(29 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and basic software equivalence to a predicate device. There is no mention of advanced algorithms or learning processes.
No.
The device is used to detect the location and distribution of gamma ray emitting radionuclides in the body for analytical purposes, indicating it is a diagnostic imaging device, not a therapeutic one.
Yes
The device is described as detecting the "location and distribution of gamma ray emitting radionuclides in the body and store data for analysis," which is a process used to diagnose conditions by visualizing and quantifying the presence of radionuclides.
No
The device description explicitly mentions hardware components like a detector head and gantry, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis." This describes an in-vivo imaging device, not a device used to examine specimens derived from the human body (which is the definition of an IVD).
- Device Description: The description focuses on the hardware (detector head, gantry, mobile platform) and its function in detecting gamma rays within the body.
- Anatomical Site: The anatomical site is "in the body," further confirming its in-vivo nature.
IVDs are typically used to test samples like blood, urine, tissue, etc., outside of the body to diagnose diseases or conditions. This device operates by detecting radiation emitted from within the patient's body.
N/A
Intended Use / Indications for Use
The intended use of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for andysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.
Product codes (comma separated list FDA assigned to the subject device)
90-KPS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
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
§ 892.1200 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
'JAN 2 0 2004
Labelling:
SUBMITTERS IDENTIFICATION
| Applicant's Name and Street Address: | IS2 Medical Systems Inc.
20 Gurdwara Rd., Units 3-10
Ottawa, Ontario, Canada
K2E 8B3 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------|
| Manufacturing Site: | IS2 Medical Systems Inc.
20 Gurdwara Rd., Units 3-10
Ottawa, Ontario, Canada
K2E 8B3 |
| FDA Registration # | 9615403 |
| Contact Person: | Victor Woodburn, Manager Quality and Regulatory |
| Contact Person E-mail address: | vwoodburn@is2medical.com |
| Telephone and Fax Number of Contact Person: | T-(613) 228-8755, F-(613) 228-8228 |
| Date of Submission: | December 3, 2003 |
| | DEVICE NAME |
| Device Name (Common): | Gamma Camera |
| Proprietary Name: | Mobile Single Circular Camera (MSC)
& Mobile Digital Cardiac Camera (MDCC) |
| Classification Name: | Emission Computed Tomography System |
| Product Code: | 90-KPS |
| CFR: | 21CFR 892.1200 |
| Device Class: | II |
| Predicate Device: | Mobile Single Rectangular Camera |
| (Predicate) 510(k) No.: | K032779 |
Labels and Instructions for Use can be found in Attachment # 1 no changes to the labels or Instructions for Use have occurred except for adding information labels and instructions specific to the application of mounting and using the Camera systems in a Mobile Environment.
1
INTRODUCTION
This 510(k) Premarket Notification has been prepared to demonstrate that the, Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) manufactured by IS2 Medical Systems Inc., is substantially equivalent to the Mobile Single Rectangular Camera (MSR) which has previously been through the 510(k) equivalent in the Movie Barge nessant of the systems include the mounting of the gantry to the mobile platform incorporating the use of "Dome Mounting" pads to facilitate high load isolation.
INTENDED USE
The intended use of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for andysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories. The Indications for Use found in Attachment 2.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The intended use of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is the same range of studies to that of the Mobile Single Rectangular Camera (MSR). The detector head is identical in hardware and software. The gantry of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) are optimised for being attached to a mobile platform which is transported from location to location in a truck and have the same range of automatic clinical motions of Mobile Single Rectangular Cumera (MSR).
The Mobile Single Circular Camera (MSC) and the Mobile Digital Camera (MDCC)) has been deemed safe and effective and is certified to the same 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 Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) with the predicate device. We conclude that the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) 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" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 0 2004
Mr. Victor Woodburn Manager Quality and Regulatory IS2 Medical Systems, Inc. 20 Gurdwara Rd., Units 3-10 Ottawa, Ontario, K2E 8B3 CANADA
Re: K033956
Trade/Device Name: Mobile Single Circular Camera (MSC & Mobile Digital Cardiac Camera (MDCC) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: December 18, 2003
Received: December 22, 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 (QS) 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
Page 2
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 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
4
510(k) Number (K033956)
Device Name: Mobile Single Circular (MSC) and the Mobile Digital Cardiac Camera (MDCC)
Indications for Use: The intended use of the Mobile Single Circular (MSC) and the Mobile Digital Cardiac Camera (MDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device gamma ray entiting factoriable in ades accessories such as signal analysis and display restics on a moone pratent and equipment supports, radionuclide anatomical markers, component parts and accessories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproduction, Abdomin | ||
| a ogical Devices K03386 | ||
| 510(k) Number |
| Prescription Use (Per 21 CFR 801.109) | YES |
|---|---|
| --------------------------------------- | ----- |
OR
| Over-The-Counter Use | NO |
|---|---|
| (Optional Format 1-2-96) |
RECEIVED DATE : 01/07 14:40'04 FROM : 3014804224