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 for neural placements.

Device Description

The 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 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

This looks like a 510(k) summary for a medical device. Based on the provided text, the device is a Catheter Introducer called the AuST Steerable Sheath.

Here's the analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of specific quantitative acceptance criteria for each performance test (e.g., "Tensile strength must be > X N"). Instead, it states that the device "passed" a series of tests. Therefore, the table below will list the tests performed and the reported outcome.

Acceptance Criteria (Test Performed)	Reported Device Performance
Biocompatibility testing (per ISO 10993-1:2023)	Passed
Sterilization validation (per ANSI/AAMI/ISO 11135)	Passed
Packaging validation (per ANSI/AAMI/ISO 11607-1)	Passed
Visual Inspection	Passed
Simulated use testing (with ancillary devices)	Passed
Deflection verifications	Passed
Valve liquid leak test	Passed
Tensile tests	Passed
Sheath and Dilator Dimensional verification (OD/ID, working length, curl diameter)	Passed
Dilator removal force	Passed
Flush test	Passed
Torque test	Passed

2. Sample size used for the test set and the data provenance:

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the individual tests.

Regarding data provenance: The studies are laboratory-based performance tests of the device itself, not human subject data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" don't directly apply in the usual clinical study sense. The testing would have been conducted by the manufacturer (CenterPoint Systems LLC) or a contract lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided for this type of device submission. The "ground truth" for catheter introducers is typically established by engineering specifications, international standards, and performance test methods, not by expert consensus on clinical images or diagnoses.

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

This is not applicable for this type of device and testing. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, where disagreements among experts need resolution. For physical device performance tests, the outcome is determined by objective measurements against predefined 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:

This is not applicable. The AuST Steerable Sheath is a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness analysis would not be performed for this product.

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

This is not applicable as the device is not an algorithm or software. It is a physical medical device.

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

The "ground truth" for the performance tests of the AuST Steerable Sheath is based on engineering specifications, recognized international and national standards (e.g., ISO 10993-1, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 11607-1), and the intended function of the device. For example, for a "Tensile test," the ground truth is a specific force value or range that the device must withstand without failure, as defined by its design and relevant standards.

8. The sample size for the training set:

This is not applicable. The device is not a machine learning model, so there is no "training set."

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

This is not applicable. There is no training set for this device.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 1, 2024

CenterPoint Systems LLC Johnson Conner Regulatory/Ouality Associate 3338 W. Parkway Blvd West Valley City, Utah 84119

Re: K240829

Trade/Device Name: AuST Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 22, 2024 Received: March 26, 2024

Dear Johnson Conner:

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.

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).

Sincerely. Misti L. Malone -S

Misti Malone, PhD Assistant Director 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

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Enclosure

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Indications for Use

510(k) Number (if known) K240829

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

1.3 Predicate Device

Predicate Name and 510(k) Number: Destino Reach Steerable Guiding Sheath, K151951

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

1.4 Device Description

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1.5 Indications for Use

Comparison of Technological Characteristics with the Predicate Devices 1.6

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	AuST Steerable Sheath(proposed device)	Primary Predicate: DestinoReach Steerable GuidingSheath (K151951)	Same / DifferentbetweenProposed &Predicates
IntendedUse/Indications forUse	The AuST Steerable Sheath isintended for the introduction ofdiagnostic and therapeuticdevices into the humanvasculature, including but notlimited to intracardiac, renaland other peripheralplacements. Do not use thisdevice for neural placements.	The Destino Reach SteerableGuiding Sheath is intended forthe introduction of diagnosticand therapeutic devices intothe human vasculature,including but not limited tointracardiac, renal and otherperipheral placements. Do notuse 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 / OuterDiameter	4 available: 8.5F (OD: 13F),10F (OD: 14.9F), 12F (OD:16.3F), 13.2F (OD: 17.4F)	3 available: 8.5F (OD: 12F),10F (OD: 14.1F), 12F (OD:15.9F)	Similar
Active Length(Sheath)	74cm	67cm, 71cm, 73 cm, 75 cm,77cm	Similar
Deflection (Degree)	Bi-directional (180 Degrees)	Bi-directional (180 Degrees)	Same
GuidewireCompatibility	Max outside diameter 0.89mm(0.035")	Max outside diameter 0.97mm(0.038")	Similar

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Feature	AuST Steerable Sheath(proposed device)	Primary Predicate: DestinoReach Steerable GuidingSheath (K151951)	Same / DifferentbetweenProposed &Predicates
Tip with RadiopaqueMaterials	Yes	Yes	Same
Materials/Biocompatibility	Standard medical devicematerials, including PEBAX,PTFE, Stainless Steel,Vestamid	Standard medical devicematerials PEBAX, PTFE,Stainless Steel, Polycarbonate,Silicone, Polyethylene	Similar
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 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.

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 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 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).