(62 days)
The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:
- Pediatric
- Peripheral Vessel and Vascular Access
- Small Organ (breast, thyroid, parathyroid, testicles)
- Musculo-skeletal (conventional and superficial)
- Cardiac (adult and pediatric)
Typical examinations performed using the Site~Rite® 8 Ultrasound System include:
Vascular: Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian)
Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access
Interventional: Guidance for biopsy and drainage
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures
Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.
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™ Needle 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 Pinpoint™ GT Needle Technology software module, 20mm Pinpoint™ GT Linear Probe and a 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, SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is bringing forward and amending the currently cleared SiteRite® 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 guidance 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 provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to demonstrate that the device meets those criteria for the "Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology".
The document focuses on establishing substantial equivalence to a predicate device (K152554) and a reference device (K140254) by comparing intended use, indications for use, and technological characteristics. While it lists various nonclinical tests and references guidance documents and standards, it does not provide specific performance metrics or thresholds for acceptance criteria, nor does it detail the results of these tests in a quantifiable manner to show how the device met them.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document lists "Design Requirements and Corresponding Nonclinical Tests" but does not explicitly state acceptance criteria in terms of numerical thresholds or performance targets. It also does not present numerical or descriptive results of how the device performed against these unstated criteria.
-
Design Requirements (from the document):
- User needs
- Physical characteristics
- Electrical, electronic, and radiation characteristics
- Thermal characteristics
- Mechanical characteristics
- Operating environment
- Labeling characteristics
- Equipment and device interfaces and mounting
- Minimum requirements for computing platform
- Usability requirements
- Operating requirements
- Software requirements
- Dimensional Characteristics
- Chemical characteristics
- Biological and biocompatibility characteristics
- Packaging characteristics
-
Corresponding Nonclinical Tests (from the document):
- Site-Rite® 8 Ultrasound System Software Verification
- Cue™ Needle Tracking System Accuracy
- Site-Rite® 8 Ultrasound System Image Verification
- Site
Rite® 8 vs. SiteRite® 6 Image Comparison - Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report
- Site-Rite® 8 Ultrasound System Electrical Safety and EMC - IEC 60601-1 Edition 3.1
- Site~Rite® 8 Operational Temperature and Humidity Testing
- Site-Rite® 8 Mechanical Testing
- Site~Rite® 8 Response Time Verification
- Cue™ VAD Library Information Verification
- Admin Tool Verification
- Site-Rite® 8 Shared Requirements Verification
- Site-Rite® 8 Verification and Validation Rationale
- Site~Rite® 8 Cleaning Solution Compatibility Verification
- Site~Rite® 8 Biocompatibility Assessment
- Cue™ Activator Ship Test Verification
- Ultrasound Probe Ship Test Verification
Reported Device Performance: The document states:
"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."
However, the actual results of these tests are not provided in this excerpt. We know that "Cue™ Needle Tracking System Accuracy" was tested, among others, suggesting a focus on the accuracy of needle tracking, but no specific accuracy values or acceptance thresholds are given.
2. Sample size used for the test set and the data provenance
- Sample Size: This information is not provided in the document.
- Data Provenance: This information is not provided in the document. The studies listed are generally non-clinical in nature (e.g., software verification, electrical safety, mechanical testing).
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 studies listed are non-clinical, the concept of "experts establishing ground truth for a test set" in a clinical context isn't directly applicable here. If "expert" refers to engineers or technicians verifying software or hardware performance, their number and qualifications are not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
- The document explicitly states: "No human clinical data was provided to support substantial equivalence."
- Therefore, an MRMC study was not performed and no effect size can be reported. The device is not described as having "AI assistance" for human readers in the traditional sense, but rather "visual needle tracking to assist with ultrasound guided vascular access."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The non-clinical tests listed include "Cue™ Needle Tracking System Accuracy" and "Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report". These sound like standalone performance tests of the system's needle tracking capabilities. However, the details of these tests (e.g., what metrics were measured, the test setup, the results) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance tests mentioned (e.g., accuracy of needle tracking), the "ground truth" would likely be established through precise mechanical or optical measurements in a controlled laboratory setting. However, the specific methodology for establishing this ground truth is not described in the provided text.
