The Wilson-Cook Celiac Plexus Neurolysis Needle is used to deliver neurolysing agents to the celiac plexus under guidance by endoscopic ultrasound. It is supplied sterile and is intended for single use only.

Device Description

The Wilson-Cook Celiac Plexus Neurolysis Needle is comprised of a stainless steel echogenic pencil point needle with four side openings toward the tip. The handle allows a stroke of approximately 8-cm to advance the needle into position. The outer sheath of the device is comprised of polytetrafluoroethylene.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Wilson-Cook Celiac Plexus Neurolysis Needle. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study involving patient outcomes or complex metrics.

Therefore, much of the requested information about acceptance criteria, study design, expert involvement, and ground truth is not present in this type of regulatory document. The document describes a "simulated use testing and clinical evaluation," but the specifics of these "tests" are not detailed in a way that allows for a breakdown according to the request.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from "Substantial Equivalence" and "Discussion of Tests"): For a 510(k), the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as existing legally marketed predicate devices. This is achieved by showing similar technological characteristics and intended use, and that performance testing (even if not explicitly detailed with specific pass/fail metrics) supports this equivalence.
- Simulated Use Testing: The device must perform as intended during simulated use.
- Clinical Evaluation: The device must perform as intended during clinical evaluation.
- Biocompatibility/Sterility/Shelf Life: While not explicitly stated as "acceptance criteria," these are standard requirements for medical devices, and their successful completion would be implicit in obtaining 510(k) clearance.
Reported Device Performance:
- "Test results provide reasonable assurance the device will perform in accordance with its intended use."
- "Being similar to predicate devices with respect to intended use and technology, and having test results that indicate the device will perform in accordance with its intended use, the Wilson-Cook Celiac Plexus Neurolysis Needle meets the requirements for 510(k) substantial equivalence."

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (Summary)
Device functions as intended during simulated use.	"Test results provide reasonable assurance the device will perform in accordance with its intended use."
Device functions as intended during clinical evaluation.	"Test results provide reasonable assurance the device will perform in accordance with its intended use."
Device has similar technological characteristics to predicates for intended use.	"Similar to predicate devices with respect to intended use and technology."
Device is safe and effective as predicate devices.	Meets "requirements for 510(k) substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document mentions "simulated use testing and clinical evaluation" but gives no details about sample size (e.g., number of uses, number of patients), or data provenance. In a 510(k) summary, clinical data might be extremely limited or not present if substantial equivalence can be shown through other means (e.g., bench testing, comparison to predicate).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This type of detail is typically associated with studies involving diagnostic accuracy or interpretations where expert consensus defines "ground truth." This document is for a medical device (a needle) and its functional performance, not a diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods are relevant for studies where a "ground truth" needs to be established from multiple expert opinions (e.g., imaging studies). This is not that kind of study as 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 relevant to the type of device (a physical needle) or the regulatory submission (510(k) for substantial equivalence of a device, not an AI diagnostic tool).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This question pertains to AI algorithms. The device is a surgical needle.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Functional performance and safety. For a device like a needle, "ground truth" would likely relate to its functional attributes:
- Ability to penetrate tissues (simulated or cadaveric).
- Ability to deliver agents to the celiac plexus.
- Integrity of the needle (no breakage, bending).
- Flow rate suitability.
- Biocompatibility.
- Sterility maintenance.
- These are assessed through engineering tests, simulated use, and potentially limited clinical observation, not typically "expert consensus" on an image or pathology.

8. The sample size for the training set

Not applicable/Not provided. This concept is relevant for machine learning algorithms. The device is a physical medical instrument.

9. How the ground truth for the training set was established

Not applicable/Not provided. Same as above.

Summary

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

Wilson-Cook Medical, Inc. Ms. Margaret J. Posner Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, North Carolina 27105-4191

JUL 2 7 2015

K030618 Trade/Device Name: Wilson-Cook Celiac Plexus Neurolysis Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia conduction needle Regulatory Class: II Product Code: BSP, GAA Dated (Date on orig SE ltr): February 14, 2003 Received (Date on orig SE ltr): February 26, 2003

Dear Ms. Posner,

Re:

This letter corrects our substantially equivalent letter of May 27, 2003.

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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Wilson-Cook Celiac Plexus Neurolysis Needle Device Name: __

Indications For Use:

(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 General, Restorative
and Neurological Devices

510(k) Number K030618

Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)

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PREMARKET NOTIFICATION FOR THE WILSON-COOK CELIAC PLEXUS RE: NEUROLYSIS NEEDLE 10306

510(K) SUMMARY OF SAFETY AND EFFECTIVENE 9.

MAY 2 7 2003

Submitted By:

Margaret J. Posner, Regulatory Affairs Specialist Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105-4191 336.744.0157

Names of Device: Wilson-Cook Celiac Plexus Neurolysis Needle Trade Name: Common/Usual Name: Celiac Plexus Neurolysis Needle Needle, Aspiration and Injection, Disposable; Classification Name/ Code: 21 CFR § 878.4800 (GAA); Class II

Predicate Devices:

The Wilson-Cook Celiac Plexus Neurolysis Needle is comparable to predicate devices including the Wilson-Cook Variable Length GI Injection Needle (K941305), the Wilson-Cook Endoscopic Ultrasound Needle (K934356), and the InjecTx PercuTx- Injection/ Aspiration Needle Probe/Device (K994151).

Device Description:

Intended Use:

Substantial Equivalence:

The Wilson-Cook Celiac Plexus Neurolysis Needle is comparable to predicate devices with similar technological characteristics and intended use, specifically to perform endoscopic injection procedures.

Discussion of Tests and Test Results:

The Wilson-Cook Celiac Plexus Neurolysis Needle underwent simulated use testing and clinical evaluation. Test results provide reasonable assurance the device will perform in accordance with its intended use.

Conclusion:

Being similar to predicate devices with respect to intended use and technology, and having test results that indicate the device will perform in accordance with its intended use, the Wilson-Cook Celiac Plexus Neurolysis Needle meets the requirements for 510(k) substantial equivalence.

Confidential

2/14/03

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).