The Expel Nephroureteral Stents are delivered percutaneously and are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage.

Expel™ Ureteral Stent System:

The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.

Device Description

The Expel Nephroureteral and Ureteral Stents are single-lumen, nonvascular intervention stents inserted using percutaneous access to provide internal and/or external drainage of the ureteropelvic junction to the bladder and stenting of the ureter. They are long-term indwelling devices not to exceed 30 days in the body.

Expel Nephroureteral Stents are available in outer diameters of 8.3 and 10.3 French, with working lengths ranging from 22 to 28 cm. They contain two pigtails each containing drainage holes. The locking, proximal pigtail forms in the renal pelvis, while the distal, concentric pigtail forms in the bladder. Drainage can occur internally (from the ureteropelvic junction to the bladder) or externally (from the bladder and ureteropelvic junction to the outside of the patient). Each pigtail has an adjacent radiopaque marker band. The distal end of the stent has a tapered tip and hydrophilic coating. The locking, proximal pigtail is activated by the Twist-Loc™ hub on the proximal end of the stent.

Expel Ureteral Stents are available in outer diameters of 6.3, 8.3, and 10.3 French, with working lengths ranging from 12 to 28 cm. The distal and proximal ends of the stent contain drainage holes within concentric pigtails. The pigtails form in opposite directions, with the proximal pigtail forming in the renal pelvis, and the distal pigtail forming in the bladder. Drainage occurs through pressure differential via gravity between the body cavities.

Each pigtail has an adjacent radiopaque marker band, and the distal end of the stent has a tapered tip and hydrophilic coating. A suture is looped through the most proximal drainage hole which allows for stent adjustment or removal during placement, and the suture is removed once placement is complete.

The Expel Nephroureteral and Ureteral Stents come with the following accessories that aid device placement.

Cannulas
Stabilizer
Plug/Cap
Pigtail Straightener

The Expel Nephroureteral and Ureteral Stents are similar in fundamental design, function, device materials, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device, the Percuflex™ Nephroureteral Stent and Percuflex™ Ureteral Stent. The modifications from the predicate device include:

Modified hub designs
New stent shaft material
Addition of radiopaque marker bands
Extended sizes/platforms
Modified packaging

AI/ML Overview

The provided text is a 510(k) summary for the Expel™ Nephroureteral Drainage Stent With Twist-Loc Hub System and Expel™ Ureteral Drainage Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance data in the typical format of a clinical study for an AI/ML device.

Therefore, many of the requested elements for an AI/ML device study are not present in this document.

Here's an analysis based on the information available in the document, and what is missing:

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

The document states: "The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Expel Nephroureteral and Ureteral Stents, including packaging, met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing."

However, a specific table detailing "acceptance criteria" (e.g., minimum tensile strength, maximum leakage rate) and the "reported device performance" (actual measured values) for each test is not provided in this summary. It only lists the types of tests performed.

Types of Bench Tests Performed (reported as meeting acceptance criteria):

Stent Dimensions OD and Working Length
Stent Shaft Tensile Strength
RO Marker Band Tensile Strength
Hub to Shaft Tensile Strength
Tip Tensile Strength
Distal Tip Robustness
Pigtail Recovery
Pigtail Retention/Removal Force
Resistance to Deformation
Kink Resistance
Flow Recovery Post Kinking
Resistance to Liquid Leakage - Under Pressure and During Aspiration/Vacuum
Stent / RO Marker Radiopacity
MRI Compatibility
Urine Compatibility
Cannula / Stent Connection Force
Cannula to Stent / Stabilizer Compatibility
Guidewire to Stent / Cannula Compatibility
Flexible Stiffening Cannula Hub to Shaft Tensile Strength
Stabilizer to Flexible Stiffening Cannula Connection Force
Coefficient of Friction
Sterile Barrier Integrity
Pouch Seal Strength
Thermoformed Tray Visual
Shelf Life
Sterilization
Biocompatibility

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 explicitly stated for each bench test. For bench testing, sample sizes typically vary depending on the specific test and statistical requirements for demonstrating equivalence/conformance.
Data Provenance: Not applicable in the context of bench testing for a medical device. The tests are performed in a laboratory setting by the manufacturer (Boston Scientific Corporation).

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):

This information is not applicable to this type of device submission. The tests performed are physical and material property tests (bench testing), not clinical or diagnostic evaluations requiring expert adjudication of "ground truth."

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

This information is not applicable as there is no expert review or "ground truth" to adjudicate in these bench tests.

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:

This information is not applicable. This submission is for a physical medical device (ureteral stent), not an AI/ML-driven diagnostic or assistive technology.

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

This information is not applicable. This is not an algorithm, but a physical medical device.

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

This information is not applicable. For this type of device, "ground truth" relates to measurable physical and material properties meeting predetermined specifications, not clinical diagnostic accuracy. The "ground truth" is adherence to predefined engineering specifications and performance standards during bench testing.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device, not an AI/ML model that requires training data.

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

This information is not applicable. See point 8.

