(219 days)
The Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy.
The Poseidon Microcatheter is a single lumen catheter constructed using an internal lubricious layer encapsulated by a metallic braid and lubricious outer layer. The distal tip includes a radiopaque marker band, and the distal 60 - 90 cm of the microcatheter has a hydrophilic coating.
The provided document is a 510(k) Premarket Notification for the Heraeus Poseidon Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria via a clinical study that would involve expert readers, complex adjudication, or MRMC studies.
Therefore, many of the questions asked cannot be answered directly from this type of FDA submission. The document details bench testing against general regulatory standards and comparisons to a predicate device's characteristics.
Here's a breakdown of what can and cannot be answered based on the provided text:
What can be answered:
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Acceptance Criteria and Reported Device Performance (as listed in bench tests): The document provides a table of in vitro bench tests conducted and states that "Samples passed the acceptance criteria and the device was found to be [performance outcome]." The specific numerical acceptance criteria themselves are generally not detailed in this type of summary, but the qualitative outcome is stated as "passed."
Test Acceptance Criteria (Qualitative) Reported Device Performance Cytotoxicity Non-cytotoxic Passed acceptance criteria; non-cytotoxic Sensitization No sensitization response Passed acceptance criteria; did not elicit sensitization Irritation No irritation response Passed acceptance criteria; did not elicit irritation Systemic Toxicity Non-toxic Passed acceptance criteria; non-toxic Pyrogenicity Non-pyrogenic Passed acceptance criteria; non-pyrogenic Hemolysis Non-hemolytic Passed acceptance criteria; non-hemolytic Hemocompatibility Comparable to predicate comparison article Passed acceptance criteria; comparable to predicate Thrombogenicity Non-thrombogenic Passed acceptance criteria; non-thrombogenic Corrosion Resistance No corrosive response Passed acceptance criteria; did not elicit corrosive response Dimensions Comparable to predicate Passed acceptance criteria; comparable to predicate Package Integrity Testing Comparable to predicate Passed acceptance criteria; comparable to predicate Tensile Strength Comparable to predicate Passed acceptance criteria; comparable to predicate Torque Strength Comparable to predicate Passed acceptance criteria; comparable to predicate Kink Resistance Comparable to predicate Passed acceptance criteria; comparable to predicate Radiopacity Comparable to predicate Passed acceptance criteria; comparable to predicate Flow Rate Comparable to predicate Passed acceptance criteria; comparable to predicate Burst Pressure/Freedom from Leakage Comparable to predicate Passed acceptance criteria; comparable to predicate -
Sample size used for the test set: Not explicitly stated as "sample size" in the context of cases/patients, but rather in terms of number of device units or samples tested for each bench test. These are standard in vitro tests, not human studies.
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Data provenance: For bench tests, this would be laboratory data.
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Training Set (for AI-related questions): This device is a microcatheter, not an AI/ML device. Therefore, there is no training set in the context of an algorithm.
What cannot be answered from this document:
- Number of experts used to establish ground truth: Not applicable for a physical medical device clearance based on substantial equivalence and bench testing.
- Qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/imaging device.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in this context refers to the defined acceptance criteria for physical properties and biological responses established through international standards (ISO, ASTM) and FDA guidance for medical devices, not clinical outcomes or expert consensus on medical images.
- Sample size for the training set: Not applicable (no AI/ML algorithm).
- How the ground truth for the training set was established: Not applicable (no AI/ML algorithm).
In summary: The provided 510(k) summary demonstrates the safety and effectiveness of the Heraeus Poseidon Microcatheter through a comparison to a legally marketed predicate device and extensive in vitro bench testing against established international standards. It is not an AI/ML device, and thus the questions related to clinical study design, human readers, ground truth establishment by experts, and training/test sets for algorithms are not applicable to this submission.
