SITE-RITE VISION II ULTRASOUND SYSTEM
Device Facts
| Record ID | K132942 |
|---|---|
| Device Name | SITE-RITE VISION II ULTRASOUND SYSTEM |
| Applicant | C.R. Bard, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 17, 2013 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Site~Rite Vision II Ultrasound System is intended for diagnostic ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications include: Fetal Abdominal Intra-operative (semi-critical) Pediatric Peripheral Vessel Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) Musculo-skeletal (conventional and superficial) Cardiac (adult and pediatric)
Device Story
Mobile ultrasound system providing real-time 2D imaging and color-flow Doppler. Piezoelectric transducers transmit sound waves into body; reflected waves converted to electrical signals for processing and display. Features include procedural cine recordings, patient-information storage, image annotations, and measurement/calculation tools. Used in hospitals, outpatient clinics, and long-term care facilities by clinicians. Output displayed on screen for real-time visualization of anatomy and blood flow; assists in vascular access guidance, biopsy, and diagnostic assessments. Benefits include improved procedural accuracy and diagnostic capability.
Clinical Evidence
Bench testing only. Verification and validation activities demonstrated compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-6, NEMA UD 2, NEMA UD 3, and ISO 10993-1 standards.
Technological Characteristics
Mobile ultrasound system; piezoelectric transducer material; 2D and color Doppler modes. Transducers: 20mm linear, 60mm ROC convex, 40mm linear. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound performance), IEC 60601-1-6 (usability), NEMA UD 2/3 (acoustic output), ISO 10993-1 (biocompatibility). DICOM compliant.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid-flow analysis in adult and pediatric patients. Applications include fetal, abdominal, intra-operative, pediatric, peripheral vessel, small organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary), musculoskeletal, and cardiac assessments. Includes guidance for vascular access (PICC, CVC, dialysis catheter, port, PIV, arterial-line) and interventional procedures (biopsy, drainage, nerve blocks).
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Site~Rite Vision Ultrasound System (K100402)
Submission Summary (Full Text)
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Ki32942
Bard Access Systems, Inc. Site~Rite Vision II' Ultrasound System Special 510(k) Premarket Notification
. '
Section 1.1 - General Information
#### 510(k) Summary 21 CFR 807.92
#### Site~Rite Vision* II Ultrasound System General Submitter Name: Bard Access Systems, Inc. Provisions Submitter Address: 605 North 5600 West Salt Lake City, UT 84116 OCT 1 7 2013 Contact Person: Kerrie Hamblin Senior Regulatory Affairs Specialist Bard Access Systems, Inc. kerrie.hamblin@crbard.com 801.522.5000 ext 4909 801.522.5425 fax Date of 18 September 2013 Preparation: Site~Rite Vision* II Ultrasound System Subject Device Trade Name: IYN 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducer Classification Name: LLZ 21 CFR 892.2050 Picture Archiving and Communications System Class II, Radiology IYN 21 CFR 892.1550 System, imaging, pulsed doppler, ultrasonic IYO 21 CFR 892.1560 System, imaging, pulsed echo, Common Name: ultrasonic ITX 21 CFR 892.1570 Transducer, ultrasonic, diagnostic LLZ 21 CFR 892.2050 System, image processing, radiological Predicate Trade Name: Site~Rite Vision* Ultrasound System Devices Classification Name: IYN 21 CFR 892.1550. Ultrasonic Pulsed Doppler Imaging System IYO 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging System ITX 21 CFR 892.1570 , Diagnostic Ultrasonic Transducers LLZ 21 CFR 892.2050 , Picture Archiving and Communications System IYN 21 CFR 892.1550 System, imaging, pulsed doppler, Common Name: ultrasonic IYO 21 CFR 892.1560 System, imaging, pulsed echo, ultrasonic
"Bard and Site-Rite Vision are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
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Transducer, ultrasonic, diagnostic
| LLZ 21 CFR 892.2050 System, image processing, radiological | |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Premarket Notification: | K100402, concurrence date 05 March 2010 |
| Manufacturer: | Bard Access Systems, Inc. |
| Device Description -<br>Site-Rite Vision* II<br>Ultrasound System | The Site-Rite Vision* II Ultrasound System is a mobile device that features real-time<br>2D ultrasound imaging, color-flow Doppler, procedural recordings (cine), patient-<br>information storage, image annotations, and various measurement and calculation<br>tools. The typical environment for ultrasound imaging may include hospitals, outpatient<br>clinics, and long-term care facilities. |
| Indications for Use / Intended<br>Use - Site-Rite Vision * II<br>Ultrasound System | The Site-Rite Vision* II Ultrasound System is intended for diagnostic ultrasound<br>imaging or fluid-flow analysis of the human body. Specific clinical applications include:<br>Fetal Abdominal Intra-operative (semi-critical1) Pediatric Peripheral Vessel Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) Musculo-skeletal (conventional and superficial) Cardiac (adult and pediatric) |
| Typical examinations performed using the Site-Rite Vision* II Ultrasound System include: | |
| Imaging Applications | Exam Type (adult & pediatric) |
| Vascular | Assessment of carotid arteries, aorta, deep veins,<br>superficial veins in the arms and legs, select small vessels<br>supporting organs |
| Vascular Access | Guidance for a PICC, CVC, dialysis catheter, port, PIV,<br>and arterial-line placement, and peripheral vein and artery<br>access |
| Abdominal | Assessment of liver, kidneys, pancreas, spleen,<br>gallbladder, bile ducts, transplanted organs, abdominal<br>vessels, appendix, and surrounding anatomical structures |
| Interventional and<br>Intraoperative | Guidance for biopsy, drainage, peripheral nerve blocks,<br>and intraoperative procedures (semi-critical1) |
| Superficial | Assessment of breast, thyroid, testicle, lymph nodes,<br>hernias, musculoskeletal procedures, soft tissue structures,<br>and surrounding anatomical structures |
ITX 21 CFR 892.1570
† Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.
