(113 days)
No
The description focuses on mechanical and electrical components for visualization and maneuverability, with no mention of AI or ML algorithms for data analysis, image processing, or decision support.
No
The device is described as a "guiding sheath" used to introduce other catheters. It facilitates procedures by providing access and maneuverability, but it does not directly treat a medical condition.
No
The device is a guiding sheath used to introduce other catheters into the heart. While it facilitates the use of diagnostic catheters, the sheath itself is not described as performing diagnostic functions such as identifying diseases or conditions.
No
The device description clearly details a physical, steerable guiding sheath with a handle, valve, sideport, and electrodes. While it interacts with a navigation system (software), the core device itself is a piece of hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to introduce cardiovascular catheters into the heart. This is a procedure performed in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
- Device Description: The description details a steerable sheath designed for navigating within the cardiac anatomy. This is a surgical/interventional tool, not a device for analyzing biological samples.
- Anatomical Site: The device is used within the heart, a living organ.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device within the body.
- Performance Studies: The studies described involve bench testing and preclinical testing in animals, focusing on the device's performance and safety during insertion and maneuvering within the heart.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
N/A
Intended Use / 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 interatrial septum.
The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
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
§ 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
1
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 | |
| OFFICIAL | |
| CORRESPONDENT | John Jimenez |
| Senior Program Lead, Regulatory Affairs | |
| Telephone: 949-923-4774 | |
| Fax: 949-450-6886 | |
| Email: jjimene7@its.jnj.com | |
| DATE SUMMARY | |
| PREPARED | 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 §870.1340 |
| Product 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