In Summary:

The provided document details a 510(k) submission for a ureteral stent, focusing on demonstrating substantial equivalence through a series of bench tests. It lists the types of tests performed and states that the device met the predetermined acceptance criteria. However, it does not provide the specific numerical acceptance criteria or the measured performance results for each test. Furthermore, as this is a physical medical device and not an AI/ML product, most of the questions related to AI/ML study design, such as expert ground truth, sample sizes for test/training sets, adjudication methods, or MRMC studies, are not relevant and consequently not present in this document.

Summary

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

October 17, 2014

Boston Scientific Corp Matt Beauchane Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K141344

Trade/Device Name: Expel™ Nephroureteral Drainage Stent With Twist-Loc Hub System Expel™ Ureteral Drainage Stent System Regulation Number: 21 CFR 876.4620 Regulation Name: Uretal Stent Regulatory Class: Class II Product Code: FAD Dated: October 9, 2014 Received: October 10, 2014

Dear Matt Beauchane.

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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" (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 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 Industry and Consumer Education 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.

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for Benjamin 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) K141344

Device Name

ExpelTM Nephroureteral Stent System with Twist-LocTM Hub

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K141344

Device Name Expel™ Ureteral Stent System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Per 21 CFR §807.92

Submitter's Nameand Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311USA
Contact Nameand Information	Matt BeauchaneRegulatory Affairs SpecialistPhone: 763-494-1789Fax: 763-494-2222Email: matt.beauchane@bsci.com
Date Prepared	20-Aug-2014
Proprietary Names	Expel™ Nephroureteral Stent System with Twist-Loc™ Hub
	Expel™ Ureteral Stent System
Common Name	Ureteral Stent
Classification	Classification: Class IIRegulation: 21 CFR 876.4620Product Code: FADClassification Panel: Gastroenterology/Urology
Predicate Device	Percuflex™ Nephroureteral Stent and Percuflex™ Ureteral Stent(K924608, 26-Jan-1994)
Intended Use /Indications for Use	Expel™ Nephroureteral Stent System with Twist-Loc™ Hub:
	The Expel Nephroureteral Stents are delivered percutaneously andare intended to establish internal drainage from the ureteropelvicjunction to the bladder while maintaining external access to thestent, as well as providing external drainage.Expel™ Ureteral Stent System:

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Device Description The Expel Nephroureteral and Ureteral Stents are single-lumen, nonvascular intervention stents inserted using percutaneous access to provide internal and/or external drainage of the ureteropelvic junction to the bladder and stenting of the ureter. They are long-term indwelling devices not to exceed 30 days in the body.

Expel Nephroureteral Stents are available in outer diameters of 8.3 and 10.3 French, with working lengths ranging from 22 to 28 cm. They contain two pigtails each containing drainage holes. The locking, proximal pigtail forms in the renal pelvis, while the distal, concentric pigtail forms in the bladder. Drainage can occur internally (from the ureteropelvic junction to the bladder) or externally (from the bladder and ureteropelvic junction to the outside of the patient). Each piqtail has an adjacent radiopaque marker band. The distal end of the stent has a tapered tip and hydrophilic coating. The locking, proximal pigtail is activated by the Twist-Loc™ hub on the proximal end of the stent.

The Expel Nephroureteral and Ureteral Stents come with the following accessories that aid device placement.

. Cannulas
Stabilizer .
Plug/Cap ●
Pigtail Straightener .
The Expel Nephroureteral and Ureteral Stents are similar in fundamental design, function, device materials, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device, the Percuflex™ Nephroureteral Stent and Percuflex™ Ureteral Stent. The modifications from the predicate device include:
. Modified hub designs
. New stent shaft material
. Addition of radiopaque marker bands
. Extended sizes/platforms
Modified packaging ●

Comparison of Technological Characteristics

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Performance Data The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Expel Nephroureteral and Ureteral Stents, including packaging, met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- · Stent Dimensions OD and Working Length
- Stent Shaft Tensile Strength
- · RO Marker Band Tensile Strength
- Hub to Shaft Tensile Strength
- · Tip Tensile Strength
- Distal Tip Robustness
- · Pigtail Recovery
- · Pigtail Retention/Removal Force
- Resistance to Deformation
- Kink Resistance
- Flow Recovery Post Kinking
- · Resistance to Liguid Leakage -Under Pressure and During Aspiration/ Vacuum
- · Stent / RO Marker Radiopacity
- MRI Compatibility
· Urine Compatibility
Cannula / Stent Connection Force
· Cannula to Stent / Stabilizer Compatibility
· Guidewire to Stent / Cannula Compatibility
· Flexible Stiffening Cannula Hub to Shaft Tensile Strength
· Stabilizer to Flexible Stiffening Cannula Connection Force
· Coefficient of Friction
· Sterile Barrier Integrity
· Pouch Seal Strength
Thermoformed Tray Visual
Shelf Life
· Sterilization
· Biocompatibility

Conclusion

Boston Scientific has demonstrated that the modifications made for the Expel Nephroureteral and Ureteral Stents are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the predicate device. Percuflex™ Nephroureteral Stent and Percuflex™ Ureteral Stent.

Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).