(150 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a steerable sheath, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as a steerable sheath used to introduce other catheters into the heart and vasculature, which is an access and positioning tool, not one that directly treats a condition.
No
Explanation: The device description and intended use indicate that the Vado® Bi-Directional Steerable Sheath is designed for introducing cardiovascular catheters and providing access/positioning, not for diagnosing medical conditions. It facilitates interventional procedures.
No
The device description clearly outlines physical components like a dilator, steerable sheath, handle with a hemostasis valve, side port, deflection knob, vent holes, and a radiopaque marker, indicating it is a hardware device.
Based on the provided information, the Vado® Bi-Directional Steerable Sheath is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "introducing various cardiovascular catheters into the vasculature and into the chambers of the heart". This describes a device used within the body for a procedural purpose, not for testing samples outside the body.
- Device Description: The description details a physical device designed for insertion and manipulation within the cardiovascular system. It mentions features like a dilator, steerable sheath, hemostasis valve, side port, deflection knob, and radiopaque marker – all consistent with an invasive medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Vado® Bi-Directional Steerable Sheath does not fit this description.
N/A
Intended Use / Indications for Use
The Vado® Bi-Directional Steerable Sheath is introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the heart through the interatrial septum.
The Vado Bi-Directional Steerable Sheath is indicated for introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum.
Product codes
DYB
Device Description
The Vado® Bi-Directional Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible, stable catheter positioning in the cardiac anatomy. A hemostasis valve in the handle minimizes blood loss during catheter introduction and/or exchange. A side port with 3-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A deflection knob on the handle deflects the tip of the sheath clockwise ≥ 180° and counterclockwise ≥ 90°. Distal tip vent holes facilitate aspiration and a radiopaque marker permits visualization of the sheath tip under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature and into the chambers of the heart including the heart through 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 510(k) notice contains summaries of device and packaging performance tests, shelf life tests, biocompatibility, and sterilization studies conducted to evaluate the performance characteristics of the Vado® Bi-Directional Steerable Sheath, FG1 008. The data presented demonstrates that the Vado® Bi-Directional Steerable Sheath met its functional and performance characteristics in accordance with applicable industry standards and is equivalent to the predicate devices.
To verify the Vado® Bi-Directional Steerable Sheath met its functional and performance requirements, representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Kalila Medical, Inc. Carrie Neuberger Regulatory Affairs 745 Camden Ave, Suite A Campbell, California 95008-4146
Re: K162427
Trade/Device Name: Vado® Bi-Directional Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 20, 2016 Received: December 28, 2016
Dear Carrie Neuberger:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando
Fernando Aguel-S
Aguel
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162427
Device Name
Vado® Bi-Directional Steerable Sheath
Indications for Use (Describe)
The Vado® Bi-Directional Steerable Sheath is introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including 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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Image /page/3/Picture/0 description: The image contains the logo for Kalila Medical. The logo consists of an orange and gray abstract shape resembling two intertwined curves, followed by the text "Kalila Medical" in a combination of orange and gray. The word "Kalila" is in orange, while "Medical" is in gray.
510(k) Summary¨¨¨¨
| 510(k) Number | K162427 | |
|---|---|---|
| Submitter Name and Address | ||
| Name: | Kalila Medical, Inc. | |
| Address: | 745 Camden Avenue, Suite A | |
| Campbell, CA 95008 | ||
| Telephone: | 408-637-2150 | |
| Fax: | 408-370-6325 | |
| Contact: | Carrie Neuberger | |
| Date Prepared: | December 20, 2016 | |
| General Device Information | ||
| Device Name: | Vado® Bi-Directional Steerable Sheath | |
| Common Name: | Catheter introducer | |
| Classification: | 21 CFR 870.1340 | |
| A catheter introducer is a sheath used to | ||
| facilitate placing a catheter through the skin | ||
| into a vein or artery. | ||
| Device Class: | Class II | |
| Product Code: | DYB | |
| Predicate Device | ||
| Manufacturer | Device Name | 510(k) Number |
| Kalila Medical | Vado Steerable Sheath | K140420 |
| St. Jude Medical | Agilis NxT Steerable | |
| Introducer | K061363 | |
| Device Description | ||
| The Vado® Bi-Directional Steerable Sheath consists of a dilator and steerable | ||
| sheath which are designed to provide intracardiac access and flexible, stable | ||
| catheter positioning in the cardiac anatomy. A hemostasis valve in the handle | ||
| minimizes blood loss during catheter introduction and/or exchange. A side port | ||
| with 3-way stopcock is provided for air or blood aspiration, fluid infusion, | ||
| blood sampling and pressure monitoring. A deflection knob on the handle | ||
| deflects the tip of the sheath clockwise ≥ 180° and counterclockwise ≥ 90°. | ||
| Distal tip vent holes facilitate aspiration and a radiopaque marker permits | ||
| visualization of the sheath tip under fluoroscopy. | ||
| Indications for Use | ||
| The Vado Bi-Directional Steerable Sheath is indicated for introducing various | ||
| cardiovascular catheters into the vasculature and into the chambers of the | ||
| heart including the left side of the heart through the interatrial septum. | ||
| Comparison to the Predicate Device | ||
| The Vado Bi-Directional Steerable Sheath has the same indications for use and | ||
| intended use as the predicate devices. The Vado Bi-Directional Steerable Sheath |
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utilizes the same or similar materials, design principals and fundamental scientific technology as the predicate device(s).
