MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION

{0}------------------------------------------------ K013620 ## 510(k) SUMMARY [Submitted pursuant to 21 CFR 807.87 (h).] ## 1. Submitter Information: | Submitter: | Medstone International Incorporated<br>100 Columbia, Suite 100<br>Aliso Viejo, California, 92656 | |--------------------------|--------------------------------------------------------------------------------------------------| | Telephone: | (949) 448-7700 | | Facsimile: | (949) 448-7880 | | Contact Person: | Ronald H. Bergeson, V.P., Regulatory Affairs | | Date Prepared: | October 30, 2001 | | 2. Device: | | | Trade/ Proprietary Name: | Medstone, Linear Tomography Option | | Common/Usual Name: | Linear Tomography Option | | Classification Name: | System, X-Ray, Tomographic | ### 3. Predicate Device: Pausch Corporation Microtom, Tomographic Option #### 4. Device Description: The Medstone, Radiographic Linear Tomography Option is designed as an 'add-on' optional device to enable the production of radiologic images of a specific linear cross-sectional plane of the body by blurring or eliminating detail from other planes. A high degree of emphasis for the design of this device was placed on error detection and reliability as well as usability and safety. #### 5. Device Intended Use: The Medstone, Radiographic Linear Tomography Option is designed as an optional additional device to the Medstone UroPro 2000 table, intended for use in general radiology. It is designed to enable the production of diagnostic radiologic images of a specific linear cross-sectional plane of the body, eliminating unwanted anatomy and detail by motion blurring of other planes. This device is designed to provide and control the sweep speed and angle of a {1}------------------------------------------------ tomography function to enable the production of a properly imaged X-ray film to accomplish diagnostic imaging of a patient. The table and tomography option are intended to be used by trained professionals, schooled in proper radiology procedures, techniques, positioning and safety. ## Device application: | Is the device a life-supporting or life sustaining device? | No | |----------------------------------------------------------------------|------| | Is the device an implant device? | No | | Is the device a sterile device? | No | | Is the device for single use? | No | | Is the device a diagnostic kit? | No | | Is the device for prescription or 'over the counter' (OTC) use? | No | | Is the device to be used in the hospital or physician's office? | Yes | | Does the device contain a drug or biological product as a component? | No | | Does the device design use software? | Yes | | Level of concern for software (if applicable)? | Mino | | Is the device a diagnostic kit? | No | ## 6. Comparison of Device Technological Characteristics: | PARAMETER | MEDSTONE TOMO OPTION | PAUSCH TOMO OPTION | |---------------------------------------------------|----------------------|----------------------| | INPUT/LINE VOLTAGE | 110 VAC 1-phase | 110 VAC 1-phase | | INPUT/LINE FREQUENCY | 50/60 Hz | 50/60 Hz | | TOMOGRAPHIC MOVEMENT | LINEAR | LINEAR | | FULCRUM RANGE | 0 mm to 250 mm | 0 mm to 240 mm | | TOMOGRAPHIC ANGLES | 20°, 10° and 5° | 40°, 30°, 20° and 8° | | EXPOSURE TIMES<br>(Controlled by X-Rav Generator) | 0.2, to 1.6 secs. | 0.4, to 4.0 secs | #### 7. Comparison of Non-Clinical Performance Data: The assessment of non-clinical performance data as to visual indication of the technique factors, time, angle, layer height and all related safety and effectiveness issues indicates substantial equivalence. The operational performance as to 'sweep time' per degree of 'sweep angle' is within 20% differential and is equivalent with respect to imaging output. This comparison indicates no differences in performance between the Medstone International, Inc. device and the predicate Pausch device. {2}------------------------------------------------ ## 8. Comparison of Clinical Performance Data: It has been concluded that clinical performance data for the Medstone Linear Tomographic, device was not needed for this 510(k) process. The determination of substantial equivalence is, therefore, not based on an assessment of clinical performance for the purpose of this 510(k) process. ## 9. Conclusions from Non-Clinical and Clinical Tests: The Medstone International Inc. Linear Tomographic Option perform the same function, in the same environment and have the same intended use as the Pausch Tomographic device. A comparison of device specifications and principals of operation, indicates that no new questions of efficacy, or substantial risk are raised. Performance tests of visual indication of the technique factors, time, angle, layer height and all related safety and effectiveness issues indicates complete equivalence between the Medstone International Inc. Linear Tomographic Option and the predicate Peusch Tomographic device. {3}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird, with three curved lines representing its wings or feathers. