(28 days)
Not Found
No
The summary describes standard ultrasound imaging technology and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is intended for ultrasound imaging and guidance, which are diagnostic and procedural assistance functions, not therapeutic.
Yes
The device is an ultrasound system intended to provide "ultrasound imaging of the human body." Imaging modalities like ultrasound are used to create images for medical diagnosis. The Device Description further states it features "real-time 2D ultrasound imaging," and that sound waves are "processed and displayed as 2D images," which indicates it is used to visualize internal structures for diagnostic purposes.
No
The device description explicitly states it is a "portable device that features real-time 2D ultrasound imaging" and mentions accessories like an upright stand and A/C adapter, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Site-Rite Prevue Ultrasound System is intended for ultrasound imaging of the human body. It uses sound waves to create images of internal structures, not to analyze biological samples like blood, urine, or tissue.
- The device description focuses on imaging technology. The description details the real-time 2D ultrasound imaging, transducer technology, and image processing. This aligns with the function of an imaging device, not an IVD.
- The clinical applications are imaging-based. The listed applications (Adult Cephalic, Neonatal Cephalic, Pediatric, Peripheral Vessel) are all areas where ultrasound imaging is used to visualize structures within the body.
In summary, the Site-Rite Prevue Ultrasound System is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Site-Rite Prevue Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
- Adult Cephalic
- Neonatal Cephalic
- Pediatric
- Peripheral Vessel
The Site-Rite Prevue+ Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
- Adult Cephalic
- Neonatal Cephalic
- Pediatric
- Peripheral Vessel
The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue® Ultrasound System. The device is intended for use with pediatrics and adults.
The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The Site-Rite Prevue® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, simple user interface, and various calculations. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide/gel cap kits, etc. The system includes USB support for storage devices with no external power connections (eg., USB flash drive).
The Site-Rite Prevue® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, and simple user interface. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide, etc. The system includes USB support for storage devices with no external power connections (e.g., USB flash drive).
The Site-Rite Prevue+® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size and a simple user interface. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide, etc. The system includes USB support for storage devices with no external power connections (eq., USB flash drive).
Mentions image processing
Sound waves are reflected back to the transducer and converted to electrical signals Technoloqical that are processed and displayed as 2D images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, Adult Cephalic, Neonatal Cephalic, Peripheral Vessel
Indicated Patient Age Range
Pediatrics and adults
Intended User / Care Setting
Medical practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation activities were designed and performed to demonstrate that the subject SiteRite Prevue® Ultrasound System and the SiteRite Prevue+® Ultrasound System met predetermined performance specifications. The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, ribbon-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2015
C.R. Bard, Inc. % Mr. Reily Inman Regulatory Affairs Associate 605 North 5600 West SALT LAKE CITY UT 84116
Re: K150529
Trade/Device Name: Site-Rite Prevue and Prevue+ Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 27, 2015 Received: March 2, 2015
Dear Mr. Inman:
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 A Ocks
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150529
Device Name
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
Indications for Use (Describe)
The Site-Rite Prevue Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
- · Adult Cephalic
- Neonatal Cephalic
- Pediatric
- · Peripheral Vessel
The Site-Rite Prevue+ Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
- · Adult Cephalic
- · Neonatal Cephalic
- Pediatric
- · Peripheral Vessel
The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue® Ultrasound System. The device is intended for use with pediatrics and adults.
The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
SiteRite Prevue® Ultrasound System and SiteRite Preve+® Ultrasound System (includes nondetachable, linear, 52 element probe with no unique operating controls)
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CW | ||||
| D | Color | |||||||
| Doppler | ||||||||
| (CD) | Combined | |||||||
| (Specify) | Other† | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (abdominal, | ||||||||
| thoracic, and vascular) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | |||||||
| Small Organ (breast, thyroid, | ||||||||
| parathyroid, testicles, | ||||||||
| prostate, uterus, ovary) | ||||||||
| Fetal Imaging & Other | Neonatal Cephalic | P | ||||||
| Adult Cephalic | P | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-Esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | P | ||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
+Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Prescription Use (Per 21 CFR 801.109)
5
510(k) Summary
6
510(k) Summary 21 CFR 807.92
The SiteRite Prevue® Ultrasound System and the SiteRite Prevue+® Ultrasound System
| General
Provisions | Submitter Name:
Submitter Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|-----------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Reily Inman
Regulatory Affairs Associate
Bard Access Systems, Inc.