*Bard and Site~Rite Vision are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
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Section 1.1 – General Information
Bard Access Systems, Inc. Site~Rite Vision II Ultrasound System
Special 510(k) Premarket Notification
.
| Technological<br>Characteristics | This device operates identically to the predicate device in that piezoelectric<br>material in the transducer is used as an ultrasound source to transmit sound waves<br>into the body. Sound waves are reflected back to the transducer and converted to<br>electrical signals that are processed and displayed as 2D images. Doppler shift<br>caused by blood flow is displayed as color flow or spectrum analysis. The modes of<br>this device (2D, color Doppler) are the same as the predicate device identified above. | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety &<br>Performance<br>Tests | Verification and validation activities were designed and performed to demonstrate that<br>the subject Site-Rite Vision* II Ultrasound System met predetermined performance<br>requirements. The following standards in conjunction with internal protocols were used<br>to determine appropriate methods for evaluating the performance of the device: | |
| | IEC 60601-1:2005,<br>CORR. 1(2006),<br>CORR 2(2007),<br>AM1(2012),<br>ANSI/AAM<br>ES 60601/A2:2012,<br>CAN/CSA-C22.2 | Medical Electrical Equipment - Medical Electrical Equipment<br>- Part 1: General Requirements for Basic Safety and<br>Essential Performance - Edition 3.1 |
| | IEC 60601-1-2:2007 | Medical Electrical Equipment - Part 1-2: General<br>Requirements for Basic Safety and Essential Performance -<br>Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests |
| | IEC 60601-2-37:2007 | Medical Electrical Equipment - Part 2-37: Particular<br>Requirements for the Basic Safety and Essential<br>Performance of Ultrasonic Medical Diagnostic and<br>Monitoring Equipment |
| | IEC 60601-1-6:2012 | Medical Electrical Equipment-Part 1-6: General<br>Requirements for Basic Safety and Essential Performance -<br>Collateral Standard: Usability |
| | NEMA UD 2:2004 | Acoustic Output Measurement Standard for Diagnostic<br>Ultrasound Equipment, Revision 3 |
| | NEMA UD 3:2004 | Standard for the Real-time Display of Thermal and<br>Mechanical Acoustic Output Indices on Diagnostic<br>Ultrasound Equipment, Revision 2 |
*Bard and Site~Rite Vision are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
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| Bard Access Systems, Inc.<br>Site-Rite Vision II Ultrasound System<br>Special 510(k) Premarket Notification | | Section 1.1 - General Information |
|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | IEC 62304:2006 | Medical device software – Software life cycle processes –<br>Edition 1.0 |
| | ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing within a Risk Management Process |
| | NEMA PS 3.1 –<br>3.18:2008 | Digital Imaging and Communications in Medicine (DICOM)<br>Set |
| | | The subject devices met all pre-determined acceptance criteria and demonstrated<br>substantial equivalence as compared to the predicate device. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject Site~Rite Vision* II Ultrasound System met the<br>minimum requirements that are considered adequate for its intended use and is<br>substantially equivalent in design, principles of operation and indications for use to the<br>predicate device, Site~Rite Vision* Ultrasound System. Based on the performance<br>testing, the Site~Rite Vision* II Ultrasound System is as safe, as effective, and performs<br>as well as, or better than the predicate, Site~Rite Vision* Ultrasound System. | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three lines curving upwards and to the right, resembling a person. The symbol is encircled by the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WORB-Cibos Silver Spring. M1) 20993-0002
October 17. 2013
KERRIE HAMBLIN C.R. BARD. INC. 605 NORTH 2600 WEST SALT LAKE CITY UT 84116
Re: K132942
Trade/Device Name: Site~Rite Vision II Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: September 18. 2013 Received: September 19, 2013
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 Vision II Ultrasound System, as described in your premarket notification:
Transducer Model Number
20 mm Lincar 60 mm ROC Convex 40 mm Lincar
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
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Page 2-Ms. Hamblin
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/Industrv/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/Safetv/ReportalProblem/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 vours.
