SITE-RITE VISION ULTRASOUND SYSTEM

K100402 · Bard Access Systems, Inc. · IYN · Mar 5, 2010 · Radiology

Device Facts

• Record ID: K100402
• Device Name: SITE-RITE VISION ULTRASOUND SYSTEM
• Applicant: Bard Access Systems, Inc.
• Product Code: IYN · Radiology
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Site-Rite Vision™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Fetal Abdominal Intraoperative (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™ 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 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, musculo-skeletal procedures, soft tissue structures, and surrounding anatomical structures

Device Story

Site-Rite Vision™ Ultrasound System is a diagnostic imaging device; utilizes ultrasound transducers (128-element linear and convex probes) to capture internal body structures and fluid flow. Operates in B-mode and Color Doppler modes. Used in clinical settings by healthcare professionals for vascular access guidance (PICC, CVC, PIV), abdominal assessment, and interventional procedures. Input signals processed to generate real-time visual images on a display; assists clinicians in needle placement and anatomical visualization. Enhances procedural accuracy; reduces complications during vascular access and interventional guidance. System supports diagnostic assessment of organs and vessels; provides visual feedback for biopsy and drainage procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence established through comparative performance testing of ultrasound imaging capabilities, safety, and effectiveness against predicate devices.

Technological Characteristics

Diagnostic ultrasound system utilizing 128-element linear (with/without buttons) and convex transducers. Modes: B-mode, Color Doppler (B+CD). Connectivity: Standard ultrasound imaging interface. Regulatory class II. Software-controlled image processing for pulsed echo and Doppler imaging.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult and pediatric patients across fetal, abdominal, intraoperative, peripheral vessel, small organ, musculoskeletal, and cardiac applications. Includes vascular access guidance for catheters and lines. Contraindicated for applications where probe contact with mucous membranes or non-intact skin is not managed as semi-critical.

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® 6 Ultrasound System (K071204)
• SonoSite, Inc. Maxx™ Series Ultrasound System (K071134)
• SonoSite, Inc. High-Resolution Ultrasound System (C3 Series) (K053069, K043559)
• SonoSite, Inc. High-Resolution Ultrasound System (C2 Series) (K043452, K033367, K030949)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters. The sequence starts with a capital letter 'K', followed by the number '1', and then two 'O's. After that, the numbers '4', '0', and '2' are written. The characters are written in black ink on a white background.

Image /page/0/Picture/1 description: The image shows the logo for "BARD Bard Access Systems". The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the phrase "Bard Access Systems" in a smaller, sans-serif font. The logo is black and white.

## Site~Rite Vision™ Ultrasound System 510(k) Summary of Safety and Effectiveness

| Device trade name: | Site-Rite Vision™ Ultrasound System | | | | | | | | | | | | | | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Device class and panel: | Class II, Radiology Devices Panel | | | | | | | | | | | | | | | |
| Classification Names: | Name Product Code CFR Number Ultrasonic Pulsed Doppler Imaging System IYN 892.1550 Ultrasonic Pulsed Echo Imaging System IYO 892.1560 Diagnostic Ultrasonic Transducers ITX 892.1570 Picture Archiving and Communications System LLZ 892.2050 | | | | | | | | | | | | | | | |
| Applicant name: | Kimberly Geisler, Henry Boland<br>Bard Access Systems, Inc. (wholly owned subsidiary of C.R. Bard, Inc.)<br>605 North 5600 West, Salt Lake City, UT 84116<br>[phone], x5421 or x5428 | | | | | | | | | | | | | | | |
| Predicate devices: | K071204 - Site-Rite® 6 Ultrasound System<br>K071134 - SonoSite, Inc. Maxx™ Series Ultrasound System<br>K053069, K043559 - SonoSite, Inc. High-Resolution Ultrasound System (C3 Series)<br>K043452, K033367, K030949 - SonoSite, Inc. High-Resolution Ultrasound System (C2 Series) | | | | | | | | | | | | | | | |
| Performance Standards: | Performance standards have not been established by the FDA under §514 of the<br>Federal Food, Drug and Cosmetic Act. | | | | | | | | | | | | | | | |
| Indications for Use: | The Site-Rite Vision™ Ultrasound System is intended for diagnostic ultrasound imaging<br>or fluid flow analysis of the human body. Specific clinical applications include:<br>Fetal Abdominal Intraoperative (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™ Ultrasound System include: | | | | | | | | | | | | | | | |
| | Imaging Applications Exam Type (adult & pediatric) Vascular Assessment of carotid arteries, aorta, deep veins, superficial veins<br>in the arms and legs, select small vessels supporting organs Vascular Access Guidance for PICC, CVC, dialysis catheter, port, PIV, and arterial<br>line placement, and peripheral vein and artery access Abdominal Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile<br>ducts, transplanted organs, abdominal vessels, appendix, and<br>surrounding anatomical structures Interventional and<br>Intraoperative Guidance for biopsy, drainage, peripheral nerve blocks, and<br>intraoperative procedures (semi-critical†) Superficial Assessment of breast, thyroid, testicle, lymph nodes, hernias,<br>musculo-skeletal procedures, soft tissue structures, and | | | | | | | | | | | | | | | |

