(100 days)
No
The document describes a standard nuclear imaging system and does not mention any AI or ML components in its description, intended use, or performance studies.
No.
The device is used for detection and imaging of gamma ray emitting radionuclides in the body, which is a diagnostic purpose, not therapeutic.
Yes
The device's intended use is to "detect the location and distribution of gamma ray emitting radionuclides in the body" and to "detect or image the distribution of radionuclides in the body or organ." This information is used for diagnostic purposes, specifically for nuclear imaging techniques like Planar Imaging, Whole Body Imaging, and Tomographic Imaging (SPECT).
No
The device description explicitly mentions a "single rectangular field of view detector heads" and a "gantry," which are hardware components. The description also states the detector head is "identical in hardware and software" to a predicate device, further indicating the presence of hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Mobile Rectangular Single Head Camera (MSR) detects and images the distribution of radionuclides within the body. This is an in vivo (within the living body) imaging technique.
- Intended Use: The intended use clearly states it detects the location and distribution of gamma ray emitting radionuclides in the body.
Therefore, based on the provided information, the device operates in vivo and does not perform testing on specimens taken from the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Mobile Rectangular Single Head Camera (MSR) is to detect the location and distribution of gamma ray enitting radionuclides in the body and store 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.
Indications for Use: The intended use of the Mobile Rectangular Single Head Camera is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and 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);
- YES NO Energy Range (keV) 50 – 400 keV (a) Planar Imaging (b) Whole Body Imaging 50 – 400 keV (c) Tomographic Imaging (SPECT) for non Positron 50 - 400 keV emitter (d) Positron imaging by coincidence (e) Positron imaging without coincidence (f) Other indication(s) in the device label, but not None included in the above list
Product codes
90-KPS
Device Description
The Mobile Rectangular Single Head Camera (MSR) nuclear imaging system has a single rectangular field of view detector heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
detect the location and distribution of gamma ray enitting radionuclides in the body
Anatomical Site
body, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 892.1200 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
501(k) SUMMARY
DEC 17 2003
SUBMITTERS IDENTIFICATION
| Applicant's Name and Street Address: | IS2 Medical Systems Inc.
20 Gurdwara Rd., Units 3-10
Ottawa, Ontario, Canada
K2E 8B3 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Victor Woodburn, Manager Quality and Regulatory |
| Telephone and Fax Number of Contact Person: | T- (613) 228-8755, F - (613) 228-8228 |
| Address of Manufacturing Site: | Same as Applicant's Address noted above |
| Date of Submission: | September 30, 2003 |
| | DEVICE NAME |
| Device Name (Common): | Gamma Camera |
| Proprietary Name: | Mobile Rectangular Single Head Camera (MSR)) |
| Classification Name: | Emission Computed Tomography System |
| Product Code: | 90-KPS |
| CFR: | 21CFR 892.1200 |
| Device Class: | II |
| Predicate Device: | Rectangular Single Head Camera (SR) |
| 510(k) No.:
(Predicate) | K982045 |
INTRODUCTION
This 510(k) Premarket Notification has been prepared to demonstrate that the Mobile Rectangular Single Head Camera (MSR), manufactured by IS2 Medical Systems Inc., is substantially equivalent to the Read Camera (SR) which has previously been through the 510(k) premarket notification process. The Mobile Rectangular Single Head Camera (MSR) nuclear imaging system has a single rectangular field of view detector heads.
1
501(k) SUMMARY
INTENDED USE
The intended use of the Mobile Rectangular Single Head Camera (MSR) is to detect the location and distribution of gamma ray enitting radionuclides in the body and store 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 Mobile Rectangular Single Head Camera (MSR) is the same range of studies to that of the Rectangular Single Head Camera (SR). The detector head is identical in hardware and software. The gantry of the Mobile Rectangular Single Head Camera (MSR) is optimized for being attached to a mobile platform which is transported from location in a truck and has the same range of automatic clinical motions of the Rectangular Single Head Camera (SR).
The Mobile Rectangular Single Head Camera (MSR) 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 comparing the features and intended use of the Mobile Rectangular Single Head Camera (MSR) with the predicate device. We conclude that the Mobile Rectangular Single Head Cameru (MSR) is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract eagle or bird-like figure, with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2003
Mr. Victor Woodburn Manager, Quality and Regulatory IS2 Medical Systems, Inc. 20 Gurdwara Road, Units 3-10 Ottawa, Ontario, K2E 8B3 CANADA
Re: K032779 Trade/Device Name: Mobile Rectangular Single Head Camera (MSR) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: September 5, 2003 Received: September 18, 2003
Dear Mr. Woodburn:
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 either class II (Special Controls) or class III (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
to proceed to the market.
4
510(k) Number (K032779)
Device Name Mobile Rectangular Single Head Camera (MSR)
Indications for Use: The intended use of the Mobile Rectangular Single Head Camera is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and 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);
- YES NO Energy Range (keV) 50 – 400 keV (a) Planar Imaging (b) Whole Body Imaging 50 – 400 keV (c) Tomographic Imaging (SPECT) for non Positron 50 - 400 keV emitter (d) Positron imaging by coincidence (e) Positron imaging without coincidence (f) Other indication(s) in the device label, but not None included in the above list
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K 032779
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use