The RSH Biliary Stone Removal Device is used for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.

Device Description

The RSH Biliary Stone Removal Device is a single-use quad lumen polyurethane balloon catheter system which can be placed with or without the need of a guide-wire. The balloon is inflated using saline with the supplied 10ml syringe. The device is equipped with two flush ports, proximal and distal to the balloon, for contrast injection. The device is provided sterile. The device is similar to the predicate device, except the balloon is polyurethane rather than latex, the fill is saline rather than air, and 4 lumens are used rather than ≤ 3 lumens. With more lumens, a somewhat larger balloon diameter range, 9 -25 mm, is achieved in one size rather than three sizes.

AI/ML Overview

The RSH Biliary Stone Removal Device is a medical device for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Test	Reported Device Performance
Biocompatibility
Cytotoxicity	Yielded passing results
Sensitization	Yielded passing results
Irritation	Yielded passing results
Bench Testing
Balloon - Sizing/Compliance, Multiple Inflation, Burst, and Leak	All catheters performed through a range of 9mm - 25mm without failure, leak, or rupture; inflated multiple times without failure, and inflated to 25mm without leakage. The working range was demonstrated.
Flush Volume	All catheters flushed lumens at or above the specified minimum flow rate demonstrating acceptable flushing capability.
Manifold – Leak	All catheters held the minimum pressure at all three ports demonstrating acceptable leak resistance.
Balloon – Inflation/Deflation	All catheters inflated and deflated as required demonstrating acceptable balloon performance.
Manifold – Tensile Strength	All catheters met the minimum bond strength with 95% Confidence/ 95% Reliability demonstrating acceptable break resistance.
Model / Wire Loading, Endoscope Compatibility, Kink Resistance (flexibility)	All catheters loaded and advanced over a .035" guide wire, were delivered through the endoscope channel, endured a 90° deflection without kinking or breaking, and endured minimum tensile load without bursting when pulled back against endoscope. Acceptable handling characteristics were demonstrated.
Stone Dislodgement Effectiveness	All catheters and the predicate devices tested dislodged the stone without balloon rupture. The catheter demonstrated comparable effectiveness to the predicate device. (This indicates the new device is at least as effective as the predicate in its primary function of stone removal.)

2. Sample Size Used for the Test Set and Data Provenance:

The provided information describes a 510(k) premarket notification for a medical device. This typically involves bench testing and biocompatibility testing, not clinical studies with patients. Therefore, terms like "test set" in the context of patient data, data provenance (country of origin), and retrospective/prospective study design are not applicable here.

The "test set" for this device consists of the physical devices themselves and the environmental conditions under which they were tested. The provenance of the data is from the bench testing laboratories conducting the specified tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This type of information (number of experts, qualifications) is not applicable for a 510(k) submission focusing on bench testing and biocompatibility. Ground truth in this context is established by the performance of the device against predefined engineering specifications and validated test methods, rather than expert interpretation of a diagnostic outcome. The tests are designed to objectively measure physical properties and biological responses.

4. Adjudication Method for the Test Set:

An adjudication method (like 2+1, 3+1, etc.) is not applicable for this type of device submission. Adjudication methods are used in clinical trials, particularly for imaging studies, where independent experts review cases to arrive at a consensus for ground truth. For this device, the "ground truth" is determined by whether the device's physical properties and performance meet the specified engineering and biocompatibility criteria through validated testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to diagnostic devices (often imaging algorithms) where human readers interpret medical images or data. This device is an interventional tool, and its efficacy is primarily demonstrated through bench testing simulating its intended use and comparison to a predicate device. Therefore, questions of "human readers improve with AI vs without AI assistance" are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical instrument, not an AI algorithm. Its performance is inherent to its design and manufacturing, and it is intended to be used by a human operator (endoscopist). Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily established by:

Engineering Specifications: Predefined performance metrics and acceptable ranges for physical properties (e.g., balloon size range, flush volume, tensile strength, leak resistance, inflation/deflation speed).
Validated Test Methods: Standardized procedures to conduct the bench tests and measure the device's performance against these specifications.
Biocompatibility Standards: Established criteria for cytotoxicity, sensitization, and irritation based on ISO standards and FDA guidance.
Predicate Device Performance: Direct comparison to the established performance of the legally marketed predicate device (Extractor™ Retrieval Balloon catheters) to demonstrate comparable effectiveness in stone dislodgement.

