The EchoTip® Ultra Fiducial Needle is composed of a delivery system (i.e., needle, sheath, handle, and stylet) with four pure gold fiducials preloaded and secured within a laser-cut track in the needle. The needle is dimpled to enhance its echogenicity, allowing the user to target tissues using endoscopic ultrasound guidance. The needle stylet is advanced to deploy the fiducials. Once deployed, the fiducials are permanent implants that serve as radiopaque reference points for future therapeutic procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the EchoTip® Ultra Fiducial Needle's acceptance criteria and studies:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a quantitative clinical study. Therefore, many of the requested data points (like sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance with precise metrics) are not present in this type of submission. The "acceptance criteria" here are implicitly related to the device meeting its intended use and safety profile, as demonstrated through non-clinical testing and comparison to predicates.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a Class II device, the "acceptance criteria" are not reported as specific quantitative thresholds (e.g., sensitivity > X%, accuracy > Y%) that would be found in a clinical performance study for an AI/diagnostic device. Instead, acceptance is based on the device demonstrating:

Ability to meet intended use: Successfully implanting fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Substantial equivalence: Demonstrating similar safety and effectiveness to legally marketed predicate devices.
Biocompatibility: Absence of toxicological concerns.
Functional performance: No detachment or breakage, fiducial visibility under imaging, and MR Conditional status.

Therefore, the table below reflects the implied acceptance criteria based on the information provided, which largely revolves around successful functional and safety performance, and the reported outcomes from the studies conducted.

Acceptance Criteria (Implied from 510(k) submission)	Reported Device Performance (Conclusions from Tests)
Intended Use: Successfully implant fiducials to radiographically mark soft tissue.	Demonstrated ability to mark soft tissues for future therapeutic procedures via endoscopic ultrasound placement.
Functional Performance (Delivery System): Effective and safe deployment of fiducials.	Simulated use demonstrated that the device could be used effectively without detachment or breakage.
Imaging Visibility: Fiducials are visible under relevant imaging modalities.	Fiducials were visible under ultrasound and common radiographic imaging techniques.
MR Compatibility/Safety: Device must be MR Conditional.	Fiducials are MR Conditional, as defined by ASTM F2503-08 and FDA guidance on Passive Implants in the MR Environment.
Biocompatibility: No toxicological concerns from implanted pure gold fiducials.	No toxicological concerns for pure gold implanted fiducials were identified by a Risk Assessment (inclusive of exhaustive extraction with chemical characterizations) and biocompatibility tests (cytotoxicity, irritation, sensitization, implantation).
Substantial Equivalence: To predicate devices in intended use, biological safety, and technological characteristics.	Established substantial equivalence to the predicate devices (BiomarC® Preloaded Tissue Marker Device and EchoTip® Ultra Ultrasound Needle) in terms of intended use, biological safety, and technological characteristics. The delivery system is a modified version of the EchoTip® Ultra Ultrasound Needle, with specific additions (laser cut track for fiducials, thumb ring) noted, but overall equivalence maintained.

Study Details (Based on available 510(k) information)

Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document mentions "simulated use" and "biocompatibility tests," but does not provide the number of devices or subjects/samples used for these tests.
- Data provenance: Not explicitly stated, but it would have been generated internally by Cook based on design verification and validation testing. There is no indication of external clinical data or specific geographic origin beyond internal company testing. The nature of the studies (biocompatibility, simulated use) suggests laboratory or animal testing rather than human clinical data.
- Retrospective or prospective: These were likely prospective engineering/pre-clinical studies conducted specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given the non-clinical nature of the tests (biocompatibility, simulated use, imaging visibility), "ground truth" as typically defined for a diagnostic AI study (e.g., expert consensus on medical images) is not applicable here. Performance was likely assessed by engineers and technicians against design specifications and international standards (e.g., ASTM for MR compatibility).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None stated/applicable. Adjudication methods are typically relevant for clinical studies involving human observers and their interpretations, especially for diagnostic devices. These were engineering and biocompatibility tests.
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, an MRMC comparative effectiveness study was not done. This device is a medical instrument (fiducial marker and delivery system), not an AI-powered diagnostic tool. Therefore, studies comparing human reader performance with and without AI assistance are not relevant or present in this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This is a hardware device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Adherence to established international standards (e.g., ISO 10993 series, implied by "cytotoxicity, irritation sensitization and implantation") and chemical characterizations.
- For functional performance: Design specifications and confirmed functional outcomes (e.g., "no detachment or breakage").
- For imaging visibility: Direct observation under ultrasound and radiographic imaging techniques.
- For MR compatibility: Adherence to ASTM F2503-08 and FDA guidance, meaning it met defined criteria for MR safety classifications.
- This is primarily a "truth by measurement/standard" or "truth by design specification" rather than a clinical "ground truth" derived from patient data.
The sample size for the training set:
- Not applicable. This device is hardware; there is no AI algorithm with a "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no AI algorithm, there is no training set or ground truth for such a set.

