(113 days)
The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the interatrial septum.
The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.
The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise < 180° and counterclockwise ≤ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to allow fluoroscopic visualization. The purpose of this Premarket Notification is to create a bidirectional, flexible-tipped, guiding sheath, with visualization capabilities to facilitate catheter accessibility to various areas of interest within the heart. The new sheath will utilize an existing cable/connector to support visualization.
The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath features a flex shaft curve design available in three curve sizes, Small, Medium, and Large curve. Each sheath with four (4) electrodes spaced along its shaft to enable shaft visualization when used with compatible CARTO® 3 EP Navigation Systems.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Usable Length | Not explicitly stated | Pass |
| Lumen Inner Diameter | Not explicitly stated | Pass |
| Distal Tip Inner Diameter | Not explicitly stated | Pass |
| Overall Length | Not explicitly stated | Pass |
| Cap to hub retention | Not explicitly stated | Pass |
| Sheath OD | Not explicitly stated | Pass |
| Sheath OD - Flex Section | Not explicitly stated | Pass |
| PU adhesion | Not explicitly stated | Pass |
| Marker Band Location | Not explicitly stated | Pass |
| Vent Hole Location | Not explicitly stated | Pass |
| Vent Hole Diameter | Not explicitly stated | Pass |
| Vent Hole Orientation | Not explicitly stated | Pass |
| Sheath leak | Not explicitly stated | Pass |
| Vacuum decay | Not explicitly stated | Pass |
| In-Plane Deflection | Not explicitly stated | Pass |
| Handle deflection direction | Not explicitly stated | Pass |
| Shaft torque | Not explicitly stated | Pass |
| Tip drag force | Not explicitly stated | Small: Pass, Large: Pass |
| Side load | Not explicitly stated | Small: Pass, Large: Pass |
| Pigtail to Connector | Not explicitly stated | Pass |
| Pigtail to Handle | Not explicitly stated | Pass |
| Hub to shaft | Not explicitly stated | Pass |
| Stopcock to handle | Not explicitly stated | Pass |
| Stopcock to tube | Not explicitly stated | Pass |
| Shaft distal segments | Not explicitly stated | Pass |
| Shaft proximal segments | Not explicitly stated | Pass |
| Hemostasis valve and sheath must not leak | No leakage | Pass |
| Valve insertion force | Not explicitly stated | Pass |
| Valve friction | Not explicitly stated | Pass |
| Curve Span | Not explicitly stated | Small: Pass, Large: Pass |
| Electrode Location | Not explicitly stated | Small: Pass, Large: Pass |
| Electrical Resistance | Not explicitly stated | Small: Pass, Large: Pass |
| Current Leakage | Not explicitly stated | Small: Pass, Large: Pass |
| Connector mating, flex fatigue, and pigtail torque testing | Not explicitly stated | Pass |
| Electrical Isolation | Not explicitly stated | Small: Pass, Large: Pass |
| External lead cable length | Not explicitly stated | Pass |
| Corrosion | Not explicitly stated | Pass |
| Continuous pouch seal | Not explicitly stated | Pass |
| Pouch particulate | Not explicitly stated | Pass |
| Label adhesion and legibility | Not explicitly stated | Pass |
| Dilator OD | Not explicitly stated | Pass |
| Dilator to cap retention force | Not explicitly stated | Pass |
| Dilator to dilator hub tensile | Not explicitly stated | Pass |
| Dilator hub has standard luer | Not explicitly stated | Pass |
| Dilator tip ID | Not explicitly stated | Pass |
| Dilator overall length (straightened) | Not explicitly stated | Pass |
| Pre-Clinical Study Endpoints: | ||
| No damage or product integrity issues | No damage/integrity issues expected | Met (No damage or product integrity issues related to CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath) |
| No leakage through hemostatic valve | No leakage expected | Met (No leakage through hemostatic valve) |
| No thrombus observed | No thrombus expected | Met (No thrombus observed inside or at the tip of the sheath) |
| No clinically significant tissue injury | No significant tissue injury expected | Met (No clinically significant tissue injury related to the use of the Test article) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each bench test. For the preclinical study:
- Sample Size: Not explicitly stated as a number, but refers to "one Test or one Control sheath in the animal." This suggests a comparative animal study.