Sanh)
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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Section 1.1 - General Information
Bard Access Systems, Inc. Site Rite Vision II Ultrasound System Special 510(k) Premarket Notification
#### Indications for Use Statement
510(k) Number (if known): __K132942
Device Name: Site~Rite Vision* II Uitrasound System
Indications for Use:
The Site Vision® II Ultrasound System is intended for diagnostic ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications include:
- . Fetal
- Abdominal .
- Intra-operative (semi-critical) .
- Pediatric .
- Peripheral Vessel .
- . Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary)
- Musculo-skeletal (conventional and superficial) .
- . Cardiac (adult and pediatric)
Typical examinations performed using the Site-Rite Vision* II Ultrasound System include:
| Imaging<br>Applications | Exam Type (adult & pediatric) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vascular | Assessment of carotid arteries, aorta, deep veins,<br>superficial veins in the arms and legs, select small vessels<br>supporting organs |
| Vascular Access | Guidance for a PICC, CVC, dialysis catheter, port, PIV,<br>and arterial-line placement, and peripheral vein and artery<br>access |
| Abdominal | Assessment of liver, kidneys, pancreas, spleen,<br>gallbladder, bile ducts, transplanted organs, abdominal<br>vessels, appendix, and surrounding anatomical structures |
| Interventional and<br>Intraoperative | Guidance for biopsy, drainage, peripheral nerve blocks,<br>and intraoperative procedures (semi-critical†) |
| Superficial | Assessment of breast, thyroid, testicle, lymph nodes,<br>hernias, musculoskeletal procedures, soft tissue structures,<br>and surrounding anatomical structures |
* Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or nonintact skin.
Prescription Use × Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K132942 Page 1 of
*Bard and Sile~Rite Vision are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
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Section 1.3 -Indications for Use
# Diagnostic Ultrasound Indications for Use (1 of 4)
TABLE 1.3-1 Ultrasound System: Site~Rite Vision* II Ultrasound System
| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|-------------------------|-------------------|---|-----|-----|---------|----------|-------------|
| General | Specific (Tracks 1 | ਤ | M | PWD | CWD | Color | Combined | Other* |
| (Track 1 | and 3) | | | | | Doppler | (B + CD) | I (specify) |
| Only) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal | Fetal | P | | | | | P | |
| Imaging and | Abdominal | P | | | | | P | |
| Other | Intra-operative (semi | P | | | | | P | |
| | critical ) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | | P | |
| | Small Organ | p | | | | | P | |
| | (breast, thyroid, | | | | | | | |
| | parathyroid, testicles, | | | | | | | |
| | prostate, uterus, | | | | | | | |
| | ovary) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. | | | | | | | |
| | (non-Card) | | | | | | | |
| | Musculo-skeletal | P | | | | | P | |
| | (Conventional) | | | | | | | |
| | Musculo-skeletal | p | | | | | P | |
| | (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | | | | | P | |
| | Cardiac Pediatric | P | | | | | P | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. | | | | | | | |
| | (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral | Peripheral Vessel | P | | | | | P | |
| Vessel | Other (specify) | | | | | | | |
N=new indication; P=previously cleared by the FDA; E=added under this appendix
"Examples of other modes of operation may include Doppler. 3-D Imaging, Harmonic Imaging, Tissue Molion Doppler, and Color Velocity Imaging
Dopper, and Odler Volocky maging
† Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-inlact skin.
