LORAD 1-650 (INTERNATIONAL 650)

{0}------------------------------------------------ 3 1999 SEP K92280 ## Section Seven - 510(k) Summary ## 7.1 Submitter Lorad Division of Trex Medical Corporation 36 Apple Ridge Road Danbury, Connecticut 06810 Contact: Philip G. Juhas 203-790-1188 #### 7.2 Device Identification 1-650 Mammography System Mammographic X-ray System 21 CFR 892.1710 Legally Marketed Device to Which Substantial Equivalence is Claimed: Lorad D-550 Mammographic X-ray System (K934870) and Lorad Elite Mammographic X-ray System (K973631). ### 7.3 Device Description #### 7.3.1 Intended Use The Lorad I-650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy. #### 7.3.2 Design The Lorad I-650 mammography system is based on Lorad's currently marketed D-550 (K934870) and Elite (K973631) Dedicated Mammographic Systems. The mechanical packaging is similar to the D-550, while the electronics are similar to the Elite. The changes made to the Elite to create the 1-650 are summarized in the table below. {1}------------------------------------------------ | Elite<br>Specification | Change | I-650<br>Result | |-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------| | LCD panel display and standard<br>QWERTY keyboard for user<br>interface | LCD panel display with cursor<br>and input keys used for technique<br>and function selections. | User interface duplicates the<br>Lorad Elite Functions. | | Automatic Exposure Modes:<br>• Auto-Time<br>• Auto-kV<br>• Auto -Filter | Automatic Exposure Modes:<br>• Auto-Time<br>• Auto-kV | Subset of Elite modes | | X-ray Tube: .1/.3 mm focal spots<br>10° target angle small focal spot,<br>16 degree target angle large focal<br>spot. | .1/.3 mAs focal spots,<br>16° Target angle | 80 mA LF, 20 mA SF | | Automatic Exposure Detector:<br>• Averaged over three<br>separate cells | Automatic Exposure Detector:<br>• Averaged over three<br>separate cells | • Same | | Compression Thickness and<br>compression force indicated with<br>digital display. | Compression Thickness and<br>compression force indicated with<br>digital display. | • Same. | ## 7.3.3 Construction The Lorad I-650 is a standalone mammography device, mounted on a base to be permanently mounted in position. The unit is AC powered, and must be connected to a 220 VAC/50-60 Hertz (nominal) line to operate. The standalone unit has two major assemblies: The C-arm and the Gantry. An I-650 configuration tree, identifying the major components and subassemblies that comprise the I-650, is provided in Attachment B. The C-arm, which contains the x-ray tube, an image receptor support, compression device, a beam limiting device, switches that actuate the C-arm functions, and sensors for detecting installed accessories and making radiation measurements, is attached to the front (patient side) of the Gantry. The C-arm frame is constructed of two vertical steel rails, which are precision machined to accept the components which it supports. Molded plastic covers enclose the x-ray tube, which is purchased from OEM manufacturers, and the beam limiting device, while aluminum covers enclose the sides, back, top and bottom of the C-arm framework. The C-arm is attached by a locking pivot mechanism to the Gantry. The pivot allows the C-arm to be manually rotated about its axis. The pivot mechanism is attached to the Gantry via a vertically moving carriage. This carriage is capable of movement in the vertical direction, driven by an AC motor and a drive screw mounted to the base of the Gantry. The pivoting action of the C-arm is locked by an electromagnetic brake attached to the vertical carriage, which, in its unactuated condition, prevents rotation. The brake must be electrically actuated to release the C-arm for movement. The Gantry is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. The operator control is mounted on the side panel of the Gantry, or {2}------------------------------------------------ may be mounted remotely. The input power and input circuit breaker are located on the lower rear panel of the Gantry. ## 7.3.4 Compatible Equipment The I-650 is equipped with accessories necessary in the performance of mammography. Bucky accessories, are provided to reduce the effects of scattered radiation on the image. Compression paddles to accommodate different sized Buckies and different