(131 days)
No
The document describes a hardware upgrade to an existing ultrasound system, focusing on improved image quality and reliability through newer components. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a diagnostic ultrasound system used for imaging and guidance during medical procedures, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SiteRite™ 9 Ultrasound System is intended for diagnostic ultrasound imaging of the human body..."
No
The device description explicitly lists hardware components such as an "Ultrasound System Console," "Ultrasound Beamformer," and "9 Ultrasound Probe." It also mentions compatibility with various hardware accessories. The performance studies include extensive testing of hardware-related aspects like electrical safety, mechanical reliability, and acoustic safety.
Based on the provided information, the SiteRite™ 9 Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- SiteRite™ 9 Function: The SiteRite™ 9 Ultrasound System is used for diagnostic ultrasound imaging of the human body in vivo (within the body). It uses sound waves to create images of internal structures and guide procedures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging of the human body" and lists various clinical applications that involve imaging internal structures and guiding procedures.
- Device Description: The description focuses on real-time 2D ultrasound imaging and features related to image acquisition, measurement, and guidance for vascular access. It does not mention any components or processes related to analyzing biological samples.
Therefore, the SiteRite™ 9 Ultrasound System falls under the category of medical imaging devices used for in-vivo diagnosis and procedural guidance, not in-vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SiteRite™ 9 Ultrasound System is intended for diagnostic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. 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)
The SiteRite™ 9 Ultrasound System is indicated for Vascular, Vascular Access, Interventional, and Superficial Imaging Applications. Typical examinations performed using the SiteRite™ 9 Ultrasound System include:
| Imaging Applications | Exam Type (Adult and Pediatric) |
|---|---|
| Vascular | Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. |
| 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, soft tissue structures, and surrounding anatomical structures. |
The SiteRite TM 9 Ultrasound System transducer operates using B mode imaging.
Product codes
IYO, ITX, LLZ
Device Description
The subject device, the SiteRite™ 9 Ultrasound System ("SiteRite 9 System") is a portable device that features real-time 2D ultrasound imaging for vascular access device placement, which includes vessel measurement tools, vascular access device selection, procedure documentation and electronic connectivity.
The subject SiteRite 9 System is intended to aid in the placement of peripheral and central line vascular access devices and ultimately increase first stick success. The system is the replacement platform for the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (i.e., the predicate device) and includes more up-to-date and reliable components aimed at providing improved image quality, while maintaining ease of operation.
The subject SiteRite 9 System can be viewed as the next generation SiteRite™ ultrasound system and is equivalent from a functionality standpoint to its predicate device, to the SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281). The SiteRite 9 System is essentially replacing its predicate device, the SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology ("Site~Rite 8 System"), due to the end-of-life obsolescence of its components.
The subject SiteRite 9 System differs from its predicate device, the Site~Rite 8 System (K182281). in that it includes newer, more "state of the art" hardware components resulting in a more efficient and reliable use of the device. Aside from these technical upgrades, most of the previously cleared features of the predicate device are being brought forward.
The subject SiteRite 9 System includes the following main components:
- Ultrasound System Console
- Ultrasound Beamformer ●
- System Software .
- 9 Ultrasound Probe
Additionally, the subject SiteRite 9 System is compatible with the following accessories:
- SiteRite™ Probe Cover Kits ●
- Site~Rite® Needle Guide Kits ●
- Pinpoint TM GT Needle Guide Kits ●
- . MER Roll Stand with Mounting Accessory (optional accessory)
- Kickstand with Mounting Accessory (optional accessory) .
- Sony Printer UP-X898MD (off-the-shelf, optional accessory) 9
- USB Storage Device (off-the-shelf, optional accessory) .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body:
- Extremities (vessels)
- Neck (vessels)
- Breast
- Thyroid
- Parathyroid
- Testicles
- Lymph nodes
- Musculoskeletal (conventional and superficial)
- Soft tissue structures
- Surrounding anatomical structures
- Thoracic vessels (superficial)
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Appropriately trained healthcare professionals in a medical setting.
