The Dib UltraNav Transseptal Catheter System is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal puncture.

Device Description

The Dib UltraNav Transseptal Catheter System is a single-use, dual lumen, non-steerable intravascular catheter and handle to be used during a percutaneous procedure to support visualization and puncture of the septum. It is to be used to cross the interatrial septum and enable placement of a guidewire into the left side of the heart. The UltraNav catheter system is used with off-the-shelf transseptal needles and ultrasound catheters (not provided).

AI/ML Overview

The provided text describes a medical device, the Dib UltraNav Transseptal Catheter System, and its acceptance criteria as well as the studies conducted to demonstrate its safety and substantial equivalence to existing predicate devices. However, the document does not contain a specific table of acceptance criteria with corresponding device performance metrics in the format requested. It outlines the types of tests performed and states that "All test requirements were met."

Therefore, I will extract the available information and structure it as best as possible to answer your questions.

Here's the information regarding the acceptance criteria and the study that proves the device meets them:

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

The document states that "All test requirements were met" for the mechanical, biocompatibility, sterilization, packaging, and animal testing. However, it does not provide specific quantitative acceptance criteria or detailed numerical performance results for each test. Instead, it lists the types of tests conducted and implies that the performance met regulatory and internal requirements.

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Mechanical Performance	All test requirements were met in compliance with ISO 10555-1: 2013 and Dib UltraNav Medical, LLC internal requirements. Tests included: Freedom from leakage (air and liquid), Tensile strength, Radiopacity, Visual inspection, Dimensional testing, Luer connection testing, Kink resistance/bend testing, Torque testing, Push transmittance, Simulated use, and Handle performance related tests.
Biocompatibility	All test requirements were met in accordance with ISO 10993-1: 2018 and FDA guidance. Tests included: Cytotoxicity, Acute Systemic Toxicity, Irritation, Pyrogenicity, Sensitization, ASTM Hemolysis, Complement Activation, Partial Thromboplastin Time, Platelet and Leukocyte Count Assay, and In Vivo Thrombogenicity.
Sterilization Validation	Sterilization validation was completed in accordance with ISO 11135-1, effective in providing a sterility assurance level (SAL) ≥ 10⁻⁶.
Packaging Validation	Packaging validation was performed to ensure product and packaging integrity after shipping and distribution simulation, in accordance with ISO 11607 (Parts 1 and 2).
Animal Testing (In Vivo Safety & Performance)	The study demonstrated safety, ability to facilitate an accurate puncture of the septum, and ability to reliably deliver a guidewire to the left side of the heart. (Compared to a reference device).
Usability Assessment (Human Factors)	The study demonstrated that the UltraNav could be used without operator use errors that lead to serious adverse events.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Mechanical, Biocompatibility, Sterilization, and Packaging Tests: The document does not specify general sample sizes for these tests. It only lists the types of tests performed and the standards followed. The provenance is internal company testing and compliance with international standards.
Animal Testing: The test set for the animal study consisted of eight canines. The document does not specify the country of origin of this data, but it was an acute GLP (Good Laboratory Practice) animal study, implying prospective data collection under controlled conditions.
Usability Assessment: The test set involved two independent users.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For the animal study, the "ground truth" (assessment of safety, accurate septum puncture, and guidewire delivery) was established through observation and measurement during the study. While experts (e.g., veterinary surgeons, clinicians) would have been involved in conducting and evaluating the animal study, the document does not specify the number or qualifications of these experts explicitly for establishing ground truth, beyond indicating it was a GLP study.
For the usability assessment, the "ground truth" (absence of operator use errors leading to serious adverse events) was established by two independent users, who evaluated the device. Their specific qualifications are not detailed beyond being "independent users" likely qualified to operate medical devices.

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

The document does not describe a formal "adjudication method" in the context of expert consensus (like 2+1 or 3+1) for establishing ground truth from human readers. The tests performed are primarily laboratory-based or direct observation (animal study, usability).

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a physical catheter system, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance does not apply.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm.

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

Mechanical, Biocompatibility, Sterilization, Packaging: Ground truth for these studies is based on quantifiable measurements against established engineering standards (ISO standards, internal requirements) and biological compatibility assay results.
Animal Testing: Ground truth was established through direct observation and measurement during an acute GLP animal study, comparing the device's performance (safety, septum puncture accuracy, guidewire delivery) to a reference device.
Usability Assessment: Ground truth was established by direct observation and assessment by independent users regarding the occurrence of operator use errors.

8. The sample size for the training set

The concept of a "training set" is not applicable here as the Dib UltraNav Transseptal Catheter System is a physical medical device, not an AI/ML algorithm. Therefore, no training set was used.

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

As there was no training set, this question is not applicable.

Summary

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March 24, 2022

Dib UltraNav Medical, LLC % Noelle Sutton Principal Consultant The Tamarack Group - MPLS, LLC 2584 Upton Avenue South Minneapolis, Minnesota 55405

Re: K213492

Trade/Device Name: Dib UltraNav Transseptal Catheter System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 18, 2022 Received: February 22, 2022

Dear Noelle Sutton:

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 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).

