(47 days)
The ADROIT™ Guiding Catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
The 5F ADROIT™ Guiding Catheter features a 5F outer diameter, with a single through lumen of 0.058". The catheter body is reinforced with tightly wound stainless steel braid wire. The catheter body transitions to progressively lower durometers from the body to the distal tip, providing a gradual decrease in stiffness. The lumen is accessed via a polycarbonate luer hub. The 5F ADROIT™ Catheter is offered in an overall length of 100cm. A broad range of tip shapes are offered for specific procedures.
This document is a 510(k) premarket notification for the ADROIT™ Guiding Catheter. The purpose of this notification is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This type of submission does not typically include a full clinical study with acceptance criteria and device performance in the way machine learning or diagnostic devices might. Instead, the focus is on engineering and performance testing to show equivalence to a predicate.
Based on the provided document, here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format for each test. Instead, it states that "Bench testing confirms that the 5F ADROIT™ Guiding Catheter can be used according to its intended use and in an equivalent manner to the predicate device." This implies that the performance of the ADROIT™ Guiding Catheter met or was comparable to the predicate device for each test.
| Test Performed | Reported Device Performance |
|---|---|
| Catheter ID | Confirmed to be usable according to intended use and equivalent to predicate. |
| Body and Tip Seal Strength | Confirmed to be usable according to intended use and equivalent to predicate. |
| Hydrostatic Pressure | Confirmed to be usable according to intended use and equivalent to predicate. |
| Hub Aspiration | Confirmed to be usable according to intended use and equivalent to predicate. |
| CSI Compatibility | Confirmed to be usable according to intended use and equivalent to predicate. |
| Kink Radius | Confirmed to be usable according to intended use and equivalent to predicate. |
| I-Torque | Confirmed to be usable according to intended use and equivalent to predicate. |
| Flexibility/3-Point Bend | Confirmed to be usable according to intended use and equivalent to predicate. |
| U-Torque | Confirmed to be usable according to intended use and equivalent to predicate. |
| Backup Support | Confirmed to be usable according to intended use and equivalent to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes bench testing, meaning the tests were performed on the device itself (hardware) rather than clinical data from patients. Therefore, terms like "test set" or "data provenance" related to patient data are not applicable in this context. The sample size would refer to the number of physical catheters tested for each performance characteristic. This specific number is not provided in the document.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of information is not applicable as the evaluation is based on objective physical and mechanical properties of the device, not on expert interpretation of data or images.
4. Adjudication Method for the Test Set
This is not applicable as the testing involves objective measurements of device performance, not subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human reader performance is being evaluated. This submission is for a physical medical device (guiding catheter).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm study was not done. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is established by engineering and performance specifications and standards for medical catheters. These include physical dimensions, material properties, and mechanical performance characteristics (e.g., strength, flexibility, torque). The predicate device's established performance serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable as this is not a machine learning device. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set was Established
This is not applicable as this is not a machine learning device.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2015
Cordis Corporation Mr. Babu Periasamy Manager, Regulatory Affairs 6500 Paseo Padre Pkwy Fremont, California 94555
Re: K143412
Trade/Device Name: ADROIT™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: December 12, 2014 Received: December 15, 2014
Dear Mr. Periasamy,
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K143412
Device Name: ADROIT™ Guiding Catheter
Indications for Use:
The ADROIT™ Guiding Catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92 in order to gain clearance to market the 5F ADROIT™ Guiding Catheter.
| APPLICANT | Cordis CorporationCordis Corporation, a Johnson & Johnson Company6500 Paseo Padre ParkwayFremont, CA 94555Tel.: 510-248-2464Fax: 510-248-2533 |
|---|---|
| OFFICIALCORRESPONDENT | Ting Liu, PhDRegulatory Affairs SpecialistPhone:(510) 248-2464Fax: 510-248-2533e-mail: bperiasa@its.jnj.com |
| ALTERNATE CONTACT | Babu PeriasamyManager, Regulatory AffairsPhone:(510) 248-2464Fax: 510-248-2533e-mail: bperiasa@its.jnj.com |
| DATE PREPARED | January 14, 2015 |
| TRADE NAME | ADROITT™ Guiding Catheter |
| COMMON NAME | Guiding Catheter |
| CLASSIFICATION NAME | Percutaneous catheter |
| DEVICE CLASSIFICATION | 21 CFR §870.1250 |
| PRODUCT CODES | DQY |
| PREDICATE DEVICE | Cordis 5F Vista Brite Tip® (VBT) Guiding Catheter,previously cleared under K000715. |
SUBSTANTIALLY EQUIVALENT TO:
The Cordis 5F ADROIT™ Guiding Catheter is substantially equivalent to the Cordis 5F Vista Brite Tip® (VBT) Guiding Catheter, previously cleared under K000715.
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DEVICE DESCRIPTION:
The 5F ADROIT™ Guiding Catheter features a 5F outer diameter, with a single through lumen of 0.058". The catheter body is reinforced with tightly wound stainless steel braid wire. The catheter body transitions to progressively lower durometers from the body to the distal tip, providing a gradual decrease in stiffness. The lumen is accessed via a polycarbonate luer hub. The 5F ADROIT™ Catheter is offered in an overall length of 100cm. A broad range of tip shapes are offered for specific procedures.
INTENDED USE:
The ADROIT™ Guiding Catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
TECHNOLOGICAL CHARACTERISTICS:
The 5F ADROIT™ Guiding Catheter incorporates a 0.058" single through lumen. A stainless steel braid is incorporated to the shaft construction to provide pushability, torqueability and kink resistance. A PTFE liner provides a lubricious inner surface for the lumen for any diagnostic or interventional device that will be passed through the guide catheter. The outer surface of the catheter comprises progressively softer polymer materials from the hub to the distal tip so that the catheter has sufficient push and torque characteristics for vascular access, with a soft atraumatic distal tip.
PERFORMANCE DATA:
The following testing was performed to verify and validate the 5F ADROIT™ Guiding Catheter:
- Catheter ID ●
- Body and Tip Seal Strength ●
- Hydrostatic Pressure
- Hub Aspiration ●
- CSI Compatibility
- Kink Radius
- I-Torque
- Flexibility/ 3-Point Bend ●
- U-Torque
- Backup Support ●
Bench testing confirms that the 5F ADROIT™ Guiding Catheter can be used according to its intended use and in an equivalent manner to the predicate device.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The Cordis 5F ADROIT™ Guiding Catheter is substantially equivalent to the Cordis 5F Vista Brite Tip® (VBT) Guiding Catheter, previously cleared under K000715. The Adroit™ Guiding
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Catheter is identical in design, intended use and performance characteristics of the VBT Guiding Catheter. A technological comparison and Design Verification and Validation testing demonstrate that the 5F ADROIT™ Guiding Catheter is substantially equivalent to the predicate device in the design, intended use and performance characteristics.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).