(207 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, biocompatibility, sterilization, and bench testing of a guiding sheath, dilator, and hemostasis valve. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is described as a guiding sheath for introducing other interventional and/or diagnostic devices and does not claim to treat or diagnose a disease itself.
No
The device is a guiding sheath intended for the introduction of other devices, not for diagnosis itself. The "Indications for Use" states it's for introducing "interventional and/or diagnostic devices."
No
The device description clearly outlines physical components (guiding sheath, vessel dilator, hemostasis valve) and mentions bench testing related to the integrity of these physical parts. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical sheath, dilator, and valve designed for insertion into blood vessels. This aligns with a medical device used for access and delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes related to in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BRITE TIP RADIANZ™ Guiding Sheath is intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature through the radial artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use in a hospital, catheterization laboratory, or other suitable healthcare facility only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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: (786) 313-8325 crystal.placona@cardinalhealth.com
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
4
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
Contact |
|---------------------|--------------------------------|--------------------------------------------------------------------------------------------------------|----------------------|
| Guiding
Sheath | Tubing | Pebax/Nylon compound, Vestamid, Bismuth
subcarbonate, Color Conc. (various),
hydrophilic coating | Direct
(≤ 24hr) |
| | Radiopaque Tip | Nylon with Bismuth Trioxide | Direct
(≤ 24hr) |
| | Liner | PTFE | Direct
(≤ 24hr) |
| | Braiding | Stainless Steel | None |
| | Hub | Polycarbonate | Indirect
(≤ 24hr) |
| Hemostasis
Valve | Hemovalve
Connector | Polycarbonate, Polyethylene, Colorant | Indirect
(≤ 24hr) |
| | Cap, brim | Polyethylene, Colorant | Indirect
(≤ 24hr) |
| | Gasket | Silicone Rubber Elastomer, Bismuth
Oxychloride | Indirect
(≤ 24hr) |
| | Medical Fluid | Polydimethylsiloxane Fluid | Indirect
(≤ 24hr) |
| | Adhesive | Pimelic Ketone | None |
| | Collar | Polyethylene, Colorant | None |
| | Tubing Extension
(Sideport) | Polyurethane | Indirect
(≤ 24hr) |
| | 3-way Stopcock
Assembly | Polycarbonate, Polyethylene | Indirect
(≤ 24hr) |
| Vessel
Dilator | Dilator Extrusion | Nylon, Barium Sulfate, Color Concentrate,
MDX Lubricant | Direct
(≤ 24hr) |
| | Dilator Hub | Nylon, Color Concentrate | Indirect
(≤ 24hr) |
The materials of construction of the BRITE TIP RADIANZ™ device are as follows:
5
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
6
- 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