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)
Non-Clinical Performance Data: C.R. Bard, Inc. has conducted extensive verification and validation testing of the SiteRite™ 9 Ultrasound System, as an ultrasonic pulsed echo imaging system capable of providing diagnostic ultrasound imaging of the human body. The subject device was tested to ensure that it can provide all the capabilities necessary to operate safely and effectively.
Acceptance criteria have been established to ensure that the subject device performs in a manner that is substantially equivalent to the cited predicate device. Testing was conducted to verify the safety and performance requirements of the subject device and the test results support substantial equivalence to the predicate device.
SiteRite™ 9 System - Nonclinical Tests Performed:
- Acoustic Safety Testing
- Electrical Safety Testing
- Electromagnetic Compatibility Testing
- FCC Compliance Testing
- Biocompatibility Testing
- Mechanical Testing
- Vibration Reliability Testing
- Fluid Ingress Testing
- Functional Testing
- Operating Temperature and Humidity Testing
- Electrical Reliability and Power Cycling Testing
- Software Verification Testing
- Cybersecurity Assessment
- Human Factors Assessment
- Ultrasound Image Testing
- Ultrasound Response Time Testing
- Cleaning/Reprocessing Testing
- Ship Testing
- Battery Testing
The SiteRite™ 9 Ultrasound System, complies with all the applicable voluntary standards related to its Regulations and Product Codes and successfully passed all respective testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
September 11, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
Bard Access Systems, Inc. (C.R. Bard, Inc.) % Fabio De Pasquale Regulatory Affairs 605 North 5600 West SALT LAKE CITY UT 84116
Re: K231283
Trade/Device Name: SiteRite™ 9 Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, LLZ Dated: August 10, 2023 Received: August 11, 2023
Dear Fabio De Pasquale:
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 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K231283
Device Name SiteRite™ 9 Ultrasound System
Indications for Use (Describe)
The SiteRite™ 9 Ultrasound System is intended for diagnostic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. 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)
The SiteRite™ 9 Ultrasound System is indicated for Vascular, Vascular Access, Interventional, and Superficial Imaging Applications. Typical examinations performed using the SiteRite™ 9 Ultrasound System include:
| Imaging
| Applications | Exam Type (Adult and Pediatric) | ||||
|---|---|---|---|---|---|
| Vascular | Assessment of vessels in the extremities and neck leading to or coming from the | ||||
| heart, superficial veins in the arms and legs, and vessel mapping. Assessment of | |||||
| superficial thoracic vessels. | |||||
| 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, soft tissue structures, and surrounding anatomical structures. |
The SiteRite TM 9 Ultrasound System transducer operates using B mode imaging.
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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3
Section 8 - 510(k) Summary
(in accordance with 21 CFR 807.92)
510(k) Number: K231283
l. Applicant Information
| Applicant: | Bard Access Systems, Inc. (C.R. Bard, Inc.
(Bard has now joined Becton Dickinson)
605 North 5600 West
Salt Lake City, UT 84116
USA |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fabio De Pasquale
Regulatory Affairs
Tel: 1-250-920-6501
e-mail: fabio.de.pasquale@bd.com |
| Application Correspondent: | Same as Applicant. |
| Date Prepared: | April 28, 2023 |
| Subject Device Identification | |
| Proprietary Name: | SiteRite™ 9 Ultrasound System |
| Common/Usual Name: | Ultrasound System with Needle Tracking |
| Regulation Name: | Ultrasonic Pulsed Echo Imaging System |
| Regulation Number: | 21 CFR 892.1560 |
| Product Code: | IYO |
| Regulation Name: | Diagnostic Ultrasonic Transducer |
| Regulation Number: | 21 CFR 892.1570 |
| Product Code: | ITX |
Medical Image Management and Processing System 21 CFR 892.2050 LLZ
Regulatory Class: Classification Panel:
Regulation Name:
Regulation Number:
Product Code:
Class II Radiology
4
III. Predicate Device
The subject device, the SiteRite™ 9 Ultrasound System, is substantially equivalent to the following cleared predicate device. The subject and predicate devices have the same fundamental scientific technology and intended use:
| 510(k) Number: | K182281 |
|---|---|
| Proprietary Name: | Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT™ Needle Technology |
| Common/Usual Name: | Ultrasound System with Needle Tracking |
| Regulation Name: | Ultrasonic Pulsed Echo Imaging System |
| Regulation Number: | 21 CFR 892.1560 |
| Product Code: | IYO |
| Regulation Name: | Diagnostic Ultrasonic Transducer |
| Regulation Number: | 21 CFR 892.1570 |
| Product Code: | ITX |
| Regulation Name: | Medical Image Management and Processing System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory Class: | Class II |
| Classification Panel: | Radiology |
IV. Subject Device Description
The subject device, the SiteRite™ 9 Ultrasound System ("SiteRite 9 System") is a portable device that features real-time 2D ultrasound imaging for vascular access device placement, which includes vessel measurement tools, vascular access device selection, procedure documentation and electronic connectivity.
