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.

Device Description

The Kalila Vado Steerable Sheath consists of an 8.8F (ID) sheath and dilator, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter exchange. A sideport with three-way stopcock is provided for aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a deflection knob, deflects the tip 140°. The steerable introducer features distal vent holes for aspiration and radiopaque markers to facilitate visualization under fluoroscopy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Kalila Medical Vado Steerable Sheath:

Acceptance Criteria and Device Performance for Kalila Medical Vado Steerable Sheath (K140420)

Based on the provided 510(k) summary, the device's acceptance criteria are derived from its functional and performance requirements, as demonstrated through a series of tests to establish substantial equivalence to the predicate device. The study primarily relies on non-clinical (bench and biocompatibility) testing, as no clinical testing was performed for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes categories of tests performed and states that the device "met its functional and performance characteristics in accordance with applicable industry standards and compares favorably to the predicate device." However, specific numerical acceptance criteria (e.g., minimum force, maximum leakage rate) and precise quantitative results are not explicitly detailed in the summary. The "reported device performance" is a general statement of compliance rather than specific measurements against a defined threshold.

Category of Test	Specific Tests Performed	Acceptance Criteria (Conceptual)	Reported Device Performance
Biocompatibility	1. Cytotoxicity2. Acute Systemic Toxicity3. Hemocompatibility (Direct and Indirect)4. Thrombosis5. Sensitization6. Irritation / Intracutaneous7. Complement Activation8. Pyrogenicity (rabbit pyrogen and bacterial endotoxin (LAL))	No adverse biological reactions; compliance with relevant ISO standards for medical devices in contact with blood.	Met all biocompatibility requirements.
Bench Tests	1. Steerable Sheath and Dilator Visual Inspection2. Steerable Sheath Dimension Inspection3. Steerable Sheath Marker Band Location Measurement4. Dilator Dimensional Inspection5. Valve Leakage Resistance at 40kPa6. Leakage Resistance at 300kPa7. Device Preparation8. Dilator Snap Disengagement Force9. Dilator Insertion and Retraction Force10. Shaft Deflection11. Curvature Dimensions12. Aspiration13. Catheter Insertion Cycling and Flexion Cycling, with Flush14. Bend Radius to Kink15. Corrosion Resistance16. Junction Strengths17. Torque and Turns to Failure18. Steerable Sheath Radiopacity Study	Device conforms to design specifications; functions as intended; withstands specified pressures; forces within acceptable ranges; maintains integrity under cycling/stress; visible under fluoroscopy.	Met all functional and performance requirements; comparable to predicate device.
Packaging Integrity	1. Pouch Seal Strength2. Gross Leak Detection	Packaging maintains sterility and integrity of the device until use.	Met all packaging integrity requirements.
Shelf Life	(Implicitly part of overall testing)	Device maintains performance and integrity over its stated shelf life.	(No specific details, but implied compliance)
Sterilization	(Implicitly part of overall testing)	Device is adequately sterilized and maintains sterility.	(No specific details, but implied compliance)

2. Sample Size Used for the Test Set and Data Provenance

The document states that "representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing." However, no specific sample sizes for any of these tests are provided or mentioned in the summary.

Data Provenance: The data is entirely non-clinical (bench and laboratory-based). There is no information regarding the country of origin of the data, as it pertains to internal testing conducted by Kalila Medical to support market clearance. The data is prospective in the sense that the tests were designed and executed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the study did not involve human interpretation or a "test set" in the context of image analysis or diagnostic performance. The "ground truth" here is objective measurement against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not applicable. As the study comprised bench and biocompatibility testing, there was no need for an adjudication method as would be used in expert consensus for clinical data. Performance was determined by direct measurement and observation against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was NOT done. The submission explicitly states: "Clinical testing is not provided in this submission." Therefore, there is no information on how human readers would improve with or without AI assistance, as AI is not a component of this device, and no human-reader study was conducted.

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

Not applicable. The Vado Steerable Sheath is a physical medical device (a catheter introducer), not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

Engineering specifications and design requirements: For dimensional accuracy, deflection, forces, etc.
Industry standards (e.g., ISO for biocompatibility): For biological safety and material compatibility.
Predicate device characteristics: For establishing substantial equivalence in performance and functionality.

