DuraSheath Introducer Sheath System

K181463 · Contract Medical International, GmbH · DYB · Dec 13, 2018 · Cardiovascular

Device Facts

• Record ID: K181463
• Device Name: DuraSheath Introducer Sheath System
• Applicant: Contract Medical International, GmbH
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediation.

Device Story

Sterile, disposable introducer sheath system; used for percutaneous access to peripheral and coronary vasculature. Components: coil-reinforced multi-layer polymer shaft (PTFE inner, polyurethane outer, stainless-steel coil), hemostasis valve with side port/stopcock, and tapered TPE dilator. Operated manually by qualified medical personnel in healthcare facilities/hospitals. Device placed over guidewire; dilator removed; sheath provides working lumen for catheters/instruments. Maximum indwelling time 24 hours. Hydrophobic coating on distal shaft enhances lubricity. Radiopaque platinum-iridium marker band aids visualization. Facilitates safe device introduction; minimizes blood loss via hemostasis valve. Not MRI compatible.

Clinical Evidence

No clinical testing submitted for 510(k) clearance. Bench testing only, including mechanical verification (kink resistance, leakage, insertion force, pull-out, coating integrity), biocompatibility (ISO 10993), sterilization validation, and accelerated aging. Usability evaluation performed per IEC 62366-1.

Technological Characteristics

Materials: Polyurethane, PTFE, stainless steel, TPE, polycarbonate, silicone. Dimensions: 4F-8F, 15-90cm lengths. Sensing: Radiopaque platinum-iridium marker. Connectivity: None. Sterilization: Ethylene oxide (SAL 10^-6). Standards: ISO 11070, ISO 10555-1, ISO 10993, ASTM F2394, EN 13868.

Indications for Use

Indicated for introduction of interventional and diagnostic devices into peripheral and coronary vasculature in patients, including pediatric populations.

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

• DuraSheath Introducer Sheath System (K142357)
• Pinnacle Destination Guiding Sheath (K091329)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2018

Contract Medical International GmbH Jan Kloboucnik Director, Regulatory and Quality Affairs Lauensteiner Str. 37 Dresden. 01277 De

Re: K181463

Trade/Device Name: DuraSheath Introducer Sheath System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: November 7, 2018 Received: November 9, 2018

Dear Jan Kloboucnik:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Nicole M. Goodsell -S

DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=2001567081,
cn=Nicole M. Goodsell -S
Date: 2018.12.13 09:10:57 -05'00'

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) K181463

### Device Name DuraSheath Introducer Sheath System

### Indications for Use (Describe)

The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediation.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary (K181463)

#### I. SUBMITTER

| Submitter: | Contract Medical International GmbH | |
|-----------------|-------------------------------------|--|
| | Lauensteiner Straße 37 | |
| | 01277 Dresden | |
| | Germany | |
| Contact Person: | Jan Kloboucnik, Director RA/QA | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Email: | [e-mail] | |
| Date Prepared: | 13 Dec 2018 | |

#### II. DEVICE

| Device Trade Name: | DuraSheath Introducer Sheath System |
|----------------------|--------------------------------------------------------------------------------|
| Device Common Name: | Introducer Sheath |
| Classification Name: | Introducer, Catheter; and<br>Dilator, Vessel, For Percutaneous Catheterization |
| Regulatory Class: | II |
| Product Code: | DYB; and<br>DRE |

#### III. PREDICATE DEVICE

Primary Predicate Device: DuraSheath Introducer Sheath System (K142357)

Secondary Predicate Device: Pinnacle Destination Guiding Sheath (K091329)

#### IV. DEVICE DESCRIPTION

The DuraSheath Introducer Sheath System is a sterile, disposable device consisting of (a) a coil reinforced shaft with an atraumatic tip at the distal end; (b) a hemostasis valve with a side port and color coded 3-way stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.

- (a) Shaft. The coil reinforced, multi-layer polymer shaft contains a tapered tip at the distal end. A continuous inner PTFE tube forms the core of the shaft and provides a circular working lumen through which devices can be passed. A single, full length

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polyurethane tube creates the outer cover of the shaft. A stainless-steel flat wire coil is fused between the two polymer tubes along the entire length of the shaft. Hydrophobic coating is applied along the distal part of the outer layer for increased lubricity in this area. The coating coverage depends on the model. 15 cm product versions have 10 cm portion of the shaft coated, while 45 cm, 60 cm and 90 cm product versions have 15 cm portion of the shaft coated. A radiopaque marker made of platinum iridium is embedded at the distal end of the shaft. At the proximal end of the shaft, a female, winged luer hub is over-molded onto the shaft to support handling and to provide for the connection for the hemostasis valve. The hub is color coded to match the French size of the device.

