Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 14, 2015 C.R. Bard, Inc. Bard Access Systems. Inc. % Ms. Kerrie Hamblin Regulatory Affairs Project Manager 605 North 5600 West SALT LAKE CITY UT 84116 Re: K152554 Trade/Device Name: Site® 8 Ultrasound System with Pinpoint™ GT Technology Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX, LLZ Dated: November 12, 2015 Received: November 13, 2015 Dear Ms. Hamblin: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert Ocks Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use # (if known) R13255 Device Name #### Site~Rite® 8 Ultrasound System with Pinpoint™ GT Technology Indications for Use (Describe) The Site~Rite" 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: - Pediatric - · Peripheral Vessel - · Small Organ (breast, thyroid, parathyroid, testicles) - · Musculo-skeletal (conventional and superficial) - · Cardiac (adult and pediatric) Typical examinations performed using the Site~Rite® 8 Ultrasound System include: | Imaging<br>Applications | Exam Type (Adult and Pediatric) | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Vascular | Assessment of vessels in the extremities and neck (e.g., jugular, carotid)<br>leading to or coming from the heart, superficial veins in the arms and legs<br>(e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel<br>mapping. Assessment of superficial thoracic vessels (e.g., axillary,<br>innominate, subclavian) | | Vascular<br>Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line<br>placement, access to fistula and grafts, and general vein and artery<br>access | | Interventional | Guidance for biopsy and drainage | | Superficial | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes,<br>hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons),<br>soft tissue structures, and surrounding anatomical structures | Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Diagnostic Ultrasound Indication for Use ### Table 1.3-1 Ultrasound System: Site~Rite® 8 Ultrasound System with 32 mm Linear Probe (Non-detachable Transducer) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |----------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Opthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(epiaortic<br>scanning) | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | Pediatric | | N | | | | | | | | | | Small Organ<br>(breast, thyroid,<br>parathyroid,<br>testicles) | | N | | | | | | | | | | Neonatal<br>Cephalic | | | | | | | | | | | | Adult Cephalic<br>Cardiac (Adult<br>and Pediatric) | | N | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transeurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral<br>Vascular | | N | | | | | | | | | | Laparoscopic<br>Musculo-skeletal<br>(Conventional) | | N | | | | | | | | | | Musculo-skeletal<br>(Superficial) | | N | | | | | | | | | | Other (Specify) | | | | | | | | | | | N=new indication; P=previously cleared by FDA; E=added under Appendix E Notes: None (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 Reproductive, Abdominal, and Radiological Devices 510(k) Number_ Prescription Use (per 21 CFR 801.109 {4}------------------------------------------------ ### Diagnostic Ultrasound Indication for Use #### Table 1.3-2 - Site~Rite" 8 Ultrasound System with Pinpoint™ GT Technology with 20mm Pinpoint™ GT Technology Linear Probe (Non-detachable transducer) | Clinical Applications | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |----------------------------------------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------| | Opthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(epiaortic<br>scanning) | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | Pediatric | | N | | | | | | | | | | Small Organ<br>(breast, thyroid,<br>parathyroid,<br>testicles) | | N | | | | | | | | | | Neonatal | | | | | | | | | | | | Cephalic | | | | | | | | | | | | Adult Cephalic<br>Cardiac (Adult<br>and Pediatric) | | N | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transeurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral<br>Vascular | | N | | | | | | | | N [1] | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal<br>(Conventional) | | N | | | | | | | | | | Musculo-skeletal<br>(Superficial) | | N | | | | | | | | | | Other (Specify) | | | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Notes: [1] Needle Guidance Imaging (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 Reproductive, Abdominal, and Radiological Devices 510(k) Number_ Prescription Use (per 21 CFR 801.109 {5}------------------------------------------------ # 510(k) Summary 21 CFR 807.92 | Site-Rite® 8 Ultrasound System and Site-Rite® 8 Ultrasound System with Pinpoint™ GT Technology | | | |------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | General<br>Provisions: | Submitter Name: | Bard Access Systems, Inc. | | | Submitter Address: | 605 North 5600 West | | | | Salt Lake City, UT84116 | | | Contact Person: | Kerrie