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.

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.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the Kalila Medical Vado® Bi-Directional Steerable Sheath (K162427). This notification is for a medical device (catheter introducer), not an AI/ML powered device, therefore much of the requested information (e.g., AI/ML specific sections like sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or available in this document.

However, I can provide information based on the device's technical and performance characteristics as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document details various performance tests conducted to demonstrate the device's functional and safety characteristics, in comparison to predicate devices, rather than explicit acceptance criteria with numerical performance targets that are then met. The general acceptance criterion for all tests is that the device "met its functional and performance characteristics in accordance with applicable industry standards and is equivalent to the predicate devices" and that differences "do not adversely affect safety and effectiveness."

Test Category	Specific Performance Test	Reported Device Performance
Biocompatibility	1. Cytotoxicity (MEM Elution)	Met requirements
	2. Sensitization (Guinea Pig Maximization)	Met requirements
	3. Irritation (Intracutaneous Reactivity)	Met requirements
	4. Acute Systemic Toxicity	Met requirements
	5. Pyrogen (Materials Mediated in Rabbits)	Met requirements
	6. Hemolysis (Direct Contact)	Met requirements
	7. Hemolysis (Indirect Contact)	Met requirements
	8. Complement Activation	Met requirements
	9. Thrombosis	Met requirements
Bench Performance	1. Radiopacity	Met requirements for visualization under fluoroscopy
	2. Corrosion Resistance	Met requirements
	3. Sheath and Dilator Visual Inspection	Met requirements
	4. Sheath Dimension Inspection	Met requirements (specific dimensions not provided, but implicitly comparable to predicate)
	5. Dilator Dimension Inspection	Met requirements (specific dimensions not provided, but implicitly comparable to predicate)
	6. Sheath Deflection	Met requirements (Bi-Directional, 180° clockwise / 90° counterclockwise, similar to predicate K061363, an improvement over K140420)
	7. Sheath Curvature Dimensions	Met requirements (specific dimensions not provided, but implicitly comparable to predicate for proper catheter positioning)
	8. Insertion and Deflection Cycling	Met requirements for durability and function over repeated use
	9. Aspiration Air Ingress	Met requirements for minimizing air ingress
	10. Valve Leakage Resistance	Met requirements for minimizing blood loss and maintaining seal during catheter introduction/exchange
	11. Sheath Leakage Resistance	Met requirements for maintaining sheath integrity
	12. Device Preparation	Met requirements (implies ease of preparation for use)
	13. Valve Integrity and Functionality	Met requirements (implies effective hemostasis and function of 3-way stopcock)
	14. Shaft Torque Strength	Met requirements for effective steering and tip deflection response
	15. Kink Resistance	Met requirements for maintaining patency and facilitating catheter advancement
	16. Marker Band Location	Met requirements for accurate visualization and positioning under fluoroscopy
	17. Tensile Strength	Met requirements for material integrity and resistance to breakage during use
Packaging Integrity	1. Pouch Seal Strength	Met requirements for maintaining sterility and product integrity during storage and transport
	2. Gross Leak Detection	Met requirements for maintaining sterility and product integrity during storage and transport
Shelf Life	Various tests (details not explicitly itemized)	Met requirements (data demonstrated maintenance of functional and performance characteristics over specified shelf life)
Sterilization	Various tests (details not explicitly itemized)	Met requirements for effective sterilization (EO gas)

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

The document does not specify the exact sample sizes used for each individual test. It states "representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing." This suggests a sufficient number of samples were tested to gain confidence in the results according to relevant standards. The data provenance is internal to Kalila Medical, Inc., as these are tests conducted by the manufacturer, or by laboratories contracted by the manufacturer, to support the 510(k) submission. These tests are inherently prospective in nature as they evaluate newly manufactured devices. There is no mention of country of origin of the data beyond the manufacturer's location in Campbell, California, USA.

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

Not applicable. This device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Its performance is evaluated through engineering and biological testing methods.

4. Adjudication method for the test set

Not applicable for a physical device. Performance is evaluated against objective engineering specifications and biological 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-powered diagnostic device.

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

Not applicable. This is not an AI-powered device.

7. The type of ground truth used

For this medical device, the "ground truth" is established by:

Engineering specifications and industry standards: Performance characteristics (e.g., dimensions, deflection angles, tensile strength, leak resistance, radiopacity) are measured against predefined engineering tolerances and relevant international/consensus standards for catheter introducers.
Biocompatibility standards: Tests (e.g., cytotoxicity, sensitization, irritation) are conducted according to ISO 10993 series standards, where the "ground truth" is compliance with established biological safety thresholds.
Sterilization efficacy standards: Validation against established methods for ethylene oxide (EO) gas sterilization.
Packaging integrity standards: Evaluation against packaging standards to ensure sterility and physical protection.

