The Amplatz Type Renal Sheaths are manufactured from extruded tubing and are available in 17cm lengths with the following interior diameters in French units (F): 14F, 16F, 18F, 20F, 22F, 24F, 26F, 28F and 30F. A 20cm length renal sheath with a 30F interior diameter is also available. The Amplatz Type Renal Sheaths are constructed of blue PTFE (polytetrafluoroethylene) material, which is bismuth loaded for fluoroscopy. The tip is designed for atraumatic placement and ease of advancement over dilators or balloons.

The Amplatz Type Renal Sheath Set includes four 17cm length (single) Amplatz Type Renal Sheaths (offered in sizes: 24F, 26F, 28F and 30 F). There are no differences between the renal sheaths offered in the Amplatz Type Renal Sheath Set and the abovementioned Amplatz Type Renal Sheaths. Aside from the renal sheaths, the Amplatz Type Renal Sheath Set contains no additional components.

The Clear Renal Sheath is a 30F, 17 cm length sheath with a guidewire notch at the proximal end and a radiopaque marker at the distal tip. Renal sheaths are used to establish percutaneous access for instrumentation.

AI/ML Overview

The provided FDA document (K172929) describes the 510(k) premarket notification for the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath. This document focuses on demonstrating substantial equivalence to a predicate device based on performance testing (bench evaluation), rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the details requested in the prompt regarding AI performance, human reader studies, and large-scale clinical ground truth establishment are not applicable.

Here's an analysis of the provided text in relation to your request:

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

The document lists the following performance tests conducted for the devices:

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Sheath Length	Met requirements
Sheath Outer Diameter	Met requirements
Sheath Distal Tip Shape	Met requirements
Sheath Distal Tip Inner Diameter	Met requirements
Sheath Inner Diameter	Met requirements
Sheath Proximal End OD Edge	Met requirements
Guidewire Compatibility (Clear Renal Sheath only)	Met requirements
Radiopaque Marker Location (Clear Renal Sheath only)	Met requirements
Compression Strength (Clear Renal Sheath only)	Met requirements

Additionally, Biocompatibility Testing was performed in accordance with EN ISO 10993-1: 2009 for the following:

MEM Elution Cytotoxicity: Met requirements
Guinea Pig Maximization Sensitization: Met requirements
Intracutaneous Reactivity: Met requirements
Acute Systemic Injection: Met requirements

The document explicitly states: "All testing performed met requirements. The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are considered safe and effective for their intended use."

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

Sample Size: The document states "Boston Scientific has conducted performance testing with representative samples of the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath." It does not specify the exact number of samples used for each test.
Data Provenance: The tests were bench evaluations conducted by Boston Scientific Corporation. The location is implied to be within Boston Scientific's facilities, likely in the USA (given the company's location in Marlborough, MA). These are prospective tests performed on newly manufactured devices for the purpose of this submission, not retrospective analysis of existing data.

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 is not applicable to the type of device and study described. The ground truth for this device is based on engineering specifications and physical measurements/biocompatibility testing, not expert clinical interpretation. Experts involved would be engineers, material scientists, and toxicologists responsible for the design, testing, and interpretation of bench evaluations and biocompatibility assessments, but the document does not specify their number or qualifications as it would for a clinical study.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where multiple readers' interpretations need to be reconciled to establish a ground truth. For bench testing, the results are typically objectively measured against specifications.

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

Not applicable. This is a medical device (renal sheath), not an AI diagnostic algorithm. No MRMC study was performed as it is not relevant to demonstrating the safety and effectiveness of this type of device.

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

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

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

The ground truth for the performance testing cited is based on engineering specifications (e.g., specific dimensions, material properties, mechanical strength) and established biocompatibility standards (EN ISO 10993-1). For example, a sheath's inner diameter is measured and compared to its design specification, or a biocompatibility test result is compared to a pass/fail threshold defined by the standard.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The device's design and manufacturing processes are validated through traditional engineering methods and quality controls.

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

Not applicable. As there is no training set for a physical device, no ground truth was established for one.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".

