(56 days)
No
The document describes a workstation for nuclear medicine data acquisition, processing, and review, focusing on standard image processing and control functions. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as a workstation for acquiring, processing, and reviewing data from gamma cameras, used for various types of diagnostic nuclear medicine studies. Its purpose is to process diagnostic images, not directly treat a disease or condition.
Yes
The Intended Use / Indications for Use section explicitly states that "The SCINTRON workstation for diagnostic nuclear medicine is designed for acquiring, processing and reviewing data..." indicating its use in diagnosis.
No
The device description explicitly mentions hardware components like a PowerPC CPU on VMEbus, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "acquiring, processing and reviewing data from all type of MiE and Siemens digital and analog gamma cameras" and performing various nuclear medicine studies. This involves imaging the patient directly after they have been administered a radioactive tracer.
- Device Description: The description reinforces its role in controlling and processing data from gamma cameras.
- Input Imaging Modality: The input is from "gamma cameras," which are used for in-vivo imaging (imaging within the living body).
- Anatomical Site: It mentions imaging the "body or organ," which is consistent with in-vivo imaging.
IVD devices, on the other hand, are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device does not process or analyze such specimens. It processes images generated from within the patient's body.
N/A
Intended Use / Indications for Use
The SCINTRON system is designed for data acquisition, reviewing and processing of analog and digital gamma cameras. It is intended to detect the location and distribution of gamma ray radionnuclides in the body or organ.
Following types of acquisition are provided:
- planar -
- dynamic
- whole body ー
- -SPECT (non positron emitting tomography)
The SCINTRON workstation for diagnostic nuclear medicine is designed for acquiring, processing and reviewing data from all type of MiE and Siemens digital and analog gamma cameras. The SCINTRON is used to perform statis. dynamic and gated studies, as well as SPECT (non positron sitting tomography), whole body or planar procedure, on standing, seated or recumbent patients.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The SCINTRON is the modification and development of the SCINTRON IV. It is designed with Graphical User Interfaces for data acquisition, reviewing and processing of analog and digital Siemens gamma cameras. It controls static, dynamic, SPECT and whole body acquisitions. The SCINTRON uses industry standard and well tried PowerPC CPU on VMEbus which ensures long term support. Additionally to the clinical and networking programs, a variety of basic functions are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
gamma camera
Anatomical Site
body or organ
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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COLORS
Submitter Identification
JUN - 7 2010 Holder / Headquarters: MiE GmbH Hauptstrasse 112 23845 Seth, Schleswig-Holstein Germany Telephone Number: +49 4194 9977 0 Fax Number: +49 4194 9977 55 Contact Person: Thomas Kuehl th.kuehl@miegermany.de Date summary prepared: 03/23/2010
Product Identifaction
| Name: | SCINTRON |
|---|---|
| Common Name: | Gamma Camera Workstation |
| for Acquisition, Reviewing and Processing | |
| Classification Name: | Emission computed tomography system |
| 21 C.F.R. § 892.1200 | |
| Classification: | Class II |
ldentification of Legally Market and Equivalent Devices
| 510(k) # | Device | Manufacturer |
|---|---|---|
| K953193 | SCINTRON IV | MiE GmbH / MiE America Inc. |
| K023190 | E.CAM Computer / e.soft Workstation | Siemens Medical Solutions ISA, Inc. |
| K914350 | ICON COMPUTER SYSTEM | Siemens Gammasonics, Inc. |
| K080575 | Corridor4DM | INVIA, LCC |
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Image /page/1/Picture/1 description: The image shows the logo for MiE, with the letters "MiE" in a bold, sans-serif font. The letters are white against a black background. The "i" in "MiE" is dotted with a circle. The letters are slightly slanted to the right, giving the logo a dynamic appearance.
Device Description
The SCINTRON is the modification and development of the SCINTRON IV. It is designed with Graphical User Interfaces for data acquisition, reviewing and processing of analog and digital Siemens gamma cameras. It controls static, dynamic, SPECT and whole body acquisitions. The SCINTRON uses industry standard and well tried PowerPC CPU on VMEbus which ensures long term support. Additionally to the clinical and networking programs, a variety of basic functions are available.
Intended Use
The Intended Use is similar and unchanged to the SCINTRON IV. The SCINTRON system is designed for data acquisition, reviewing and processing of analog and digital gamma cameras. It is intended to detect the location and distribution of gamma ray radionnuclides in the body or organ.
Following types of acquisition are provided:
- planar -
- dynamic
- whole body ー
- -SPECT (non positron emitting tomography)
Device Comparsion
Most vendors of gamma camera workstations provide an extensive acquiring and processing software packet as the SCINTRON has. The acquiring and processing software and hardware, which is designed of years by experiences and customer wishes, uses similar techniques to those of the predicate devices like the modified device SCINTRON IV.
Conclusion
The SCINTRON has similar intended use, operating principle and fundamental technologies as legally market devices. The design and development processes of the SCINTRON are conform to currently valid standards including applicable medical device safety and performance. All modifications do not significantly affect the safety and effectiveness of the device. All test results are, in opinion of MiE GmbH, that the SCINTRON is substantially equivalent to the predicated devices.
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Image /page/2/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 bars representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
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
MiE GmbH % Mr. Norman Von Hollen Regulatory Manager MiE America, Inc. 420 Bennett Road ELK GROVE VILLAGE IL 60007
JUN - 7 2010
Re: K101013.
Trade/Device Name: Scintron Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: May 24, 2010 Received: May 24, 2010
Dear Mr. Von Hollen:
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 (reporting of
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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.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K101013
Device Name: SCINTRON
Indications for Use:
The SCINTRON workstation for diagnostic nuclear medicine is designed for acquiring, processing and reviewing data from all type of MiE and Siemens digital and analog gamma cameras. The SCINTRON is used to perform statis. dynamic and gated studies, as well as SPECT (non positron sitting tomography), whole body or planar procedure, on standing, seated or recumbent patients.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101013