(26 days)
Not Found
No
The description focuses on the mechanical and structural features of a steerable introducer and its performance in bench and in-vivo testing, with no mention of AI or ML.
No.
The device is an introducer used to facilitate the placement of other cardiovascular catheters, not directly provide therapy itself.
No
The device is an introducer used to facilitate the placement of other cardiovascular catheters. Its function is to provide access, not to diagnose a condition.
No
The device description clearly outlines a physical, sterile, single-use introducer with a handle, tip, marker, vent holes, and dilator. It is a hardware device used for introducing catheters.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "introducing various cardiovascular catheters into the heart." This is a procedural device used in vivo (within a living organism) to facilitate a medical procedure.
- Device Description: The description details a physical device designed for insertion into the body and manipulation within the cardiovascular system.
- Anatomical Site: The device is used within the "Heart."
- Input Imaging Modality: The device is used with "Fluoroscopy," which is an imaging technique used in vivo.
- Performance Studies: The studies described are "In-Vitro Bench Top Testing and In-Vivo Simulated Use Testing (Single Swine Model)," further indicating its use in a living system.
IVD devices are used in vitro (outside of a living organism) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
DYB
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, includes left side of the interatrial septum
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)
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 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.
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 meet the requirements of ISO 10993-1 and FDA guidance. The following tests were completed:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemolysis
- Thromboresistance
- Complement Activation
Sterilization: The device was adopted into an existing ethylene oxide sterilization validation per TIR 28:2009.
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.
Not Found
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 contains 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 the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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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3
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
Predicate Device:
St. Jude Agilis™ Steerable Catheter Introducer
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".
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
4
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 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. |
| 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
5
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).