Who is the manufacturer of REVERSE MEDICAL REFLEX GUIDE CATHETER?

Reverse Medical Corporation filed the 510(k) submission for REVERSE MEDICAL REFLEX GUIDE CATHETER (K110055).

What is the FDA product code for REVERSE MEDICAL REFLEX GUIDE CATHETER?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for REVERSE MEDICAL REFLEX GUIDE CATHETER?

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

What are the predicate devices for REVERSE MEDICAL REFLEX GUIDE CATHETER?

Penumbra Neuron™ Intracranial Access System (K070970); HD Guide Catheter (K090335).

Who can help prepare an FDA 510(k) submission like REVERSE MEDICAL REFLEX GUIDE 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.

REVERSE MEDICAL REFLEX GUIDE CATHETER

K110055 · Reverse Medical Corporation · DQY · Apr 5, 2011 · Cardiovascular

Device Facts

Record ID	K110055
Device Name	REVERSE MEDICAL REFLEX GUIDE CATHETER
Applicant	Reverse Medical Corporation
Product Code	DQY · Cardiovascular
Decision Date	Apr 5, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature.

Device Story

ReFlex™ Guide Catheter is a single-lumen, flexible, variable-stiffness composite catheter; used to introduce interventional devices into peripheral and neuro vasculature. Features PTFE-lined polymeric shaft with hydrophilic coating; Nitinol support; radiopaque distal marker; proximal luer fitting for accessory attachment/infusion. Operated by physicians in clinical settings; provides access for guidewires up to 0.038 inches. Device is sterile, single-use. Facilitates navigation through complex anatomy; aids in placement of interventional tools. Benefits include improved deliverability and compatibility during neuro/peripheral procedures.

Clinical Evidence

Bench testing only. Included dimensional/visual inspection, guidewire compatibility, torque response/strength, kink resistance, flexibility, tensile strength, leak/burst testing, aspiration, and corrosion resistance. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity). In vivo testing confirmed deliverability, compatibility, visibility, aspiration performance, and acute histopathology of treated vessels.

Technological Characteristics

Single-lumen, variable-stiffness composite catheter. Materials: PTFE-lined polymer, Nitinol shaft support, hydrophilic coating. Radiopaque distal marker. Dimensions vary by size. Connectivity: None. Sterilization: Ethylene Oxide (EtO) per ANSI/AAMI/ISO 11135. No software or electronic components.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neuro vasculature. Intended for prescription use.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

Penumbra Neuron™ Intracranial Access System (K070970)
HD Guide Catheter (K090335)

