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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the Phenom™ Catheters. As such, it's a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving device meeting specific clinical acceptance criteria in the way a clinical trial would.

Therefore, many of the requested points related to a specific clinical study (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or directly derivable from this type of regulatory document.

However, I can extract information regarding the bench testing performed to establish substantial equivalence, which serves as the "study" in this context to prove the device meets certain performance characteristics relative to predicate devices.

Here's the breakdown based on the provided text, addressing the applicable points and explaining why some are not applicable:

Description of Acceptance Criteria and Substantiating Study

The Phenom™ Catheters are submitted as substantially equivalent to predicate devices, meaning their performance characteristics must be comparable to those existing devices and demonstrate no new safety or effectiveness concerns. The "acceptance criteria" are implicitly defined by the safety and performance standards established by the predicate devices and general regulatory requirements for this class of device. The "study" proving the device meets these criteria is a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various bench tests conducted to support the substantial equivalence. The "acceptance criteria" for these tests would typically be defined internally by the manufacturer to ensure the new device performs comparably to or within acceptable limits derived from the predicate devices. Since specific numerical acceptance criteria (e.g., "burst pressure > X bar") are not explicitly stated in this summary, the table will list the performance tests performed, implying that the acceptance was meeting the internal specifications aligned with the predicate performance.

Acceptance Criteria Category (Performance Test)	Reported Device Performance (Implied)
Dimensional Inspection	Met specifications (OD, ID, Length, Distal Tip Configuration) comparable to predicate devices.
Material Verification	Materials verified as similar to predicate devices, with extensive clinical history of safe use.
Accessibility/Trackability	Demonstrated performance suitable for accessing small, tortuous vasculature, comparable to predicate devices. "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."
Device Compatibility	Compatible with Guide Catheter, Guide Wire, RHV, comparable to predicate devices.
Shaft Stiffness	Met specifications, with slight variations differentiating it for specific applications, comparable to predicate devices.
Chemical Compatibility	Compatible with Saline, Contrast Medium.
Tip Shapeability	Met specifications to aid navigation.
Kink Resistance	Demonstrated resistance to kinking in tortuous paths.
Conical Fitting for Hub	Met specifications for secure connection.
Dead Space Volume	Met specifications.
Corrosion Resistance	Met specifications.
Tensile Strength (Body & Hub Attachment)	Met specifications, demonstrating structural integrity.
Liquid/Air Leakage at Hub	No leakage during aspiration.
Burst Pressure	Met specifications, demonstrating structural integrity under pressure.
Particulate Testing	Met specifications to ensure minimal particulate release.
Outer Surface Coating/Lubricity/Durability	Enhanced navigation as designed, comparable durability to predicate devices.
Catheter Flow Rate	Met specifications for infusion of agents.
Flexural Fatigue	Demonstrated durability under repeated bending.
Torque Strength	Met specifications for rotational control.
Tip Mark Radiopacity Testing	Radiopaque markers aid visualization and positioning under fluoroscopy.
Biocompatibility Testing	Passed tests to ensure biological safety.
Shelf-life Testing	Validated for sterility and performance over time.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This refers to the number of devices or components tested for each bench test. This information is not provided in this summary. Bench testing typically involves a statistically significant number of samples for each test, but the exact numbers are not detailed here.
Data Provenance: The bench tests are laboratory-based, performed by the manufacturer (Cathera, Inc., Mountain View, CA). This is not human data, so "country of origin" or "retrospective/prospective" does not directly apply in the usual clinical sense. The worst case representation was chosen considering neurovascular anatomy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Bench testing for substantial equivalence does not involve establishing ground truth from human expert interpretation in the way clinical studies with AI algorithms do. Performance is measured against engineering specifications and comparisons to predicate device data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a catheter, not an AI diagnostic algorithm. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its regulatory approval in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a catheter, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench tests are engineering specifications, material standards, and performance characteristics derived from predicate devices. For example, "burst pressure" has a defined threshold, and "biocompatibility" is assessed against ISO standards. The evaluation included performance in "more complex and higher risk neurovascular anatomy," implying simulated environments or models representing this.

8. The sample size for the training set

Not applicable. As this is a physical medical device (catheter) undergoing bench testing for substantial equivalence, there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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.

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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

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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:

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:

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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 ●

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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 withrespect to design characteristics. The slight variations in flexibility,length of coated segments and lubricity are what differentiate thesecatheters. Each manufacturer optimizes these design variationstowards a more specific application (e.g. infusion of diagnostic andtherapeutic agents) or for the introduction of a specific devices suchas embolic agents, coils and stents.
Function:	The subject and predicate devices are substantially equivalent withrespect to functional characteristics.
Manufacturing:	The subject and predicate devices are similar with respect totechnological manufacturing processes.
Materials:	The subject and predicate devices are composed of similarmaterials, all of which have an extensive clinical history of safe usein medical devices.
Indications:	The subject and predicate devices maintain similar indications.
Packaging:	The subject and predicate devices utilize similar packagingconfigurations.
Sterilization:	The subject and predicate devices are both sterilized utilizing anEthylene Oxide sterilization cycle validated in accordance withISO 11135 - Medical Devices - Validation and Routine Control ofEthylene 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.

Regulation Number and Section

§ 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).