- (b) Hemostasis valve. A removable hemostasis valve is thread onto the luer hub at the proximal end of the shaft. Inside the valve housing, a lubricated, silicone slit disc provides a seal around devices passed through the sheath, thereby preventing blood leakage through the valve. Just distal of the valve, the valve housing is connected to a side port tube leading to three-way stopcock valve. The side port is used for flushing the introducer sheath. At the proximal end of the valve housing, the color-coded housing cap provides a snap fit connection to the hub of the dilator.
- (c) Dilator. The dilator made of TPE contains a full-length round lumen to allow placement over a guide wire. The distal end of the dilator is configured as a tapered tip that extends about 2 cm beyond the end of the sheath when the dilator is fully inserted through the sheath. An integral, color coded luer hub that is over-molded onto the proximal end of the dilator supports handling of the dilator and provides a snap fit connection to the valve housing cap at the proximal end of the sheath introducer.

The shaft and the hemostasis valve are pre-assembled and packaged together with one or two dilators (depending on the model), that is sealed inside a medical grade Tyvek pouch on which a product label is placed. Devices are packaged in labeled packers containing five units and one Instruction for Use (IFU) booklet. The device has a shelf life of three years.

The DuraSheath Introducer Sheath System is a prescription medical device that is used only in healthcare facilities or hospitals. The device is placed in patients for up to 24 hours.

Devices are sterilized using ethylene oxide (maximum levels of remaining tested sterilant residuals of EO < 2.9mg/24h and ECH < 1mg/24h; sterilant residual limits of EO < 4mg/24h and ECH < 9mg/24h; Sterility Assurance Level, SAL 10t9).

## Operation and Compatibility

The device is operated manually and is to be handled aseptically by qualified medical personnel familiar with its application. The device includes metal components and cannot be exposed to MRI.

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After removal from the sterile pouch packaging using aseptic techniques, the device is placed into the vasculature. Prior to use, the introducer sheath and dilator are flushed with heparinized solution. The dilator is then inserted completely into the introducer sheath and locked into place through the snap fit connection at the housing of the hemostasis valve. The dilator-sheath-combination is then passed as one unit over a guide wire with a maximum size of up to 0.035 inches for 4 French, 5 French and 6 French models, up to 0.038 inches for 7 French and 8 French models . 15 cm models contain an additional dilator compatible with guidewires up to 0.018 inches. Guide wire is not part of the device. Once the introducer sheath is fully placed in the patient, the guide wire and dilator are removed and compatible catheters and instruments can be inserted through the introducer sheath.

The various models of the device are compatible with catheters and instruments with outside diameters up to the French size labeled for each model. The DuraSheath Introducer Sheath System is placed in patients for several hours depending on the procedure type for which the compatible catheters and other instruments are intended, but the maximum time is up to 24 hours (i.e. biocompatibility contact classification of less than 24-hour duration).

For removal of the sheath, a guide wire is inserted past the distal tip of the sheath and the dilator is passed over the wire into the sheath. Sheath and dilator are then removed as one unit.

No energy source nor software are employed in the operation of the device. The device includes no electrical components and therefore does not require EMC and Electrical safety evaluation.

## Physical Description

The schematic diagram below illustrates the range of dimensions for the full range of models.

Image /page/5/Figure/8 description: The image shows two diagrams of medical instruments with labels and measurements. The top diagram includes components labeled as 'Luer Hub,' 'Valve,' 'Stopcock,' 'Sheath,' and 'Marker band,' with a length measurement of '150-900 mm' and a coating coverage of '100-150mm.' The bottom diagram features a 'Dilator' with a length of '215-965 mm' and an inner diameter (ID) of '0.46 - 0.89mm.'