reily.inman@crbard.com
801.522.5937
801.522.5425 |
| | Date of Preparation: | February 27, 2015 |
Subject Devices for Which Clearance is Requested:
| Subject Device(s) | Trade Names: | SiteRite Prevue® Ultrasound SystemRite Prevue+® Ultrasound System |
Site
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | Classification Name: IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System
ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers
Class II, Radiology | |
| | Common Name: IYO 21 CFR 892.1560 System, Imaging, Pulsed Echo, Ultrasonic
ITX 21 CFR 892.1570 Transducer, Ultrasonic, Diagnostic | |
| Predicate Device | Trade Name: | Site~Rite Prevue® Ultrasound System |
| | Classification Name: | IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System
ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers
Class II, Radiology |
| | Common Name: | IYO 21 CFR 892.1560 System, Imaging, Pulsed Echo, Ultrasonic
ITX 21 CFR 892.1570 Transducer, Ultrasonic, Diagnostic |
| | | Premarket Notification: K120882, concurrence date 30 May, 2012 |
7
Subject Device Descriptions:
| Device
Description -
SiteRiteRite Prevue® Ultrasound System is a portable device
Prevue®
Ultrasound
System | The Site
that features real-time 2D ultrasound imaging. Additional features
include compact size, simple user interface, and various
calculations. The system may incorporate various accessories,
including an upright stand, A/C adapter, needle guide/gel cap kits,
etc. The system includes USB support for storage devices with no
external power connections (eg., USB flash drive). |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description -
SiteRiteRite Prevue® Ultrasound System is a portable device
Prevue®
Ultrasound
System | The Site
that features real-time 2D ultrasound imaging. Additional features
include compact size, and simple user interface. The system may
incorporate various accessories, including an upright stand, A/C
adapter, needle guide, etc. The system includes USB support for
storage devices with no external power connections (e.g., USB
flash drive). |
| Device
Description -
SiteRiteRite Prevue+® Ultrasound System is a portable
Prevue+®
Ultrasound
System | The Site
device that features real-time 2D ultrasound imaging. Additional
features include compact size and a simple user interface. The
system may incorporate various accessories, including an upright
stand, A/C adapter, needle guide, etc. The system includes USB
support for storage devices with no external power connections
(eq., USB flash drive). |
Subject Device Indications for Use/Intended Use:
| Indications for
Use/Intended
Use - SiteRiteRite Prevue® Ultrasound System is intended to
Prevue®
Ultrasound
System | The Site
provide ultrasound imaging of the human body. Specific clinical
applications include:
• Adult Cephalic
• Neonatal Cephalic
• Pediatric
• Peripheral Vessel |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use/Intended
Use - SiteRiteRite Prevue+® Ultrasound System is intended to
Prevue+®
Ultrasound
System | The Site
provide ultrasound imaging of the human body. Specific clinical
applications include:
• Adult Cephalic
• Neonatal Cephalic
• Pediatric
• Peripheral Vessel |
8
| Indications for
Use/Intended
Use - Pinpoint®
Gel Cap and
Pinpoint®
Needle Guide | The gel cap is intended for use as an ultrasound coupling medium
for use with the Site~Rite Prevue® Ultrasound System. The
device is intended for use with pediatrics and adults.
The needle guides are intended to provide guidance for a needle
to intersect an ultrasound beam at a fixed distance below the skin
to assist the medical practitioner in placing the tip of a needle in a
specific structure. This device is intended for use with pediatrics
and adults. |
| ------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Subject Devices Technological Characteristics:
With respect to the fundamental scientific technology, the subject devices and the predicate device are the same. The subject devices operate identically to the predicate device 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 Technoloqical that are processed and displayed as 2D images. However, the Characteristics subject devices will utilize a new beamformer board set (ultrasound generator) and accompanying software, which affects ultrasound generation for the subject devices. Design verification has been conducted and test results show that the subject devices are safe and effective for their intended use/indications for use and the difference in technological characteristics did not raise any new questions regarding safety and effectiveness.
| Safety &
Performance
Tests | Verification and validation activities were designed and performed
to demonstrate that the subject SiteRite Prevue® UltrasoundRite Prevue+® Ultrasound System met
System and the Site
predetermined performance specifications. The following
standards in conjunction with in-house protocols were used to
determine appropriate methods for evaluating the performance of
the device: |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IEC 60601-1:2005 |
| CORR. 1(2006), | For Basic Safety and Essential Performance - Edition 3 |
| CORR. 2(2007) | |
| IEC 60601-1-2:2007 | Medical Electrical Equipment – Part 1.2: General Requirements |
| For Basic Safety and Essential Performance – Edition 3.1 | |
IEC 60601-2-37:2007 Medical Electrical Equipment - Part 2-37: Particular Requirements For the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitory Equipment
9
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices – Part 1: Evaluation and
Testing within a Risk Management Process |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| NEMA UD 2-2004
(R2009) | Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment Revision 3 |
The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.
| Safety &
Performance
Tests | Based on the intended use/indications for use, technological
characteristics, and safety and performance testing, the subject
SiteRite Prevue® Ultrasound System and the SiteRite
Prevue+® Ultrasound System meet the minimum requirements
that are considered adequate for their intended use and are
substantially equivalent in design, principles of operation, and
intended use/indications for use to the predicate device, the
SiteRite Prevue® Ultrasound System (K120882). Based on theRite Prevue®
performance testing, the subject devices, the Site
Ultrasound System and the SiteRite Prevue+® UltrasoundRite Prevue® Ultrasound System
System are as safe, as effective, and perform as well as the
predicate device, the Site
(K120882). |
| ---------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|