(28 days)
No
The 510(k) summary describes a physical catheter device and its performance characteristics, with no mention of AI, ML, or any software-driven analytical capabilities.
No.
The device is described as a catheter intended for the introduction of other interventional devices or diagnostic agents, not for directly treating a condition itself.
No
Explanation: The device is intended for the introduction of interventional devices or diagnostic agents. While it can introduce diagnostic agents, its primary function is delivery, not diagnosis itself.
No
The device description clearly outlines a physical catheter with various material properties, coatings, and radiopaque markers, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Phenom™ Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures. This describes a device used within the body for procedural purposes, not for testing samples outside the body.
- Device Description: The description details a catheter designed for navigation within blood vessels, with features like variable stiffness, coatings for lubricity, a liner for device passage, and radiopaque markers for visualization under fluoroscopy. These are characteristics of an invasive medical device used for access and delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, tissue, etc.) or to provide diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Phenom™ Catheter's function is to facilitate procedures within the body.
N/A
Intended Use / Indications for Use
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
Product codes (comma separated list FDA assigned to the subject device)
DQY, KRA, QJP
Device Description
The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The Phenom™ 17, 21, and 27 Catheters have a hydrophilic coating that spans the distal 100cm. The Phenom™ Plus Catheters have a hydrophilic coating that spans the distal 90cm. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy. The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split introducer sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Neuro, Peripheral, and Coronary 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 Data – Bench:
The following non-clinical bench testing was performed to evaluate the performance of the Phenom™ Catheters. The passing results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the predicate devices.
Tests conducted:
- Compatibility – Guide Catheter: The Phenom™ Catheters were evaluated for compatibility with guide catheters in a simulated tortuous path model. Results: The Phenom™ Catheters are compatible for use with a guide catheter.
- Compatibility – Guide Wire: The Phenom™ Catheters were evaluated for compatibility with guide wires in a simulated tortuous path model. Results: The Phenom™ Catheters are compatible for use with a guide wire.
- Compatibility – RHV: The Phenom™ Catheters were evaluated for compatibility with a standard RHV. Results: The Phenom™ Catheters are compatible with the standard used RHV.
- Coating Lubricity (Friction Force): The Phenom™ Catheters were evaluated for coating lubricity under simulated clinical conditions. Results: The Phenom™ Catheters exhibit acceptable friction force under simulated clinical conditions.
- Hub Functional & Dimensional: The Phenom™ Catheters were evaluated per ISO 80369-7:2016 and ISO 80369-20:2015. Results: The Phenom™ Catheters met the acceptance criteria for hub functional & dimensional requirements.
- Torque Strength: The Phenom™ Catheters were evaluated for torsional strength integrity during use in a simulated path model. Results: The Phenom™ Catheters exhibit acceptable torsional strength integrity.
- Tensile: The Phenom™ Catheters were evaluated per ISO 10555-1:2013, Annex B. Results: The Phenom™ Catheters met the acceptance criteria for tensile strength.
- Air Aspiration: The Phenom™ Catheters were evaluated per ISO 10555-1:2013. Results: The Phenom™ Catheters met the acceptance criteria for air aspiration.
- Liquid Leak: The Phenom™ Catheters were evaluated per ISO 10555-1:2013. Results: The Phenom™ Catheters met the acceptance criteria for liquid leak.
- Particulate: The Phenom™ Catheters were evaluated per USP . Results: The Phenom™ Catheters met the acceptance criteria for particulate.
- Design Validation: The Phenom™ Catheters were evaluated per ANSI/AAMI HE75:2009/(R) 2018. Results: The Phenom™ Catheters met the user needs and intended use(s) for which it was designed and tested.
Biocompatibility:
Biocompatibility was conducted for the Phenom™ Catheters. The Phenom™ Catheters are categorized as a limited exposure (
§ 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 shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 25, 2021
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Prerana Gurubasavaraj Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K210230
Trade/Device Name: Phenom Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA, QJP Dated: January 27, 2021 Received: January 28, 2021
Dear Prerana Gurubasavaraj:
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.
