The BioCardia 8.5 F Avance™ Steerable Introducer is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Description

The BioCardia 8.5 F Avance™ Steerable Introducer (Avance) is a sterile, single use, bidirectional introducer. When the handle is fully actuated, the distal tip deflects to a nominal 180° arc in either of two directions with a nominal curve distance as indicated by the product label. The introducer tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Avance handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock.

Avance includes a dilator with a pre-curved, tapered tip which extends up to 2.5 cm beyond Avance to facilitate transseptal placement. The dilator hub snaps into the Avance hemostasis valve and can accommodate a guidewire diameter of up to .038".

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the BioCardia 8.5 F Avance™ Steerable Introducer. It aims to prove the device's substantial equivalence to a predicate device (St. Jude Agilis™ Steerable Introducer, K042623). However, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device with acceptance criteria for classification performance (e.g., accuracy, sensitivity, specificity).

Instead, it pertains to an interventional medical device (a catheter introducer) and its performance is evaluated against engineering and biological criteria, not diagnostic accuracy. Therefore, most of the requested information regarding AI/ML device performance (like MRMC study, standalone performance, training/test set ground truth, number of experts, etc.) is not applicable to this document.

I will attempt to extract what is relevant to "acceptance criteria and the study that proves the device meets the acceptance criteria" for a physical, interventional medical device based on the provided text.

Here's an interpretation based on the information provided, recognizing that the context is a physical device and not an AI/ML algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted. The "acceptance criteria" are implied by the nature of these tests, which confirm the device meets "all product performance requirements." The "reported device performance" is a statement that these tests were "conducted to confirm that the design of the Avance meets all product performance requirements." Specific numerical results for each test are not provided in this summary; rather, it states that the device successfully met these requirements.

Test Category	Specific Tests (Implied Acceptance Criteria)	Reported Device Performance
In-Vitro Bench Top Testing	Distal Tip: Right/left deflection angle, curve distance, residual curvature in neutral position, angular deviation from plane.Catheter and Dilator Dimensional Verification: Inner diameter, outer diameter, effective length, dilator extension length.Catheter Functionality: Freedom from leakage, tension and torsional forces, bend kink resistance, corrosion, column support.Handle Functionality: Actuation force, brake mechanism resisting actuation, brake engagement/disengagement, gradual brake, handle separation force, pull-wire tensile force.Hemostasis Valve: Freedom from leakage, dilator detachment force, hemostasis valve swivel functionality.Fatigue Resistance: Actuation fatigue resistance, torque fatigue resistance.Package Integrity: Atmospheric Conditioning ASTM D4332-14 and Shipping Simulation ASTM D7386-16 Test Schedule 3 – Manual Handling, Random Vibration, Low Pressure Hazard, Tip Over, Rotational Edge Drop, Bridge Impact, Concentrated Impact, Gross Leak (Bubble Test) ASTM F2096-11.	"The following tests were conducted to confirm that the design of the Avance meets all product performance requirements." (Implies successful completion within acceptable ranges)
In-Vivo Simulated Use Testing (Single Swine Model)	Distal Tip AttachmentRadiopaque Marker visible under fluoroscopyCatheter Navigation to all intended anatomyDeflection MechanismBrake MechanismHandle ErgonomicsDevice Compatibility to guide therapeutic catheters	"The following tests were conducted to confirm that the design of the Avance meets all product performance requirements." (Implies successful operation during simulated use)
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Thromboresistance, Complement Activation (meeting ISO 10993-1 and FDA guidance requirements).	"The materials used in the BioCardia Avance Steerable Introducer meet the requirements of ISO 10993-1 and FDA guidance..." and "The following biocompatibility tests were completed." (Implies successful completion and compliance)
Sterilization	Ethylene oxide sterilization validation (per TIR 28:2009).	"The Avance Steerable Introducer was adopted into an existing ethylene oxide sterilization validation for BioCardia products per TIR 28:2009." (Implies successful validation of the sterilization process for the device)

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

Sample Size:
- For in-vitro bench testing, no specific numerical sample sizes are given for each test (e.g., number of devices tested for deflection, fatigue, etc.).
- For in-vivo simulated use testing, it explicitly states: "Single Swine Model". This indicates a sample size of 1 animal.
Data Provenance: The tests are described as "In-Vitro Bench Top Testing" and "In-Vivo Simulated Use Testing (Single Swine Model)". Since this is a premarket notification, these are prospective tests conducted specifically for this submission. The origin (country/location of testing) is not specified, but it would have been performed by or on behalf of the manufacturer, BioCardia, Inc., San Carlos, CA.

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

This concept is not applicable to this type of device and study. The "ground truth" for a physical device's performance is established by engineering measurements, physical properties, and physiological outcomes in a simulated use environment, not by expert interpretation of images or data.

4. Adjudication method for the test set

This concept is not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic studies. For a physical device, performance is measured against quantifiable engineering standards or observed physical functionality.