The subject SiteRite 9 System is intended to aid in the placement of peripheral and central line vascular access devices and ultimately increase first stick success. The system is the replacement platform for the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (i.e., the predicate device) and includes more up-to-date and reliable components aimed at providing improved image quality, while maintaining ease of operation.
The subject SiteRite 9 System can be viewed as the next generation SiteRite™ ultrasound system and is equivalent from a functionality standpoint to its predicate device, to the SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281). The SiteRite 9 System is essentially replacing its predicate device, the SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and
5
Pinpoint™ GT Needle Technology ("Site~Rite 8 System"), due to the end-oflife obsolescence of its components.
The subject SiteRite 9 System differs from its predicate device, the Site~Rite 8 System (K182281). in that it includes newer, more "state of the art" hardware components resulting in a more efficient and reliable use of the device. Aside from these technical upgrades, most of the previously cleared features of the predicate device are being brought forward.
The subject SiteRite 9 System includes the following main components:
- Ultrasound System Console
- Ultrasound Beamformer ●
- System Software .
- 9 Ultrasound Probe
Additionally, the subject SiteRite 9 System is compatible with the following accessories:
- SiteRite™ Probe Cover Kits ●
- Site~Rite® Needle Guide Kits ●
- Pinpoint TM GT Needle Guide Kits ●
- . MER Roll Stand with Mounting Accessory (optional accessory)
- Kickstand with Mounting Accessory (optional accessory) .
- Sony Printer UP-X898MD (off-the-shelf, optional accessory) 9
- USB Storage Device (off-the-shelf, optional accessory) .
As discussed in the following sections, the intended use, technological characteristics, principles of operation and materials of the subject device are substantially equivalent to the respective ones of the predicate device.
V. Indications for Use
The SiteRite™ 9 Ultrasound System is intended for diagnostic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. 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 SiteRite™ 9 Ultrasound System include:
6
| Imaging
| Applications | Exam Type (Adult and Pediatric) | |||
|---|---|---|---|---|
| Vascular | Assessment of vessels in the extremities and neck leading to or coming | |||
| from the heart, superficial veins in the arms and legs, and vessel | ||||
| mapping. Assessment of superficial thoracic vessels. | ||||
| 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, soft tissue structures, and surrounding | ||||
| anatomical structures. |
The SiteRite 9 Ultrasound System transducer operates using B mode imaging.
VI. Substantial Equivalence
Intended Use
The SiteRite™ 9 Ultrasound System and its predicate device have the same intended use: diagnostic ultrasound imaging of the human body.
Indications for Use
The SiteRite™ 9 Ultrasound System includes substantially equivalent Indications for Use with respect to its predicate device.
Technological Characteristics
The subject SiteRite™ 9 Ultrasound System employs the same identical fundamental scientific technology as the predicate device, the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281), 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.
In addition, the subject and predicate devices share substantially equivalent patient contacting materials and software features, allowing the SiteRite™ 9 Ultrasound System to perform in a substantially equivalent fashion with respect to the predicate device.
The following table summarizes the substantial equivalence comparison between the subject and the predicate device.
