(161 days)
No
The device description and performance studies focus on the mechanical and physical properties of the sheath and dilator, with no mention of AI or ML.
No.
The device is described as a sheath and dilator used for the "percutaneous introduction of various types of cardiovascular catheters and guidewires," which are tools for accessing and navigating the heart chambers, not for treating a condition itself.
No
The device is described as providing a conduit for catheterization and angiography, enabling the introduction of other cardiovascular catheters and guidewires. While angiography can involve diagnostic imaging, the sheath itself is a tool for access and delivery, not for generating a diagnosis.
No
The device description clearly outlines physical components such as a catheter, hemostasis valve, stopcock, flush port, radiopaque marker, dilator, and syringes. The performance studies also detail testing of physical properties like tensile strength, stiffness, and leak testing, indicating a hardware-based device.
Based on the provided information, the Talon Transseptal Sheath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a catheter, sheath, dilator, and syringes used for accessing heart chambers. This aligns with a surgical or interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Talon Transseptal Sheath is a medical device used for a cardiovascular procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Talon Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation/puncture.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Talon Transseptal Sheath (“Sheath”) provides a conduit for catheterization and angiography of specific heart chambers and locations. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. The Sheath is packaged with a dilator and two 60 cc syringes. The dilator is compatible with a 0.035" guidewire and has a tapered tip which aids insertion and positioning of the Sheath. The dilator attaches to the Sheath hemostasis valve, and a Y-connector with hemostasis valve connects to the dilator luer connector. A quick-release syringe is provided to connect to the Sheath sideport, and a standard VacLok syringe is provided to connect to the Sheath flush port and dilator connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart (all chambers), including the left atrium
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)
Non-Clinical Testing:
Verification and validation testing were identified to support the substantial equivalence of the Talon Transseptal Sheath to the predicate device. These tests included:
- Packaging Integrity
- Visual and Dimensional Inspections
- Guidewire and Sheath Compatibility
- Dilator Compatibility
- Test Small-Bore Connectors for Intravascular Applications
- Insertion and Removal Force of Dilator
- Simulated Use, Track and Transseptal Access
- Simulated Use, Track and Triever20 Curve Compatibility
- Shape Recovery Angles
- Simulated Use, Track and Pigtail Compatibility
- Torque Testing
- Simulated Use, Track and Kink Radius
- Simulated Use, Track and Torque Testing Talon
- Simulated Use, Track and Torque Testing Talon and Triever20 Curve
- Leak Testing Sheath and Dilator
- Vacuum Testing
- Air Leakage During Aspiration
- Tensile Testing
- Particulate Evaluation
- Snare Compatibility
- Shaft Stiffness Testing
- Tip Stiffness Testing
- Force Transmission
- Flowrate through Sheath
- Torque to Failure
- Radiopacity
Key results: Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
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.
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.
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 shows 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 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.
September 27, 2023
Inari Medical, Inc. Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K231108
Trade/Device Name: Talon Transseptal Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 22, 2023 Received: August 22, 2023
Dear Ellen Nguyen:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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. Rachel E. Neubrander -S
Rachel Neubrander, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231108
Device Name Talon Transeptal Sheath
Indications for Use (Describe)
The Talon Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation/puncture.
| 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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3
PAGE 1 OF 4
510(K) SUMMARY
| Date prepared | September 22, 2023 | | Subject Device
Talon Transseptal Sheath | Primary Predicate
VersaCross Transseptal Sheath |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.