Prescription use per 21 CFR 801.109
*Bard and Site-Rite Vision are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
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## Diagnostic Uitrasound Indications for Use (2 of 4)
TABLE 1.3-2
Ultrasound System: Site~Rite Vision* II Ultrasound System Transducer: 60mm ROC convex Probe (128 element)
| Clinical Application | | | Mode of Operation | | | | | |
|----------------------|----------------------|---|-------------------|-----|-----|---------|----------|-----------|
| General | Specific (Tracks 1 | ਛ | . M | PWD | CWD | Color | Combined | Other |
| (Track 1 | and 3) | | | | | Doppler | (B+CD) | (specīfy) |
| Only) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal | Felal | P | | | | | P | |
| Imaging and | Abdominal | P | | | | | P | |
| Other | Intra-operative | P | | | | | P | |
| | (semi-critical) | | | | | | | |
| | Intra-operative | | | | | | | |
| | (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | | P | |
| | Small Organ | | | | | | | |
| | (breast, thyroid, | | | | | | | |
| | parathyroid. | | | | | | | |
| | testicles, prostate, | | | | | | | |
| | uterus. ovary) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. | | | | | | | |
| | (non-Card) | | | | | | | |
| | Musculo-skeletal | P | | | | | P | |
| | (Conventional) | | | | | | | |
| | Musculo-skeletal | | | | | | | |
| | (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | | | | | P | |
| | Cardiac Pediatric | P | | | | | P | |
| | Intravascular | | | | | | | |
| | (Cardiac) | | | | | | | |
| | Trans-esoph. | | | | | | | |
| | (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral | Peripheral Vessel | P | | | | | P | |
| Vessel | Other (specify) | | | | | | | |
N=new indication: P=previously cleared by the FDA; E=added under this appendix
Neller model of other model of the PSP, a "note, Amplitude Oppler. 3-D Imaging. Harmonic Imaging. Tissue Molion Doppler, and Color Velocity Imaging
t Semi-critical is defined as cinical applications in which the probe contacts mucous membranes or non-intact skin.
Prescription use per 21 CFR 801.109
*Bard and Site-Rite Vision are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
{9}------------------------------------------------
## Diagnostic Ultrasound Indications for Use (3 of 4)
TABLE 1.3-3
## Ultrasound System: Site~Rite Vision* II Ultrasound System Transducer: 40mm Linear Probe (128 element)
| Clinical Application | | Mode of Operation | | | | | | |
|-------------------------------|--------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|--------------------|---------------------|
| General<br>(Track 1<br>Only) | Specific (Tracks 1<br>and 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(B+CD) | Other*<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging and<br>Other | Fetal | P | | | | | P | |
| | Abdominal | P | | | | | P | |
| | Intra-operative<br>(semi-critical 1) | P | | | | | P | |
| | Intra-operative<br>(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | | P | |
| | Small Organ<br>(breast, thyroid,<br>parathyroid,<br>testicles, prostate,<br>uterus, ovary) | P | | | | | P | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | | | | | P | |
| | Musculo-skeletal<br>(Superficial) | P | | | | | P | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | | | | | P | |
| | Cardiac Pediatric | P | | | | | P | |
| | Intravascular<br>(Cardiac) | | | | | | | |
| | Trans-esoph.<br>(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | P | | | | | P | |
| | Other (specify) | | | | | | | |
N=new indication; P=previously cleared by the FDA; E=added under this appendix
N=4eew indication (1 -p. evels of the Part, e aboce ander inns opperial.
"Examples of other modes of operation may include: A mode, Amplitude Doppler. 3-D Imaging, Tissue Mo Doppler, and Color Velocity Imaging
t Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.
# Prescription use per 21 CFR 801.109
*Bard and Site~Rite Vision are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
{10}------------------------------------------------
## Diagnostic Ultrasound Indications for Use (4 of 4)
TABLE 1.3-4
Ultrasound System: Site~Rite Vision* II Ultrasound System Transducer: 20 mm Linear Probe (64 elements)
| Clinical Application | | Mode of Operation | | | | | | |
|-------------------------------|--------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|--------------------|---------------------|
| General | Specific (Tracks 1 | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(B+CD) | Other*<br>(specify) |
| (Track 1<br>Only) | and 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging and<br>Other | Fetal | P | | | | | P | |
| | Abdominal | P | | | | | P | |
| | Intra-operative<br>(semi-critical 1) | P | | | | | P | |
| | Intra-operative<br>(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | | P | |
| | Small Organ<br>(breast, thyroid,<br>parathyroid,<br>testicles, prostate,<br>uterus, ovary) | P | | | | | P | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | | | | | P | |
| | Musculo-skeletal<br>(Superficial) | P | | | | | P | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | | | | | P | |
| | Cardiac Pediatric | P | | | | | P | |
| | Intravascular<br>(Cardiac) | | | | | | | |
| | Trans-esoph.<br>(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | P | | | | | P | |
| | Other (specify) | | | | | | | |
N=new indication: P=previously cleared by the FDA, E=added under this appendix
"Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Molon Doppler, and Color Velocity Imaging
Doppic. and Gold Velocity mights
t Semi-critical is delined as clinical applications in which the probe contacts mucous membranes or non-intect skin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription use per 21 CFR 801.109
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