(149 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheter, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section states that the catheters are intended for the "infusion of diagnostic or therapeutic agents".
No
The device is a catheter intended for the introduction of interventional devices and infusion of agents. While it can infuse diagnostic agents, its primary function is not to diagnose or provide diagnostic information itself.
No
The device description clearly describes a physical catheter with various material properties, coatings, and radiopaque markers, indicating it is a hardware device.
Based on the provided information, the Phenom™ Catheters are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the catheters are for "introduction of interventional devices and infusion of diagnostic or therapeutic 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 to diagnose conditions.
- Device Description: The description focuses on the physical characteristics and function of a catheter designed for navigation within blood vessels. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, tissue), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Phenom™ Catheters do not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KRA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The following bench testing was performed in support of the Phenom™ Catheter and to establish substantial equivalence to the predicate devices:
- Dimensional Inspection (OD, ID, Length, Distal Tip Configuration)
- Material Verification
- Accessibility/ Trackability
- Device Compatibility (with Guide Catheter, Guide Wire, RHV)
- Shaft Stiffness
- Chemical Compatibility (Saline, Contrast Medium)
- Tip Shapeability
- Kink Resistance
- Conical Fitting for Hub
- Dead Space Volume
- Corrosion Resistance
- Tensile Strength of Catheter (Body & Hub Attachment)
- Liquid Leakage at Air Leakage During Aspiration Hub
- Burst Pressure
- Particulate Testing
- Outer Surface Coating Lubricity and Durability
- Catheter Flow Rate
- Flexural Fatigue
- Torque strength
- Tip Mark Radiopacity testing
- Biocompatibility Testing
- Shelf-life Testing
Testing was conducted to show that no new risks were identified and that the performance profile is similar to well-established predicate devices cleared for the market. Evaluation was performed in the more complex and higher risk neurovascular anatomy, which is the worst case representation of the cardiac and peripheral vascular anatomies.
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.
Prowler® 14 Infusion Catheter (510K # K021591), Prowler® Plus Infusion Catheter (510K # K993266), Marksman™ Catheter (510K # K091559), Tracker® Infusion Catheter (510k # K862117)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one in front of the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
Cathera, Inc. Victor Ham Chief Regulatory & Quality Officer 627 National Ave. Mountain View, California 94043
Re: K151638
Trade/Device Name: Phenom™ Catheters Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: October 9, 2015 Received: October 13, 2015
Dear Mr. Ham:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M.A. Hillebrand
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) K151638
Device Name Phenom™ Catheter
Indications for Use (Describe)
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.
| 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
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Submitted by:
Cathera, Inc. 627 National Ave. Mountain View, CA 94043 Tel.: (650) 388-5088 Fax: (650) 390-0107
Contact Person: Victor Ham
Date summary prepared: May 29, 2015
Trade Name: Phenom™ Catheter
Common Name: Catheter
| Classification Name & Product Codes: Continuous Flush Catheter | |
|---|---|
| (21 CFR 870.1210, Product Code KRA) |
Predicate Devices: Prowler® 14 Infusion Catheter (510K # K021591) Prowler® Plus Infusion Catheter (510K # K993266) Marksman™ Catheter (510K # K091559) Tracker® Infusion Catheter (510k # K862117)
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 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.
Indications for Use:
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.
Performance Data:
4
The following bench testing was performed in support of the Phenom™ Catheter and to establish substantial equivalence to the predicate devices:
- Dimensional Inspection (OD, ID, Length, Distal Tip Configuration) ●
- Material Verification ●
- . Accessibility/ Trackability
- Device Compatibility (with Guide Catheter, Guide Wire, RHV) ●
- Shaft Stiffness ●
- Chemical Compatibility (Saline, Contrast Medium) .
- Tip Shapeability ●
- Kink Resistance ●
- Conical Fitting for Hub ●
- Dead Space Volume .
- Corrosion Resistance
- Tensile Strength of Catheter (Body & Hub Attachment) ●
- Liquid Leakage at Air Leakage During Aspiration Hub ●
- Burst Pressure ●
- Particulate Testing
- Outer Surface Coating Lubricity and Durability ●
- Catheter Flow Rate ●
- Flexural Fatigue ●
- Torque strength
- Tip Mark Radiopacity testing ●
- Biocompatibility Testing ●
- Shelf-life Testing ●
5
Substantial Equivalence Determination
The information presented in the 510k shows that the Phenom™ Catheters are substantially equivalent to predicate endovascular catheters in regards to the following aspects:
| Design: | The subject and predicate devices are substantially equivalent with
respect to design characteristics. The slight variations in flexibility,
length of coated segments and lubricity are what differentiate these
catheters. Each manufacturer optimizes these design variations
towards a more specific application (e.g. infusion of diagnostic and
therapeutic agents) or for the introduction of a specific devices such
as embolic agents, coils and stents. |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function: | The subject and predicate devices are substantially equivalent with
respect to functional characteristics. |
| Manufacturing: | The subject and predicate devices are similar with respect to
technological manufacturing processes. |
| Materials: | The subject and predicate devices are composed of similar
materials, all of which have an extensive clinical history of safe use
in medical devices. |
| Indications: | The subject and predicate devices maintain similar indications. |
| Packaging: | The subject and predicate devices utilize similar packaging
configurations. |
| Sterilization: | The subject and predicate devices are both sterilized utilizing an
Ethylene Oxide sterilization cycle validated in accordance with
ISO 11135 - Medical Devices - Validation and Routine Control of
Ethylene Oxide Sterilization. |
| Labeling: | Both the subject and predicate devices have similar labeling. |
Testing was conducted to show that no new risks were identified and that the performance profile is similar to well-established predicate devices cleared for the market. Evaluation was performed in the more complex and higher risk neurovascular anatomy, which is the worst case representation of the cardiac and peripheral vascular anatomies.