(97 days)
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:
Vascular: Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian)
Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access
Interventional: Guidance for biopsy and drainage
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures
Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
The Site-Rite® 8 Ultrasound System 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 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.
The provided document is a 510(k) Summary for the Bard Access Systems, Inc. Site® 8 Ultrasound System with Pinpoint™ GT Technology. This document declares substantial equivalence to predicate devices and outlines the intended use, technological characteristics, and safety and performance testing. However, it does not describe specific quantitative acceptance criteria or a dedicated study proving device performance against those criteria in the way a clinical trial or algorithm validation study would.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared devices. It states that the device "met all pre-determined acceptance criteria" and refers to a series of safety and performance tests based on established medical device standards.
Therefore, I can extract information regarding the types of tests performed and the general statement of compliance, but cannot provide a table of precise acceptance criteria with corresponding performance metrics from the provided text. The document does not describe a study involving humans or experts to evaluate the AI component (Pinpoint™ GT Technology) in clinical performance terms.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
The document states: "The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the primary predicate device." It lists various standards that were used for "Verification and validation activities" to "demonstrate that the subject SiteRite® 8 Ultrasound System and subject SiteRite® 8 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements."
However, specific quantitative acceptance criteria (e.g., "accuracy > X%", "sensitivity > Y%") and measured performance values for the device are not provided in this summary. The "reported device performance" is qualitatively stated as meeting "predetermined performance requirements" and demonstrating "substantial equivalence".
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| General Performance | Met all pre-determined acceptance criteria and demonstrated substantial equivalence compared to primary predicate device. |
| Safety & Essential Performance | Met requirements of IEC 60601-1:2005, CORR. 1(2006), CORR 2(2007) |
| Electromagnetic Compatibility | Met requirements of IEC 60601-1-2:2007 |
| Ultrasonic Medical Diagnostic & Monitoring Equipment Safety | Met requirements of IEC 60601-2-37:2007 |
| Usability (Human Factors) | Met requirements of IEC 60601-1-6:2010 and IEC 62366:2007 |
| Software Life Cycle Processes | Met requirements of IEC 62304:2006 |
| Biological Evaluation (Biocompatibility) | Met requirements of ISO 10993-1:2009 |
| Acoustic Output Measurement | Met requirements of NEMA UD-2:2004 |
| Radio Frequency Devices (FCC) | Met requirements of Title 47 CFR FCC, Part 15 B, 15 C, and Part 18 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set with a sample size or data provenance. The verification and validation activities mentioned are typically engineering and bench-testing based, referring to compliance with standards rather than clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The type of testing described does not involve expert-established ground truth in the context of clinical accuracy or diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as there is no described test set that would require adjudication.
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
There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance in the provided text. The "Pinpoint™ GT Technology" is described as providing "visual tools for passive magnetic tracking of a needle with respect to ultrasound image data," implying a guidance system rather than an AI performing diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the "Pinpoint™ GT Technology" as an algorithm is not detailed in terms of clinical accuracy or diagnostic performance in the provided text. The safety and performance tests listed are standard for medical electrical equipment and ultrasound systems, addressing general device functionality and electrical/biological safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the establishment of a "ground truth" in a clinical diagnostic sense. The verification and validation activities would rely on manufactured test environments and calibrated measurement tools to confirm compliance with technical specifications and standards. For the Pinpoint™ GT Technology's needle tracking, the "ground truth" would likely be the known physical position of the needle in a phantom or test setup.
8. The sample size for the training set
The document does not mention a training set, as it does not describe the development or validation of a machine learning algorithm in the context of a "training set." The Pinpoint™ GT Technology uses passive magnetic tracking, which is typically a sensor-based technology, not a machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
As no training set is mentioned, information on how its ground truth was established is also not provided.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2015
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: K152554
Trade/Device Name: Site® 8 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, LLZ Dated: November 12, 2015 Received: November 13, 2015
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.
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 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education 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,
Robert Ocks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
(if known)
R13255
Device Name
Site~Rite® 8 Ultrasound System with Pinpoint™ GT 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
- · 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 coming from the heart, superficial veins in the arms and legs(e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vesselmapping. Assessment of 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 arteryaccess |
| Interventional | Guidance for biopsy and drainage |
| Superficial | Assessment of breast, thyroid, parathyroid, testicle, lymph nodes,hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons),soft tissue structures, and surrounding anatomical structures |
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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{3}------------------------------------------------
Diagnostic Ultrasound Indication for Use
Table 1.3-1 Ultrasound System: Site~Rite® 8 Ultrasound System with 32 mm Linear Probe (Non-detachable Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(epiaorticscanning) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | |||||||||
| Small Organ(breast, thyroid,parathyroid,testicles) | N | |||||||||
| NeonatalCephalic | ||||||||||
| Adult CephalicCardiac (Adultand Pediatric) | N | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transeurethral | ||||||||||
