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.

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.

AI/ML Overview

The provided text describes the regulatory clearance for the Talon Transseptal Sheath. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the context of an AI/human reader study.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set details) are not applicable or not provided in this document, as they relate to the evaluation of AI-driven diagnostic devices, which the Talon Transseptal Sheath is not.

Here's the information that can be extracted from the provided text, primarily focusing on the non-clinical testing section, which serves as the "study" for this device's regulatory submission:

1. A table of acceptance criteria and the reported device performance

The document states that "Test results demonstrated that all acceptance criteria were met," but it does not provide specific numerical acceptance criteria or reported device performance metrics for each test. It simply lists the types of tests performed.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met biological safety requirements per ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility)
Sterilization	Achieved a sterility assurance level (SAL) of 10-6 using a validated sterilization process in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.
Performance Tests	All acceptance criteria were met; device conforms to established product specifications. (Specific details of acceptance criteria or performance values are not provided for individual tests like Packaging Integrity, Visual and Dimensional Inspections, Guidewire and Sheath Compatibility, etc.)

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified for any of the non-clinical tests.
Data Provenance: Not applicable in the context of device performance testing. These are laboratory/bench tests, not studies involving human data.

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

Not Applicable. This device is not an AI diagnostic device that relies on expert interpretation to establish ground truth for a test set. Its performance is evaluated through engineering and biological testing.

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

Not Applicable. See explanation above.

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

No. An MRMC study was not done as this is a medical device (transseptal sheath), not an AI-driven diagnostic or imaging aid.

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

Not Applicable. This is not an algorithm or AI device. Its "standalone" performance is measured by its physical and biological properties.

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

For Biocompatibility: Standards (ISO 10993-1) and validated laboratory test methodologies.
For Sterilization: Standards (ISO 11135:2014/Amd 1:2018, AAMI TIR 28:2016) and validated sterilization processes.
For Performance Tests: Established product specifications, engineering standards, and functional requirements, identified through a Design Failure Modes and Effects Analysis. The "ground truth" is adherence to these predefined criteria.

8. The sample size for the training set

Not Applicable. This device does not use a training set as it is not an AI/machine learning product.

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

Not Applicable. See explanation above.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K231108

Device Name Talon Transeptal 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

Date prepared	September 22, 2023		Subject DeviceTalon Transseptal Sheath	Primary PredicateVersaCross Transseptal Sheath
Name	Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747	K Number	TBD	K183655
Contact person	Ellen NguyenSr. Regulatory Affairs Specialist	Manufacturer	Inari Medical, Inc.	Baylis Medical Company, Inc.
Trade name	Talon Transseptal Sheath	Regulations	21 CFR 870.1340Introducer, catheter	21 CFR 870.1340Introducer, catheter
Common name	Catheter introducer	Product Code	DYB	DYB
Regulation name	Catheter introducer	Indications for Use	The Talon Transseptal Sheath is usedfor the percutaneous introduction ofvarious types of cardiovascularcatheters and guidewires to all heartchambers, including the left atrium viatransseptal perforation/puncture.	The VersaCross Transseptal Sheath isused for the percutaneous introductionof various types of cardiovascularcatheters and guidewires to all heartchambers, including the left atrium viatransseptal 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)	Guidewirecompatibility	0.035"	0.035"
Reference device(s)	Cook, Extra Large Check-Flo Introducer (K203670)Inari Medical, Triever24 (K213402)	SheathDimensions	OD: 23 FrID: 20.7 FrLength: 80 cm	OD: 10.5 FrID: 8.5 FrLength: 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.	ShaftMaterials	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
Accessoriesprovided	Dilator, quick-release syringe,standard VacLok syringe, Y-connector	Dilator, J-tipped guidewire

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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)

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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.

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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.

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).