BLADDERSCAN BVI 6100

{0}------------------------------------------------ KD221LB AUG 1 5 2002 # DIAGNOSTIC ULTRASOUND ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92. #### Submitter's name, address, telephone number, contact person: 1) Russ Garrison Senior Vice President, Operations Diagnostic Ultrasound Corporation 21222 30th Drive SE, Suite 120 Bothell, WA 98021 Phone: (425) 867-1348 x1350 E-mail: rgarrison@dxu.com Date prepared: August 1, 2002 - 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known: Common/ Usual Name Diagnostic Ultrasound System with Accessories Proprietary Name BladderScan™ BVI 6100 Classification Names Ultrasonic Pulsed Echo Imaging System (892.1560; 90-IYO) Diagnostic Ultrasound Transducer (892.1570; 90-ITX) {1}------------------------------------------------ #### Identification of the predicate or legally marketed device: 3) Diagnostic Ultrasound believes that the BVI 6100 System is substantially the previously cleared Diagnostic Ultrasound equivalent to BladderManager™ BVI 5000 System (K955850), Diagnostic Ultrasound BladderScan™ BVI 2500 System (K915436), and the SonoSite™ Hand-Carried Ultrasound System (K990806). #### 4) Device Description: The BladderScan™ BVI 6100 Ultrasound System is a hand-held, batterypowered, software-controlled ultrasound system used to acquire and display real-time B-mode images of the bladder. The System is intended to non-invasively monitor bladder volume on an intermittent basis. The System is an effective, low cost, simple option for use in a clinical hospital or nursing home setting or for home use under medical supervision. The BVI 6100 System is designed to comply with the standards listed below. - EN 60601-1:1997 . - . EN 60601-1-1:1993 - EN 60601-1-2:1998 . - EN 60601-2-37:2001 . - CAN/CSA C22.2, No. 601.1 M90 . - UL 2601-1:1999 . - IEC 61000-4-2:1999 . - . IEC 61000-4-3:1997 - IEC 61000-4-4:1995 ● - IEC 61000-4-5:1999 . - . CEI/IEC 61157:1992 - . CISPR11:1997 - Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment. American Institute of Ultrasound in Medicine, 1998. - Acoustic Output Labeling Standard for Diagnostic Ultrasound . Equipment: A Standard for How Manufacturers Should Specify Acoustic Output Data, American Institute of Ultrasound in Medicine, 1998. - Medical Ultrasound Safety, American Institute of Ultrasound in . Medicine (AIUM), 1994 - European Medical Device Directive (93/42/EEC) . {2}------------------------------------------------ The BVI 6100 is a Track 1 System and meets the FDA's pre-amendment acoustic output limits for "fetal imaging and other" applications. #### 5) Intended Use: The intended uses of the BVI 6100 System, as defined by FDA quidance documents, is for Abdominal (Adult and Pediatric) applications. The BVI 6100 System is intended to project ultrasound energy through the lower abdomen of a nonpregnant patient to obtain an image of the bladder and measure urinary bladder volume non-invasively on an intermittent basis. The indications for use are the same as for Diagnostic Ultrasound's predicate devices. The BladderScan BVI 6100 is contraindicated for fetal use and for use on pregnant patients. #### 6) Technological Characteristics: The BVI 6100 and its integrated 3.7 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume. Bladder volume, patient gender, non-optimal directional aiming, battery status, and usage rate indicators are all displayed on the BVI 6100 scanner. The ultrasonic power transmitted by the System is not user adjustable. The hand-held BVI 6100 is applied to the patient's abdomen with a single patient use Sontac® hydrogel pad, manufactured by Diagnostic Ultrasound to optimize the performance of the BVI 6100. The transducer collects cross-sectional images of the bladder from twelve (12) scan planes. From this information, the BVI 6100 constructs a finite element model of the bladder and automatically computes the volume of urine via volumetric integration. A Calibration Targeting System, consisting of a heli-coil shaped calibration target along with a specially designed container, allows the user to easily scan a known geometrically shaped target. - Data may be optically transmitted to a remote location when connected to the clinician's personal computer via a communication cradle. Connection to this communication cradle allows for battery charging, remote calibration, usage monitoring, software updates, and data transfer through a web-based interface, referenced as "ScanPoint™". The BVI 6100 System also includes a universal charger cradle for the non-replaceable lithium ion batterv incorporated into the handheld instrument. {3}------------------------------------------------ Electrostatic Techniques-Section 4.2: Measurement Discharge/Immunity Test-Basic EMC Publication IEC 61000-4-3:1997, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Measurement Techniques-Section 3: Radiated Radio-Frequency, Electromagnetic Field Immunity Test IEC 61000-4-4:1995, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Techniques-Section 4, Measurement Electrical Fast Transient/Burst Immunity Test-Basic EMC Publication IEC 61000-4-5:1999, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Measurement Techniques-Section 5, Surge Immunity Test CISPR11:1997, International Electrotechnical Commission. International Special Committee on Radio Interference. Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement IEC 60601-2-37:2001, International Electrotechnical Commission, Medical Electrical Equipment-Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AlUM), 1994 for Acoustic Output Measurement Standard Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1998. Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How Manufacturers Should Specify Acoustic Output Data, American Institute of Ultrasound in Medicine, 1998. The BVI 6100 will be cleared and/or approved by the following agencies: -U. S. Food and Drug Administration (FDA) -Canadian Standards Association (CSA) - European Medical Device Directive 93/42/EEC Notified Body । Section 4.2, page 3 {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image. Public Health Service AUG 15 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Diagnostic Ultrasound Corporation % Mr. Mark Job Program Manager TÜV Product Service. Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K022153 Trade Name: BladderScan™ BVI 6100 Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: August 5, 2002 Received: August 6, 2002 Dear Mr. Job: We have reviewed your Section 510(k) premarket 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. This determination of substantial equivalence applies to the following transducers intended for use with the BladderScan™ BVI 6100 Ultrasound System, as described in your premarket notification: ### Transducer Model Number ### 3.7 MHz If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device {5}------------------------------------------------ can be found in the Code of Federal Regulations, Title 21, Parts 800 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your 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 market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". {6}------------------------------------------------ Page 3 – Mr. Job If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212. Sincerely yours, David b. Lyman Morr Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {7}------------------------------------------------ KC2215,3 # DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM # System: BladderScan™ BVI 6100 Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|----------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& Other | Fetal | | | | | | | | | | Abdominal | P | | | | | | | | | Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (breast,<br>thyroid, testicles) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (card.) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA (K955840, K915436) Prescription Use (Per 21 CFR 801.109) David E. Seum (Division Sign-Off) Division It Frenchictive Abdom D. distribut at Devices 510x, Nimmer 000010 Section 4.3, page 2