(86 days)
Not Found
No
The summary describes a remanufactured gamma camera system with proprietary imaging and processing software. There is no mention of AI, ML, or related terms, and the performance studies focus on electrical safety, EMC, and NEMA standards, not AI/ML performance metrics.
No
The device is described as a Gamma Camera System used for performing diagnostic procedures like static, dynamic, gated studies, SPECT, or planar procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is used to "perform static, dynamic and gated studies, as well as spect or planar procedure". The "Device Description" also mentions that the mechanical units "make sure it can be moved around or along the patient for the optimal diagnostic procedure." These phrases indicate that the device is used to acquire data for diagnostic purposes.
No
The device description explicitly states that the system includes hardware components such as detector units, mechanical units (camera head and supporting beam), and proprietary low voltage circuit boards, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes performing imaging procedures (static, dynamic, gated studies, SPECT, planar) on patients using a gamma camera. This is a diagnostic imaging device that works in vivo (within the living body) by detecting radiation emitted from a radiopharmaceutical administered to the patient.
- Device Description: The description details a gamma camera system, which is a piece of medical imaging equipment used to capture images of the distribution of radioactive tracers within the body. This is consistent with in vivo imaging.
- Input Imaging Modality: The input modality is nuclear medicine, which is an in vivo imaging technique.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the living body), which is the defining characteristic of an IVD.
Therefore, the MIE - Gamma Camera Systems for nuclear medicine are considered medical imaging devices used for in vivo diagnostic procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MIE - Gamma Camera Systems for nuclear medicine, are used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients
Product codes (comma separated list FDA assigned to the subject device)
KPS, IYX
Device Description
All MiE remanufactured Gamma Camera System have 3 functional units equivalent to the Siemens or GE Gamma Camera Systems. The modification to the SIEMENS- or GE-Gamma Camera System consisted of removal of certain low voltage cicuit boards in the gamma Camera and the gantry portions of the Siemens – or GE Gamma Camera System and installing proprietary low voltage circuit board that allow the use of our SCINTRON Computer and its software. All MIE Gamma Camera Systems consist of the same detector unit that is in use in the Siemens- or GE Gamma Camera System. The mechanical units (camera head with its supporting beam) hold the detector and make sure it can be moved around or along the patient for the optimal diagnostic procedure. The only difference to the basic SIEMENS or GE Gamma Camera system consists in our own imaging and processing software SCINTRON (already cleared by the FDA, K953193).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear medicine (Gamma Camera)
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)
Performance testing addressed the following issues: Electrical safety, Electromagnetic compatibility and NEMA Performance standards.
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.
Not Found
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.
0
KD53086
JAN 2 7 2006
Image /page/0/Picture/3 description: The image shows a logo with the letters "MiE" in bold, white font against a black rectangular background. The letters are stylized and appear to be slightly slanted. The logo is cropped on the right side, suggesting it may be part of a larger image or document.
Submitted by:
Telephone:
Fax:
MIE America Inc. 420 Benett Road
Elk Grove Village, IL 60007
847 981 6100
847 981 3232
Contact Person:
Date Summary prepared
06/24/2005
Kay Warren
Trade Name of Devices
Gamma Camera Systems
Common Name Classification
Class I
MIE - BODYSCAN SCINTRON MIE - SD-X 37 SCINTRON MIE - LFOV SCINTRON
MIE - Gamma Camera Systems
Class II
- MIE ORBITER SCINTRON MIE - DIACAM SCINTRON MIE - MULTISPECT 2 SCINTRON MIE - MULTISPECT 3 SCINTRON MIE - GE-XR/T SCINTRON MIE - GE-AC/T) SCINTRON
Summary 30-06-2005 doc
1
Image /page/1/Picture/1 description: The image shows a logo with the letters 'MiE' in a bold, sans-serif font. The letters are white and set against a black rectangular background. The 'i' in 'MiE' has a circular dot above it. The logo appears to be a stylized representation of the company or brand name.
| Substantial Equivalence: | MIE Gamma Camera
System | Substantial equivalent
system |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | MIE - ORBITER-SCINTRON | SIEMENS ORBITER II CCI / Spect |
| | MIE - DIACAM- SCINTRON | SIEMENS DIACAM GAMMA CAMERA |
| | MIE - MULTISPECT 2 - SCINTRON | SIEMENS MULTISPECT ™ 2 DUAL
DETECTOR CAMERA SYSTEM |
| | MIE - MULTISPECT 3 - SCINTRON | SIEMENS MULTISPECT ™ 3 TRIPLE
DETECTOR CAMERA SYSTEM |
| | MIE - BODYSCAN- SCINTRON | SIEMENS BODYSCAN |
| | MIE - LFOV - SCINTRON | BASICAM Counter balanced |
| | MIE - 9SD-X 37 - SCINTRON | BASICAM Counter balanced |
| | MIE - GE-XR/T - SCINTRON | GE Starcam 4000 |
| | MIE - GE-AC/T - SCINTRON | GE Maxicamera 400 ac |
| | The MIE - Gamma Camera Systems for nuclear medicine,
used to perform static, dynamic and gated studios, as well as | |
rm static, dynamic and gated studies, as well as Intended Use: spect or planar procedure, on standing, seated or recumbent patients
A Description of the device:
All MiE remanufactured Gamma Camera System have 3 functional units equivalent to the Siemens or GE Gamma Camera Systems.
