The ThermopeutiX TAPAS™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 1.8 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

The TAPAS™ Catheter is contraindicated for use in the coronary and intracranial arteries.

The TAPAS™ Catheter is not intended for embolic protection or as an aspiration catheter.

Device Description

Other than deletion of an optional extracorporeal circuit connection and the addition of a second balloon, the TAPAS™ catheter that is the subject of this submission is a substantially equivalent to the predicate ThermopeutiX DuoFlo catheter. The TAPAS™ catheter, as does the DuoFlo™ catheter, consists of two coaxial tubular shafts (inflow and outflow lumens) that can infuse diagnostic and/or therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are three additional smaller lumen is used for inflation of the distal balloon on the inflow lumen. one is for optional pressure monitoring and the third lumen permits inflation of the balloon on the outflow lumen.

AI/ML Overview

This document is a 510(k) summary for the ThermopeutiX TAPAS™ Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	In accordance with ISO 10993-1 standards for patient contact materials.	Demonstrated through biocompatibility studies.
Tip and Shaft Dimensions	In compliance with relevant standards and product specifications.	Results were acceptable.
Balloon Compliance & Inflation Volume	In compliance with relevant standards and product specifications.	Results were acceptable.
Balloon Inflation & Deflation Times	In compliance with relevant standards and product specifications.	Results were acceptable.
Balloon Fatigue	In compliance with relevant standards and product specifications.	Results were acceptable.
Balloon Burst	In compliance with relevant standards and product specifications.	Results were acceptable.
Balloon Bond Strength	In compliance with relevant standards and product specifications.	Results were acceptable.
Shaft/Lumen Joint Bond Strength	In compliance with relevant standards and product specifications.	Results were acceptable.
Sheath Compatibility	In compliance with relevant standards and product specifications.	Results were acceptable.
Shaft Kink	In compliance with relevant standards and product specifications.	Results were acceptable.
Shaft Torque	In compliance with relevant standards and product specifications.	Results were acceptable.
Shaft Burst Pressure	In compliance with relevant standards and product specifications.	Results were acceptable.
Tip Bond Strength	In compliance with relevant standards and product specifications.	Results were acceptable.
Concentric Shaft Movement	In compliance with relevant standards and product specifications.	Results were acceptable.
Manifold Lumen Joint Strength	In compliance with relevant standards and product specifications.	Results were acceptable.
Stopcock Lumen Joint Strength	In compliance with relevant standards and product specifications.	Results were acceptable.
Sterility	Sterility Assurance Level (SAL) of 10⁻⁶.	Conforms to SAL of 10⁻⁶ (adopted into existing validated ethylene oxide sterilization cycle).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify numerical sample sizes for the mechanical and biocompatibility tests performed. It states "Physical testing was performed and results were in compliance with relevant standards and the product specification." and "The biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the standards outlined in ISO 10993-1."

There is no information regarding data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical, in-vitro/bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed are mechanical and biological (biocompatibility) in nature, not involving expert interpretation of data like medical image analysis. The "ground truth" for these tests would be established by the physical and chemical properties of the materials and device components, measured against established standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method. The outcomes of the tests are objective measurements against predefined specifications or standards.

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 medical catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance and safety tests described (biocompatibility, dimensions, balloon characteristics, bond strengths, etc.) is based on established industry standards (e.g., ISO 10993-1) and ThermopeutiX's internal product specifications. These serve as objective benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device submission, which does not involve machine learning models or training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

Summary

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K112219/KS
P. 1 of 2

510 (k) SUMMARY

NOV 1 8 2011

Applicant and Manufacturer

ThermopeutiX, Inc. 9951B Businesspark Avenue San Diego, California 92131 Phone: (858) 549-1760 Fax: (858) 549-1717

Contact Person

Thomas Schroeder, Director, RA/QA

Device Classification

Common Names:	Vascular Clamp, Temporary Occlusion Catheter
Classification Name:	Devices of this type are classified as Class II under 21 CFR Part CFR Part870.4450, Vascular Clamp (Product Code MJN).
Proprietary Name:	TAPASTM Catheters

Predicate Device

The Predicate device is the ThermopeutiX DuoFlo™ catheter cleared via 510k's K080700 and K093647.

TAPAS™ Catheter

The ThermopeutiX TAPAS™ Catheter utilizes the identical materials, design and construction methods that are used in the fabrication of DuoFlo™ catheter. These materials and construction methods have met applicable biocompatibility and shelf life requirements. The ThermopeutiX TAPAS™ Catheter has the same intended use as the DuoFlo™ catheter except that the extracorporeal connection option was deleted and a second balloon was added. The same contraindications that apply to the DuoFlo™ catheter apply to the TAPAS™ catheter.

Indications for Use

The TAPAS™ Catheter is contraindicated for use in the coronary and intracranial arteries. The TAPAS™ Catheter is not intended for embolic protection or as an aspiration catheter.

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Device Description

Technological Characteristics Comparison

The TAPAS™ Catheter utilizes the same design, construction, materials and processes as the DuoFlo catheter with no technological differences. The TAPAS™ catheter features smaller shaft sizes and a second occlusion balloon on the outflow lumen (shaft).

Performance and Safety

The biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the standards outlined in ISO 10993-1. Physical testing was performed and results were in compliance with relevant standards and the product specification. The following non-clinical tests were performed and results were acceptable;

Tip and shaft dimensions
Balloon compliance and inflation volume .
Balloon Inflation and deflation times .
. Balloon fatigue
. Balloon burst
Balloon bond strength ●
Shaft/lumen joint bond strength ●
Sheath compatibility
Shaft kink .
Shaft torque .
. Shaft burst pressure
Tip bond strength .
Concentric shaft movement .
. Manifold lumen joint strength
Stopcock lumen joint strength ♥

The device is supplied sterile and was adopted into an existing validated ethylene oxide sterilization cycle. Sterility conforms to a Sterility Assurance Level (SAL) of 10 °. The supplied instructions for use provide the user with the applicable warnings and cautions during use. There are no new safety or effectiveness issues related to this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ThermopeutiX, Inc c/o Mr. Thomas P. Schroeder Director, RA/QA 9951B Businesspark Avenue San Diego, CA 92131

Re: K112219

Trade Name: TAPAS Catheters Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: October 24. 2011 Received: October 27, 2011

Dear Mr. Schroeder:

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

NOV 1 8 2011

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Page 2 - Mr. Thomas P. Schroeder

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Bram Zuckerman, M.D.

Bram 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 STATEMENT

510(k) Number (if known): K112219

Device Name: TAPAS™ Catheter

Indications for use: The ThermopeutiX TAPAS™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 1.8 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

The TAPAS™ Catheter is contraindicated for use in the coronary and intracranial arteries.

The TAPAS™ Catheter is not intended for embolic protection or as an aspiration catheter.

Prescription Use: × (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
e 1 of 1	(Division Signature)
	Division of Cardiovascular Devices
	510(k) Number

Page

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).