SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE

{0}------------------------------------------------ # 510(k) Summary 21 CFR 807.92 # Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide | General<br>Provisions | Submitter Name: | Bard Access Systems, Inc. | |---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 | | | Contact Person: | Kerrie Hamblin<br>Senior Regulatory Affairs Specialist<br>Bard Access Systems, Inc.<br>kerrie.hamblin@crbard.com<br>801.522.5000 ext 4909<br>801.522.5425 fax | | | Date of Preparation: | 17 May 2012 | | Subject Device | Trade Name: | Site~Rite Prevue* Ultrasound System | | | Classification Name: | IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System<br>ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers<br>Class II, Radiology | | Predicate<br>Devices | Trade Name: | Site~Rite Vision* Ultrasound System | | | Classification Name: | IYN 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System<br>IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System<br>ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers<br>LLZ 21 CFR 892.2050 Picture Archiving and Communications System | | | Premarket Notification: | K100402, concurrence date 05 March 2010 | | | Manufacturer: | Bard Access Systems, Inc. | | | Trade Name: | Site~Rite* 6 Ultrasound System | | | Classification Name: | IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System<br>ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers | | | Premarket Notification: | K071204, concurrence date 18 May 2007 | | | Manufacturer: | Bard Access Systems, Inc. | | Subject Device | Trade Name: | Pinpoint* Gel Cap | | | Classification Name: | MUI 21 CFR 892.1570 Diagnostic Ultrasonic Transducer<br>Class II, Radiology | | Predicate Devices | Trade Name: | Embrace™ Gel Pad | | | Classification Name: | MUI 21 CFR 892.1570 Diagnostic Ultrasonic Transducer | | | Premarket Notification: | K072515, concurrence date 20 September 2007 | | | Manufacturer: | Orison Corporation | | | Trade Name: | ScanTac™ Pad | | | Classification Name: | MUI 21 CFR 892.1570 Diagnostic Ultrasonic Transducers | | | Premarket Notification: | K031894, concurrence date 18 July 2003 | | | Manufacturer: | SONOTECH, Inc. | | Subject Device | Trade Name: | Pinpoint* Needle Guide | | | Classification Name: | ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducer<br>Class II, Radiology | | Predicate Device | Trade Name: | Site~Rite* Needle Guide Kits and Site~Rite* Probe Cover Kit | | | Classification Name: | ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers | | | Premarket Notification: | K042445, concurrence date 19 October 2004 | | | Manufacturer: | Bard Access Systems, Inc. | | Device Description -<br>Site~Rite Prevue*<br>Ultrasound System | The Site~Rite Prevue* Ultrasound System is a portable device that features real-time 2D<br>ultrasound imaging. Additional features include compact size, simple user interface, and various<br>calculations. The system may incorporate various accessories, including an upright stand, A/C<br>adapter, needle guide/gel cap kits, etc. The system includes USB support for storage devices<br>with no external power connections (e.g., USB flash drive). | | | Device Description -<br>Pinpoint* Gel Cap | Bard Access Systems, Inc.'s, Pinpoint* Gel Cap is a sterile, single use accessory for use with<br>the Site~Rite Prevue* Ultrasound System. The device is intended for use as an ultrasound<br>coupling medium. This device attaches to the ultrasound transducer and contains a hydrogel<br>pad that interfaces directly with the transducer face and the patient's skin to provide an acoustic<br>coupling pathway. The device contains a feature that accommodates attachment of the<br>Pinpoint* Needle Guide. A removable lid protects the hydrogel pad during transit and while the<br>clinician is attaching the device on the Site~Rite Prevue* ultrasound transducer. | | | Device Description -<br>Pinpoint* Needle Guide | The Pinpoint* Needle Guide is a sterile, single use accessory for use with ultrasound. The<br>device is intended to provide guidance for a needle to intersect an ultrasound beam at a fixed<br>distance below the skin to assist the medical practitioner in placing the tip of the needle in a<br>specific structure. The Pinpoint* Needle Guide attaches to the Pinpoint* Gel Cap which<br>attaches to the ultrasound probe. Each needle guide accommodates multiple vein depths. | | | Indications for<br>Use / Intended<br>Use - Site-Rite<br>Prevue*<br>Ultrasound<br>System,<br>Pinpoint* Gel<br>Cap and<br>Pinpoint* Needle<br>Guide | The Site-Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of the<br>human body. Specific clinical applications include:<br>• Adult Cephalic<br>• Neonatal Cephalic<br>• Pediatric<br>• Peripheral Vessel<br><br>The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite<br>Prevue* Ultrasound System. The device is intended for use with pediatrics and adults.<br><br>The needle guides are intended to provide guidance for a needle to intersect an ultrasound<br>beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a<br>needle in a specific structure. This device is intended for use with pediatrics and adults. | | | Technological<br>Characteristics | Technological characteristics of the subject Site-Rite Prevue* Ultrasound System, Pinpoint* Gel<br>Cap and Pinpoint* Needle Guide are equivalent with respect to the basic design and function to that<br>of the predicate devices, Site-Rite Vision* Ultrasound System, Site~Rite* 6 Ultrasound System,<br>Embrace™ Gel Pad, ScanTac™ Pad, and Site-Rite* Needle Guide Kits and Site-Rite* Probe Cover<br>Kit respectively. | | | Safety &<br>Performance<br>Tests | Verification and validation activities were designed and performed to demonstrate that the<br>subject Site-Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle<br>Guide met predetermined performance specifications. The following standards in conjunction<br>with in-house protocols were used to determine appropriate methods for evaluating the<br>performance of the device: | | | | IEC 60601-1:1988/1991/1995 | Medical Electrical Equipment - Part 1: General<br>Requirements for Safety, 1988; Amendment 1, 1991-11,<br>Amendment 2, 1995 | | | IEC 60601-1-2:2007 | Medical Electrical Equipment - Part 