(298 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a vascular introducer sheath and dilator. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an introducer set, intended to introduce therapeutic or diagnostic devices into the vasculature, not to provide therapy itself.
No
Explanation: The device is described as an "Introducer Set" intended to "introduce therapeutic devices into the vasculature". While it mentions that it can be used to introduce diagnostic devices, its primary function is not to perform diagnosis itself, but rather to facilitate the introduction of other devices, whether therapeutic or diagnostic.
No
The device description clearly outlines physical components (introducer sheath, dilator) made of materials like polycarbonate, Teflon, nylon, and polyethylene. It also describes manufacturing processes and physical performance testing, indicating it is a hardware 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 therapeutic devices into the vasculature". This is a direct intervention within the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device (introducer sheath and dilator) used to facilitate access to blood vessels. This is consistent with a medical device used for procedures, not for diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide a pathway for other devices to enter the body.
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 Shuttle® -SL Flexor® Tuohy-Borst Side-Arm Introducer Set is composed of an introducer sheath and a dilator. These devices will be manufactured in 4.0, 5.0. 6.0, 7.0. and 8.0 French and in lengths of 80. 90 and 110 centimeters.
The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Sets are manufactured with a polycarbonate Tuohy-Borst proximal fitting on a Teflon lined, coil-reinforced nylon introducer sheath (Flexor material). The dilator (composed of nylon or polyethylene depending on French size) is characterized by a distal taper allowing for a smooth transition with the appropriately sized wire guide. A hydrophilic coating is applied to the distal portion of both the sheath and dilator components
The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the Shuttle-SL introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.
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
physician
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)
The proposed Shuttle® -SL Flexor® Tuohy-Borst Side-Arm Introducer 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 (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.
- 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.
- . 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 mechanical abrasion Testing verified that the . hydrophilic coating for the device met the requirements for durability. The predetermined acceptance criterion was 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 gram during the course of 10 cycles. The predetermined acceptance criteria were met.
- 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.
- Acute performance Testing verified that performance parameters were . acceptable for clinical use. The predetermined acceptance criterion was 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.
- Dimensional verification testing Testing verified that the dilator can accept the o appropriately sized wire guide, the dilator can pass through the sheath, the inner diameter of the sheath is within the specified French size, and the sheath length is within a specified tolerance.
- . 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.
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 the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
Cook, Inc. % Mr. Steven Lawrie Regulatory Affairs Team Lead 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402
Re: K142819
Trade/Device Name: Shuttle-SL Flexor Tuohy-Borst Side-Arm Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 16, 2015 Received: June 17, 2015
Dear Mr. Lawrie:
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
1
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/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,
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) K142819
Device Name
Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image shows the Cook Medical logo. The logo has a red background with the word "COOK" in white, sans-serif font. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font, on a red banner.
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
5.0 510(k) Summary
Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set Traditional 510(k) Summary 21 CFR §807.92
Submitter Information:
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Contact: | Steven Lawrie |
| Email: | steven.lawrie@cookmedical.com |
| Contact Phone Number: | 812-335-3575 ext. 104518 |
| Contact Fax Number: | 812-332-0281 |
| Date Prepared: | June 16, 2015 |
| Device Information: | |
| Trade Name: | Shuttle®-SL Flexor® Tuohy-Borst Side-Arm |
| Introducer Set | |
| Common Name: | Introducer Set |
Predicate Devices:
Classification Name:
The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set is substantially equivalent to the following devices: the Pinnacle® Destination® Peripheral Guiding Sheath (K091329) cleared on May 29, 2009 and the Cordis Brite Tip® Catheter Sheath Introducer (K984500) cleared on December 23, 1998.
Introducer, Catheter
DYB (21 CFR §870.1340)
4
Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The red background is shaped like a rectangle with a corner cut off.
Device Description:
The Shuttle® -SL Flexor® Tuohy-Borst Side-Arm Introducer Set is composed of an introducer sheath and a dilator. These devices will be manufactured in 4.0, 5.0. 6.0, 7.0. and 8.0 French and in lengths of 80. 90 and 110 centimeters.
The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Sets are manufactured with a polycarbonate Tuohy-Borst proximal fitting on a Teflon lined, coil-reinforced nylon introducer sheath (Flexor material). The dilator (composed of nylon or polyethylene depending on French size) is characterized by a distal taper allowing for a smooth transition with the appropriately sized wire guide. A hydrophilic coating is applied to the distal portion of both the sheath and dilator components
The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the Shuttle-SL introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.
Comparison to Predicates:
The proposed device is substantially equivalent to the predicates in terms of intended use, duration of use, principles of operation, technological characteristics, and insertion method. The proposed device has the same components (introducer sheath and dilator) with the same or comparable materials as those of the predicate devices. Additionally, the specifications of the proposed device components generally fall within the range of those of the predicate devices. The differences between the subject device and the two predicate devices, including intended use language, material (e.g., proximal fitting, coating, dilator), dilator wire guide compatibility, and shelf-life, do not raise any new issues of safety and effectiveness.
5
Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font, set against a darker red background.
Intended Use:
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Test Data:
The proposed Shuttle® -SL Flexor® Tuohy-Borst Side-Arm Introducer 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 (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.
- 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.
- . 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 mechanical abrasion Testing verified that the . hydrophilic coating for the device met the requirements for durability. The predetermined acceptance criterion was 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 gram during the course of 10 cycles. The predetermined acceptance criteria were met.
- 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.
6
Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red square. Below the red square is a smaller red rectangle with the word "MEDICAL" in white, uppercase letters. The logo is simple and clean, with a focus on the company name.
- Acute performance Testing verified that performance parameters were . acceptable for clinical use. The predetermined acceptance criterion was 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.
- Dimensional verification testing Testing verified that the dilator can accept the o appropriately sized wire guide, the dilator can pass through the sheath, the inner diameter of the sheath is within the specified French size, and the sheath length is within a specified tolerance.
- . 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.