(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound functionalities.
No
The device is intended for diagnostic imaging and fluid-flow analysis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasound imaging or fluid-flow analysis of the human body."
No
The device description explicitly states it is an "Ultrasound System" and mentions real-time 2D ultrasound imaging and color-flow Doppler, which are hardware-dependent functions. It also refers to "Verification and validation activities" that would typically include hardware performance testing for an ultrasound system.
Based on the provided information, the Site~Rite Vision* II Ultrasound System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid-flow analysis of the human body." This describes a device that is used to visualize internal structures and processes within the living body, not to perform tests on samples taken from the body.
- Device Description: The description focuses on the features and functionality of an ultrasound system used for real-time imaging and analysis in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on these samples. IVDs are specifically designed for these purposes.
- Regulation Mentioned: The mention of "LLZ 21 CFR 892.2050, System, image processing, radiological" points to regulations related to radiological devices, which include ultrasound systems, not IVDs.
In summary, the Site~Rite Vision* II Ultrasound System is a medical imaging device used for diagnostic purposes within the human body, which is distinct from an In Vitro Diagnostic device that performs tests on samples taken from the body.
N/A
Intended Use / 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)
Typical examinations performed using the Site-Rite Vision* II Ultrasound System include:
Imaging Applications:
Vascular: Assessment of carotid arteries, aorta, deep veins, superficial veins in the arms and legs, select small vessels supporting organs
Vascular Access: Guidance for a PICC, CVC, dialysis catheter, port, PIV, and arterial-line placement, and peripheral vein and artery access
Abdominal: Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, appendix, and surrounding anatomical structures
Interventional and Intraoperative: Guidance for biopsy, drainage, peripheral nerve blocks, and intraoperative procedures (semi-critical)
Superficial: Assessment of breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, LLZ
Device Description
The Site-Rite Vision* II Ultrasound System is a mobile device that features real-time 2D ultrasound imaging, color-flow Doppler, procedural recordings (cine), patient-information storage, image annotations, and various measurement and calculation tools. The typical environment for ultrasound imaging may include hospitals, outpatient clinics, and long-term care facilities.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal
Abdominal
Intra-operative (semi-critical)
Pediatric
Peripheral Vessel
Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary)
Musculo-skeletal (conventional and superficial)
Cardiac
Indicated Patient Age Range
Adult & Pediatric
Intended User / Care Setting
Hospitals, outpatient clinics, and long-term care facilities.
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 Site-Rite Vision* II Ultrasound System met predetermined performance requirements. The following standards in conjunction with internal protocols were used to determine appropriate methods for evaluating the performance of the device:
IEC 60601-1:2005, CORR. 1(2006), CORR 2(2007), AM1(2012), ANSI/AMES 60601/A2:2012, CAN/CSA-C22.2 - Medical Electrical Equipment - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - Edition 3.1
IEC 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: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
IEC 60601-1-6:2012 - Medical Electrical Equipment-Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
NEMA UD 2:2004 - Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3
NEMA UD 3:2004 - Standard for the Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2
IEC 62304:2006 - Medical device software – Software life cycle processes – Edition 1.0
ISO 10993-1:2009 - Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
NEMA PS 3.1 – 3.18:2008 - Digital Imaging and Communications in Medicine (DICOM) Set
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
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
SiteRite 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: SiteRite 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.
1
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 - | |
| Site-Rite Vision* II | |
| Ultrasound System | The Site-Rite Vision* II Ultrasound System is a mobile device that features real-time |
| 2D ultrasound imaging, color-flow Doppler, procedural recordings (cine), patient- | |
| information storage, image annotations, and various measurement and calculation | |
| tools. The typical environment for ultrasound imaging may include hospitals, outpatient | |
| clinics, and long-term care facilities. | |
| Indications for Use / Intended | |
| Use - Site-Rite Vision * II | |
| Ultrasound System | 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-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, |
| superficial veins in the arms and legs, select small vessels | |
| supporting organs | |
| Vascular Access | Guidance for a PICC, CVC, dialysis catheter, port, PIV, |
| and arterial-line placement, and peripheral vein and artery | |
| access | |
| Abdominal | Assessment of liver, kidneys, pancreas, spleen, |
| gallbladder, bile ducts, transplanted organs, abdominal | |
| vessels, appendix, and surrounding anatomical structures | |
| Interventional and | |
| Intraoperative | Guidance for biopsy, drainage, peripheral nerve blocks, |
| and intraoperative procedures (semi-critical1) | |
| Superficial | Assessment of breast, thyroid, testicle, lymph nodes, |
| hernias, musculoskeletal procedures, soft tissue structures, | |
| 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.
