The ND Infusion Catheter is a multi-channel balloon catheter designed to isolate a specific vascular treatment region from biood flow while allowing infusion of physician-specified fluids into the target region.

Device Description

The ND Infusion Catheter is a multilumen (3) and multichannel (6) balloon catheter designed to isolate a specific treatment region from blood flow while directing infusion of fluids into the specified region. The catheter has a length of 135cm and diameter of 3F, and is intended to be used with a 6F or larger guide catheter along with a 0.014" rapid exchange guide wire for positioning the catheter in the desired region. The bifurcated proximal hub provides for the following functionality: 1) Balloon Port · Inflation of a compliant balloon to requlate blood flow during therapy infusion; target vessel diameter = 2.0 - 4.5 mm. · Balloon is prepared via a 3-way stopcock connection using a 10cc syringe and inflated using a 50:50 contrast/saline solution delivered via a 1cc syringe for precise inflation under fluoroscopic guidance. 2) Infusion Port · Infusion of a therapeutic agent into the vasculature through multiple fluid channels (each with diameter = 0.006"). · Physician-specified fluid is administered through the infusion port via a 1-way stopcock connection using a 1cc syringe. The catheter is designed with 3 shaft transitions. As a result, the catheter has 4 contiguous segments: PROXIMAL, MID, EXPANSION, and DISTAL. Radiopaque marker bands at each end of the balloon and at the distal tip allow for catheter positioning under fluoroscopic guidance.

AI/ML Overview

This document is a 510(k) summary for the ND Infusion Catheter, a medical device. It does not describe an AI/ML device or its performance in diagnostic tasks. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests, not clinical performance studies involving human readers or AI.

Therefore, most of the requested information (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for training) is not applicable to this document as it pertains to a traditional medical device submission, not specifically an AI/ML diagnostic or assistive device.

However, I can extract the closest analogous information regarding the device's functional and safety testing as presented in the document:

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

The document doesn't provide explicit "acceptance criteria" values in a table for each test. Instead, it describes general conclusions, indicating that the device "meets requirements" or that results were "not considered significant."

Here's a summary of the technical and biocompatibility testing results, which serve as the reported performance, implying they met internal acceptance criteria for substantial equivalence:

Test Category	Specific Test	Reported Device Performance
Technical Testing	Balloon Fatigue	Results imply conformance to requirements.
	Balloon Burst Testing	Results imply conformance to requirements.
	Balloon Inflation/Deflation	Results imply conformance to requirements.
	Balloon Radial Force Testing	Results imply conformance to requirements.
	Track Force Testing	Results imply conformance to requirements.
	Torque Strength Test	Results imply conformance to requirements.
	Tensile Testing	Results imply conformance to requirements.
	Separation Force at Break	Results imply conformance to requirements.
	Flexibility-Kink Resistance Test	Results imply conformance to requirements.
	Liquid Leakage Under Pressure	Results imply conformance to requirements.
Biocompatibility	Cytotoxicity -- L929 MEM Elution Test	Non-Cytotoxic (meets requirements, not considered cytotoxic)
	Cytotoxicity -- L929 Neutral Red Uptake	Non-Cytotoxic (meets requirements, not considered cytotoxic)
	Sensitization -- Kligman Maximization	Non-Sensitizing (Grade I not significant, meets ISO guidelines)
	Irritation -- Intracutaneous Injection	Non-Irritating (no significantly greater biological reaction)
	Systemic Toxicity -- Systemic Injection	Nontoxic (no significantly greater biological reaction)
	Genotoxicity -- S Typhimurium & E Coli Reverse Mutation	Non-Genotoxic (no statistically significant increase in revertants)
	Hemolysis -- Rabbit Blood	Non-Hemolytic (meets requirements, not considered hemolytic)
	Thrombogenicity - Study in Dogs	Non-Thrombogenic (minimal thrombosis, not significant)
	Complement Activation Assay	Non-Complement Activating (meets requirements, no complement activation)
	Coagulation - Unactivated PTT Assay	Non-Coagulating (meets requirements, no effect on coagulation)
	Hemocompatibility -- In Vitro Assay	Hemocompatible (meets requirements, no effect on hematological parameters)
Animal Studies	Acute animal study (swine arterial vasculature)	Excellent trackability, pushability, balloon inflation, deflation, removal, fluid infusion, marker band visibility, no hub/catheter leak, and no vascular injury.

