Brite Tip Radianz Guiding Sheath

K202167 · Cordis Corporation · DYB · Feb 26, 2021 · Cardiovascular

Device Facts

• Record ID: K202167
• Device Name: Brite Tip Radianz Guiding Sheath
• Applicant: Cordis Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

BRITE TIP RADIANZ™ Guiding Sheath is intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery.

Device Story

The BRITE TIP RADIANZ™ Guiding Sheath is a vascular catheter introducer used to facilitate the introduction of interventional or diagnostic devices into the peripheral vasculature via the radial artery. The system comprises a 6F guiding sheath, a vessel dilator, and a removable hemostasis valve. The sheath features a lubricious hydrophilic coating and a low-profile outer diameter to minimize radial artery trauma and spasm. The vessel dilator is tapered to ensure a smooth transition between the guidewire and the sheath tip. The hemostasis valve minimizes blood backflow and includes a side-port arm with a 3-way stopcock for flushing or aspiration. The device is intended for professional use in hospitals or catheterization laboratories. By providing a stable access conduit, the device enables clinicians to perform peripheral vascular procedures, potentially reducing vessel trauma during entry and withdrawal.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), sterilization validation (ISO 11135), and mechanical performance testing per ISO 11070, ISO 10555-1, ISO 594-1/2, and ISO 80369-7.

Technological Characteristics

Components: Pebax/Nylon sheath with hydrophilic coating, PTFE liner, stainless steel braiding, polycarbonate hub, and silicone gasket. Dimensions: 6F diameter, 110 cm or 135 cm lengths. Sterilization: Ethylene oxide (ISO 11135). Biocompatibility: ISO 10993-1 compliant. Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Terumo R2P™ Destination Slender™ (K171491)

Submission Summary (Full Text)

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February 26, 2021

Cordis Corporation Crystal Placona Manager, Regulatory Affairs 14201 NW 60th Avenue Miami Lakes, Florida 33014

Re: K202167

Trade/Device Name: Brite Tip Radianz Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 26, 2021 Received: January 27, 2021

Dear Crystal Placona:

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

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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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Finn Donaldson Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202167

Device Name BRITE TIP RADIANZ™ Guiding Sheath

Indications for Use (Describe)

BRITE TIP RADIANZ™ Guiding Sheath is intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery.

Type of Use (*Select one or both, as applicable*)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

### I. SUBMITTER

Applicant: Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014 USA Establishment Registration: 1016427

Contact: Crystal Placona Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014 USA Tel: [phone] [e-mail]

Date Prepared: July 31, 2020

II. DEVICE

Name of Device: BRITE TIP RADIANZ™ Guiding Sheath Common Name: Vascular Catheter Introducer Classification Name: Introducer, Catheter (21 CFR 870.1340), Class II Product Code: DYB

### III. PREDICATE DEVICE

Terumo R2P™ Destination Slender™ cleared on 11/21/2014 under K171491.

Predicate device cited above has not been the subject of a recall.

#### IV. INDICATIONS FOR USE

BRITE TIP RADIANZ™ Guiding Sheath is indicated for intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery.

The Indications for Use statement for BRITE TIP RADIANZ™ is similar to that of the predicate device. The subject and predicate devices have the same fundamental intended use, which is to facilitate introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery. Minor differences in the Indications for Use statements do not alter the intended use.

### V. DEVICE DESCRIPTION

Each BRITE TIP RADIANZ™ device consists of a 6F compatible guiding sheath, a vessel dilator (0.035" guidewire compatible) and a removable hemostasis valve.

The guiding sheath has a lubricious hydrophilic coating to enhance entry and withdrawal during vessel access, and a low-profile outer diameter with a smooth transition to the vessel dilator to minimize or prevent radial vasculature trauma and spasm of the radial artery. The sheath is available in two lengths, 110 cm and 135 cm. The sheath hub is an over-molded hub with a luer and is compatible with the removable hemostasis valve provided (described

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below) and with other hemostasis valves or common vascular accessories of the user's choice.

