(27 days)
Not Found
No
The document describes a medical device (a steerable sheath) for introducing other devices into the human vasculature. There is no mention of any AI, DNN, or ML components in its functionality or design. The performance studies focus on mechanical and sterilization validation, not AI model evaluation.
No
The device is described as an "introduction" device for diagnostic and therapeutic devices, but it does not perform a therapeutic function itself.
No
The device is described as a "pathway through which diagnostic and therapeutic devices are introduced," indicating it is an accessory device, not a diagnostic device itself.
No
The device is a physical medical device (a catheter/sheath) designed for introducing other devices into the human vasculature. The description explicitly details its hardware components (braid-reinforced catheter shaft, deflectable segment, handle with stopcock, hemostasis valve) and the performance studies relate to physical properties and function, rather than software. There is no mention of software forming any part of its intended use or operation.
No.
The device is a steerable sheath intended for introducing diagnostic and therapeutic devices into the human vasculature. It does not perform in vitro examinations of specimens derived from the human body.
N/A
Intended Use / Indications for Use
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 or other peripheral placements. Do not use this device for neural placements.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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 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, bi-directional 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Sterilization validation per ANSI/AAMI/ISO 11135
- Visual Inspection
- Simulated use testing, including use/compatibility with ancillary devices
- Valve liquid leak test
- Tensile tests
- Sheath and Dilator Dimensional verification
- Dilator removal force
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AuST Steerable Sheath, K242106
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
FDA 510(k) Clearance Letter - AuST Steerable Sheath
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
CenterPoint Systems LLC
Conner Johnson
Senior Regulatory Specialist
3338 Parkway Blvd
West Valley City, Utah 84119
Re: K251051
Trade/Device Name: AuST Steerable Sheath
Regulation Number: 21 CFR 870.1340
Regulation Name: Catheter introducer
Regulatory Class: Class II
Product Code: DYB
Dated: April 3, 2025
Received: April 3, 2025
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" (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).
April 30, 2025
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K251051 - Conner Johnson
Page 2
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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K251051 - Conner Johnson
Page 3
Sincerely,
FINN E. DONALDSON -S
Digitally signed by FINN E. DONALDSON -S
Date: 2025.04.30 15:27:57 -04'00'
Finn Donaldson
Acting 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
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251051
Device Name
AuST Steerable Sheath
Indications for Use (Describe)
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 or other peripheral placements. Do not use this device for neural placements.
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.
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:
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"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."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 5
K251051
Page 1 of 4
510(k) Summary
1.1 Submitter
Name: CenterPoint Systems LLC
Address: 3338 Parkway Blvd
West Valley City UT
Phone: 801-602-1923
Contact Person: Conner Johnson, Senior Regulatory Specialist
Date Prepared: 29 April 2025
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: AuST Steerable Sheath, K242106
This predicate has not been subject to a design-related recall.
1.4 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 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, bi-directional 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.
Page 6
K251051
Page 2 of 4
1.5 Indications for Use
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.
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 Steerable Sheath (proposed device) | Primary Predicate: AuST Steerable Sheath (K242106) | Same / Different between Proposed & Predicates |
|---|---|---|---|
| Intended Use/Indications for Use | The modified 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. | The currently cleared AuST Steerable Sheath (K242106) 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. | 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) | 44cm, 65cm, 74cm and 84cm | 74cm and 84cm | Substantially equivalent |
| Deflection (Degree) | Bi-directional (180 Degrees) | Bi-directional (180 Degrees) | Same |
| Guidewire Compatibility | Max outside diameter 0.89mm (0.035") | Max outside diameter 0.89mm (0.035") | Same |
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K251051
Page 3 of 4
| Feature | Modified AuST Steerable Sheath (proposed device) | Primary Predicate: AuST Steerable Sheath (K242106) | Same / Different between Proposed & Predicates |
|---|---|---|---|
| Tip with Radiopaque Materials | Yes | Yes | Same |
| Materials/ Biocompatibility | Standard medical device materials, including PEBAX*, PTFE, Stainless Steel, Vestamid |
Standard medical device materials.
The biocompatibility tests demonstrate that there are no adverse biocompatibility risks associated with use of this material. All test results met the requirements of ISO 10993-1. | Standard medical device materials, including PEBAX, PTFE, Stainless Steel, Vestamid
Standard medical device materials.
The biocompatibility tests demonstrate that there are no adverse biocompatibility risks associated with use of this material. All test results met the requirements of ISO 10993-1. | Substantially Equivalent |
| Features | Bi-directional Deflectable Sheath, Soft Atraumatic Tip with ventilation holes, Handle with Deflection Control, Hemostasis Valve*, Side Port (Irrigation/Aspiration), Dilator (curved and straight) | Bi-directional Deflectable Sheath, Soft Atraumatic Tip with ventilation holes, Handle with Deflection Control, Hemostasis Valve, Side Port (Irrigation/Aspiration), Dilator (straight) | Substantially Equivalent |
*Note: This submission includes the addition of a composite valve configuration and a shaft configuration with different extrusion lengths (while maintaining overall working length). Both of these modifications are substantially equivalent to the predicate.
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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K251051
Page 4 of 4
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:
- Sterilization validation per ANSI/AAMI/ISO 11135
- Visual Inspection
- Simulated use testing, including use/compatibility with ancillary devices
- Valve liquid leak test
- Tensile tests
- Sheath and Dilator Dimensional verification
- Dilator removal force
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, the modified AuST Steerable Sheath is substantially equivalent to the predicate device.