7
Substantial Equivalence Comparison Table
| | Subject Device: | Predicate Device:
(K182281) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SiteRite™ 9 Ultrasound System | Site-Rite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
Needle Technology |
| Product Codes | IYO – ITX – LLZ | IYO – ITX – LLZ |
| Regulation #s | 892.1560-892.1570 - 892.2050 | 892.1560, 892.1570, 892.2050 |
| Device Class | II | II |
| Intended Use /
Indications for
Use | The SiteRite™ 9 Ultrasound System is intended for
diagnostic ultrasound imaging of the human body. | The Site-Rite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
Needle Technology 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
SiteRite™ 9 Ultrasound System include: | 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: |
| Device Name | Subject Device:
SiteRite™ 9 Ultrasound System | Predicate Device:
(K182281)
SiteRite® 8 Ultrasound System with Cue™Rite® 8 Ultrasound System with
Needle Tracking System and Pinpoint™ GT
Needle Technology |
| Imaging Applications | Exam Type (Adult and Pediatric)
Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. | Exam Type (Adult and Pediatric)
Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. |
| Vascular | | |
| 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 vein and artery access. |
| Interventional | Guidance for biopsy and drainage. | Guidance for biopsy and drainage. |
| Superficial | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures. | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures. |
| Device Name | Subject Device: | Predicate Device:
(K182281) |
| | SiteRite™ 9 Ultrasound System | Site-Rite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
Needle Technology |
| | (The Cue™ Needle Tracking System is not included
in the current version of the SiteRite™ 9
Ultrasound System.) | Cue™ Needle Tracking System and Pinpoint™
GT Needle Technology are each intended to
provide visual needle tracking to assist with
ultrasound guided vascular access. |
| Environment of
Use | Hospital/clinic medical setting. | Hospital/clinic medical setting. |
| Track 1 or
Track 3 | Track 1 | Track 1 |
| Power Source | AC Adapter with Internal Lithium-Ion Battery
Pack.
Power Consumption: 150 W | AC Adapter with Internal Lithium-Ion Battery
Pack.
Power Consumption: 60 W |
| Main System
Components | The SiteRite™ 9 Ultrasound System includes the
following main components:
● SiteRite™ 9 Console
● Ultrasound Beamformer
● System Software
● Ultrasound Probe
● (no Cue™ Needle Tracking System
functionality is currently included in the
subject device) | The Site-Rite® 8 Ultrasound System includes the
following main components:
● Site-Rite® 8 Console
● Ultrasound Beamformer
● System Software
● Ultrasound Probes
● Cue™ Needle Tracking System Hardware |
| System Console | The SiteRite™ 9 Ultrasound System includes:
● 15.6" Touch Screen Monitor
● Portable | The Site-Rite® 8 Ultrasound System includes:
● 10.4" Touch Screen Monitor
● Portable |
| Device Name | Subject Device: | Predicate Device:
(K182281) |
| | SiteRite™ 9 Ultrasound System | Site
Needle Tracking System and Pinpoint™ GT
Needle Technology |
| | • Weight 6.8 lbs | • Weight 5 lbs |
| | Graphic User Interface (GUI):
Touchscreen user interface to access all available
functionality ( no Cue™ Needle Tracking System
functionality is currently included in the subject
device ). | Graphic User Interface (GUI):
Touchscreen user interface to access all available
functionality, including the Cue™ Needle
Tracking System. |
| Ultrasound
Beamformer | The SiteRite™ 9 Ultrasound System uses B mode
for the compatible probe. | The SiteRite® 8 Ultrasound System uses BRite® 8 Ultrasound System includes the
mode for all compatible probes. |
| Ultrasound
Features | The SiteRite™ 9 Ultrasound System includes the
following features:
• Intuitive controls allowing for rapid and
easy operation;
• Choice of battery or line voltage power;
• Portable system;
• Operating parameters of scanner
determined by image depth;
• Image freeze frame;
• Simplified, touch screen user interface;
• Image saving;
• Vessel assessment tools: | The Site
following features:
• Intuitive controls allowing for rapid and
easy operation;
• Choice of battery or line voltage power;
• Portable system;
• Operating parameters of scanner
determined by image depth;
• Image freeze frame;
• Simplified, touch screen user interface;
• Image saving;
• Vessel assessment tools: |
| Device Name | Subject Device:
SiteRite™ 9 Ultrasound System | Predicate Device:
(K182281)
Site-Rite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
Needle Technology |
| | Patient information and file management; and On-screen keyboard. | Patient information and file management; and On-screen keyboard. |
| Software | Operating System (OS): MS Windows 10 Embedded | Operating System (OS): MS Windows 7 Embedded |
