Teleport Microcatheter

K182360 · Orbusneich Medical Trading, Inc. · DQY · Nov 9, 2018 · Cardiovascular

Device Facts

• Record ID: K182360
• Device Name: Teleport Microcatheter
• Applicant: Orbusneich Medical Trading, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Teleport microcatheters are indicated for: supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature. exchanging guidewires in the coronary and peripheral vasculature. the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

Device Story

Single-lumen microcatheter; used in coronary, peripheral, and abdominal vasculature. Facilitates guidewire placement/exchange and contrast media delivery. Operated by physicians in clinical settings. Features tapered shaft (2.6F to 2.0F or 2.7F to 2.1F); hydrophilic outer coating for lubricity; fluoropolymer-lined lumen for guidewire movement. Compatible with 0.014-inch guidewires and 4F guiding catheters. Provides mechanical support for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included visual/dimension inspection, flow rate, simulated use, vacuum leakage, shaft burst pressure, torque strength, flexibility/kinking, radiopacity, corrosion resistance, guidewire compatibility, bond/tip strength, coating integrity, and particulate evaluation. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, PTT, complement activation, in vivo thromboresistance), pyrogenicity, and genotoxicity. All results met acceptance criteria.

Technological Characteristics

Single-lumen catheter; 2.0F and 2.1F shaft sizes; 135cm/150cm lengths. Hydrophilic polymer outer coating; fluoropolymer-lined lumen. Compatible with 0.014" guidewires and 4F guiding catheters. Max pressure 300 psi. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for patients requiring guidewire placement, guidewire exchange, or contrast media delivery within the coronary, peripheral, and abdominal vasculature.

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

• ASAHI Corsair Pro (K161126)

Reference Devices

• Terumo Finecross MG (K082519)
• OrbusNeich Sapphire NC Plus (K162209)

Submission Summary (Full Text)

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November 9, 2018

OrbusNeich Medical Trading Inc. John Pazienza General Manager and Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, Florida 33060

## Re: K182360

Trade/Device Name: Teleport Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 29, 2018 Received: August 30, 2018

## Dear John Pazienza:

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 (QS) 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,

## Lydia S. Glaw -S 2018.11.09 15:20:29 -05'00'

Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| Indications for Use |

| Form Approved: OMB No. 0910-0120 |
|----------------------------------|
| Expiration Date: 06/30/2020 |
| See PRA Statement below. |

| 510(k) Number (if known) | K182360 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Teleport Microcatheter |
| Indications for Use (Describe) | The Teleport microcatheters are indicated for: <ul><li>supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.</li><li>exchanging guidewires in the coronary and peripheral vasculature.</li><li>the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.</li></ul> |

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

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## 510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).

| Submitter: | OrbusNeich Medical Trading, Inc.<br>5363 NW 35th Avenue<br>Fort Lauderdale, FL 33309<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John D. Pazienza |
| Date Prepared: | August 29, 2018 |
| Trade Name: | Teleport Microcatheter |
| Common Name: | Microcatheter |
| Classification Name: | Percutaneous Catheter<br>21 CFR 870.1250 |
| Product Code: | DQY |
| Device Class: | Class II |
| Predicate Device: | ASAHI Corsair Pro (K161126; DQY; cleared August 25, 2016) |
| Reference Devices: | Terumo Finecross MG (K082519; cleared September 26, 2008)<br>OrbusNeich Sapphire NC Plus (K162209; cleared October 6, 2016) |
| Device Description: | The Teleport family of microcatheters are single lumen catheters,<br>offered in two shaft sizes (2.0F and 2.1F) with working lengths of<br>135cm or 150cm, designed for use in the coronary, peripheral, and<br>abdominal vasculature. The shaft profiles gradually decrease from<br>2.6F (0.034") to 2.0F (0.0265") for the 2.0F configuration (Teleport),<br>and 2.7F (0.036") to 2.1F (0.0275") for the 2.1F configuration<br>(Teleport Control) respectively. The catheter consists of four sections:<br>body shaft, proximal tip shaft, distal tip shaft, and a radiopaque tip.<br>The distal most 60cm of the outer surface is coated with a hydrophilic<br>polymer to increase lubricity and the lumen of the catheter is lined with<br>a fluoropolymer to facilitate movement of the guidewire. The catheter<br>is compatible with a standard 0.014 inch (0.36mm) guidewire. |
| Intended Use: | The Teleport microcatheters are indicated for:<br>supporting and facilitating the placement of guidewires in the<br>●<br>coronary and peripheral vasculature.<br>exchanging guidewires in the coronary and peripheral<br>●<br>vasculature.<br>the delivery of contrast media into the coronary, peripheral,<br>●<br>and abdominal vasculature. |

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Technological Characteristics:

At a high level, the subject and predicate devices are based on the same technological elements:

- the same indications for use .
- catheter design .
- hydrophilic coating .
- 0.014" guidewire compatibility .
- . 4F guiding catheter compatibility
- Maximum allowable pressure of 300 psi .
- . EO sterilization

The following technological differences exist between the subject and predicate device:

- . specific materials selected
- . exact dimensions of components and catheter
- permissible rotations .

Performance Data:

Testing was performed to support the use of the Teleport microcatheter:

- Sterilization
- . Shelf-Life
- Performance Testing .
- Visual Inspection O
- Dimension Inspection O
- Flow Rate O
- Simulated Use o
- O Vacuum Leakage
- O Shaft Burst Pressure
- O Torque Strength
- o Flexibility and Kinking
- Radiopacity O
- Corrosion Resistance O
- Guidewire Compatibility O
- Bond Strength O
- Tip Strength O
- Coating Integrity O
- Particulate Evaluation O
- Biocompatibility ●
- O Cytotoxicity
- O Sensitization
- Intracutaneous Reactivity O
- Acute Systemic Toxicity O
- Hemocompatibility O
- Hemolysis .
- Partial Thromboplastin Time
- Complement Activation
- . In vivo Thromboresistance
- Pyrogenicity O
- Genotoxicity O

The Teleport microcatheter test results met all acceptance criteria and were similar to the predicate and reference devices.

Conclusion:

This information supports a determination of substantial equivalence between the Teleport microcatheter and the predicate device described above.