SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6

K071204 · C.R. Bard, Inc. · IYO · May 18, 2007 · Radiology

Device Facts

• Record ID: K071204
• Device Name: SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6
• Applicant: C.R. Bard, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.

Device Story

Lightweight, portable, real-time B-mode ultrasonic pulsed echo imaging system; assists physicians with vascular access (veins/arteries) and diagnostic imaging. Used at bedside or in clinical settings (ICU, ER, OR, angiography suites, catheterization labs). Operates by emitting ultrasonic pulses and processing echoes to generate real-time images on a display. Physician uses visual output to guide needle/catheter placement; facilitates accurate vascular access; reduces complications; improves patient outcomes. Simple controls designed for ease of use by clinicians.

Clinical Evidence

Bench testing only. Verification and validation tests performed in accordance with Design Controls per 21 CFR 820.30.

Technological Characteristics

Portable, real-time B-mode ultrasonic pulsed echo imaging system. Class II device (21 CFR 892.1560, 892.1570). Operates via ultrasonic transducer. Identical technological characteristics to predicate Site~Rite® 5.

Indications for Use

Indicated for ultrasound-guided needle and catheter placement in vascular structures (intraoperative or percutaneous) and diagnostic ultrasound imaging of vascular structures, organs, and body structures in patients requiring such procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Site~Rite® 5 Ultrasound System (K052517)

Submission Summary (Full Text)

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071204 Site~Rite® 6 Ultrasound System Special 510(k)

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| | Site~Rite® 6 Ultrasound System<br>510(k) Summary | MAY 18 2007 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device trade name: | Site~Rite® 6 Ultrasound System | |
| Device class and panel: | Class II, 21 CFR §892.1560, Ultrasonic Pulsed Echo Imaging System, 90IYO<br>Class II, 21 CFR §892.1570, Diagnostic Ultrasonic Transducer, 90ITX | |
| Applicant name: | Kimberly Geisler<br>Bard Access Systems, Inc. [wholly owned subsidiary of C.R. Bard, Inc.]<br>5425 West Amelia Earhart Drive<br>Salt Lake City, UT 84116<br>[phone], x5421 (phone) | |
| Predicate device: | K052517, Site~Rite® 5 Ultrasound System | |
| Performance Standards: | Performance standards have not been established by the FDA under<br>section 514 of the Federal Food, Drug and Cosmetic Act. | |
| Indications for Use: | The Site~Rite® 6 Ultrasound System with associated probe and<br>accessories provide ultrasound guidance for placement of needles<br>and catheters in vascular structures. Ultrasound guidance may<br>occur intraoperatively or percutaneously. Ultrasound imaging of<br>vascular structures, various organs and structures of the body may<br>also be performed. | |
| Device description: | The Site~Rite® 6 Ultrasound System is a lightweight, low-output,<br>real-time B-mode ultrasonic pulsed echo imaging system designed<br>primarily to assist physicians in gaining vascular access to major<br>veins and arteries. The Site~Rite® 6 Ultrasound System is portable<br>and therefore easy to use at the bedside and in a variety of clinical<br>scenarios, including intensive care units, emergency rooms,<br>operating rooms, angiography suites, catheterization laboratories,<br>etc. In addition, the Site~Rite® 6 Ultrasound System is designed with<br>simple operating controls to facilitate easy operation. | |
| Technological<br>Characteristics: | Technological similarities between the subject Site~Rite® 6<br>Ultrasound System and the predicate device remain identical. There<br>are no new questions raised regarding safety or efficacy of the<br>Site~Rite® 6 Ultrasound System. | |
| Safety & Performance<br>Tests: | Verification and validation tests have been performed in accordance<br>with Design Controls per 21 CFR 820.30. | |
| Summary of Substantial<br>Equivalence: | Based on the indications for use, technological, and safety and<br>performance testing, the subject Site~Rite® 6 Ultrasound System<br>meets the minimum requirements that are considered adequate for<br>its intended use and is substantially equivalent in design, material,<br>principles of operation and indications for use to the current<br>commercially available Site~Rite® 5 Ultrasound System. | |

®Site~Rite is a registered trademark of C.R. Bard, Inc.

# 000061

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2007

Ms. Kimberly Geisler Regulatory Affairs Specialist C.R. Bard, Inc. Bard Access Systems, Inc. 5425 West Amelia Earhart Drive LAKE CITY UT 84116

Re: K071204

Trade Name: Site~Rite® 6 Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: April 30, 2007 Received: May 1, 2007

Dear Ms Geisler:

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® 6 Ultrasound System, as described in your premarket notification:

## Transducer Model Number

Site~Rite 6

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

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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); 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Sincerely yours,

Nancyc brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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#### 1.2 Indications for Use Statement

510(k) Number (if known):

Device Name:

Site~Rite® 6 Ultrasound System

Kollade

Indications for Use:

The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

000008

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Site~Rite® 6 Ultrasound System Special 510(k)

### Site~Rite® 6 Ultrasound System

#### Diagnostic Ultrasound Indications for Use Form

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | |
| Intraoperative (specify) | | P | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | P | | | | | | | | |
| Neonatal Cephalic | | P | | | | | | | | |
| Adult Cephalic | | P | | | | | | | | |
| Cardiac | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | P | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: _________________________________________________________________________________________________________________________________________________________

Intraoperative (epiaortic scanning)

Small organ (breast, testes, thyroid, etc.) __________________________________________________________________________________________________________________________________

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

Prescription Use (Per 21 CFR §801.109)

Nancy C. Brogdon

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(Division Sigr n of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Image /page/4/Picture/14 description: The image shows the number 000167 in a bold, sans-serif font. The numbers are closely spaced together and are all the same size. The image is black and white, and the numbers are black against a white background. The number appears to be a label or identifier.

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Image /page/5/Picture/0 description: The image shows the logo for Bard Access Systems. The logo consists of the word "BARD" in large, bold, sans-serif font. Below the word "BARD" is the text "Bard Access Systems" in a smaller, regular font. The logo is simple and professional, and it is likely used to identify the company and its products.

# Site~Rite® 6 Ultrasound Transducer

#### Diagnostic Ultrasound Indications for Use Form

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | |
| Intraoperative (specify) | | P | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | P | | | | | | | | |
| Neonatal Cephalic | | P | | | | | | | | |
| Adult Cephalic | | P | | | | | | | | |
| Cardiac | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | P | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify | | | | | | | | | | |

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

______________________________________________________________________________________________________________________________________________________________________________

Additional Comments:

______________________________________________________________________________________________________________________________________________________________________________

. ·

Intraoperative (epiaortic scanning)

Small organ (breast, testes, thyroid, etc.)

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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) (Concurrence of CDRH, Office of Device Evaluation (ODE))

______________________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR §801.109)

Nancy C. Brogdon

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on of Reproductive, Abdominal. Radiological Devices 510(k) Number

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