(131 days)
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:
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 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-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)
- USB Storage Device (off-the-shelf, optional accessory)
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SiteRite™ 9 Ultrasound System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not include a specific table of quantitative acceptance criteria and corresponding device performance metrics for the SiteRite™ 9 Ultrasound System itself. Instead, it relies on a qualitative comparison to a predicate device and a statement that the device "successfully passed all respective testing" based on applicable standards and guidance documents.
However, based on the text, the overarching acceptance criterion is substantial equivalence to the predicate device (Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology, K182281), particularly in terms of:
- Intended Use: Diagnostic ultrasound imaging of the human body.
- Indications for Use: Pediatric, Peripheral Vessel and Vascular Access, Small Organ, Musculo-skeletal, Cardiac imaging applications, and guidance for procedures.
- Technological Characteristics: Same fundamental scientific technology (piezoelectric material, 2D ultrasound imaging), patient-contacting materials, and software features.
- Safety and Performance: Demonstrated through non-clinical testing to meet relevant safety and performance requirements.
Reported Device Performance:
The document primarily states that the device "passed all respective testing" and that its performance "support[s] substantial equivalence to the predicate device." It also highlights that the SiteRite™ 9 includes "newer, more 'state of the art' hardware components resulting in a more efficient and reliable use of the device" and aims for "improved image quality" compared to its predicate.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for any specific individual non-clinical test set. The data provenance is internal to Bard Access Systems, Inc. (C.R. Bard, Inc.) through their conducted "extensive verification and validation testing." As this is a non-clinical submission, the data would be laboratory-based and not related to patient retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Given that the testing is non-clinical (primarily bench testing) and relies on compliance with standards rather than expert review of images, the concept of "ground truth" established by experts in the clinical sense is not applicable here.
4. Adjudication method
This information is not provided and is not relevant for the type of non-clinical testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described is an ultrasound system, not an AI-powered diagnostic tool, and the submission explicitly states: "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."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study in the context of an algorithm's performance was not done. This device is a hardware-software integrated ultrasound system, not an independent algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" would be defined by engineering specifications, established physical properties, and compliance with recognized standards (e.g., acoustic output limits, electrical safety parameters, image quality metrics as defined by test phantoms or calibrated equipment). For example, "Acoustic Safety Testing" would have acceptance criteria based on standard limits for acoustic output, and the "ground truth" is that the device's output should not exceed those limits when measured.
8. The sample size for the training set
This information is not applicable and not provided. The SiteRite™ 9 Ultrasound System is not described as an AI/ML device that requires a training set for model development. It's a traditional medical imaging device.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set mentioned for an AI/ML model.
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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
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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
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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:
| ImagingApplications | Exam Type (Adult and Pediatric) | ||||
|---|---|---|---|---|---|
| Vascular | Assessment of vessels in the extremities and neck leading to or coming from theheart, superficial veins in the arms and legs, and vessel mapping. Assessment ofsuperficial thoracic vessels. | ||||
| Vascular Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial lineplacement, 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, musculoskeletalprocedures, 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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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 WestSalt Lake City, UT 84116USA |
|---|---|
| Contact Person: | Fabio De PasqualeRegulatory AffairsTel: 1-250-920-6501e-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
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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
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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:
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| ImagingApplications | Exam Type (Adult and Pediatric) | |||
|---|---|---|---|---|
| Vascular | Assessment of vessels in the extremities and neck leading to or comingfrom the heart, superficial veins in the arms and legs, and vesselmapping. Assessment of superficial thoracic vessels. | |||
| VascularAccess | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterialline placement, access to fistula and grafts, and general vein and arteryaccess. | |||
| Interventional | Guidance for biopsy and drainage. | |||
| Superficial | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes,musculoskeletal procedures, soft tissue structures, and surroundinganatomical 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.