| | Needle Guidance Technology: (no Cue™ Needle Tracking System functionality is currently included in the subject device) | Needle Guidance Technology: Passive magnetic tracking using the Cue™ Needle Tracking System Passive magnetic tracking using the Pinpoint GT Needle Technology |
| | Image Depths: 1 cm 1.5 cm 3 cm 4.5 cm 6 cm | Image Depths: 1 cm 1.5 cm 3 cm 4.5 cm 6 cm |
| | Ultrasound Settings: Gain/Brightness Image filter | Ultrasound Settings: Gain/Brightness Image filter Contrast (low/high) |
| Device Name | Subject Device:
SiteRite™ 9 Ultrasound System | Predicate Device:
(K182281)
Site-Rite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
Needle Technology |
| Magnetic Field
Detection
Technology | (The Cue™ Needle Tracking System is not included
in the current version of the SiteRite™ 9
Ultrasound System.) | The Cue™ Needle Tracking System requires the use of: Site-Rite® 8 Ultrasound System Console. Detachable Cue™ compatible Probe. Cue™ RFID-Reader/Magnetizer unit (i.e.,
the "Activator", a component of the
Cue™ Needle Tracking System) externally
connected to the console via USB cable. Qualified disposable needle that is present
in the system's needle library and
packaged in Cue™ compatible packaging. |
| Visualization
Features | The SiteRite™ 9 Ultrasound System Console
includes the following visualization features: Visualization of a vessel and surrounding
anatomy. Visualization and measure of catheter size
relative to a vessel. Visualization of virtual catheter size during
vascular access placement. Measure of remaining catheter length based
on vessel depth and assumed insertion angle. | The Site-Rite® 8 Ultrasound System Console
includes the following visualization features: Visualization of a vessel and surrounding
anatomy. Visualization and measure of catheter size
relative to a vessel. Visualization of virtual catheter size during
vascular access placement. Measure of remaining catheter length based
on vessel depth and assumed insertion angle. Visualization of a needle trajectory. |
| Device Name | Subject Device:
SiteRite™ 9 Ultrasound System | Predicate Device:
(K182281)
Site-Rite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
Needle Technology |
| | (no Cue™ Needle Tracking System
functionality is currently included in the
subject device) | Visualization of the insertion angle while
using the Cue™ Needle Tracking System,
allowing the user to set a “maximum angle
rule” for system notification.
Visualization of the remaining catheter
length while using the Cue™ Needle
Tracking System, allowing the user to set a
“minimum remaining catheter length” rule
for system notification. |
| Ultrasound
Transducers | The SiteRite™ 9 Ultrasound System includes the
following probe:
• Detachable Linear 25 mm Probe | The Site-Rite® 8 Ultrasound System includes the
following 3 probes:
• Detachable Cue™ 20mm Linear Probe
• Detachable 20mm Pinpoint™ GT Linear
probe
• Detachable 32mm Linear Probe |
| | SiteRite™ 9 Probe Characteristics:
• Cue™ compatible → No
(no CueTM Needle Tracking System
functionality is currently included in the
subject device) | Site-Rite® 8 Probes Characteristics:
• Cue™ compatible → Yes |
| Device Name | Subject Device: | Predicate Device:
(K182281) |
| | SiteRite™ 9 Ultrasound System | Site-Rite® 8 Ultrasound System with Cue™
Needle Tracking System and Pinpoint™ GT
Needle Technology |
| | SiteRite™ Needle Guides compatible → Yes Probe Buttons → Yes Acoustics → B-mode imaging | SiteRite™ Needle Guides compatible → Yes Probe Buttons → Yes Acoustics → B-mode imaging |
| Accessories | The SiteRite™ 9 Ultrasound System is compatible
with the following accessories:
SiteRite™ Probe Cover Kits Site-Rite® Needle Guide Kits Pinpoint™ GT Needle Guide Kits MER Roll Stand with Mounting Accessory (optional) Kickstand with Mounting Accessory (optional) (no Cue™ Needle Tracking System functionality is
currently included in the subject device) | The Site-Rite® 8 Ultrasound System is
compatible with the following accessories:
SiteRite™ Probe Cover Kits Site-Rite® Needle Guide Kits Pinpoint™ GT Needle Guide Kits MER Roll Stand with Mounting Accessory (optional) Kickstand with Mounting Accessory (optional) Cue™ Compatible Needles Cue™ Activator Mounting Arm Site-Rite® 8 Ultrasound System Roller Bag |
| | Keyboard (touchscreen only) Sony Printer UP-X898MD with mounting
hardware (optional)() USB storage device (optional)() | Keyboard (optional) Optional printers with mounting hardware
(optional)() USB storage device (optional)() |
| Device Name | Subject Device: SiteRite™ 9 Ultrasound System | Predicate Device: (K182281) Site-Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology |
| | Wireless connectivity provided by an internal component equivalent to the Silex® Wireless Bridge() | Silex® Wireless Bridge (optional)() |
| Compatible Needles and Catheters | All needles available in the market are compatible with the SiteRite™ 9 Ultrasound System.
