The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal and other peripheral placements. Do not use this device for neural placements.

Device Description

The modified AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements.

The modified AuST Steerable Sheath includes a longer catheter shaft, longer dilator, longer hydrophilic coating, modified hemostatic valve, and modified packaging.

The modified AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bidirectional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

The provided document is a 510(k) summary for a medical device (AuST Steerable Sheath) and does not describe a study involving an AI algorithm or human readers. It details the premarket notification process for a physical medical device, not a software or AI-driven diagnostic tool. Therefore, many of the requested points, such as expert consensus, MRMC studies, standalone algorithm performance, training set details, and specific performance metrics like sensitivity/specificity, are not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence of a modified physical device to a previously cleared predicate device, rather than proving a diagnostic algorithm's performance.

Below is the information that can be extracted from the provided text, primarily focusing on the performance criteria for the device itself rather than AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (catheter introducer) and not an AI algorithm, the "acceptance criteria" are generally that the device passes specific engineering and safety tests, and performs as intended. Specific quantitative acceptance values are not always explicitly stated in this type of summary but are implied by meeting standard requirements.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Biocompatibility	ISO 10993-1	All test results met the requirements of ISO 10993-1, demonstrating no adverse biocompatibility risks.
Sterilization	ANSI/AAMI/ISO 11135	Passed sterilization validation.
Packaging Integrity	ANSI/AAMI/ISO 11607-1	Passed packaging validation.
Visual Inspection	-	Passed visual inspection.
Simulated Use/Compatibility	-	Passed simulated use testing, including use/compatibility with ancillary devices.
Deflection	-	Passed deflection verifications (Bi-directional, 180 Degrees).
Valve Functionality	-	Passed valve liquid/air leak test.
Mechanical Strength	-	Passed tensile tests.
Dimensional Accuracy	-	Passed sheath and dilator dimensional verification, including OD/ID, working length, and curl diameter.
Dilator Removal Force	-	Passed dilator removal force test.
Flush Functionality	-	Passed flush test.
Torque Performance	-	Passed torque test.

Regarding AI-specific questions (2-9):

The provided document is a 510(k) premarket notification for a physical medical device (AuST Steerable Sheath), which is a catheter introducer. It does not describe an AI algorithm or a diagnostic study involving AI. Therefore, the following points are not applicable (N/A) to this document:

Sample size used for the test set and the data provenance: N/A (Not an AI study)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI study)
Adjudication method for the test set: N/A (Not an AI study)
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: N/A (Not an AI study)
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI study)
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Not an AI study)
The sample size for the training set: N/A (Not an AI study)
How the ground truth for the training set was established: N/A (Not an AI study)

The performance data listed in the document (Section 1.7) refers to the physical and functional aspects of the steerable sheath itself, not the performance of an AI system.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CenterPoint Systems LLC Conner Johnson Official Correspondent 3338 Parkway Blvd West Valley City, Utah 84119

Re: K242106

Trade/Device Name: AuST Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRA Dated: September 4, 2024 Received: September 4, 2024

Dear Conner Johnson:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Sevan R. 2024.10.04 Oungoulian -S 12:38:42 -04'00' For Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242106

Device Name

AuST Steerable Sheath

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)

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510(k) Summary

1.1 Submitter

Name	CenterPoint Systems LLC
Address	3338 Parkway BlvdWest Valley City UT
Phone	801-602-1923
Contact Person:	Conner Johnson, Regulatory/Quality Associate
Date Prepared:	22 March 2024

1.2 Device

Name of Device:	AuST Steerable Sheath
Classification Name:	Catheter Introducer
Regulatory Class:	Class II per 21 CFR 870.1340
Product Code:	DYB

Predicate Device 1.3

Predicate Name and 510(k) Number: AuST Steerable Sheath, K240829

This predicate has not been subject to a design-related recall.

1.4 Device Description

The modified AuST Steerable Sheath includes a longer catheter shaft, longer dilator, longer hydrophilic coating, modified hemostatic valve, and modified packaging.

