(87 days)
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.
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This document describes the 510(k) summary for Park Medical Systems' 511 KeV collimator for their ISOCAM I and ISOCAM II nuclear imaging systems. The submission aims to demonstrate substantial equivalence to a predicate device, the Dyna camera 2 series high energy collimators, rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial or performance study with defined thresholds for sensitivity, specificity, etc. Instead, it presents a comparison table of technological characteristics and performance metrics against a predicate device to demonstrate substantial equivalence.
| Feature/Spec. | Predicate (Dyna Camera 2 Series High Energy Collimator) | Park 511 KeV Collimator (ISOCAM I/II) | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) |
|---|---|---|---|
| Intended Use | Detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body. | Same as predicate. | Be suitable for the same intended use. |
| Physical Description: | |||
| 1) Name | High Energy Collimator | Ultra High Energy Collimator | Be a collimator for high energy imaging. |
| 2) No. of holes | 1,100 (round) | 7,500 (hex) | Number and shape of holes is a design choice, not a direct performance criterion for equivalence. |
| 3) Energy Range | 44 - 525 KeV | 50 - 562 KeV | Operate within a similar high-energy range. |
| 4) Thickness | 2.5 inches = 63.5 mm | 76 mm | Have a physical thickness suitable for high-energy attenuation. |
| 5) Hole Size | 0.20 inches = 5.08 mm | 4 mm | Hole size is a design choice affecting resolution and sensitivity trade-offs. |
| 6) Septa thickness | 0.156 inches = 3.94 mm | 2 mm | Septa thickness is a design choice affecting resolution and septal penetration. |
| 7) Field Size | 11.8 inches = 300 mm (diameter) | 419 mm × 566 mm (rectangular) | Have a field size suitable for nuclear imaging. |
| Performance | Resolution | Resolution | Resolution performance comparable to the predicate. |
| FWHM 99mTc (surface) | 5.59 mm | N/A |
§ 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.