Peel-Away Introducer Set

K170020 · Cook Incorporated · DYB · Sep 28, 2017 · Cardiovascular

Device Facts

• Record ID: K170020
• Device Name: Peel-Away Introducer Set
• Applicant: Cook Incorporated
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or nontapered end catheters into central and peripheral vasculature, and for non-vascular use.

Device Story

Peel-Away Introducer Sets are single-use, sterile, disposable devices providing initial percutaneous access. The assembly consists of a co-axial introducer (peel-away sheath and dilator), often including a wire guide and access needle. The device is used by clinicians in clinical settings to facilitate the placement of catheters or other devices. The sheath features a winged hub to facilitate tearing for removal after the catheter is positioned. By providing a temporary conduit, the device allows for the safe introduction of therapeutic or diagnostic instruments into the vasculature or non-vascular sites, aiding in procedures such as catheter placement.

Clinical Evidence

Bench testing only. Testing included introducer knob-to-shaft tensile strength, peel force characterization, dilator hub-to-shaft tensile strength (BS EN ISO 11070:2014), radiopacity (ASTM F6540-12), wire guide corrosion, fracture, flex, and tensile evaluation. Biocompatibility testing (ISO 10993-1) included cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, thrombogenicity, material-mediated pyrogenicity, and hemocompatibility. All results met predetermined criteria.

Technological Characteristics

Co-axial introducer assembly (peel-away sheath and dilator). Materials: Radiopaque Polyethylene or Vinyl (dilator), Radiopaque TFE (sheath), Stainless Steel (wire guide). Dimensions: 3.5-26 Fr diameter. Standards: BS EN ISO 11070:2014 (tensile), ASTM F6540-12 (radiopacity), ISO 10993-1 (biocompatibility). Sterilization: Ethylene oxide. Single-use, disposable.

Indications for Use

Indicated for percutaneous introduction of balloon, electrode, and closed or non-tapered end catheters into central and peripheral vasculature, and for non-vascular use in adult patients.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Galt Medical Tearaway Introducer Sheath (K153533)
• Kimberly-Clark Enteral Access Dilation System (K093312)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 28, 2017

Cook Incorporated Colin Jacob Capital Equipment Specialist, Regulatory Affairs 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402

Re: K170020

Trade/Device Name: Peel-Away® Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, KNT Dated: August 28, 2017 Received: August 29, 2017

Dear Colin Jacob:

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 devicerelated 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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

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# Indications for Use

510(k) Number (if known) K170020

Device Name Peel-Away Introducer Set

Indications for Use (Describe)

The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or nontapered end catheters into central and peripheral vasculature, and for non-vascular use.

Type of Use (Select one or both, as applicable)

| <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------|
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary

# Peel-Away® Introducer Sets (21 CFR §870.1340, 21 CFR §876.5980) Date Prepared: August 28, 2017

K170020

#### Submitted By:

| Applicant: | Cook Incorporated |
|-----------------------|---------------------------------------------------------------|
| Contact: | Colin Jacob |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact Phone Number: | [phone] x 104965 |
| Contact Fax Number: | [phone] |

#### Device Information:

| Trade Name: | Peel-Away® Introducer Set |
|----------------------------|----------------------------------------------------------------------------------------------------------|
| Common Name: | Introducer, Catheter; Tube, Gastro-Enterostomy |
| Classification Name/Panel: | Catheter Introducer, Gastrointestinal tube and accessories –<br>Gastroenterology/Urology, Cardiovascular |
| Regulation: | 21 CFR §876.5980, 21 CFR §870.1340 |
| Product Code: | DYB, KGC |

#### Predicate Devices:

- Primary: Galt Medical Tearaway Introducer Sheath (K153533)
- Secondary: Kimberly-Clark Enteral Access Dilation System (K093312)

#### Device Description:

Cook's Peel-Away® Introducer Sets are single-use, sterile, disposable products that are used to provide initial percutaneous access. They are comprised of a co-axial introducer assembly (peel-away sheath and dilator). Sets may contain a wire guide in a size fitted to the endhole of the dilator and may contain an access needle in a gage that allows the included wire guide to pass through its lumen. Additional set components (e.g., luer-slip syringe, thumb scalpel) are available.