| Intravascular | ||||||||||
| PeripheralVascular | N | |||||||||
| LaparoscopicMusculo-skeletal(Conventional) | N | |||||||||
| Musculo-skeletal(Superficial) | N | |||||||||
| Other (Specify) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E Notes: None
(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_
Prescription Use (per 21 CFR 801.109
{4}------------------------------------------------
Diagnostic Ultrasound Indication for Use
Table 1.3-2 - Site~Rite" 8 Ultrasound System with Pinpoint™ GT Technology with 20mm Pinpoint™ GT Technology Linear Probe (Non-detachable transducer)
| Clinical Applications | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(epiaorticscanning) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | |||||||||
| Small Organ(breast, thyroid,parathyroid,testicles) | N | |||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult CephalicCardiac (Adultand Pediatric) | N | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transeurethral | ||||||||||
| Intravascular | ||||||||||
| PeripheralVascular | N | N [1] | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal(Conventional) | N | |||||||||
| Musculo-skeletal(Superficial) | N | |||||||||
| Other (Specify) |
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_
Prescription Use (per 21 CFR 801.109
{5}------------------------------------------------
510(k) Summary
21 CFR 807.92
| Site-Rite® 8 Ultrasound System and Site-Rite® 8 Ultrasound System with Pinpoint™ GT Technology | ||
|---|---|---|
| GeneralProvisions: | Submitter Name: | Bard Access Systems, Inc. |
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, UT84116 | ||
| Contact Person: | Kerrie Hamblin | |
| Regulatory Affairs Project Manager | ||
| Bard Access Systems, Inc. | ||
| Kerrie.Hamblin@crbard.com | ||
| 801-522-5000 ext. 4909 | ||
| 801-522-5425 fax | ||
| Date of Preparation: | 13 November 2015 | |
| Site-Rite® 8 Ultrasound System | ||
| Subject Devices: | Trade Names: | Site-Rite® 8 Ultrasound System with Pinpoint™ GTTechnology |
| Classification Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystem | |
| ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | ||
| LLZ, 21 CFR 892.2050, Picture Archiving andCommunications System | ||
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,Ultrasonic | |
| ITX, 21 CFR 892.1570, Transducer, Ultrasonic,Diagnostic | ||
| LLZ, 21 CFR 892.2050, System, Image Processing,Radiological | ||
| Primary PredicateDevice: | Trade Name: | Site-Rite Vision® II Ultrasound System |
| Classification Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystem | |
| ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | ||
| LLZ, 21 CFR 892.2050, Picture Archiving andCommunications SystemIYN, CFR 892.1550, Ultrasonic Pulsed Doppler ImagingSystem | ||
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,Ultrasonic | |
| ITX, 21 CFR 892.1570, Transducer, Ultrasonic,Diagnostic | ||
| LLZ, 21 CFR 892.2050, System, Image Processing,Radiological | ||
| IYN, CFR 892.1550, System, Imaging, Pulsed Doppler,Ultrasonic | ||
| PremarketNotification: | K132942, concurrence, 17 October 2013 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Predicate Device: | Trade Name: | Site~Rite® 6 Ultrasound System with Pinpoint™ GTTechnology |
| Classification Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystem | |
| ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | ||
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,Ultrasonic | |
| ITX, 21 CFR 892.1570, Transducer, Ultrasonic,Diagnostic | ||
| PremarketNotification: | K142443, concurrence, 30, October, 2014 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Predicate Device: | Trade Name: | Site~Rite Prevue® Ultrasound System |
| Classification Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo ImagingSystem | |
| ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | ||
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo,Ultrasonic | |
| ITX, 21 CFR 892.1570, Transducer, Ultrasonic,Diagnostic |
{6}------------------------------------------------
{7}------------------------------------------------
| Premarket Notification: | K120882, concurrence, 30, May, 2012 |
|---|---|
| Manufacturer: | Bard Access Systems, Inc. |
Device Descriptions:
The Site-Rite® 8 Ultrasound System 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 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.
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:
| Imaging Applications | Exam Type (Adult and Pediatric) |
|---|---|
| Vascular | Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian) |
| Vascular | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and |
Intended Use/Indications for
Use for Site-Rite®
Ultrasound System
and Site-Rite® 8
Ultrasound System
with Pinpoint™ GT
Technology:
Technology:
Access
Interventional
Superficial joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures Pinpoint™ GT Technology is intended to provide clinicians with visual tools for
grafts, and general vein and artery access
Guidance for biopsy and drainage
midline, arterial line placement, access to fistula and
Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g.,
passive magnetic tracking of a needle with respect to ultrasound image data.
{8}------------------------------------------------
| TechnologicalCharacteristics: | The subject Site | |
|---|---|---|
| Safety andPerformance Tests: | Verification and validation activities were designed and performed to demonstratethat the subject Site | |
| IEC 60601-1:2005,CORR. 1(2006),CORR 2(2007) | Medical Electrical Equipment - Medical ElectricalEquipment - Part 1: General Requirements for BasicSafety and Essential Performance - Edition 3 | |
| IEC 60601-1-2:2007 | Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard: ElectromagneticCompatibility - 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 EssentialPerformance - Collateral Standard: Usability | |
| IEC 62304:2006 | Medical Device Software - Software Life CycleProcesses - 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 | |
| NEMA UD-2:2004 | Acoustic Output Measurement Standard for DiagnosticUltrasound Equipment |
{9}------------------------------------------------
| Title 47 CFR FCC, Part 15 B, 15 C, and Part 18 | Title 47 - Telecommunication; Part 15 - Radio Frequency Devices; Subpart B - Unintentional Radiators; Subpart C - Intentional Radiators; and subpart 18, Industrial, Scientific, and Medical Equipment |
|---|---|
| The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the primary predicate device. Where differences between the subject devices and the primary predicate device exist with respect to technological characteristics, consideration to the predicate devices was given to support substantial equivalence for those technological characteristics. | |
| Accessories | The following accessories are covered under this premarket notification and have been qualified for use with the subject devices described herein. The following accessories are intended for use with the subject devices, Site |
| Summary of Substantial Equivalence | The subject devices, Site |
the producte deviloes, Site Trile "o Ultrasound Oystem with Timportion
Technology (K142443) and Site~Rite Prevue® Ultrasound System (K120882).
§ 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.