(84 days)
KPS
Not Found
No
The device description explicitly states that the system does not include data analysis capability and relies on external, commercially available software for analysis. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is used for detection and imaging (diagnosis), not for treating a disease or condition.
Yes
Explanation: The device is described as detecting and imaging the distribution of radionuclides in the body or organ to identify their location and distribution, which is a diagnostic purpose.
No
The device description explicitly mentions "accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories," indicating hardware components are included. The device itself is described as a "nuclear imaging system" with a "rectangular field of view," which points to a physical imaging device, not just software.
Based on the provided information, this device 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.
- Device Intended Use: The intended use of the NuCamma Rx system is to "detect the location and distribution of gamma ray and positron emitting radionuclides in the body" and "detect or image the distribution of radionuclides in the body or organ". This clearly indicates that the device is used on or within the patient's body, not on samples taken from the body.
- Imaging Modality: The input imaging modality is "Gamma ray and positron emitting radionuclides," which are administered to the patient and detected externally. This is characteristic of in vivo imaging, not in vitro testing.
Therefore, the NuCamma Rx nuclear imaging system is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of NuCamma Rx is to detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s):
A. Planar Imaging
B. Whole Body Imaging
C. Tomographic imaging (SPECT) for non Positron emitter
Product codes
90 KPS
Device Description
The NuCamma Rx nuclear imaging system has a rectangular field of view. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma Camera
Anatomical Site
Body or organ
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
ISOCAM I
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
iS² Research Inc
r
510(K) SUMMARY
Image /page/0/Picture/3 description: The image shows a logo with a square in the center containing the roman numeral "I". The square is surrounded by a circle that is not fully closed, with gaps at the top left and bottom right. The logo is black and white and appears to be a simple, minimalist design.
2 1998 SEP
SUBMITTER IDENTIFICATION
Applicant's Name and Street Address:
IS2 Research Inc. 20 Gurdwara Road, Units 3 - 6, Nepean, Ontario, Canada K2E 8B3
Contact Person: Peter Schultz, Manager Quality and Regulatory
Telephone and Fax Numbers of Contact Person: T - (613) 228-8755, F - (613) 228-8228
same as Applicant's address above Address of Manufacturing Site:
Date of Submission: June, 1998
DEVICE NAME
Device Name (common): Gamma Camera NuCamma Rx Proprietary Name: Emission Computed Tomography System Classification Name:
INTRODUCTION
This 510(k) Premarket Notification has been prepared to demonstrate that the NuCamma Rx , manufactured by IS? Research Inc., is substantially equivalent to the ISOCAM I gamma camera which has previously underwent the 510(k) premarket notification process. The NuCamma Rx nuclear imaging system has a rectangular field of view.
INTENDED USE
The intended use of NuCamma Rx is to detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The intended use of the two devices is identical except that the NuCamma Rx system only detects the location and distribution of the radionuclides in the body. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.
The NuCamma Rx has been deemed safe and effective and is certified to the same electrical safety standards as the predicate device by a third party organization prior to use on patients. A matrix was constructed companing the features and intended use of the NuCamma Rx with the predicate device. We conclude that the NuCamma Rx is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.
Me d i c a l D i a g n o s t i c l m a g i n g
20 Gurdwara Road, #3-6, Nepean ON K2E 8B3 Canada (613) 228-8755 Fax: (613) 228-8228
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/3 description: The image shows a partial view of a logo or emblem, featuring a stylized graphic element resembling three abstract, curved shapes stacked on top of each other. To the left of the graphic, there is text arranged vertically, reading 'DEPARTMENT OF HEALTH &'. The text is oriented so that it is readable when the image is viewed with the graphic on the right side.
SEP 2 1998
Peter Schultz Manager, Quality Assurance and Regulatory Affairs IS2 Research, Inc. Medical Diagnostic Imaging 20 Gurdwara Road, #3-6 Nepean, Ontario K2E 8B3 CANADA
K982045 Re:
NuCamma Rx Dated: June 5, 1998 Received: June 10, 1998 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Schultz:
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 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). You may, therefore, market the device, subject to the general controls provisions of 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 (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 (OS) 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/dsmaldsmam.n.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | K982045 |
|---|---|
| Device Name: | GAMMA CAMERA (NUCAMMA Rx) |
Nuclear Medicine Device
Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s):
| YES | NO | Energy Range (keV) | ||
|---|---|---|---|---|
| A. | Planar Imaging | ✓ | - | 50 - 400 |
| B. | Whole Body Imaging | ✓ | - | 50 - 400 |
| C. | Tomographic imaging (SPECT) for non Positron emitter | ✓ | - | 50 - 400 |
| D. | Positron imaging by coincidence | - | ✓ | |
| E. | Positron imaging without coincidence | - | ✓ | |
| F. | Other indication(s) in the device label, but not included in above list |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
510(k) Number.
Over-the-Counter Use __
(Optional Format 1-2-96)
8
Tamil C. Segarra
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi-