(87 days)
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No
The summary does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML-driven image analysis or processing. The device is described as a collimator for a gamma camera, which is a passive component.
No
The device is used to detect and image the distribution of radioactive agents, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as detecting and imaging the distribution of a radioactive agent in the human body, which is a process used for diagnostic purposes (to identify or investigate medical conditions).
No
The device is described as a "collimator," which is a physical component used in imaging systems to shape and direct radiation. The description focuses on detecting and imaging photons, which is a function of hardware. There is no mention of software as the primary or sole component.
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 and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body." This describes an in vivo imaging process, where the radioactive agent is administered to the patient and the device images its distribution within the living body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The Dyna Camera 2 series collimator is a component used in a gamma camera system for nuclear medicine imaging, which is an in vivo diagnostic technique.
N/A
Intended Use / Indications for Use
The intended use of the Dyna Camera 2 series collimator is to detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body. Same as predicate.
Product codes
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Device Description
We manufacture single and dual detector gamma cameras, hereafter, called ISOCAM I and ISOCAM II respectively, which recently underwent FDA review. At the request of the FDA, this 510(K) is being submitted specifically for the 511 KeV collimator option for the Park Medical Systems ISOCAM I and ISOCAM II nuclear imaging systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Nuclear imaging
Anatomical Site
human body
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Although no applicable performance standards have been issued under Section 514 of the FD and C Act, the following is the basis for the performance specifications for the 511 KeV collimators for the ISOCAM I and ISOCAM II systems: NEMA NU 1-1994 National Electrical Manufactures Association Performance Measurements of Scintillation Cameras.
Performance:
Predicate - Resolution FWHM = 5.59 mm 99mTc (surface), = 5.70 mm 18F (surface), FWHM = 11.76 mm 99mTc (3" from surface), = 13.20 mm 18F (3" from surface) (3" = 7.62 cm)
Park 511 KeV Collimator - Resolution FWHM = N/A 99mTc (surface), = 5.74 mm (surface), FWHM = 10.1 mm 99mTc (10 cm from surface), = 11.8 mm 18F (10 cm from surface)
Key Metrics
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Predicate Device(s)
Dyna camera 2 series high energy collimators
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 Systemes Medical System. The logo consists of a circular graphic on the left, the word "PARK" in bold black letters in the center, and the words "SYSTEMES MEDICAL SYSTEM" stacked on top of each other on the right. The circular graphic appears to be a stylized representation of a spiral or vortex.
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: January 10, 1997
분
11.000
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510(k) Premarket Notification Summary
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2. DEVICE NAME
Device Name: 511 KeV Collimator
ISOCAM I (Single Head Gamma Camera) Proprietary Name: ISOCAM II (Dual Head Gamma Camera)
System, Tomography, Computed, Emission Classification Name:
....
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510(k) Premarket Notification Summary
3. INTRODUCTION
We manufacture single and dual detector gamma cameras, hereafter, called ISOCAM I and ISOCAM II respectively, which recently underwent FDA review.
At the request of the FDA, this 510(K) is being submitted specifically for the 511 KeV collimator option for the Park Medical Systems ISOCAM I and ISOCAM II nuclear imaging systems.
The format for this submission follows the FDA document entitled, "Premarket Notification 510(k) Regulatory Requirements for Medical Devices". In addition to the information in our previous 510(k) which included high energy imaging with 511 KeV collimators, the information requested in the recent FDA letter to industry concerning 511 KeV collimators, has also been included in this submission.
This submission shows substantial equivalence of Park 511 KeV collimators to the pre-ammendment high energy collimators used with the Dyna camera.
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510(k) Premarket Notification Summary
4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE -SAFETY AND EFFECTIVINESS
The ISOCAM I and ISOCAM II imaging systems have been deemed by Park Medical Systems Inc. to be safe and effective. With regard to safety, they have 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
UL544
Underwriters Laboratories Inc. Standard for Medical and Dental Equipment
Although no applicable performance standards have been issued under Section 514 of the FD and C Act, the following is the basis for the performance specifications for the 511 KeV collimators for the ISOCAM I and ISOCAM II systems:
NEMA NU 1-1994 National Electrical Manufactures Association Performance Measurements of Scintillation Cameras
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510(k) Premarket Notification Summary
5. SUBSTANTIAL EQUIVALENCE COMPARISON
Introduction
Based upon the following comparison, Park 511 KeV collimators for the ISOCAM I and II imaging systems have the same characteristics as the predicate device, the Dyna camera 2 series high energy collimators. The comparison table is given in the following pages. The product data sheets for the predicate device are included following the comparison table.
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5. SUBSTANTIAL EQUIVALENCE COMPARISON (Continued)
Comparison Table (Technological Characteristics)
| Feature/Spec. | Predicate | Park 511 KeV Collimator |
|---|---|---|
| Intended Use | The intended use of the Dyna Camera 2 series | |
| collimator is to detect and image the distribution | ||
| of high energy photons from an administered | ||
| positron emitting radioactive agent in the human | ||
| body. | Same as predicate. | |
| Physical | ||
| Description: | ||
| 1) Name | High Energy Collimator | Ultra High Energy Collimator |
| 2) No. of holes | 1,100 (round) | 7,500 (hex) |
| 3) Energy Range | 44 - 525 KeV | 50 - 562 KeV |
| 4) Thickness | 2.5 inches = 63.5 mm | 76 mm |
| 5) Hole Size | 0.20 inches = 5.08 mm | 4 mm |
| 6) Septa thickness | 0.156 inches = 3.94 mm | 2 mm |
| 7) Field Size | 11.8 inches = 300 mm (diameter) | 419 mm × 566 mm (rectangular) |
| Performance | Resolution | |
| FWHM = 5.59 mm 99mTc (surface) | ||
| = 5.70 mm 18F (surface) | ||
| FWHM = 11.76 mm 99mTc (3" from surface) | ||
| = 13.20 mm 18F (3" from surface) | ||
| (3" = 7.62 cm) | Resolution | |
| FWHM = N/A 99mTc (surface) | ||
| = 5.74 mm (surface) | ||
| FWHM = 10.1 mm 99mTc (10 cm from surface) | ||
| = 11.8 mm 18F (10 cm from surface) |