Summary

{0}------------------------------------------------

KIII895

Submitted By:

Marge Walls-Walker, Senior Regulatory Specialist: Engineering Wilson-Cook Medical, Inc./Cook Endoscopy 4900 Bethania Station Road (336) 744-0157 June 30, 2011

510(k) SUMMARY

Name of Device

Trade Name:	EchoTip ® Ultra Fiducial Needle
Common/Usual Name:	Implantable clip
Proposed Classification Name(s):	Marker, Radiographic, Implantable
	21CFR 878.4300, NEU, Class II, and
	Kit, Needle, Biopsy
	21 CFR 876.1075, FCG, Class II.

Predicate Devices

BiomarC® Preloaded Tissue Marker Device, 510(k) No. K042296, cleared September 20, 2004

EchoTip® Ultra Ultrasound Needle, 510(k) No. K083330, cleared February 6, 2009

Intended Use

This device is intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

Device Description

Substantial Equivalence

The EchoTip® Ultra Fiducial Needle is substantially equivalent to the Biomarce Preloaded Tissue Marker Device (510(k) No. K042296). Both devices are composed of fiducials (i.e., tissue markers) preloaded within a delivery system. Once deployed, the radiopaque fiducials permanently mark soft tissue for therapeutic procedures.

APR 2 7 2012

{1}------------------------------------------------

The delivery system (i.e., needle, sheath, handle, and stylet) of EchoTip® Ultra Fiducial Needle is substantially equivalent to the EchoTip® Ultra Ultrasound Needle (510(k) No. K083330). Both are dimpled, endoscopic ultrasound needles that may be used to inject materials into tissues. The delivery system of the EchoTip® Ultra Fiducial Needle is a modified version of the EchoTip® Ultra Ultrasound Needle. Specifically, a laser cut track with notch has been added to the needle to secure the fiducials and a thumb ring has been added to the stylet hub to improve the ergonomics of fiducial deployment.

Discussion of Tests and Test Results

Cook conducted verification and validation testing establishing that design outputs met the design inputs. No toxicological concerns for pure gold implanted fiducials were identified by a Risk Assessment inclusive of exhaustive extraction under polar and non-polar conditions with accompanying chemical characterizations as well as the following biocompatibility tests: cytotoxicity, irritation sensitization and implantation. Additionally, simulated use demonstrated that the device could be used effectively without detachment or breakage, the fiducials were visible under ultrasound and common radiographic imaging techniques, and the fiducials are MR Conditional, as defined by ASTM F2503-08, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment and the FDA guidance, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

Conclusions Drawn from the Tests

Outcomes from the evaluation of the EchoTip® Ultra Fiducial Needle provide evidence of its ability to mark soft tissues for future therapeutic procedures via endoscopic ultrasound placement and establish that it is substantially equivalent to the predicate devices in terms of intended use, biological safety and technological characteristics.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

APR 2 7 2012

Ms. Marge Walls-Walker Senior Regulatory Specialist: Engineering Wilson-Cook Medical, Inc. /Cook Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105

Re: K111895

Trade/Device Name: EchoTip® Ultra Fiducial Needle Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU and FCG Dated: April 19, 2012 Received: April 23, 2012

Dear Ms. Walls-Walker:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{3}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

EchoTip® Ultra Fiducial Needle

Indications for Use:

Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

Prescription Use XX

AND/OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

(21 CRF 801 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 Sign-Off)
Division of Radiologic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
810K. K111895

Page 1 of

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.