VITASCAN LT SCANMASTER

{0}------------------------------------------------ 121689 ## 510(K) Summary This summary is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92. - 1) Submittor's name, address, telephone number, contact person: Ron Evans VP Product Development Vitacon Medical Inc. 5355 Parkwood Place Richmond, BC, Canada V6V 2N1 Telephone: (604)291-7747 x237 Fax: (604)294-2355 e-mail: rnd@datrend.com Date Prepared: May 10, 2012 - 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: | Bladder Scanner | |----------------------|-----------------------------------------------------------------------------------------------------------------| | Proprietary Name: | VitaScan LT, and<br>Scanmaster | | Classification Name: | Ultrasonic Pulsed Echo Imaging System (892.1560; 90-IYO)<br>Diagnostic Ultrasound Transducer (892.1570; 90-ITX) | - 3) Identification of the predicate or legally marketed device: Vitacon Medical Inc. believes this product is similar in design and function to the Life-Tech Inc. Vesiscan (K093485) and the Diagnostic Ultrasound Corporation BladderScan™ BVI 6100 (K022153), and BladderScan™ BVI 9400 (K071217) which are legally marketed post-amendment devices. {1}------------------------------------------------ #### 4) Device Description: The VitaScan LT (aka. Scanmaster) is a hand held, B mode ultrasound scanner with a USB interface to a personal computer. This software controlled ultrasound system is used to acquire and display representations of the bladder, from which the bladder volume can be calculated. The system is intended to non-invasively monitor bladder volume on an intermittent basis which may be used to assist in the determination of time for bladder emptying and for the detection of post void residual volume (PVR). The VitaScan LT (aka. Scanmaster) is a Track 1 System and meets the FDA's preammendment acoustic output limits for "fetal imaging and other" applications. #### 5) Intended Use: The VitaScan LT (aka. Scanmaster) is a B-mode ultrasonic instrument which projects ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder which is used to determine bladder volume non-invasively, on an intermittent basis. Bladder scanning measures ultrasonic reflections within a patient's body and differentiates the urinary bladder from the surrounding tissues. The intended use of the device, as defined by FDA guidance documents, is for Abdominal (adult and pediatric) applications. VitaScan LT is applicable in many clinical areas to determine bladder volume, time for bladder emptying and detection of post void residual volume (PVR). - 6) Technological Characteristics: The VitaScan LT (aka. Scanmaster) is a 2.3 MHz mechanical sector scanner which operates only in the B mode to locate the bladder and automatically calculate the bladder volume. The ultrasonic power transmitted by the system is not user adjustable. Bladder Volume, Patient ID, Patient Name, Gender, Age and Hospital Name are displayed and stored on the personal computer application program provided with the VitaScan LT (aka. Scanmaster), which is connected to, and receives power through, the USB port of the personal computer. VitaScan LT (aka. Scanmaster) is applied to the patient's abdomen, immediately superior to the patient's symphysis pubis with an ultrasound gel interface. The transducer collects cross-sectional images of the bladder from up to 24 scan planes and transmits the image information to the personal computer via the USB connection. Using this information, the VitaScan LT application program constructs a finite element model of the bladder and automatically computers the volume of the bladder via volumetric integration. {2}------------------------------------------------ For confirmation of operation and accuracy, the user may scan a known volume contained within an optional phantom. #### 7) Technical Comparison to Predicate Devices: The VitaScan LT (aka. Scanmaster) is substantially equivalent to the currently marketed Vesiscan, and the BladderScan™ BVI 6100 and BVI9400, referenced previously. All devices are pulsed echo ultrasonic imaging instruments dedicated to non-invasive measurement of urinary bladder volume. Although there are some technological differences between the devices, such as frequency of operation and acoustic output, these differences are minor and raise no new questions of safety and effectiveness. #### 8) Performance Data: Non-clinical testing included acoustic output testing; thermal, mechanical and electrical safety testing; electromagnetic emissions and immunity testing; biocompatibility testing; and, testing with a physiological phantom of a urine filled bladder. All nonclinical testing demonstrated the subject device to be substantially equivalent to the predicate devices in terms of safety, effectiveness and performance. Clinical testing of the subject device was performed on healthy volunteers. No adverse effects or complications were noted, and the results demonstrated that the subject device is substantially equivalent to the predicate devices in terms of safety and effectiveness. 9) Conclusion: All testing demonstrated the VitaScan LT (aka. Scanmaster) is as safe, as effective, and performs as well as the legally marketed predicate devices. The VitaScan LT (aka. Scanmaster) is substantially equivalent to the currently marketed Vesiscan and BladderScan™ BVI 6100 and BVI 9400 with respect to intended use, technological characteristics, and performance. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 1 9 2012 Mr. Ron Evans VP Product Development Vitacon Medical Inc. 5355 Parkwood Place RICHMOND BC V6V 2N1 CANADA Re: K121689 Trade/Device Name: VitaScan LT (a.k.a. Scanmaster) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: July 26, 2012 Received: July 27, 2012 Dear Mr. Evans: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaudi of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to tegair for segment date of the Medical Device Amendments, or to conimeres process into to May 20, 1978) in accordance with the provisions of the Federal Food, DNA 1 de vices mat nave been recuire approval of a premarket approval application (PMA). alle Cosmeter ror (110.) that to nevice, subject to the general controls provisions of the Act. The I ou may, dicterere, miance are 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 class II (Special Controls), it may be subject to such 11 your device is classified (see as ce regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 1 loast of advised that I Dr Fribulations your device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I coloral statutes and regarations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket while with 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 Parts 801 and 11 you done contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Four may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications For Use The VitaScan LT (aka. Scanmaster) is a B-mode ultrasonic instrument which projects ultrasound rne vitasoan in (and over abdomen of the non-pregnant patient to obtain an image of the energy through used to determine bladder volume non-invasively, on an intermittent basis. Prescription Use______________________________________________________________________________________________________________________________________________________________ Part 21 CFR801 Subpart D (Division Sign-Off) Division of Radiological Devices K121689 {6}------------------------------------------------ ### Diagnostic Ultrasound Indications For Use System: VitaScan LT (aka. Scanmaster) | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|---------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------| | Gerneral<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | | Opthalmic | Opthalmic | | | | | | | | | Fetal<br>Imaging &<br>Other | Fetal | | | | | | | | | | Abdominal | | P | | | | | | | | Inter-operative (Specify) | | | | | | | | | | Inter-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (Non-Card) | | | | | | | | | | Musculo-skelatal (Conventional) | | | | | | | | | | Musculo-skelatal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other(Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral Vessel | | | | | | | | | | Other (Specify) | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body, as follows: P = Previously cleared by FDA (K022153, K071217) Prescription Use (Per 21 CFR 801.109) --- (Division Sign-Off) Division of Radiological Devices Division of Radiological Devices 510k K121684 OHYD