TRANSGATE GUIDE CATHETER

K132542 · Stryker Neurovascular · DQY · Nov 15, 2013 · Cardiovascular

Device Facts

• Record ID: K132542
• Device Name: TRANSGATE GUIDE CATHETER
• Applicant: Stryker Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

TransGate™ Guide Catheters are intended to facilitate the placement of interventional devices into the coronary, peripheral, and neurovasculature.

Device Story

TransGate Guide Catheter is a percutaneous catheter used to facilitate placement of interventional devices into coronary, peripheral, and neurovasculature. Device features PTFE-lined inner lumen for lubricity, stainless steel wire reinforcement for trackability/strength, and polymer shaft for flexibility. Includes atraumatic tip, hub for connectivity, and strain relief. Distal segment is radiopacified with embedded marker for fluoroscopic visualization. Available in 5F and 6F diameters, 90 and 100 cm lengths, with straight or pre-shaped distal tips. Operated by clinicians in clinical settings under fluoroscopic guidance. Device provides a conduit for interventional tools, aiding in navigation through complex vasculature to target sites, potentially improving procedural success and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included kink distance, torque, tip shape retention, flexibility, pushability, tensile strength, chemical compatibility, corrosion resistance, particulate, leakage, unscrewing torque, stress cracking, assembly, luer gauging, and radiopacity. Biocompatibility testing conducted per EN ISO 10993-1 (hemolysis, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity). Sterilization validated per EN ISO 11135-1.

Technological Characteristics

Materials: PTFE inner lumen, stainless steel wire braid, nylon/thermoplastic elastomer shaft. Dimensions: 5F (1.75mm OD) and 6F (2.1mm OD); 90cm and 100cm lengths. Radiopaque distal tip/marker. Connectivity: Hub with female luer conical lock fitting. Sterilization: Ethylene Oxide (EO). Standards: EN ISO 10555-1, EN ISO 10555-2, EN 1707, EN ISO 10993-1, EN ISO 11135-1.

Indications for Use

Indicated for facilitating the placement of interventional devices into the coronary, peripheral, and neurovasculature systems in patients requiring such procedures.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Codman & Shurtleff, Inc. Envoy® Guide Catheter (K093184)
• Boston Scientific Guider Softip™ XF 5F Guide Catheter (K010853)
• Boston Scientific Guider Softip™ XF 6F Guide Catheter (K980453)

Submission Summary (Full Text)

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jK132542

## 510(k) Summary

| Summary Date: | August 9. 2013 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and<br>Address: | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA. 94538 |
| Contact: | Anjali Atal-Gupta<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name: | TransGate™ Guide Catheter |
| Common Name: . | Guide Catheter |
| Classification Name: | Percutaneous Catheter /Class II device under 21 CFR 870.1250<br>(Product Code: DQY). |

#### Legaliy Marketed Predicate Devices:

| Reference (Clearance Date) | Device |
|----------------------------|----------------------------------------------------------|
| K093184 (Nov 6, 2009) | Codman & Shurtleff, Inc. Envoy® Guide<br>Catheter |
| K010853 (Apr 18, 2001) | Boston Scientific Guider Softip™ XF 5F Guide<br>Catheter |
| K980453 (Aug 11, 1998) | Boston Scientific Guider Softip™ XF 6F Guide<br>Catheter |

Premarket Notification, Stryker Neurovascular TransGate™ Guide Catheter

August 2013

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#### Device Description:

Stryker Neurovascular's TransGate Guide Catheters are constructed with polytetrafluoroethylene (PTFE) on the inner lumen for lubricity, stainless steel wire reinforcement within the wall for trackability. torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip, a hub for device connectivity and device handling, and a strain relief at the hub for kink resistance. The distal segment of the device shaft is radiopacified and. in addition, a radiopaque marker is embedded at the distal tip of the device to aid visualization under fluoroscopy. .

The Stryker Neurovascular TransGate Guide Catheter has straight (ST) and pre-shaped distal tips, available in 40 (40), and Multipurpose (MP) shapes. The TransGate Guide Catheters are offered in both 90 and 100 cm lengths and 5 and 6 French diameters.

#### Indications for Use / Intended Use:

TransGate™ Guide Catheters are intended to facilitate placement of interventional devices into the coronary. peripheral and neurovasculature.

#### Accessories:

There are no accessories to the TransGate™ Guide Catheters.

