(22 days)
Not Found
No
The document describes a standard medical device (introducer set) and does not mention any AI or ML components or functionalities. The performance studies focus on physical and biological properties, not algorithmic performance.
No
The device is described as an introducer set intended to introduce other diagnostic and interventional devices, not to provide a therapeutic effect itself.
No
The device is described as an introducer access set intended to introduce diagnostic and interventional devices, not to perform diagnostics itself.
No
The device description clearly outlines physical components (introducer sheath, dilator, wire guide, access needle) and mentions performance studies related to these physical components (leakage testing, biocompatibility). 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 clearly states the device is for "introducing diagnostic and interventional devices in radial artery access procedures." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details components like an introducer sheath, dilator, wire guide, and access needle, all of which are used for accessing and navigating within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the Flexor® Radial Hydrophilic Introducer Access Set is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
Product codes
DYB
Device Description
The Flexor® Radial Hydrophilic Introducer Access Set is an introducer set, supplied with an introducer sheath, dilator, wire guide and access needle. The introducers are available in whole French sizes from 4.0 through 7.0 French and in lengths of 7, 13 and 23 centimeters. The sets are compatible with the supplied 0.018" wire guide. The sets are supplied sterile and intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
radial artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The following tests were performed to demonstrate that the Flexor® Radial Hydrophilic Introducer Access Set met applicable design and performance requirements and support a determination of substantial equivalence.
- . Acute Performance - Testing performed verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met.
- . Check-Flo valve liquid leakage testing - Testing verified that the Check-Flo valve will not experience excessive leakage when utilized according to the device's intended use. The predetermined acceptance criteria were met.
- . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) demonstrated the device as biocompatible. In conformance with the applicable sections of ISO 10993-1:2009, the predetermined acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2015
Cook Incorporated Sarah Reeves Regulatory Engineer 750 Daniels Way, P.O. Box 489 Bloomington, IN, 47402
Re: K152044
Trade/Device Name: Flexor Radial Hydrophilic Introducer Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: July 22, 2015 Received: July 23, 2015
Dear Ms. Reeves:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
1
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,
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
K152044 510(k) Number (if known):
Device Name: Flexor® Radial Hydrophilic Introducer Access Set
Indications for Use for the Flexor® Radial Hydrophilic Introducer Access Set:
The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
Submitted By:
Sarah Reeves Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x105024 Fax: (812) 332-0281 Date Prepared: July 22, 2015
Device:
Trade Name: Common Name: Classification Name: Flexor® Radial Hydrophilic Introducer Access Set Introducer Set Catheter, Introducer DYB (21 CFR §870.1340)
Indications for Use:
The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
Predicate Device:
The device, subject of this submission, is substantially equivalent to the predicate device of identical name, the Flexor® Radial Hydrophilic Introducer Access Set, cleared under 510(k) number K132592.
Comparison to Predicate Device:
It has been demonstrated that the Flexor® Radial Hydrophilic Introducer Access Set is comparable to the predicate device. The Flexor® Radial Hydrophilic Introducer Access Sets are identical in terms of intended use, principles of operation, basic technological characteristics, and
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 48
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materials of construction, with the exception of the check-flo valve, to the predicate device. The check-flo valve has been modified in response to physician feedback. The safety and effectiveness of the modifications are supported by testing.
Device Description:
The Flexor® Radial Hydrophilic Introducer Access Set is an introducer set, supplied with an introducer sheath, dilator, wire guide and access needle. The introducers are available in whole French sizes from 4.0 through 7.0 French and in lengths of 7, 13 and 23 centimeters. The sets are compatible with the supplied 0.018" wire guide. The sets are supplied sterile and intended for one-time use.
Test Data:
The following tests were performed to demonstrate that the Flexor® Radial Hydrophilic Introducer Access Set met applicable design and performance requirements and support a determination of substantial equivalence.
- . Acute Performance - Testing performed verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met.
- . Check-Flo valve liquid leakage testing - Testing verified that the Check-Flo valve will not experience excessive leakage when utilized according to the device's intended use. The predetermined acceptance criteria were met.
- . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) demonstrated the device as biocompatible. In conformance with the applicable sections of ISO 10993-1:2009, the predetermined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.