This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

Device Description

The Endoscopic Ultrasound Needle is offered in various needle gauges for injection or aspiration. This device is used in conjunction with an ultrasound endoscope to gain access to the target site. The needle which is dimpled for ultrasonic visualization is advanced into the target site for injection of therapeutic materials or aspiration. The device allows for adjustment of the length of the sheath and needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the needle which is removed for injection and aspiration. The device is supplied sterile and intended for single use only.

AI/ML Overview

The provided document describes a 510(k) Summary for the Cook Endoscopy EchoTip Ultra Ultrasound Needle, submitted to the FDA in 2009. This document is a premarket notification for a medical device seeking to demonstrate substantial equivalence to previously cleared predicate devices. It largely focuses on the device's technical specifications, intended use, and its equivalence to other legally marketed devices, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from this document as it is not a clinical study report.

However, I can extract the following based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

"Performance testing performed under simulated use conditions demonstrates that the Endoscopic Ultrasound Needle met the performance requirements of the expanded indications for use."

This indicates that internal performance requirements were established and met under simulated conditions for the expanded indications. However, the specific acceptance criteria (e.g., minimum tensile strength, maximum deflection, aspiration efficiency, injection rate) and the numerical results for these criteria are not provided in this summary. The "reported device performance" is a general statement of compliance.

Acceptance Criteria (General)	Reported Device Performance
Performance requirements for expanded indications under simulated use.	Met the performance requirements for the expanded indications for use.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified. The document mentions "performance testing," but does not provide details on the number of devices or simulated scenarios tested.
Data Provenance: The testing was "performed under simulated use conditions," implying laboratory or bench testing rather than clinical data. No country of origin is specified for the simulated use data, nor is it explicitly stated as retrospective or prospective (though simulated testing is inherently prospective in its design).

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

Not applicable. This document describes simulated performance testing, not a clinical study where ground truth would be established by experts.

4. Adjudication Method for the Test Set:

Not applicable. As this was simulated performance testing, not a study involving human interpretation of data, an adjudication method for a test set is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. The document does not describe an MRMC study. Its focus is on demonstrating substantial equivalence through technical and simulated performance, not on comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only) Performance Was Done:

Not applicable. This device is a physical medical instrument (an ultrasound needle), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant. The performance mentioned refers to the physical device's characteristics.

7. The Type of Ground Truth Used:

Not applicable / N/A. For simulated use performance testing of a physical device, "ground truth" in the sense of expert consensus or pathology is typically not established. The ground truth refers to the expected physical performance standards the device is designed to meet, validated through engineering specifications and experimental measurements.

8. The Sample Size for the Training Set:

Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or algorithms.

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

Not applicable. There is no training set for this type of device.

Summary Limitations:

It is crucial to understand that 510(k) summaries are for demonstrating substantial equivalence to existing devices, not necessarily for proving novel clinical efficacy or diagnostic accuracy through extensive clinical trials. The "clinical evidence" mentioned generally refers to information supporting the safety and effectiveness of the device type for the proposed indications, often referencing scientific literature or previous uses of similar devices, rather than a specific, new clinical trial conducted for this particular submission. The document explicitly states: "The Clinical Evidence supports the substantial equivalence of this device for the new indications for use." This supports the claim that the expanded indications do not pose new safety or effectiveness concerns beyond what is understood for the predicate devices.

Summary

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Kобзэзо

COOK®
MEDICAL

COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. 744.0157 TOLL PREC: 800.245.4707 WW.COOKMEDICAL.COM

510(k) Summarv

FEB - 6 2009

Name: Address:

Phone: Fax: Contact: Date:
Trade Name: Common Name: Classification Name:

Legally Marketed Devices:

Description of the Device:

Intended Use:

Cook Endoscopy 4900 Bethania Station Road Winston-Salem, North Carolina 27105 (336)744-0157 (336)201-5994 Scottie Fariole, Global Regulatory Affairs Specialist February 6, 2009

EchoTip Ultra Ultrasound Needle Endoscopic Ultrasound Needle Kit, Needle, Biopsy (21 CFR 876.1075, Product Code FCG)

Medi-Globe SonoTip II Ultrasound Needle System (K070129) PercuTx Injection/Aspiration Needle Probes with Control Handpiece (K994151) Endoscopic Ultrasound Needle (K934356)

AORTIC INTERVENTION	CARDIOLOGY	CRITICAL CARE	ENDOSCOPY	PERIPHERAL INTERVENTION	SURGERY	UROLOGY	WOMEN'S HEALTH
---------------------	------------	---------------	-----------	-------------------------	---------	---------	----------------

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The expansion of the indications for use is not critical as supported by the Clinical Evidence specifically addressing the expanded target sites and delivery of injectable materials. The evidence discusses the expanded use of the device (or similar design) and the risks associated with that use. The Clinical Evidence supports the substantial equivalence of this device for the new indications for use.

1208333

Comparison of Characteristics:

We believe the proposed device to be substantially equivalent to currently marketed predicate devices as cleared by K070129, K994151 and K934356 in terms of Intended Use, Product Description, and Sterility,

Performance testing performed under simulated use conditions demonstrates that the Endoscopic Ultrasound Needle met the performance requirements of the expanded indications for use. The device will be substantially equivalent to currently cleared predicate devices.

Performance Data:

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized representation of an abstract human figure. The figure is composed of three curved lines that form the shape of a person with arms outstretched. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are written vertically along the left side of the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 2009

Mr. Scottie Fariole Global Regulatory Affairs Specialist Cook Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105

Re: K083330

Trade/Device Name: Endoscopic Ultrasound Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: FCG Dated: November 6, 2008

Received: November 12, 2008

Dear Mr. Fariole:

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 such 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.

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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 Incant 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/odrh/industry.suppo/index.html.

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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Indications for Use

510(k) Number (if known): _KOダ 3330

Device Name: Endoscopic Ultrasound Needle

Indications for Use:

Prescription Use S (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Aomi Whiter

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 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.