(21 days)
No
The document describes a standard nuclear medicine imaging system and does not mention any AI or ML capabilities. The focus is on the hardware components, scanning modes, and image acquisition features.
No
The device is described as a medical tool for detecting, localizing, and diagnosing diseases, and for assessment of organ function, but not for treating them. While it can be used for "planning, guiding, and monitoring therapy," it does not directly provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended "to aid in detecting, localizing, diagnosing of diseases".
No
The device description explicitly lists hardware components such as an "NM Gantry with Single detector head, patient table, Remote Control Unit and NM operation console." This indicates it is a physical system, not software only.
Based on the provided information, the GE Brivo NM 615 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the GE Brivo NM 615 system is used for imaging the patient body directly to detect radioisotope tracer uptake. It does not involve the analysis of blood, urine, tissue, or other bodily fluids or substances outside of the body.
- The system is a Nuclear Medicine (NM) system. Nuclear medicine involves administering a radioactive tracer to a patient and then using a scanner to detect the radiation emitted by the tracer within the body. This is an in-vivo (within the living organism) procedure, not an in-vitro (in glass or outside the living organism) procedure.
The GE Brivo NM 615 is a medical imaging device used for diagnostic purposes, but it falls under the category of in-vivo diagnostic imaging systems, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce crosssectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types.
This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories.
Indications for Use:
The GE Brivo NM 615 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
The GE Brivo NM 615 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.
The GE Brivo NM 615 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.
Product codes
KPS, JAK
Device Description
The BrivoNM615 is an all-purpose single detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Brivo NM 615 system are: NM Gantry with Single detector head, patient table, Remote Control Unit and NM operation console. The Brivo NM 615 is a modification of its predicate device Discovery NM 630 using only single head detector instead of Dual Head detector like in the Discovery NM 630
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT)
Anatomical Site
body
Indicated Patient Age Range
all ages
Intended User / Care Setting
appropriately trained healthcare professionals
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
The subject of this premarket submission. Brivo NM 615. did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Discovery NM 630 , K111445
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
DEC - 5 2011
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. There are four decorative swirls around the outside of the circle, positioned at roughly equal intervals.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
November 9, 2011 Date: Submitter: GE Healthcare GE Healthcare, GE Medical Systems Israel, Functional Imaging 4 HAYOZMA St TIRAT HACARMEL, 30200, ISRAEL Primary Contact Person: Eli Werner Regulatory Affairs Leader GE Healthcare GE Healthcare, GE Medical Systems Israel, Functional Imaging (972) 4-8563666
(972) 4-8577664
Secondary Contact Person:
John Jaeckle Regulatory Affairs Manager, MI&CT GE Healthcare, 262-424-9547
Device: Trade Name: Brivo NM 615
Single Photon Emission Computed Tomography (SPECT ) Common/Usual Name: Classification Names: 21CFR 829.1200 Product Code: KPS
Predicate Device(s): Discovery NM 630 , K111445
The BrivoNM615 is an all-purpose single detector nuclear Device Description: imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Brivo NM 615 system are: NM Gantry with Single detector head, patient table, Remote Control Unit and NM operation console. The Brivo NM 615 is a modification of its predicate device Discovery NM 630 using only single head detector instead of Dual Head detector like in the Discovery NM 630
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are in black, while the background is white. There are some white accents around the border, giving it a slightly stylized appearance.
GE Healthcare 510(k) Premarket Notification Submission
Intended Use:
The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce crosssectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types.
This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories.
Indications for Use:
The GE Brivo NM 615 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
The GE Brivo NM 615 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.
The GE Brivo NM 615 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.
2
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white.
GE Healthcare 510(k) Premarket Notification Submission
Technology:
technology as its predicate devices.
The Brivo NM 615 employs the same fundamental scientific
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The Brivo NM615 and its applications comply with voluntary standards as detailed in Section 9, of this premarket submission. The modifications from the predicate Discovery NM 630 system were completed in accordance with GE's quality management system design controls. Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or identify any new risks. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Requirements Reviews .
- . Design Reviews
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- Performance testing (Verification) .
- . Safety testing (Verification)
- . Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission. Brivo NM 615. did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Brivo Nm 615 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device Discovery NM 630 (K111445).
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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
Mr. Eli Werner Regulatory Affairs Leader GE Healthcare GE Medical Systems Israel, Functional Imaging 4 Hayozma Street 30200 TIRAT HACARMEL ISRAEL
DEC - 5 2011
Re: K113350
Trade/Device Name: Brivo NM 615 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS & JAK Dated: November 9, 2011 Received: November 14, 2011
Dear Mr. Werner:
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 of
4
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.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular border. The letters and the border are white, set against a black background, creating a high-contrast design. The logo is simple, recognizable, and represents the General Electric brand.
GE Healthcare 510(k) Premarket Notification Submission
Indications for Use Form
510(k) Number (if known): _ |