ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)

{0} PARK SYSTEMES MEDICAUX INC. MEDICAL SYSTEMS INC. K970128 APR 11 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:** January 10, 1997 3195 Louis A. Amos, Lachine (Québec), Canada H8T 1C4 Tel. (514) 633-9988 Fax (514) 633-8674 {1} 510(k) Premarket Notification Summary ## 2. DEVICE NAME Device Name: 511 KeV Collimator Proprietary Name: ISOCAM I (Single Head Gamma Camera) ISOCAM II (Dual Head Gamma Camera) Classification Name: System, Tomography, Computed, Emission {2} 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. {3} 510(k) Premarket Notification Summary # 4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE - SAFETY AND EFFECTIVENESS 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 {4} 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. {5} 510(k) Premarket Notification # 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^{99m}Tc (surface) = 5.70 mm^{18}F (surface) FWHM = 11.76 mm^{99m}Tc (3" from surface) = 13.20 mm^{18}F (3" from surface) (3" = 7.62 cm) | Resolution FWHM = N/A^{99m}Tc (surface) = 5.74 mm (surface) FWHM = 10.1 mm^{99m}Tc (10 cm from surface) = 11.8 mm^{18}F (10 cm from surface) |