(42 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties 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 and dilator used for introducing catheters, not for directly treating a medical condition.
No
Explanation: The device is a steerable sheath used for introducing catheters, not for diagnosing medical conditions. Its function is to facilitate the placement of other instruments for procedures such as aspiration, fluid infusion, blood sampling, and pressure monitoring, but it does not inherently diagnose.
No
The device description clearly outlines physical components such as a sheath, dilator, hemostasis valve, sideport, handle with a deflection knob, distal vent holes, and radiopaque markers, indicating it is a hardware device.
Based on the provided information, this device 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 in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical device designed for insertion into the body, with features like a sheath, dilator, hemostasis valve, sideport for aspiration/infusion/sampling/pressure monitoring, and a steerable tip. These are characteristics of a medical device used for interventional procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. The sideport is for sampling from the body or infusing into the body, not for analyzing samples by the device itself.
In summary, the Vado Steerable Sheath is a medical device used for facilitating cardiovascular procedures within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac anatomy, vasculature, chambers of the heart, left side of 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 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:
- Cytotoxicity
- Acute Systemic Toxicity
- Hemocompatibility (Direct and Indirect)
- Thrombosis
- Sensitization
- Irritation / Intracutaneous
- Complement Activation
- Pyrogenicity (rabbit pyrogen and bacterial endotoxin (LAL)
Bench Tests:
- Steerable Sheath and Dilator Visual Inspection
- Steerable Sheath Dimension Inspection
- Steerable Sheath Marker Band Location Measurement
- Dilator Dimensional Inspection
- Valve Leakage Resistance at 40kPa
- Leakage Resistance at 300kPa
- Device Preparation
- Dilator Snap Disengagement Force
- Dilator Insertion and Retraction Force
- Shaft Deflection
- Curvature Dimensions
- Aspiration
- Catheter Insertion Cycling and Flexion Cycling, with Flush
- Bend Radius to Kink
- Corrosion Resistance
- Junction Strengths
- Torque and Turns to Failure
- Steerable Sheath Radiopacity Study
Packaging Integrity Tests:
- Pouch Seal Strength
- Gross Leak Detection
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
| 510(k) Number | K140420 | |
|---|---|---|
| Submitter Name and Address | ||
| Name: | Kalila Medical | |
| Contact: | Carrie Neuberger | |
| Address: | 745 Camden Avenue, Suite A | |
| Campbell, 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 870.1340 | |
| A catheter introducer is a sheath used to | ||
| facilitate placing a catheter through the skin into | ||
| á vein or artery. | ||
| Device Class: | Class II | |
| Product Code: | DYB | |
| Predicate Device | ||
| Manufacturer | Device Name | 510(k) Number |
| St. Jude Medical | Agilis NxT Steerable | |
| Introducer | K061363 |
Section 5 510(k) Summarv
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.
Intended Use (Indications)
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.
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
1
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:
-
- Cytotoxicity
-
- Acute Systemic Toxicity
-
- Hemocompatibility (Direct and Indirect)
-
- Thrombosis
-
- Sensitization
-
- Irritation / Intracutaneous
-
- Complement Activation
-
- Pyrogenicity (rabbit pyrogen and bacterial endotoxin (LAL)
Bench Tests:
-
- Steerable Sheath and Dilator Visual Inspection
-
- Steerable Sheath Dimension Inspection
-
- Steerable Sheath Marker Band Location Measurement
-
- Dilator Dimensional Inspection
-
- Valve Leakage Resistance at 40kPa
-
- Leakage Resistance at 300kPa
-
- Device Preparation
-
- Dilator Snap Disengagement Force
-
- Dilator Insertion and Retraction Force
-
- Shaft Deflection
-
- Curvature Dimensions
-
- Aspiration
-
- Catheter Insertion Cycling and Flexion Cycling, with Flush
-
- Bend Radius to Kink
-
- Corrosion Resistance
-
- Junction Strengths
-
- Torque and Turns to Failure
-
- Steerable Sheath Radiopacity Study
Packaging Integrity Tests:
2
Image /page/2/Picture/0 description: The image shows the logo for Kalila Medical. The logo consists of a stylized, abstract symbol on the left, followed by the text "Kalila Medical" on the right. The symbol appears to be a geometric shape with curved lines, possibly representing a stylized "S" or a DNA strand.
-
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.
3
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
4
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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Image /page/5/Picture/0 description: The image contains the logo for Kalila Medical. The logo consists of a stylized graphic to the left of the company name. The graphic is a black abstract shape, and the text "Kalila Medical" is written in a bold, sans-serif font.
Page 1/1
Indications for Use
K140420 510(k) Number (if known):
Device Name: Kalila Medical Vado Steerable Sheath
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.
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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