Related Devices

K231218 — Distal Access Catheter · Accumedical Beijing , Ltd. · Jan 19, 2024
K161152 — Navien Intracranial Support Catheter · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Oct 12, 2016
K191237 — CERENOVUS Large Bore Catheter · Codman & Shurtleff, Inc. · Nov 8, 2019
K112828 — REVIVE INTERMEDIATE CATHETER (REVIVE IC) · Codman & Shurtleff, Inc. · Oct 25, 2011
K252569 — Carrier XL Delivery Catheter · Balt USA, LLC · Oct 22, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ # 4. 510(k) Summary according to 807.92 Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Reverse Medical Corporation is providing the summary of Substantial Equivalence for the ReFlex™ Guide Catheter, # 4.1 Sponsor /Applicant Name and Address Reverse Medical Corporation 13900 Alton Parkway Suite 123 Irvine, CA 92618 #### 4.2 Sponsor Contact Information Jeff Valko President/CEO Phone: 949-215-0660 949-215-0661 Fax: email: jvalko@reversemed.com #### 4.3 Date of Preparation of 510(k) Summary March 10, 2011 # 4.4 Device Trade or Proprietary Name ReFlex™ Guide Catheter #### 4.5 Device Common/Usual or Classification Name Catheter, Percutaneous (Product Code: DQY) ### 4.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed: | Name of Predicate Device | Name of Manufacturer (Town, State) | 510(k) Number | |------------------------------------------------|-----------------------------------------------|---------------| | Penumbra Neuron™ Intracranial Access System | Penumbra, Inc. Alameda, CA | K070970 | | HD Guide Catheter | Concentric Medical, Inc. Mountain View, CA | K090335 | APR - 5 2011 {1}------------------------------------------------ ### 510(k) Summary according to 807.92 (continued) ### 4.7 Device Description The ReFlex™ Guide Catheter is a single lumen, flexible, variable stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The ReFlex™ Guide Catheter shaft is visible under fluoroscopy. The ReFlex™ Guide Catheter dimensions are included on the individual device label. The ReFlex™ Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The proximal end of the ReFlex™ Guide Catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only. ### 4.8 Intended Use The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature. | | | 4.9 Comparison to Predicate Devices | | |--|--|-------------------------------------|--| |--|--|-------------------------------------|--| | | Penumbra Neuron™ Intracranial Access System | HD Guide Catheter | ReFlex™ Guide Catheter | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K070970 | K090335 | TBD | | Classification | Class II, DQY | Class II, DQY | Class II, DQY | | Indication | The ... is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | The ... is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. | The ... is indicated for the introduction of interventional devices into the peripheral, , and neuro vasculature. | | Materials | | | | | - Shaft Materials | PTFE lined nylon/polyurethane catheter, with hydrophilic coating | PTFE lined polymeric catheter with hydrophilic coating | PTFE lined polymeric catheter, with hydrophilic coating | | - Catheter shaft support | Stainless Steel | Stainless Steel | Nitinol | | - Proximal End Configuration | Luer Hub | Luer Hub | Luer Hub | | - Radiographic markers / Radiopacity | • Radiopaque marker at distal tip | • Radiopaque marker at distal tip | • Radiopaque marker at distal tip | {2}------------------------------------------------ ### 510(k) Summary according to 807.92 (continued) 4.9 Comparison to Predicate Devices (continued) | | Penumbra Neuron™ Intracranial Access System | HD Guide Catheter | ReFlex™ Guide Catheter | |-------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | -Packaging | Catheter attached to packaging card inside PET/PE/Tyvek pouch inside SBS carton | Catheter in polyethylene hoop inside PET/PE/Tyvek pouch inside SBS carton | Catheter in polyethylene hoop attached to packaging card inside PET/PE/Tyvek pouch inside SBS carton | | Packaged Accessory Devices | Packaged with an rotating hemostatic valve (RHV) | Packaged with an rotating hemostatic valve (RHV) | Not Applicable | | Sterilization | EtO | EtO | EtO | ### 4.10 Summary of Non-clinical Data # 4.10.1 Biocompatibility and Sterilization The ReFlex™ Guide Catheter is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (≤ 24 hours). Results of the testing demonstrate that the blood contacting materials are biocompatible. Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1 guidelines "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The ReFlex™ Guide Catheter successfully passed all of the following biocompatibility tests: | Test | Method | |----------------------------------------|--------------------------------------------------------| | Cytotoxicity | L929 MEM Elution Test | | Sensitization | Kligman Maximization | | Intracutaneous Reactivity (Irritation) | Intracutaneous Injection Test | | Systemic Toxicity (Acute) | ISO Acute Systemic Injection Test | | Hemocompatibility | Complement Activation | | | Hemolysis | | | Inactivated Partial Thromboplastin Time Test | | | In vivo thrombogenicity | | Pyrogenicity | USP Material Mediated Rabbit Pyrogen Test | | EtO Residuals | Ethylene oxide and Ethylene chlorohydrins residuals | Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, Sterilization of Health Care Products-Part 1: Requirement, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10 °. # । ਤੇ {3}------------------------------------------------ # 510(k) Summary according to 807.92 (continued) 4.10.2 Design Verification (Bench-Top Testing) The physical, mechanical and performance testing of the ReFlex™ Guide Catheter demonstrates that the product is substantially equivalent to the currently marketed predicate devices. Design Verification testing was conducted to evaluate the physical and mechanical properties of the ReFlex™ Guide Catheter. All studies were conducted in accordance with Reverse Medical Design Control procedures. All testing was performed on units which were sterilized and met all inspection criteria. Tests on the ReFlex™ Guide Catheter included: Verification and Test Summary | In vitro Tests | Result | |-----------------------------------------------------------------------------------|--------------------------| | Dimensional and Visual Inspection | Met established criteria | | Guidewire Compatibility | Met established criteria | | Torque Response | Met established criteria | | Torque Strength | Met established criteria | | Kink Resistance | Met established criteria | | Flexibility Test | Met established criteria | | Tensile Strength | Met established criteria | | Catheter Leak Test (Liquid Leakage) | Met established criteria | | Catheter Leak Test (Air Leakage) | Met established criteria | | Dynamic Pressure Test | Met established criteria | | Static Burst Test | Met established criteria | | Aspiration Test | Met established criteria | | Hub Gauging | Met established criteria | | Corrosion Resistance | Met established criteria | | USP Particulate Test | Met established criteria | | Navigation and Accessibility Capabilities in vitro | Met established criteria | | In vivo Tests | Result | | System Deliverability, Compatibility, Visibility and Aspiration Performance | Met established criteria | | Acute histopathology of treated vessels | Met established criteria | | Biocompatibility testing | Met established criteria | The physical, mechanical and performance testing of the subject ReFlex™ Guide Catheter demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices. ### 4.11 Substantial Equivalence The performance of the ReFlex™ Guide Catheter in this submission demonstrates that the product is substantially equivalent to the performance of the predicate devices. The equivalence was shown through comparison of component materials and specification, performance and biocompatibility testing and sterilization validation. The ReFlex™ Guide Catheter is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate devices. Differences between the devices do not raise any significant issues of safety or effectiveness. 14 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes extending upwards. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Reverse Medical Corporation c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25° St. NW Buffalo, MN 55313 APR - 5 2011 Re: K110055 Trade/Device Name: ReFlex™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: March 18, 2011 Received: March 21, 2011 Dear Mr. Job 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. 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. {5}------------------------------------------------ Page 2 - Mr. Mark Job 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Duna R. Vahner Image /page/5/Picture/7 description: The image shows a handwritten symbol or character. It appears to be a stylized letter or a combination of lines and curves. The symbol is drawn with thick strokes, and it has a somewhat angular appearance. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # 3. Indications for Use 510(k) Number (if known):_K 110055 Device Name: Reverse Medical ReFlex™ Guide Catheter Indications for Use: The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature. 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) Dana R. Vahine on of Cardiovascular Devices 510(k) Number_K 110055 10