(86 days)
Not Found
No
The provided text does not mention AI, ML, or any related terms, and the description of the device focuses on standard imaging technology and signal analysis.
No.
The device is used for diagnostic imaging to aid in the evaluation of lesions, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts."
No
The device description explicitly states it is a "photon radiation detector" and a "high performance and compact planar nuclear imaging system," indicating it includes hardware components for image acquisition. While it mentions "signal analysis and display equipment," this is part of a larger hardware system, not a standalone software device.
Based on the provided information, the Discovery NM 750b Gamma Camera is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Discovery NM 750b Function: The Discovery NM 750b Gamma Camera works by detecting and imaging the distribution of radioisotopes within the human body. It does not analyze specimens taken from the body.
The device is clearly described as an imaging system that measures and images the distribution of radioisotopes in the human body to aid in the evaluation of lesions. This falls under the category of in vivo diagnostic imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200keV for the detection and display of radioisotope tracer uptake in patients of all ages.
Product codes (comma separated list FDA assigned to the subject device)
IYX
Device Description
The Discovery NM 750b is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. The device may include signal analysis and display equipment, patient and equipment supports, and accessories. The Discovery NM 750b is a high performance and compact planar nuclear imaging system, available in a dual head configuration or a single head configuration. This system is intended to measure and image the distribution of selected single photon emission radioisotopes in the breast and other small body parts in order to aid in the evaluation of lesions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scintigraphy (Gamma camera)
Anatomical Site
breast and other small body parts / human body
Indicated Patient Age Range
all ages
Intended User / Care Setting
qualified medical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The 510(k) application does not contain information from GEHC sponsored clinical studies as provided for under 21CFR 54.2(e), and therefore does not require Clinical trials data.
The proposed device has undergone bench testing that was designed to simulate clinical factors.
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.
K022960- INFINIA, K993813 LumaGEM scintillation Gamma camera
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.
Not Found
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
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).
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K102231/
NOV - 3 2010
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: August, 1, 2010 Submitter: 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 Medical Systems Israel, Functional Imaging +972-4-8563666 +972-4-8577664 Secondary Contact Person: Laurence Bigio QA site manager GE Healthcare, GE Medical Systems Israel, Functional Imaging +972-4-8563666 +972-4-8577664 Device: Discovery NM 750b Trade Name: Common/Usual Name: Scintillation (gamma) camera Classification Names: 21CFR 892.1100 90 IYX Product Code: Predicate Device(s): K022960- INFINIA; K993813 LumaGEM scintillation Gamma camera The Discovery NM 750b is a device intended to image the Device Description: distribution of radionuclides in the body by means of a photon radiation detector. The device may include signal analysis and display equipment, patient and equipment supports, and accessories. The Discovery NM 750b is a high performance and compact planar nuclear imaging system, available in a dual head configuration or a single head configuration. This system is intended to measure and image the distribution of selected single photon emission radioisotopes in the breast and other small body parts in order to aid in the evaluation of lesions. The Discovery NM 750b Gamma Camera is intended to measure Intended Use: and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when
Confidential and Privileged. This document confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved DOC0799869
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used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200keV for the detection and display of radioisotope tracer uptake in patients of all ages.
The Discovery NM 750b employs the same fundamental Technology: scientific technology as its predicate devices, the Nuclear Medicine SPECT system - Infinia K022960, and the LumaGEM Scintillation Camera K993813. It employs the readout chain and processing software of the Infinia and compact radiation detectors of CZT similar to the LumaGEM. The Discovery NM 750b system comprises one or two CZT Nuclear Medicine detectors mounted an upright positioning gantry.
Determination of Substantial Equivalence:
The Discovery NM 750b and its applications is designed to comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
Risk Analysis Requirements Reviews Design Reviews Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification)
Clinical Tests Submitted The 510(k) application does not contain information from GEHC sponsored clinical studies as provided for under 21CFR 54.2(e), and therefore does not require Clinical trials data.
The proposed device has undergone bench testing that was designed to simulate clinical factors.
- Conclusion: GE Healthcare considers the Discovery NM 750b to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)
Confidential and Privileged. This document contains confidential and privileged trade secrets and other . information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved DOC0799869
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
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 RA Leader GE Healthcare, GE Medical Systems Israel, Functional Imaging 4 Hayozma Street Tirat Hacarmel, 30200 ISRAEL
Re: K102231
Trade/Device Name: Discovery NM 750b Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: 1 Product Code: IYX Dated: August 1, 2010 Received: August 9, 2010
NOV - 3 2010
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 (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,
signature
David G. Brown, Ph.D. 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): K102231 Device Name: Discovery NM 750b
Indications for Use:
The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200keV for the detection and display of radioisotope tracer uptake in patients of all ages.
Prescription Use X (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)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K102231
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