(248 days)
Not Found
No
The summary describes a physical catheter device and its intended use, with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
The device is intended to provide support for guidewire placement and infusion of contrast media, which are diagnostic and interventional support functions, not therapeutic.
No
The device description and intended use indicate that the Odyssey Micro Catheter is an interventional tool used to facilitate guidewire placement and exchange, and for contrast media infusion. These are procedural functions, not diagnostic ones.
No
The device description clearly outlines physical components like a PTFE liner, metallic coil, polymer outer layer, and a radiopaque polymer tip, indicating it is a physical medical device, not software-only.
Based on the provided information, the Odyssey Micro Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) to facilitate guidewire placement and infuse contrast media in the coronary and peripheral vasculatures. IVD devices are used to examine specimens from the body (in vitro), such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The description details a catheter designed for insertion into blood vessels, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
Therefore, the Odyssey Micro Catheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DOY, DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculatures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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);
1
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
2
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 510(k) Summary | K170664 |
|---|---|
| Submitter: | Heraeus Medical Components, LLC |
| 2605 Fernbrook Lane North, Suite J | |
| Plymouth, MN 55447 USA | |
| Contact Person: | Margaret Batchelder, |
| Principal Regulatory Specialist | |
| 2605 Fernbrook Lane North, Suite J | |
| Plymouth, MN 55447 USA | |
| 763-225-6675 (voice) | |
| 763-559-7676 (fax) | |
| Date Prepared: | October 25, 2017 |
| Trade Name: | Odyssey Micro Catheter |
| Classification: | Class II |
| Regulation Number: 21 CFR 870.1250 | |
| Percutaneous Catheter | |
| Product Code: | DQY |
| Predicate Device: | The subject device is substantially equivalent to K151103; |
| ASAHI Corsair Microcatheter manufactured by Asahi Intecc | |
| Co., LTD. | |
| 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. | |
| Indication for 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. This micro catheter is | |
| not intended to be used in the neurovasculature. | |
| Contraindications: | None known. |
| Principle of | |
| Operation: | The Odyssey Micro Catheter is manually inserted into |
| vasculature through a compatible guiding catheter over a | |
| compatible guidewire and advance with the guidewire to the | |
| target region. | |
| Comparison of | |
| Technological | |
| Characteristics: | The key technological and performance similarities examined |
| between the approved devices and the proposed device are as | |
| follows: | |
| Indications for use - The Indications for use for the proposed | |
| device is a subset of indications for use of the predicate device | |
| as proposed device, | |
| Fundamental scientific technology, including design are | |
| 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 - | |
| equivalent to the predicate devices | |
| The length and diameter of the device are similar to the | |
| dimensions of the predicate devices. | |
| The proposed device and that of the predicate device are | |
| equivalent in that they are constructed with equivalent materials | |
| to provide equivalent performance characteristics and coating | |
| properties. | |
| Substantial | |
| Equivalence: | The Heraeus Odyssey Micro Catheter is substantially equivalent |
| to the ASAHI Corsair Microcatheter (K151103). Substantial | |
| equivalence, which is summarized in the following table, is | |
| based on indications for use, physical and technological | |
| characteristics, and comparative device testing. |
4
| | Odyssey Micro Catheter | Predicate:
Asahi Corsair Microcatheter
(K151103) |
|--------------------------------|------------------------|--------------------------------------------------------|
| Device
Common/Usual
Name | 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 |
5
| | Odyssey Micro Catheter | Predicate:
Asahi Corsair Microcatheter
(K151103) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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.
This micro catheter is not intended
to be used in the neurovasculature. | The ASAHI Corsair Microcatheter
is intended to provide support to
facilitate the placement of Guide
wires in the coronary and
peripheral vasculatures and can be
used to exchange one guide wire
for another. The Corsair
Microcatheter is also intended to
assist in the delivery of contrast
media into the coronary,
peripheral, and abdominal
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,
PTFE, Adhesive, SBC,
Polycarbonate | Stainless Steel, Tungsten, Polymer
Jacket, 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:
6
- 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.