mammographic applications are supplied. Thev are interchangeable by the operator. A magnification table is provided, which provides a means to obtain geometrically enlarged views of suspicious areas of the breast. Footswitches are provided that operate (1) the C-arm vertical position function, to place the breast platform appropriately to the patient's height, and (2) the compression function, allowing the operator to use both hands to position the patient while applying and releasing breast compression. The 1-650 is capable of use with Lorad's StereoLoc II Breast Biopsy system which was separately cleared by FDA (K952210). Use of the 1-650 with the StereoLoc II does not alter the operation of the 1-650. The 1-650 will be configured for application in a mobile van. #### 7.3.5 Physical and Functional Specifications #### 7.3.5.1 Electrical Input | Mains Voltage: | 200/208/220/230/240 VAC nominal, ±10%, 50/60 Hz | |----------------------------|-------------------------------------------------------------------------------------| | Mains Impedance: | Maximum line impedance not to exceed 0.25 ohms | | Maximum Power Consumption: | 4.4 KVA for 5 seconds duration | | Standby Power: | 0.50 KVA nominal | | Maximum Line Current: | 25 amps for 5 seconds | | Circuit Breaker Rating: | 15A, time delay curve to allow for inrush currents<br>(200% overload for 7 seconds) | {3}------------------------------------------------ Duty Cycle: Full load 5 seconds on, 30 seconds off (1:7) ## 7.3.5.2 Dimensions | Height: | 70 inches (178 cm.) | |---------|------------------------------| | Width: | 24 inches (60 cm.) | | Depth: | 39.75 inches (100 cm.) | | Weight: | 660 lb. (300 kg) approximate | ## 7.3.5.3 Operating Environment | Temperature Range: | 10° C. to 40° C. | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Relative Humidity Range: | 30% to 75% non-condensing | | ESD Susceptibility: | Level of 3 kV for contact discharge to conductive<br>accessible parts that are not grounded. A level of 8<br>kV for air discharge to all accessible parts. Test<br>Methods IEC 801-2, Test Level: IEC 601-1-2 | | EMI Susceptibility: | The system shall be immune from levels of 1 v/m for<br>the frequency range of 26 mHz to 1 gHz (IEC 801-3) | | EMI Generation Limits: | System shall comply with the requirements of CISPR<br>11 for conducted and radiated emission | | Input Line Protection: | Surge, fast transient/burst, lightning, IEC 801-4, IEC<br>801-5 | # 7.3.5.4 Storage Environment | Temperature Range: | -25° C. to +60° C. | |--------------------|---------------------------------------------------------------------| | Humidity: | 0 to 95% RH (non-condensing) - not packaged for<br>outdoor storage. | ## 7.3.5.5 Mechanical Specifications · | C-arm Rotation: | +195° to 0° to -150° with detents at 0°, ±45°, ±90°,<br>±135° and +180°. | |-----------------|--------------------------------------------------------------------------| | Rotation Lock: | Electromagnetic | {4}------------------------------------------------ Vertical Travel: 26 to 55 inches (66-140 cm) from surface of Bucky to floor at 0° Alignment of Focal Spot, Compression Device and Image Receptor: The focal spot of the x-ray tube shall be located such that the ray falling on the edge of the image receptor closest to the chest wall is perpendicular to the image receptor. The system shall allow the plane formed by the focal spot and the chest wall of the device shall be perpendicular to that ray, and motion of the compression device shall provide essentially parallel compression of the breast with respect to the plane of the image receptor. The compression paddle and xray tube shall be adjustable, chest wall to nipple, to provide for this alignment requirement. Source to Image Distance: 65 cm (measured from nominal position of film in Bucky to the large focal spot. ## Compression - A. Force - a. Manual Compression: Shall be limited to 65 lb. ±7 lb. maximum - b. Motorized Compression: Full compression: provides compression in a range of 20-40 lb., user selected Note: motorized compression to be limited to 40 lb. - B. Control: C-arm pushbuttons or 2 position footswitch - C. Compression Release: Motorized, initiated by pushbutton controls on C-arm and on operator panel. Automatic release enabled by software to release at end of