2. Sample size used for the test set and the data provenance:

Technical Testing: Sample sizes are not specified for individual bench tests (e.g., how many catheters for balloon burst, how many cycles for fatigue). The provenance is "bench testing," meaning laboratory-based tests.
Biocompatibility Testing: Sample sizes are generally small for these types of tests (e.g., refers to mice for systemic toxicity, rabbits for hemolysis, dogs for thrombogenicity). The provenance is laboratory testing using biological materials/animals.
Animal Studies: "2/2 test sites and 2/2 control sites" for the thrombogenicity study in dogs. The acute animal study was performed in "swine arterial vasculature." These are prospective animal studies.

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

This information is not applicable. The evaluations are based on direct measurement, observation of physical properties, and biological reactions in laboratory or animal settings, not on expert interpretation of data like images for ground truth.

4. Adjudication method for the test set:

This information is not applicable. Adjudication typically refers to resolving discrepancies between human readers or between human readers and AI. These are direct measurements and observations from engineered and biological tests.

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:

This is not applicable as the device is an infusion catheter, not an AI/ML diagnostic device requiring human reader or AI performance evaluation.

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

This is not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used:

Technical Testing: Physical measurements, engineering specifications, and established test methods define the "ground truth" or acceptance criteria.
Biocompatibility Testing: Accepted standards for biological reaction, cellular response, and material interaction with biological systems (e.g., ISO 10993 guidelines) define the "ground truth."
Animal Studies: Angiography, gross examination for vascular injury, and direct observation of catheter performance and thrombosis define the "ground truth."

8. The sample size for the training set:

This is not applicable. The device is not an AI/ML model, so there is no "training set."

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

This is not applicable for the reasons stated above.

Summary

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TRANSLATIONAL RESEARCH INSTITUTE
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ND INFUSION CATHETER

K130569, 510(k) Summary Page 1 of 3

510(K) SUMMARY

Contact Information

Submitter's Name and Address:	TRANSLATIONAL RESEARCH INSTITUTE3420 S Mercy Road, #312Gilbert, Arizona 85297Tel: 480-726-1904 / Fax: 480-612-0641
Name of Contact Person:	DeAnn Dana, Project ManagerTranslational Research Institute3420 S Mercy Road, #312Gilbert, AZ 85297Tel: 480-726-1904 / Fax: 480-612-0641
Date Summary was Prepared:	October 14, 2013
Name of Device
Name of the Device:Trade or Proprietary Name:	NDTM Nabil Dib Infusion CatheterNDTM Nabil Dib Infusion Catheter

I rade or Proprietary Name: Common or Usual Name: Classification Name: CFR Reference Product Code Regulatory Class

Nabil Dib Infusion Catheter Infusion Catheter Continuous Flush Catheter 21 CRF 870.1210 KRA Class II

Predicate Device

510(K)	MANUFACTURER	DEVICE	APPROVAL DATE
K081147	Vascular Designs	IsoFlow Infusion Catheter	05-29-09

Device Description

The bifurcated proximal hub provides for the following functionality:

1. Balloon Port · Inflation of a compliant balloon to requlate blood flow during therapy infusion; target vessel diameter = 2.0 - 4.5 mm.
- · Balloon is prepared via a 3-way stopcock connection using a 10cc syringe and inflated using a 50:50 contrast/saline solution delivered via a 1cc syringe for precise inflation under fluoroscopic guidance.

Infusion Port

· Infusion of a therapeutic agent into the vasculature through multiple fluid channels (each with diameter = 0.006").
· Physician-specified fluid is administered through the infusion port via a 1-way stopcock connection using a 1cc syringe.

K130569

510(K) SUMMARY

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TRANSLATIONAL RESEARCH INSTITUTE

The catheter is designed with 3 shaft transitions. As a result, the catheter has 4 contiguous segments: PROXIMAL, MID, EXPANSION, and DISTAL.

SEGMENT	FUNCTIONALITY
PROXIMAL	Two lumens in the PROXIMAL segment --- for fluid infusion and ballooninflation -- extend from the bifurcated hub to the MID section.
MID	MID section includes the guidewire Rx port and lumen. and theballoon located distally. The balloon is compliant and designed toexpand to accommodate blood vessels with diameters of 2.0 - 4.5mm while regulating blood flow during infusion.
EXPANSION	EXPANSION segment extends distally from balloon towards the cathetertip and is designed to provide for volumetric expansion of infusate.
DISTAL	In DISTAL segment, infusion lumen divides into 6 independentchannels (0.006") delivering infusate to target region at multichannel tip.

Radiopaque marker bands at each end of the balloon and at the distal tip allow for catheter positioning under fluoroscopic guidance.

Indications for Use

The ND Infusion Catheter is a multi-channel balloon catheter designed to isolate a specific vascular treatment region from blood flow while allowing infusion of physician-specified fluids into the target region.

