Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on sensor-based needle tracking and software interpretation of sensor data to create a visual representation, without mentioning AI or ML algorithms for image analysis, diagnosis, or prediction.

Therapeutic

No
Explanation: The device is intended for diagnostic imaging and provides guidance for procedures, but it does not directly treat a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including the ultrasound system console, probes, and an activator, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Site~Rite® 8 Ultrasound System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Site~Rite® 8 Intended Use: The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. It uses ultrasound waves to create images of internal structures for diagnostic and interventional purposes (like guiding needle placement). It does not involve the analysis of specimens taken from the body.
Device Description: The description focuses on the hardware (ultrasound console, probes, activators) and software that facilitate real-time imaging and needle tracking within the body. It does not mention any components or processes related to handling or analyzing biological samples.

Therefore, the Site~Rite® 8 Ultrasound System falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, 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.

Product codes

IYO, ITX, LLZ

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 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Pediatric, Peripheral Vessel, Vascular Access, Small Organ (breast, thyroid, parathyroid, testicles), Musculo-skeletal (conventional and superficial), Cardiac (adult and pediatric), extremities, neck (jugular, carotid), superficial veins in the arms and legs (basilic, cephalic, brachial, femoral, radial, saphenous), superficial thoracic vessels (axillary, innominate, subclavian), lymph nodes, hernias, joints, ligaments, tendons, soft tissue structures, surrounding anatomical structures.

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

Clinicians (implied)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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 characteristics: Site-Rite® 8 Verification and Validation Rationale
Chemical characteristics: Site~Rite® 8 Cleaning Solution Compatibility Verification
Biological and biocompatibility characteristics: Site~Rite® 8 Biocompatibility Assessment
Packaging characteristics: Cue™ Activator Ship Test Verification, Ultrasound Probe Ship Test Verification

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K152554

Reference Device(s)

K140254

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.

Summary

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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)

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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
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
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
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.

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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

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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.
1. 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".
1. 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).
1. 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.

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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

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| | SiteRite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
Needle Technology
(Subject Device) | | SiteRite® 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 | SiteRite® 8 Ultrasound System Console Detachable Cue™ 20mm Linear Probe Detachable 20mm Pinpoint™ GT Linear probe Detachable 32mm Linear Probe Cue™ Needle Tracking System Activator | | SiteRite® 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 |

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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

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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

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Design Requirements and Corresponding Nonclinical Tests
	Characteristics
●	Chemical characteristics	Site~Rite® 8 Cleaning Solution Compatibility Verification
●	Biological and biocompatibility characteristics	Site~Rite® 8 Biocompatibility Assessment
●	Packaging characteristics	Cue™ Activator Ship Test Verification
Ultrasound Probe Ship Test Verification

The following guidance documents and standards were used to determine appropriate methods for evaluating the performance of the subject device:

| List of the Recognized Standards and Guidance Documents Applicable to Subject

Device
Standard Number	Standard Description
FDA Guidance	Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers
FDA Guidance	Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices
FDA Guidance	Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices
FDA Guidance	Postmarket Management of Cybersecurity in Medical Devices
FDA Guidance	Applying Human Factors And Usability Engineering To Medical
Devices
IEC 60601-1: 2012-08	Medical Electrical Equipment - Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance

Edition 3.1 |
| ISO 14971:2007 | Medical Devices - Application of Risk Management To Medical
Devices - Edition 2 |
| IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: General Requirements for
Basic Safety and Essential Performance - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests - Edition
4.0 |
| IEC 60601-2-37:2007 | Medical Electrical Equipment – Part 2-37: Particular Requirements
for the Basic Safety and Essential Performance of Ultrasonic
Medical Diagnostic and Monitoring Equipment – Edition 2 |
| IEC 60601-1-6:2013 | Medical Electrical Equipment-Part 1-6: General Requirements for
Basic Safety and Essential Performance – Collateral Standard:
Usability – Edition 3.1 |
| IEC 62304:2015 | Medical device software - Software Life Cycle Processes – Edition
1.1 |
| IEC 62366-1:2015 | Medical Devices – Part 1: Application of Usability Engineering to
Medical Devices - Edition 1.0 |
| NEMA UD 2: 2004
(R2009) | Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment, Revision 3 |

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| List of the Recognized Standards and Guidance Documents Applicable to Subject

Device
Standard Number	Standard Description
ISO 10993-1:2009	Biological Evaluation of Medical Devices – Part 1: Evaluation and
Testing within a Risk Management Process
ISO 15223-1:2016	Medical Devices - Symbols To Be Used With Medical Device Labels,
Labelling, And Information To Be Supplied - Part 1: General
Requirements

8. Clinical Performance Data

No human clinical data was provided to support substantial equivalence.

9. Conclusion Regarding Substantial Equivalence

The subject device, Site~~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint" GT Needle Technology, has the same intended use as the predicate device, Site~~Rite® 8 Ultrasound System with Pinpoint™ GT Needle Technology (K152554). The subject device has similar indications for use, technological characteristics, and safety and performance testing as the predicate device. The subject SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology will meet the predetermined performance requirements for its intended use and is as safe, as effective, and performs as well as or better than the predicate device, SiteRite® 8 Ultrasound System with Pinpoint™ GT Needle Technology. Based on this assessment, the subject Site~~Rite® 8 Ultrasound System with Cue" Needle Tracking System and Pinpoint" GT Needle Technology is determined to be substantially equivalent to the predicate device, Site~~Rite® 8 Ultrasound System with Pinpoint GT Needle Technology (K152554). The presence of the additional needle guidance technology, Cue" Needle Tracking System, is supported by the presence of needle quidance technology on the predicate device, with additional consideration of the reference device's (eZono® 4000 Ultrasound System K140254) needle guidance technology. The Cue™ Needle Tracking System is based on the needle guidance technology available on the reference device.