exposure, unless inhibited by presence of localization paddle. - D. Release Distance: Automatic release shall move the compression device a distance of 15 cm. {5}------------------------------------------------ - After compression applied, backdrive of device shall E. Backdrive: not exceed 1.5 mm in either motorized or manual modes between -90°, 0°, and +90° C-arm positions, and no greater than 3 mm in any C-arm position outside that range. - In the event of a power failure, there will be means for F. Failure Mode: manual release of compression - Vertical C-arm drive and C-arm rotation will be G. Movement Interlock: disabled if there is approximately 10 lb. or more of compression force. - H. Compression Force Display: Located on upper cover of compression device in combination with compression thickness and AEC detector position. - I. Compression Force Display Accuracy: ±3 lb. from 10 lb. to 35 lb. (±13.35 N from 44.5 N to 155.75 N); ±5 lb. Above 35 lb. (±22.25 N above 155.75 N); - J. Compression Thickness Measurement and Display: Thickness shall be measured between 0 and 15 cm above the image receptor and displayed. The display shall be compensated for the type of image receptor installed. Display will be in 0.1 cm increments on compression device cover and on user interface screen. - K. Compression Thickness Accuracy: ±0.5 cm. at thickness between 0.5 and 10 cm. ±0.8 cm. at thickness greater than 10 cm. {6}------------------------------------------------ - L. Compression Paddles: The compression paddles will be transparent and marked with the location of the AEC sensor positions. The composition shall be either polycarbonate or PETg. The sensor position marking shall not be detectable on film when imaged with 1 cm of acrylic attenuator at 22 kVp to an optical density of 1.2 OD. The paddle attenuation shall be less than 15% (reduction of mR/mAs) AT 25 kVp. The paddles will be designed to provide a parallel plane to the image receptor under 40 lb. of compression force. The paddles will be adjustable to provide the focal spot, compression device and image receptor alignment requirement. - Magnification is provided using either a plateform Magnification: assembly or a table assembly. - 1.8x for objects 22.5 mm above the magnification A. Maqnification Factor: stand breast support surface (the breast support surface will be at approximately 1.7x) - B. Material of Breast Support Surface: Transparent polycarbonate or carbon fiber composite. - C. Size of Breast Support Surface: 15 cm wide x 12 cm deep for table construction, or 18x24 cm for the plateform construction. ## 7.3.5.6 Image Receptor Support Device The IRSD contain sensors for accessory detection and houses the 3 cell AEC detector moveable to 7 positions at 1.7 cm. increments. The image receptor support device shall limit the x-ray transmission to no more than 0.1 mR (1 uGy) for the maximum technique exposure to comply with 21 CFR 1020.31 and IEC 601-1-3. Section 29.207.2. {7}------------------------------------------------ ## 7.3.5.7 X-ray Source Insert Specifications | X-ray Tube: | Varian model M185L/B115 | |------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Focal Spot Size: | Large 0.3 mm, Small 0.1 mm, nominal NEMA/IEC.<br>The tube will be tilted 6° with a target angle of 16° to<br>result in a total target angle to image plane angle of<br>22°. This will provide a system resolution of equal to<br>or greater than 13 lp/mm in the width dimension and<br>11 Ip/mm in the length dimension as measured per<br>the ACR/Quality Control Manual protocol. | | Tube Voltage: | 22 kVp to 39 kVp maximum | | Tube Current: | Large Focus - 80 mA max.<br>Small Focus - 20 mA max. | | Anode Rotation: | 3400 rpm (standard speed)/60Hz<br>2800rpm (standard sped)/50Hz | #### Thermal Characteristics: A. Anode Heat Storage : 210 kJ (300 kHU) - B. Maximum Anode Heat Dissipation Rate: 525 W (740 HU/s) - C. Housing Heat Storage Capacity: 610 kJ (860 kHU) min. 16° - D. Maximum Housing Heat Dissipation Rate: 72 W (6 kHU/min) without air-circulator, 300 W (25 kHU/min) with air cooling Anode Angle: {8}------------------------------------------------ Anode Material: #### Molybdenum X-ray window: Beryllium, 0.8 mm thickness maximum ## X-ray Tube Housing and Tube Head Cover Continuous Heat Dissipation: 300 watts Maximum Temperature