January 10, 2018

Boston Scientific Corporation Daniel FitzDaniel Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K172929

Trade/Device Name: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LJE Dated: December 8, 2017 Received: December 11, 2017

Dear Daniel FitzDaniel:

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Benjamin R. Fisher -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) To be determined. K 172929

Device Name

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath

Indications for Use (Describe)

The Amplatz Type Renal Sheath is recommended for the establishment of percutaneous access.

The Amplatz Type Renal Sheath Set is recommended for the establishment of percutaneous access.

The Clear Renal Sheath is recommended for the establishment of percutaneous access.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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SECTION 5 510(k) SUMMARY

510(k) Summary for Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath

A. Sponsor

Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01756

B. Contact

Daniel FitzDaniel Specialist, Regulatory Affairs 508-683-4156 Dan.FitzDaniel@bsci.com or

Virginia Garcia Manager, Regulatory Affairs 508-683-4430 Virginia.Garcia@bsci.com

Date Prepared: 8 December 2017

C. Device Name

Trade name:	Amplatz Type Renal Sheaths, Amplatz Type RenaSheath Set, Clear Renal Sheath
Common/usual name:	Catheter, Nephrostomy
Classification Name:	None
Regulation Name:	Unclassified
Regulation Class:	II
Product Code:	LJE
Panel:	Gastroenterology/Urology

D. Predicate Device

Trade name:	Ultraxx™ Nephrostomy Balloon Set
Common/usual name:	Catheter, Nephrostomy
Classification Name:	LJE – Catheter, Nephrostomy

Premarket Notification: K024050, February 27, 2003 Ultraxx TM Nephrostomy Balloon Set (formerly Cook Nephrostomy Balloon Dilation Catheter Set, Cook Urological, Inc., Spencer, IN)

E. Device Description

Amplatz Type Renal Sheaths

Proprietary and Confidential Information of Boston Scientific Corporation

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SECTION 5

510(k) SUMMARY

Amplatz Type Renal Sheath Set

Clear Renal Sheath

F. Intended Use

Amplatz Type Renal Sheath and Amplatz Type Renal Sheath Set The Amplatz Type Renal Sheath is recommended for the establishment of percutaneous access.

Clear Renal Sheath

The Clear Renal Sheath is recommended for the establishment of percutaneous access.

G. Indications for Use

Same as Intended Use.

H. Technological Characteristics

The Amplatz Type Renal Sheaths and Amplatz Type Renal Sheath Set consist of an extruded tube (made of radiopaque PTFE) that has a tapered tip designed for atraumatic placement and ease of advancement over dilators or balloons.

The Clear Renal Sheath consists of an extruded tube made of clear polyvinyl chloride with a guide-wire notch at the proximal end and a radiopaque marker at the distal tip. The Clear Renal Sheath has a tapered tip designed for atraumatic placement and ease of advancement over dilators or balloons.

I. Substantial Equivalence

A direct comparison of key characteristics has been performed and demonstrates that the proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are substantially equivalent to the predicate device in terms of intended use,

Proprietary and Confidential Information of Boston Scientific Corporation

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Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set & Clear Renal Sheath Boston Scientific Traditional 510(k)

SECTION 5

510(k) SUMMARY

technological characteristics, method of sterilization and performance characteristics. The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are as safe and effective as the predicate device.

J. Performance Testing (Bench Evaluation)

Boston Scientific has conducted performance testing with representative samples of the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath.

The performance testing included:

Sheath Length
Sheath Outer Diameter
Sheath Distal Tip Shape
Sheath Distal Tip Inner Diameter
Sheath Inner Diameter
Sheath Proximal End OD Edge
Guidewire Compatibility (Clear Renal Sheath only)
Radiopaque Marker Location (Clear Renal Sheath only) ●
Compression Strength (Clear Renal Sheath only)

The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath were evaluated in accordance with EN ISO 10993-1: 2009. The following tests were performed on the devices: MEM Elution Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Reactivity and Acute Systemic Injection.

All testing performed met requirements. The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are considered safe and effective for their intended use.

Conclusion

The information provided in this submission demonstrate that the proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are substantially equivalent to the renal sheath which is a kit component in the Ultraxx™ Nephrostomy Balloon Set cleared in K024050.

Regulation Number and Section

N/A