(58 days)
The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The SiteRite® 6 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. In addition, the SiteRite® 6 Ultrasound System is designed with simple operating controls to facilitate easy operation.
The Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a 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 throughout the insertion process.
This document is a 510(k) summary for the Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology, indicating its substantial equivalence to predicate devices for ultrasound guidance and imaging.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several standards that the device met. It does not provide specific numerical acceptance criteria or performance metrics for the Pinpoint™ GT Technology itself beyond confirming it met "predetermined performance requirements." The listed standards are primarily for general medical electrical equipment, usability, software, and biological evaluation, rather than specific performance metrics for the needle tracking feature.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005, CORR. 1(2006), CORR 2(2007) (Medical Electrical Equipment - Basic Safety and Essential Performance) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-1-2:2007 (Medical Electrical Equipment - Electromagnetic Compatibility) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-2-37:2007 (Particular Requirements for Ultrasonic Medical Diagnostic and Monitoring Equipment) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-1-6:2010 (Medical Electrical Equipment – Usability) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 62304:2006 (Medical Device Software - Software Life Cycle Processes) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 62366:2007 (Medical Devices - Application of Usability Engineering) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| ISO 10993-1:2009 (Biological Evaluation of Medical Devices) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "Verification and validation activities were designed and performed to demonstrate that the subject Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements." However, specific sample sizes for any test sets used to evaluate the Pinpoint™ GT Technology are not provided.
The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
This information is not provided in the document. The filing discusses engineering standards rather than clinical trial data involving expert interpretations for ground truth.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on showing substantial equivalence through adherence to technical standards and comparison to predicate devices, rather than measuring human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
The document describes the Pinpoint™ GT Technology as "software installed on an ultrasound system and sensors incorporated into the ultrasound probe" that "interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display." This implies that the technology functions as an algorithm providing visual tools for tracking. However, a specific standalone performance study comparing the algorithm's output against a defined ground truth for the needle tracking functionality is not explicitly detailed with performance metrics. The evaluation appears to be integrated into the overall system's verification and validation.
7. Type of Ground Truth Used:
Given the nature of the evaluation mentioned (adherence to technical standards and comparison to predicate devices for imaging features and needle tracking visualization), the "ground truth" would likely involve physical measurements and phantom studies for accuracy and precision of needle tracking and imaging quality, rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in a clinical setting. However, the specific methods for establishing ground truth for the Pinpoint™ GT Technology's performance are not explicitly stated beyond meeting technical requirements.
8. Sample Size for the Training Set:
This document is a 510(k) summary for a medical device (ultrasound system with a needle tracking technology). The listed studies are for verification and validation, primarily addressing compliance with electrical, safety, usability, and software standards. There is no mention of a training set in the context of machine learning, as this document predates broad discussions of AI/ML in FDA filings in this manner. The "technology" refers to creating a virtual image from sensor data, which is more likely a deterministic algorithm than a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set for the reasons stated above, this information is not applicable and therefore not provided in the document.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2014
C.R. Bard, Inc. Bard Access Systems. Inc. % Ms. Kerrie Hamblin Regulatory Affairs Project Manager 605 North 5600 West SALT LAKE CITY UT 84116
Re: K142443
Trade/Device Name: Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: August 29, 2014 Received: September 2, 2014
Dear Ms. Hamblin:
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. 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology, as described in your premarket notification:
Transducer Model Number
Pinpoint™ GT 20 mm 64 Element Linear Probe
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.