8. The sample size for the training set
This information is not provided. The document does not describe any machine learning or AI components that would typically require a "training set." The needle tracking technologies (Cue™ and Pinpoint™ GT) are based on detecting magnetic fields from needles, which is a physics-based approach rather than a data-driven machine learning approach requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
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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
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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:
| ImagingApplications | Exam Type (Adult and Pediatric) |
|---|---|
| Vascular | Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or comingfrom 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, accessto 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 | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other*(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(epiaortic scanning) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ(breast, thyroid,parathyroid,testicles) | P | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult andPediatric) | 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
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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
Transducer: 32mm Linear Probe (detachable transducer)
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other*(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(epiaortic scanning) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ(breast, thyroid,parathyroid,testicles) | P | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult andPediatric) | 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
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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
Transducer: 20mm Pinpoint™ GT Linear Probe (detachable transducer)
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other*(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(epiaortic scanning) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ(breast, thyroid,parathyroid,testicles) | P | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult andPediatric) | 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
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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
Transducer: Cue™ 20mm Linear Probe (detachable transducer)
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| ClinicalApplications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other*(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(epiaortic scanning) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | |||||||||
| Small Organ(breast, thyroid,parathyroid,testicles) | N | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Adult andPediatric) | 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
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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 TrackingSystem 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 |
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| 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 System21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging System21 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, SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint" GT Needle Technology is bringing forward and amending the currently cleared SiteRite® 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
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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 SiteRite® 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 SiteRite® 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:
| ImagingApplications | Exam Type (Adult and Pediatric) |
|---|---|
| Vascular | Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leadingto or coming from the heart, superficial veins in the arms and legs (e.g., basilic,cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessmentof superficial thoracic vessels (e.g., axillary, innominate, subclavian) |
| VascularAccess | 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, hernias,musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissuestructures, 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
SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology and its predicate device have the same intended use. SiteRite® 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:
-
- 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.
-
- 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".
-
- 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).
-
- 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 SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology employ the same fundamental scientific technology as the predicate device, SiteRite® 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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| Site~Rite® 8 Ultrasound System with Cue™Needle Tracking System and Pinpoint™ GTNeedle Technology(Subject Device) | Site~Rite® 8 Ultrasound System withPinpoint™ GT Needle Technology(Predicate Device - K152554) | eZono® 4000 Ultrasound SystemSpecifically: Needle guidance using theTransducer L3-12NGS and “eZMag” NeedleMagnetizer(Reference Device - K140254) | |||
|---|---|---|---|---|---|
| Interventional | Guidance for biopsyand drainage | Interventional | Guidance for biopsyand drainage | ||
| Superficial | Assessment of breast,thyroid, parathyroid,testicle, lymph nodes,hernias,musculoskeletalprocedures (e.g.,joints, ligaments,tendons), soft tissuestructures, andsurroundinganatomical structures | Superficial | Assessment of breast,thyroid, parathyroid,testicle, lymph nodes,hernias,musculoskeletalprocedures (e.g.,joints, ligaments,tendons), soft tissuestructures, andsurroundinganatomical structures | ||
