(241 days)
No
The description focuses on the mechanical and functional aspects of a steerable guiding sheath and its compatibility with a navigation system, with no mention of AI or ML capabilities.
No.
The device is designed to introduce catheters into the heart, not to provide therapy itself.
No
The device is a guiding sheath intended for introducing other catheters into the heart. While it facilitates procedures that might involve diagnosis, the sheath itself does not perform any diagnostic function. Its purpose is access and maneuverability, not the detection or identification of a disease or condition.
No
The device description clearly outlines a physical, steerable sheath with a handle, valves, sideport, and radiopaque tip marker, indicating it is a hardware device. The performance studies also focus on physical characteristics and testing of a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce cardiovascular catheters into the heart. This is a procedural device used in vivo (within the body) for accessing anatomical sites.
- Device Description: The description details a physical sheath with features for manipulation and access within the body. It does not describe a device that analyzes biological samples (like blood, urine, or tissue) in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing. The device facilitates a medical procedure, it doesn't perform a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Reprocessed Carto Vizigo 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.
Product codes (comma separated list FDA assigned to the subject device)
PNE
Device Description
The Reprocessed Carto Vizigo 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).
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March 10, 2022
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K212165
Trade/Device Name: Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: PNE Dated: March 7, 2022 Received: March 8, 2022
Dear Amanda Babcock:
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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (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 (OS) 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 Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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K212165 - Amanda Babcock
The item number included in the scope of this submission is as follows:
| Product Description | Item Number | Curve size | Outer Diameter | Usable length | Inner Diameter | Number of Electrode |
|---|---|---|---|---|---|---|
| Reprocessed | ||||||
| Carto Vizigo | ||||||
| Bi-Directional | ||||||
| Guiding | ||||||
| Sheath | D138501 | Small (17 mm) | 11.5F | 71 cm | 8.5F | 4 |
| D138502 | Medium (22 mm) | 11.5F | 71 cm | 8.5F | 4 | |
| D138503 | Large (50 mm) | 11.5F | 71 cm | 8.5F | 4 |
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Indications for Use
510(k) Number (if known) K212165
Device Name
Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath
Indications for Use (Describe)
The Reprocessed Carto Vizigo 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.
| 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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SECTION 5: 510(k) SUMMARY
As required by 21 CFR 807.92(c)
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Amanda Babcock Requlatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
July 09, 2021
Device Information:
Trade/Proprietary Name: Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath Common or Usual Name: Guiding Sheath Classification Name: Reprocessed Catheter Introducer Classification Number: Class II, 21 CFR 870.1340 Product Code: PNE
Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K170997 | Carto Vizigo Bi-Directional Guiding Sheath | Biosense Webster |
Reference Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K170311 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC. |
Device Description:
The Reprocessed Carto Vizigo 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.
Note: Only the steerable sheath and dilator are subject of this submission. The quidewire is purchased off-the shelf (K935170) and packaged with the reprocessed devices.
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The item numbers in scope of this submission are as follows:
| Product
Description | Item
Number | Curve
size | Outer
Diameter | Usable
length | Inner
Diameter | Number of
Electrode |
|--------------------------------------------------------------------|----------------|-------------------|-------------------|------------------|-------------------|------------------------|
| Reprocessed
Carto Vizigo
Bi-Directional
Guiding
Sheath | D138501 | Small
(17 mm) | 11.5F | 71 cm | 8.5F | 4 |
| | D138502 | Medium
(22 mm) | 11.5F | 71 cm | 8.5F | 4 |
| | D138503 | Large
(50 mm) | 11.5F | 71 cm | 8.5F | 4 |
Table 5.1: Device Scope
Indications for Use:
The Reprocessed Carto Vizigo 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.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed device is identical to the predicate device. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the reprocessed device includes removal of visible soil and decontamination. Each device is inspected, and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath. This included the following:
- Biocompatibility ●
- Cleaning Validation .
- Sterilization Validation
- Functional testing ●
- · Visual Inspection
- = Dimensional Verification
- . Dynamic Continuity
- . Simulated Use
- . Leak
- Mechanical Characteristics ■
- . Electrical Safety Testing
- . Dielectric and Current Leakage
- o Packaging Validation
The device is reprocessed no more than one (1) time. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cvcles. the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is substantially equivalent to the predicate devices described herein.