The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to electrosurgically cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract. It is supplied sterile and is intended for single use.

Device Description

The Wilson-Cook Cystotome consists of an inner wire with needle knife tip, a 5 Fr inner sheath, and a 10 Fr outer sheath equipped with a diathermic ring at its distal tip. The proximal end of the device will include a handle with connectors for active cords and a fitting to provide for injection of contrast fluid.

AI/ML Overview

The provided text describes a 510(k) submission for the Wilson-Cook Cystotome, a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than proving effectiveness through a study against acceptance criteria. Therefore, the information requested in the prompt, which pertains to AI/algorithm performance and detailed study methodologies with specific acceptance criteria, is not present in the provided document.

Here's why and what can be inferred:

Device Type: The Wilson-Cook Cystotome is an "Endoscopic electrosurgery device" for surgical procedures, not an AI or diagnostic imaging device.
Submission Type: A "510(k) Premarket Notification" is for devices that are "substantially equivalent" to legally marketed predicate devices. This means the primary evidence required is a comparison of the new device's technological characteristics and intended use to an existing device, rather than extensive clinical trials with pre-defined performance metrics like sensitivity, specificity, etc., against a gold standard.
"Discussion of Tests and Test Results": The document briefly mentions "electrical testing, simulated use testing, and clinical testing." However, it does not elaborate on the specific acceptance criteria for these tests, the methodologies, sample sizes, or a detailed report of the results that would allow for filling the requested table regarding device performance against acceptance criteria. The "clinical testing" mentioned is likely to demonstrate safety and basic performance in a clinical setting, not a comparative effectiveness study in the sense of AI.
Lack of AI-specific elements: The prompt asks about "AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "ground truth for the training set." These are all concepts related to AI or machine learning device evaluation, which are completely irrelevant to a surgical instrument like the Wilson-Cook Cystotome.

Therefore, I cannot populate the table or answer most of the questions as the provided document does not contain the required information.

If this were an AI/ML device submission, the acceptance criteria would typically be detailed quantitative performance metrics (e.g., sensitivity, specificity, AUC) and the study would describe a rigorous clinical or retrospective evaluation to meet those metrics. The provided document is for a traditional medical device and follows a different regulatory pathway.

Summary

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OCT 1 7 2002

510(k) for Wilson-Cook Cystotome

K022595 -12-
Page 1 of 1

9. 510(K) SUMMARY

Submitted By:

Margaret J. Posner, Regulatory Affairs Specialist Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105-4191 336-744-0157 July 29, 2002

Names of Device:

Trade Name: Common/Usual Name: Classification Name:

Wilson-Cook Cystotome Endoscopic electrosurgery device Endoscopic electrosurgery accessory 21 CFR 876.4300 (78KNS); Class II

Predicate Devices:

The Wilson-Cook Cystotome is comparable to predicate devices including the Wilson-Cook Needle Knife Papillotome (K972674); the Boston Scientiffic Autotome™ RX (K013153); and the Boston Scientific Microvasive Gold Probe (K970278).

Device Description:

Intended Use:

Substantial Equivalence:

The Wilson-Cook Cystotome is comparable to predicate devices with similar technological characteristics and intended use, specifically to perform electrosurgical procedures through an endoscope.

Discussion of Tests and Test Results:

The Wilson-Cook Cystotome underwent electrical testing, simulated use testing, and clinical testing. Test results provide reasonable assurance the device will perform in accordance with its intended use.

Conclusions Drawn from Tests:

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 Cystotome meets the requirements for 510(k) substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN" written around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services.

OCT 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret J. Posner Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105

Re: K022595

Trade/Device Name: Wilson-Cook Cystotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories

Regulatory Class: II Product Code: 78 KNS Dated: August 2, 2002 Received: August 5, 2002

Dear Ms. Posner:

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 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); 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.

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This letter will allow you to begin marketing your device as described in your 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 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K02259

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Lehman

(Division Sign-Off) Division of Reproductive and Radiological Device. 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).