(78 days)
AuST Steerable Sheath, K240829
Not Found
No
The document describes a physical medical device (a steerable sheath) and its mechanical properties and performance. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No.
The device is intended for the introduction of diagnostic and therapeutic devices, not as a therapeutic device itself.
No
The device description clearly states "The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature," indicating it is a tool for delivering other devices, not a diagnostic device itself.
No
The device description clearly outlines a physical catheter with various components (shaft, dilator, valve, handle, etc.) and mentions performance testing related to physical properties and functionality, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of diagnostic and therapeutic devices into the human vasculature. This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to analyze samples like blood, urine, or tissue.
- Device Description: The description details a physical catheter designed to be inserted into the body. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
The AuST Steerable Sheath is a medical device used for interventional procedures within the 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 and 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 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.
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 and 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:
- 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 ●
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, K240829
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).
0
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"
1
(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)
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 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)
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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, 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 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.
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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.
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 (K240829) | 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 (K240829) 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) | 74cm and 84cm | 74cm | Similar |
| 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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| Feature | Modified AuST Steerable
Sheath (proposed device) | Primary Predicate: AuST
Steerable Sheath (K240829) | 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. | Same |
| Features | Bi-directional Deflectable
Sheath, Soft Atraumatic Tip
with ventilation holes, Handle
with Deflection Control,
Hemostasis Valve, Side Port
(Irrigation/Aspiration), Dilator | Bi-directional Deflectable
Sheath, Soft Atraumatic Tip
with ventilation holes, Handle
with 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.