2
Section 1.1 – General Information
Bard Access Systems, Inc. Site~Rite Vision II Ultrasound System
Special 510(k) Premarket Notification
.
| Technological
Characteristics | This device operates 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 that are processed and displayed as 2D images. Doppler shift
caused by blood flow is displayed as color flow or spectrum analysis. The modes of
this device (2D, color Doppler) are the same as the predicate device identified above. | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety &
Performance
Tests | Verification and validation activities were designed and performed to demonstrate that
the subject Site-Rite Vision* II Ultrasound System met predetermined performance
requirements. The following standards in conjunction with internal protocols were used
to determine appropriate methods for evaluating the performance of the device: | |
| | IEC 60601-1:2005,
CORR. 1(2006),
CORR 2(2007),
AM1(2012),
ANSI/AAM
ES 60601/A2:2012,
CAN/CSA-C22.2 | Medical Electrical Equipment - Medical Electrical Equipment
- Part 1: General Requirements for Basic Safety and
Essential Performance - Edition 3.1 |
| | IEC 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: Particular
Requirements for the Basic Safety and Essential
Performance of Ultrasonic Medical Diagnostic and
Monitoring Equipment |
| | IEC 60601-1-6:2012 | Medical Electrical Equipment-Part 1-6: General
Requirements for Basic Safety and Essential Performance -
Collateral Standard: Usability |
| | NEMA UD 2:2004 | Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment, Revision 3 |
| | NEMA UD 3:2004 | Standard for the Real-time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic
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.
3
| Bard Access Systems, Inc.
Site-Rite Vision II Ultrasound System
| Special 510(k) Premarket Notification | Section 1.1 - General Information | |
|---|---|---|
| IEC 62304:2006 | Medical device software – Software life cycle processes – | |
| Edition 1.0 | ||
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1: | |
| Evaluation and Testing within a Risk Management Process | ||
| NEMA PS 3.1 – | ||
| 3.18:2008 | Digital Imaging and Communications in Medicine (DICOM) | |
| Set | ||
| The subject devices met all pre-determined acceptance criteria and demonstrated | ||
| substantial equivalence as compared to the predicate device. | ||
| Summary of | ||
| Substantial | ||
| Equivalence | Based on the indications for use, technological characteristics, and safety and | |
| performance testing, the subject Site~Rite Vision* II Ultrasound System met the | ||
| minimum requirements that are considered adequate for its intended use and is | ||
| substantially equivalent in design, principles of operation and indications for use to the | ||
| predicate device, Site~Rite Vision* Ultrasound System. Based on the performance | ||
| testing, the Site~Rite Vision* II Ultrasound System is as safe, as effective, and performs | ||
| as well as, or better than the predicate, Site~Rite Vision* Ultrasound System. |
4
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
5
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
6
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
| Applications | Exam Type (adult & pediatric) |
|---|---|
| Vascular | Assessment of carotid arteries, aorta, deep veins, |
| superficial veins in the arms and legs, select small vessels | |
| supporting organs | |
| Vascular Access | Guidance for a PICC, CVC, dialysis catheter, port, PIV, |
| and arterial-line placement, and peripheral vein and artery | |
| access | |
| Abdominal | Assessment of liver, kidneys, pancreas, spleen, |
| gallbladder, bile ducts, transplanted organs, abdominal | |
| vessels, appendix, and surrounding anatomical structures | |
| Interventional and | |
| Intraoperative | Guidance for biopsy, drainage, peripheral nerve blocks, |
| and intraoperative procedures (semi-critical†) | |
| Superficial | Assessment of breast, thyroid, testicle, lymph nodes, |
| hernias, musculoskeletal procedures, soft tissue structures, | |
| 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.
7
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.
8
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 | ||||||||
| (Track 1 | ||||||||
| Only) | Specific (Tracks 1 | |||||||
| and 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (B+CD) | Other* | |||||||
| (specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging and | ||||||||
| Other | Fetal | P | P | |||||
| Abdominal | P | P | ||||||
| Intra-operative | ||||||||
| (semi-critical 1) | P | P | ||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | ||||||
| Small Organ | ||||||||
| (breast, thyroid, | ||||||||
| parathyroid, | ||||||||
| testicles, prostate, | ||||||||
| uterus, ovary) | P | P | ||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | P | P | ||||||
| Musculo-skeletal | ||||||||
| (Superficial) | P | P | ||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | P | P | |||||
| Cardiac Pediatric | P | P | ||||||
| Intravascular | ||||||||
| (Cardiac) | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| 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 | ||
| Doppler | Combined | |||||||
| (B+CD) | Other* | |||||||
| (specify) | ||||||||
| (Track 1 | ||||||||
| Only) | and 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging and | ||||||||
| Other | Fetal | P | P | |||||
| Abdominal | P | P | ||||||
| Intra-operative | ||||||||
| (semi-critical 1) | P | P | ||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | ||||||
| Small Organ | ||||||||
| (breast, thyroid, | ||||||||
| parathyroid, | ||||||||
| testicles, prostate, | ||||||||
| uterus, ovary) | P | P | ||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | P | P | ||||||
| Musculo-skeletal | ||||||||
| (Superficial) | P | P | ||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | P | P | |||||
| Cardiac Pediatric | P | P | ||||||
| Intravascular | ||||||||
| (Cardiac) | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| 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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