of theTube Housing Surface: 55° C. Maximum Temperature of the Tube Head Cover Surface: 41° C. Over Temperature Protection Sensor: Internally provided in series with stator common Safety Class: IEC 601-2-28 #### 7.3.5.9 X-ray Beam Filtration - Inherent Filtration: 0.0 mm Al equivalent - Added Filtration: 30 microns Molybdenum foil, or 25 microns Rhodium foil - Beam Quality: At a given kilovoltage, the measured HVL for Mo/Mo operation with the compression paddle in the x-ray beam will be equal to or greater than the value of kVp/100+0.03 in units of mm of aluminum but less than the value of kVp/100+0.12 in units of mm of aluminum. For Mo/Rh, min>kVp/100+0.03, Max<kVp/100+0.19. {9}------------------------------------------------ The radiation output through the compression paddle Radiation Output: at the entrance surface of the breast (4.5 cm above the breast support, 4 cm from the chest wall) for the Mo/Mo target/filter, large focal spot combination operating at 28 kV shall be equal to or greater than 800 mR/second for at least 3 seconds. #### 7.3.5.10 X-ray Collimation: Collimation is provided by fixed apertures. An aperture detect system will be used to insure that the correct aperture is used with the selected Image Receptor. #### 7.3.5.11 Light Field Indication Light Field to X-ray Field Congruency: Must be within 1% of the SID (0.65 cm) at all edges of the defined x-ray field. (21 CFR states that the light field to x-ray field misalignment be no greater than 2% of the SID for either the length or width which means our design criteria is 1% for each edge, or a total of 2% for length or width edges) Comply with IEC 601-1-3 pg. 51, 94 edition. Light Field Lamp: The lamp will be activated for a period of 30 seconds by switches located in the C-arm, or whenever the compression down motor is activated. The lamp will be extinquished whenever the x-ray exposure is initiated. A shatter shield will be provided. - Light Field Illuminance: The light localizer shall have a minimum illuminance of 160 lux and meet all of the requirements of 21 CFR, subchapter J. section 1020.31. The voltage at the lamp will be the least amount to assure 160 lux at low line conditions and there will be a surqistor in series with the lamp. These two elements will extend the life of the lamp considerable. The lamp will be surrounded by a shatter shield. The lamp will be adjustable to provide alignment of the light field to xray field. {10}------------------------------------------------ #### 7.3.5.12 High Voltage Generator | Output Rating: | 2.24 kilowatt (70 mA at 32 kV) isowatt | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Ripple: | Typically no greater than 2% with a maximum of 4%<br>at lower output loads (less than 2.4 kW) and at low<br>line voltages. | | Topology: | Pulse width modulated high frequency, active servo<br>controlled. | | Duty Cycle: | 5 seconds on, 30 seconds off (1:7)<br>Note: this specification is for the thermal conditions<br>of the high voltage generator. Thermal equilibrium<br>testing will be done at technique factors of 200 mAs,<br>28 kV, at a rate of 1 exposure every 90 seconds. | #### 7.3.5.13 kV/mA Range | kV | Large | Small | |-------|-------|-------| | 22-24 | 80 | 20 | | 25-28 | 80 | 20 | | 29-32 | 70 | 18 | | 33-35 | 60 | 16 | ## 7.3.5.14 mAs Range The I-650 will employ an integrating mAs timer for use as the manual timing as well as the back up timer. There will be an additional hardware safety timer employed to limit the maximum exposure time to 6 seconds. | Manual mAs Range: | 3.0 through 400 mAs in 55 increments as follows: 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0, 14.0, 16.0, 18.0, 20.0, 22.0, 24.0, 26.0, 28.0, 30.0, 32.5, 35.0, 37.5, 40.0, 42.5, 45.0, 47.5, 50.0, 55.0, 60.0, 65.0, 70.0, 75.0, 80.0, 85.0, 90.0, 95.0, 100.0, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 220, 240, 260, 280, 300, 325, 350, 375, 400 mAs. | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### 7.3.5.15 Accuracy, Reproducibility and Linearity {11}------------------------------------------------ | Reproducibility: | Less than 0.05 coefficient of variation for 10<br>consecutive exposures (21 CFR) Internal<br>specification 0.04. | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Linearity: | (radiation output versus selected mAs) Less than 0.10<br>for adjacent mAs selections per the following (X1-<br>X2)=to or less than 0.10(X1+X2) where X1 and X2<br>are average mR/mAs values for consecutive<br>exposures (21CFR). | | Accuracy: | kVp - the actual value will not differ by more than 1 kV<br>from the indicated value. The difference between 2<br>actual kV stations will be in compliance with the<br>difference of the indicated values.