The vessel dilator is compatible with 0.035" guidewires (not included) and is tapered such that it creates a smooth transition between the guiding sheath tip and the guidewire. The vessel dilator hub is over molded and includes a locking feature located in the distal end of the hub to facilitate locking the vessel dilator to the sheath cannula proximal hemostasis valve.

The system contains a removable hemostasis valve to facilitate entry and withdrawal of intravascular devices through the guiding sheath and minimize the backflow of blood. It also has a side-port arm with attached 3-way stopcock for flushing or aspiration. The preassembled hub connector is removable, such that it can be exchanged for a hemostasis valve or other common vascular accessory of the user's preference.

BRITE TIP RADIANZ™ device is for professional use in a hospital, catheterization laboratory, or other suitable healthcare facility only. It is available in the following configurations:

| Catalog Numbers | Description |
|-----------------|-----------------------|
| 687280110 | 6Fr, straight, 110 cm |
| 687280135 | 6Fr, straight, 135 cm |

| Component | Description | Materials | Patient<br>Contact |
|---------------------|--------------------------------|--------------------------------------------------------------------------------------------------------|----------------------|
| Guiding<br>Sheath | Tubing | Pebax/Nylon compound, Vestamid, Bismuth<br>subcarbonate, Color Conc. (various),<br>hydrophilic coating | Direct<br>(≤ 24hr) |
| | Radiopaque Tip | Nylon with Bismuth Trioxide | Direct<br>(≤ 24hr) |
| | Liner | PTFE | Direct<br>(≤ 24hr) |
| | Braiding | Stainless Steel | None |
| | Hub | Polycarbonate | Indirect<br>(≤ 24hr) |
| Hemostasis<br>Valve | Hemovalve<br>Connector | Polycarbonate, Polyethylene, Colorant | Indirect<br>(≤ 24hr) |
| | Cap, brim | Polyethylene, Colorant | Indirect<br>(≤ 24hr) |
| | Gasket | Silicone Rubber Elastomer, Bismuth<br>Oxychloride | Indirect<br>(≤ 24hr) |
| | Medical Fluid | Polydimethylsiloxane Fluid | Indirect<br>(≤ 24hr) |
| | Adhesive | Pimelic Ketone | None |
| | Collar | Polyethylene, Colorant | None |
| | Tubing Extension<br>(Sideport) | Polyurethane | Indirect<br>(≤ 24hr) |
| | 3-way Stopcock<br>Assembly | Polycarbonate, Polyethylene | Indirect<br>(≤ 24hr) |
| Vessel<br>Dilator | Dilator Extrusion | Nylon, Barium Sulfate, Color Concentrate,<br>MDX Lubricant | Direct<br>(≤ 24hr) |
| | Dilator Hub | Nylon, Color Concentrate | Indirect<br>(≤ 24hr) |

The materials of construction of the BRITE TIP RADIANZ™ device are as follows:

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## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

BRITE TIP RADIANZ™ and the predicate device both facilitate access into the peripheral vasculature through the radial artery using the same fundamental mechanism of action. Both contain a traditional sheath with a bleed-back valve and a stopcock. Sheaths for both devices have a hemostasis valve. BRITE TIP RADIANZ™ and R2P Destination Slender™ both have hydrophilic coatings. During radial access of both devices, the dilator taper and close fit with the sheath combined with the hydrophilic coating on the sheath act to expand the arteriotomy and facilitate entry into the radial artery. Taper length of the BRITE TIP RADIANZ™ dilator is comparable to that of the R2P Destination Slender™. Thus, both the BRITE TIP RADIANZ™ and R2P Destination Slender™ have a combination of a hydrophilic coating, tip geometry and fit with dilator to facilitate entry and reduce friction within the radial artery.

