(69 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional gamma camera technology.
No
The device is a diagnostic imaging system (gamma camera) used to measure and image the distribution of radionuclides in the human body, which is for diagnostic purposes, not therapeutic treatment.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "measuring and imaging the distribution of radionuclides in the human body by means of photon detection" and that these "images are intended to be interpreted by qualified medical personnel." This process of measuring, imaging, and interpreting to assess the state of the human body is characteristic of a diagnostic device.
No
The device description explicitly states that the LumaGEM™ gamma camera includes hardware components such as a scintillator, photomultiplier tubes, signal analysis and display equipment, equipment supports, and accessories. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the LumaGEM™ scintillation camera is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body ("in vitro").
- LumaGEM™ Function: The LumaGEM™ is a gamma camera system that measures and images the distribution of radionuclides within the human body ("in vivo"). It detects photons emitted from radionuclides that have been administered to the patient.
The device operates by detecting radiation directly from the patient's body, not by analyzing samples taken from the patient. This clearly places it outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The LumaGEM™ scintillation camera is a gamma camera system, which is intended for measuring and imaging the distribution of radionuclides in the human body by means of photon detection. These images are intended to be interpreted by qualified medical personnel.
A. Planar Imaging: X (Energy Range: 30-300keV)
B. Whole body imaging: No
C. Tomographic Imaging (SPECT) for non-positron imaging: No
D. Positron coincidence imaging: No
E. Positron non-coincidence imaging: No
Product codes (comma separated list FDA assigned to the subject device)
90 IYX
Device Description
The principles of operation and technology incorporated in the LumaGEM™ are equivalent to scintillation gamma cameras which use a combination of a scintillator with photomultiplier tubes as a photon radiation detector. The LumaGEM™ gamma camera includes signal analysis and display equipment, equipment supports and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
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.
ADAC S315 (Transcam), K921296, the Elscint APEX SPX-4, the DIGIRAD Notebook Imager K961104, the Siemens Orbiter and the SCINTICOR System Seventy Five (SIM-400), K885054.
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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for YMI. The logo is a black rectangle with the letters YMI in white. The Y is stylized with a curved tail. There is a circle in the upper right corner of the rectangle, which appears to be a hole. The rectangle is tilted slightly to the right.
Gamma Medica" Instruments
Division of Photon Imaging, Inc.
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is:_K973813
Bradlev E. Patt, PhD Submitted by: Regulatory Officer Gamma Medica Instruments Division of Photon Imaging, Inc. 19355 Business Center Drive, Suite 8 Northridge, CA 91324
Telephone #: (818) 709-2468 Facsimile #: (818) 709-2464
Date Prepared: November 8, 1999
Establishment Registration Number:
Gamma Medica Instruments, Division of Photon Imaging, Inc. is located at 19355 Business Center Drive, Suite 8, Northridge, CA 91324. Applicant has recently submitted a form FDA 2891, and is awaiting receipt of an Establishment Number.
Classification Name:
Scintillation (Gamma) Camera, Class I 21 CFR § 892.1100 (1990)
Common/Usual Name:
Gamma Camera
Proprietary Name: LumaGEM™ Scintillation Camera
19355 Business Center Dr.
Suite #8
Northridge, CA 91324
Tel (818) 709-2468
Fa. 18)709-2464
1
Gamma Medica" Instruments
Image /page/1/Picture/1 description: The image shows a logo with the letters "YMI" in white on a black, tilted rectangle. The "Y" is stylized with a curved tail. A black circle is attached to the top right corner of the rectangle, with a small white dot inside it. The logo has a simple, modern design.
Division of Photon Imaging, Inc.