(no Cue™ Needle Tracking System functionality is currently included in the subject device). | All needles available in the market are compatible with the Site-Rite 8 system.
Additionally, the system is also compatible with all Cue™ needles/catheters currently cleared for sale. |
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9
10
11
12
13
14
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(*) The optional printer(s) and the USB storage device are standard off-the-shelf (non-medical) accessories qualified to be used with both products.
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VII. Non-Clinical Performance Data
C.R. Bard, Inc. has conducted extensive verification and validation testing of the SiteRite™ 9 Ultrasound System, as an ultrasonic pulsed echo imaging system capable of providing diagnostic ultrasound imaging of the human body. The subject device was tested to ensure that it can provide all the capabilities necessary to operate safely and effectively.
Acceptance criteria have been established to ensure that the subject device performs in a manner that is substantially equivalent to the cited predicate device. Testing was conducted to verify the safety and performance requirements of the subject device and the test results support substantial equivalence to the predicate device. The following table lists the nonclinical tests performed on the subject SiteRite™ 9 Ultrasound System for a determination of substantial equivalence.
| SiteRite™ 9 System - Nonclinical Tests Performed |
|---|
| Acoustic Safety Testing |
| Electrical Safety Testing |
| Electromagnetic Compatibility Testing |
| FCC Compliance Testing |
| Biocompatibility Testing |
| Mechanical Testing |
| Vibration Reliability Testing |
| Fluid Ingress Testing |
| Functional Testing |
| Operating Temperature and Humidity Testing |
| Electrical Reliability and Power Cycling Testing |
| Software Verification Testing |
| Cybersecurity Assessment |
| Human Factors Assessment |
| Ultrasound Image Testing |
| Ultrasound Response Time Testing |
| Cleaning/Reprocessing Testing |
| Ship Testing |
| Battery Testing |
The SiteRite™ 9 Ultrasound System, complies with all the applicable voluntary standards related to its Regulations and Product Codes and successfully passed all respective testing.
The following quidance documents and standards were followed to determine appropriate methods for evaluating the performance of the subject device.
