ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM

K093713 · Civco Medical Instruments · ITX · Jan 19, 2010 · Radiology

Device Facts

• Record ID: K093713
• Device Name: ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
• Applicant: Civco Medical Instruments
• Product Code: ITX · Radiology
• Decision Date: Jan 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission: Ultra-Pro II™ Needle Guides, Ultra-Pro 3™ Needle Guides, AccuSITE Transverse Needle Guides, Infiniti™ Needle Guides, Multi-Pro 2000™ Needle Guides, MAGGI II Plus™ Needle Guides. The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

Device Story

Device consists of mechanical brackets and disposable guides attached to diagnostic ultrasound transducers. System facilitates percutaneous procedures by directing instruments (catheters, electrodes, needles) to targeted anatomical locations. Used in clinical settings by trained healthcare professionals to improve accuracy and repeatability of needle-guided procedures. Device provides physical alignment for the instrument relative to the ultrasound imaging plane; no electronic or software-based processing involved.

Clinical Evidence

Bench testing only. Verification performed to ensure device meets specified tolerances and functions correctly with designed adapter clip area.

Technological Characteristics

Mechanical bracket and disposable guide assembly. Materials and specifications equivalent to predicate devices. No energy source, connectivity, or software components. Sterilization status not specified.

Indications for Use

Indicated for patients undergoing percutaneous procedures requiring needle or catheter placement into targeted anatomical locations under ultrasound guidance. Intended for use by healthcare workers trained in ultrasonography.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• MAGGI SERIES ULTRA. NEEDLE. BIOPSY/CATHETER GUIDES (K882383)
• SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 (K071204)
• ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY (K030064)

Submission Summary (Full Text)

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K0937/3

# 510(k) SUMMARY (as required by 807.92(c))

# JAN 1 9 2010

# Regulatory Correspondent:

AJW Technology Consultants Inc 962 Allegro Lane Apollo Beach, FL 33572 Arthur Ward [e-mail]/[e-mail] 813-645-2855 813-677-4787

Ultrasound General Purpose Guidance System

Diagnostic Ultrasound Transducers

## Submitter of 510(k):

Civco Medical Instruments 102 First Street South Kalona, IA 52247-9589 James Leong [e-mail]

Date of Summary:

Trade/Proprietary Name:

Classification Name:

Product Code:

#### Intended Use:

The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission:

12/21/2009

ITX

| MODEL | INTENDED USE |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ultra-Pro II™ Needle Guides | The bracket and disposable guide provide<br>physicians with a tool for performing<br>needle-guided (or catheter) procedures with<br>the use of diagnostic ultrasound<br>transducers. |
| Ultra-Pro 3™ Needle Guides | |
| AccuSITE Transverse Needle Guides | |
| Infiniti™ Needle Guides | |
| Multi-Pro 2000™ Needle Guides | |
| MAGGI II Plus™ Needle Guides | |

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| Device Description: | The bracket and disposable guide provide<br>physicians with a tool for performing needle-guided<br>(or catheter) procedures with the use of diagnostic<br>ultrasound transducers. The guide facilitates<br>directing the device to a target to improve accuracy<br>and repeatability. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |

K882383 - MAGGI SERIES ULTRA. NEEDLE. BIOPSY/CATHETER GUIDES

K071204 - SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6

K030064 - ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY

## Substantial Equivalence:

Predicate Device:

CIVCO Medical Instruments claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K882383. K071204 and K030064. CIVCO claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles and physical operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 8 of this submission. These differences have no effect on safety and effectiveness

### Performance Testing:

Verification was performed to ensure that device meets specified tolerances and works in conjunction with specifically designed adapter clip area. All of the appropriate performance testing can be found in Section 12 of this submission.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, capitalized letters. To the left of the text is a symbol that includes a circular border with text and a stylized graphic of a human figure.

Public Health Service

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

CIVCO Medical Instruments % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 250 Street NW BUFFALO MN 55313

JAN 1 9 2010

Re: K093713

Trade/Device Name: Ultrasound General Purpose Guidance Systems Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: ITX Dated: January 4, 2010 Received: January 5, 2010

Dear Mr. Job:

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 indictions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish find 21 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 Ilsting (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Ultrasound General Purpose Guidance System

Indications for Use:

The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging, instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission:

| MODEL | INTENDED USE |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ultra-Pro II™ Needle Guides | The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. |
| Ultra-Pro 3™ Needle Guides | |
| AccuSITE Transverse Needle Guides | |
| Infiniti™ Needle Guides | |
| Multi-Pro 2000™ Needle Guides | |
| MAGGI II Plus™ Needle Guides | |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

(Division Sign-Off) (Division Sign-Off)
Division of Radiological Previous of CDRH, Office of Device Business (ODD) ( O I )

510(k) Number KD98713

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