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 Description

The Odyssey Micro Catheter is a single lumen catheter constructed using a PTFE liner inside of metallic coil and a polymer outer layer. The distal tip is a radiopaque polymer material and the distal 30 cm to 60 cm of the micro catheter has a hydrophilic coating. The key components of the catheter are the core, coil(s), tip, and coatings.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Odyssey Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study in the typical sense of a novel AI/software medical device.

Therefore, the information requested for AI/software-centric studies (like sample sizes for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission, as it concerns a physical medical device and its performance in in vitro bench tests.

However, I can extract the acceptance criteria (inferred from the tests performed) and summarize the study's findings:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria values for each test but states that the Odyssey Micro Catheter "met all predetermined acceptance criteria." The "reported device performance" is essentially that the device performed comparably or favorably to the predicate and met established standards.

Acceptance Criteria (Inferred from Tests)	Reported Device Performance (Summary)
Biocompatibility:	Met all predetermined acceptance criteria
- Cytotoxicity	Conducted in compliance with ISO10993-1:2009 and G95-1
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Pyrogenicity Testing
- Hemolysis
- Complement Activation
- In-Vivo Thrombogenicity
- Chemical Characterization
Particulate testing	Met all predetermined acceptance criteria
Corrosion resistance	Met all predetermined acceptance criteria
Dimensional inspection	Met all predetermined acceptance criteria
Sterile package integrity testing	Met all predetermined acceptance criteria
Tensile strength	Met all predetermined acceptance criteria
Torque strength	Met all predetermined acceptance criteria
Kink resistance	Met all predetermined acceptance criteria
Radiopacity	Met all predetermined acceptance criteria
Flow rate	Met all predetermined acceptance criteria
Burst pressure/freedom from leakage	Met all predetermined acceptance criteria
Equivalency to Predicate Device	Compared favorably with the predicate device (ASAHI Corsair Microcatheter - K151103)
Functional Specifications	Met
Shelf Life	Met

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The testing involved in vitro bench tests on the device itself. The number of units tested for each specific bench test is not detailed.
Data Provenance: Not applicable in the context of human data. The "study" here refers to "Performance in vitro bench tests" conducted by the manufacturer, Heraeus Medical Components, LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in this context, would refer to the validated methods and standards used for in vitro testing (e.g., ISO standards, internal validation of test equipment). This isn't about expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or when establishing ground truth from expert readings. This was in vitro bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical micro catheter, not an AI/software device that would assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's functional performance against engineering and safety specifications in vitro.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance "study" was established by validated international standards (ISO 10555-1:2013, ISO10993-1:2009) and FDA guidance (G95-1) for in vitro functional performance and biocompatibility. The specific outcomes were measurements of physical and biological properties.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set."

Summary of the Study:

The "study" described in the 510(k) summary involves a series of in vitro bench tests designed to demonstrate the safety and effectiveness of the Odyssey Micro Catheter by proving its substantial equivalence to a legally marketed predicate device (ASAHI Corsair Microcatheter, K151103).

The key aspects of the study include:

Tests Conducted: Biocompatibility testing (cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, in-vivo thrombogenicity, chemical characterization), particulate testing, corrosion resistance, dimensional inspection, sterile package integrity, tensile strength, torque strength, kink resistance, radiopacity, flow rate, and burst pressure/freedom from leakage.
Standards Followed: ISO 10555-1:2013 (Intravascular catheters - sterile and single-use catheters - Part 1: General requirements) for functional testing, and ISO10993-1:2009 and G95-1 (FDA guidance) for biocompatibility testing.
Outcome: The Odyssey Micro Catheter "met all predetermined acceptance criteria and compared favorably with the predicate device." The study supported claims of substantial equivalence based on indications for use, physical and technological characteristics, and comparative device testing, without raising new questions of safety and effectiveness.

Summary

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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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

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510(k) Summary	K170664
Submitter:	Heraeus Medical Components, LLC2605 Fernbrook Lane North, Suite JPlymouth, MN 55447 USA
Contact Person:	Margaret Batchelder,Principal Regulatory Specialist2605 Fernbrook Lane North, Suite JPlymouth, MN 55447 USA763-225-6675 (voice)763-559-7676 (fax)
Date Prepared:	October 25, 2017
Trade Name:	Odyssey Micro Catheter
Classification:	Class IIRegulation Number: 21 CFR 870.1250Percutaneous Catheter
Product Code:	DQY
Predicate Device:	The subject device is substantially equivalent to K151103;ASAHI Corsair Microcatheter manufactured by Asahi InteccCo., LTD.
Device Description:	The Odyssey Micro Catheter is a single lumen catheterconstructed using a PTFE liner inside of metallic coil and apolymer outer layer. The distal tip is a radiopaque polymermaterial and the distal 30 cm to 60 cm of the micro catheter hasa hydrophilic coating. The key components of the catheter arethe core, coil(s), tip, and coatings.
Indication for Use:	The Odyssey Micro Catheter is intended to provide support tofacilitate the placement of guidewires in the coronary andperipheral vasculatures and can be used to exchange one guidewire for another. The Odyssey Micro Catheter is also intendedto assist in the infusion of contrast media. This micro catheter isnot intended to be used in the neurovasculature.
Contraindications:	None known.
Principle ofOperation:	The Odyssey Micro Catheter is manually inserted intovasculature through a compatible guiding catheter over acompatible guidewire and advance with the guidewire to thetarget region.
Comparison ofTechnologicalCharacteristics:	The key technological and performance similarities examinedbetween the approved devices and the proposed device are asfollows:
	Indications for use - The Indications for use for the proposeddevice is a subset of indications for use of the predicate deviceas proposed device,
	Fundamental scientific technology, including design areequivalent 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 -equivalent to the predicate devices
	The length and diameter of the device are similar to thedimensions of the predicate devices.
	The proposed device and that of the predicate device areequivalent in that they are constructed with equivalent materialsto provide equivalent performance characteristics and coatingproperties.
SubstantialEquivalence:	The Heraeus Odyssey Micro Catheter is substantially equivalentto the ASAHI Corsair Microcatheter (K151103). Substantialequivalence, which is summarized in the following table, isbased on indications for use, physical and technologicalcharacteristics, and comparative device testing.

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	Odyssey Micro Catheter	Predicate:Asahi Corsair Microcatheter(K151103)
DeviceCommon/UsualName	Catheter, Percutaneous	Catheter, Percutaneous
Device Class	Class II	Class II
Product Code /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:Asahi Corsair Microcatheter(K151103)
Indications for Use	The Odyssey Micro Catheter isintended to provide support tofacilitate the placement ofguidewires in the coronary andperipheral vasculatures and can beused to exchange one guide wirefor another. The Odyssey MicroCatheter is also intended to assistin the infusion of contrast media.This micro catheter is not intendedto be used in the neurovasculature.	The ASAHI Corsair Microcatheteris intended to provide support tofacilitate the placement of Guidewires in the coronary andperipheral vasculatures and can beused to exchange one guide wirefor another. The CorsairMicrocatheter is also intended toassist in the delivery of contrastmedia into the coronary,peripheral, and abdominalvasculatures.
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,PTFE, Adhesive, SBC,Polycarbonate	Stainless Steel, Tungsten, PolymerJacket, PTFE, Adhesive, SBC,Polycarbonate
Catheter Coating	Hydrophilic coating	Hydrophilic coating
Sterile Device	Yes	Yes
Sterilization Type	Ethylene Oxide	Ethylene Oxide
Disposable /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.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).