1 Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.

surrounding anatomical structures

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# APR 2 9 2010

Bard Access Systems, Inc. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K100402

Trade/Device Name: Site-Rite Vision™ Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LLZ Dated: February 12, 2010 Received: February 16, 2010

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of March 5, 2010.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Site-Rite Vision™ Ultrasound System, as described in your premarket notification:

Transducer Model Number

128 Element Linear Probe with Buttons 128 Element Linear Probe without Buttons 128 Element Convex Probe

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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): 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely yours.

Robert Frecker (for)

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Bard Accesss Systems, Inc.
Site~Rite Vision" Ultrasound System
Traditional 510(k) Premarket Notification

510(k) Number (if known):

Device Name:

Site~Rite Vision™ Ultrasound System

Indications for Use:

The Site Vision™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include:

- Fetal .
- Abdominal .
- Intraoperative (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™ Ultrasound System include:

| Imaging Applications | Exam Type (adult & pediatric) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vascular | Assessment of carotid arteries, aorta, deep veins, superficial veins in the arms<br>and legs, select small vessels supporting organs |
| Vascular Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, and arterial line<br>placement, and peripheral vein and artery access |
| Abdominal | Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile ducts,<br>transplanted organs, abdominal vessels, appendix, and surrounding anatomical<br>structures |
| Interventional and<br>Intraoperative | Guidance for biopsy, drainage, peripheral nerve blocks, and intraoperative<br>procedures (semi-critical1) |
| Superficial | Assessment of breast, thyroid, testicle, lymph nodes, hemias, musculoskeletal<br>procedures, soft tissue structures, and surrounding anatomical structures |

T Semi-citical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.

Prescription Use V (Part 21 CFR §801 Subpart D)

510K

AND/OR

Over-The-Counter Use (21 CFR §801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)-

Toby H Becker

Division Sign not Parlingia Office of In ion and Safety

K180402

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| Clinical Application | | Mode of Operation | | | | | | Other*<br>(Specify) |
|---------------------------|--------------------------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | | | | | B+CD | |
| | Abdominal | N | | | | | B+CD | |
| | Intra-operative (semi-critical¹) | N | | | | | B+CD | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | | | | | B+CD | |
| | Small Organ (breast, thyroid,<br>parathyroid, testicles, prostate,<br>uterus, ovary) | N | | | | | B+CD | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | | | | | | | |
| Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-Esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | | | | | B+CD | |
| | Musculo-skeletal (Superficial) | N | | | | | B+CD | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N | | | | | B+CD | |
| | Cardiac Pediatric | N | | | | | B+CD | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | N | | | | | B+CD | |
| | Other (Specify) | | | | | | | |

### Table 1.3-1 Diagnostic Ultrasound Indications for Use Form - Site~Rite Vision™ Ultrasound System

N = new indication; P = previously cleared by FDA; E = added under this appendix

1 Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.