Comparison to Predicate

ND Infusion Catheter vs. Predicate Device

PARAMETER	ND Infusion Catheter	IsoFlow Infusion Catheter
Length	135 cm	150 cm
Diameter	2.4F	3.5F
Number of Lumens	3	3
Number of Infusion Ports	6	3
Materials	Shaft -- PebaxBalloon -- Pellethane	Not known

Technical Testing

The results of bench testing provide reasonable assurance that the device has been designed and performs in conformance to the requirements for its intended use. The technical testing included (but was not limited to) the following:

Balloon Fatigue
· Balloon Burst Testing
· Balloon Inflation/Deflation
· Balloon Radial Force Testing
· Track Force Testing
· Torque Strength Test
· Tensile Testing
· Separation Force at Break
· Flexibility-Kink Resistance Test
· Liquid Leakage Under Pressure

K130569

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TRANSLATIONAL RESEARCH INSTITUTE

Biocompatibility

Blood-contacting materials were tested for biocompatibility as summarized below.

TEST	RESULTS	CONCLUSIONS
Cytotoxicity -- L929 MEM ElutionTest	Test article meets requirements of the test and isnot considered to have a cytotoxic effect.	Non-Cytotoxic
Cytotoxicity -- L929 Neutral RedUptake Test	Test article meets requirements of the test and isnot considered to have a cytotoxic effect.	Non-Cytotoxic
Sensitization -- KligmanMaximization Test	Grade I sensitization rate is not consideredsignificant and the test article meets therequirements of the ISO 10993-10 guidelines.	Non-Sensitizing
Irritation -- Intracutaneous InjectionTest	The test article sites did not show a significantlygreater biological reaction than the sites injectedwith the control article.	Non-Irritating
Systemic Toxicity -- SystemicInjection Test	The test article did not induce a significantlygreater biological reaction than the controlextracts, when tested in Swiss Albino mice.	Nontoxic
Genotoxicity -- S Typhimurium& E Coli Reverse Mutation	The mean number of revertants per plate wascalculated for the test article extracts, and for thenegative and positive control articles.A statistically significant increase in the number ofcolonies was not observed with the test article.	Non-Genotoxic
Hemolysis -- Rabbit Blood	The test article meets the requirements of the testand is not considered hemolytic.	Non-Hemolytic
Thrombogenicity - Study in Dogs	Minimal thrombosis with a Grade of 0 (a very smallclot is acceptable) was observed in 2/2 test sitesand in 2/2 control sites; the amount of thrombosiswas not considered significant.	Non-Thrombogenic
Complement Activation Assay	The test article meets the requirements of the testand is not considered having activated thecomplement system in human plasma.	Non-ComplementActivating
Coagulation - Unactivated PTTAssay	The test article meets the requirements of the testand is not considered having an effect on thecoagulation of human plasma via UPTT.	Non-Coagulating
Hemocompatibility -- In Vitro Assay	The test article meets the requirements of the testand is not considered having an effect on selectedhematological parameters.	Hemocompatible

Animal Studies

An acute animal study in the swine arterial vasculature catheter demonstrated excellent trackability, pushability, balloon inflation, deflation, removal, infusion of fluid through the infusion lumen, marker band visibility, and no hub or catheter leak. There was no vascular injury in any of the vessels that were evaluated (LCx, LAD, RCA, Renal, Femoral, Iliac, Carotid) as assessed by angiography and gross examination. In summary, this study robustly validated the functional performance and safety of the ND Infusion Catheter.

The results of the Technical Testing, Biomaterial Assessments, and Animals Study summarized above did not raise new safety or performance questions.

Conclusions

Based on the above testing, the ND Infusion Catheter is substantially equivalent to devices legally marketed in the United States.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three intertwined figures instead of snakes.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2013

Translational Research Institute DeAnn Dana, RN Project Manager 3420 S Mercy Rd #312 Gilbert, AZ 85297 US

Re: K130569

Trade/Device Name: ND™ Nabil Dib Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: October 15, 2013 Received: October 16, 2013

Dear Ms. Dana,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Deann Dana, Rn

the quality systems (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 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,

M.A. Lillehemen

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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K130569 Page 1 of 1

Indications for Use Statement

Device Name: ND™ Nabil Dib Infusion Catheter

K130569 510(k) Number:

Indications for Use: The ND Infusion Catheter is a multi-channel balloon catheter designed to isolate a specific vascular treatment region from biood flow while allowing infusion of physician-specified fluids into the target region.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

M.A. Stilleman

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).