<br>mAs: ±5% from indicated | ### 7.3.5.16 Image Receptors The image receptor support device will be designed to accept the three standard image receptors, and the optional receptors listed below, which will be inserted from the front of the C-arm. | Standard items include: | A. 18x24 cm cassette holder<br>B. 18x24 cm Bucky with linear lead strip grid<br>C. 24x30 cm Bucky with linear lead strip grid | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Optional Items include: | A. StereoLoc II with Digitizer<br>B. Magnification platform | - C. 24 x30 cm Cassette Holder ## 7.3.5.17 Automatic Exposure Control (AEC) AEC Detector: The active sensing area will be 3 square centimeters, derived from three 1 cm square sensors. {12}------------------------------------------------ AEC Detector Positioning: The detector will be able to be positioned in 7 locations, centered laterally in the image receptor support device. Position #1 will be located 1 cm from the chest wall, with detected positions at 3, 5, and 7 in 3.4 cm. increments from position #1. The AEC position indicators will be 7 LEDs which indicate the detented positions. The position indicators will be located on the upper compression device cover. AEC kV and Thickness Tracking: The AEC system shall have compensation for kV between 22 kV and 35 kV, as well as compensation for breast thickness tracking including different breast compositions. Tracking will include film reciprocity failure compensation. The optical density shall be within 0.15 O.D. from the mean Optical Density value at any point within the clinically defined range of kVs for breast thicknesses between 2 cm and 6 cm of breast tissue equivalent material. (MSQA/2002) Reproducibility: See section 7.3.5.15. Exposure Termination: The system shall determine if the exposure will reach "Back-up Time" and if so, will terminate the x-ray exposure within one of the following limits. - A. 50 milliseconds - B. 4 mAs - C. with an entrance exposure to the ACR Accreditation Phantom of less than 50 mR. Indication will be made to the operator, and a manual reset will be required to continue the exam. Density Range: There will be 11 density adjustment steps between -5 and +5 with a difference of approximately 10% in mAs from adjacent steps. {13}------------------------------------------------ Post-mAs Display: There will be a display of the post-exposure mAs. The accuracy of the mAs displayed will be within 5% of the actual mAs. The display will hold until the initiation of the next exposure. Modes of Operation: - A. Manual: In this mode, the kV and mAs are both selectable. - B. Auto-Time: In this mode, the kV is the only factor selectable. The exposure is then terminated at a mAs value as determined by the AEC system microprocessor to vield an optical density to which the unit has been calibrated. A post-mAs readout indicates the mAs value at the end of the exposure and remains displayed until the initiation of the next exposure. This mode is valid for use with either the molybdenum or rhodium filter selected. The exposure may be modified up to ±50% of calculated mAs by incrementing the DENSITY function. If determination is made that the exposure will exceed the Backup Time, the exposure will be terminated in less than one of following limits: (a) 50 ms, (b) 4 mAs, or (c) with an entrance exposure to the ACR accreditation phantom of less than 50 mR, and indicate the termination to the operator. - C. Auto-kV: When this mode and the Moly filter are selected, the kV. If the Rhodium filter is selected, the kV will be limited to 28-32 kV. The kV will default to 28 kV and the mA will be set to 70 mA. Normally there is no requirement to make any selection of technique in this mode. Upon exposure initiation, the AEC signal is sampled and the kV is incremented upward to a maximum of 28 kV if the Moly filter is selected, or 32 kV if the Rhodium filter is selected, to provide