(15 days)
Not Found
Not Found
No
The description focuses on a mechanical accessory for an ultrasound system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an accessory that facilitates proper needle placement but does not directly provide therapy. Its function is to assist in a procedure, not to treat a condition itself.
No
The device is an accessory to a diagnostic ultrasound system, designed to facilitate needle placement in procedures rather than to diagnose medical conditions itself. It guides the needle, but the diagnosis is made by the accompanying ultrasound system.
No
The device description explicitly states it is an "accessory" made up of a "bracket" and "polymeric part" (needle guide), which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate proper needle placement to various depths in vascular or other anatomical structures from the transducer surface." This describes a device used during a medical procedure to guide a physical instrument (a needle) within the body.
- Device Description: The description details a physical accessory that attaches to an ultrasound transducer to guide a needle. It includes components like a bracket, needle guides, a sterile sheath, and ultrasound gel. These are all physical components used for procedural guidance.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of bodily specimens.
The device is an accessory for an ultrasound system, designed to aid in image-guided procedures, not to perform diagnostic tests on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The 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, unrasound transmission gel, and hands
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
vascular or other anatomical structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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
1
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
- CIVCO Sterne Ontra I To II Neodie Guides and Dr.
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
2
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
3
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.
4
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
5
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)
000024