Who is the manufacturer of REBOA Balloon Catheter?

NuMED, Inc. filed the 510(k) submission for REBOA Balloon Catheter (K160598).

What is the FDA product code for REBOA Balloon Catheter?

MJN. It is classified under 21 CFR 870.4450 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for REBOA Balloon Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for REBOA Balloon Catheter?

PTS-X PTV Catheter (K041306, K110903, K131869); Fogarty Occlusion Catheter (K152762, K093911).

Who can help prepare an FDA 510(k) submission like REBOA Balloon Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

REBOA Balloon Catheter

K160598 · NuMED, Inc. · MJN · Jun 20, 2016 · Cardiovascular

Device Facts

Record ID	K160598
Device Name	REBOA Balloon Catheter
Applicant	NuMED, Inc.
Product Code	MJN · Cardiovascular
Decision Date	Jun 20, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4450
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Recommended for temporary occlusion of the aorta.

Device Story

REBOA Catheter is a coaxial, percutaneous, single-use device for temporary aortic occlusion. It features a non-compliant distal balloon mounted on a multi-layer polyamide/stainless steel braid shaft. The device includes a through-lumen for guidewire passage and an inflation lumen for the balloon. Radiopaque platinum markers and shaft markings facilitate placement under fluoroscopy. Used by clinicians in clinical settings to manage hemorrhage or control blood flow; the device is inserted percutaneously. The clinician monitors placement via fluoroscopy and inflates the balloon to occlude the aorta, providing a temporary benefit of flow control. The device is supplied sterile via EtO.

Clinical Evidence

Bench testing only. Testing included visual inspection, balloon preparation, diameter/profile, distensibility, burst strength/volume, fatigue (repeated inflation), inflation/deflation timing, deflatability, tip pull/torque, bond strength, and catheter body maximum pressure. All tests met established acceptance criteria and were comparable to the PTS-X predicate results.

Technological Characteristics

Coaxial catheter; outer body polymeric tubing; inner tubing multi-layer polyamide (Vestamid PA12) with 304 LV Stainless Steel braid. Distal non-compliant balloon. Radiopaque platinum marker bands. EtO sterilization. Single-use. Percutaneous delivery. Size range 15mm-40mm balloon diameter.

Indications for Use

Indicated for temporary occlusion of the aorta in patients requiring vascular occlusion.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

PTS-X PTV Catheter (K041306, K110903, K131869)
Fogarty Occlusion Catheter (K152762, K093911)

Related Devices

K243795 — pREBOA-PRO Catheter · Prytime Medical Devices, Inc. · Sep 5, 2025
K172790 — ER-REBOA Catheter · Prytime Medical Devices, Inc. · Nov 8, 2017
K151821 — ER-REBOA Catheter · Pryor Medical Devices, Inc. · Oct 23, 2015
K193440 — ER-REBOA PLUS Catheter · Prytime Medical Devices, Inc. · Jan 9, 2020
K170411 — ER-REBOA Catheter · Prytime Medical Devices, Inc. · Apr 4, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K160598 ## 510(k) Summary | Contact Information | NuMED, Inc. 2880 Main Street Hopkinton, NY 12965 Telephone - (315) 328-4491 Contact Person: Nichelle LaFlesh, RAC Date summary was prepared – 29 April 2016 | | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | General Provisions | Trade Name: REBOA Catheter | | | | Common Name: Catheter, Intravascular Occluding, Temporary | | | | Classification Name: Catheter, Intravascular Occluding, Temporary | | | Name of Predicate Devices | PTS-X PTV Catheter – K041306, K110903, and K131869 Class II, 21 CFR 870.4450 - Product Code MJN | | | | Fogarty Occlusion Catheter – K152762 and K093911 Class II, 21 CFR 870.4450 – Product Code MJN | | | Classification | Class II, 21 CFR 870.4450 - Product Code MJN | | | Performance Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act. | | | Intended Use | Recommended for temporary occlusion of the aorta. | | | | Continued on next page | | {4}------------------------------------------------ ### 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. | Continued on next page {5}------------------------------------------------ | 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. | | Test Performed | Acceptance Criteria | REBOA Results | Predicate Device - PTS-X Results | | 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. | {6}------------------------------------------------ {7}------------------------------------------------ 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.