The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. On the proximal end of the device, there is a blue handle with three ports that lead to the three internal lumens. On one side of the handle there is a leur lock injection port. In the center of the handle is the wire guide lumen port that is capped with a clear adapter. This clear adapter allows for contrast injection while the wire guide is in place. The remaining port is used for balloon inflation with a stopcock to control air movement in and out of the balloon.

The balloon can be inflated to three sizes, 8.5 mm, 12 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter has a working length of 190cm. There are ink markings on the catheter for endoscopic visualization.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Howell D.A.S.H Extraction Balloon With Multiple Sizing." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study with specific acceptance criteria and performance data for an AI/ML-driven device.

Therefore, the information required to answer the prompt for acceptance criteria and the study that proves the device meets the acceptance criteria (specifically for an AI/ML-driven device) is not present in the provided text.

The document details:

Device Name: Howell D.A.S.H Extraction Balloon With Multiple Sizing
Intended Use: Endoscopic removal of biliary stones and for contrast injection.
Predicate Device: Tri-Ex Extraction Balloon with Multiple Sizing (K170292)
Minor Design Changes made to the predicate device (reduced catheter length and diameter, new ink markings).
Performance Data: States "Design verification and validation testing was performed as a result of the risk analysis assessment. Results from design validation and verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness."
Non-Clinical Testing: Functional Testing (Balloon Inflation, Distal Ink Marking Validation), Shelf Life Testing, Packaging Validation, and Biocompatibility testing.
Design Control Procedures (21 CFR § 820.30) were followed, including Risk Analysis (DFMECA).

The listed tests (Functional, Shelf Life, Packaging, Biocompatibility) are standard for physical medical devices to ensure mechanical integrity, shelf-life stability, and material safety, not for evaluating the performance of an AI/ML algorithm. There is no mention of an algorithm, AI, machine learning, or any form of software that would require the specific types of clinical validation outlined in the prompt (e.g., MRMC studies, standalone algorithm performance, ground truth establishment methods for a test set, etc.).

In conclusion, based on the provided text, it is not possible to fill out the table or answer the questions related to AI/ML device acceptance criteria and study proving performance. The document is for a traditional physical medical device seeking 510(k) clearance based on substantial equivalence.

Summary

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July 6, 2018

Wilson-Cook Medical, Inc. Tiffanny A. Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K173659

Trade/Device Name: Howell D.A.S.H Extraction Balloon With Multiple Sizing Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: GCA Dated: June 7, 2018 Received: June 11, 2018

Dear Tiffanny A. Thomas:

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 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.

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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 of medical device-related adverse events) (21 CFR 803); 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Glenn B. Bell -S

for

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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Indications for Use

510(k) Number (if known)

K173659

Device Name

Howell D.A.S.H Extraction Balloon With Multiple Sizing

Indications for Use (Describe)

This device is used for endoscopic removal of biliary stones and for contrast injection.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Name :Address:Phone:Date:	Tiffanny A. Thomas, Global Regulatory Affairs SpecialistWilson-Cook Medical, Inc.4900 Bethania Station Road, Winston-Salem NC 27105336-744-015711/2/2017
Name of Device:Trade Name:Common/Usual Name:	Howell D.A.S.H Extraction Balloon with Multiple SizingExtraction Balloon
Classification Name:	Biliary Catheter and Accessories21 CFR 876.5010, GCA, Class II
Predicate Device:	Tri-Ex Extraction Balloon with Multiple Sizing,K170292, 09/20/2017

Intended Use

This device is used for endoscopic removal of biliary stones and for contrast injection.

Device Description:

Substantial Equivalence:

Minor design changes were made to the predicate Tri-Ex Extraction Balloon with Multiple Sizing. These changes on the subject device include a reduced catheter length and diameter, along with new additional ink markings on the catheter. The subject extraction balloon is equivalent to the predicate device with respect to intended use, technological characteristics, and materials of construction.

Performance Data:

A Risk Analysis was completed to assess the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method.

Design verification and validation testing was performed as a result of the risk analysis assessment. Results from design validation and verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.

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K173659 Page 2 of 2

Summary on Non-Clinical Testing:

The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.

. Functional Testing
Balloon Inflation
. Distal Ink Marking Validation
Shelf Life Testing
Packaging Validation ●

The subject extraction balloon developed utilizing our internal Design Control procedures as required by 21 CFR § 820.30. Design Control Procedures are inclusive of the following elements:

Design Planning
Risk Analysis
. Design Input
Design Output
Design Review ●
Design Verification
. Design Validation
Process Validation
DFMECA/ PFMECA ●
Design Changes ●
Design Transfer

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices-Evaluation and testing within risk management process.

Conclusions:

We believe that the subject device is substantially equivalent to the predicate device in terms of intended use, key operating principles, materials and technological characteristics. We believe the risks associated with the modifications to the subject device have been adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device.

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.