(49 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard medical introducer sheath, with no mention of AI/ML capabilities or data processing.
No
The device is described as an introducer and guiding sheath, intended to introduce therapeutic devices into the vasculature, rather than being a therapeutic device itself.
No
Explanation: The device description and intended use clearly state that the Performer introducers and guiding sheaths are "intended to introduce therapeutic devices into the vasculature." There is no mention of it being used to collect data, analyze, or diagnose medical conditions, which are characteristics of a diagnostic device. It serves as a tool for delivering other devices.
No
The device description clearly outlines physical components such as tubing, a stopcock, connecting tube, Y-Connector, and dilator, indicating it is a hardware device, not software-only.
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 purpose (introducing other devices for treatment).
- Device Description: The description details a physical device (sheath, dilator, stopcock, etc.) designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is clearly designed for use inside the body.
N/A
Intended Use / Indications for Use
Performer introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.
Product codes
DYB
Device Description
The Performer® Introducer is manufactured using radiopaque tubing with a radiopaque band at the tip. The proximal end consists of a stopcock, connecting tube and the Y-Connector, which connects the sheath to the connecting tube and stopcock; the Y-Connector contains a hemostatic valve. The subject device is available with outside diameters ranging from 5.5 - 7 French and a length of 6 centimeters. The dilator is compatible with wire guides 0.035 inches in diameter. The supplied dilator is designed to extend beyond the tip of the sheath when the dilator is fully inserted through the hemostatic valve of the Y-Connector. The Performer® Introducer is a sterile device intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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: Performed in accordance with ISO 10993-1:2009 - cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemolysis, partial thromboplastin time, and compliment activation. The predetermined acceptance criteria were met.
- Dimensional Sheath I.D and Length, and Sheath/Dilator/Wire Guide Compatibility Testing: The results verified, under the proper clinical use of the subject device, the sheath inner diameter, sheath length and sheath/dilator/wire guide compatibility met the predetermined acceptance criteria.
- Gravity Flow Testing: The results verified, under the proper clinical use of the subject device, the Y-Connector Clamp was able to prevent flow through the connecting tube. Thus, the predetermined acceptance criterion was met.
- Leakage Testing: The results verified, under the proper clinical use of the subject device, there was no liquid leakage when tested in accordance with BS EN ISO 11070-1:2014, Annex D and/or E. The predetermined acceptance criteria were met.
- Radiopacity Testing: The results verified, under the proper clinical use of the subject device, the test articles were visible when imaged under fluoroscopy. The predetermined acceptance criteria were met.
- Rollback and Kink Testing: Test results verified, under proper clinical use of the subject device, there was no rollback and/or kink of the sheath when tested in accordance with BS EN ISO 11070, Annex A. The predetermined acceptance criteria were met.
- Tensile Testing: Of the Sheath Radiopaque Tip to Shaft Joint Strength, Sheath Shaft to Hub Joint Strength, Hub to Connecting Tube Joint Strength, Connecting Tube to Side-arm Y-Connector Joint Strength and Dilator Hub to Shaft Joint Strength. The results verified, under the proper clinical use of the subject device, the bond strengths were in accordance with BS EN ISO 11070:2014, Annex C. The predetermined acceptance criteria were met.
- Aged Testing: Accelerated aging to the equivalence of three years was conducted on the Performer® Introducers. Thereafter, the performance testing listed here was conducted again on aged Performer® Introducers in accordance with BS EN ISO 11070:2014. The predetermined acceptance criteria for the respective aged performance testing were met.
Key results: The results of the tests support the conclusion, the Performer® Introducer met the design input requirements based on the intended use. These results also support the conclusion that the intended use, design and material differences for the subject device, when compared to the predicate device, the Performer® Introducer (K171999), do not raise new questions of safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are displayed side-by-side.
November 17, 2017
Cook Incorporated Mr. Reuben Lidster Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN47402
Re: K173068
Trade/Device Name: Performer Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 28, 2017 Received: September 29, 2017
Dear Mr. Lidster:
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 - Mr. Reuben Lidster
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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) K173068
Device Name Performer Introducer
Indications for Use (Describe)
Performer introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.