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850 ## JAN 2 2 2002 Mr. Ronald H. Bergeson Vice President, Regulatory Affairs Medstone International, Inc. 100 Columbia, Suite 100 ALISO VIEJO CA 92656 Re: K013620 Trade/Device Name: Medstone, Linear Tomography Option Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: II Product Code: 90 IZF Dated: October 18, 2001 Received: November 5, 2001 #### Dear Mr. Bergeson: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) prometice is substantially equivalent (for the indications referenced above and nave decemblic are actrood predicate devices marketed in interstate for the stated in the cherosale) to regally management date of the Medical Device Amendments, or to commerce prior to May 28, 1776, the enaounce with the provisions of the Federal Food. Drug, devices that have been recassince in accessfire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approva and Cosment ACT (Acc) that do not requent of the general controls provisions of the Act. The You may, dielefore, market the dovros, seejest to annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adultcration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classifica (sec above) into extine major regulations affecting your device can be it may be subject to additional concess. Extrement with and to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean ITIcase oe advised that I DA 3 issuation or our device complies with other requirements of the Act that IDA has made a decommanding administered by other Federal agencies. You must of any roderal statures and roguirenents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labornig (21 CFR Part 820); and if applicable, the electronic rolation and quality of stoms (QS) regisment {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device to a legally marketed notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantial equivalise of 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), please s the regulation and the filler of the fillers awmbers, based on the regula If you desire specific advice for your device of our laboring organization in the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the pothouor and as encle or equation entitled, "Misbranding Office of Compliance at (301) 594-4639. Also, please note the regulation on Office of Compliance at (301) 394-4057. This, Part 807.97). Other general information on by reference to premarket notification (21 Cr Cr r r the Division of Small Manufacturers, your responsibilities under the Act may be obtained from the C001 or (301) A43-659 your responsibilities under the Acstiller in the 1000 638-2041 or (301) 433-2041 or (301) 443-6597 International and Consumer Assistance at its tollers (800) 638-2041 or (301 Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html. Sincerely yours, Nancy C. Snogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Kobeck Page 1 of # MEDSTONE INTERNATIONAL, INC. # INDICATIONS FOR USE Unknown at this time. 510(k) Number: Medstone, UroPro 2000, Tomographic Option Device Name: Indications for Use: The Medstone, Radiographic Linear Tomography Option is designed as an optional additional The Medstone, Radiographic Lincal I onography Option in use in general radiology. - It is device to the Medstone UroPro 2000 table, intended for use in general radiology. - I designed to enable the production of diagnosic radiologic images of a specific linear crossdesigned to enable the finin since areasons and detail by motific linear crossdesigned to enable the production of diagnostic racionogle anaged and of a province of other planes. This device is designed to provide and control the sweep speed and angle of a tomography the same the the became of any first and consects imaged. Y-ray film to accomplish di This device is designed to provide and control the sweep spocallars and ang function to enable the production of a properly imaged X-ray film to accomplish diagnstic imaging of a patient. The table and tomography option are intended to be used by trained professionals, schooled in the mography and submit was negitioning and safety I he table and toningtaphy option are are and safety. in proper radiology procedures, techniques, positioning and safety. # (Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ਤੇ ਰੋ Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _ (Per 21 CFR 801.109) Ylanci C. Brogdon (Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510kki Nimma (Optional Format 1-2-96) \$\zeta\$