Hamblin | | | | Regulatory Affairs Project Manager | | | | Bard Access Systems, Inc. | | | | Kerrie.Hamblin@crbard.com | | | | 801-522-5000 ext. 4909 | | | | 801-522-5425 fax | | | Date of Preparation: | 13 November 2015 | | | | Site-Rite® 8 Ultrasound System | | Subject Devices: | Trade Names: | Site-Rite® 8 Ultrasound System with Pinpoint™ GT<br>Technology | | | Classification Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System | | | | ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | | | | LLZ, 21 CFR 892.2050, Picture Archiving and<br>Communications System | | | Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic | | | | ITX, 21 CFR 892.1570, Transducer, Ultrasonic,<br>Diagnostic | | | | LLZ, 21 CFR 892.2050, System, Image Processing,<br>Radiological | | Primary Predicate<br>Device: | Trade Name: | Site-Rite Vision® II Ultrasound System | | | Classification Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System | | | | ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | | | | LLZ, 21 CFR 892.2050, Picture Archiving and<br>Communications System<br>IYN, CFR 892.1550, Ultrasonic Pulsed Doppler Imaging<br>System | | | Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic | | | | ITX, 21 CFR 892.1570, Transducer, Ultrasonic,<br>Diagnostic | | | | LLZ, 21 CFR 892.2050, System, Image Processing,<br>Radiological | | | | IYN, CFR 892.1550, System, Imaging, Pulsed Doppler,<br>Ultrasonic | | | Premarket<br>Notification: | K132942, concurrence, 17 October 2013 | | | Manufacturer: | Bard Access Systems, Inc. | | Predicate Device: | Trade Name: | Site~Rite® 6 Ultrasound System with Pinpoint™ GT<br>Technology | | | Classification Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System | | | | ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | | | Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic | | | | ITX, 21 CFR 892.1570, Transducer, Ultrasonic,<br>Diagnostic | | | Premarket<br>Notification: | K142443, concurrence, 30, October, 2014 | | | Manufacturer: | Bard Access Systems, Inc. | | Predicate Device: | Trade Name: | Site~Rite Prevue® Ultrasound System | | | Classification Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging<br>System | | | | ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | | | Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,<br>Ultrasonic | | | | ITX, 21 CFR 892.1570, Transducer, Ultrasonic,<br>Diagnostic | {6}------------------------------------------------ {7}------------------------------------------------ | Premarket Notification: | K120882, concurrence, 30, May, 2012 | |-------------------------|-------------------------------------| | Manufacturer: | Bard Access Systems, Inc. | **Device Descriptions:** The Site-Rite® 8 Ultrasound System is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled). The Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process. The Site-Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: - Pediatric - Peripheral Vessel - Small Organ (breast, thyroid, parathyroid, testicles) - Musculo-skeletal (conventional and superficial) - Cardiac (adult and pediatric) Typical examinations performed using the Site-Rite® 8 Ultrasound System include: | Imaging Applications | Exam Type (Adult and Pediatric) | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Vascular | Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian) | | Vascular | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and | **Intended Use/Indications for Use for Site-Rite® Ultrasound System and Site-Rite® 8 Ultrasound System with Pinpoint™ GT Technology:** Technology: Access Interventional Superficial joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures Pinpoint™ GT Technology is intended to provide clinicians with visual tools for grafts, and general vein and artery access Guidance for biopsy and drainage midline, arterial line placement, access to fistula and Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g., passive magnetic tracking of a needle with respect to ultrasound image data. {8}------------------------------------------------ | Technological<br>Characteristics: | The subject Site~Rite® 8 Ultrasound System and subject Site~Rite® 8 Ultrasound<br>System with Pinpoint™ GT Technology employ the same fundamental scientific<br>technology as the primary predicate device, Site~Rite Vision® II Ultrasound<br>System (K132942), in that piezoelectric material in the transducer is used as an<br>ultrasound source to transmit sound waves into the body. Sound waves are<br>reflected back to the transducer and converted to electrical signals that are<br>processed and displayed as 2D images. The subject devices have also been<br>evaluated with consideration to the predicate devices, Site~Rite® 6 Ultrasound<br>System with Pinpoint™ GT Technology and Site~Rite Prevue® Ultrasound System<br>where differences in technology between the subject devices and the primary<br>predicate device are