Sincerely. Rachel E. Neubrander -S

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular 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

510(k) Number (if known) K213492

Device Name

Dib UltraNav Transseptal Catheter System

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 for The Dib UltraNav Transseptal Catheter System

Prepared March 24, 2022

Submitter

Manufacturer:	Contact Person:
Dib UltraNav Medical, LLC	Noelle Sutton
123 W. Mills Avenue	Principle Regulatory Consultant
STE 600	The Tamarack Group - MPLS, LLC
El Paso TX 79901	763-670-6538
	noelle.sutton@tgmpls.com

General Information

Device Name:	Dib UltraNav Transseptal Catheter System
Trade Name:	Dib UltraNav Transseptal Catheter System
Common / Usual Name:	Introducer Catheter
Classification Name:	Catheter Introducer
Product Code and Classification:	DYB; Class 2 – 21 CFR 870.1340
Review Panel:	Cardiovascular
Predicate Device:	VersaCross Transseptal Sheath (K183655)
Reference Device:	Swartz Braided Transseptal Guiding Introducer (K052644)

Intended Use / Indications for Use

Device Description

Substantial Equivalence

The Dib UltraNav Transseptal Catheter System, the predicate device and reference device are intravascular catheters designed to introduce various cardiovascular catheters or guidewires to all chambers of the heart, including the left atrium via transseptal puncture. The subject device, predicate device and reference device are similar in regulatory aspects, intended use, fundamental scientific

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technology, including principles of operation and mechanism of action. The differences in design and technological characteristics between the subject device and the predicate device and reference device do not raise new questions of safety and effectiveness. The results of verification and validation testing provide reasonable assurance of substantial equivalence of the Dib UltraNav Transeptal Catheter System with the predicate device.

Safety and Performance Data

The Dib UltraNav Transseptal Catheter System was evaluated to demonstrate substantial equivalence. All test requirements were met. The Dib UltraNav Transseptal Catheter was subjected to the safety and performance tests described below.

Mechanical testing

To support substantial equivalence, bench testing evaluated critical visual, dimensional and mechanical performance characteristics of the Dib UltraNav Transseptal Catheter System. Testing was conducted in compliance with ISO 10555-1: 2013 Intravascular catheters - sterile and single-use catheters - Part 1: General requirements and Dib UltraNav Medical, LLC internal requirements. The following tests were performed:

-Freedom from leakage (air and liquid)
-Tensile strength
-Radiopacity
-Visual inspection
-Dimensional testing
-Luer connection testing
-Kink resistance/bend testing
-Torque testing
-Push transmittance
-Simulated use
-Handle performance related tests

Biocompatibility

The biological safety of the Dib UltraNav Transseptal Catheter System was evaluated in accordance with ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The following tests were performed:

-Cytotoxicity

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-Acute Systemic Toxicity
-Irritation
-Pyrogenicity
-Sensitization
-ASTM Hemolysis
-Complement Activation
-Partial Thromboplastin Time
-Platelet and Leukocyte Count Assay
-In Vivo Thrombogenicity

Sterilization Validation

Sterilization validation was completed for the Dib UltraNav Transseptal Catheter System in accordance with the requirements of ISO 11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. In accordance with the standard, the process is effective in providing a sterility assurance level (SAL) ≥ 10°.

Packaging Validation

Packaging validation was performed to ensure that, after shipping and distribution simulation, the product and packaging maintain integrity. Package sterile barrier integrity and seal strength were tested in accordance with ISO 11607 Packaging for terminally sterilized medical devices (Parts 1 and 2).

Animal Testing

The in vivo safety and performance of the Dib UltraNav Transseptal Catheter System was evaluated in an acute GLP animal study using eight canines. The Dib UltraNav Transseptal Catheter System was used to deliver an ultrasound catheter, needle and guidewire into heart chambers and compared to the reference device. The study demonstrated safety, ability to facilitate an accurate of the septum and ability to reliably deliver a guidewire to the left side of the heart.

To confirm that the UltraNav Transseptal Catheter System user interface has been designed such that errors that occur during normal use of the device that could cause harm or degrade medical treatment are eliminated or reduced to the extent possible, a usability assessment was performed by two independent users. The study demonstrated that the UltraNav could be used without operator use errors that lead to serious adverse events.

Conclusion

The intended use and fundamental scientific technology of the Dib UltraNav Transseptal Catheter System are similar to the predicate device, the VersaCross Transseptal Sheath (K183655) and reference

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device, the Swartz Braided Transseptal Guiding Introducer (K052644). The results of safety and performance testing support the substantial equivalence of the Dib UltraNav Transseptal Catheter System to the predicate device. The differences in design and technological characteristics do not raise any new questions of safety and effectiveness.

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).