Who can help prepare an FDA 510(k) submission like Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech

Q: Who is the manufacturer of Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

C. R. Bard filed the 510(k) submission for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (K182281).

Q: What is the FDA product code for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

IYO. It is classified under 21 CFR 892.1560 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

510(k) clearance (submission type: Traditional).

K182281 · C. R. Bard · IYO · Oct 24, 2018 · Radiology

Device Facts

Record ID	K182281
Device Name	Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
Applicant	C. R. Bard
Product Code	IYO · Radiology
Decision Date	Oct 24, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1560
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: Pediatric Peripheral Vessel and Vascular Access 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: 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 Access Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access Interventional Guidance for biopsy and drainage Superficial Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.

Device Story

Portable ultrasound system providing real-time 2D imaging for vascular access, biopsy, and drainage. Features two needle-tracking technologies: Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology. Both systems use sensors in detachable linear probes to detect passive magnetic fields from specialized needles. Software interprets sensor data to overlay a virtual needle image, trajectory, and intersection window onto the ultrasound display. Used in clinical settings by healthcare providers to guide needle insertion. Benefits include improved visualization of needle position and trajectory during vascular access procedures, potentially increasing accuracy and reducing complications. System includes console, probes, and magnetic activators. Data is processed on-device; connectivity options include USB storage and wireless bridge.

Clinical Evidence

No human clinical data provided. Substantial equivalence supported by non-clinical bench testing, including software verification, needle tracking accuracy, image verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility, and usability engineering.

Technological Characteristics

Portable ultrasound console with detachable linear probes (20mm, 32mm). Uses piezoelectric transducers for 2D imaging. Needle tracking via magnetic sensors detecting passive magnetic fields from compatible needles. Powered by AC adapter or internal non-removable Li-ion battery. Connectivity via USB and wireless bridge. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.

Indications for Use

Indicated for diagnostic ultrasound imaging of the human body, including pediatric, peripheral vessel, vascular access, small organ (breast, thyroid, parathyroid, testicles), musculoskeletal (conventional and superficial), and cardiac (adult and pediatric) applications. Provides visual needle tracking to assist with ultrasound-guided vascular access.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

Site~Rite® 8 Ultrasound System with Pinpoint™ GT Needle Technology (K152554)

Reference Devices

eZono® 4000 Ultrasound System (K140254)