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December 19, 2019
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Heraeus Medical Components, LLC Dustin Andrist Sr. Product Line Manager - Catheters 2605 Fernbrook Lane North, Suite J Plymouth, Minnesota 55447
Re: K191305
Trade/Device Name: Hereaeus Poseidon Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY Dated: November 15, 2019 Received: November 19, 2019
Dear Dustin Andrist:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Lydia Glaw, Ph.D. Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191305
Device Name Poseidon Microcatheter
Indications for Use (Describe)
The Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitter: | Heraeus Medical Components, LLC1805 Fernbrook Lane North, Suite JPlymouth, MN 55447 USA |
|---|---|
| Contact Person: | Dustin Andrist, Product Line Manager2605 Fernbrook Lane North, Suite JPlymouth, MN 55447 USA612-413-8853 (voice)763-559-7676 (fax) |
| Date Prepared: | March 20, 2019 |
| Trade Name: | Poseidon Microcatheter |
| Common Name: | Microcatheter |
| Classification: | Class IIRegulation Number: 21 CFR 870.1210, 21 CFR 870.1250Continuous flush catheter, Percutaneous catheter |
| Product Code: | KRA, DQY |
| Predicate Device: | The subject device is substantially equivalent to K131772; CookCantata Microcatheter manufactured by Cook, Incorporated. |
| Device Description: | The Poseidon Microcatheter is a single lumen catheter constructedusing an internal lubricious layer encapsulated by a metallic braidand lubricious outer layer. The distal tip includes a radiopaquemarker band, and the distal 60 - 90 cm of the microcatheter has ahydrophilic coating. |
| Indication for Use: | The Poseidon Microcatheter is intended for use in peripheral andcoronary vessels for diagnostic and interventional proceduresincluding small or superselective anatomy. |
| Contraindications: | None known. |
| Principle ofOperation: | The Poseidon Microcatheter is manually inserted into vasculaturethrough a compatible guiding catheter over a compatible guidewireand advance with the guidewire to the target region. |
| SubstantialEquivalenceComparison: | The Heraeus Poseidon Microcatheter is substantially equivalent tothe Cook Cantata Microcatheter (K131772). Substantial equivalenceis based on indications for use, physical and technologicalcharacteristics, and comparative device testing. |
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Indications for use:
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The indications for use for the Poseidon Microcatheter are ● equivalent to the predicate.
Fundamental scientific technology -
Dimensional characteristics the length and diameter of the ● device are similar to the dimensions of the predicate devices
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. Materials - the device is constructed of equivalent materials to provide equivalent performance characteristics and coating properties
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Operating principle - equivalent to the predicate device
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Packaging materials - equivalent to the predicate device
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Sterility assurance level and method of sterilization equivalent to the predicate devices
| Heraeus PoseidonMicrocatheter | Predicate:Cook CantataMicrocatheter | Equivalence | |
|---|---|---|---|
| Indications for Use | The PoseidonMicrocatheter isintended for use inperipheral andcoronary vessels fordiagnostic andinterventionalprocedures includingsmall orsuperselectiveanatomy. | The CantataMicrocatehter isdesigned for use insmall vessel orsuperselectiveanatomy for diagnosticand interventionalproecedures includingneuro, peripheral,coronary use. | Equivalent |
| Comparative Technological Characteristics | |||
| Inner Lumen | PTFE | PTFE | Equivalent |
| Braid Wire Material | Stainless Steel | Stainless Steel | Equivalent |
| Outer Layer | Pellethane, Pebax,Nylon | Nylon, Peabx | Equivalent |
| Radiopaque Marker Band | 90 % Platinum /10% Iridium | Metallic Marker | Equivalent |
| Luer Connector | Polypropylene | Polycarbonate | Equivalent1 |
Substantial Equivalence Summary
l The difference in the luer connector material allows for an expanded range of materials that can be injected through the device as Polypropylene material is Dimethylsulfoxide (DMSO) compliant whereas the Polycarbonate material is not.
