(88 days)
Not Found
Not Found
No
The document describes a SPECT gamma camera with a new collimator and mentions image processing, but there is no mention of AI, ML, or related concepts like training or test sets for algorithms.
No.
The device is a diagnostic imaging system (SPECT gamma camera) used to image the distribution of radionuclides in the body, but it does not provide therapy.
Yes
The device is a gamma camera used to image the distribution of radionuclides in the body, which is a diagnostic procedure to identify and assess physiological processes.
No
The device description explicitly states it is a "Single Photon Emission Computed Tomography (SPECT) gamma camera" and includes physical components like a collimator, signal analysis and display equipment, and patient/equipment supports. This indicates it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, the ISOCAM II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "image the distribution of radionuclides in the body by means of a single photon radiation detector." This describes an in vivo imaging process, where the device interacts with the patient's body to produce images.
- Device Description: The description confirms it's a "Single Photon Emission Computed Tomography (SPECT) gamma camera," which is a type of medical imaging equipment used on living patients.
- Input Imaging Modality: SPECT is an in vivo imaging modality.
- Anatomical Site: "image the distribution of radionuclides in the body" refers to imaging within the living body.
IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The ISOCAM II operates directly on the patient.
N/A
Intended Use / Indications for Use
The “ISOCAM II” manufactured by Park Medical Systems Inc. is a Single Photon Emission Computed Tomography (SPECT) gamma camera which is intended to image the distribution of radionuclides in the body by means of a single photon radiation detector. This system includes 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)
Not Found
Device Description
The ISOCAM II is a Dual Head Gamma Camera. This submission is for a modification to the ISOCAM II, specifically an additional collimator called MCAT™, which stands for Modular Coded Apperture Technology. The MCAT™ collimator is a position sensitive device that improves the overall effectiveness of the ISOCAM II system by enabling clearer images. There are no additional materials, mechanical changes, or electrical changes to the ISOCAM II needed to secure and support the MCAT™ collimator. The collimator is totally interchangeable with other collimators available for the ISOCAM II system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT) gamma camera
Anatomical Site
Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / 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)
The performance specifications contained in the System Specification are identical to the ISOCAM II system with the exception of System Sensitivity and Image Resolution. The ISOCAM II with MCAT™ shows better sensitivity and resolution measurements compared to the original ISOCAM II.
- System Sensitivity:
- ISOCAM II: 190 cpm/μCi/min (with LEHR collimator)
- ISOCAM II with MCAT™: ≥ 1000 cpm/μCi/min
- Image Resolution:
- ISOCAM II: 3.7-12.3 mm FWHM (0 to 20 cm)
- ISOCAM II with MCAT™: 5-8 mm FWHM (0 to 20 cm)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Sensitivity, Image Resolution.
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for PARK MEDICAL SYSTEMS INC. The logo consists of a circular graphic on the left, followed by the word "PARK" in bold, sans-serif font. To the right of "PARK" are the words "SYSTÈMES MÉDICAUX INC." above "MEDICAL SYSTEMS INC.", with a horizontal line separating the two phrases. The circular graphic appears to be a stylized representation of a spiral or vortex.
FEB 2 8 1997
510(K) SUMMARY
1. SUBMITTER IDENTIFICATION
Submitter's Name and Street Address:
Park Medical Systems Inc. 3195 Louis A. Amos Lachine, Quebec, Canada H8T 1C4
Contact Person: Peter Schultz, Manager Quality and Regulatory
Telephone and Fax Numbers of Contact Person: T- (514) 633-9988, F- (514) 633-8674
Date of Summary: November 29, 1996
:
1
2. DEVICE NAME
Device Name: Gamma Camera
j
:
Proprietary Name: ISOCAM II (Dual Head Gamma Camera)
.
را
Classification Name: Camera, Scintillation (Gamma)
2
3. INTRODUCTION
The ISOCAM II is a legally marketed device manufactured by Park Medical Systems Inc.
This 510(K) is being submitted because of a modification to our ISOCAM II, more specifically, an additional collimator for the ISOCAM II, that allows better images. This modification changes the effectiveness of the ISOCAM II, therefore, we are submitting another premarket notification.
The collimator is called MCAT™, which stands for Modular Coded Apperture Technology.
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
The intended use of the ISOCAM II with MCAT™ is identical to the intended use of the ISOCAM II system we are claiming equivalence to.
3
4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Introduction
The MCAT™ collimator is a position sensitive device that improves the overall effectiveness of the ISOCAM II system. Use of the MCAT™ collimator enables physicians to examine clearer images in which to base their diagnosis.
ISOCAM II with MCAT™ is not going to be marketed for a new or different intended use. Of the criteria referenced in 21 CFR §807.81, para. 3 (i) and 3 (ii), including safety, the only change is effectiveness. The MCAT™ collimator will be added to the list of collimators presently available for use with the system.