Image /page/1/Figure/6 description: The image shows a block diagram of a system with three main components. The components are labeled as "Mechanical unit (SIEMENS or GE)", "Detector SIEMENS ZLC Digitrac or GE Autotune", and "MIE SCINTRON WORKSTATION". Arrows indicate that the mechanical unit and detector are connected to the MIE SCINTRON workstation.
2
Image /page/2/Picture/1 description: The image shows a logo with the letters 'MiE' in white against a black background. The letters are stylized and bold. The logo appears to be cropped on the right side.
The modification to the SIEMENS- or GE-Gamma Camera System consisted of removal of certain low voltage cicuit boards in the gamma Camera and the gantry portions of the Siemens – or GE Gamma Camera System and installing proprietary low voltage circuit board that allow the use of our SCINTRON Computer and its software.
Detecting units
All MIE Gamma Camera Systems consist of the same detector unit that is in use in the Siemens- or GE Gamma Camera System, and we claim substantial equivalence in comparison to that detector unit.
Mechanical units
The mechanical units (camera head with its supporting beam) hold the detector and make sure it can be moved around or along the patient for the optimal diagnostic procedure.
For more details see the descriptions of the devices in Annex 2.
There are no differences between the mechanical units from the SIEMENS or GE Gamma Cameras and the MIE remanufactured Gamma Cameras.
SCINTRON Workstation
The only difference to the basic SIEMENS or GE Gamma Camera system consists in our own imaging and processing software SCINTRON (already cleared by the FDA, K953193).
The technical data's and specifications in Annex 1 show that the MIE remanufactured Gamma Camera System achieve the same technical data's as the basic SIEMENS or GE Gamma Camera systems.
B Substantial Equivalence Summary
The MIE remanufactured Gamma Camera Systems have the same indications for use and target population as the predicate devices. There are no differences regarding the diagnostic effect. The MIE remanufactured devices have the same technological characterstics as the basic SIEMENS or GE Devices. For all technical data performance data are provided to assure equivalence.
C Technical Characteristics
The technological characteristics are the same as those of the predicate devices.
3
Image /page/3/Picture/1 description: The image shows a logo with the letters "MiE" in a bold, sans-serif font. The letters are white and are set against a black rectangular background. The letters are slightly slanted to the right, giving the logo a dynamic appearance. The logo is simple and modern, with a focus on readability and visual impact.
D Testing
Performance testing addressed the following issues:
- Electrical safety .
- . Electromagnetic compatibility and
- NEMA Performance standards .
E Conclusions
This pre-market notification has demonstrated Substantial Equivalence between the MIE remanufactured Gamma Camera Systems and the basic SIEMENS or GE Gamma Camera System as defined and understood in Sections 513 (f) (1) and 513 (i) (1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
4
Image /page/4/Picture/1 description: The image shows a logo with the letters "MiE" in white against a black rectangle. The letters are stylized, with the "i" having a circular dot above it. The black rectangle is positioned in the upper left corner of the image. The rest of the image is white.
510 (k) number:
Device Name: MIE Gamma Camera System
- Indication for Use: The MIE Gamma Camera Systems for nuclear medicine, used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients
5
Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
JAN 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kay Warren Official Correspondent MIE America, Inc. 420 Benett Road ELK GROVE VILLAGE IL 60007 Re: K053086
Trade/Device Name: MiE-Gamma Camera Systems Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: I and II Product Code: KPS and IYX Dated: March 17, 2005 Received: November 15, 2005
Dear Ms. Warren:
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 (Premarket Approval), 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.
Please be advised that FDA 's issuance of a substantial equivalence determination docs 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
6
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. Brigdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
长053086
510(k) Number (if known):
Device Name:
Indications For Use:
MiE - Gamma Camera Systems MiE - Gamma Camera Systems
The MIE - Gamma Camera Systems for nuclear medicine, are used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients
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 Device Evaluation (ODE)
Daniel Ch. Nguyen
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page I of ____________________________________________________________________________________________________________________________________________________________________