Premarket Notification, Stryker Neurovascular TransGate™ Guide Catheter

August 2013

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## 510(k) Summary Of Safety And Effectiveness (cont.)

| | Comparison to Predicate Device: | | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | TransGate Guide<br>Catheter (Subject<br>Device) | Codman Envoy Guiding<br>Catheter | Boston Scientific Guider<br>Softip XF 5F and 6F<br>Guide Catheters |
| 510(k)<br>Number | TBD | K093184 | K980453, K010853 |
| Classification | Class II, DQY | Class II, DQY | Class II, DQY |
| Indication | TransGate Guide<br>Catheters are<br>intended to facilitate<br>the placement of<br>interventional<br>devices into the<br>coronary, peripheral,<br>and<br>neurovasculature. | The ... is intended for use<br>in the peripheral,<br>coronary, and<br>neurovasculature for the<br>intravascular introduction<br>of<br>interventional/diagnostic<br>devices. | The ... is intended to<br>facilitate the placement of<br>interventional devices<br>into the coronary,<br>peripheral, and<br>neurovascular systems. |
| Materials | | | |
| -Shaft<br>Materials | PTFE lined.<br>nylon/thermoplastic<br>elastomer with<br>stainless steel braid | PTFE lined<br>nylon/polyurethane with<br>stainless steel braid1 | PTFE lined<br>nylon/thermoplastic<br>elastomer/thermoplastic<br>polyester with stainless<br>steel braid |
| -Proximal End<br>Configuration | Hub with female luer<br>conical lock fitting | Hub with female luer<br>conical lock fitting | Hub with female luer<br>conical lock fitting |
| -Radiopacity | Radiopaque tip with<br>distal marker | Radiopaque distal tip | Radiopaque distal tip |
| -Packaging | Catheter attached to<br>SBS packaging card<br>inside<br>Nylon/PE/Tyvek<br>pouch, inside SBS<br>carton | Catheter attached to<br>packaging card inside<br>pouch, inside carton | Catheter attached to SBS<br>packaging card, inside<br>PET/LDPE/Tyvek pouch,<br>inside SBS carton |
| -Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Dimensions | | | |
| -Effective<br>Length | 5F: 90 cm, 100 cm<br>6F: 90 cm, 100 cm | 5F: 90 cm, 100 cm<br>6F: 90 cm, 100 cm | 5F: 90 cm, 100 cm<br>6F: 90 cm, 100 cm |
| -Outer | 5 F: 1.75 mm | 5F: 1.65 mm | 5F: 1.70 mm |
| | TransGate Guide<br>Catheter (Subject<br>Device) | Codman Envoy Guiding<br>Catheter | Boston Scientific Guider<br>Softip XF 5F and 6F<br>Guide Catheters |
| Diameter | 6F: 2.1 mm | 6F: 2.0 mm | 6F: 2.0 mm |
| Inner Diameter | 5F: .057 in | 5F: .056 in | 5F: .053 in |
| | 6F: .072 in | 6F: .070 in | 6F: .064 in |
| Tip Shapes | 40, MP, Straight | MPD*, MPC*, Straight | 40. MP. Straight |

## Compurison to Predicate Device:

1 Materials used for Envoy are not known with certainty

·

Premarket Notification, Stryker Neurovascular TransGate™ Guide Catheter

r

August 2013

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*MPD is similar to 40 tip shape and MPC is similar to MP shape

Design verification of the TransGate™ Guide Catheters consisted of:

| Performance Test | Result |
|------------------------------------------------------------|--------------------------|
| Kink Distance | Met established criteria |
| Torque Degrees Rotation to Kink | Met established criteria |
| Tip Shape Retention | Met established criteria |
| Distal Shaft Flexibility | Met established criteria |
| Pushability | Met established criteria |
| Tensile Strength | Met established criteria |
| Chemical Compatibility | Met established criteria |
| Corrosion Resistance | Met established criteria |
| Particulate | Met established criteria |
| Liquid Leakage | Met established criteria |
| Air Leakage | Met established criteria |
| Unscrewing Torque | Met established criteria |
| Resistance to Overriding | Met established criteria |
| Stress Cracking | Met established criteria |
| Ease of Assembly | Met established criteria |
| Luer Gauging | Met established criteria |
| Luer Separation Force | Met established criteria |
| Freedom from leakage and damage under high static pressure | Met established criteria |
| Flow Rate Testing | Characterization test |
| Radiopacity | Met established criteria |

Testing was conducted in accordance with EN ISO 10555-1, EN ISO 10555-2, and EN 1707.

