over the set of acquired projections. The resulting STASYS corrected projections are presented to the operator for acceptance or rejection of the correction. With STASYS software, cardiac SPECT studies acquired with both parallel hole and non-parallel hole collimators, can be motion corrected. The STASYS software has the same indications for use and function as the Cedars-Sinai designed MoCo software, currently being used on Digirad SPECT imaging systems and processing workstations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and Validation tests were conducted to demonstrate the STASYS software worldedion and with specifications. All tests passed with the actual results module raneitoned as per expected results. Testing included an evaluation of the software Substitually matering are sompared to the predicate devices, with results showing it performs as well.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Appendix 2: 510(k) Summary
Sponsor A.
DEC 1 7 2008
Digirad Corporation 13950 Stowe Drive Poway, California 92064 Contact Person: Joel Tuckey Tel: (858) 726-1527 Fax: (858) 726-1700
Date Prepared: September 26, 2008 B.
Device Name C.
Trade Name: STASYSTM Motion Correction Software Common Name: Gamma Camera System Classification Name: System, Emission Tomography Product Code: KPS
Cleared/Predicate Devices D.
The STASYS™ Motion Correction Software is substantially equivalent to the following cleared devices:
Cedars-Sinai Motion Correction (MoCo) Software cleared November 22, 2002 under (1) K023110 for Digirad Corporation.
Cedars-Sinai BPGS and MoCo software cleared April 27, 2001 under K010509 for (2) GE/SMV America.
E. Device Description
STASYS™ is a software application developed by Digirad for the correction of SPECT acquisition motion artifacts from gated and non-gated projection datasets. When the program is activated, STASYS uses algorithms developed by Digirad to minimize motion error metrics over the set of acquired projections. The resulting STASYS corrected projections are presented to the operator for acceptance or rejection of the correction. With STASYS software, cardiac SPECT studies acquired with both parallel hole and non-parallel hole collimators, can be motion corrected. The STASYS software has the same indications for use and function as the Cedars-Sinai designed MoCo software, currently being used on Digirad SPECT imaging systems and processing workstations.
F. Intended Use
The indications for use are the same as the predicate devices. The STASYS Motion Correction Software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
1
G. Technology
In STASYS, Digirad internally developed proprietary algorithms are implemented using in DTAB Pro, Digital Interesternally developed algorithms used in the predicate devices are also implemented using software technology.
H. Testing
Verification and Validation tests were conducted to demonstrate the STASYS software worldedion and with specifications. All tests passed with the actual results module raneitoned as per expected results. Testing included an evaluation of the software Substitually matering are sompared to the predicate devices, with results showing it performs as well.
I. Conclusion
Testing results demonstrate that the STASYS software meets the specifications and is as safe, as effective, and performs as well as the predicate devices.
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel Tuckey Vice President. Quality Digirad Corporation 13950 Stowe Drive POWAY CA 92064-8803
Re: K082904
Trade/Device Name: STASYSTM Motion Correction Software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 26, 2008 Received: September 30, 2008
Dear Mr. Tuckey:
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.
3
Page 2
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 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) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 CDRH'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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Vogue M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 510(k) Number (if known): IBS K 082904 Device Name: STASYSTM Motion Correction Software
Indications for Use:
The STASYS Motion Correction software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
Prescription Use 1 (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)
Helut Remen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number