(104 days)
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 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.
Based on the provided text, the Cook EchoTip® Ultra Endobronchial High Definition Ultrasound Needle is a Fine Needle Aspiration (FNA) device. The information provided focuses on its substantial equivalence to predicate devices and its indications for use, rather than a clinical study establishing specific performance metrics against defined acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not explicitly present in the given text. The document is a 510(k) summary for premarket notification, which typically focuses on demonstrating substantial equivalence through non-clinical testing and comparison with legally marketed predicate devices, rather than detailed performance studies with clinical endpoints and statistical significance.
Here's a breakdown of what can be extracted and what is not available from the provided input:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document implies general safety and effectiveness.
- Reported Device Performance: The primary "performance data" mentioned is that "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." Specific numerical results of this non-clinical testing are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided. The text only mentions "Non-clinical testing."
- Data Provenance: Not provided, as this was non-clinical testing likely conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Since the document only mentions "Non-clinical testing" for equivalence and does not describe clinical studies requiring expert ground truth, this information is not available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device (an aspiration needle), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As the performance data is based on "non-clinical testing" to demonstrate "equivalence" to predicate devices, there's no mention of clinical ground truth like pathology or outcomes. It likely involved comparisons of physical characteristics, materials, and functional aspects in a laboratory setting against the predicate devices.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
{0}------------------------------------------------
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 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 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.