(368 days)
Not Found
No
The summary describes a mechanical introducer set and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended to introduce diagnostic and interventional devices, not to directly treat a medical condition.
No
Explanation: The device is an introducer set used to access the radial artery for diagnostic and interventional devices, but it is not a diagnostic device itself. It facilitates the introduction of other devices that may be diagnostic.
No
The device description explicitly states it is composed of physical components like an introducer sheath, dilator, wire guide, needle, and syringe, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "introduce 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 test samples like blood or tissue.
- Device Description: The description details components like an introducer sheath, dilator, wire guide, and needle, which are all tools 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 Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a medical device used for procedural access, not an IVD.
N/A
Intended Use / Indications for Use
The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
Product codes
DYB
Device Description
The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a Class II device according to 21 CFR §870.1340; product code DYB (Catheter Introducer). The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is composed of an introducer sheath and dilator. The subject device also includes additional procedural components such as a wire guide and a 21 gage needle with a 4 inch length. Some subject device configurations also include a luer locking syringe. Table 1 of this 510(k) Summary provides a product matrix of the subject device components. The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a packaged, sterile device intended for single patient use.
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
Not Found
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
Biocompatibility Testing: Testing was performed in accordance with BS EN ISO 10993-1:2009. The materials and methods used to manufacture the subject device are non-toxic and met the predetermined acceptance criteria for their intended use.
Dimensional Stability: Dimensional Stability and Compatibility Testing of the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set was performed in accordance with an approved study protocol. The predetermined acceptance criteria were met.
Dilator and Introducer Sheath Tensile Testing: Tensile testing verified that under proper clinical use of the dilator and introducer sheath, the peak load values shall be in accordance with BS EN ISO 11070:2014. Annex C. The predetermined acceptance criteria were met.
Liquid leakage under pressure: Leakage testing verified that under proper clinical use the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set shall not leak when tested in accordance with an approved study protocol. The predetermined acceptance criteria were met.
Valve leakage testing under pressure testing: Valve leakage testing verified that under proper clinical use the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set shall not leak past the hemostasis valve when tested in accordance with ISO 11070 Annex E. and an approved study protocol. The predetermined acceptance criteria for the respective testing were met.
Rollback and Kink Resistance: Insertion testing of the Cook Inc. Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set in accordance with ISO 11070:2014. Annex A verified that under proper clinical use of the dilator and introducer sheath, each test article shall show no signs of damage such as rollback or cracks at the tip and/or signs of kinking of the shaft. The predetermined acceptance criteria for the respective testing were met.
Age Testing: Performance testing was conducted on aged Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set devices in accordance with BS EN ISO 11070:2014. The predetermined acceptance criteria for the respective testing were met.
Acute Performance: Acute Performance Evaluation of the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set was performed in an animal model. The predetermined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.
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).
0
Image /page/0/Picture/0 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
June 4, 2018
Cook Incorporated Jennifer Allman Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K171609
Trade/Device Name: Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 3, 2018 Received: May 4, 2018
Dear Jennifer Allman:
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 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);
1
Page 2 - Jennifer Allman
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 medical devices and radiation-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.
Kenneth J. Cavanaugh -S
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) K171609
Device Name
Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set
Indications for Use (Describe)
The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
| 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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Image /page/3/Picture/1 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, sans-serif font at the top. Below "COOK" is the word "MEDICAL" in white, sans-serif font.
510(k) SUMMARY
Submitted By:
K171609
Jennifer L. Allman Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x104280 Fax: (812) 332-0281 Date Prepared: May 30, 2018
Device:
| Trade Name: | Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set |
|---|---|
| Common Name: | Catheter Introducer |
| Classification Name: | Introducer, Catheter DYB (21 CFR §870.1340) |
Indications for Use:
The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
Predicate Device:
The predicate device for this submission is the Cook Incorporated Flexor® Radial Hydrophilic Introducer Access Set cleared for commercial distribution under 510(k) number K152044, on August 14, 2015.
Comparison to Predicate Device:
It has been demonstrated that the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is comparable to the predicate device (K152044) in terms of intended use, principles of operation, and basic technological characteristics. The subject device provides additional lengths, fewer diameters, and differing materials as compared to the predicate device (K152044). Additionally, the subject device includes with differing materials and dimensions as compared to the predicate device. The substantial equivalence of the subject device to the predicate device is supported by performance and biocompatibility testing.
