Odyssey Micro Catheter

K170664 · Heraeus Medical Components, LLC · DQY · Nov 9, 2017 · Cardiovascular

Device Facts

• Record ID: K170664
• Device Name: Odyssey Micro Catheter
• Applicant: Heraeus Medical Components, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.

Device Story

Single-lumen percutaneous catheter; used to support guidewire placement/exchange and contrast media infusion in coronary and peripheral vasculatures. Manually inserted by physician through guiding catheter over guidewire; advanced to target region. Construction: PTFE liner, metallic coil, polymer outer layer, radiopaque polymer tip; hydrophilic coating on distal 30-60 cm. Provides mechanical support for navigation; facilitates contrast delivery. Benefits patient by enabling access to complex vascular anatomy. Used in clinical settings (e.g., cath lab).

Clinical Evidence

Bench testing only. No clinical data. Performance demonstrated via in vitro testing per ISO 10555-1:2013. Biocompatibility established per ISO 10993-1:2009. Tests included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, in-vivo thrombogenicity, chemical characterization, particulate testing, corrosion resistance, dimensional inspection, package integrity, tensile/torque strength, kink resistance, radiopacity, flow rate, and burst pressure/leakage. All acceptance criteria met.

Technological Characteristics

Single-lumen catheter; materials: stainless steel, Pebax, Pellethane, PTFE, adhesive, SBC, polycarbonate. Features radiopaque polymer tip and hydrophilic coating. Dimensions: 90-225 cm length; 0.032-0.042 in. OD. Sterilization: Ethylene Oxide. Mechanical sensing/actuation; no software/electronics.

Indications for Use

Indicated for support to facilitate guidewire placement and exchange in coronary and peripheral vasculatures, and for contrast media infusion. Not for use in neurovasculature.

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 Microcatheter (K151103)

Submission Summary (Full Text)

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November 9, 2017

Heraeus Medical Components, LLC Margaret Batchelder Principal Regulatory Specialist 2605 Fernbrook Lane North, Suite J Plymouth, Minnesota 55447

Re: K170664

Trade/Device Name: Odyssey Micro Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: October 11, 2017 Received: October 12, 2017

## Dear Margaret Batchelder:

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);

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## Page 2 - Margaret Batchelder

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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K170664

Device Name Odyssey Micro Catheter

Indications for Use (Describe)

The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 100%;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 100%;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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| 510(k) Summary | K170664 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Heraeus Medical Components, LLC<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 USA |
| Contact Person: | Margaret Batchelder,<br>Principal Regulatory Specialist<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 USA<br>763-225-6675 (voice)<br>763-559-7676 (fax) |
| Date Prepared: | October 25, 2017 |
| Trade Name: | Odyssey Micro Catheter |
| Classification: | Class II<br>Regulation Number: 21 CFR 870.1250<br>Percutaneous Catheter |
| Product Code: | DQY |
| Predicate Device: | The subject device is substantially equivalent to K151103;<br>ASAHI Corsair Microcatheter manufactured by Asahi Intecc<br>Co., LTD. |
| Device Description: | The Odyssey Micro Catheter is a single lumen catheter<br>constructed using a PTFE liner inside of metallic coil and a<br>polymer outer layer. The distal tip is a radiopaque polymer<br>material and the distal 30 cm to 60 cm of the micro catheter has<br>a hydrophilic coating. The key components of the catheter are<br>the core, coil(s), tip, and coatings. |
| Indication for Use: | The Odyssey Micro Catheter is intended to provide support to<br>facilitate the placement of guidewires in the coronary and<br>peripheral vasculatures and can be used to exchange one guide<br>wire for another. The Odyssey Micro Catheter is also intended<br>to assist in the infusion of contrast media. This micro catheter is<br>not intended to be used in the neurovasculature. |
| Contraindications: | None known. |
| Principle of<br>Operation: | The Odyssey Micro Catheter is manually inserted into<br>vasculature through a compatible guiding catheter over a<br>compatible guidewire and advance with the guidewire to the<br>target region. |
| Comparison of<br>Technological<br>Characteristics: | The key technological and performance similarities examined<br>between the approved devices and the proposed device are as<br>follows: |
| | Indications for use - The Indications for use for the proposed<br>device is a subset of indications for use of the predicate device<br>as proposed device, |
| | Fundamental scientific technology, including design are<br>equivalent to the predicate devices |
| | Operating principle - equivalent to the predicate devices |
| | Packaging materials - equivalent to the predicate device |
| | Sterility assurance level and method of sterilization -<br>equivalent to the predicate devices |
| | The length and diameter of the device are similar to the<br>dimensions of the predicate devices. |
| | The proposed device and that of the predicate device are<br>equivalent in that they are constructed with equivalent materials<br>to provide equivalent performance characteristics and coating<br>properties. |
| Substantial<br>Equivalence: | The Heraeus Odyssey Micro Catheter is substantially equivalent<br>to the ASAHI Corsair Microcatheter (K151103). Substantial<br>equivalence, which is summarized in the following table, is<br>based on indications for use, physical and technological<br>characteristics, and comparative device testing. |