1-2: General<br>Requirements for Basic Safety and Essential Performance<br>- Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests | | | IEC 60601-2-37:2008 | Medical Electrical Equipment - Part 2-37: Particular<br>Requirements for the Basic Safety and Essential<br>Performance of Ultrasonic Medical Diagnostic and<br>Monitoring Equipment | | | NEMA UD 2:2004 | Acoustic Output Measurement Standard for Diagnostic<br>Ultrasound Equipment | | | ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing within a Risk Management Process | | | ISO 11607-1:2006 | Packaging for Terminally Sterilized Medical Devices | | | ISO 11607-2:2006 | Packaging for Terminally Sterilized Medical Devices | | | ISO 11137-1:2006/(R) 2010 | Sterilization of health care products - Radiation - Part 1:<br>Requirements for development, validation, and routine<br>control of a sterilization process for medical devices | | | ISO 11137-2:2006 | Sterilization of health care products - Radiation - Part 2:<br>Establishing the sterilization dose | *Site-Rite Prevue and Pinpoint are trademarks and/or registered trademarks of C.R. Bard, Inc. {1}------------------------------------------------ Bard Access Systems, Inc. K120882 - Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide Traditional 510(k) Premarket Notification · · : . . . . ・ *Site-Rite Prevue and Pinpoint are trademarks and/or registered trademarks of C.R. Bard, Inc. ・ · {2}------------------------------------------------ Bard Access Systems, Inc. K120882 - Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide Traditional 510(k) Premarket Notification . : ・ " . . . . : *Site~Rite Prevue and Pinpoint are trademarks and/or registered trademarks of C.R. Bard, Inc. . : {3}------------------------------------------------ ## ISO 11137-3:2006/(R)2010 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspect The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate devices. | Non-Clinical<br>Comparative<br>Testing | Test Characteristic | Pinpoint* Gel Cap | Aquasonic 100<br>Ultrasound Trans. Gel | |-------------------------------------------------|------------------------------------|-------------------|----------------------------------------| | | Sound Velocity (m/s) | 1502 | 1558 | | Summary of<br>Acoustic Testing<br>(mean values) | Acoustic Impedance (MRayls) | 1.526 | 1.641 | | | Attenuation 5 MHz (dB/(cm<br>MHz)) | 0.0657 | 0.0792 | Substantial Equivalence testing, the subject Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide, met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate devices, Site~Rite Vision* Ultrasound System, Site~Rite* 6 Ultrasound System, Embrace™ Gel Pad, ScanTac™ Pad, and Site~Rite* Needle Guide Kits and Site~ Rite* Probe Cover Kits respectively. . {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. # 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 CR Bard, Inc. % Mr. Mark Job Owner/Reviewer Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313 MAY 3 0 2012 Re: K120882 Trade/Device Name: Site~Rite Prevue*, Pinpoint* Gel Cap and Pinpoint* Needle Guide Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: May 17, 2012 Received: May 18, 2012 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major 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 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 Parts 801 and 809); medical device reporting (reporting of {5}------------------------------------------------ ## Page 2 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 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 Parts 801 and 809), please 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 Division 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 Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health #### Enclosure {6}------------------------------------------------ Bard Access Systems, Inc. Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide Traditional 510(k) Premarket Notification . ## Indications for Use 510(k) Number (if known): K120882 Device Names: Site~Rite Prevue*, Pinpoint* Gel Cap and Pinpoint* Needle Guide Indications for Use: The Site~Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include: - ·Adult Cephalic ·Neonatal Cephalic ·Pediatric ·Peripheral Vessel The gel cap is intended for use as an ultrasound coupling medium for use with the Site~Rite Prevue* Ultrasound System. The device is intended for use with pediatrics and adults. The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults. Prescription Use (Part 21 CFR §801 Subpart D) AND/OR Over-The-Counter Use (21 CFR §801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED | Concurrence of CDRH Office of Device Evaluation (ODE) | | |------------------------------------------------------------|--| | (Division Sign-Off) | | | Division of Radiological Devices | | | Office of In Vitro Diagnostic Device Evaluation and Safety | | | 510K. | K120882 | |-------|---------| |-------|---------| *Site~Rite Prevue and Pinpoint are trademarks and/or registered trademarks of C.R. Bard, Inc. {7}------------------------------------------------ | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|--------------------------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|-----------------------|---------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(Specify) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (abdominal,<br>thoracic, and vascular) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | | | | | | | | | Small Organ (breast, thyroid,<br>parathyroid, testicles,<br>prostate, uterus, ovary) | | | | | | | | | Fetal Imaging<br>& Other | Neonatal Cephalic | N | | | | | | | | | Adult Cephalic | N | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-Esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal<br>(Conventional) | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral Vessel | N | | | | | | | | | Other (Specify) | | | | | | | | # Diagnostic Ultrasound Indications for Use Form - Site~Rite Prevue* Ultrasound System N = new indication; P = previously cleared by FDA; E = added under this appendix - * Examples of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K. K120882 * Pinpoint, Site-Rite, Site-Rite Prevue, and Site-Rite Vision are trademarks and/or registered trademarks of C.R. Bard. Inc. 279