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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The red background is a rectangle with a diagonal line at the bottom.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 2.339.2235 TOLL FREE: 800.457.4500 www.cookmedical.com
Device Description:
The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a Class II device according to 21 CFR §870.1340; product code DYB (Catheter Introducer). The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is composed of an introducer sheath and dilator. The subject device also includes additional procedural components such as a wire guide and a 21 gage needle with a 4 inch length. Some subject device configurations also include a luer locking syringe. Table 1 of this 510(k) Summary provides a product matrix of the subject device components. The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
| Introducer Outside
Diameter (French) | Introducer
Length (cm) | Dilator Tip Inside
Diameter (inches) | Wire Guide (cm) | |
|-----------------------------------------|---------------------------|-----------------------------------------|-------------------|-------------|
| | | | Diameter (inches) | Length (cm) |
| 4.0 | 5.5 | 0.018 | 0.018 | 30 |
| | 13 | | 0.018 | 40 |
| | 23 | | 0.018 | 40 |
| 5.0 | 5.5 | 0.018 | 0.018 | 25 |
| | 7 | | 0.018 | 30 |
| | 13 | | 0.018 | 40 |
| | 23 | | 0.018 | 80 |
| 6.0 | 5.5 | 0.018 | 0.018 | 25 |
| | 7 | | 0.018 | 25 |
| | 13 | | 0.018 | 40 |
| | 23 | | 0.018 | 80 |
| Table 1: Dimensional Variants of the Subject Device | ||
|---|---|---|
| ----------------------------------------------------- | -- | -- |
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Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, smaller letters on a red background.
Table 2: Comparison of Technological Characteristics
| Technological Characteristic | | PREDICATE DEVICE
Flexor Radial Hydrophilic
Introducer Access Set
(K152044) | SUBJECT DEVICE
Check-Flo® Performer™
Introducer Micropuncture®
Radial Artery Access Set |
|------------------------------|-------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | | Introducer | |
| Outside Diameter (French) | Length (cm) | | |
| 4.0 | 5.5 | | X |
| 4.0 | 7 | | X |
| 4.0 | 13 | X | X |
| 4.0 | 23 | X | X |
| 5.0 | 5.5 | | X |
| 5.0 | 7 | X | X |
| 5.0 | 13 | X | X |
| 5.0 | 23 | X | X |
| 6.0 | 5.5 | | X |
| 6.0 | 7 | X | X |
| 6.0 | 13 | X | X |
| 6.0 | 23 | X | X |
| 7.0 | 13 | X | |
| 7.0 | 23 | X | |
| Check-Flo Valve Assembly | | X | X |
| Wire Guide | | | |
| Diameter (inch) | 0.018 | X | X |
| Needle | | | |
| Diameter (gage) | 21 | X | X |
The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a packaged, sterile device intended for single patient use.
There are no prior submissions for the subject device.
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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font, also on a red background. The red background for the word "MEDICAL" is a rectangle that is slightly offset from the red background for the word "COOK".
COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Test Data:
The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- Biocompatibility Testing Testing was performed in accordance with . BS EN ISO 10993-1:2009, the materials and methods used to manufacture the subject device are non-toxic and met the predetermined acceptance criteria for their intended use.
- Dimensional Stability Dimensional Stability and Compatibility Testing of the Check-. Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set was performed in accordance with an approved study protocol. The predetermined acceptance criteria were met.
- . Dilator and Introducer Sheath Tensile Testing – Tensile testing verified that under proper clinical use of the dilator and introducer sheath, the peak load values shall be in accordance with BS EN ISO 11070:2014. Annex C. The predetermined acceptance criteria were met.
- Liquid leakage under pressure Leakage testing verified that under proper clinical use . the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set shall not leak when tested in accordance with an approved study protocol. The predetermined acceptance criteria were met.
- Valve leakage testing under pressure testing Valve leakage testing verified that under . proper clinical use the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set shall not leak past the hemostasis valve when tested in accordance with ISO 11070 Annex E. and an approved study protocol. The predetermined acceptance criteria for the respective testing were met.
- Rollback and Kink Resistance Insertion testing of the Cook Inc. Check-Flo® . Performer™ Introducer Micropuncture® Radial Artery Access Set in accordance with ISO 11070:2014. Annex A verified that under proper clinical use of the dilator and introducer sheath, each test article shall show no signs of damage such as rollback or cracks at the tip and/or signs of kinking of the shaft. The predetermined acceptance criteria for the respective testing were met.
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Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters, with a registered trademark symbol next to it. Below "COOK" is the word "MEDICAL" in white, block letters. The background is a solid red color.
- Age Testing Performance testing was conducted on aged Check-Flo® Performer™ . Introducer Micropuncture® Radial Artery Access Set devices in accordance with BS EN ISO 11070:2014. The predetermined acceptance criteria for the respective testing were met.
- Acute Performance Acute Performance Evaluation of the Check-Flo® Performer™ . Introducer Micropuncture® Radial Artery Access Set was performed in an animal model. The predetermined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.