(104 days)
Not Found
No
The description focuses on the mechanical and functional aspects of a needle for fine needle aspiration under ultrasound guidance. There is no mention of AI, ML, or any computational analysis of the ultrasound images or aspirated data.
No
This device is used for sampling and aspiration (diagnostic purposes) rather than for treating a condition.
Yes
The device is used for Fine Needle Aspiration (FNA) to sample lesions, which is a procedure aimed at collecting tissue for diagnostic evaluation.
No
The device description clearly details a physical needle, sheath, stylet, adaptor, and syringe, all of which are hardware components. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is used to obtain the specimen (tissue or fluid) from within the body.
- The intended use describes a procedure for sampling targeted lesions. The device's function is to facilitate the collection of a sample through FNA.
- The device description focuses on the mechanical aspects of the needle and its use in conjunction with an endoscope for aspiration. It doesn't describe any components or processes for analyzing the collected sample.
- There is no mention of analyzing the collected specimen within the device itself. The syringe is used for aspiration, implying the collected sample is then processed and analyzed elsewhere (likely in a laboratory).
In summary, this device is a surgical instrument used for obtaining a sample, not a device that performs diagnostic testing on a sample. The diagnostic testing would be performed on the sample after it is collected using this device.
N/A
Intended Use / Indications for Use
This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultra sound endoscope for Fine Needle Aspiration (FNA).
Product codes
FCG
Device Description
The EchoTip® Ultra Endobronchial High Definition Ultrasound Needle is an endoscopic ultrasound needle used for fine needle aspiration (FNA). The device is used in conjunction with an endobronchial ultrasound (EBUS) endoscope to gain access to the target site. The needle is dimpled for ultrasonic visualization. The needle is advanced into the target site for aspiration. The device allows for the adjustment of the sheath length and the needle length to enable the user to adiust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet which is removed for aspiration. The device is supplied with an adaptor which allows the EchoTip® Ultra Endobronchial High Definition Ultrasound Needle to be connected to the endoscope's accessory channel. The device is also supplied with a syringe that is used to aspirate the specimen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
tracheobronchial tree or gastrointestinal tract
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
Non-clinical testing was carried out on the device to determine the equivalence of the EchoTip® Ultra Endobronchial High Definition Ultrasound Needle to the predicate devices to provide assurance of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Cook Echo Tip® Ultra Endobronchial High Definition Ultrasound Needle Page 8 of 45
Section 5.0 510(k) Summary
Name: Address:
Phone:
Contact Persons:
Fax:
Cook Ireland Ltd O'Halloran Road National Technology Park Limerick, Ireland
JAN 2 1 2010
353 61 334440 353 61 334441 Emmett Devereux, Quality & Regulatory Manager Jacinta Kilmartin, Regulatory Affairs Specialist
353 61 334440 353-61-239293
October 7, 2009
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle
Aspiration Needle
Kit, Needle, Biopsy (21 CFR 876.1075, Product Code: FCG)
Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503) Cook Endoscopic Ultrasound Needle (K083330)
The EchoTip® Ultra Endobronchial High Definition Ultrasound Needle is an endoscopic ultrasound needle used for fine needle aspiration (FNA). The device is used in conjunction with an endobronchial ultrasound (EBUS) endoscope to gain access to the target site. The needle is dimpled for ultrasonic visualization. The needle is
Phone: Fax:
Date:
Trade Name:
Common Name:
Classification Name:
Predicate Devices:
Description of the Device:
1
advanced into the target site for aspiration. The device allows for the adjustment of the sheath length and the needle length to enable the user to adiust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet which is removed for aspiration. The device is supplied with an adaptor which allows the EchoTip® Ultra Endobronchial High Definition Ultrasound Needle to be connected to the endoscope's accessory channel. The device is also supplied with a syringe that is used to aspirate the specimen.
This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultra sound endoscope for Fine Needle Aspiration (FNA).
The EchoTip® Ultra Endobronchial High Definition Ultrasound Needle is substantially equivalent to the currently marketed predicate devices, the Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503) and Cook Endoscopic Ultrasound Needle (K083330).
Non-clinical testing was carried out on the device to determine the equivalence of the EchoTip® Ultra Endobronchial High Definition Ultrasound Needle to the predicate devices to provide assurance of safety and effectiveness.
Indications for use:
Comparison of Characteristics:
Performance Data:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 2 1 2010
Ms. Jacinta Kilmartin Regulatory Affairs Specialist Cook Ireland Limited O'Hallorañ Road National Technology Park LIMERICK IRELAND
Re: K093195
Trade/Device Name: EchoTip® Ultra Endobronchial High Definition Ultrasound Needle Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: December 22, 2009 Received: December 24, 2009
Dear Ms. Kilmartin:
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 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been deternined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 onay publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Jacinta Kilmartin
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
, Hebert Leven
Janine M. Morris, Director (Acting) Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Section 4.0 Indications for Use
093195 510(k) Number (if known): _
Device Name: EchoTip® Ultra Endobronchial High Definition Ultrasound Needle
Indications for Use:
. "
This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultra sound endoscope for Fine Needle Aspiration (FNA).
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K093195 |
|---|---|
| --------------- | --------- |
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