an exposure within the user selected window of approximately 80 mAs. 120 mAs. or 160 mAs. as selected by the user. After the kV is incremented (approximately 50 msec into the exposure) the Auto-Time function completes the exposure. The post-kV and post-mAs are then displayed. {14}------------------------------------------------ ## 7.4 Summary of Non-Clinical Testing #### 7.4.1 Overview of Performance Evaluations To assess and provide measurement data on the mammographic imaging performance of the 1-650 unit, a series of bench tests was developed and performed. The bench tests used the geometry and components of the I-650 system to (1) obtain system resolution measurements, (2) to provide images of standard mammographic quality assurance phantoms, (3) to evaluate tracking performance of the Automatic Exposure Control system, and (4) to evaluate performance in stereotactic localization. The tests and the results are summarized in this section. ## 7.4.2 Focal Spot Performance Testing #### 7.4.2.1 Focal Spot Measurement - A. Measurement Method: - 0.5° and 1.5° star patterns were imaged with the center of the . star pattern located approximately 1 cm from the chest wall. - Images were made at 25, 28, and 30kV - Back ground optical density at 1.2 to 1.4 OD . - Kodak MinR-2000 film and screens . - 90 second developing Kodak chemistry . #### B. Pass Criteria: (NEMA method) - . Large focal spot (nominal 0.3 mm): Maximum dimensions = 0.45mm W x 0.65mm L - . Small focal spot (nominal 0.1 mm): Maximum dimensions = 0.15mm W x 0.15mm L #### c. Results: | Focal Spot | kV | Length<br>(mm) | Width<br>(mm) | |------------|----|----------------|---------------| | Large | 25 | 0.47 | 0.33 | | Large | 28 | 0.46 | 0.31 | | Large | 30 | 0.46 | 0.30 | | Small | 25 | 0.11 | 0.087 | | Small | 28 | 0.11 | <0.10* | | Small | 30 | 0.11 | <0.10* | *unmeasurable with star pattern {15}------------------------------------------------ ## 7.4.2.2 Svstem Resolution: - A. Measurement Method: - 5-20 lp/mm Line Pair Bar Pattern (Nuclear Associates # 07-555-. EY) positioned 4.5 cm above the breast support surface (Lorad Bucky for Large focal spot - Lorad 1.8X magnification plate for Small focal spot) - 25, 28, and 30 kV ● - Kodak MinR-2000 film and screens . - 90 second processing Kodak chemistry . - B. Pass Criteria: (MQSA) - Lines parallel to tube axis = 13 lp/mm minimum . - Lines perpendicular to tube axis = 11 lp/mm minimum . #### c. Results: | Focal spot | kV | Length<br>(lp/mm) | Width<br>(lp/mm) | |------------|----|-------------------|------------------| | Large | 25 | 14 | 16 | | Large | 28 | 14 | 16 | | Large | 30 | 14 | 16 | | Small | 25 | 19 | 19 | | Small | 28 | 16 | 19 | | Small | 30 | 15 | 19 | ## 7.4.3 Object Phantom Tests Tests were performed using a standard ACR Map Phantom (RMI-156 or Nuclear Assoc. #18-220) The phantom was imaged following normal clinical procedures to yield a film with an average optical density of 1.5. To provide a true indication of imaging performance, the mean glandular dose for the phantom images was evaluated. to ensure that the imaging performance was obtained at an absorbed dose level within the range acceptable for mammography. The phantom images were scored according to standard ACR procedure, using three readers for each of two phantom films readers. The results are averaged summarized below. {16}------------------------------------------------ | Object Group | ACR/MQSA<br>Minimum | Phantom Film 1 | Phantom Film 2 | |--------------|---------------------|----------------|----------------| | Fibers | 4 | 4.5 | 4.5 | | Specks | 3 | 3.5 | 3.5 | | Masses | 3 | 4 | 4 | | Score | 10 | 12 | 12 | | Mean Glandular Dose Limit for<br>Screening Mammography Image<br>(ACR) | MGD Measured for<br>Phantom Film 1 | MGD Measured<br>for Phantom Film 2 | |-----------------------------------------------------------------------|------------------------------------|------------------------------------| | 3 mGy | 1.48 mGy | 1.71 mGy | | Parameter | Phantom Film 1 | Phantom Film 2 | |---------------------------------------------------------|----------------|----------------| | Optical Density | 1.52 | 1.52 | | Contrast Diff. Ratio (Avg.