BRITE TIP RADIANZ™ has the following similarities to the predicate device:

- Same intended use
- Same principle of operation ●
- Same mechanism of action
- Same method of sterilization and sterility assurance level ●
- Same biocompatibility classification ●
- . Biocompatible for intended use
- . Labeled non-pvrogenic
- Similar materials
- Similar components .
- . Similar device dimensions
- Similar packaging configuration ●
- Similar compatibility with other devices used in radial access procedures .

The following technological differences exist between the subject and predicate device:

- BRITE TIP RADIANZ™ Guiding Sheath is secured in a tray whereas the predicate . device is secured by a mounting card.
Based on a thorough analysis of technological characteristics, including design, materials, dimensions, mechanism of action, and clinical use, the BRITE TIP RADIANZ™ device is substantially equivalent to the predicate device.

## VII. PERFORMANCE DATA

The performance data described below were provided in support of the substantial equivalence determination.

## Biocompatibility Testing

BRITE TIP RADIANZ™ Guiding Sheath, like the predicate, is an externally communicating device with limited contact duration (≤ 24 hours) with circulating blood. Biocompatibility testing was performed for BRITE TIP RADIANZ™ in accordance with FDA Guidance, Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (June 2016) and ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. On the basis of the testing listed below, BRITE TIP RADIANZ™ is biocompatible for its intended use:

- . Physical and/or Chemical Information

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- Chemical Characterization ●
- Toxicology Risk Assessment
- Cytotoxicity .
- Sensitization .
- . Irritation or Intracutaneous Reactivity
- . Acute Systemic Toxicity
- Material Mediated Pyrogenicity ●
- Hemocompatibility ●

### Sterilization

Testing was performed to permit the adoption of the subject device into existing Cordis validated sterilization cycles. The sterilization cycle used to sterilize BRITE TIP RADIANZ™ Guiding Sheath was validated per ISO 11135:2014+A1:2018 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices to provide a sterility assurance level (SAL) of 10-6.

Ethylene oxide and ethylene chlorohydrin residuals meet requirements for limited exposure devices (contact < 24 hours) in accordance with ISO 10993-7:2008. Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals. The levels of residuals will not exceed 4 mq EO /device or 9 mg ECH/device.

## Bench Testing

The substantial equivalence of the BRITE TIP RADIANZ™ Guiding Sheath to the predicate device has been demonstrated through data collected during non-clinical design verification and validation testing. The following testing was successfully performed or leveraged for the BRITE TIP RADIANZ™ device per applicable sections of the indicated standards and/or validated internal test methods:

- Sheath ISO 11070:2014, 10555-1:2013+A1:2017, ISO 594-1:1986, ISO 594-. 2:1998, USP 788 and internal test methods
- Dilator ISO 11070:2014, 10555-1:2013+A1:2017, USP 788 and internal test . methods
- Hemostasis Valve ISO 80369-7:2016, USP 788 and internal test methods ●
- . Packaging integrity - ISO 11607-1:2019 and ISO 11607-2:2019

The passing results for the testing provide reasonable assurance that the subject device has been designed to meet its intended use.

### Clinical Studies

No clinical studies were deemed necessary to support substantial equivalence.

### VIII. CONCLUSIONS

The information presented in this Premarket Notification demonstrates the following for the BRITE TIP RADIANZ™ Guiding Sheath:

- BRITE TIP RADIANZ™ has a legally-marketed predicate ●
- BRITE TIP RADIANZ™ has the same Intended Use as the predicate ●
- BRITE TIP RADIANZ™ incorporates the same fundamental technology as the . predicate

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- Accepted scientific methods and international standards were used to evaluate . substantial equivalence of the BRITE TIP RADIANZ™ device relative to the predicate
- Performance characteristics of the BRITE TIP RADIANZ™ device are equivalent to . the predicate device.

On the basis of the intended use, design, performance characteristics and non-clinical performance testing, and of detailed comparisons to the legally marketed predicate device, it is concluded that the BRITE TIP RADIANZ™ Guiding Sheath is substantially equivalent to R2P ™ Destination Slender™.