(55 days)
The 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® 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 hemostatis 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 steerable sheath is coated with silicone lubricant on the
entire shaft and dilator surface to help minimize friction at the insertion site.
The sheath has electrodes on the outer surface to allow interface with compatible CARTO® 3 EP Navigation Systems.
Based on the provided text, the device in question is a CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath. It is a catheter introducer. The submission is not for a new AI/ML device but rather a modification to the Instructions For Use (IFU) of an existing device to allow for additional imaging guidance and to update labeling based on FDA guidance. Therefore, the detailed questions about AI model acceptance criteria, ground truth, training and test sets, and multi-reader studies are not applicable to this submission.
Here's a breakdown of why this is the case based on the provided document:
- Device Type: This is a physical medical device (catheter introducer), not a software or AI/ML diagnostic tool.
- Purpose of Submission: The 510(k) summary explicitly states: "The sole purpose of this submission is to revise the instructions for use (IFU) to (1) allow for the use of direct imaging guidance, such as fluoroscopy or ultrasound, during catheter manipulation, and (2) to adhere to FDA Guidance 'Intravascular Catheters, Wire, and Delivery Systems with Lubricious Coatings -Labeling Considerations' (October 2019)."
- Technological Comparison: "The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is identical in technological characteristics with the predicate device, as there are no changes in the materials, design, or other from those of the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath cleared under K170997."
- Clinical Study Data (Mentioned): The text mentions: "The safety and performance of the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath with the additional workflow has been validated through clinical study data." And "The clinical study data demonstrated that the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is as safe and effective as the predicate device." However, no details about this "clinical study data" (e.g., sample size, design, endpoints) are provided in the excerpt. This study would not be for an AI model.
Therefore, it is impossible to answer the specific questions about AI/ML acceptance criteria, test sets, ground truth establishment, or MRMC studies because the submission is not for an AI/powered device. The acceptance criteria for this type of submission would relate to demonstrating that the change in IFU does not negatively impact the safety or effectiveness of the physical device, likely through non-clinical (bench) testing and review of existing clinical data, rather than AI model performance metrics.
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July 10, 2023
Biosense Webster, Inc. Caleb Lau Senior Regulatory Affairs Program Lead 31 Technology Drive, Suite 200 Irvine. California 92618
Re: K231412
Trade/Device Name: CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S. D-1385-03-S) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 16, 2023 Received: May 16, 2023
Dear Caleb Lau:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
K231412
Device Name
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
Indications for Use (Describe)
The 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® 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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510(k) Summary
Prepared on: 2023-05-14
21 CFR 807.92(a)(5)
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Biosense Webster, Inc. |
| Applicant Address | 31 Technology Drive, Suite 200 Irvine CA 92618 United States |
| Applicant Contact Telephone | 949-704-1584 |
| Applicant Contact | Mr. Caleb Lau |
| Applicant Contact Email | clau21@its.jnj.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) |
|---|---|
| Common Name | Catheter introducer |
| Classification Name | Introducer, Catheter |
| Regulation Number | 870.1340 |
| Product Code | DYB |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K170997 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath | DYB |
Device Description Summary
21 CFR 807.92(a)(4)
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 hemostatis 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 steerable sheath is coated with silicone lubricant on the
entire shaft and dilator surface to help minimize friction at the insertion site.
The sheath has electrodes on the outer surface to allow interface with compatible CARTO® 3 EP Navigation Systems.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The 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® EP Navigation Systems.
Indications for Use Comparison
The predicate device is the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath, 510(k)#: K170997.
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The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is substantially equivalent to the legally marketed device, as defined in FDA's The 510(k) Program: Evaluating Substantial Equivalence in the Premarket Notifications [510(k)). The sole purpose of this submission is to revise the instructions for use (IFU) to (1) allow for the use of direct imaging guidance, such as fluoroscopy or ultrasound, during catheter manipulation, and (2) to adhere to FDA Guidance "htravascular Catheters, Wire, and Delivery Systems with Lubricious Coatings -Labeling Considerations" (October 2019).
Intended Use: The proposed CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath has the same intended use as the predicate CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath. Specifically, both devices are indicated for introducing various cardiovascular catheters into the heart, including the left of the heart through the interatrial septum.
Technological Comparison
21 CFR 807.92(a)(6)
The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is identical in technological characteristics with the predicate device, as there are no changes in the materials, design, or other from those of the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath cleared under K170997.
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 this sheath to facilitate the introduction of various cardiovascular catheters into the heart.
The safety and performance of the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath with the additional workflow has been validated through clinical study data. Since the catheter design and intended use is identical for the proposed device, there is no significant difference in the safety and performance of the device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The clinical study data demonstrated that the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is as safe and effective as the predicate device. The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is substantially equivalent to the predicate device in terms of fundamental scientific technology based on the identical design, principles of 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).