AuST Steerable Sheath

K240829 · CenterPoint Systems, LLC · DYB · May 1, 2024 · Cardiovascular

Device Facts

• Record ID: K240829
• Device Name: AuST Steerable Sheath
• Applicant: CenterPoint Systems, LLC
• Product Code: DYB · Cardiovascular
• Decision Date: May 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended 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.

Device Story

Single-use percutaneous catheter; provides pathway for diagnostic/therapeutic devices into human vasculature. Features braid-reinforced shaft, bidirectional deflectable segment, radiopaque distal tip, handle with 3-way stopcock (flushing/aspiration), and hemostasis valve. Operated by clinicians in clinical settings. Physician manipulates handle to deflect sheath, navigating vasculature to target site; hemostasis valve prevents fluid/air leakage. Facilitates precise placement of interventional tools; benefits patient by enabling minimally invasive access to intracardiac/peripheral sites.

Clinical Evidence

Bench testing only. Performance validated via biocompatibility (ISO 10993-1), sterilization (ISO 11135), packaging (ISO 11607-1), and mechanical testing including simulated use, deflection verification, valve leak, tensile strength, dimensional verification, dilator removal force, flush, and torque tests.

Technological Characteristics

Braid-reinforced catheter shaft; bidirectional deflectable segment (180 degrees); radiopaque distal tip. Materials: PEBAX, PTFE, Stainless Steel, Vestamid. Sterilization: Ethylene Oxide. Dimensions: 8.5F-13.2F ID. Features: hemostasis valve, 3-way stopcock, handle-based deflection control.

Indications for Use

Indicated for introduction of diagnostic and therapeutic devices into human vasculature, including intracardiac, renal, and peripheral placements. Contraindicated for neural placements.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Destino Reach Steerable Guiding Sheath (K151951)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary

#### 1.1 Submitter

| Name | CenterPoint Systems LLC |
|-----------------|----------------------------------------------|
| Address | 3338 Parkway Blvd<br>West 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

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.

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#### 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.

#### 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<br>(proposed device) | Primary Predicate: Destino<br>Reach Steerable Guiding<br>Sheath (K151951) | Same / Different<br>between<br>Proposed &<br>Predicates |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended<br>Use/Indications for<br>Use | The AuST Steerable Sheath is<br>intended for the introduction of<br>diagnostic and therapeutic<br>devices into the human<br>vasculature, including but not<br>limited to intracardiac, renal<br>and other peripheral<br>placements. Do not use this<br>device for neural placements. | The Destino Reach Steerable<br>Guiding Sheath is intended for<br>the introduction of diagnostic<br>and therapeutic devices into<br>the human vasculature,<br>including but not limited to<br>intracardiac, renal and other<br>peripheral placements. Do not<br>use this device for neural<br>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<br>Diameter | 4 available: 8.5F (OD: 13F),<br>10F (OD: 14.9F), 12F (OD:<br>16.3F), 13.2F (OD: 17.4F) | 3 available: 8.5F (OD: 12F),<br>10F (OD: 14.1F), 12F (OD:<br>15.9F) | Similar |
| Active Length<br>(Sheath) | 74cm | 67cm, 71cm, 73 cm, 75 cm,<br>77cm | Similar |
| Deflection (Degree) | Bi-directional (180 Degrees) | Bi-directional (180 Degrees) | Same |
| Guidewire<br>Compatibility | Max outside diameter 0.89mm<br>(0.035") | Max outside diameter 0.97mm<br>(0.038") | Similar |

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| Feature | AuST Steerable Sheath<br>(proposed device) | Primary Predicate: Destino<br>Reach Steerable Guiding<br>Sheath (K151951) | Same / Different<br>between<br>Proposed &<br>Predicates |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Tip with Radiopaque<br>Materials | Yes | Yes | Same |
| Materials/<br>Biocompatibility | Standard medical device<br>materials, including PEBAX,<br>PTFE, Stainless Steel,<br>Vestamid | Standard medical device<br>materials PEBAX, PTFE,<br>Stainless Steel, Polycarbonate,<br>Silicone, Polyethylene | Similar |
| Features | Bi-directional Deflectable<br>Sheath, Soft Atraumatic Tip<br>with ventilation holes, Handle<br>with Deflection Control,<br>Hemostasis Valve, Side Port<br>(Irrigation/Aspiration), Dilator | Bi-directional Deflectable<br>Sheath, Soft Atraumatic Tip<br>with ventilation holes, Handle<br>with Deflection Control,<br>Hemostasis Valve, Side Port<br>(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.