8. The sample size for the training set

Not applicable. This is not an AI-powered device and therefore does not have a training set in the AI/ML sense.

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

Not applicable. As this is not an AI-powered device, there is no training set or associated ground truth for a training set.

Summary

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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.

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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

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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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510(k) Summary¨¨¨¨

510(k) Number	K162427
Submitter Name and Address
Name:	Kalila Medical, Inc.
Address:	745 Camden Avenue, Suite ACampbell, 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 870.1340A catheter introducer is a sheath used tofacilitate placing a catheter through the skininto 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 SteerableIntroducer	K061363
Device Description
The Vado® Bi-Directional Steerable Sheath consists of a dilator and steerablesheath which are designed to provide intracardiac access and flexible, stablecatheter positioning in the cardiac anatomy. A hemostasis valve in the handleminimizes blood loss during catheter introduction and/or exchange. A side portwith 3-way stopcock is provided for air or blood aspiration, fluid infusion,blood sampling and pressure monitoring. A deflection knob on the handledeflects the tip of the sheath clockwise ≥ 180° and counterclockwise ≥ 90°.Distal tip vent holes facilitate aspiration and a radiopaque marker permitsvisualization of the sheath tip under fluoroscopy.
Indications for Use
The Vado Bi-Directional Steerable Sheath is indicated for introducing variouscardiovascular catheters into the vasculature and into the chambers of theheart 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 andintended 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).

DeviceCharacteristic	Subject Device:Vado Bi-DirectionalSteerable Sheath	Predicate Device:Vado Steerable Sheath(K140420)	Predicate Device:Agilis NxT Introducer(K061363)
Description	Dilator/introducer withhemostatic hubdesigned to introducesheath into the vessel;steerable catheterintroducer	Dilator/introducerwith hemostatic hubdesigned to introducesheath into the vessel;steerable catheterintroducer	Dilator/introducer withhemostatic hubdesigned to introducesheath into the vessel;steerable catheterintroducer
Indicationsfor Use	The Vado Bi-DirectionalSteerable Sheath isindicated forintroducing variouscardiovascularcatheters into thevasculature and into thechambers of the heartincluding the left side ofthe heart through theinteratrial septum.	The Vado SteerableSheath is indicated forintroducing variouscardiovascularcatheters into thevasculature and intothe chambers of the heartincluding the leftside of the heartthrough the interatrialseptum.	The Agilis NxTSteerable Introducer isindicated whenintroducing variouscardiovascularcatheters into the heart,including the left side ofthe heart through theinteratrial septum.
Intended Use	Catheter Introducer	Catheter Introducer	Catheter Introducer
HandleDeflectionMechanism	Rotary type deflection	Rotary type deflection	Rotary type deflection
SheathFrench Size	8.8 Fr	8.8 Fr	8.5 Fr
SheathLength(Total)	91 cm	83 cm	91 cm (and 81cm)
DilatorLength(Usable)	93 cm	85 cm	94 cm (and 85 cm)
Guide wirecompatibility	0.032" max	0.032" max	0.032" max
TipDeflection	Bi-Directional(180°/90°)	Uni-Directional(140°)	Bi-Directional(180°/90°)
PackagingConfiguration	Tray inside pouchinside shelf carton	Tray inside pouchinside shelf carton	Tray inside pouchinside 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:

1. Cytotoxicity (MEM Elution)
1. Sensitization (Guinea Pig Maximization Sensitization)
1. Irritation (Intracutaneous Reactivity Irritation in Rabbits)
1. Acute Systemic Toxicity
1. Pyrogen (Materials Mediated in Rabbits)
1. Hemolysis (Direct Contact)
1. Hemolysis (Indirect Contact)
1. Complement Activation
1. Thrombosis

Bench Performance Tests:

1. Radiopacity
1. Corrosion Resistance
1. Sheath and Dilator Visual Inspection
1. Sheath Dimension Inspection
1. Dilator Dimension Inspection
1. Sheath Deflection
1. Sheath Curvature Dimensions
1. Insertion and Deflection Cycling
1. Aspiration Air Ingress
1. Valve Leakage Resistance
1. Sheath Leakage Resistance
1. Device Preparation
1. Valve Integrity and Functionality
1. Shaft Torque Strength
1. Kink Resistance
1. Marker Band Location
1. Tensile Strength

Packaging Integrity Tests:

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1. Pouch Seal Strength
1. 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.

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).