<br>density - contrast disk)* | 0.48 | 0.50 | * ACR Requirement = 0.40 minimun #### 7.4.4 AEC Tracking: A. Test Method: Obtain automatically timed exposures using breast tissue equivalent material from 2 through 8 cm thickness at appropriate clinical kV for those thicknesses. Evaluate consistency of the resulting exposures in terms of optical density. B. Test Materials: - 2 to 6 cm of 50/50 breast tissue equivalent material . - . Kodak MinR-2000 film and screens - . Film processing - 90 seconds - Kodak Chemistry ## C. Pass Criteria (MQSA) The optical density of any film is to be within 0.15 OD of the Mean optical density. (MQSA - Oct. 28, 2002) {17}------------------------------------------------ - D. Results: | | _arge focal spot - contact- Molybdenum filter | |--|-----------------------------------------------| | | | | kV | 2 cm | 4 cm | 6cm | |----|------|------|------| | 25 | 1.63 | 1.60 | n/a | | 26 | 1.5 | 1.52 | 1.52 | | 27 | 1.51 | 1.50 | 1.45 | | 28 | 1.47 | 1.42 | 1.59 | | 29 | 1.59 | 1.59 | 1.53 | | 30 | 1.50 | 1.51 | 1.41 | #### Results: Mean OD = 1.52 +0.11/-0.10 Large focal spot - contact - Rhodium filter | kV | 2 cm | 4 cm | 6 cm | |----|------|------|------| | 28 | 1.43 | 1.37 | 1.48 | | 29 | 1.65 | 1.49 | 1.41 | | 30 | 1.61 | 1.58 | 1.49 | #### Results: Mean OD = 1.50 +0.15/-0.13 Small focal spot - magnification - Molybdenum filter | kV | 2 cm | 3 cm | 4 cm | |----|------|------|------| | 25 | 1.61 | 1.51 | 1.49 | | 26 | 1.51 | 1.54 | 1.47 | | 27 | 1.51 | 1.51 | 1.44 | | 28 | 1.47 | 1.48 | 1.38 | | 29 | 1.56 | 1.57 | 1.60 | | 30 | 1.50 | 1.45 | 1.56 | +0.10/-0.13 Results: Mean OD = 1.51 The results verify that the AEC tracking is within the MQSA requirements for 2002. {18}------------------------------------------------ ## 7.4.5 Stereotactic evaluation To evaluate the 1-650 in terms of performing as a host mammography unit for an add-on stereotactic localization device, a prototype 1-650 was fitted with a Lorad StereoLoc II device. The tests results supported compatibility with stereotactic procedures suing the StereoLoc II device with the film based Digitizer System. ## 7.4.5.1 Needle Positioning and Targeting Test In this test, the positioning controls of the StereoLoc II device are calibrated and used to position a simulated lesion 1mm in diameter to a known 3-dimensional position (X=10mm, Y= 20mm and Z=30mm). Stereotactic images are then obtained and the simulated lesion is localized using the StereoLoc II system controls. The localized X, Y and Z values are compared to the originally set X, Y and Z positions as an evaluation of accuracy of localization. This test confirms that the system is capable of providing accurate readings with the geometry of the 1-650 host mammography unit. Stereotactic Localization Results with StereoLoc II - Film Equipped | Set Position | Localized Results | Error | |--------------|-------------------|-------| | X=10 | X=10.1 | 0.1 | | Y=20 | Y=20.4 | 0.4 | | Z=30 | Z=30.1 | 0.1 | Cumulative Error = sar(Xerr2+Yerr2+Zerr2)=0.42 Specified Accuracy ±1 mm. Results meet specification. {19}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/19/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is an abstract image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. SEP 3 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Lorad Division of Trex Medical Corporation C/O Phillip G. Juhas, Ph.D. Director of Regulatory Affairs 36 Apple Ridge Road Danbury, CT 06810 Dear Dr. Juhas: Re: K992280 Lorad 1-650 Dated: August 23, 1999 Received: August 26, 1999 Regulatory Class: II (two) Product Code: 90 IZH 21 CFR 892.1710 We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html". Sincerely yours, CAST Daniel S. Ochiel, M.D. CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {20}------------------------------------------------ Image /page/20/Picture/0 description: The image shows the logo for TREX Medical Corporation. The word "TREX" is in large, bold, black letters, with the "X" slightly overlapping the "E". To the right of "TREX" is the text "Medical Corporation" in a smaller, thinner font. Page 1 of 1 510(k) Number (if known): K992280 Device Name: LORAD 1-650 Mammography System Intended Use: The 1-650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy. Concurrence of CDRH, Office of Device Evaluation (ODE) David a. Segner (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number Prescription Use 21 CFR 801.109 OR Over-the-Counter Use