* 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)

Robert Zeckel
(Division Signer - Printed)

(Division Sign-Off) Division of Radiological De Office of In Vitro Dit on and Safety

510K. 5100402

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| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|-----------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | | | | | B+CD | |
| | Abdominal | N | | | | | B+CD | |
| | Intra-operative (semi-critical1) | N | | | | | B+CD | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | | | | | B+CD | |
| | Small Organ (breast, thyroid,<br>parathyroid, testicles, prostate,<br>uterus, ovary) | N | | | | | B+CD | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-Esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | | | | | B+CD | |
| | Musculo-skeletal (Superficial) | N | | | | | B+CD | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N | | | | | B+CD | |
| | Cardiac Pediatric | N | | | | | B+CD | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | N | | | | | B+CD | |
| | Other (Specify) | | | | | | | |

### Table 1.3-2 Diagnostic Ultrasound Indications for Use Form - Site~Rite Vision™ Ultrasound System 128 Element Linear Probe with buttons

N = new indication; P = previously cleared by FDA; E = added under this appendix

1 Semi-crilical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.

- * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Hamonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Prescription Use (Per 21 CFR 801.109)

Robert H. Beckerd
(Division Sign-Off)

Division of Radiological Dey Office of In Vitro Diagnostic Device Evaluation and Safety 510H

: ଉତ୍ତରସିଟ

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| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|-----------------------|---------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | | | | | B+CD | | |
| | Abdominal | N | | | | | B+CD | | |
| | Intra-operative (semi-critical¹) | N | | | | | B+CD | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | | | | | B+CD | | |
| | Small Organ (breast, thyroid,<br>parathyroid, testicles, prostate,<br>uterus, ovary) | N | | | | | B+CD | | |
| Fetal Imaging & | Neonatal Cephalic | | | | | | | | |
| Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-Esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | | | | | B+CD | | |
| | Musculo-skeletal (Superficial) | N | | | | | B+CD | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Cardiac Adult | N | | | | | B+CD | | |
| | Cardiac Pediatric | N | | | | | B+CD | | |
| | Intravascular (Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral Vessel | N | | | | | B+CD | | |
| Vessel | Other (Specify) | | | | | | | | |

## Table 1.3-3 Diagnostic Ultrasound Indications for Use Form – Site~Rite Vision™ Ultrasound
1.3-3. Diagnostic 1997 Diagnostic Officasour.Linear Probe without buttons

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.

- * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Hamonic Imaging, N.
The satinity off and and Cales Velecib Imaging Examples of other modes of operation of Color Velocity Imaging
Prescription Use (Per 21 CFR 801.109)

Robert Becker
(Division Sign-Off)

Division of Radiological Device Division of Radiological Device Evaluation and Safety

510K K100402

: ØØØST

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| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|-----------------------|---------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | | | | | B+CD | | |
| | Abdominal | N | | | | | B+CD | | |
| | Intra-operative (semi-critical¹) | N | | | | | B+CD | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | | | | | B+CD | | |
| | Small Organ (breast, thyroid,<br>parathyroid, testicles, prostate,<br>uterus, ovary) | | | | | | | | |
| Fetal Imaging & | Neonatal Cephalic | | | | | | | | |
| Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-Esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | | | | | B+CD | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Cardiac Adult | N | | | | | B+CD | | |
| | Cardiac Pediatric | N | | | | | B+CD | | |
| | Intravascular (Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral Vessel | N | | | | | B+CD | | |
| Vessel | Other (Specify) | | | | | | | | |

#### Table 1.3-4 Diagnostic Ultrasound Indications for Use Form - Site~Rite Vision™ Ultrasound System 128 Element Convex Probe

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Semi-crilical is defined as clinical applications in which the probe conlacts mucous membranes or non-intact skin.

- * 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)

Robert B. Bley/
(Division Sign Off)

(Division Sign-Off) Division of Radiological De Office of In Vitro Diagnostic Device Evaluation and Safety

510K K100402