#### Indications for Use:

The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for non-vascular use.

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Cook Incorporated – Traditional 510(k) Peel-Away Introducer Sets August 28, 2017

| | Comparison to Predicates: | | | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | SUBJECT DEVICE | PRIMARY PREDICATE | SECONDARY PREDICATE | |
| | Peel-Away® Introducer<br>Sets | Tearaway Introducer Sheath | Kimberly-Clark Enteral<br>Access Dilation System | |
| Manufacturer | Cook Incorporated | Galt Medical Corp. | Kimberly-Clark Corporation →<br>Halyard | |
| 510(k) | K170020 | K153533 | K093312 | |
| Regulation | 21 CFR § 870.1340,<br>21 CFR § 876.5980 | 21 CFR § 870.1340 | 21 CFR § 876.5980 | |
| Product Code | DYB, KGC | DYB | KGC | |
| Classification | IDENTICAL TO<br>PREDICATES | II | II | |
| Indications<br>for Use | The Peel-Away Introducer<br>Set is intended for the<br>percutaneous introduction<br>of balloon, electrode and<br>closed or non-tapered end<br>catheters into central and<br>peripheral vasculature, and<br>for non-vascular use. | Adult Only – Tearaway<br>Introducer Sheath: The<br>introducer is used for the<br>percutaneous introduction of<br>diagnostic or therapeutic<br>devices, such as catheters and<br>pacing leads, into the<br>vasculature.* | The Kimberly-Clark Enteral<br>Access Dilation System is<br>intended to facilitate stoma tract<br>dilation prior to placement of the<br>Kimberly-Clark MIC and MIC-<br>Key brand Enteral Feeding<br>Tubes.<br>It is recommended that these<br>dilator be used only with the<br>Kimberly-Clark MIC and MIC-<br>KEY brand Enteral Feeding<br>Tubes. | |
| Patient<br>Population | Adults | Adults | Adults | |
| Placement | IDENTICAL TO<br>PREDICATES | Percutaneous | Percutaneous | |
| Clinical<br>Application | General (i.e., for vascular<br>and non-vascular use) | Vascular use | Non-vascular use (specifically<br>for placement of feeding tubes) | |
| Design | IDENTICAL TO<br>PREDICATES | Galt Tearaway Introducers<br>assembly includes outer<br>peelable sheath and a dilator.<br>Peelable sheath has a winged<br>hub to facilitate the tear in the<br>sheath. | Kimberly Clark Peel-Away<br>Introducers assembly includes<br>outer peelable sheath and a<br>dilator. Peelable sheath has a<br>winged hub to facilitate the tear<br>in the sheath. | |
| Shape | IDENTICAL TO<br>PREDICATES | Introducer Sheath: winged<br>hub, cylindrical cannula<br>Dilator: Round hub,<br>cylindrical cannula | Introducer Sheath: winged hub,<br>cylindrical cannula<br>Dilator: Round hub, cylindrical<br>cannula | |
| | | SUBJECT DEVICE | PRIMARY PREDICATE | SECONDARY PREDICATE |
| | | Peel-Away® Introducer<br>Sets | Tearaway Introducer Sheath | Kimberly-Clark Enteral<br>Access Dilation System |
| Dimensions | Introducer<br>(Dilator +<br>Sheath)<br>Diameter | 3.5-26 Fr | 3-16 Fr | 16-24 Fr |
| | Dilator<br>Length | 11, 13, 20 cm | Unknown | Unknown |
| | Sheath<br>Length | 7, 9, 13, 15.5 cm | Unknown | Unknown |
| | Wire<br>Guide<br>Diameter | 0.018, 0.021, 0.025, 0.035,<br>0.038 in | 0.008, 0.010, 0.014, 0.018,<br>0.035, 0.038 in | 0.025, 0.035 in |
| | Wire<br>Guide<br>Length | 30, 50, 70, 100 cm | 20, 40, 60 cm | Unknown |
| Materials | Dilator | 3.5 to 12 Fr: Radiopaque<br>Polyethylene<br>13 to 26 Fr: Vinyl | Unknown | Unknown |
| | Sheath | Thick Wall Sheathing<br>Radiopaque TFE (VRTS) | Unknown | High density polyethylene<br>(HDPE) |
| | Wire<br>Guide | Stainless Steel<br>Solder | Unknown | Unknown |
| Additional Set<br>Components | | Entry access needle, needle<br>holder cup, luer-slip<br>syringe, serial dilators,<br>thumb scalpel | Entry access needles,<br>additional serial dilators | Entry access needle, syringe,<br>#11 safety scalpel, gauze pads,<br>catheter tip syringe, introducer<br>cannula |
| Duration of<br>Use | | IDENTICAL TO<br>PREDICATES | Single Use<br>Limited Duration (≤ 24 hours) | Single Use<br>Limited Duration (≤ 24 hours) |
| Shelf Life | | 3 years | Unknown | Unknown |
| Sterilization<br>Process | | IDENTICAL TO<br>PREDICATES | Ethylene oxide | Ethylene oxide |

