(18 days)
The Resound EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
The Resound Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.
The provided text describes a medical device, the Resound™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA), and its 510(k) submission for substantial equivalence. However, the document does not contain information related to specific acceptance criteria, studies proving the device meets those criteria, or details regarding performance data in the structured format requested (e.g., sample sizes, expert qualifications, MRMC studies, ground truth establishment methods).
The "Performance Data" section explicitly states:
- "Bench Testing has been performed on the finished Resound EUS-FNA device to demonstrate that the proposed device is substantially equivalent to the predicate devices."
This indicates that the main type of study conducted was bench testing (physical and/or mechanical testing), not clinical performance studies involving human subjects or AI algorithms, which are typically where the detailed performance metrics, sample sizes, and expert adjudications mentioned in your request would originate.
The submission focuses on demonstrating substantial equivalence to predicate devices (Wilson-Cook EchoTip Ultrasound Needle and Olympus Single-Use Aspiration Needle) based on technological characteristics and bench testing, rather than establishing specific clinical performance metrics against a defined set of acceptance criteria.
Therefore, I cannot provide the requested information from the given text because it is not present. The document focuses on regulatory approval through substantial equivalence, which often relies on non-clinical data for devices of this type (biopsy needles used for aspiration).
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K1007/2
SECTION 6 510(k) SUMMARY
1. Submitter
MAR 3 0 2010
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-281-2163 Fax: 508-683-5939
Contact: Ashley Pyle Sr. Regulatory Affairs Specialist Date Prepared: December 18, 2009
2. Device
Trade Name: Resound Endoscopic Ultrasound Aspiration Needle Common Name: Kit, Needle, Biopsy Classification Name: Gastroenterology-Urology Biopsy Instruments Regulation Number: 876.1075 Product Code: FCG Classification: Class II
3. Predicate Devices
Wilson-Cook EchoTip Ultrasound Needle (K934356) Olympus Single-Use Aspiration Needle (K023272)
4. Device Description
The Resound Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.
5. Indication for Use:
The Resound EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
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6. Technological Characteristics:
The proposed Resound EUS-FNA device has the same technological characteristics as the currently marketed Wilson-Cook EchoTip Ultrasound Needle and Olympus Aspiration Needle.
7. Performance Data:
Bench Testing has been performed on the finished Resound EUS-FNA device to demonstrate that the proposed device is substantially equivalent to the predicate devices.
8. Conclusion:
Boston Scientific has demonstrated that the proposed Resound EUS-FNA device is substantially equivalent to the currently marketed Wilson-Cook EchoTip Ultrasound Needle and the Olympus Aspiration Needle.
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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 stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087
MAR 3 0 2010
Re: K100712
Trade/Device Name: Resound™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCG and ODG Dated: March 11, 2010 Received: March 12, 2010
Dear Mr. Lehtonen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
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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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 5 INDICATIONS FOR USE STATEMENT
Indications for Use:
510(k) Number (if known): 40 Be Determined
K100 1/2
Device Name: Resound™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA)
Indications for Use:
The Resound EUS-FNA device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Prescription Use X (Part 21 CFR 801 Part D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devje
510(k) Number.
Premarket Notification, Resound™ EUS-FNA Proprietary and Confidential Information of Boston Scientific Corporation
000094
§ 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.