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## Device Models

The DuraSheath Introducer Sheath System contains twenty (20) models with different sizes (4 French, 5 French, 6 French, 7 French and 8 French) and effective lengths (15 cm, 45 cm, 60 cm and 90 cm). Different model numbers and configurations are listed in the table below.

| Length/ Size | 15 cm | 45 cm | 60 cm | 90 cm |
|--------------|----------|----------|----------|----------|
| 4 French | FG-04015 | FG-04045 | FG-04060 | FG-04090 |
| 5 French | FG-05015 | FG-05045 | FG-05060 | FG-05090 |
| 6 French | FG-06015 | FG-06045 | FG-06060 | FG-06090 |
| 7 French | FG-07015 | FG-07045 | FG-07060 | FG-07090 |
| 8 French | FG-08015 | FG-08045 | FG-08060 | FG-08090 |

### Device Model Numbers

All models have the same design and contain identical features. Manufacturing processes are identical across sizes and lengths.

### Materials Used

Materials used for the manufacture of the DuraSheath Introducer Sheath System are listed in the table below. The materials that make up the device are either the same or very similar to those used for the predicates. Any differences in material do not raise any issues of safety or effectiveness, as demonstrated by the design verification test results.

| Part Description | Material | Patient Contact |
|-------------------------------------------|-----------------------------------------------------|-----------------|
| Shaft outer cover | Polyurethane, colour additives, hydrophobic coating | Direct |
| Shaft inner liner | PTFE | Indirect |
| Coil between inner and outer shaft layers | Stainless steel | None |
| Shaft luer hub | TPE - thermoplastic elastomer, colour additives | Direct |
| Shaft marker band | Platinum iridium | None |
| Valve body and cap | Polycarbonate, colour additives | Indirect |
| Valve disc | Silicone | Indirect |
| Valve disc lubricant fluid | Silicone | Indirect |

### Materials Contained in the Device

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| Part Description | Material | Patient Contact |
|-------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------|
| Swivel nut | Copolyester | None |
| Stopcock extension line | TPU-thermoplastic polyurethane | Indirect |
| Stopcock valve cap | ABS, colour additives | Indirect |
| Stopcock | Polycarbonate - body, Acetal -<br>handle, colour additives | Indirect |
| Dilator body | TPE - thermoplastic elastomer<br>with 20% Barium-sulphate (4F) or<br>with 30% Barium-sulphate (5F,<br>6F, 7F, 8F) | Direct |
| Dilator Luer hub | TPE - thermoplastic elastomer,<br>colour additives | Indirect |

#### V. INDICATIONS FOR USE

The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.

The Indications for Use statement for the DuraSheath Introducer Sheath System is not identical to that of the two legally marketed predicate devices; however, the differences are not critical as they do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate devices when used as labeled. The DuraSheath Introducer Sheath System and the two predicate devices each have the same intended use, namely to support the introduction of interventional and diagnostic devices.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The DuraSheath Introducer Sheath System is a manually operated, sterile, single patient use sheath system made predominantly of thermoplastic polymers. The sheath is reinforced with a stainless-steel coil in order to provide kink resistance when passed through tortuous paths. With regard to the design, device features, method of sterilization, and mode of operation, the DuraSheath Introducer Sheath System does not differ from the predicate devices. Materials used for manufacture of the DuraSheath Introducer Sheath System are identical as for the legally marketed primary predicate device, or very similar to those contained in the legally marketed secondary predicate devices.

Technological characteristics of the subject device do not differ from the primary predicate devices and differ from the secondary predicate only with respect to materials for selected components and the choice of lubricious coating on the sheath. Both the polyurethane used for the outer layer and the hydrophobic coating applied to the distal end of the sheath of the

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DuraSheath Introducer Sheath System are commonly used in medical devices, including introducer sheaths and catheters and are identical with those used in the primary predicate. There are no differences in the material and technological characteristics between the subject device and the primary predicate device.

Differences in technological characteristics between the subject device and the secondary predicate do not raise and concerns of safety and effectiveness, as demonstrated by the performance data collected.

#### VII. PERFORMANCE DATA

Nonclinical and clinical performance data demonstrate that the DuraSheath Introducer Sheath System is safe and effective and its performance is substantially equivalent to the predicates. The following performance data from non-clinical tests are being provided in support of the substantial equivalence determination:

- Mechanical testing, including tests required under relevant international standards, coating adhesion and particulate testing, and transportation integrity testing, performed to verify and validate the design.
- Biocompatibility Risk Assessment (BRA) and performed biocompatibility device testing to demonstrate biocompatibility.
- Sterilization information to confirm sterility of the device upon exposure to the selected sterilization cycle.
- Accelerated aging testing to confirm product performance at end of shelf life. ●

