The REBOA Balloon Occlusion Catheter is a coaxial catheter recommended for temporary occlusion of the aorta. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi-layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter, and will accept the passage of the appropriate guidewire. All catheter sizes will have radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. There are also markings on the catheter shaft to aid in placement. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.

AI/ML Overview

This document describes testing and acceptance criteria for the REBOA Catheter, a device intended for temporary occlusion of the aorta.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria	REBOA Results	Predicate Device - PTS-X Results
Visual Inspection	The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device.	All catheters were visually inspected without any anomalies.	All catheters were visually inspected without any anomalies.
Balloon Preparation Test	Each catheter shall be prepped per the procedure without functional difficulties or anomalies.	All catheters tested were without functional difficulties or anomalies.	All catheters tested were without functional difficulties or anomalies.
Diameter and Profile Test	The balloon diameter at rated burst pressure / volume shall be within +/- 10% of the labeled balloon diameter and the samples should fit through the selected introducer with no problems.	All catheters met the acceptance criteria.	All catheters met the acceptance criteria.
Balloon Distensibility	The results must demonstrate that the balloon diameter are within +/- 10% of the labeled diameter at the RBP / rated volume and will not be significantly increased at increasingly higher pressures.	All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the rated volume. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.	All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.
Balloon Minimum Burst Strength / Volume	The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure / volume.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Repeated Balloon Inflation (Balloon Fatigue) Test	No breaks allowed.	No Breaks.	No breaks.
Balloon Inflation/Deflation Test	Inflation achieved in less than 12 seconds and deflation achieved in less than 59 seconds.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Balloon Deflatability Test	There should be no interference with balloon deflation.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Tip Pull and Torque Test	Must withstand at least 8 turns without breaking.	No breaks.	No breaks.
Bond Strength Test	All bonds must withstand at least 8.9 Newtons / 2 lbs. of pull strength.	All bonds met the established acceptance criteria.	All bonds met the established acceptance criteria.
Catheter Body Maximum Pressure Test	All samples must withstand 700 psi.	All samples met the established acceptance criteria.	All samples met the established acceptance criteria.

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

The document does not explicitly state the specific sample sizes used for each in-vitro test. It mentions "All catheters" or "All samples" met the criteria, suggesting that a representative sample was tested for each evaluation.

The data provenance is from in-vitro testing, meaning the tests were conducted in a laboratory setting, not on human subjects. There is no information regarding country of origin, retrospective or prospective data.

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

This information is not applicable as the "ground truth" for the in-vitro tests conducted on the REBOA Catheter is based on objective, measurable physical and mechanical properties, not expert interpretation of diagnostic data.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are objective physical measurements, not requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

This information is not applicable as the REBOA Catheter is a medical device, not an AI diagnostic tool that would involve human readers.

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

This information is not applicable for the same reason as point 5.

7. The Type of Ground Truth Used:

The ground truth for the in-vitro tests is based on objective, measurable physical and mechanical properties (e.g., diameter, pressure resistance, burst strength, inflation/deflation times, pull strength).

8. The Sample Size for the Training Set:

This information is not applicable as there is no mention of a "training set" in the context of this device. The testing described is for performance verification of the final device, not for training a model or algorithm.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

Summary of the Study:

The study detailed in the 510(k) Summary is an in-vitro performance verification study of the REBOA Catheter. It compares the performance of the REBOA Catheter against pre-defined acceptance criteria and, in some cases, against a predicate device (PTS-X PTV Catheter and Fogarty Occlusion Catheter). The study aims to demonstrate that the REBOA Catheter meets the necessary physical and mechanical specifications for its intended use, establishing substantial equivalence to legally marketed predicate devices. The "study" here refers to a series of laboratory tests, not a clinical trial or an AI algorithm validation.

Summary

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

June 20, 2016

NuMED, Inc. Nichelle LaFlesh Regulatory Affairs Manager/ Compliance Officer 2880 Main Street Hopkinton, New York 12965

Re: K160598

Trade/Device Name: REBOA Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: May 17, 2016 Received: May 19, 2016

Dear Nichelle LaFlesh:

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 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,

Bram D. Zuckerman -S

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) K160598

Device Name REBOA Catheter

Indications for Use (Describe)
Recommended for temporary occlusion of the aorta.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K160598

510(k) Summary

ContactInformation	NuMED, Inc.2880 Main StreetHopkinton, NY 12965Telephone - (315) 328-4491Contact Person: Nichelle LaFlesh, RACDate summary was prepared – 29 April 2016
GeneralProvisions	Trade Name: REBOA Catheter
	Common Name: Catheter, Intravascular Occluding, Temporary
	Classification Name: Catheter, Intravascular Occluding, Temporary
Name ofPredicateDevices	PTS-X PTV Catheter – K041306, K110903, and K131869Class II, 21 CFR 870.4450 - Product Code MJN
	Fogarty Occlusion Catheter – K152762 and K093911Class II, 21 CFR 870.4450 – Product Code MJN
Classification	Class II, 21 CFR 870.4450 - Product Code MJN
PerformanceStandards	Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act.
Intended Use	Recommended for temporary occlusion of the aorta.
	Continued on next page

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510(k) Summary, Continued

Device Description	The REBOA Balloon Occlusion Catheter is a coaxial catheter recommended for temporary occlusion of the aorta. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi-layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter, and will accept the passage of the appropriate guidewire. All catheter sizes will have radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. There are also markings on the catheter shaft to aid in placement. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.
Biocompatibility	All materials used to manufacture the REBOA Catheter are available on other commercially available NuMED, Inc. devices (K041360, K022722, K081680, and K014124) and have passed all relevant biocompatibility tests. No additional biocompatibility testing was conducted for the REBOA Catheter.
In-Vitro Testing	A complete list of tests performed and the results are provided in the table below.

