(58 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a sheath introducer system, with no mention of AI or ML capabilities.
No.
The device facilitates the placement of a catheter but does not directly treat a condition. It is an accessory device for a procedure.
No
The device is indicated to facilitate placing a catheter into a radial artery, which is a procedural/interventional function, not a diagnostic one.
No
The device description explicitly details physical components such as a sheath introducer, vessel dilator, needles, and a guidewire. It also mentions materials, coatings, and physical dimensions, indicating it is a hardware device.
Based on the provided information, the RAIN Sheath™ Transradial is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "facilitate placing a catheter through the skin into a radial artery." This is a procedural device used for accessing a blood vessel, not for performing tests on samples taken from the body.
- Device Description: The components (sheath introducer, dilator, needles, guidewire) are all tools used for accessing and introducing a catheter into a blood vessel. They do not perform any diagnostic testing on biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, tissue, or any other biological sample for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The RAIN Sheath™ Transradial does not fit this description.
N/A
Intended Use / Indications for Use
RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery.
Each RAIN Sheath™ device consists of a sheath introducer, a vessel dilator (0.021" quidewire compatible), an IV cannula needle and/or a bare access needle, and a 45 cm 0.021" guidewire (either bare or hydrophilic). The device configurations with the hydrophilic guidewire contain only the IV cannula needle whereas device configurations with the bare wire contain only the bare needle.
The sheath introducer has a lubricious hydrophilic coating, a smooth shoulder transition to the dilator and low-profile outer diameters (OD). To provide an atraumatic transition between the dilator tip and the 0.021" mini guide wire, the RAIN Sheath™ dilator is tapered at the distal end and the inner diameter (ID) of the dilator has been optimized. The hub is overmolded to the dilator and includes a locking mechanism between the hub of the vessel dilator and the hub of the sheath cannula to facilitate insertion of the product while preventing the vessel dilator from backing out of the cannula. RAIN Sheath™ device is available in sixteen (16) product configurations which differ based on French size and length, and the specific wire and needle included in the system, as indicated in the table below. It is offered in French sizes of 4F, 5F, 6F and 7F, with lengths of 10 cm and 16 cm. RAIN Sheath™ device is a single-use sterile device, sterilized by ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
RAIN Sheath™ device is for 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: RAIN Sheath™, like the predicate, is an externally communicating device with limited contact duration (≤ 24 hours) with circulating blood. Biocompatibility testing was performed for RAIN Sheath™ 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 10993-1:2009/Cor 1:2010, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. On the basis of the testing listed below, RAIN Sheath™ is biocompatible for its intended use:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Pyrogenicity
- Hemocompatibility
Sterilization: The sterilization cycle used to sterilize RAIN Sheath™ was validated per ISO 11135:2014 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 contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue and white.
Cordis Corporation Ankita Phophalia Regulatory Affairs Project Manager 1820 McCarthy Boulevard Milpitas, California 95035
Re: K181592
Trade/Device Name: RAIN Sheath Transradial Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 15, 2018 Received: June 18, 2018
Dear Ms. Ankita Phophalia:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 E.
Donaldson -S
Digitally signed by Finn E. Donaldson -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=2000979673,
cn=Finn E. Donaldson -S
Date: 2018.08.15 07:26:59 -04'00'
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181592
Device Name RAIN Sheath Transradial
Indications for Use (Describe)
RAIN Sheath Transradial is indicated to facilitate placing a catheter through the skin into a radial artery.
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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3
510(k) Summary
I. SUBMITTER
Applicant: Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014 USA Establishment Reqistration: 1016427
Contact: Ankita Phophalia Cordis Corporation 1820 McCarthy Boulevard Milpitas, CA 95035 USA Tel: (408) 273-3228 Fax: (408) 955-0704
Date Prepared: June 15, 2018
II. DEVICE
Name of Device: RAIN Sheath™ Transradial Common Name: Vascular Catheter Introducer Classification Name: Introducer, Catheter (21 CFR 870.1340), Class II Product Code: DYB
III. PREDICATE DEVICE
Terumo Glidesheath Slender® cleared on 11/21/2014 under K142183
Predicate device cited above has not been the subject of a recall.
IV. DEVICE DESCRIPTION
RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery.
Each RAIN Sheath™ device consists of a sheath introducer, a vessel dilator (0.021" quidewire compatible), an IV cannula needle and/or a bare access needle, and a 45 cm 0.021" guidewire (either bare or hydrophilic). The device configurations with the hydrophilic guidewire contain only the IV cannula needle whereas device configurations with the bare wire contain only the bare needle.
