(219 days)
Not Found
No
The summary describes a physical microcatheter and its performance characteristics. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device's stated intended use is for diagnostic and interventional procedures, but it does not specify that it treats a condition. While it can be used in "interventional procedures," this could also mean procedures that gather information for treatment, rather than directly administrating treatment. Additionally, a microcatheter is a delivery device, not a therapeutic agent itself.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic and interventional procedures".
No
The device description clearly outlines a physical catheter with specific material components, a radiopaque marker band, and a hydrophilic coating. The performance studies focus on bench testing of the physical device's properties and biocompatibility, not software validation.
Based on the provided information, the Poseidon Microcatheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "diagnostic and interventional procedures including small or superselective anatomy" within "peripheral and coronary vessels." This describes a device used within the body for procedures, not a device used to test samples outside the body.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with an in-vivo medical device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD testing.
Therefore, the Poseidon Microcatheter is an in-vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy.
Product codes (comma separated list FDA assigned to the subject device)
KRA, DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vessels
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 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."
The following bench tests were conducted or evaluated to support the proposed device:
- Cytotoxicity (ISO MEM Elution Using L-929 Mouse Fibroblast Cells): Samples passed the acceptance criteria and the device was found to be non-cytotoxic.
- Sensitization (ISO Guinea Pig Maximization Sensitization Test): Samples passed the acceptance criteria and the device did not elicit a sensitization response.
- Irritation (ISO Intracutaneous Irritation Test): Samples passed the acceptance criteria and the device did not elicit an irritation response.
- Systemic Toxicity (ISO Acute Systemic Injection Test): Samples passed the acceptance criteria and the device was found to be non-toxic.
- Pyrogenicity (ISO Materials Mediated Rabbit Pyrogen): Samples passed the acceptance criteria and the device was found to be non-pyrogenic.
- Hemolysis (ASTM Hemolysis Assay – Direct Contact and Extract Method): Samples passed the acceptance criteria and the device was found to be non-hemolytic.
- Hemocompatibility (Complement Activation C3a and SC5b-9 Assay): Samples passed the acceptance criteria and the device was found to be comparable to the predicate comparison article.
- Thrombogenicity (In-vitro Blood Loop Assay): Samples passed the acceptance criteria and the device was found to be non-thrombogenic.
- Corrosion Resistance (ISO 10555-1:2013 Annex A): Samples passed the acceptance criteria and the device did not elicit a corrosive response.
- Dimensions (Dimensions were tested under nominal conditions using standard measuring tools (e.g. micrometers, rulers).): Samples passed the acceptance criteria and the results were comparable to the predicate.
- Package Integrity Testing (ASTM F 1929-98): Samples passed the acceptance criteria and the results were comparable to the predicate.
- Tensile Strength (ISO 10555-1:2013 Annex B and Amd 1:2017): Samples passed the acceptance criteria and the results were comparable to the predicate.
- Torque Strength (Torque strength was tested in a tortuous anatomical model in temperature controlled aqueous solution.): Samples passed the acceptance criteria and the results were comparable to the predicate.
- Kink Resistance (Kink resistance was testing under nominal conditions and measure the buckling point in millimeters of the catheter column.): Samples passed the acceptance criteria and the results were comparable to the predicate.
- Radiopacity (ASTM F640-12): Samples passed the acceptance criteria and the results were comparable to the predicate.
- Flow Rate (ISO 10555-1:2013 Annex E): Samples passed the acceptance criteria and the results were comparable to the predicate.
- Burst Pressure/freedom from leakage (ISO 10555-1:2013 Annex F and G): Samples passed the acceptance criteria and the results were comparable to the predicate.
The Poseidon Microcatheter 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
§ 870.1210 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).
