VASCUVIEW ULTRASOUND SYSTEM

{0}------------------------------------------------ K080049 Pg. 10f 3 JAN 23 2008 Image /page/0/Picture/2 description: The image shows a logo for Escalon Vascular Access, a division of Escalon Medical Corp. The logo features the letters 'VA' in a stylized font, with the word 'ESCALON' above and 'VASCULAR ACCESS' below. To the right of the 'VA' is a symbol resembling radio waves. The text 'A Division of Escalon Medical Corp' is located below the logo. 2440 South 179th Street New Berlin, Wi 53146 Tel 800-433-8197 Fax 262-821-9927 www.escalonvascularaccess.com # 510(k) Summary ### Submitted By Escalon Medical Corp 2440 South 179th Street New Berlin, WI 53146 800-433-8197 | 262-821-9182 Fax 262-821-9927 ### Contact Person Mark Wallace Vice-President Quality ### Date Prepared December 27, 2007 #### Trade Name VascuView Ultrasound System ## Common Name Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer ## Classification Name ﻳ Ultrasonic Pulsed Echo Imaging System FR Number: 892.1560 Product Code: 90-IYO Diagnostic Ultrasound Transducer FR Number: 892-1570 Product Code: 90-ITX ### Legally-Marketed Equivalent Devices Interson SR 7.5 MHz USB Ultrasound Probe System (k070907) Sonosite iLook 25 Personal Imaging Tool (k021628) VascuView 510(k) Summary {1}------------------------------------------------ K080049 PG-2of3 ### Description of the Device The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guldance for placement of needles and catheters in these structures. The VascuView system consists of the following components: Ultrasound Probe and Cable. The handheld ultrasound probe is the Interson SR 7.5 MHz USB ultrasound probe (the same as the predicate device listed previously). The probe consists of a single-element mechanical sector scanner that contains the ultrasound pulser and receiver within the hand piece. It has a push button to activate scanning and capturing of images and video clips. The probe is connected to the Included USB cable. The fundamental scan frequency (excitation frequency) is 7.5 MHz, allowing visualization of vessels at depths of 0.5 to 6.0 cm. The nose cone of the ultrasound probe is made of blocompatible material sufficient for its use (RT-18 TPX Polymethyl Pentene). Tablet PC. A Kiosk tablet pc is provided which facilitates intuilive touch screen operation. The tablet pc is provided with a medical-grade power supply and medical-grade power cord. The pc provides a 5 vdc power supply to the ultrasound probe via the USB cable. The pc also provides for the operation of the software and storage of archived images and video clips. VascuView Software. All features and controls of the system are provided for in the VascuView software which comes pre-loaded onto the tablet pc. The VascuView software uses an iconbased interface whereby the user can select any of the primary functional screens at any time by clicking on an icon located on the screen, for that function. The software enables ultrasound image capture and review, image controls for near, mid, and far gain, as well as image intensity and contrast, linear measurement calipers, image depth grid lines, zoom, display of needle guide lines, and printing. #### Intended Use The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guidance for placement of needles and catheters in these structures. The VascuView ultrasound system is not intended for fetal or ophthalmic applications. The intended use of the VascuView system is slightly more limited than that of the Interson USB Ultrasound Probe System in that it's intended use does not include visualization of small organs (although that intended use was for the range of probes cleared under k070907). Likewise, the intended use of the VascuView system is also more limited than the Sonosite iLook 25, although the iLook 25 is marketed for vascular access. ## Technological Characteristics Compared with Predicate Devices The VascuView Ultrasound System utilizes the Interson model SR 7.5 MHz ultrasound probe, which was previously cleared under k070907 (formerly referred to as model number VC 7.5 MHz ultrasound probe - see Attachment 5A). The probe is indicated for use for peripheral vascular and small organ (intended for use in biopsy). The scope of the application for the VascuView has been limited to just peripheral vascular, primarily for assistance in vascular access (see Attachment 5B for transducer indication for use form). There are no differences or modifications made to the Interson probe. The differences between the iLook 25 and the VascuView Ultrasound System include that the iLook is a dedicated device, while the VascuView system utilizes a tablet pc. This makes little difference in the actual use of the device since the VascuView is set up to launch immediately into the VascuView software. The VasculView does provide for a significantly larger screen, approximately 4 times greater in viewing area to aid in visualization. Additionally, while the il ook 25 is limited to storage capacity of 74 images, the VascuView system has virtually unlimited storage (tens of thousands of images on tablet pc hard drive and ability to connect external hard drives if additional storage is required). {2}------------------------------------------------ K050049 pg. 3 of 3 The iLook 25 also provides a power Doppler mode that is intended indicate by different colors (red or blue) directionality of blood flow