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| | Odyssey Micro Catheter | Predicate:<br>Asahi Corsair Microcatheter<br>(K151103) |
|--------------------------------|------------------------|--------------------------------------------------------|
| Device<br>Common/Usual<br>Name | Catheter, Percutaneous | Catheter, Percutaneous |
| Device Class | Class II | Class II |
| Product Code /<br>Regulation | DQY / 21 CFR 870.1250 | DQY / 21 CFR 870.1250 |
| Regulation Name | Percutaneous catheter | Percutaneous catheter |

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| | Odyssey Micro Catheter | Predicate:<br>Asahi Corsair Microcatheter<br>(K151103) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Odyssey Micro Catheter is<br>intended to provide support to<br>facilitate the placement of<br>guidewires in the coronary and<br>peripheral vasculatures and can be<br>used to exchange one guide wire<br>for another. The Odyssey Micro<br>Catheter is also intended to assist<br>in the infusion of contrast media.<br>This micro catheter is not intended<br>to be used in the neurovasculature. | The ASAHI Corsair Microcatheter<br>is intended to provide support to<br>facilitate the placement of Guide<br>wires in the coronary and<br>peripheral vasculatures and can be<br>used to exchange one guide wire<br>for another. The Corsair<br>Microcatheter is also intended to<br>assist in the delivery of contrast<br>media into the coronary,<br>peripheral, and abdominal<br>vasculatures. |
| Catheter OD | 0.032 in. / 0.042 in. | 0.037 in. |
| Catheter Length | 90 - 225 cm | 90 - 150 cm |
| Catheter Materials | Stainless Steel, Pebax, Pellethane,<br>PTFE, Adhesive, SBC,<br>Polycarbonate | Stainless Steel, Tungsten, Polymer<br>Jacket, PTFE, Adhesive, SBC,<br>Polycarbonate |
| Catheter Coating | Hydrophilic coating | Hydrophilic coating |
| Sterile Device | Yes | Yes |
| Sterilization Type | Ethylene Oxide | Ethylene Oxide |
| Disposable /<br>Reusable | Disposable | Disposable |

Performance In vitro bench tests were utilized to demonstrate equivalence with reference to ISO 10555-1:2013, Intravascular catheters - sterile and single-use catheters -Testing: Part 1: General requirements.

> The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed micro catheter device were met.

> The Odyssey Micro Catheter device test data supports the claims of substantial equivalence to the predicate devices. Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO10993-1:2009 and G95-1, FDA General Program Memorandum: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

The following bench tests were conducted or evaluated to support the proposed device:

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- Biocompatibility testing: .
- Cytotoxicity o
- Sensitization o
- Intracutaneous Reactivity O
- Acute Systemic Toxicity o
- Pyrogenicity Testing o
- Hemolysis o
- Complement Activation o
- In-Vivo Thrombogenicity o
- o Chemical Characterization
- Particulate testing
- Corrosion resistance .
- Dimensional inspection ●
- Sterile package integrity testing ●
- Tensile strength
- Torque strength ●
- Kink resistance ●
- Radiopacity .
- Flow rate ●
- Burst pressure/freedom from leakage .

The Odyssey Micro Catheter met all predetermined acceptance criteria and compared favorably with the predicate device.

- Heraeus considers the Odyssey Micro Catheter to be equivalent to the Conclusion: predicate device. This conclusion is based upon the fact that device has an equivalent intended use, and there are no differences that raise new types of questions of safety and effectiveness.