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

This concept is not applicable. An MRMC study pertains to evaluating diagnostic performance, often with AI assistance for human readers. This document is about the physical performance and safety of an interventional introducer device.

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

This concept is not applicable. This refers to the standalone performance of an AI algorithm. The device in question is a physical catheter introducer.

7. The type of ground truth used

The "ground truth" (or basis for evaluation) for this device includes:

Engineering specifications and measurements (e.g., deflection angles, dimensions, forces, resistance to leakage, fatigue limits).
Compliance with recognized standards (e.g., ASTM, ISO 10993-1, TIR 28:2009).
Direct observation of functionality in a simulated physiological environment (e.g., in the swine model, observing navigation, deflection, brake mechanism, compatibility).

8. The sample size for the training set

This concept is not applicable. There is no "training set" in the context of validating a physical medical device. The device design is developed through engineering processes, not by training an algorithm on a dataset.

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

This concept is not applicable. See point 8.

Summary

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May 6, 2019

BioCardia, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K190941

Trade/Device Name: BioCardia 8.5 F Avance™ Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: April 8, 2019 Received: April 10, 2019

Dear Mark Job:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Nicole G. Ibrahim, Ph.D. 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) K190941

Device Name

8.5 F Avance Steerable Introducer

Indications for Use (Describe)

The BioCardia 8.5 F Avance Steerable Introducer is introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

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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This summary of 510(k) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: 26 March, 2019

510(k) number: K190941

Applicant Information:

BioCardia, Inc. 125 Shoreway Road, Suite B San Carlos CA 94070

Contact Person

Kevin DeMartini Sr. Quality Engineer 650-226-0134 kdemartini@biocardia.com

Device Information:

Trade Name: Classification: Classification Name: Product Code:

Avance™ 8.5 F Steerable Introducer 870.1340. - Class II Catheter Introducer DYB

K042623

Predicate Device:

St. Jude Agilis™ Steerable Catheter Introducer

Device Description:

Indications for Use:

The BioCardia 8.5 F Avance™ Steerable Introducer is intended for introducing various cardiovascular catheters into the heart, including the left side of the interatrial septum

Comparison of Technological Characteristics with the Predicate Device:

The Avance is the same or substantially equivalent to many geometric specifications, product features, and performance specifications in the predicate Agilis. Avance has minor design differences versus the predicate, such as a rotating versus fixed hemostasis valve, a rocker arm versus a lead screw for creating pull-wire tension and spiraling versus straight pull-wires. The

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Avance does not include a guidewire in the product box. These minor differences do not alter the conclusion that the Avance is substantially equivalent to the predicate.

Supporting Data/Information:

Performance

The following tests were conducted to confirm that the design of the Avance meets all product performance requirements:

In-Vitro Bench Top Testing
Distal Tip - right/left deflection angle, curve distance, residual curvature inneutral position, angular deviation from plane
Catheter and Dilator Dimensional Verification – inner diameter, outer diameter,effective length, dilator extension length
Catheter Functionality - Freedom from leakage, tension and torsional forces,bend kink resistance, corrosion, column support
Handle Functionality – Actuation force, brake mechanism resisting actuation,brake engagement/disengagement, gradual brake, handle separation force,pull-wire tensile force
Hemostasis Valve – Freedom from leakage, dilator detachment force,hemostasis valve swivel functionality
Fatigue Resistance – Actuation fatigue resistance, torque fatigue resistance
Package Integrity – Atmospheric Conditioning ASTM D4332-14 and ShippingSimulation ASTM D7386-16 Test Schedule 3 – Manual Handling, RandomVibration, Low Pressure Hazard, Tip Over, Rotational Edge Drop, BridgeImpact, Concentrated Impact, Gross Leak (Bubble Test) ASTM F2096-11.
In-Vivo Simulated Use Testing (Single Swine Model)
Distal Tip Attachment
Radiopaque Marker visible under fluoroscopy
Catheter Navigation to all intended anatomy
Deflection Mechanism
Brake Mechanism

Handle Ergonomics

Device Compatibility to guide therapeutic catheters

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Biocompatibility

The materials used in the BioCardia Avance Steerable Introducer meet the requirements of ISO 10993-1 and FDA guidance, "Use of International Standard ISO 10993-1 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The following biocompatibility tests were completed:

Cytotoxicity ●
Sensitization .
Irritation
. Acute Systemic Toxicity
. Material Mediated Pyrogenicity
. Hemolysis
Thromboresistance ●
. Complement Activation

Sterilization

The Avance Steerable Introducer was adopted into an existing ethylene oxide sterilization validation for BioCardia products per TIR 28:2009.

Summary:

Based on the intended use, product performance, biocompatibility and sterilization information provided in this notification, the BioCardia Avance™ Steerable Introducer has been shown to be substantially equivalent to the predicate St. Jude Agilis Steerable Introducer (K042623).

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).