Shelf Life Testing (Product and Packaging) and Distribution / Shipping Challenge Conditioning and Testing were performed and the devices met established criteria.

Premarket Notification, Stryker Neurovascular TransGate™ Guide Catheter

August 2013

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Packaging Verification Testing complies with EN ISO 11607-1 and -2 and assessed the ability of finished packages to withstand the effects of anticipated hazards of the distribution environment on essential packaging characteristics and the ability of packaging to protect the device and to maintain sterility (sterile barrier testing).

Biocompability and Sterilization testing were conducted in accordance with EN ISO 10993-1 and EN ISO 11135-1. TransGate Guide Catheters have been classified according to EN ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing as follows:

> Category: Externally Communicating Contact type: Circulating blood Contact Duration: Limited exposure (< 24 hours)

Based on this classification, tests relevant to the device described within this premarket notification were selected and conducted in accordance with EN ISO 10993-1 and its applicable sub-parts.

The TransGate Guide Catheter devices meet ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals limits specified in EN ISO 10993-7:2008. Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. All process and product sterilization validation activities have been conducted and completed in accordance with EN ISO 11135-1:2007, Sterilization of health care products – Ethylene oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. The sterility of the devices conforms to the requirements of EN 556-1:2001, Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1 : requirements for terminally sterilized medical devices.

A sterility assurance level (SAL) of 10th has been demonstrated. Test samples consisted of 2X EtO sterilized devices (entire device).

Premarket Notification, Stryker Neurovascular TransGate™ Guide Catheter

August 2013

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· Testing showed the device, including its packaging, to be biocompatible for its intended use as an externally communicating, circulating blood contacting device as classified under EN ISO 10993-1:2009. The TransGate Guide Catheter successfully passed all of the following biocompatibility lests:

| Test | Method |
|-------------------------------------------|--------------------------------------------------------|
| Hemolysis | MEM Elution Assay |
| Sensitization | Kligman Maximization |
| Intracutaneous Reactivity<br>(Irritation) | Intracutaneous Injection Test |
| Systemic Toxicity (Acute) | ISO Acute Systemic Injection<br>Test |
| Hemocompatibility | Complement Activation |
| | Hemolysis |
| | Inactivated Partial |
| | Thromboplastin Time Test |
| | In vitro hemocompatibility |
| Physicochemical Tests | USP <661> Aqueous |
| Plastics | Extraction |
| Fourier Transform Infrared<br>(FTIR) Scan | FTIR |
| Latex | ASTM D6499-07 |
| Pyrogenicity | USP Material Mediated Rabbit<br>Pyrogen Test |
| EtO Residuals | Ethylene oxide and Ethylene<br>chlorohydrins residuals |

Premarket Notification, Stryker Neurovascular TransGate™ Guide Catheter

August 2013

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#### Conclusion:

Because intended use and indications for use are the same as for the predicate devices, and because there is no difference in the fundamental scientific technology of the devices, and because risk assessments and successful verification testing, including testing to EN ISO 10555-1 and EN ISO 10555-2, raise no new questions of safety and effectiveness. Stryker Neurovascular has determined the TransGate™ Guide Catheters to be substantially equivalent to the current legally marketed predicate devices.

Premarket Notification, Stryker Neurovascular TransGate™ Guide Catheter

August 2013

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Image /page/7/Picture/0 description: The image shows a black and white logo. The logo consists of two parts: a circular text element on the left and a stylized abstract symbol on the right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" and is arranged along the circumference of the circle. The abstract symbol is composed of three curved lines that resemble a stylized human figure or a flowing ribbon.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## November 15, 2013

Stryker Neurovascular % Ms. Anjali Atal-Gupta Senior Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, CA 94538

Re: K132542

> Trade/Device Name: TransGate™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 16, 2013 Received: August 19, 2013

Dear Ms. Atal-Gupta:

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 or any I outher and 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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Page 2 - Ms. Anjali Atal-Gupta

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang -S

Victor Krauthamer, Ph.D. for Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K132542

Device Name: TransGate™ Guide Catheter

· Indications For Use:

TransGate™ Guide Catheters are intended to facilitate the placement of interventional devices into the coronary, peripheral, and neuro vasculature.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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