Related Devices

K240146 — BD Prevue II Peripheral Vascular Access System · Bard Access Systems, Inc. · Feb 18, 2024
K152554 — Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology · C.R. Bard, Inc. · Dec 14, 2015
K142443 — Site-Rite 6 Ultrasound System with Pinpoint GT Technology · C.R. Bard, Inc. · Oct 30, 2014
K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE · Bard Access Systems, Inc. · May 30, 2012
K211193 — BD Prevue II Peripheral Vascular Vascular Access System · Bard Access Systems, Inc. (C.R. Bard, Inc.) · Jun 25, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 24, 2018 Bard Access Systems, Inc. C.R. Bard, Inc. Sari Stevens Regulatory Affairs Specialist 605 North 5600 West SALT LAKE CITY, UT 84116 Re: K182281 Trade/Device Name: Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Tech Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX, LLZ Dated: August 22, 2018 Received: August 23, 2018 Dear Sari Stevens: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/5 description: The image shows the name "Michael D. O'hara -S" in a large font. To the right of the name is a digital signature with the same name. The signature includes the date 2018.10.24 and the time 10:11:39-04'00'. Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### 510(k) Number (if known) ### K182281 #### Device Name Site~Rite® 8 Ultrasound System with Cue " Needle Tracking System and Pinpoint" GT Needle 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 and Vascular Access - · 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 Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access | | Interventional | Guidance for biopsy and drainage | | Superficial | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures | Cue" Needle Tracking System and Pinpoint" GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access. 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 Indications for Use Ultrasound System: Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint" GT Needle Technology (ultrasound console without transducer) Intended Use: Diagnostic ultrasound imaging of the human body as follows: | Clinical | | | | | | | Mode of Operation | | | | |----------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | Applications | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other* (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (epiaortic scanning) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | | | | | | | | | | Small Organ (breast, thyroid, parathyroid, testicles) | | P | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac (Adult and Pediatric) | | P | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transeurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vascular | | P | | | | | | | | P[1], N[2] | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal (Conventional) | | P | | | | | | | | | | Musculo-skeletal (Superficial) | | P | | | | | | | | | | Intravascular | | | | | | | | | | | | Other: Vascular access | | P | | | | | | | | P[1], N[2] | N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [1] Pinpoint" GT Needle Technology Guidance Imaging, [2] Cue " Needle Tracking System Guidance Imaging {4}------------------------------------------------ # Diagnostic Ultrasound Indications for Use Ultrasound System: Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint" GT Needle Technology Transducer: 32mm Linear Probe (detachable transducer) Intended Use: Diagnostic ultrasound imaging of the human body as follows: | Clinical | | | | | | | Mode of Operation | | | | |----------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | Applications | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other* (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (epiaortic scanning) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | | | | | | | | | | Small Organ (breast, thyroid, parathyroid, testicles) | | P | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac (Adult and Pediatric) | | P | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transeurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vascular | | P | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal (Conventional) | | P | | | | | | | | | | Musculo-skeletal (Superficial) | | P | | | | | | | | | | Intravascular | | | | | | | | | | | | Other: Vascular Access | | P | | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: None {5}------------------------------------------------ # Diagnostic Ultrasound Indications for Use Ultrasound System: Site~Rite® 8 Ultrasound System with Cue" Needle Tracking System and Pinpoint" GT Needle Technology Transducer: 20mm Pinpoint™ GT Linear Probe (detachable transducer) Intended Use: Diagnostic ultrasound imaging of the human body as follows: | Clinical | | | | | | | Mode of Operation | | | | |----------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | Applications | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other* (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (epiaortic scanning) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | | | | | | | | | | Small Organ (breast, thyroid, parathyroid, testicles) | | P | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac (Adult and Pediatric) | | P | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transeurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vascular | | P | | | | | | | | P[1] | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal (Conventional) | | P | | | | | | | | | | Musculo-skeletal (Superficial) | | P | | | | | | | | | | Intravascular | | | | | | | | | | | | Other: Vascular Access | | P | | | | | | | | P[1] | N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [1] Pinpoint™ GT Needle Technology Guidance Imaging {6}------------------------------------------------ # Diagnostic Ultrasound Indications for Use Ultrasound System: Site~Rite® 8 Ultrasound System with Cue" Needle Tracking System and Pinpoint" GT Needle Technology Transducer: Cue™ 20mm Linear Probe (detachable transducer) Intended Use: Diagnostic ultrasound imaging of the human body as follows: | Clinical Applications | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other* (Specify) | |----------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (epiaortic scanning) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | | | | | | | | | | Small Organ (breast, thyroid, parathyroid, testicles) | | N | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac (Adult and Pediatric) | | N | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transeurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vascular | | N | | | | | | | | N[2] | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal (Conventional) | | N | | | | | | | | | | Musculo-skeletal (Superficial) | | N | | | | | | | | | | Intravascular | | | | | | | | | | | | Other: Vascular access | | N | | | | | | | | N[2] | N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [2] Cue™ Needle Tracking System Guidance Imaging {7}------------------------------------------------ # Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology 510(k) Summary 21CFR 807.92 As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows: #### 1. Submitter Information Bard Access Systems, Inc. C.R. Bard, Inc. (Bard has joined BD) 605 North 5600 West Salt Lake City, UT 84116 Phone: (801)522-5000 Fax: (801)522-4907 | Contact Person: | Sari Stevens, Regulatory Affairs Specialist | |---------------------|---------------------------------------------| | Date of Submission: | August 22, 2018 | #### 2. Subject Device Name | Name of Device: | Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology | |-----------------------|-------------------------------------------------------------------------------------------------------| | Common or Usual Name: | Ultrasound System with Needle Tracking/Guide | | Regulation Name: | 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging System | | | 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | | | 21 CFR 892.2050, Picture Archiving and Communications System | | Regulatory Class: | Class II | | FDA Product Code: | IYO, ITX, LLZ | #### 3. Predicate Device and Reference Device #### Predicate Device | 510(k) Number: | K152554 | |-----------------------|--------------------------------------------------------------| | Name of Device: | Site~Rite® 8 Ultrasound System with Pinpoint™ GT Needle | | | Technology | | Owner/Manufacturer: | Bard Access Systems, Inc. | | Common or Usual Name: | Ultrasound System with Needle Tracking/Guide | | Regulation Name: | 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging System | | | 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | | | 21 CFR 892.2050, Picture Archiving and Communications System | | Regulatory Class: | Class II | | FDA Product Codes: | IYO, ITX, LLZ | {8}------------------------------------------------ | Reference Device | | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K140254 | | Name of Device: | eZono® 4000 Ultrasound System | | Owner/Manufacturer: | eZono AG | | Common or Usual Name: | Diagnostic Ultrasound System with Accessories | | Regulation Name: | 21 CFR 892.1550, Ultrasonic Pulsed Doppler Imaging System 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging System 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | | Regulatory Class: | Class II | | FDA Product Code: | IYN, IYO, ITX | ## 4. Device Description The subject Site-Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology 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 Site~Rite® 8 Ultrasound System has two optional needle guidance technologies available depending on the selected probe. Both available needle guidance technologies are designed to track and display the location and trajectory of a needle under ultrasound guidance. The technologies consist of software installed on an ultrasound system and sensors incorporated into the ultrasound probes. The sensors detect a passive magnetic field emitted from the 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 during the insertion process. Cue" Needle Tracking System requires the use of a Site-Rite" 8 Ultrasound System with the Cue" Needle Tracking System software module, Cue" 20mm Linear Probe, the Cue" Needl Tracking System Activator and a Cue" compatible needle. The Cue" 20mm Linear Probe contains sensors for tracking Cue™ compatible needles (following magnetization by the Cue"" Needle Tracking System Activator). The tracked needle's current position, trajectory, and Intersection Window are displayed over the ultrasound image. Pinpoint™ GT Needle Technology requires the use of a Site~Rite® 8 Ultrasound System with the ™ GT Needle Technology software module, 20mm Pinpoint™ GT Linear Probe and a Pinpoint™ Pinpoint" GT Safety Introducer Needle. The 20mm Pinpoint" GT Linear Probe contains sensors for tracking Pinpoint™ GT Safety Introducer Needles, which contain a permanent magnet within the safety canister of the needle. The tracked needle's current position, trajectory, and point of intersection with the ultrasound plane are displayed over the ultrasound image. The subject device, Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint" GT Needle Technology is bringing forward and amending the currently cleared Site~Rite® 8 Ultrasound System with Pinpoint™ GT Needle Technology's functionality (K152554). The subject Site~Rite® 8 Ultrasound System with Cue " Needle Tracking System and Pinpoint™ GT Needle Technology differs from its predicate device (K152554) primarily because it incorporates an additional needle quidance technology (Cue "" Needle Tracking System) that is similar to the one present in the reference device (K140254). Cue " Needle Tracking System tracks a qualified needle that has been magnetized using the Cue™ Needle {9}------------------------------------------------ Tracking System Activator. All other previously cleared features of the predicate device are being brought forward. Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology includes the following components: - Site~Rite® 8 Ultrasound System Console . - Cue™ 20mm Linear Probe ● - 20mm Pinpoint™ GT Probe ● - . 32mm Linear Probe - Cue™ Needle Tracking System Activator . Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is compatible with the following accessories: - Cue™ Activator mounting arm ● - Pinpoint™ GT Needle Guide Kits . - . Site~Rite® Needle Guide Kits - . Site~Rite® Probe Cover Kits - MER Roll Stand - Optional printers* with mounting hardware ● - Kickstand mounting accessory ● - Probe holder accessory - Site~Rite® Keyboard . - USB storage device* (flash/pen drive) with no external power connection - Silex® Wireless Bridge* . *The Optional printer(s) and the Silex® Wireless Bridge are standard off-the-shelf (non-medical) accessories qualified to be used with the Site~Rite® 8 Ultrasound System. Customers are also able to save files or perform software updates using standard off-the-shelf USB storage devices. To make transporting the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology more convenient, a Site~Rite® 8 Ultrasound System Roller Bag is also available. {10}------------------------------------------------ ## 5. Indications for Use The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: - . Pediatric - . Peripheral Vessel and Vascular Access - . 