Indications for Use:
The LumaGEM™ scintillation camera is a gamma camera system, which is intended for measuring and imaging the distribution of radionuclides in the human body by means of photon detection. These images are intended to be interpreted by qualified medical personnel.
| Yes | No | Energy Range | ||
|---|---|---|---|---|
| A. | Planar Imaging | X | 30-300keV | |
| B. | Whole body imaging | X | ||
| C. | Tomographic Imaging (SPECT) for non-positron imaging | X | ||
| D. | Positron coincidence imaging | X | ||
| E. | Positron non-coincidence imaging | X |
Device Description:
The principles of operation and technology incorporated in the LumaGEM™ are equivalent to scintillation gamma cameras which use a combination of a scintillator with photomultiplier tubes as a photon radiation detector. The LumaGEM™ gamma camera includes signal analysis and display equipment, equipment supports and accessories.
Substantial Equivalence Claim:
The LumaGEM™ gamma camera has the same intended use, uses the same principle of radiation detection, and has very similar performance characteristics as the predicate devices; the the ADAC S315 (Transcam), K921296, the Elscint APEX SPX-4, the DIGIRAD Notebook Imager K961104, the Siemens Orbiter and the SCINTICOR System Seventy Five (SIM-400), K885054. The main difference is that the LumaGEM™ camera uses position sensitive photomultiplier tubes, which eliminate a substantial part of the volume and weight of the predicate camera heads and improves substantially the spatial resolution. When compared to the conventional camera system, these changes will either have no effect on the patient's safety, or possibly decrease the risk to the patients, because of the reduced weight of the detector.
Suite #8
Northridge, CA 91324
Tel (818) 709-2468
Fc. 18)709-2464
ADAC S315 (Transcam Camera System) Product: Manufacturer: ADAC Laboratories 510(k) Number: K921296 05/28/92 Substantial Equivalence Date:
2
Image /page/2/Picture/14 description: The image shows a logo with the letters "YMI" in white against a black, tilted square. The "Y" is stylized with a curved tail. A black circle is attached to the top right corner of the square, with a small white dot inside it. The logo has a simple, graphic design.
Gamma Medica" Instruments
Division of Photon Imaging, Inc. Product: APEX SPX-4 Manufacturer: Elscint NM 510(k) Number: Unknown Substantial Equivalence Date: Unknown
Product: Notebook Imager (Model 2020tc) Manufacturer: Digirad Corp. 510(k) Number: K961104 Substantial Equivalence Date: 05/28/97 Substantial equivalence notification K961104 is presented as Exhibit H.
Product: Orbiter Manufacturer: Siemens Medical Systems. Inc. 510(k) Number: Unknown Substantial Equivalence Date: Unknown
Product: System Seventy Seven Manufacturer: Scintcor. Inc. 510(k) Number: K885054 Substantial Equivalence Date: 04/19/89
-end of summary-
19355 Business Center Dr.
Suite #8
Northridge, CA 91324
Tel (818) 709-2468
Fc. 18)709-2464
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the bird symbol.
Public Health Service
JAN 1 8 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bradley E. Pratt, Ph.D. Regulatory Officer Gamma Medica™ Instruments Division of Photon Imaging, Inc. 19355 Business Center Dr. Suite #8 Northridge, CA 91324
Re:
K993813 LimaGEM™ Scintillation Camera Dated: November 8, 1999 Received: November 10, 1999 Regulatory class: I 21 CFR 892.1100/Procode: 90 IYX
Dear Dr. Pratt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Gamma Medica Instruments Privileged and Confidential - TRADE SECRET
510(k) Number (if known): _ 993813
Device Name: LumaGEM™ Scintillation (Gamma) Camera
INDICATIONS FOR USE:
The LumaGEM™ scintillation camera is a gamma camera system, which is intended for measuring and imaging the distribution of radionuclides in the human body by means of photon detection. These images are intended to be interpreted by qualified medical personnel.
| | | Yes | No | Energy
Range |
|----|---------------------------------------------------------|-----|----|-----------------|
| A. | Planar Imaging | X | | 30-300keV |
| B. | Whole body imaging | | X | |
| C. | Tomographic Imaging (SPECT) for
non-positron imaging | | X | |
| D. | Positron coincidence imaging | | X | |
| E. | Positron non-coincidence imaging | | X | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED,
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thind 4. Seppon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K94138
Prescription Use V (Per 21 CFR 801.109
Over-The Counter Use
(Optional Format 1-2-96)