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1.5 Indications for Use

1.6 Comparison of Technological Characteristics with the Predicate Devices

The Proposed Device and Predicate Device are similar in indications for use, intended use, technological characteristics, and principles of operation.

The differences between the Proposed Device and the Predicate Device are minor and raise no different questions of safety and effectiveness. In accordance with 21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.

Feature	Modified AuST SteerableSheath (proposed device)	Primary Predicate: AuSTSteerable Sheath (K240829)	Same / DifferentbetweenProposed &Predicates
IntendedUse/Indications forUse	The modified AuST SteerableSheath is intended for theintroduction of diagnostic andtherapeutic devices into thehuman vasculature, includingbut not limited to intracardiac,renal and other peripheralplacements. Do not use thisdevice for neural placements.	The currently cleared AuSTSteerable Sheath (K240829) isintended for the introduction ofdiagnostic and therapeuticdevices into the humanvasculature, including but notlimited to intracardiac, renal andother peripheral placements. Donot use this device for neuralplacements.	Same
Device Class	II	II	Same
Product Code	DYB	DYB	Same
Regulation number	21 CFR 870.1340	21 CFR 870.1340	Same
Duration of use	Single-use, Transient	Single-use, Transient	Same
Sterilization	Ethylene Oxide	Ethylene Oxide	Same
Prescription Device	Yes	Yes	Same
Inner Diameter /Outer Diameter	4 available: 8.5F (OD: 13F),10F (OD: 14.9F), 12F (OD:16.3F), 13.2F (OD: 17.4F)	4 available: 8.5F (OD: 13F),10F (OD: 14.9F), 12F (OD:16.3F), 13.2F (OD: 17.4F)	Same
Active Length(Sheath)	74cm and 84cm	74cm	Similar
Deflection (Degree)	Bi-directional (180 Degrees)	Bi-directional (180 Degrees)	Same
GuidewireCompatibility	Max outside diameter 0.89mm(0.035")	Max outside diameter 0.89mm(0.035")	Same

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Feature	Modified AuST SteerableSheath (proposed device)	Primary Predicate: AuSTSteerable Sheath (K240829)	Same / DifferentbetweenProposed &Predicates
Tip with RadiopaqueMaterials	Yes	Yes	Same
Materials/Biocompatibility	Standard medical devicematerials, including PEBAX,PTFE, Stainless Steel,VestamidStandard medical devicematerials.The biocompatibility testsdemonstrate that there are noadverse biocompatibility risksassociated with use of thismaterial. All test results metthe requirements of ISO10993-1.	Standard medical devicematerials, including PEBAX,PTFE, Stainless Steel, VestamidStandard medical devicematerials.The biocompatibility testsdemonstrate that there are noadverse biocompatibility risksassociated with use of thismaterial. All test results met therequirements of ISO 10993-1.	Same
Features	Bi-directional DeflectableSheath, Soft Atraumatic Tipwith ventilation holes, Handlewith Deflection Control,Hemostasis Valve, Side Port(Irrigation/Aspiration), Dilator	Bi-directional DeflectableSheath, Soft Atraumatic Tipwith ventilation holes, Handlewith Deflection Control,Hemostasis Valve, Side Port(Irrigation/Aspiration), Dilator	Same

The modified AuST Steerable Sheath is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device.

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1.7 Performance Data

All necessary performance testing has been conducted on the AuST Steerable Sheath to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

The device passed the following tests, which were conducted in accordance with noted standards:

Biocompatibility testing per FDA Final . Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (2023)
Sterilization validation per ● ANSI/AAMI/ISO 11135
Packaging validation per ● ANSI/AAMI/ISO 11607-1
. Visual Inspection
. Simulated use testing, including use/compatibility with ancillary devices
Deflection verifications .
Valve liquid/air leak test .
. Tensile tests
Sheath and Dilator Dimensional . verification, including OD/ID, working length, and curl diameter
Dilator removal force
. Flush test
Torque test ●

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1.8 Conclusions

Based on the similarity of the subject and predicate devices in terms of the intended use, principle of operation and overall technological characteristics, and the results of the testing summarized in section 1.8, the modified AuST Steerable Sheath is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).