1
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) 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 (OS) 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 Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-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-regulatoryassistance/contact-us-division-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.
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210230
Device Name Phenom™ Catheters
Indications for Use (Describe)
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
| 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
K210230
510(k) Summary
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration: 2029214 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Prerana Gurubasavaraj
Specialist, Regulatory Affairs
Telephone: (949) 297-5804
Email: prerana.gurubasavaraj@medtronic.com |
| Date Summary
Prepared: | February 24, 2021 |
| Trade Name of
Device: | Phenom™ Catheters |
| Device Classification
Name: | Catheter, Percutaneous |
| Regulation Medical
Specialty: | Cardiovascular |
| 510(k) Review Panel: | Cardiovascular |
| Classification Product
Code: | DQY |
| Subsequent Product
Code: | KRA, QJP |
| Regulation Number: | 870.1250
870.1210 |
| Regulation
Description: | Percutaneous catheter
Continuous flush catheter |
| Device Classification: | Class II |
| Predicate Device: | Phenom™ 17 Catheter, Phenom™ 21 Catheter, Phenom™ 27
Catheter, Phenom™ Plus Catheter
510(k): K151638
Phenom™ 27 Catheter
510(k): K180959 |
| Reference Device: | React™ 68 Catheter
510(k): K180715
Navien™ Intracranial Support Catheter |
Device Description:
The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The Phenom™ 17, 21, and 27 Catheters have a hydrophilic coating that spans the distal 100cm. The Phenom™ Plus Catheters have a hydrophilic coating that spans the distal 90cm. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy. The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split introducer sheath.
4
Indication for Use Statement:
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
| | Legally Marketed Predicate Devices
(K151638 & K180959) | | | | Phenom™
Catheters |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use
Statement | The Phenom™ Catheters are intended for the introduction of
interventional devices and infusion of diagnostic or therapeutic
agents into the neuro, peripheral, and coronary vasculatures. | | | | Phenom™
Catheters are
intended for the
introduction of
interventional
devices or
diagnostic
agents into the
neuro,
peripheral, and
coronary
vasculatures. |
| Dimensions | Phenom™ 17
(K151638) | Phenom™ 21
(K151638) | Phenom™ 27
(K180959) | Phenom™ Plus
(K151638) | |
| Proximal/Distal
Outer Diameter
(OD) | 2.2 F / 1.8 F | 2.6 F / 2.3 F | 3.1 F / 2.8 F | 4.7 F / 4.2 F | Same |
| Internal
Diameter (ID) | 0.017" | 0.021" | 0.027" | 0.0445" | Same |
| Min. Guiding
Catheter ID | ≥ 0.035" | ≥ 0.038" | ≥ 0.0445" | ≥ 0.070 | Same |
| Max. Guidewire
OD | ≤ 0.014" | ≤ 0.018" | ≤ 0.025" | ≤ 0.041 | Same |
| Effective Length
(cm) | 75 - 170 | 75 - 170 | 75 - 160 | 75 - 150 | Phenom 17:
150
Phenom 21:
150, 160
Phenom 27:
150, 160
Phenom Plus:
120 |
| Distal segment
length (cm) | 6 - 20 | 6 - 20 | 6 - 20 | 6 - 20 | Same |
| Inner Lumen | Inner lumen lined with lubricious PTFE to facilitate movement of
guidewires and other devices. | | | | Same |
| No. of lumens | Single lumen | | | | Same |
| Shaft | Progressively softer from proximal end to distal tip | | | | Same |
| Method of
delivery/tracking | Coaxial tracking over steerable guidewire | | | | Same |
