(88 days)
Not Found
No
The summary describes a standard scintillation camera system for imaging radionuclide distribution and does not mention any AI or ML components for image processing, analysis, or other functions.
No
The device is used to image and evaluate lesions, serving as an adjunct to other imaging modalities, not for treatment.
Yes
The device is described as aiding in the "evaluation of lesions" and being intended to "determine the presence of disease" within breast tissue. This falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "scintillation camera system" that uses "Cadmium Zinc Telluride (CZT) detectors" and is provided with a "customized gantry" and a "workstation". This indicates significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The LumaGEM™ Molecular Breast Imaging System works by detecting photons emitted from radionuclides within the patient's body. It images the distribution of these radionuclides in vivo (within a living organism).
- Lack of Specimen Examination: The device does not examine specimens (like blood or tissue samples) that have been removed from the body.
The LumaGEM™ is an in vivo imaging device that uses nuclear medicine principles to visualize physiological processes within the body.
N/A
Intended Use / Indications for Use
The LumaGEM™ Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM™ Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM™ Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 keV for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.
Product codes
IYX
Device Description
The LumaGEM™ Molecular Breast Imaging System is a scintillation camera system, which uses Cadmium Zinc Telluride (CZT) detectors to create an image of radionuclide distribution. The LumaGEM™ Molecular Breast Imaging System is available in a dualhead or single-head configuration and can be used to help identify suspected lesions in breast tissue as an adjunct to standard mammography. The LumaGEM™ Molecular Breast Imaging System is provided with a customized gantry, which allows flexible positioning to facilitate accurate breast imaging, and a workstation to enable image acquisition and analysis functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scintigraphy (gamma camera)
Anatomical Site
Breast tissue and other small body parts
Indicated Patient Age Range
patients of 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)
All necessary bench testing was conducted on the LumaGEM™ Molecular Breast Imaging System to support a determination of substantial equivalence to the predicate devices. The following list includes the testing that was performed on the LumaGEM™ Molecular Breast Imaging System:
- . Gamma camera verification testing
- . System verification testing
- . Electrical and mechanical safety testing
- . Electromagnetic compatibility testing
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
§ 892.1100 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).
0
GAMMA MEDICA-IDEAS, INC.
SECTION 5 510(k) SUMMARY (CONT.)
510(k) Notification K 111791
GENERAL INFORMATION
Applicant:
Gamma Medica-Ideas, Inc. 19355 Business Center Drive, Suite #8 Northridge, CA, 91324 U.S.A. Phone: 818-709-2468 Fax: 818-709-2464
Contact Person:
Albert Boniske Regulatory Consultant for Gamma Medica-Ideas, Inc. 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 408-400-0856 ext. 113 Fax: 408-400-0865
Date Prepared: June 24, 2011
DEVICE INFORMATION
Classification:
21 CFR8892.1100
Product Code:
IYX
Trade Name:
LumaGEM™ Molecular Breast Imaging System
Generic/Common Name:
Scintillation (gamma) camera
PREDICATE DEVICES
Gamma Medica LumaGEM™ Scintillation Camera (K993813) . GE Healthcare Discovery NM 750b Gamma Camera (K102231) SEP 2 3 2011
1
SECTION 5 510(k) SUMMARY (CONT.)
INDICATIONS FOR USE
The LumaGEM™ Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM™ Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM™ Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 keV for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.
PRODUCT DESCRIPTION
The LumaGEM™ Molecular Breast Imaging System is a scintillation camera system, which uses Cadmium Zinc Telluride (CZT) detectors to create an image of radionuclide distribution. The LumaGEM™ Molecular Breast Imaging System is available in a dualhead or single-head configuration and can be used to help identify suspected lesions in breast tissue as an adjunct to standard mammography. The LumaGEM™ Molecular Breast Imaging System is provided with a customized gantry, which allows flexible positioning to facilitate accurate breast imaging, and a workstation to enable image acquisition and analysis functions.
SUBSTANTIAL EQUIVALENCE
The proposed indications for use for the LumaGEM™ Molecular Breast Imaging System is substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the LumaGEM™ Molecular Breast Imaging System is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the LumaGEM™ Molecular Breast Imaging System to support a determination of substantial equivalence to the predicate devices. The following list includes the testing that was performed on the LumaGEM™ Molecular Breast Imaging System:
- . Gamma camera verification testing
- . System verification testing
- . Electrical and mechanical safety testing
- . Electromagnetic compatibility testing
SUMMARY
The LumaGEM™ Molecular Breast Imaging System is substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image is a black and white abstract design. The design features a series of irregular, dark shapes scattered across a white background. The shapes vary in size and orientation, creating a sense of randomness and visual texture. The overall impression is one of simplicity and contrast.
Profit and and and a
Food the bring - at . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10903 New Hampshire . Fenue Document Control Rocin - WO65-G502 Silver Spring, MD 20993-0002
Gamma Medical-Ideas Incorporated % Mr. Albert Boniske Senior Manager of Regulatory Affairs Experian Group LLC – Regulatory Affairs 755 N. Mathilda Avenue, Suite 100 SUNNYVALLE CA 94085
SEP 2 3 2011
Re: K111791
KT1771
Trade/Device Name: LumaGEM™ Molecular Breast Imaging System Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: August 24, 2011 Received: August 27, 2011
Dear Mr. Boniske:
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 deternination 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
3
medical device-related adverse events) (2) CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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 Viiro 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/ReportalProblem/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/cdrlv/industry/support/index.html.
Sincerely Yours.
Mary Patel
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
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Indications for Use
510(k) Number (if known): K111791
Device Name: LumaGEM™ Molecular Breast Imaging System
Indications for Use:
The LumaGEM™ Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM™ Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM" Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 keV for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
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Zuhal D. O'Hare
Division of Ra Office of In
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