The list of tests performed in support of determination of substantial equivalence is provided in the table below.

| No. | Verification / Validation<br>Activity | Test Type | Applicable Standard(s) |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Sheath/dilator fit test | Mechanical | Internal requirement |
| 2 | Sheath pull out test | Mechanical | ASTM F2394<br>ASTM 1929-15<br>EN 868-5<br>ISO 11737-2<br>Internal requirement |
| 3 | Sheath kink resistance test | Mechanical | EN 13868:2002 |
| 4 | Sheath force at break test | Mechanical | ISO 11070:2014<br>ISO 10555-1:2013 |
| 5 | Sheath creep to break test | Mechanical | ISO 11070:2014<br>ISO 10555-1:2013 |
| No. | Verification / Validation<br>Activity | Test Type | Applicable Standard(s) |
| 6 | Sheath system insertion force | Mechanical | Internal requirement |
| 7 | Coating integrity test | Mechanical<br>(External Laboratory) | Internal requirement |
| 8 | Coating integrity test (particle<br>evaluation) | Mechanical<br>(External Laboratory) | AAMI TIR42:2010<br>ASTM F2394<br>ISO 8536-4:2010<br>Class II Special Controls<br>Guidance Document for Certain<br>Percutaneous Transluminal<br>Coronary Angioplasty (PTCA)<br>Catheters<br>USP 788 |
| 9 | Sheath Liquid Leakage | Mechanical | ISO 11070:2014<br>ISO 10555-1:2013 |
| 10 | Valve Leak Test | Mechanical | ISO 11070:2014 |
| 11 | Dilator hub bond strength | Mechanical | ISO 11070:2014<br>ISO 10555-1:2013 |
| 12 | Sheath stiffness test | Mechanical | Internal requirement based on<br>ISO 178:2010 |
| 13 | EO Sterilization Validation | External service provider | ISO 11135-1:2007<br>ISO 10993-7:2008<br>ISO 11737-1:2006<br>AAMI TIR28:2009<br>ANSI/AAMI ST72:2011 |
| 14 | Sterilization adoption | Documented assessment/<br>External laboratory testing | AAMI TIR28:2009 |
| 15 | Accelerated age test<br>(3 years) | Mechanical/ External<br>Laboratory | ASTM F1980-16<br>Various per performed tests |
| 16 | Package integrity testing | Mechanical/External<br>laboratory | ISO 11607-1:2006<br>ISTA 2A:2011<br>ASTM F 1929-12<br>ASTM F1886:1998<br>EN 556-1<br>EN 13868:2002<br>EN 868-5 Annex D<br>ISO 11070:1998 |
| 17 | Simulated use test | Mechanical | Internal requirement |
| No. | Verification / Validation<br>Activity | Test Type | Applicable Standard(s) |
| 18 | <b>Biocompatibility testing</b><br>Cytotoxicity test<br>Thromboresistance<br>Complement activation<br>Hemolysis<br>Pyrogenity<br>Acute Systemic Toxicity<br>Irritation<br>Sensitization | External Laboratory | ISO 10993-1:2009<br>ISO 10993-4:2017<br>ISO 10993-5:2009<br>ISO 10993-10:2010<br>ISO 10993-11:2017<br>ISO 10993-12:2012 |
| 19 | Biological Risk Assessment | Documented assessment | ISO 10993-1:2009<br>EN ISO 14971:2012<br>FDA Guidance Use of<br>International Standard ISO<br>10993-1 |
| 20 | Testing assessment 15cm | Documented assessment | Internal assessment |
| 21 | Usability evaluation | Usability Study | IEC 62366-1 |

## List of Tests

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The device is cleared for use in Europe (CE certification no.2017847CE05). Feedback recorded from 16 clinical cases performed in 7 centers in Germany in April and May 2014 demonstrated that the subject device performs comparably with the secondary predicate and other legally marked devices and is safe and effective. The performance is identical with the primary predicate. No clinical testing is being submitted to support review of this 510(k) premarket notification.

#### VIII. CONCLUSIONS

Results demonstrate that the DuraSheath Introducer Sheath System performs identically with the primary predicate, comparably with the second predicate and other legally marketed devices, and is safe and effective. The DuraSheath Introducer Sheath System is substantially equivalent to the two predicates devices in terms of intended use, design and materials, technological characteristics, and principle of operation. Any differences between the subject device and the predicates do not raise any issues of safety or effectiveness.