The sheath introducer has a lubricious hydrophilic coating, a smooth shoulder transition to the dilator and low-profile outer diameters (OD). To provide an atraumatic transition between the dilator tip and the 0.021" mini guide wire, the RAIN Sheath™ dilator is tapered at the distal end and the inner diameter (ID) of the dilator has been optimized. The hub is overmolded to the dilator and includes a locking mechanism between the hub of the vessel dilator and the hub of the sheath cannula to facilitate insertion of the product while preventing the vessel
4
dilator from backing out of the cannula. RAIN Sheath™ device is available in sixteen (16) product configurations which differ based on French size and length, and the specific wire and needle included in the system, as indicated in the table below. It is offered in French sizes of 4F, 5F, 6F and 7F, with lengths of 10 cm and 16 cm. RAIN Sheath™ device is a single-use sterile device, sterilized by ethylene oxide.
RAIN Sheath™ device is for professional use in a hospital, catheterization laboratory, or other suitable healthcare facility only.
| Catalog Code | 0.021" Mini
Guidewire | Needle | French Size and
Length |
|--------------|--------------------------|-------------|---------------------------|
| 506410S | Bare | Bare needle | 4 F, 10 cm |
| 506416S | | | 4 F, 16 cm |
| 506510S | | | 5 F, 10 cm |
| 506516S | | | 5 F, 16 cm |
| 506610S | | | 6 F, 10 cm |
| 506616S | | | 6 F, 16 cm |
| 506710S | | | 7 F, 10 cm |
| 506716S | | | 7 F, 16 cm |
| 506410H | Hydrophilic | IV cannula | 4 F, 10 cm |
| 506416H | | | 4 F, 16 cm |
| 506510H | | | 5 F, 10 cm |
| 506516H | | | 5 F, 16 cm |
| 506610H | | | 6 F, 10 cm |
| 506616H | | | 6 F, 16 cm |
| 506710H | | | 7 F, 10 cm |
| 506716H | | | 7 F, 16 cm |
The materials of construction of the RAIN Sheath™ device components are as follows:
| RAIN Sheath™ Transradial Materials of Construction | ||
|---|---|---|
| Component | Materials | Patient |
| Contact | ||
| Sheath | ||
| Introducer | Nylon, Pebax, Barium Sulfate, color concentrate, | |
| hydrophilic coating, PTFE, Polyethylene, Silicone | Direct | |
| (≤ 24hr) | ||
| Dilator | Nylon, HDPE, Barium sulfate, color concentrate | Direct |
| (≤ 24hr) | ||
| Bare Wire | Stainless steel | Direct |
| (≤ 24hr) | ||
| Hydrophilic | ||
| Wire | Nitinol, Tungsten, hydrophilic coating | Direct |
| (≤ 24hr) | ||
| Bare Needle | Stainless steel, Polyethylene | Direct |
| (≤ 24hr) | ||
| IV Cannula | ||
| Needle | Stainless steel, MABS, Polypropylene, FEP | Direct |
| (≤ 24hr) |
5
V. INDICATIONS FOR USE
RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery.
The Indications for Use statement for RAIN Sheath™ is identical to that of the predicate device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
RAIN Sheath™ device and the predicate device facilitate low profile access into the radial artery using the same fundamental mechanism of action. Both devices have introducer sheaths with hydrophilic coating which imparts lubricity and facilitates ease of insertion of the device. The dilator component of each device supports the sheath in which it is inserted and dilates the vessel during radial insertion. The introducer sheath with hydrophilic coating and the tapered dilator which provides a smooth transition between the guidewire and the introducer sheath facilitates atraumatic entry into the radial artery over a guide wire and minimizes tissue damaqe.
RAIN Sheath™ 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-pyrogenic
- Similar materials ●
- . Similar components
- Similar device dimensions ●
- Similar packaging configuration
- Similar compatibility with other devices used in radial access procedures ●
Based on a thorough analysis of technological characteristics, including design, materials, dimensions, mechanism of action, and clinical use, the RAIN Sheath 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.
6
Biocompatibility Testing
RAIN Sheath™, like the predicate, is an externally communicating device with limited contact duration (≤ 24 hours) with circulating blood. Biocompatibility testing was performed for RAIN Sheath™ 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 10993-1:2009/Cor 1:2010, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. On the basis of the testing listed below, RAIN Sheath™ is biocompatible for its intended use:
- Cytotoxicity .
- Sensitization .
- Irritation .
- Systemic toxicity ●
- Pyrogenicity ●
- Hemocompatibility .
Sterilization
The sterilization cycle used to sterilize RAIN Sheath™ was validated per ISO 11135:2014 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