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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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm. 77)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology
Indications for Use (Describe)
The Site® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
| 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 Indication for Use
Ultrasound System: Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology (Ultrasound without transducer)
| ClinicalApplications | A | B | M | PWD | CWD | Mode of Operation | Combined(specify) | Other(specify) | ||
|---|---|---|---|---|---|---|---|---|---|---|
| ColorDoppler | AmplitudeDoppler | Color VelocityImaging | ||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative(epiaortic scanning) | P | |||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(breast, testes, thyroid, etc.) | P | |||||||||
| NeonatalCephalic | P | N [1] | ||||||||
| Adult Cephalic | P | N [1] | ||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transeurethral | ||||||||||
| Intravascular | ||||||||||
| PeripheralVascular | P | N [1] | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal(Conventional) | P | |||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Other (Specify) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Notes: [1] Needle Guidance Imaging |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
(Please do not write below this line – Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K142443
Prescription Use (per 21 CFR 801.109
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Diagnostic Ultrasound Indication for Use
Ultrasound System: Site~Rite 6 Ultrasound System with Pinpoint™ GT Technology Transducer: Pinpoint™ GT 20 mm 64 Element Linear Probe
| Clinical Applications | A | B | M | PWD | CWD | Mode of Operation | Other(specify) | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined(specify) | |||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative(epiaorticscanning) | P | |||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(breast, testes,thyroid, etc.) | P | |||||||||
| NeonatalCephalic | P | N [1] | ||||||||
| Adult Cephalic | P | N [1] | ||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transeurethral | ||||||||||
| Intravascular | ||||||||||
| PeripheralVascular | P | N [1] | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal(Conventional) | P | |||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Other (Specify) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Notes: [1] Needle Guidance Imaging (Please do not write below this line – Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K142443
Prescription Use (per 21 CFR 801.109
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510(k) Summary
21 CFR 807.92
| General Provisions: | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | |
| Contact Person: | Kerrie HamblinRegulatory Affairs Project ManagerBard Access Systems, Inc.Kerrie.Hamblin@crbard.com801-522-5000 ext. 4909801-522-5425 fax | |
| Date of Preparation: | 29 August 2014 | |
| Subject Devices: | Trade Names: | Site-Rite® 6 Ultrasound System with Pinpoint™ GTTechnology |
| ClassificationName: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystemITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | |
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,UltrasonicITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic | |
| PrimaryPredicateDevice: | Trade Name: | Site-Rite® 6 Ultrasound System |
| ClassificationName: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystemITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | |
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,UltrasonicITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic | |
| PremarketNotification: | K071204, concurrence, 18 May 2007 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| ReferenceDevices: | Trade Name: | Site-Rite Vision® II Ultrasound System |
| ClassificationName: | IYN, CFR 892.1550, Ultrasonic Pulsed Doppler ImagingSystemIYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystem | |
| LLZ, 21 CFR 892.2050, Picture Archiving andCommunications System | ||
| Common Name: | IYN, CFR 892.1550, System, Imaging, Pulsed Doppler,UltrasonicIYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,UltrasonicITX, 21 CFR 892.1570, Transducer, Ultrasonic, DiagnosticLLZ, 21 CFR 892.2050, System, Image Processing,Radiological | |
| PremarketNotification: | K132942, concurrence, 17 October 2013 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Trade Name: | GE LOGIQ E9 | |
| ClassificationName: | IYN, CFR 892.1550, Ultrasonic Pulsed Doppler ImagingSystemIYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystemITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | |
| Common Name: | IYN, CFR 892.1550, System, Imaging, Pulsed Doppler,UltrasonicIYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,UltrasonicITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic | |
| PremarketNotification: | K092271, concurrence, 17 November 2009 | |
| Manufacturer: | GE Healthcare | |
| Trade Name: | Electromagnetic Tracking System (VirtuTRAX) | |
| ClassificationName: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystemJAK, 21 CFR 892.1750, Computed Tomography X-RaySystem | |
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,UltrasonicJAK, 21 CFR 892.1750, System, X-Ray, Tomography,Computed | |
| PremarketNotification: | K092619, concurrence, 13 November 2009 | |
| Manufacturer: | CIVCO Medical | |
| Descriptions: | mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The Site | |
| IntendedUse/Indications forUse: | The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data. | |
| TechnologicalCharacteristics: | The Site | |
| Safety andPerformance Tests: | Verification and validation activities were designed and performed to demonstrate that the subject Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements. The following standards in conjunction with internal protocols were used to determine appropriate methods for evaluating the performance of the subject device:IEC 60601-1:2005,CORR. 1(2006),CORR 2(2007) Medical Electrical Equipment - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - Edition 3.1IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | |
| IEC 60601-2-37:2007 | Medical Electrical Equipment - Part 2-37: ParticularRequirements for the Basic Safety and EssentialPerformance of Ultrasonic Medical Diagnostic andMonitoring Equipment | |
| IEC 60601-1-6:2010 | Medical Electrical Equipment-Part 1-6: GeneralRequirements for Basic Safety and Essential Performance– Collateral Standard: Usability | |
| IEC 62304:2006 | Medical Device Software - Software Life Cycle Processes– Edition 1.0 | |
| IEC 62366:2007 | Medical Devices - Application of Usability Engineering toMedical Devices – Edition 1.0 | |
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk ManagementProcess | |
| The subject device met all pre-determined acceptance criteria and demonstratedsubstantial equivalence as compared to the primary predicate device. Wheredifferences between the subject and primary predicate device exist with respectto technological characteristics, consideration to the reference devices was givento support those technological characteristics. | ||
| Summary ofSubstantialEquivalence | The subject device, Site |
Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology
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§ 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.