| Cue™ Needle Tracking System and Pinpoint™ GTNeedle Technology are each intended to providevisual needle tracking to assist with ultrasoundguided vascular access. | Pinpoint™ GT Needle Technology is intended toprovide clinicians with visual tools for passivemagnetic tracking of a needle with respect toultrasound image data. | ||||
| UltrasoundMode | 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) | ||
| NeedleGuidanceTechnology | Cue Needle Tracking SystemPinpoint GT Needle Technology | Pinpoint GT Needle Technology | eZGuide Needle Guidance System | ||
| ComputingPlatformPower Source | AC Adapter, Internal Lithium Ion Battery Pack (notremovable by the end-user) | AC Adapter, Internal Lithium Ion Battery Pack (notremovable by the end-user) | AC Adapter, Removable Battery | ||
| Components | Site~Rite® 8 Ultrasound System Console Detachable Cue™ 20mm Linear Probe Detachable 20mm Pinpoint™ GT Linear probe Detachable 32mm Linear Probe Cue™ Needle Tracking System Activator | Site~Rite® 8 Ultrasound System Console Detachable 20mm Pinpoint™ GT Linear probe Detachable 32mm Linear Probe Cue™ Needle Tracking System Activator | eZono® 4000 Ultrasound System Detachable L3-12NGS probe eZMag Magnetizer | ||
| Accessories | Cue™ Activator mounting arm Site | Site | 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 CueTMNeedle Tracking System and PinpointTM GTNeedle Technology(Subject Device) | Site-Rite® 8 Ultrasound System withPinpointTM GT Needle Technology(Predicate Device - K152554) | eZono® 4000 Ultrasound SystemSpecifically: Needle guidance using theTransducer L3-12NGS and "eZMag" NeedleMagnetizer(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) withno external power connection Silex® Wireless Bridge* * The Optional printer(s) and the Silex® WirelessBridge are standard off-the-shelf (non-medical)accessories qualified to be used with the Site-Rite®8 Ultrasound System. Customers are also able tosave files or perform software updates usingstandard off-the-shelf USB storage devices. Forcustomer convenience a Site-Rite® 8 UltrasoundSystem Roller Bag is also offered for transportingthe Site-Rite® 8 Ultrasound System. | Kickstand mounting accessory Probe holder accessory Site-Rite® Keyboard USB storage device* (flash/pen drive) withno 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 theSite-Rite® 8 Ultrasound System.. Customers arealso able to save files or perform software updatesusing standard off-the-shelf USB storage devices.For customer convenience a Site-Rite® 8Ultrasound System Roller Bag is also offered fortransporting 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 VerificationCue™ Needle Tracking System AccuracySite-Rite® 8 Ultrasound System Image VerificationSite |
| ● | 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 3.1Site~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 AccuracySite |
| ● | Software requirements | Cue™ Needle Tracking System AccuracyCue™ VAD Library Information VerificationAdmin Tool VerificationSite-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 VerificationUltrasound 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 SubjectDevice | |
|---|---|
| Standard Number | Standard Description |
| FDA Guidance | Information for Manufacturers Seeking Marketing Clearance ofDiagnostic Ultrasound Systems and Transducers |
| FDA Guidance | Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices |
| FDA Guidance | Content of Premarket Submissions for Management ofCybersecurity in Medical Devices |
| FDA Guidance | Postmarket Management of Cybersecurity in Medical Devices |
| FDA Guidance | Applying Human Factors And Usability Engineering To MedicalDevices |
| 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 MedicalDevices - Edition 2 |
| IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: General Requirements forBasic Safety and Essential Performance - Collateral Standard:Electromagnetic Compatibility - Requirements and Tests - Edition4.0 |
| IEC 60601-2-37:2007 | Medical Electrical Equipment – Part 2-37: Particular Requirementsfor the Basic Safety and Essential Performance of UltrasonicMedical Diagnostic and Monitoring Equipment – Edition 2 |
| IEC 60601-1-6:2013 | Medical Electrical Equipment-Part 1-6: General Requirements forBasic Safety and Essential Performance – Collateral Standard:Usability – Edition 3.1 |
| IEC 62304:2015 | Medical device software - Software Life Cycle Processes – Edition1.1 |
| IEC 62366-1:2015 | Medical Devices – Part 1: Application of Usability Engineering toMedical Devices - Edition 1.0 |
| NEMA UD 2: 2004(R2009) | Acoustic Output Measurement Standard for Diagnostic UltrasoundEquipment, Revision 3 |
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| List of the Recognized Standards and Guidance Documents Applicable to SubjectDevice | |
|---|---|
| Standard Number | Standard Description |
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices – Part 1: Evaluation andTesting 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: GeneralRequirements |
8. Clinical Performance Data
No human clinical data was provided to support substantial equivalence.
9. Conclusion Regarding Substantial Equivalence
The subject device, SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint" GT Needle Technology, has the same intended use as the predicate device, SiteRite® 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 SiteRite® 8 Ultrasound System with Cue" Needle Tracking System and Pinpoint" GT Needle Technology is determined to be substantially equivalent to the predicate device, SiteRite® 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.
§ 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.