The biocardia morph universal deflectable guide catheter is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

Device Description

The BioCardia 8F Morph® DNA Deflectable Guide Catheter is a sterile, single use, bi-directional deflectable guide catheter. When the handle is fully actuated, the distal tip deflects to a minimum 135° arc in either of two directions with a nominal curve distance of 30 mm. The catheter tip includes a fluoroscopic marker to help visualize the tip location. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock.

AI/ML Overview

The BioCardia 8F Morph DNA Deflectable Guide Catheter is a sterile, single-use, bi-directional deflectable guide catheter. Its intended use is to provide a pathway for medical instruments (like balloon dilatation catheters, guidewires, or other therapeutic devices) into the peripheral vasculature or chambers and coronary vasculature of the heart.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Since this is a submission for substantial equivalence to a predicate device, the acceptance criteria are largely demonstrated by ensuring the new device's performance is comparable to the predicate and meets relevant safety standards. The document doesn't explicitly list numerical 'acceptance criteria' in the traditional sense with specific thresholds. Instead, it lists various tests conducted to confirm that modifications did not negatively impact performance. The "Reported Device Performance" for each test is that the device "did not affect the ability to meet all product specification requirements," implying successful adherence to the established performance characteristics for guide catheters.

Test Category	Specific Tests	Reported Device Performance (Implied Acceptance)
In-Vitro Bench Top Testing	Distal Tip - right/left deflection angle, curve distance, residual curvature in neutral position, angular deviation from plane; Catheter Dimensional Verification - inner diameter, outer diameter, effective 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, hemostasis valve swivel functionality; Fatigue Resistance - Actuation fatigue resistance, torque fatigue resistance	Modifications did not affect the ability to meet all product specification requirements for these mechanical and functional aspects.
Package Integrity Testing	Atmospheric Conditioning (ASTM D4332-14); 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)	Demonstrated package integrity and protection of the device under various conditions.
In-Vivo Simulated Use Testing	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	Demonstrated appropriate function and safety within a living system and compatibility with other medical devices.
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Thromboresistance, Complement Activation	Materials meet the requirements of ISO 10993-1 and FDA guidance, ensuring the device is safe for biological contact.
Sterilization	Adoption into an existing ethylene oxide sterilization validation per TIR 28:2009.	Device is effectively sterilized, ensuring it is safe for single-use in patients.

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

Sample Size for Test Set: Not explicitly stated for each test. For in-vivo testing, it was a "Single Swine Model." For benchtop and package integrity tests, it's typically a statistically significant number of units, but the exact count is not provided in this summary.
Data Provenance: The studies were conducted by BioCardia, Inc. as part of their 510(k) submission. These are internal validation studies, not indicating specific country of origin or whether they were retrospective or prospective beyond the stated testing methods. Benchtop and package integrity tests are inherently prospective, as is the single swine model.

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

Not applicable. This is a medical device for providing access, not a diagnostic device that requires expert interpretation for a "ground truth" establishment in the traditional sense (e.g., for image analysis). The "ground truth" for this device's performance relates to its physical and functional specifications meeting engineering standards and biological safety. The "experts" involved would be the engineers, toxicologists, and biologists conducting and evaluating the studies against established ISO and ASTM standards and FDA guidance. Their qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable in the context of diagnostic interpretation, as this is a medical device. Performance is evaluated against objective engineering specifications and biological safety standards.

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

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve "human readers" in its intended use.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on:

Engineering Specifications: Successful adherence to predefined dimensions, force tolerances, deflection angles, and functional requirements.
Relevant ISO and ASTM Standards: Compliance with recognized international and national standards for medical devices, biocompatibility, sterilization, and packaging.
FDA Guidance: Adherence to FDA's recommendations for medical device evaluation.
Biological Response: Demonstrated safety and compatibility in in-vitro and in-vivo (swine model) biological tests.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

Summary

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January 7, 2020

Patrick Lee Director of Regulatory Affairs 125 Shoreway Road, Suite B San Carlos, California 94070

Re: K192774

Trade/Device Name: BioCardia 8F Morph DNA Deflectable Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 10, 2019 Received: December 11, 2019

Dear Patrick Lee:

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 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

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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 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) K192774

Device Name 8F Morph DNA Deflectable Guide Catheter

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

Date Prepared: September 27, 2019

510(k) number: K192774

Applicant Information:

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

Contact Person

Patrick Lee Director of Regulatory Affairs 650-226-0146 Plee@biocardia.com

Device Information:

Trade Name:	8F Morph ® DNA Deflectable Guide Catheter
Classification:	870.1250. - Class II
Classification Name:	Percutaneous Catheter
Product Code:	DQY

Predicate Device:

BioCardia Morph Universal Deflectable Guide Catheter K042553

Device Description:

Indications for Use:

The 8F Morph® DNA Deflectable Guide Catheter is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

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Comparison of Technological Characteristics with the Predicate Device:

The Morph DNA Deflectable catheter is identical to the predicate device with respect to the following attributes:

Intended use ●
Classification (870.1250. Class II) ●
Basic Design
Fundamental Technology
Method of operation
Inner PTFE lining with external Pebax extrusion jacket ●
0.071" nominal inner diameter
0.104" nominal outer diameter
Rocker mechanism in handle for deflecting catheter tip via pull wire tensioning.
Tip deflection curve of 30mm
Catheter mounted onto inner backer card, sealed by Tyvek pouch, and enclosed in ● product box
. Sterilization via Ethylene Oxide
. Compliance with ISO 10993
Compliance with ISO 10555 ●
Compliance with ISO 11070 ●
. Compliance with ISO 11135

The specific design differences between Morph DNA and the predicate device are the following:

Minor differences in catheter shaft construction, where Morph DNA includes an . additional braid layer, a bidirectional deflection mechanism, and a distal tip radiopaque marker
. Minor differences in the handle, where Morph DNA includes a brake feature (for adjusting deflection friction) and an integrated hemostasis valve with 3-way stopcock.
A longer working length of 115cm for Morph DNA vs 110cm for Morph UDGC ●

Supporting Data/Information:

Performance

The following tests were conducted to confirm that the modifications made between the Morph DNA device and predicate did not affect the ability to meet all product specification requirements.

In-Vitro Bench Top Testing
Distal Tip - right/left deflection angle, curve distance, residual curvature inneutral position, angular deviation from plane
Catheter Dimensional Verification - inner diameter, outer diameter, effectivelength
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, hemostasis valve swivelfunctionality
Fatigue Resistance - Actuation fatigue resistance, torque fatigue resistance

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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.

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

Biocompatibility

The materials used in the BioCardia Morph DNA Deflectable Guide Catheter meet the requirements of ISO 10993-1 and FDA quidance. "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 Morph DNA Deflectable Guide Catheter 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 8F Morph DNA Deflectable Guide Catheter has been shown to be substantially equivalent to the predicate device. We conclude that the BioCardia 8F Morph DNA Deflectable Guide Catheter is as safe and effective as the predicate device described herein.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).