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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™ GTNeedle 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 forUse | The SiteRite™ 9 Ultrasound System is intended fordiagnostic ultrasound imaging of the human body. | The Site-Rite® 8 Ultrasound System with Cue™Needle Tracking System and Pinpoint™ GTNeedle Technology is intended for diagnosticultrasound imaging of the human body. |
| Specific clinical applications include:Pediatric Peripheral Vessel and Vascular Access Small Organ (breast, thyroid, parathyroid,testicles) Musculo-skeletal (conventional andsuperficial) Cardiac (adult and pediatric) Typical examinations performed using theSiteRite™ 9 Ultrasound System include: | Specific clinical applications include:Pediatric Peripheral Vessel and Vascular Access Small Organ (breast, thyroid,parathyroid, testicles) Musculo-skeletal (conventional andsuperficial) Cardiac (adult and pediatric) Typical examinations performed using theSite-Rite® 8 Ultrasound System include: | |
| Device Name | Subject Device:SiteRite™ 9 Ultrasound System | Predicate Device:(K182281)Site~Rite® 8 Ultrasound System with Cue™Needle Tracking System and Pinpoint™ GTNeedle 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™ GTNeedle Technology | |
| (The Cue™ Needle Tracking System is not includedin the current version of the SiteRite™ 9Ultrasound System.) | Cue™ Needle Tracking System and Pinpoint™GT Needle Technology are each intended toprovide visual needle tracking to assist withultrasound guided vascular access. | |
| Environment ofUse | Hospital/clinic medical setting. | Hospital/clinic medical setting. |
| Track 1 orTrack 3 | Track 1 | Track 1 |
| Power Source | AC Adapter with Internal Lithium-Ion BatteryPack.Power Consumption: 150 W | AC Adapter with Internal Lithium-Ion BatteryPack.Power Consumption: 60 W |
| Main SystemComponents | The SiteRite™ 9 Ultrasound System includes thefollowing main components:● SiteRite™ 9 Console● Ultrasound Beamformer● System Software● Ultrasound Probe● (no Cue™ Needle Tracking Systemfunctionality is currently included in thesubject device) | The Site-Rite® 8 Ultrasound System includes thefollowing 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~Rite® 8 Ultrasound System withNeedle Tracking System and Pinpoint™ GTNeedle Technology | |
| • Weight 6.8 lbs | • Weight 5 lbs | |
| Graphic User Interface (GUI):Touchscreen user interface to access all availablefunctionality ( no Cue™ Needle Tracking Systemfunctionality is currently included in the subjectdevice ). | Graphic User Interface (GUI):Touchscreen user interface to access all availablefunctionality, including the Cue™ NeedleTracking System. | |
| UltrasoundBeamformer | The SiteRite™ 9 Ultrasound System uses B modefor the compatible probe. | The Site~Rite® 8 Ultrasound System uses Bmode for all compatible probes. |
| UltrasoundFeatures | The SiteRite™ 9 Ultrasound System includes thefollowing features:• Intuitive controls allowing for rapid andeasy operation;• Choice of battery or line voltage power;• Portable system;• Operating parameters of scannerdetermined by image depth;• Image freeze frame;• Simplified, touch screen user interface;• Image saving;• Vessel assessment tools: | The Site~Rite® 8 Ultrasound System includes thefollowing features:• Intuitive controls allowing for rapid andeasy operation;• Choice of battery or line voltage power;• Portable system;• Operating parameters of scannerdetermined 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™ GTNeedle 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™ GTNeedle Technology |
| Magnetic FieldDetectionTechnology | (The Cue™ Needle Tracking System is not includedin the current version of the SiteRite™ 9Ultrasound 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 theCue™ Needle Tracking System) externallyconnected to the console via USB cable. Qualified disposable needle that is presentin the system's needle library andpackaged in Cue™ compatible packaging. |
| VisualizationFeatures | The SiteRite™ 9 Ultrasound System Consoleincludes the following visualization features: Visualization of a vessel and surroundinganatomy. Visualization and measure of catheter sizerelative to a vessel. Visualization of virtual catheter size duringvascular access placement. Measure of remaining catheter length basedon vessel depth and assumed insertion angle. | The Site-Rite® 8 Ultrasound System Consoleincludes the following visualization features: Visualization of a vessel and surroundinganatomy. Visualization and measure of catheter sizerelative to a vessel. Visualization of virtual catheter size duringvascular access placement. Measure of remaining catheter length basedon 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™ GTNeedle Technology |