present. The subject devices are technologically similar to<br>the predicate devices in that both the subject and predicate devices incorporate a<br>similar passive magnetic tracking technology and/or they share similar patient<br>contacting materials. | | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Safety and<br>Performance Tests: | Verification and validation activities were designed and performed to demonstrate<br>that the subject Site~Rite® 8 Ultrasound System and subject Site~Rite® 8<br>Ultrasound System with Pinpoint™ GT Technology met predetermined<br>performance requirements. The following standards in conjunction with internal<br>protocols were used to determine appropriate methods for evaluating the<br>performance of the subject device. | | | | IEC 60601-1:2005,<br>CORR. 1(2006),<br>CORR 2(2007) | Medical Electrical Equipment - Medical Electrical<br>Equipment - Part 1: General Requirements for Basic<br>Safety and Essential Performance - Edition 3 | | | IEC 60601-1-2:2007 | Medical Electrical Equipment - Part 1-2: General<br>Requirements for Basic Safety and Essential<br>Performance - Collateral Standard: Electromagnetic<br>Compatibility - Requirements and Tests | | | IEC 60601-2-37:2007 | 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 | | | IEC 60601-1-6:2010 | Medical Electrical Equipment-Part 1-6: General<br>Requirements for Basic Safety and Essential<br>Performance - Collateral Standard: Usability | | | IEC 62304:2006 | Medical Device Software - Software Life Cycle<br>Processes - Edition 1.0 | | | IEC 62366:2007 | Medical Devices - Application of Usability Engineering to<br>Medical Devices - Edition 1.0 | | | ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing Within a Risk Management<br>Process | | | NEMA UD-2:2004 | Acoustic Output Measurement Standard for Diagnostic<br>Ultrasound Equipment | {9}------------------------------------------------ | Title 47 CFR FCC, Part 15 B, 15 C, and Part 18 | Title 47 - Telecommunication; Part 15 - Radio Frequency Devices; Subpart B - Unintentional Radiators; Subpart C - Intentional Radiators; and subpart 18, Industrial, Scientific, and Medical Equipment | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the primary predicate device. Where differences between the subject devices and the primary predicate device exist with respect to technological characteristics, consideration to the predicate devices was given to support substantial equivalence for those technological characteristics. | | | Accessories | The following accessories are covered under this premarket notification and have been qualified for use with the subject devices described herein. The following accessories are intended for use with the subject devices, Site~Rite® 8 Ultrasound System and Site~Rite® 8 Ultrasound System with Pinpoint™ GT Technology:<br>MER Roll Stand Brother™ Printer MW-260 with mounting hardware Kickstand mounting accessory Probe holder accessory Site~Rite® Keyboard USB storage device (flash/pen drive) with no external power connection Site~Rite® 8 Ultrasound System Roller Bag | | Summary of Substantial Equivalence | The subject devices, Site~Rite® 8 Ultrasound System and Site~Rite® 8 Ultrasound System with Pinpoint™ GT Technology, have the same intended use as the primary predicate device, Site-Rite Vision® II Ultrasound System (K132942) and the predicate devices, Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology (K142443) and Site~Rite Prevue® Ultrasound System (K120882). The subject devices have similar indications for use, technological characteristics, and safety and performance testing as the primary predicate device. Where there are differences in indications for use and technological characteristics between the subject devices and the primary predicate device, consideration to the predicate devices, Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology (K142443) and Site-Rite Prevue® Ultrasound System (K120882) was given. The subject Site-Rite® 8 Ultrasound System and subject Site-Rite® 8 Ultrasound System with Pinpoint™ GT Technology met the predetermined performance requirements for their intended use and are as safe, as effective, and perform as well as or better than the primary predicate device, Site-Rite Vision® II Ultrasound System (K132942) and the predicate devices, Site-Rite® 6 Ultrasound System with Pinpoint™ GT Technology (K142443) and Site-Rite Prevue® Ultrasound System (K120882). Based on this assessment, the subject Site-Rite® 8 Ultrasound System and subject Site~Rite® 8 Ultrasound System with Pinpoint™ GT Technology are determined to be substantially equivalent to the primary predicate device, Site~Rite Vision® II Ultrasound System (K132942) and the predicate devices, Site~Rite® 6 Ultrasound System with Pinpoint™ GT | the producte deviloes, Site Trile "o Ultrasound Oystem with Timportion Technology (K142443) and Site~Rite Prevue® Ultrasound System (K120882).