TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING by WILSON-COOK MEDICAL, INC.

The proposed Extraction Balloon is a modification to existing extraction balloons currently marketed by Wilson-Cook. The Tri-Ex Extraction Balloon with Multiple Sizing is supplied sterile and intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Tri-Ex Extraction Balloon) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a typical AI/software device submission would. This document is for a physical medical device, not a software or AI product.

Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details," are not applicable and are not present in the provided text.

The device's performance is assessed through substantial equivalence to a predicate device, meaning it is considered equally safe and effective based on similar design, materials, and intended use, rather than meeting specific quantifiable performance metrics through a clinical study.

Here's a breakdown of what can be extracted or inferred based on the document's content:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (K953951)	Believed to be substantially equivalent.
Safe and effective for intended use	Believed to be substantially equivalent in terms of Intended Use, performance characteristics tested, and biocompatibility.
Use for endoscopic removal of stones in the biliary system	Intended use: endoscopic removal of stones in the biliary system.
Use for contrast injection	Intended use: contrast injection.
Sterility	Supplied sterile.
Single use only	Intended for single use only.

Explanation: The "acceptance criteria" for this type of device (a Class II medical device cleared via 510(k)) primarily revolve around demonstrating "substantial equivalence" to a legally marketed predicate device. This means the device is as safe and effective as the predicate. The performance data section broadly states that the device is believed to be substantially equivalent in terms of "Intended Use, performance characteristics tested and biocompatibility." No specific numerical performance metrics (e.g., success rate, complication rate) are provided in this summary.

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

Sample Size: Not applicable / Not mentioned. This submission relies on substantial equivalence to a predicate device, not a new clinical trial with a "test set" in the context of AI/software.
Data Provenance: Not applicable / Not mentioned.

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)

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

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

Adjudication method: Not applicable.

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

MRMC study: No, this is not an AI/software device.
Effect size: Not applicable.

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

Standalone performance: No, this is not an AI/software device.

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

Type of ground truth: Not applicable in the context of an AI/software device. For this physical device, the "ground truth" concept aligns with established performance and safety of the predicate device, validated through various non-clinical (e.g., bench testing, biocompatibility) and potentially some clinical safety data (though not detailed here as a study).

8. The sample size for the training set

Sample size for training set: Not applicable. This is not an AI/software device.

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

How ground truth was established: Not applicable. This is not an AI/software device.

In summary: The document describes a traditional medical device cleared via the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting results from a new clinical study with specific performance metrics and ground truth establishment, as would be common for AI/software devices. Therefore, much of the requested information regarding "acceptance criteria" and "study details" is not present or relevant in the context of this 510(k) summary for a physical extraction balloon.

Summary

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FEB 27 2004

510(k) Summary of Safety and Effectiveness: K040129

SPONSOR:	Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105
CONTACT/SUBMITTER:	Marge Walls-Walker Regulatory Affairs Specialist [336] 744-0157 Ex.290
DATE OF SUBMISSION:	February 13, 2004
DEVICE:	Tri-Ex Extraction Balloon with Multiple Sizing
Trade Name:	Tri-Ex Extraction Balloon with Multiple Sizing
Common Name:	Extraction Balloon
Classification:	Catheter, Biliary, Surgical, Class II 21 CFR § 876.5010 78 GCA
PREDICATE DEVICES:	Wilson-Cook Triple Lumen Balloon Stone Extractor (K953951)
INTENDED USE:	Wilson-Cook's Tri-Ex Extraction Balloon with Multiple Sizing is for endoscopic removal of stones in the biliary system and for contrast injection.
DEVICE DESCRIPTION:	The proposed Extraction Balloon is a modification to existing extraction balloons currently marketed by Wilson-Cook. The Tri-Ex Extraction Balloon with Multiple Sizing is supplied sterile and intended for single use only.
COMPARISON OF CHARACTERISITICS:	We believe the proposed device to be substantially equivalent to currently marketed Wilson-Cook biliary extraction balloons as cleared by K953951
PERFORMANCE DATA:	We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 2004

Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105

Re: K040129

Trade/Device Name: Wilson-Cook Tri-Ex Extraction Balloon with Multiple Sizing Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 GCA Dated: February 13, 2004 Received: February 17, 2004

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 cither 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 Section S10(k) I mis lotter 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon

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): _KO40129

Device Name: Wilson-Cook Tri-Ex Extraction Balloon with Multiple Sizing

Indications for Use:

The Tri-Ex Extraction Balloon with Multiple sizing is used for endoscopic removal of stones in the biliary system and for contrast injection.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only
(Per 21 CFR § 801.109

Over-the-Counter

Nancy broadon

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

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.