Essentially, the ground truth is objective, measurable performance against predefined and accepted engineering and safety standards.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The ground truth for the device's development would have been established through a combination of engineering design, materials science, and functional requirements based on the intended use and predicate device.

Summary

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510(k) Number	K140420
Submitter Name and Address
Name:	Kalila Medical
Contact:	Carrie Neuberger
Address:	745 Camden Avenue, Suite ACampbell, CA 95008
Telephone:	415-640-3377
Fax:	408-903-4095
Date Prepared:	February 7, 2014
General Device Information
Product Name:	Vado Steerable Sheath
Common Name:	Steerable catheter introducer
Classification:	21 CFR 870.1340A catheter introducer is a sheath used tofacilitate placing a catheter through the skin intoá vein or artery.
Device Class:	Class II
Product Code:	DYB
Predicate Device
Manufacturer	Device Name	510(k) Number
St. Jude Medical	Agilis NxT SteerableIntroducer	K061363

Section 5 510(k) Summarv

Device Description

Intended Use (Indications)

Comparison to the Predicate Device

The Vado Steerable Sheath has the same intended use and fundamental scientific technology as the predicate device, including biocompatibility, packaging, sterilization, and labeling. Where dimensional differences exist between the subject device and the predicate device, performance testing demonstrates that these differences do not adversely affect safety and effectiveness.

APR 0 1 2014

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Kalila Medical

This submission supports the position that the Vado Steerable Sheath is substantially equivalent to the St. Jude Medical Agilis NxT Steerable Introducer (K061363).

Summary of Non-Clinical and Clinical Testing

The 510(k) notice contains summaries of biocompatibility and in vitro studies conducted to evaluate the performance characteristics of the Vado Steerable Sheath. The data presented demonstrate that the Vado Steerable Sheath met its functional and performance characteristics in accordance with applicable industry standards and compares favorably to the predicate device.

To verify that the Vado 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:

1. Cytotoxicity
1. Acute Systemic Toxicity
1. Hemocompatibility (Direct and Indirect)
1. Thrombosis
1. Sensitization
1. Irritation / Intracutaneous
1. Complement Activation
1. Pyrogenicity (rabbit pyrogen and bacterial endotoxin (LAL)

Bench Tests:

1. Steerable Sheath and Dilator Visual Inspection
1. Steerable Sheath Dimension Inspection
1. Steerable Sheath Marker Band Location Measurement
1. Dilator Dimensional Inspection
1. Valve Leakage Resistance at 40kPa
1. Leakage Resistance at 300kPa
1. Device Preparation
1. Dilator Snap Disengagement Force
1. Dilator Insertion and Retraction Force
1. Shaft Deflection
1. Curvature Dimensions
1. Aspiration
1. Catheter Insertion Cycling and Flexion Cycling, with Flush
1. Bend Radius to Kink
1. Corrosion Resistance
1. Junction Strengths
1. Torque and Turns to Failure
1. Steerable Sheath Radiopacity Study

Packaging Integrity Tests:

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Pouch Seal Strength
Gross Leak Detection

Pre-Clinical testing is not provided in this submission.

Clinical testing is not provided in this submission.

The fundamental scientific technology and technological characteristics of the Vado Steerable Sheath are the same as the predicate device including mechanism of action, packaging, biocompatibility, sterilization, and labeling. Through bench performance testing it was demonstrated that the Vado Steerable Sheath does not raise any new questions of safety and effectiveness.

Statement of Equivalence

The Vado Steerable Sheath has the same indications for use and technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device and the predicate device have been shown to be substantially equivalent.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-002

April 1, 2014

Kalila Medical, Inc. C/O Carrie Neuberger 745 Camden Ave, Suite A Campbell, CA 95008 US

K140420 Re:

Trade/Device Name: Vado Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 9, 2014 Received: February 18, 2014

Dear Ms. 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

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Page 2 - Ms. Neuberger

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K140420 510(k) Number (if known):

Device Name: Kalila Medical Vado Steerable Sheath

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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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).