| Device
Characteristic | Subject Device:
Vado Bi-Directional
Steerable Sheath | Predicate Device:
Vado Steerable Sheath
(K140420) | Predicate Device:
Agilis NxT Introducer
(K061363) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Dilator/introducer with
hemostatic hub
designed to introduce
sheath into the vessel;
steerable catheter
introducer | Dilator/introducer
with hemostatic hub
designed to introduce
sheath into the vessel;
steerable catheter
introducer | Dilator/introducer with
hemostatic hub
designed to introduce
sheath into the vessel;
steerable catheter
introducer |
| Indications
for Use | The Vado Bi-Directional
Steerable Sheath is
indicated for
introducing various
cardiovascular
catheters into the
vasculature and into the
chambers of the heart
including the left side of
the heart through the
interatrial septum. | The Vado Steerable
Sheath is indicated for
introducing various
cardiovascular
catheters into the
vasculature and into
the chambers of the heart
including the left
side of the heart
through the interatrial
septum. | The Agilis NxT
Steerable Introducer is
indicated when
introducing various
cardiovascular
catheters into the heart,
including the left side of
the heart through the
interatrial septum. |
| Intended Use | Catheter Introducer | Catheter Introducer | Catheter Introducer |
| Handle
Deflection
Mechanism | Rotary type deflection | Rotary type deflection | Rotary type deflection |
| Sheath
French Size | 8.8 Fr | 8.8 Fr | 8.5 Fr |
| Sheath
Length
(Total) | 91 cm | 83 cm | 91 cm (and 81cm) |
| Dilator
Length
(Usable) | 93 cm | 85 cm | 94 cm (and 85 cm) |
| Guide wire
compatibility | 0.032" max | 0.032" max | 0.032" max |
| Tip
Deflection | Bi-Directional
(180°/90°) | Uni-Directional
(140°) | Bi-Directional
(180°/90°) |
| Packaging
Configuration | Tray inside pouch
inside shelf carton | Tray inside pouch
inside shelf carton | Tray inside pouch
inside shelf carton |
| Sterilization | EO gas | EO gas | EO gas |
Where design differences exist between the subject device and the predicate device, performance testing demonstrates that these differences do not adversely affect safety and effectiveness.
This submission supports the position the Vado® Bi-Directional Steerable Sheath, FG1_008, is substantially equivalent to the Vado Steerable Sheath (K140420) and the Agilis NxT Steerable Introducer (K061363).
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Summary of Non-Clinical and Clinical Testing
The 510(k) notice contains summaries of device and packaging performance tests, shelf life tests, biocompatibility, and sterilization studies conducted to evaluate the performance characteristics of the Vado® Bi-Directional Steerable Sheath, FG1 008. The data presented demonstrates that the Vado® Bi-Directional Steerable Sheath met its functional and performance characteristics in accordance with applicable industry standards and is equivalent to the predicate devices.
To verify the Vado® Bi-Directional Steerable Sheath met its functional and performance requirements, representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing.
Biocompatibility Tests:
-
- Cytotoxicity (MEM Elution)
-
- Sensitization (Guinea Pig Maximization Sensitization)
-
- Irritation (Intracutaneous Reactivity Irritation in Rabbits)
-
- Acute Systemic Toxicity
-
- Pyrogen (Materials Mediated in Rabbits)
-
- Hemolysis (Direct Contact)
-
- Hemolysis (Indirect Contact)
-
- Complement Activation
-
- Thrombosis
Bench Performance Tests:
-
- Radiopacity
-
- Corrosion Resistance
-
- Sheath and Dilator Visual Inspection
-
- Sheath Dimension Inspection
-
- Dilator Dimension Inspection
-
- Sheath Deflection
-
- Sheath Curvature Dimensions
-
- Insertion and Deflection Cycling
-
- Aspiration Air Ingress
-
- Valve Leakage Resistance
-
- Sheath Leakage Resistance
-
- Device Preparation
-
- Valve Integrity and Functionality
-
- Shaft Torque Strength
-
- Kink Resistance
-
- Marker Band Location
-
- Tensile Strength
Packaging Integrity Tests:
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-
- Pouch Seal Strength
-
- Gross Leak Detection
Clinical testing is not provided in this submission.
Statement of Equivalence
The Vado Bi-Directional Steerable Sheath has the same indications for use and the same or similar technological characteristics as the predicate devices. Testing has demonstrated that the Vado Bi-Directional Steerable Sheath does not raise any new questions of safety and effectiveness. Based on this and the data provided in this pre-market notification, the subject device and the predicate devices have been shown to be substantially equivalent.