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 Description

The iLook™ 25 Needle Guide Attachment and Bracket Assembly is an accessory to the iLook™ 25 Diagnostic Ultrasound System. The accessory is made up of a bracket designed in such a way to facilitate easy and secure attachment to the iLook™ 25 transducer. There are features on the bracket that prevent the bracket from being attached incorrectly to the transducer. The needle guide is a separate polymeric part that attaches to the bracket through a sterile sheath. Multiple needle guides are available corresponding to different depths that the clinician may need for accurate guided needle placement into vascular or other anatomical structures. The needle guides are designed to accept and retain various sized needles. The kit is shipped separately with a sterile sheath, ultrasound transmission gel, and contains multiple needle guides, sterile sheath, ultrasound transmission gel, and bands.

AI/ML Overview

The provided text describes a 510(k) submission for the "iLook™ 25 Needle Guide Attachment and Bracket Assembly." This is a premarket notification for a Class II medical device, and as such, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and precise performance metrics in the way a pivotal clinical trial for a novel device would.

Based on the information provided, here's a breakdown of the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) are not explicitly stated in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence through various types of testing to ensure safety and effectiveness.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Security: Bracket securely attaches to the iLook™ transducer and prevents disengagement.	"The bracket is designed in such a way to facilitate easy and secure attachment to the iLook™ transducer. There are features on the bracket that prevent the bracket from being disengaged from the transducer." "The needle guides are designed to accept and retain the needle guides in a mechanically secure way."
Needle Guide Retention: Needle guides are securely retained by the bracket.	"The needle guides are designed to accept and retain the needle guides in a mechanically secure way."
Biocompatibility: Device materials meet relevant standards for patient contact.	"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."
Sterilization: Sterilization method is validated and effective.	"Sterilization requirements were met through validations performed by the contract manufacturer."
Environmental, Packaging, Shipping, Shelf Life: Device withstands typical handling and storage conditions.	"Environmental, packaging, shipping, shelf life... requirements were met through validations performed by the contract manufacturer."
Substantial Equivalence: Similarities in technological characteristics and intended use to predicate devices.	The conclusion states: "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."

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify sample sizes for the various tests performed. The testing described appears to be primarily non-clinical (bench testing and validation studies), rather than a clinical trial with a "test set" in the sense of patient data.

Test Set Sample Size: Not specified.
Data Provenance: The document implies in-house testing and third-party validation by the contract manufacturer. No country of origin for clinical data is applicable as no clinical data is reported. The tests are prospective validations for manufacturing and material compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to the provided document. The device is an accessory (needle guide), and its performance is assessed through mechanical, biocompatibility, and sterilization validations, not typically through expert-adjudicated "ground truth" on a test set of medical outcomes or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done and is not mentioned. This type of study is for image interpretation or diagnostic tools, not for a mechanical accessory like a needle guide.

6. If a Standalone (i.e. algorithm only without human-in-the-loop) Performance Was Done

This is not applicable. This device is a physical accessory designed for human use with an ultrasound system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed would be established by:

Engineering specifications and test standards: For mechanical and functional performance (e.g., proper fit, retention force).
ISO 10993-01 and FDA Memorandum #G95-1: For biocompatibility.
Validated sterilization protocols: For sterility.
Established environmental and packaging standards: For shelf-life, shipping.

There is no "expert consensus, pathology, or outcomes data" as ground truth in the context of this device's testing for 510(k) clearance.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML algorithm or a diagnostic imaging device that requires training data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

Summary

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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:

michael.hoffman@sonosite.com

Telephone: (425) 951-1297 Facsimile: (425) 951-1201

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.

000046

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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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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)

000024

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.