| Shaft Materials | PTFE and Pebax | | | | Same |
| Shaft
reinforcement | Metallic (Stainless Steel) reinforced | | | | Same |
| Inner Liner | PTFE liner | | | | Same |
| Tip Markers | 1 or 2 | 1 or 2 | 1 | 1 | Same |
| Tip Shaping | Steam shapeable straight tip;
Pre-shaped 45°, 90° and J | | Steam shapeable tip | Steam shapeable tip | Same |
| Coating | Hydrophilic coating | | | | |
| Packaging | | | | | |
| Pouch Material | PET/Tyvek | | | | NYLON/Tyvek |
| Pouch Dimensions | 11" X 12" (Hoop configuration)
11" X 13.75" (Tray configuration) | | | | 13" X 10.94" |
| Carton | Cardboard, Solid Bleach Sulfate | | | | Same |
| Accessories | | | | | |
| Shaping Mandrel | | | Yes | | Same |
| Split Introducer
Sheath
(Phenom™ 17) | | | No | | Yes |
| Sterilization | | | | | |
| Method | Ethylene Oxide (EO) | | | | Same |
| Stability | | | | | |
| Shelf Life | | | 36 Months | | 12 Months |
Device Comparison:
5
Performance Data – Bench:
The following non-clinical bench testing was performed to evaluate the performance of the Phenom™ Catheters. The passing results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the predicate devices.
| Test | Test Method Summary | Results |
|---|---|---|
| Performance | ||
| Compatibility – Guide Catheter | The Phenom™ Catheters were | |
| evaluated for compatibility with | ||
| guide catheters in a simulated | ||
| tortuous path model. | The Phenom™ Catheters are | |
| compatible for use with a guide | ||
| catheter. | ||
| Compatibility – Guide Wire | The Phenom™ Catheters were | |
| evaluated for compatibility with | ||
| guide wires in a simulated | ||
| tortuous path model. | The Phenom™ Catheters are | |
| compatible for use with a guide | ||
| wire. | ||
| Compatibility – RHV | The Phenom™ Catheters were | |
| evaluated for compatibility with | ||
| a standard RHV. | The Phenom™ Catheters are | |
| compatible with the standard | ||
| used RHV. | ||
| Coating Lubricity (Friction | ||
| Force) | The Phenom™ Catheters were | |
| evaluated for coating lubricity | ||
| under simulated clinical | ||
| conditions. | The Phenom™ Catheters exhibit | |
| acceptable friction force under | ||
| simulated clinical conditions. | ||
| Hub Functional & Dimensional | The Phenom™ Catheters were | |
| evaluated per ISO 80369- | ||
| 7:2016 and ISO 80369-20: |
-
| The Phenom™ Catheters met
the acceptance criteria for hub
functional & dimensional
requirements. |
| Torque Strength | The Phenom™ Catheters were
evaluated for torsional strength
integrity during use in a
simulated path model. | The Phenom™ Catheters exhibit
acceptable torsional strength
integrity. |
6
| Test | Test Method Summary | Results |
|---|---|---|
| Tensile | The Phenom™ Catheters were evaluated per ISO 10555-1:2013, Annex B. | The Phenom™ Catheters met the acceptance criteria for tensile strength. |
| Air Aspiration | The Phenom™ Catheters were evaluated per ISO 10555-1:2013 | The Phenom™ Catheters met the acceptance criteria for air aspiration. |
| Liquid Leak | The Phenom™ Catheters were evaluated per ISO 10555-1:2013 | The Phenom™ Catheters met the acceptance criteria for liquid leak. |
| Particulate | The Phenom™ Catheters were evaluated per USP . | The Phenom™ Catheters met the acceptance criteria for particulate. |
| Design Validation | The Phenom™ Catheters were evaluated per ANSI/AAMI HE75:2009/(R) 2018 | The Phenom™ Catheters met the user needs and intended use(s) for which it was designed and tested. |
Biocompatibility:
Biocompatibility was conducted for the Phenom™ Catheters. The Phenom™ Catheters are categorized as a limited exposure (