Substantial equivalence of ISOCAM II with MCAT™ is being claimed relative to our present ISOCAM II system. A comparison table is given in the following pages.
4
4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE (Continued)
Toble (Technological Characteristics)
-jj-
…
| Comparison Table (Technological Characteristics) | ||
|---|---|---|
| Comparison | ISOCAM II | ISOCAM II with MCAT™ |
| FDA Status | Class I post amendment device | n/a |
| Intended Use | The “ISOCAM II” manufactured by Park Medical | |
| Systems Inc. is a Single Photon Emission | ||
| Computed Tomography (SPECT) gamma camera | ||
| which is intended to image the distribution of | ||
| radionuclides in the body by means of a single | ||
| photon radiation detector. This system includes | ||
| signal analysis and display equipment, patient and | ||
| equipment supports, radionuclide anatomical | ||
| markers, component parts, and accessories. | Same as ISOCAM II. | |
| Energy | ||
| Used/Delivered | There is no new energy source requirement. No | |
| energy is delivered or given off. The energy | ||
| requirement is 220 V, 60 Hz (or 240 V, 50 Hz). | Same as ISOCAM II. | |
| User Instructions | --- | No additional instructions are required in the |
| Operator's Manual. Use of the MCAT™ | ||
| collimator is transparent to the user in all | ||
| respects, including acquisition set-up and | ||
| image processing. The MCAT™ collimator | ||
| will be added to the list of collimators with an | ||
| ISOCAM II system. | ||
| Material Changes | --- | There is no addition of materials to the |
| ISOCAM II in order to secure and support the | ||
| collimator. The weight of the collimator is 200 | ||
| lbs., which is substantially lower than some | ||
| collimators presently available for an ISOCAM | ||
| II system. | ||
| Warnings | A warning label is applied to all collimators | |
| highlighting instructions. | The same label will be applied to MCAT™ | |
| collimator. No changes have been made to the | ||
| label. | ||
| Comparison Table (Technological Characteristics) | ||
| Comparison | ISOCAM II | ISOCAM II with MCAT™ |
| Mechanical | ||
| Changes | --- | There is no mechanical changes to the |
| ISOCAM II to secure and support the | ||
| MCAT™ collimator. All connection points: | ||
| collimator to frame, and frame to detector, are | ||
| identical to the ISOCAM II system. The | ||
| collimator has been designed to be totally | ||
| interchangeable with the collimators already | ||
| available with an ISOCAM II system. | ||
| Electrical | ||
| Changes | --- | There is no electrical changes. The electronics |
| that read and identify collimators inserted in | ||
| the detectors is totally unchanged, in other | ||
| words, the electronics that presently read the | ||
| collimators available with an ISOCAM II | ||
| system is able to read the MCAT™ collimator | ||
| in the same manner. | ||
| Software Changes | --- | No software has been added except for some |
| decoding software necessary to decode the | ||
| initial image data as it appears at the crystal | ||
| after the photons have passed through the | ||
| collimator. The decoding software was | ||
| developed under the same development and | ||
| change procedures as previously submitted in | ||
| the ISOCAM II 510(k). | ||
| Performance | ||
| (change in | ||
| effectiveness) | --- | |
| System Sensitivity = 190 cpm/μCi/min | ||
| (with LEHR collimator) | ||
| Image Resolution = 3.7-12.3 mm FWHM | ||
| (0 to 20 cm) | All performance specifications contained in the | |
| System Specification are identical to ISOCAM | ||
| II system with the exception of System | ||
| Sensitivity and Image Resolution. Better | ||
| sensitivity and resolution measurements change | ||
| the effectiveness of the ISOCAM II system. |
- System Sensitivity ≥ 1000 cpm/μCi/min
Image Resolution = 5-8 mm FWHM
(0 to 20 cm) |
5
4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE (Continued)
acterictics) で 1
్రాక్
(
6
5. DETERMINATION OF SUBSTANTIAL EQUIVALENCE - SAFETY
The ISOCAM II with MCAT™ has been deemed by Park Medical Systems Inc. to be safe and effective. With regard to safety, the ISOCAM II has been designed (as a minimum) using the following safety standards:
CAN/CSA-C22.2 No 114-M90
Canadian Standards Association Diagnostic Imaging and Radiation Therapy Imaging
IEC 601-1
International Electrotechnical Commission Medical Electrical Equipment - General Requirements for Safety
NEMA XR13
National Electrical Manufactures Association Mechanical Safety Standard for Power Driven Motions of Electromedical Equipment
NEMA NU 1-1994 National Electrical Manufactures Association Performance Measurements of Scintillation Cameras
UL544
Underwriters Laboratories Inc. Standard for Medical and Dental Equipment