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| Coatings | Hydrophilic coating(distal coating) | Hydrophilic coating(distal coating) | Equivalent |
|---|---|---|---|
| Coating Length (cm) | 60 cm to 90 cm | 60 cm | Equivalent |
| Nominal Diameter (in) | 0.029 in. - 0.038 in. | 0.032 in. - 0.038 in. | Equivalent |
| Length (cm) | 100 cm - 190 cm | 100 cm - 150 cm | Equivalent |
| Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Equivalent |
| Packaging Configuration | Hoop in pouch | Hoop in Pouch | Equivalent |
| Compatible Guidewire | 0.014 in. OD – 0.018in. OD | 0.014 in. OD – 0.018in. OD | Equivalent |
| Compatible GuideCatheter | ≥ 4 Fr | ≥ 4 Fr | Equivalent |
Performance Testing: In vitro bench tests were utilized to demonstrate equivalence with reference to ISO 10555-1:2013, Intravascular catheters - sterile and single-use catheters - 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 Poseidon Microcatheter 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 ISO 10993-1:2018 and the 2016 FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."
| Test | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity | ISO MEM Elution Using L-929 Mouse Fibroblast Cells | Samples passed the acceptance criteria and thedevice was found to be non-cytotoxic. |
| Sensitization | ISO Guinea PigMaximization SensitizationTest | Samples passed the acceptance criteria and thedevice did not elicit a sensitization response. |
| Irritation | ISO Intracutaneous IrritationTest | Samples passed the acceptance criteria and thedevice did not elicit an irritation response. |
| Systemic Toxicity | ISO Acute SystemicInjection Test | Samples passed the acceptance criteria and thedevice was found to be non-toxic. |
| Pyrogenicity | ISO Materials MediatedRabbit Pyrogen | Samples passed the acceptance criteria and thedevice was found to be non-pyrogenic. |
| Hemolysis | ASTM Hemolysis Assay –Direct Contact and ExtractMethod | Samples passed the acceptance criteria and thedevice was found to be non-hemolytic. |
The following bench tests were conducted or evaluated to support the proposed device:
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| Hemocompatibility | Complement Activation C3aand SC5b-9 Assay | Samples passed the acceptance criteria and thedevice was found to be comparable to thepredicate comparison article. |
|---|---|---|
| Thrombogenicity | In-vitro Blood Loop Assay | Samples passed the acceptance criteria and thedevice was found to be non-thrombogenic. |
| CorrosionResistance | ISO 10555-1:2013 Annex A | Samples passed the acceptance criteria and thedevice did not elicit a corrosive response. |
| Dimensions | Dimensions were testedunder nominal conditionsusing standard measuringtools (e.g. micrometers,rulers). | Samples passed the acceptance criteria and theresults were comparable to the predicate. |
| Package IntegrityTesting | ASTM F 1929-98 | Samples passed the acceptance criteria and theresults were comparable to the predicate. |
| Tensile Strength | ISO 10555-1:2013 Annex Band Amd 1:2017 | Samples passed the acceptance criteria and theresults were comparable to the predicate. |
| Torque Strength | Torque strength was testedin a tortuous anatomicalmodel in temperaturecontrolled aqueous solution. | Samples passed the acceptance criteria and theresults were comparable to the predicate. |
| Kink Resistance | Kink resistance was testingunder nominal conditionsand measure the bucklingpoint in millimeters of thecatheter column. | Samples passed the acceptance criteria and theresults were comparable to the predicate. |
| Radiopacity | ASTM F640-12 | Samples passed the acceptance criteria and theresults were comparable to the predicate. |
| Flow Rate | ISO 10555-1:2013 Annex E | Samples passed the acceptance criteria and theresults were comparable to the predicate. |
| BurstPressure/freedomfrom leakage | ISO 10555-1:2013 Annex Fand G | Samples passed the acceptance criteria and theresults were comparable to the predicate. |
The Poseidon Microcatheter met all predetermined acceptance criteria and compared favorably with the predicate device.
Conclusion: Heraeus considers the Poseidon Microcatheter to be equivalent to the 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.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).