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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3
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5.0 510(k) SUMMARY
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON, IN 47402-0489 WW.COOKMEDI
K173068 Page 1 of 3
Performer® Introducer 21 CFR §807.92 Date Prepared: September 28, 2017
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Reuben G. Lidster |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x104866 |
| Contact Fax Number: | (812) 332-0281 |
Subject Device Information:
| Trade Name: | Performer® Introducer |
|---|---|
| Common Name: | Catheter Introducer |
| Classification Name: | Catheter Introducer |
| Regulation/Product Code: | 21 CFR §870.1340/DYE |
| Device Class/Panel: | Class II/Cardiovascular |
Predicate Device:
The Performer® Introducer (COOK, Inc. K171999) was cleared for commercial distribution on July 31, 2017.
Subject Device Description:
The Performer® Introducer is manufactured using radiopaque tubing with a radiopaque band at the tip. The proximal end consists of a stopcock, connecting tube and the Y-Connector, which connects the sheath to the connecting tube and stopcock; the Y-Connector contains a hemostatic valve. The subject device is available with outside diameters ranging from 5.5 - 7 French and a length of 6 centimeters. The dilator is compatible with wire guides 0.035 inches in diameter. The supplied dilator is designed to extend beyond the tip of the sheath when the dilator is fully inserted through the
4
Cook Incorporated - Traditional 510(k) Performer® Introducer September 28, 2017
hemostatic valve of the Y-Connector. The Performer® Introducer is a sterile device intended for single use only.
Intended Use:
Performer Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.
Comparison to the Predicate:
The indication for use for both the predicate device and the subject device are identical. The predicate device includes a broader scope of diameters and length as compared to the subject device. Furthermore, the subject device is similar to the predicate device in terms of design, the fundamental technological characteristics and method of operation. These differences do not raise additional questions of safety or effectiveness.
Reference Device:
The subject device is similar in design and identical in fundamental technological characteristics and method of operation to the reference device, the Prelude® Short Sheath Introducer (K082063).
Technological Characteristics:
The following tests were performed to demonstrate the Performer® Introducer met the applicable design and performance requirements and these tests support a determination of substantial equivalence.
- Biocompatibility Testing - The following tests were performed in accordance with ISO 10993-1:2009 - cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemolysis, partial thromboplastin time, and compliment activation. The predetermined acceptance criteria were met.
- Dimensional Sheath I.D and Length, and Sheath/Dilator/Wire Guide Compatibility Testing - The results verified, under the proper clinical use of the subject device, the sheath inner diameter, sheath length and sheath/dilator/wire guide compatibility met the predetermined acceptance criteria.
5
- Gravity Flow Testing - The results verified, under the proper clinical use of the subject device, the Y-Connector Clamp was able to prevent flow through the connecting tube. Thus, the predetermined acceptance criterion was met.
- = Leakage Testing - The results verified, under the proper clinical use of the subject device, there was no liquid leakage when tested in accordance with BS EN ISO 11070-1:2014, Annex D and/or E. The predetermined acceptance criteria were met.
- . Radiopacity Testing - The results verified, under the proper clinical use of the subject device, the test articles were visible when imaged under fluoroscopy. The predetermined acceptance criteria were met.
- . Rollback and Kink Testing - Test results verified, under proper clinical use of the subject device, there was no rollback and/or kink of the sheath when tested in accordance with BS EN ISO 11070, Annex A. The predetermined acceptance criteria were met.
- Tensile Testing of the Sheath Radiopaque Tip to Shaft Joint Strength, Sheath Shaft to Hub Joint Strength, Hub to Connecting Tube Joint Strength, Connecting Tube to Side-arm Y-Connector Joint Strength and Dilator Hub to Shaft Joint Strength - The results verified, under the proper clinical use of the subject device, the bond strengths were in accordance with BS EN ISO 11070:2014, Annex C. The predetermined acceptance criteria were met.
- . Aged Testing - Accelerated aging to the equivalence of three years was conducted on the Performer® Introducers. Thereafter, the performance testing listed here was conducted again on aged Performer® Introducers in accordance with BS EN ISO 11070:2014. The predetermined acceptance criteria for the respective aged performance testing were met.
Conclusion:
The results of the tests support the conclusion, the Performer® Introducer met the design input requirements based on the intended use. These results also support the conclusion that the intended use, design and material differences for the subject device, when compared to the predicate device, the Performer® Introducer (K171999), do not raise new questions of safety or effectiveness.