(103 days)
Flexor® Introducers and Guiding Sheaths are intended to introduce therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
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.
The provided text describes a 510(k) premarket notification for a medical device (Flexor® Tuohy-Borst Side-Arm Introducers Shuttle Select®) and its comparison to a predicate device. The information focuses on the physical and performance characteristics of the device rather than diagnostic or AI-driven performance. Therefore, many of the requested categories (like ground truth, expert opinions, AI assistance, effect size, etc.) are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the available and inapplicable information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acute Performance: Acceptable performance parameters for clinical use. | Verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met. |
| Biocompatibility: In conformance with AAMI/ANSI/ISO 10993-1:2009 (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time). | Demonstrated that the device is biocompatible. The predetermined acceptance criteria were met. |
| Coating Integrity and Device Compatibility: Absence of defects in coating appearance before and after simulated use. | Verified that the coating appearance was absent of defects before and after simulated use. (Implicitly, acceptance criterion met). |
| Dilator and Introducer Sheath Liquid Leakage: Shall not leak when tested in accordance with BS EN ISO 11070:1999, Annex D and E, under proper clinical use. | Verified that under proper clinical use, each test article shall not leak. The predetermined acceptance criteria were met. |
| Dilator and Introducer Sheath Lubricity: 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. | Verified that during the course of 10 cycles, the peak force over a 10 centimeter stroke was less than 100 grams. The predetermined acceptance criteria were met. |
| Dilator and Introducer Sheath Tensile Testing: Peak load values shall be in accordance with the applicable values of BS EN ISO 11070:1999, under proper clinical use. | Verified that under proper clinical use, the peak load values were in accordance with the applicable values of BS EN ISO 11070:1999. The predetermined acceptance criteria were met. |
| Dimensional Verification: Component compatibility and dimensional tolerances. | Verified component compatibility and dimensional tolerances. (Implicitly, acceptance criterion met). |
| Thromboresistance Testing: 0% to 25% estimated patency impact due to thrombus associated with the test articles. | 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: Device could withstand one full rotation without failure under proper clinical use. | Verified that under proper clinical use, the device could withstand one full rotation without failure. (Implicitly, acceptance criterion met). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Test Data" and the types of tests performed (e.g., Acute performance Testing, Biocompatibility testing). It does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These are typically internal validation tests conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical device, and its performance is evaluated through engineering and biological tests, not by expert interpretation of diagnostic images or data for ground truth establishment in that context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human readers, which is not the nature of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an introducer sheath, not a diagnostic imaging device or an AI algorithm. Therefore, no MRMC study or assessment of AI assistance for human readers would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of diagnostic "ground truth." For this device, "ground truth" refers to the established engineering specifications, material properties, and biological safety standards (e.g., ISO, ASTM, internal specifications) that the device must meet through testing.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a physical medical device being evaluated for substantial equivalence through performance and safety testing.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth" in the AI/diagnostic sense for this device.
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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
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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
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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) |
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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.
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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.
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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.
§ 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).