| (no Cue™ Needle Tracking Systemfunctionality is currently included in thesubject device) | Visualization of the insertion angle whileusing the Cue™ Needle Tracking System,allowing the user to set a “maximum anglerule” for system notification.Visualization of the remaining catheterlength while using the Cue™ NeedleTracking System, allowing the user to set a“minimum remaining catheter length” rulefor system notification. | |
| UltrasoundTransducers | The SiteRite™ 9 Ultrasound System includes thefollowing probe:• Detachable Linear 25 mm Probe | The Site-Rite® 8 Ultrasound System includes thefollowing 3 probes:• Detachable Cue™ 20mm Linear Probe• Detachable 20mm Pinpoint™ GT Linearprobe• Detachable 32mm Linear Probe |
| SiteRite™ 9 Probe Characteristics:• Cue™ compatible → No(no CueTM Needle Tracking Systemfunctionality is currently included in thesubject 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™ GTNeedle 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 compatiblewith 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 iscurrently included in the subject device) | The Site-Rite® 8 Ultrasound System iscompatible 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 mountinghardware (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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(*) 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 andTransducers | |
| FDA Guidance | Applying Human Factors and Usability Engineering to MedicalDevices | |
| FDA Guidance | Content of Human Factors Information in Medical DeviceMarketing Submissions (DRAFT) | |
| FDA Guidance | Format for Traditional and Abbreviated 510(k)s | |
| FDA Guidance | Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices | |
| FDA Guidance | Content of Premarket Submissions for Device Software Functions(DRAFT) | |
| FDA Guidance | Content of Premarket Submissions for Management ofCybersecurity in Medical Devices | |
| FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerationsand 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 forCyber Devices and Related Systems Under Section 524B of theFD&C Act | |
| FDA Guidance | Use of International Standard ISO 10993-1, "Biological evaluationof medical devices - Part 1: Evaluation and testing within a riskmanagement process" | |
| FDA Guidance | Recommended Content and Format of Non-Clinical BenchPerformance Testing Information in Premarket Submissions | |
| FDA Guidance | The 510(k) Program: Evaluating Substantial Equivalence inPremarket Notifications [510(k)] | |
| FDA Guidance | Appropriate Use of Voluntary Consensus Standards in PremarketSubmissions 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 forbasic safety and essential performance | |
| IEC 60601-1-2:2020 | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests | |
| IEC TR 60601-4-2:2016 | Medical electrical equipment - Part 4-2: Guidance andinterpretation - Electromagnetic immunity: performance of medicalelectrical equipment and medical electrical systems | |
| IEC 60601-1-6:2020 | Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:usability | |
| IEC 60601-2-37:2015 | Medical electrical equipment - Part 2-37: Particular requirementsfor the basic safety and essential performance of ultrasonicmedical 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 thedetermination of thermal and mechanical indices related to medicaldiagnostic ultrasonic field | |
| IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or other non-acidelectrolytes - Safety requirements for portable sealed secondarycells, and for batteries made from them, for use in portableapplications - 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 tomedical devices | |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process | |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with information to besupplied by the manufacturer - Part 1: General requirements | |
| ISO 14971:2019 | Medical devices - Application of risk management to medicaldevices | |
| FCC Title 47 CFR part18 | Telecommunication, Part 18 - Industrial, Scientific and MedicalEquipment | |
| FCC Title 47 CFT Part15 B | Telecommunication, Part 15 - Radiofrequency devices, Part B(Clan A) - Unintentional Radiators | |
| FCC Title 47 CFRpart 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.
§ 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.