(103 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a traditional introducer sheath and dilator, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device's intended use is to introduce therapeutic devices, not to be a therapeutic device itself.
No
Explanation: The device is described as an introducer sheath and dilator intended to introduce therapeutic devices into the vasculature. Its function is to facilitate the delivery of other medical instruments, not to diagnose a condition.
No
The device description and performance studies clearly indicate a physical medical device (introducer sheath and dilator) with associated material and mechanical testing. There is no mention of software as the primary or sole component.
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 therapeutic devices into the vasculature." This describes a device used in vivo (within the body) for a therapeutic procedure, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description of an introducer sheath and dilator aligns with devices used for accessing blood vessels during medical procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for direct use within the patient's circulatory system to facilitate other medical interventions.
N/A
Intended Use / Indications for Use
Flexor® Introducers and Guiding Sheaths are intended to introduce therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Product codes
DYB
Device Description
The Flexor® Tuohy-Borst Side-Arm Introducers Shuttle Select® are composed of an introducer sheath and a dilator. These devices will be manufactured in 5.0 and 6.0 French and in a length of 90 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature, excluding coronary and neuro vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
- Acute performance Testing verified that performance parameters were acceptable for . clinical use. The predetermined acceptance criterion was met.
- Biocompatibility testing Testing (i.e., cytotoxicity, sensitization, intracutaneous . reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time) demonstrated that the device is biocompatible. In conformance with the applicable sections of AAMI/ANSI/ISO 10993-1:2009, the predetermined acceptance criteria were met.
- Coating integrity and device compatibility testing under simulated use Testing verified ● that the coating appearance was absent of defects before and after simulated use.
- Dilator and introducer sheath liquid leakage Testing verified that under proper clinical . use of the dilator and introducer sheath, each test article shall not leak when tested in accordance with BS EN ISO 11070:1999, Annex D and E. The predetermined acceptance criteria were met.
- Dilator and introducer sheath lubricity Testing verified that, while hydrated and . subjected to a 300 gram normal force, the peak force over a 10 centimeter stroke shall be less than 100 grams during the course of 10 cycles. The predetermined acceptance criteria were met.
- Dilator and introducer sheath tensile testing Testing verified that under proper clinical ● use of the dilator and introducer sheath, the peak load values shall be in accordance with the applicable values of BS EN ISO 11070:1999. The predetermined acceptance criteria were met.
- Dimensional verification testing Testing verified component compatibility and ● dimensional tolerances.
- . Thromboresistance testing – Testing verified that there would be 0% to 25% estimated patency impact due to thrombus associated with the test articles. The predetermined acceptance criterion was met.
- . Torque strength testing – Testing verified that under proper clinical use, the device could withstand one full rotation without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2016
Cook Incorporated Ms. Sarah Reeves Regulatory Engineer 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K153430
Trade/Device Name: Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: February 9, 2016 Received: February 10, 2016
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
1
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
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) K153430
Device Name
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
Indications for Use (Describe)
Flexor® Introducers and Guiding Sheaths are intended to introduce therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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.
510(k) SUMMARY
K153430
| 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: 09 February 2016 | |
Device:
Trade Name:
Common Name: Classification Name:
Flexor® Tuohy-Borst Side-Arm Introducers Shuttle Select® Introducer Set Introducer, Catheter DYB (21 CFR §870.1340)
Indications for Use:
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Predicate Device:
The device, subject of this submission, is substantially equivalent to the predicate device, Cook Incorporated Shuttle® -SL Flexor® Tuohy-Borst Side-Arm Introducer cleared for commercial distribution under 510(k) number K142819 on 24 July 2015.
Comparison to Predicate Device:
It has been demonstrated that the Flexor® Tuohy-Borst Side-Arm Introducers Shuttle Select® are comparable to the predicate device. The subject device is identical to the predicate in terms of intended use, principles of operation and basic technological characteristics to the predicate device. Additional shaft materials have been included. The substantial equivalence of the modifications is supported by testing.
4
Image /page/4/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 to the right of the word. Below the word "COOK" is the word "MEDICAL" in white, block letters. The words are set against a red background.
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
Device Description:
The Flexor® Tuohy-Borst Side-Arm Introducers Shuttle Select® are composed of an introducer sheath and a dilator. These devices will be manufactured in 5.0 and 6.0 French and in a length of 90 cm.
Test Data:
The following tests were performed to demonstrate that the Flexor® Tuohy-Borst Side-Arm Introducers met applicable design and performance requirements and support a determination of substantial equivalence.
- Acute performance Testing verified that performance parameters were acceptable for . clinical use. The predetermined acceptance criterion was met.
- Biocompatibility testing Testing (i.e., cytotoxicity, sensitization, intracutaneous . reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time) demonstrated that the device is biocompatible. In conformance with the applicable sections of AAMI/ANSI/ISO 10993-1:2009, the predetermined acceptance criteria were met.
- Coating integrity and device compatibility testing under simulated use Testing verified ● that the coating appearance was absent of defects before and after simulated use.
- Dilator and introducer sheath liquid leakage Testing verified that under proper clinical . use of the dilator and introducer sheath, each test article shall not leak when tested in accordance with BS EN ISO 11070:1999, Annex D and E. The predetermined acceptance criteria were met.
- Dilator and introducer sheath lubricity Testing verified that, while hydrated and . subjected to a 300 gram normal force, the peak force over a 10 centimeter stroke shall be less than 100 grams during the course of 10 cycles. The predetermined acceptance criteria were met.
- Dilator and introducer sheath tensile testing Testing verified that under proper clinical ● use of the dilator and introducer sheath, the peak load values shall be in accordance with the applicable values of BS EN ISO 11070:1999. The predetermined acceptance criteria were met.
- Dimensional verification testing Testing verified component compatibility and ● dimensional tolerances.
5
Image /page/5/Picture/0 description: The image is a logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, with a registered trademark symbol next to it. The word "COOK" is placed on a red rectangle. Below the red rectangle is a smaller red shape with the word "MEDICAL" in white, sans-serif font.
- . Thromboresistance testing – Testing verified that there would be 0% to 25% estimated patency impact due to thrombus associated with the test articles. The predetermined acceptance criterion was met.
- . Torque strength testing – Testing verified that under proper clinical use, the device could withstand one full rotation without failure.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.