ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY

K030064 · Sonosite,Inc. · ITX · Jan 22, 2003 · Radiology

Device Facts

• Record ID: K030064
• Device Name: ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
• Applicant: Sonosite,Inc.
• Product Code: ITX · Radiology
• Decision Date: Jan 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The intended use of the iLook™ 25 Needle Guide Attachment and Bracket Assembly when used in conjunction with the Ultrasound System and attached to the Ultrasound System's transducer is to facilitate proper needle placement to various depths in vascular or other anatomical structures from the transducer surface.

Device Story

The iLook™ 25 Needle Guide Attachment and Bracket Assembly is a mechanical accessory for the iLook™ 25 Diagnostic Ultrasound System. It consists of a bracket that attaches to the ultrasound transducer and a separate, sterile needle guide. The bracket design ensures secure attachment to the transducer; it is non-sterile and covered by a sterile sheath during use. The needle guide attaches to the bracket through the sterile sheath. Multiple needle guide sizes are available to accommodate different depths for needle placement. The system is used by clinicians to facilitate accurate needle guidance into vascular or other anatomical structures. The device benefits patients by improving the precision of needle placement during ultrasound-guided procedures.

Clinical Evidence

Bench testing only. The device underwent biocompatibility testing per ISO 10993-01 and FDA Memorandum #G95-1. Environmental, packaging, shipping, shelf life, and sterilization requirements were validated by the manufacturer.

Technological Characteristics

Mechanical accessory for ultrasound transducers. Comprised of a bracket and needle guide. Materials meet ISO 10993-01 biocompatibility standards. Non-sterile bracket; sterile needle guide. Attaches via sterile sheath. No electronic or software components.

Indications for Use

Indicated for clinicians requiring assistance with needle placement into vascular or other anatomical structures at various depths using an ultrasound system.

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

• Site-Rite Disposable Needle Guides with Brackets
• CIVCO Sterile Ultrasound Needle Guides and Brackets

Submission Summary (Full Text)

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K030064

JAN 2 2 2003

# 510(k) SUMMARY

# iLook™ 25 Needle Guide Attachment and Bracket Assembly

SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904

## Corresponding Official:

Michael A. Hoffman Director - Regulatory Affairs and Quality Systems 21919 30th Drive SE Bothell, WA 98021-3904

### E-mail:

[e-mail]

Telephone: [phone] Facsimile: [phone]

### Date of Summary: December 16, 2002

### Device Name:

iLook™ 25 Needle Guide Attachment and Bracket Assembly

### Common Name:

Diagnostic Ultrasound Transducer Accessory

### Classification:

Device Class: II Radiology Classification Panel: C.F.R. Section: 892.1570 Product Code: ITX

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gally Marketed Predicate Device:

Je predicate devices that SonoSite, Inc. is claiming
a) Site-Rite Disposable Needle Guides with Brea

- - CIVCO Sterne Ontra I To II Neodie Guides and Dr.
Class and District Claides and Dr. Claim

evice Description:

ne iLook™ 25 Needle Guide Attachment and Bracket Assembly is an access.
Book™ 25 Diemostio Ultraceund System The seconserv is mode we of a co 20 Diagnostic Onrasotano o yotchi. "The accessory is made up 6 ket designed in such a way to facilitate easy and secure attachment to the iLook "M
ducer. There are features on the bracket that prevent the bracket from being sucer. There are teatures on the bracket that prevent the bracket tools been production of the program.
maria nort that ottoobed to the broadcer. The needle guide is a separ ymeric part that attaches to the bracker through a sterile sheath. "Multiple needle ides are available corresponding to different depths that the climitian may need for led needle piacement into Vascular of other analonical stractures. The necase blues of secure thinks upport various sized needle mide later guide at schipped separates mile sheath, ultrasound transmission gel and contains multiple needle guides, b
rile sheath, ultrasound transmission gel, and hands

ente sheath, unrasound transmission gel, and bands.
he intended use: of the iLook™ 25 Needle Guide Attachment and Bracket Associated to the Ultra other anatomical structures from the transducer sur

other anatomical structures trom the unisudicer surface
comparison of the iLook™ 25 Needle Courises in the Aracket Assembly to issembly to issembly to issess are edicate devices show similariues and some differences. The brickets in all ymeric devices that attach to or are part of an unfrasound transducer. The blo s are not sterile and will be covered with a sterlie sheath province in a mechanically secure wa are designed to accept and retain the needle guides in a mechanically secure w the medium of the sterile sheath. The needle guides are separate sterle c parts that are offered in drifferent sizes, or a single size that may in on a multicket." Separate sizes colrespond to the unferent depuis that the chricial inay ed for accurate guides, sterile sheath, ultrasound transmission gel, and many
ntain multiple needle guides, sterile sheath, ultrasmission gel, and make

g on the iLook™ 2
fory tests which de 23 Neethe Guide Attachment and Bracket Assem

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Additionally, the iLook™ 25 Needle Guide Attachment and Bracket Assembly met biocompatibility requirements specified by ISO 10993-01 and FDA Memorandum #G95-1 for their classification. Environmental, packaging, shipping, shelf life, and sterilization requirements were met through validations performed by the contract manufacturer.

### Conclusion:

The testing described above supports the conclusion that the iLook™ 25 Needle Guide Attachment and Bracket Assembly should be substantially equivalent to the safety and effectiveness demonstrated by the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 22 2003

SonoSite, Inc. % Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K030064

Trade/Device Name: iLook™ Needle Guide Attachment and Bracket Assembly Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: January 6, 2003 Received: January 7, 2003

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 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.

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 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.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

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

Enclosure

Page 2

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# 1203

# INDICATIONS FOR USE

### 510(k) Number (if known):

Device Name: iLook™ 25 Needle Guide Attachment and Bracket Assembly

### Indications for Use:

The intended use of the iLook™ 25 Needle Guide Attachment and Bracket Assembly when used in conjunction with the Ultrasound System and attached to the Ultrasound System's transducer is to facilitate proper needle placement to various depths in vascular or other anatomical structures from the transducer surface.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

*Prescription Use* ✓

(Optional Format 3-10-98)

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