6001 Oak Canyon, Suite 100
Irvine, CA 92618
877.923.4747 | K Number | TBD | K183655 |
| Contact person | Ellen Nguyen
Sr. Regulatory Affairs Specialist | Manufacturer | Inari Medical, Inc. | Baylis Medical Company, Inc. |
| Trade name | Talon Transseptal Sheath | Regulations | 21 CFR 870.1340
Introducer, catheter | 21 CFR 870.1340
Introducer, catheter |
| Common name | Catheter introducer | Product Code | DYB | DYB |
| Regulation name | Catheter introducer | Indications for Use | The Talon Transseptal Sheath is used
for the percutaneous introduction of
various types of cardiovascular
catheters and guidewires to all heart
chambers, including the left atrium via
transseptal perforation/puncture. | The VersaCross Transseptal Sheath is
used for the percutaneous introduction
of various types of cardiovascular
catheters and guidewires to all heart
chambers, including the left atrium via
transseptal perforation/puncture. |
| Classification number | 21 CFR 870.1340 | Target Vessel | Heart (all chambers) | Heart (all chambers) |
| Product code | DYB | Sterility | SAL 10-6, EO | SAL 10-6, EO |
| Regulatory class | II | Shelf-life | 6 months | Unknown |
| Predicate device(s) | Baylis Medical, VersaCross Transseptal Sheath (K183655) | Guidewire
compatibility | 0.035" | 0.035" |
| Reference device(s) | Cook, Extra Large Check-Flo Introducer (K203670)
Inari Medical, Triever24 (K213402) | Sheath
Dimensions | OD: 23 Fr
ID: 20.7 Fr
Length: 80 cm | OD: 10.5 Fr
ID: 8.5 Fr
Length: 63 cm, 81 cm |
| Description | The Talon Transseptal Sheath (“Sheath”) provides a conduit for catheterization and angiography of specific heart chambers and locations. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. The Sheath is packaged with a dilator and two 60 cc syringes. The dilator is compatible with a 0.035" guidewire and has a tapered tip which aids insertion and positioning of the Sheath. The dilator attaches to the Sheath hemostasis valve, and a Y-connector with hemostasis valve connects to the dilator luer connector. A quick-release syringe is provided to connect to the Sheath sideport, and a standard VacLok syringe is provided to connect to the Sheath flush port and dilator connector. | Shaft
Materials | Pebax 3533-7233 | Unknown |
| Indications for Use | The Talon Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation/puncture. | Tip curve | 90° in plane, 30° perpendicular | 45°, 55°, 90° in plane |
| Accessories
provided | Dilator, quick-release syringe,
standard VacLok syringe, Y-connector | Dilator, J-tipped guidewire | | |
4
Summary of substantial equivalence
A tabular comparison of the predicate and subject devices is provided below:
Summary of substantial equivalence
Biocompatibility
●
The following biocompatibility tests were completed for the subject device:
- . Cytotoxicity
- Sensitization
- Intracutaneous Reactivity Acute Systemic Toxicity .
- Material-Mediated Pyrogenicity ●
- . Hemocompatibility (Hemolysis, Complement Activation, Thromboresistance, Platelet and Leukocyte Count, and Partial Thromboplastin Time)
5
The passing results demonstrate that the subject device and accessories meet biological safety requirements per ISO 10993-1.
Sterilization
The subject device, including its accessories, is sterilized using EtO to achieve a sterility assurance level (SAL) of 106 using a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the Talon Transseptal Sheath to the predicate device. These tests included:
Performance Tests
- Packaging Integrity ●
- Visual and Dimensional Inspections ●
- Guidewire and Sheath Compatibility ●
- Dilator Compatibility
- Test Small-Bore Connectors for Intravascular Applications
- Insertion and Removal Force of Dilator
- Simulated Use, Track and Transseptal Access ●
- Simulated Use, Track and Triever20 Curve Compatibility
- Shape Recovery Angles
- Simulated Use, Track and Pigtail Compatibility
- Torque Testing ●
- Simulated Use, Track and Kink Radius ●
- Simulated Use, Track and Torque Testing Talon ●
- Simulated Use, Track and Torque Testing Talon and Triever20 ● Curve
- Leak Testing Sheath and Dilator ●
- Vacuum Testing .
- Air Leakage During Aspiration
- Tensile Testing
- Particulate Evaluation
- Snare Compatibility ●
- Shaft Stiffness Testing ●
- Tip Stiffness Testing ●
- Force Transmission ●
- Flowrate through Sheath
- Torque to Failure ●
- Radiopacity ●
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
6
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
Conclusion
The Talon Transseptal Sheath has the same intended use/indications for use and principles of operation as the predicate. Non-clinical performance data show that the different technological characteristics between the devices do not raise any new or different questions of safety or effectiveness and support the Talon Transseptal Sheath's substantial equivalence to the predicate device.