Device Description

Biocompatibility

All materials used to manufacture the REBOA Catheter are available on other commercially available NuMED, Inc. devices (K041360, K022722, K081680, and K014124) and have passed all relevant biocompatibility tests. No additional biocompatibility testing was conducted for the REBOA Catheter.

In-Vitro Testing

A complete list of tests performed and the results are provided in the table below.

Continued on next page

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TestPerformed	AcceptanceCriteria	REBOAResults	PredicateDevice -PTS-X Results
VisualInspection	The cathetersshall be free fromcontamination,discoloration, andany form ofdamage that couldimpact the properfunctioning of thedevice.	All catheterswere visuallyinspected withoutany anomalies.	All catheters werevisually inspectedwithout anyanomalies.
BalloonPreparation Test	Each cathetershall be preppedper the procedurewithout functionaldifficulties oranomalies.	All catheterstested werewithoutfunctionaldifficulties oranomalies.	All catheterstested werewithout functionaldifficulties oranomalies.
Diameter andProfile Test	The balloondiameter at ratedburst pressure /volume shall bewithin +/- 10% ofthe labeledballoon diameterand the samplesshould fit throughthe selectedintroducer withno problems.	All catheters metthe acceptancecriteria.	All catheters metthe acceptancecriteria.
BalloonDistensibility	The results mustdemonstrate thatthe balloondiameter arewithin +/- 10% ofthe labeleddiameter at theRBP / ratedvolume and willnot besignificantlyincreased atincreasinglyhigher pressures	All data obtaineddemonstrates that theballoon diameter iswithin +/- 10% of thelabeled diameter atthe rated volume. Alldata obtaineddemonstrates that thediameter of theballoons will not besignificantlyincreased atincreasingly higherpressures.	All data obtaineddemonstrates that theballoon diameter iswithin +/- 10% of thelabeled diameter at theRBP. All dataobtained demonstratesthat the diameter ofthe balloons will notbe significantlyincreased atincreasingly higherpressures.
TestPerformed	AcceptanceCriteria	REBOAResults	PredicateDevice -PTS-X Results
Balloon MinimumBurst Strength /Volume	The results mustshow statisticallythat with at least95% confidence,99.9% of theballoons will notburst at or belowthe maximumrecommendedrated burstpressure / volume.	All catheters metthe establishedacceptancecriteria.	All catheters metthe establishedacceptancecriteria.
Repeated BalloonInflation (BalloonFatigue) Test	No breaksallowed	No Breaks.	No breaks.
BalloonInflation/DeflationTest	Inflation achievedin less than 12seconds anddeflation achievedin less than 59seconds	All catheters metthe establishedacceptancecriteria.	All catheters metthe establishedacceptancecriteria.
BalloonDeflatability Test	There should beno interferencewith balloondeflation	All catheters metthe establishedacceptancecriteria.	All catheters metthe establishedacceptancecriteria.
Tip Pull andTorque Test	Must withstand atleast 8 turnswithout breaking	No breaks	No breaks
Bond StrengthTest	All bonds mustwithstand at least8.9 Newtons / 2lbs. of pullstrength.	All bonds met theestablishedacceptancecriteria.	All bonds met theestablishedacceptancecriteria.
Catheter BodyMaximumPressure Test	All samples mustwithstand 700 psi.	All samples metthe establishedacceptancecriteria.	All samples metthe establishedacceptancecriteria.

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Comparison of The technological characteristics of the REBOA balloon are identical to those Technological in the predicate (PTS-X) in terms of the following: Characteristics with the Mode of Operation; ● predicate Materials: ● Device

Design;
Performance testing;
Method of delivery; ●
. Sterilization Method;
Packaging Method. ●

The technological characteristics of the REBOA balloon is substantially equivalent in intended use, indications for use, sterilization, and size range to those in the predicate device (Fogarty).

Both devices are for temporary vessel occlusion. The REBOA is specific to the aorta, whereas, the larger Fogarty balloon catheters are for the aorta. The Fogarty balloon catheter has a broader indications for use than the REBOA.

Both devices are provided sterilized via EtO sterilization and are for single use only.

Both devices are catheters with distal end balloons that are inserted percutaneously.

Both devices are similar in the size ranges being offered. The REBOA catheter is available in balloon diameters of 15mm - 40mm, and the Fogarty larger balloon catheters are available in sizes of 11mm - 45mm.

Conclusions The REBOA Catheter has been tested and/or compared to the predicate devices listed herein. All data gathered demonstrate the REBOA Catheter is substantially equivalent. No new issues of safety or efficacy have been raised.

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).