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 Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access | | Interventional | Guidance for biopsy and drainage | | Superficial | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures | Cue"" Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access. ## 6. Substantial Equivalence ### Intended Use Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology and its predicate device have the same intended use. Site~Rite® 8 Ultrasound System with Cue" Needle Tracking System and Pinpoint" GT Needle Technology and its reference device eZono® 4000 Ultrasound System include the same intended use of the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint GT Needle Technology is diagnostic ultrasound imaging of the human body. ## Indications for Use Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology adopts the Indications for Use of its predicate device, with some minor changes. The Indications for Use for the subject and predicate devices are described in the Substantial Equivalence Table below. The differences do not change the intended use of the Site® 8 Ultrasound System with Cue" Needle Tracking System and Pinpoint" GT Needle Technology when compared with the intended use of its predicate device. Indications for use for the subject Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint" GT Needle Technology are primarily unchanged from the indications for {11}------------------------------------------------ use for the predicate device, Site~Rite® 8 Ultrasound System with Pinpoint™ GT Needle Technology (K152554), with the following exceptions: - 1. Cue" Needle Tracking System, an additional type of needle guidance technology, is being added to the subject Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint" GT Needle Technology. Updates have been made to include Cue " Needle Tracking System throughout the Indications for Use, with select clinical applications including peripheral vessel and vascular access. - 2. The statement about available needle guidance technologies is being reworded to note that the technologies "provide visual needle tracking to assist with ultrasound guided vascular access". - 3. The system's specific clinical applications are being clarified to include "Vascular Access". This reflects the use of the product for vascular access (which had been included previously as a typical examination performed using the Site~Rite® 8 Ultrasound System). - 4. The intended use statement included with the subject ultrasound system's indications for use table is being limited to reflect the device's intended use for "Diagnostic ultrasound imaging of the human body". These updates to the Indications for Use support the addition of the Cue™ Needle Tracking System to the subject Site~Rite® 8 Ultrasound System with Cue " Needle Tracking System and Pinpoint" GT Needle Technology. For a comparison of indications for use between the subject devices and predicate devices, see the Substantial Equivalence Table below. ### Technological Characteristics The subject Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology employ the same fundamental scientific technology as the predicate device, Site~Rite® 8 Ultrasound System with Pinpoint™ GT Needle Technology (K152554), in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D images. The subject device is technologically similar to the predicate device in that it incorporates the same needle quidance technology as the predicate device (Pinpoint" GT Needle Technology) as well as an additional needle quidance technology (Cue™ Needle Tracking System), and they share both the same and similar patient contacting materials. The following table summarizes the substantial equivalence comparison of the subject device with the cited predicate and reference devices. {12}------------------------------------------------ | Substantial Equivalence Comparison Table | | | | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Site-Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (Subject Device) | Site-Rite® 8 Ultrasound System with Pinpoint™ GT Needle Technology (Predicate Device – K152554) | eZono® 4000 Ultrasound System Specifically: Needle guidance using the Transducer L3-12NGS and "eZMag" Needle Magnetizer (Reference Device – K140254) | | Indications for Use | The Site-Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: Pediatric Peripheral Vessel and Vascular Access 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: | 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: | The Indications for Use of the eZono® 4000, as defined by FDA guidance documents, are: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Invasive diagnostic or therapeutic procedures, Retroperitoneum, Female reproductive system and fetus. Superficial structures & pathologies, Peripheral Vessel, Magnetic Needle guidance. | | Imaging Applications | Exam Type (Adult and Pediatric) | 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) | 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 Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general | | {13}------------------------------------------------ | | Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (Subject Device) | | Site~Rite® 8 Ultrasound System with Pinpoint™ GT Needle Technology (Predicate Device - K152554) | | eZono® 4000 Ultrasound System Specifically: Needle guidance using the Transducer L3-12NGS and “eZMag” Needle Magnetizer (Reference Device - K140254) | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Interventional | Guidance for biopsy and drainage | Interventional | Guidance for biopsy and drainage | | | | Superficial | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures | Superficial | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures | | | | Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access. | | Pinpoint™ GT Needle Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data. | | | | Ultrasound Mode | B mode for all three compatible probes | | B mode for both compatible probes | | B mode + Color Flow Doppler (CF) and B mode + Color Power Doppler (CPD) | | Needle Guidance Technology | Cue Needle Tracking System Pinpoint GT Needle Technology | | Pinpoint GT Needle Technology | | eZGuide Needle Guidance System | | Computing Platform Power Source | AC Adapter, Internal Lithium Ion Battery Pack (not removable by the end-user) | | AC Adapter, Internal Lithium Ion Battery Pack (not removable by the end-user) | | AC Adapter, Removable Battery | | Components | Site~Rite® 8 Ultrasound System Console Detachable Cue™ 20mm Linear Probe Detachable 20mm Pinpoint™ GT Linear probe Detachable 32mm Linear Probe Cue™ Needle Tracking System Activator | | Site~Rite® 8 Ultrasound System Console Detachable 20mm Pinpoint™ GT Linear probe Detachable 32mm Linear Probe Cue™ Needle Tracking System Activator | | eZono® 4000 Ultrasound System Detachable L3-12NGS probe eZMag Magnetizer | | Accessories | Cue™ Activator mounting arm Site~Rite® Needle Guide Kits (not qualified with Cue™ Needle Tracking System or with Pinpoint™ GT Needle Technology) Pinpoint™ GT Needle Guide Kits Site~Rite® Probe Cover Kits | | Site~Rite® Needle Guide Kits (not for use with Pinpoint™ GT Needle Technology) Pinpoint™ GT Needle Guide Kits Site~Rite® Probe Cover Kits MER Roll Stand Brother™ Printer MW-260 with mounting hardware | | eZMag Needle Magnetizer eZono® Battery Pack (lithium 14.4V Lithium ion battery, capacity 6.6 Ah.) eZono Dual Bay Battery Charger Power Supply Power Cord VESA mountings, Quick Release Bracket eZono® Stand | {14}------------------------------------------------ | Substantial Equivalence Comparison Table | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Site-Rite® 8 Ultrasound System with CueTM Needle Tracking System and PinpointTM GT Needle Technology (Subject Device) | Site-Rite® 8 Ultrasound System with PinpointTM GT Needle Technology (Predicate Device - K152554) | eZono® 4000 Ultrasound System Specifically: Needle guidance using the Transducer L3-12NGS and "eZMag" Needle Magnetizer (Reference Device - K140254) | | MER Roll Stand Optional printers* with mounting hardware Kickstand mounting accessory Probe holder accessory Site-Rite® Keyboard USB storage device* (flash/pen drive) with no external power connection Silex® Wireless Bridge* * The Optional printer(s) and the Silex® Wireless Bridge are standard off-the-shelf (non-medical) accessories qualified to be used with the Site-Rite® 8 Ultrasound System. Customers are also able to save files or perform software updates using standard off-the-shelf USB storage devices. For customer convenience a Site-Rite® 8 Ultrasound System Roller Bag is also offered for transporting the Site-Rite® 8 Ultrasound System. | Kickstand mounting accessory Probe holder accessory Site-Rite® Keyboard USB storage device* (flash/pen drive) with no external power connection Silex® Wireless Bridge* *The BrotherTM Printer MW-260 and the Silex® Wireless Bridge are standard off-the-shelf (non- medical) accessories qualified to be used with the Site-Rite® 8 Ultrasound System.. Customers are also able to save files or perform software updates using standard off-the-shelf USB storage devices. For customer convenience a Site-Rite® 8 Ultrasound System Roller Bag is also offered for transporting the Site-Rite® 8 Ultrasound System. | REOMED isolation transformer USB Memory Stick - 8GB | {15}------------------------------------------------ ## 7. Performance Data Acceptance criteria have been determined to ensure that the subject device performs in a manner that is substantially equivalent to the cited predicate device. Testing verifying the performance requirements of the subject device software when connected to a Cue" 20mm Linear Probe was conducted and is included in this Abbreviated premarket notification, the results of which support substantial equivalence. This submission is adding two components (Cue™ 20mm Linear Probe, and Cue™ Needle Tracking System Activator) and one accessory (Cue"" Activator mounting arm) to the list of compatible components and accessories that are legally marketed with the predicate device and will continue to be marketed with the subject device. The following table lists subject device design requirements and corresponding nonclinical tests submitted, referenced, or relied on in the premarket notification for a determination of substantial equivalence. | Design Requirements and Corresponding Nonclinical Tests | | | |---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ● | User needs | Site-Rite® 8 Ultrasound System Software Verification Cue™ Needle Tracking System Accuracy Site-Rite® 8 Ultrasound System Image Verification Site~Rite® 8 vs. Site~Rite® 6 Image Comparison Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report | | ● | Physical characteristics ● Electrical, electronic, and radiation characteristics ● Thermal characteristics ● Mechanical characteristics | Site-Rite® 8 Ultrasound System Electrical Safety and EMC - IEC 60601-1 Edition 3.1 | | ● | Operating environment | Site~Rite® 8 Operational Temperature and Humidity Testing | | ● | Labeling characteristics | Site-Rite® 8 Ultrasound System Electrical Safety and EMC - IEC 60601-1 Edition 3.1 Site~Rite® 8 Operational Temperature and Humidity Testing | | ● | Equipment and device interfaces and mounting | Site~Rite® 8 Ultrasound System Software Verification | | ● | Minimum requirements for computing platform | Site~Rite® 8 System Software Verification | | ● | Usability requirements | Site-Rite® 8 Mechanical Testing | | ● | Operating requirements | Cue™ Needle Tracking System Accuracy Site~Rite® 8 Ultrasound System Software Verification Site~Rite® 8 Response Time Verification Site~Rite® 8 Ultrasound System Software Verification Site-Rite® 8 System Software Verification | | ● | Software requirements | Cue™ Needle Tracking System Accuracy Cue™ VAD Library Information Verification Admin Tool Verification Site-Rite® 8 Shared Requirements Verification | | ● | Dimensional | Site-Rite® 8 Verification and Validation Rationale | {16}------------------------------------------------ | Design Requirements and Corresponding Nonclinical Tests | | | |-----------------------…