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| Standards and Guidance Documents Applicable to the SiteRite 9 System | ||
|---|---|---|
| Standard/Guidance | Title | |
| FDA Guidance | Marketing Clearance of Diagnostic Ultrasound Systems and | |
| Transducers | ||
| FDA Guidance | Applying Human Factors and Usability Engineering to Medical | |
| Devices | ||
| FDA Guidance | Content of Human Factors Information in Medical Device | |
| Marketing Submissions (DRAFT) | ||
| FDA Guidance | Format for Traditional and Abbreviated 510(k)s | |
| FDA Guidance | Guidance for the Content of Premarket Submissions for Software | |
| Contained in Medical Devices | ||
| FDA Guidance | Content of Premarket Submissions for Device Software Functions | |
| (DRAFT) | ||
| FDA Guidance | Content of Premarket Submissions for Management of | |
| Cybersecurity in Medical Devices | ||
| FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations | |
| and Content of Premarket Submissions (DRAFT) | ||
| FDA Guidance | Post Market Management of Cybersecurity in Medical Devices | |
| FDA Guidance | Cybersecurity in Medical Devices: Refuse to Accept Policy for | |
| Cyber Devices and Related Systems Under Section 524B of the | ||
| FD&C Act | ||
| FDA Guidance | Use of International Standard ISO 10993-1, "Biological evaluation | |
| of medical devices - Part 1: Evaluation and testing within a risk | ||
| management process" | ||
| FDA Guidance | Recommended Content and Format of Non-Clinical Bench | |
| Performance Testing Information in Premarket Submissions | ||
| FDA Guidance | The 510(k) Program: Evaluating Substantial Equivalence in | |
| Premarket Notifications [510(k)] | ||
| FDA Guidance | Appropriate Use of Voluntary Consensus Standards in Premarket | |
| Submissions for Medical Devices | ||
| FDA Guidance | Refuse to Accept Policy for 510(k)s | |
| FDA Guidance | eCopy Program for Medical Device Submissions | |
| IEC 60601-1:2020 | Medical electrical equipment - Part 1: General requirements for | |
| basic safety and essential performance | ||
| IEC 60601-1-2:2020 | Medical electrical equipment - Part 1-2: General requirements for | |
| basic safety and essential performance - Collateral standard: | ||
| Electromagnetic disturbances - Requirements and tests | ||
| IEC TR 60601-4-2:2016 | Medical electrical equipment - Part 4-2: Guidance and | |
| interpretation - Electromagnetic immunity: performance of medical | ||
| electrical equipment and medical electrical systems | ||
| IEC 60601-1-6:2020 | Medical electrical equipment - Part 1-6: General requirements for | |
| basic safety and essential performance - Collateral standard: | ||
| usability | ||
| IEC 60601-2-37:2015 | Medical electrical equipment - Part 2-37: Particular requirements | |
| for the basic safety and essential performance of ultrasonic | ||
| medical diagnostic and monitoring equipment | ||
| Standards and Guidance Documents Applicable to the SiteRite 9 System | ||
| Standard/Guidance | Title | |
| IEC 62359:2017 | Ultrasonics - Field characterization - Test methods for the | |
| determination of thermal and mechanical indices related to medical | ||
| diagnostic ultrasonic field | ||
| IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or other non-acid | |
| electrolytes - Safety requirements for portable sealed secondary | ||
| cells, and for batteries made from them, for use in portable | ||
| applications - Part 2: Lithium systems | ||
| IEC 62304:2015 | Medical device software - Software life cycle processes | |
| IEC 62366-1:2020 | Medical devices - Part 1: Application of usability engineering to | |
| medical devices | ||
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and | |
| testing within a risk management process | ||
| ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be | |
| supplied by the manufacturer - Part 1: General requirements | ||
| ISO 14971:2019 | Medical devices - Application of risk management to medical | |
| devices | ||
| FCC Title 47 CFR part | ||
| 18 | Telecommunication, Part 18 - Industrial, Scientific and Medical | |
| Equipment | ||
| FCC Title 47 CFT Part | ||
| 15 B | Telecommunication, Part 15 - Radiofrequency devices, Part B | |
| (Clan A) - Unintentional Radiators | ||
| FCC Title 47 CFR | ||
| part 15 C | Telecommunication, Part 15 - Radio Frequency Devices; Part C - | |
| Intentional Radiators |
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VIII. Clinical Performance Data
No clinical testing was conducted in support of the SiteRite™ 9 Ultrasound System, as the intended use, indications and technology are equivalent to those of the predicate device. The non-clinical testing summarized in this submission supports the substantial equivalence of this device to the predicate with respect to safety and effectiveness.
IX. Statement of Substantial Equivalence
Based on substantially equivalent intended use, technological characteristics and safety and performance testing as the predicate device, the SiteRite™ 9 Ultrasound System is deemed to be substantially equivalent to its predicate, the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology cleared under K182281.
The SiteRite™ 9 Ultrasound System, as designed and manufactured, does not raise new questions regarding safety and effectiveness as compared to its predicate device and is concluded to be substantially equivalent to its predicate device.