- Data Provenance: Pre-clinical testing performed "under simulated clinical conditions" and "in the animal." This indicates an animal study, which is often considered prospective in nature. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide information on the number of experts or their qualifications for establishing ground truth for either the bench tests or the pre-clinical study. The "Pass" results for bench tests imply internal testing against predetermined specifications, while the pre-clinical study endpoints would typically be assessed by veterinary or medical professionals, but this is not detailed here.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method. For bench tests, it's likely a pass/fail against internal criteria. For the pre-clinical study, the endpoints imply an assessment by the study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not conducted or described. The device is a guiding sheath, not an imaging analysis algorithm that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a physical medical instrument (a guiding sheath), not an algorithm or AI system. While it has "visualization capabilities" with a compatible navigation system (CARTO® 3 EP Navigation System), the performance data presented focuses on the physical sheath itself rather than the performance of an independent algorithm for interpretation.
7. The Type of Ground Truth Used
- For Bench Tests: The ground truth is implied to be predefined engineering specifications and performance criteria. Each test has a "Pass" result, indicating it met these criteria.
- For Pre-Clinical Study: The ground truth for safety and performance refers to direct observation of the animal model for damage, leakage, thrombus, and tissue injury during and after the procedure. This could be considered outcomes data or direct observational data from a controlled biological setting.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2017
Biosense Webster, Inc. John Jimenez Senior Program Lead, Regulatory Affairs 33 Technology Drive Irvine, California 92618
Re: K170997
Trade/Device Name: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 9, 2017 Received: June 12, 2017
Dear John Jimenez:
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 of medical device
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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 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.
M & Tillelrem
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) K170997
Device Name
CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath
Indications for Use (Describe)
The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the interatrial septum.
The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.
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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1. 510(K) SUMMARY
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Biosense Webster, Inc. |
|---|---|
| 33 Technology Drive | |
| Irvine, CA 92618 | |
| OFFICIALCORRESPONDENT | John JimenezSenior Program Lead, Regulatory AffairsTelephone: 949-923-4774Fax: 949-450-6886Email: jjimene7@its.jnj.com |
| DATE SUMMARYPREPARED | March 31, 2017 |
| TRADE NAME | CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath |
| COMMON NAME | Guiding Sheath |
| CLASSIFICATION NAME | Catheter Introducer |
| DEVICE CLASSIFICATION | Class II, 21 CFR §870.1340Product Code: DYB |
| PRODUCT CODES | D-1385-01-S, D-1385-02-S, D-1385-03-S |
| PREDICATE DEVICE | St. Jude Agilis™ NxT Steerable Introducer[510(k) K081645] |
| REFERENCE DEVICE | Webster® CS Catheter with EZ Steer® Technology[510(k) K101345] |
SUBSTANTIALLY EQUIVALENT TO:
The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is substantially equivalent to the St. Jude Agilis™ NxT Steerable Introducer [510(k) K081645, cleared December 9, 2008]. Like the predicate device, the CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath features a rotary-type deflection mechanism, allowing for bi-directional deflection of the shaft. The proposed sheath also has similar Flex Shaft Curve Size offerings, the same French Size, the same patient contact materials, and the same Useable Length. The original intended use of the predicate device as a catheter delivery system remains the same in the proposed device; however, the proposed device will now have the added ability of shaft visualization when used with a compatible
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CARTO® 3 EP navigation System. This latter capability is substantially equivalent to and can be referenced in the Webster® CS Catheter with EZ Steer® Technology. The Webster® CS Catheter with EZ Steer® Technology utilizes the same visualization technology and was approved under 510(k) K101345, cleared June 22, 2010.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise < 180° and counterclockwise ≤ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to allow fluoroscopic visualization. The purpose of this Premarket Notification is to create a bidirectional, flexible-tipped, guiding sheath, with visualization capabilities to facilitate catheter accessibility to various areas of interest within the heart. The new sheath will utilize an existing cable/connector to support visualization.