### Comparison to Predicates:

K153533 was a bundled submission that included 2 to 3 Fr sizes for adult and pediatric use.

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Cook Incorporated – Traditional 510(k)
Peel-Away Introducer Sets
August 28, 2017

## Comparison to Predicates (continued):

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Cook Incorporated - Traditional 510(k) Peel-Away Introducer Sets August 28, 2017

### Technological Characteristics:

The proposed device, Peel-Away® Introducer Sets, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:

- . Introducer knob to Shaft Tensile - Test articles must meet the force break requirements. Test results met predetermined criteria.
- . Peel Force – Characterization of peel force for various Peel-Away Introducer sheath sizes was successfully performed.
- . Dilator Hub to Shaft Tensile - Test articles must statistically demonstrate that 90% of test articles at the 95% confidence can be expected to meet or exceed the requirements of BS EN ISO 11070: 2014. Test results met predetermined criteria.
- . Radiopacity Evaluation - Test articles must demonstrate that the shaft gradient shall fall along the gradient of an aluminum X-ray step wedge gauge, following the method described in ASTM F6540-12, "Standard Test Methods For Determining Radiopacity for Medical Use." Test results met predetermined criteria.
- . Wire guide Corrosion evaluation - Wire guides should not have any visual evidence of corrosion that could affect their functional performance. Test results met predetermined criteria.
- . Wire Guide Fracture evaluation -The wire shall not fracture when wound around an appropriate former for at least three complete turns. Test results met predetermined criteria.
- . Wire Guide Flex evaluation -The wire guide should show no signs of defects or damage, including flaking or material loss, when subjected to repeat flexing. Test results met predetermined criteria.
- . Wire Guide Tensile Evaluation – Test articles must demonstrate Per the standard, minimum tensile strength for wire guides with having a diameter greater than or equal to 0.55 mm but less than 0.75 mm should have a peak load to failure greater than or equal to 5 N, and wire guides with diameters greater than 0.75 mm should have a peak load to failure greater than 10 N. The standard does not specify tensile strength for wire guide diameters less than 0.55 mm and requires the values to determined based on the risk assessment. Test results met predetermined criteria.

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Cook Incorporated - Traditional 510(k) Peel-Away Introducer Sets August 28, 2017

- Biocompatibility Per ISO 10993-1, testing for cytotoxicity, sensitization, . intracutaneous irritation, acute systemic toxicity, thrombogenicity, materialmediated pyrogenicity, and hemocompatibility were performed to ensure the biocompatibility of the subject device set. Test results indicated that all materials are biocompatible.
### Conclusion:

The results of these tests show that the Peel-Away® Introducer Sets meet the design input requirements based on the intended use. Further, these results support the conclusion that the Peel-Away® Introducer Sets do not raise new questions of safety or effectiveness and support a determination of substantial equivalence.