The DuoFlo™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 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 when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The DuoFlo™ Catheter is contraindicated for use in the coronary and intracranial arteries. The DuoFlo™ Catheter is not intended for embolic protection or as an aspiration catheter.

Device Description

The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.

AI/ML Overview

The provided text is a 510(k) summary for the ThermopeutiX DuoFlo Catheter (Heparin Coated). This document is primarily focused on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves a device meets specific acceptance criteria in the way a diagnostic software or AI model might.

Here's an analysis based on the available information, addressing your specific points where possible, and noting where information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria or detailed performance results in the format typically used for a diagnostic device's clinical study. The device is a "Temporary Intravascular Occluding Catheter" and the focus is on its safety and equivalence.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Meet ISO 10993-1 standards for patient contact materials.	"Demonstrated through biocompatibility studies"
Sterility	Conform to a Sterility Assurance Level (SAL) of 10⁻⁶	"Conforms to a Sterility Assurance Level (SAL) of 10⁻⁶"
Design/Construction	Identical to predicate (K080700) with added heparin coating.	"Identical in design and construction to the currently marketed DuoFlo™ catheter with the exception that bound heparin has been included in the catheter coating."
Thrombus Minimization	Heparin coating helps to minimize thrombus formation.	"The heparin in the coating helps to minimize thrombus formation on the catheter surfaces." (This is a design claim rather than a quantifiable performance criterion with specific data in this document).
Safety/Effectiveness	No new safety or effectiveness issues compared to predicate.	"There are no new safety or effectiveness issues related to this device."

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

This information is not provided in the given text. The document refers to "biocompatibility studies" but does not detail their methodology, sample sizes, or data provenance. This is a medical device clearance, not typically a clinical trial for a diagnostic algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The ground truth establishment by experts is relevant for diagnostic AI/software evaluations, not for the clearance of a mechanical catheter based on substantial equivalence and biocompatibility.

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

This information is not applicable/provided for the same reasons as 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

An MRMC study is not applicable/provided. This device is a catheter, not an AI or imaging diagnostic tool.

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

A standalone performance study is not applicable/provided. This device is a physical medical instrument, not a software algorithm.

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

The "ground truth" in this context revolves around:

Biocompatibility: Adherence to ISO standards, likely demonstrated through in vitro and in vivo testing (e.g., cytotoxicity, sensitization, irritation, genotoxicity, hemocompatibility studies).
Sterility: Verification of the sterilization process to achieve the specified SAL.
Physical/Mechanical Properties: Verification that the design and construction are identical to the predicate (except for the coating), which implies similar mechanical performance.
Heparin Coating Efficacy (implied): The claim that the heparin helps minimize thrombus formation would ideally be supported by in vitro or in vivo studies demonstrating reduced thrombus compared to the uncoated predicate. However, detailed data for this is not presented in the summary, only the claim is made.

8. The sample size for the training set

This information is not applicable/provided. A "training set" is relevant for machine learning algorithms, not for the type of device being described.

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

This information is not applicable/provided. (See point 8).

Summary of the Study Mentioned (as much as can be gleaned):

The primary "study" mentioned for the ThermopeutiX DuoFlo™ Catheter (Heparin Coated)'s performance and safety is:

Biocompatibility Studies: These were conducted on the patient contact materials in accordance with ISO 10993-1 standards. The exact details (e.g., specific tests, sample sizes, animal models if any) are not provided in this summary, but the claim is that biological safety has been "demonstrated."
Sterility Validation: The device's sterility "conforms to a Sterility Assurance Level (SAL) of 10⁻⁶." This indicates that sterilization processes were validated to meet this standard.

The overall approach for this 510(k) is demonstrating substantial equivalence to a predicate device (K080700). The "study" largely consists of showing that the device is identical in design and construction, with the only change being the addition of a bound heparin coating. The safety of this change hinges on the biocompatibility studies of the new material and the claim that the heparin helps minimize thrombus, implying it's a beneficial addition without new safety concerns. No comparative clinical effectiveness study against the predicate is described in this document to quantify improvement due to the heparin coating.

Summary

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K093847

ThermopeutiX, Inc. Special 510(k) Premarket Notification December11, 2009

510 (k) SUMMARY

Applicant

AUG 25 2010

ThermopeutiX, Inc. 9925B Businesspark Avenue San Diego, California 92131 Phone: (858) 549-1760 Fax: (858) 549-1717

Manufacturer

ThermopeutiX, Inc. 9925B Businesspark Avenue San Diego, California 92131 Phone: (858) 549-1760 Fax: (858) 549-1717

Contact Person

Thomas Schroeder, Director, RA/QA

Common Names:	Temporary Intravascular Occluding Catheter
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Classification Name: Devices of this type are classified as Class II under 21 CFR Part CFR Part 870.4450, Vascular Clamp (Product Code MJN).
DuoFlo™ Catheter (Heparin Coated) Proprietary Name:

Predicate Devices

The ThermopeutiX DuoFlo™ Catheter (Heparin Coated) is substantially equivalent in indications, design, construction and features to the ThermopeutiX DuoFlo™ catheter cleared under 510k K080700 with the exception that bound heparin has been included in the catheter's hydrophilic coating ..

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Indications for Use

There is no change in the indications for use for the DuoFlo™ Catheter (Heparin Coated). The existing DuoFlo™ catheter indications statement remains unchanged.

Device Description

Technological Characteristics Comparison

The DuoFlo™ Catheter identical in design and construction to the currently marketed DuoFlo™ catheter with the exception that bound heparin has been included in the catheter coating. The heparin in the coating helps to minimize thrombus formation on the catheter surfaces.

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.

The device is supplied 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 a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH &" is visible along the left side of the logo, oriented vertically.

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

ThermopeutiX, Inc c/o Mr. Thomas Schroeder Director, RA/QA 9925B Businesspark Avenue San Diego, CA 92131

AUG 2 5 2010

Re: K093847

Trade/Device Name: DuoFlo Catheter (Heparin Coated) Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: MJN Dated: July 22, 2010 Received: July 26, 2010

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.

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Page 2 - Mr. Thomas Schroeder

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.

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/CDRHOffices/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,

W.M.D.

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 STATEMENT

K093847

Device Name: DuoFlo™ Catheter and DuoFlo™ Catheter (Heparin Coated)

Indications for use: The DuoFlo™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 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 when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

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

The DuoFlo™ 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)

(Division Sign-Off)
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Division of Cardiovascular Devices

510(k) Number	2093847
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Page 17 of 44

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).