The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath features a flex shaft curve design available in three curve sizes, Small, Medium, and Large curve. Each sheath with four (4) electrodes spaced along its shaft to enable shaft visualization when used with compatible CARTO® 3 EP Navigation Systems.
INDICATIONS FOR USE:
The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.
TECHNICAL CHARACTERISTICS:
The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is a typical bi-directional guiding sheath that is unique only in the presence of four ring electrodes spaced along its shaft. Otherwise, there are no special technical aspects of the ability of this sheath to facilitate the introduction of various cardiovascular catheters into the heart.
PERFORMANCE DATA:
The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath underwent bench and preclinical testing under simulated clinical conditions to verify the safety and effectiveness of its features. The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath passed all tests in accordance with appropriate test criteria and standards.
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| Summary of Bench Tests and Results | ||
|---|---|---|
| Test Description | Results | |
| Usable Length | Pass | |
| Lumen Inner Diameter | Pass | |
| Distal Tip Inner Diameter | Pass | |
| Overall Length | Pass | |
| Cap to hub retention | Pass | |
| Sheath OD | Pass | |
| Sheath OD - Flex Section | Pass | |
| PU adhesion | Pass | |
| Marker Band Location1 | Pass | |
| Vent Hole Location | Pass | |
| Vent Hole Diameter | Pass | |
| Vent Hole Orientation | Pass | |
| Sheath leak | Pass | |
| Vacuum decay | Pass | |
| In-Plane Deflection | Pass | |
| Handle deflection direction | Pass | |
| Shaft torque | Pass | |
| Tip drag force | Small: Pass | |
| Large: Pass | ||
| Side load | Small: Pass | |
| Large: Pass | ||
| Pigtail to Connector2 | Pass | |
| Pigtail to Handle | Pass | |
| Hub to shaft | Pass | |
| Stopcock to handle | Pass | |
| Stopcock to tube | Pass | |
| Shaft distal segments | Pass | |
| Shaft proximal segments | Pass | |
| Hemostasis valve and sheath must not leak | Pass | |
| Valve insertion force | Pass | |
| Valve friction | Pass | |
| Curve Span | Small: Pass | |
| Large: Pass | ||
| Electrode Location | Small: Pass | |
| Large: Pass | ||
| Electrical Resistance | Small: Pass | |
| Large: Pass | ||
| Current Leakage | Small: Pass | |
| Large: Pass | ||
| Connector mating, flex fatigue, and pigtail torque testing | Pass | |
| Electrical Isolation | Small: Pass | |
| Large: Pass | ||
| External lead cable length | Pass | |
| Corrosion | Pass | |
| Continuous pouch seal | Pass | |
| Pouch particulate | Pass | |
| Label adhesion and legibility | Pass | |
| Dilator OD | Pass | |
| Dilator to cap retention force | Pass |
Dilator to dilator hub tensile
Dilator hub has standard luer
Dilator tip ID
Dilator overall length (straightened)
Pass
Pass
Pass
Pass
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Summary of Pre-Clinical Tests and Results
The study placed one Test or one Control sheath in the animal to aid in maneuvering of various therapeutic and diagnostic catheters for mapping of the right atrium, right ventricle, left atrium and left ventricle of the heart.
The findings met all Study Endpoints concerning safety and
performance of the CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath:
-
- No damage or product integrity issues related to CARTO VIZIGO™ 8.5F
Bi-Directional Guiding Sheath.
- No damage or product integrity issues related to CARTO VIZIGO™ 8.5F
-
- No leakage through hemostatic valve.
-
- No thrombus observed inside or at the tip of the sheath.
- No clinically significant tissue injury related to the use of the Test article.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is substantially equivalent to its currently cleared predicate based on the successful completion of nonclinical bench testing and pre-clinical studies, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use.
§ 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).