0
December 19, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
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
1
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
2
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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3
510(k) Summary
| Submitter: | Heraeus Medical Components, LLC
1805 Fernbrook Lane North, Suite J
Plymouth, MN 55447 USA |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dustin Andrist, Product Line Manager
2605 Fernbrook Lane North, Suite J
Plymouth, MN 55447 USA
612-413-8853 (voice)
763-559-7676 (fax) |
| Date Prepared: | March 20, 2019 |
| Trade Name: | Poseidon Microcatheter |
| Common Name: | Microcatheter |
| Classification: | Class II
Regulation Number: 21 CFR 870.1210, 21 CFR 870.1250
Continuous flush catheter, Percutaneous catheter |
| Product Code: | KRA, DQY |
| Predicate Device: | The subject device is substantially equivalent to K131772; Cook
Cantata Microcatheter manufactured by Cook, Incorporated. |
| Device Description: | 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. |
| Indication for Use: | The Poseidon Microcatheter is intended for use in peripheral and
coronary vessels for diagnostic and interventional procedures
including small or superselective anatomy. |
| Contraindications: | None known. |
| Principle of
Operation: | The Poseidon Microcatheter is manually inserted into vasculature
through a compatible guiding catheter over a compatible guidewire
and advance with the guidewire to the target region. |
| Substantial
Equivalence
Comparison: | The Heraeus Poseidon Microcatheter is substantially equivalent to
the Cook Cantata Microcatheter (K131772). Substantial equivalence
is based on indications for use, physical and technological
characteristics, and comparative device testing. |
4
Indications for use:
-
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
-
. Materials - the device is constructed of equivalent materials to provide equivalent performance characteristics and coating properties
-
Operating principle - equivalent to the predicate device
-
Packaging materials - equivalent to the predicate device
-
Sterility assurance level and method of sterilization equivalent to the predicate devices
| | Heraeus Poseidon
Microcatheter | Predicate:
Cook Cantata
Microcatheter | Equivalence |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Indications for Use | The Poseidon
Microcatheter is
intended for use in
peripheral and
coronary vessels for
diagnostic and
interventional
procedures including
small or
superselective
anatomy. | The Cantata
Microcatehter is
designed for use in
small vessel or
superselective
anatomy for diagnostic
and interventional
proecedures including
neuro, 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.
5
| 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 – 0.018
in. OD | 0.014 in. OD – 0.018
in. OD | Equivalent |
| Compatible Guide
Catheter | ≥ 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 the | |
| device was found to be non-cytotoxic. | ||
| Sensitization | ISO Guinea Pig | |
| Maximization Sensitization | ||
| Test | Samples passed the acceptance criteria and the | |
| device did not elicit a sensitization response. | ||
| Irritation | ISO Intracutaneous Irritation | |
| Test | Samples passed the acceptance criteria and the | |
| device did not elicit an irritation response. | ||
| Systemic Toxicity | ISO Acute Systemic | |
| Injection Test | Samples passed the acceptance criteria and the | |
| device was found to be non-toxic. | ||
| Pyrogenicity | ISO Materials Mediated | |
| Rabbit Pyrogen | Samples passed the acceptance criteria and the | |
| device was found to be non-pyrogenic. | ||
| Hemolysis | ASTM Hemolysis Assay – | |
| Direct Contact and Extract | ||
| Method | Samples passed the acceptance criteria and the | |
| device was found to be non-hemolytic. |
The following bench tests were conducted or evaluated to support the proposed device:
6
| Hemocompatibility | Complement Activation C3a
and SC5b-9 Assay | Samples passed the acceptance criteria and the
device was found to be comparable to the
predicate comparison article. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Thrombogenicity | In-vitro Blood Loop Assay | Samples passed the acceptance criteria and the
device was found to be non-thrombogenic. |
| Corrosion
Resistance | ISO 10555-1:2013 Annex A | Samples passed the acceptance criteria and the
device did not elicit a corrosive response. |
| Dimensions | Dimensions were tested
under nominal conditions
using standard measuring
tools (e.g. micrometers,
rulers). | Samples passed the acceptance criteria and the
results were comparable to the predicate. |
| Package Integrity
Testing | ASTM F 1929-98 | Samples passed the acceptance criteria and the
results were comparable to the predicate. |
| Tensile Strength | ISO 10555-1:2013 Annex B
and Amd 1:2017 | Samples passed the acceptance criteria and the
results were comparable to the predicate. |
| Torque Strength | Torque strength was tested
in a tortuous anatomical
model in temperature
controlled aqueous solution. | Samples passed the acceptance criteria and the
results were comparable to the predicate. |
| Kink Resistance | Kink resistance was testing
under nominal conditions
and measure the buckling
point in millimeters of the
catheter column. | Samples passed the acceptance criteria and the
results were comparable to the predicate. |
| Radiopacity | ASTM F640-12 | Samples passed the acceptance criteria and the
results were comparable to the predicate. |
| Flow Rate | ISO 10555-1:2013 Annex E | Samples passed the acceptance criteria and the
results were comparable to the predicate. |
| Burst
Pressure/freedom
from leakage | ISO 10555-1:2013 Annex F
and G | Samples passed the acceptance criteria and the
results 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.