within vessels which, given the anatomical location of the vessel and orientation of the ultrasound probe, assists the user in determining whether the vessel is a vein or artery. This determination may also be made in either the iLook 25 or the VascuView system by observing whether the vessel is pulsing (indicating an artery) or not (indicating a vein), in addition to anatomical location. The iLook 25 incorporates a linear array, while the VascuView system utilizes a single-element sector scan transducer. The linear array allows a deeper penetration by the il.ook (deeper than that typically required for peripheral vascular), although a narrower profile. The sector scan sweep of the VascuView provides for a full 60° viewing angle at a depth of up to 6.0cm (sufficient for peripheral vascular). Therefore, the VascuView provides a greater field of view which combined with the larger monitor offers an enhanced resolution of scan. The stated measurement accuracy of the iLook 25 is ±2% plus 1% full scale, while the VascuView has a slightly better measurement accuracy of ±2% plus 0.5% full scale. #### Non-Clinical Performance Data The VascuView has been tested and assessed as compliant with the requirements of several international safety standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-2-37 (including acoustic output limits), and others. Additionally, the measurement accuracy of the VascuView system was confirmed via a measurement validation test protocol using wire phantoms. The software has been also been validated using a test protocol. #### Clinical Performance Data None submitted. #### Conclusions from Non-Clinical (and Clinical) Data Based upon the results of the data as summarized above, the VascuView system has demonstrated that it is as safe, as effective, and performs as well as or better than the predicate devices. Furthermore, based on the comparison with the predicate devices as shown in the discussion above, as well as guidance provided by FDA 510(k) Substantial Equivalence Decision-Making Process Flowchart, the Escalon Vascular Access VascuView ultrasound system is deemed to be substantially equivalent to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three horizontal lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 23 2008 Escalon Medical Corp. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313 Re: K080049 Trade/Device Name: VU62000 VascuView Ultrasound System Regulation Number: 21 CFR §892.1560 Regulatory Class: II Procode: IYO Dated: January 7, 2008 Received: January 8, 2008 Dear Mr. Job: 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. This determination of substantial equivalence applies to the Interson SR 7.5 MHz Mechanical Sector Probe intended for use with the VU62000 VascuView Ultrasound System, as described in your premarket notification. If your device is classified (see above) into either class II (Special Controls) or 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 Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. {4}------------------------------------------------ # Page 2 -- Mr. Mark Job Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 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 premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed needicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (240) 276-0120. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (240) 276-0100. 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". If you have any questions regarding the content of this letter, please contact Ms. Lauren Hefner at (240) 276-3666. Sincerely vours, Hori M. Zhang So Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {5}------------------------------------------------ Appendix F # Ultrasound Device Indication For Use # 510(k) Number # Device Name VU62000 VascuView Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | N | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | Additional Comments: (PLEASE OO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) _ (Division Sign-Off)_ Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ E-3 {6}------------------------------------------------ # Ultrasound Device Indication For Use # 510(k) Number # Device Name Interson SR 7.5 MHz Mechanical Sector Probe Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | |----------------------------------|-------------------|---|---|---------|---------------|-------------------|------------------------|--------------------|-----------------| | Clinical Application | A | B | M | PWD CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | Fetal | | | | | | | | | | | Abdominal | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (specify) | | P | | | | | | | Note 3 | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Cardiac | | | | | | | | | | | Transesophageal | | | | | | | | | | | Transrectal | | | | | | | | | | | Transvaginal | | | | | | | | | | | Transurethral | | | | | | | | | | | Intravascular | | | | | | | | | | | Peripheral Vascular | | P | | | | | | | Note 3 | | Laparoscopic | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | Other (specify) | | | | | | | | | | usly cleared by FDA; E= added under Appe Additional Comments:__Note 3: Includes imaging for guidance of biopsy (previously cleared under 510(k) 070907 - model no. VC 7.5 MHz) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) ``` (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K080049 F-3