8. The Sample Size for the Training Set:

Not applicable. This submission focuses on a physical medical device, not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as point 8.

Summary

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RSH LLC

5121 Feagan St
Houston, TX 77007
Phone: (713) 679-8657

510(k) Number
Contact Person:	Amy SpringsManager of RSH LLC5121 Feagan StHouston, TX 77007Phone: (713) 679-8657

AUG 07 2013

Summary Date:	June 3, 2013
Product Trade Name:	RSH Biliary Stone Removal Device
Common Name:	Dislodger, stone, biliary (LQR)Catheter, biliary, diagnostic (FGE)
Classification Name:	Biliary catheter and accessories (21 CFR 876.5010, Class 2)
Predicate(s):	K102082/K041606 Extractor™ Retrieval Balloon catheters
Intended Use:	The RSH Biliary Stone Removal Device is used for endoscopicremoval of stones in the biliary system or for contrast injectionwhile occluding the duct.
Device Description:	The RSH Biliary Stone Removal Device is a single-use quadlumen polyurethane balloon catheter system which can be placedwith or without the need of a guide-wire. The balloon is inflatedusing saline with the supplied 10ml syringe. The device isequipped with two flush ports, proximal and distal to the balloon,for contrast injection. The device is provided sterile.The device is similar to the predicate device, except the balloon ispolyurethane rather than latex, the fill is saline rather than air, and4 lumens are used rather than ≤ 3 lumens. With more lumens, asomewhat larger balloon diameter range, 9 -25 mm, is achieved inone size rather than three sizes.

Safety & Performance:

	Equivalency was demonstrated through comparison to thepredicate device, biocompatibility, and bench testing.
	Biocompatibility testing consisted of cytotoxicity, sensitizationand irritation, all of which yielded passing results.
	Bench testing conducted is listed below along with conclusions:
Balloon - Sizing/Compliance. MultipleInflation. Burst and Leak	All catheters performed through a range of 9mm - 25mm without failure, leak, or rupture; inflated multipletimes without failure, and inflated to 25mm withoutleakage. The working range was demonstrated.
Flush Volume	All catheters flushed lumens at or above the specifiedminimum flow rate demonstrating acceptable flushingcapability.

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RSH LLC

5121 Feagan St Houston, TX 77007 Phone: (713) 679-8657

K131642 pg 2 of 2

Manifold – Leak	All catheters held the minimum pressure at all threeports demonstrating acceptable leak resistance.
Balloon – Inflation/Deflation	All catheters inflated and deflated as requireddemonstrating acceptable balloon performance..
Manifold – TensileStrength	All catheters met the minimum bond strength with95% Confidence/ 95% Reliability demonstratingacceptable break resistance.
Model / Wire Loading.Endoscope Compatibility,Kink Resistance(flexibility)	All catheters loaded and advanced over a .035" guidewire, were delivered through the endoscope channel.endured a 90° deflection without kinking or breaking.and endured minimum tensile load without burstingwhen pulled back against endoscope. Acceptablehandling characteristics were demonstrated.All catheters and the predicated devices testeddislodged the stone without balloon rupture. Thecatheter demonstrated comparable effectiveness to thepredicate device.

Based on the results of comparison, biocompatibility testing and bench testing summarized above, the RSH Biliary Stone Removal Device has been demonstrated to be acceptable for the intended use and substantially equivalent to the predicate device in safety, effectiveness and performance.

Conclusion:

1 This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.

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Public Health Service

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

August 7, 2013

RSH LLC % Amy Springs Manager 5121 Feagan Street HOUSTON TX 77007

Re: K131642

Trade/Device Name: RSH Biliary Stone Removal Device Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: LQR, FGE Dated: June 3, 2013 Received: June 4, 2013

Dear Amy Springs,

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. You must

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Page 2 - Amy Springs

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 (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.

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/ReportalProblem/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,

Herbert P. Lerner -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): K131642

Device Name: RSH Biliary Stone Removal Device

Indications for Use:

The RSH Biliary Stone Removal Device is used for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131642 510(k) Number _

Page 1 of 1

Submission Page 11

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.