REVERSE MEDICAL MICROCATHETER

K122684 · Reverse Medical Corporation · DQY · Dec 7, 2012 · Cardiovascular

Device Facts

• Record ID: K122684
• Device Name: REVERSE MEDICAL MICROCATHETER
• Applicant: Reverse Medical Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reverse Medical Microcatheter is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.

Device Story

Single lumen, flexible, variable-stiffness composite microcatheter; wire-reinforced shaft with hydrophilic coating. Features standard luer adapter and dual radiopaque markers at distal tip for fluoroscopic visualization. Used by physicians in neuro, peripheral, and coronary procedures. Device tracks coaxially over steerable guidewires (up to 0.018 inches) to access distal tortuous vasculature. Once positioned, enables controlled, selective infusion of diagnostic or therapeutic agents. Benefits include improved access to complex vascular anatomy and precise delivery of embolic or therapeutic materials, potentially reducing procedural time and improving clinical outcomes.

Clinical Evidence

Bench testing only. No clinical data. Verification testing included dimensional inspection, coating lubricity, tip buckling, flexibility, flow rate, priming volume, kink resistance, guidewire/guide catheter compatibility, leak testing, pressure testing, torque strength, tensile strength, corrosion resistance, and particulate testing. In vivo testing confirmed system deliverability, compatibility, and visibility.

Technological Characteristics

Single lumen, wire-reinforced, variable-stiffness catheter. Hydrophilic coating. Dual radiopaque markers at distal tip. Luer hub. Compatible with guidewires up to 0.018 inches. Sterilized via Ethylene Oxide (EtO) per ANSI/AAMI/ISO 11135. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring infusion of diagnostic contrast media or therapeutic agents (e.g., occlusion coils) into neuro, peripheral, or coronary vasculature. Used for accessing distal tortuous vasculature via coaxial tracking over a steerable guidewire.

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

• Headway™ Microcatheter (K083343)
• ev3 Rebar-18 (K001966)

Submission Summary (Full Text)

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Reverse Medical Corporation

Reverse Medical Microcatheter 510(k) Submission

# 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 Reverse Medical Microcatheter.

K122684

### Sponsor /Applicant Name and Address 4.1

Reverse Medical Corporation 13700 Alton Parkway Suite 167 Irvine, CA 92618

DEC 0 7 2012

Sponsor Contact Information 4.2 Linda D'Abate, Vice President RA/CA/QA Phone: [phone] x202 Mobile [phone] Fax: [phone] Email: [e-mail]

Date of Preparation of 510(k) Summary 4.3 August 31, 2012

4.4 Device Trade or Proprietary Name Reverse Medical Microcatheter

#### 4.5 Device Common/Usual or Classification Name

Catheter, Percutaneous (Product Code: DQY) and Catheter, Infusion (Product Code KRA)

4.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:

| Name of Predicate Devices | Name of Manufacturer<br>(Town, State) | 510(k) Number |
|---------------------------|---------------------------------------|---------------|
| Headway™ Microcatheter | MicroVention, Inc.<br>Tustin, CA | K083343 |
| ev3 Rebar-18 | Covidien<br>Mansfield, MA | K001966 |

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Reverse Medical Corporation

Reverse Medical Microcatheter 510(k) Submission

### 510(k) Summary according to 807.92 (continued)

### 4.7 Device Description

The Reverse Medical Microcatheter is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter dimensions are included on the individual device labels. The Reverse Medical Microcatheter inner lumen can accommodate guidewires up to 0.018 inches in diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization.

The Reverse Medical Microcatheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

#### 4.8 Intended Use

The Reverse Medical Microcatheter is intended for use in neuro, peripheral, and coronary vasculature. The Reverse Medical Microcatheter coaxially tracks over a steerable guidewire in order to access distal tortuous vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

| | MicroVention Headway™<br>Microcatheter | ev3 Rebar-18 | Reverse Medical<br>Microcatheter |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K083343 | K001966 | TBD |
| Classification | Class II, DQY | Class II, KRA | Class II, DQY |
| Indication | Intended for use in neuro,<br>peripheral, and coronary<br>vasculature for the infusion<br>of diagnostic agents, such as<br>contrast media and<br>therapeutic agents such as<br>occlusion coils | Intended for the controlled<br>selective infusion of<br>physician-specified<br>therapeutic agents or<br>contrast media into the<br>vasculature of the<br>peripheral and neuro<br>anatomy | Intended for use in neuro,<br>peripheral and coronary<br>vasculature for the infusion<br>of diagnostic agents such as<br>contrast media, and<br>therapeutic agents such as<br>occlusion coils |
| Shaft Materials | Coaxial lumen braided shaft<br>variable stiffness catheter<br>with radiopaque marker on<br>distal end. | Semi-rigid proximal shaft<br>that transitions into the<br>flexible distal shaft with<br>single or dual radiopaque<br>markers at the distal end. | Single lumen, wire<br>reinforced shaft, variable<br>stiffness catheter with dual<br>radiopaque markers on<br>distal end. |
| Proximal End<br>Configuration<br>Radiographic<br>markers/radiopacity | Luer Hub | Luer Hub | Luer Hub |
| | Dual radiopaque marker at<br>distal tip | Single or dual radiopaque<br>markers at distal end of<br>shaft. | Dual radiopaque marker at<br>distal tip |
| Packaging | Polyethylene hoop and<br>PET/PE/Tyvek pouch<br>inside SBS carton. | Polyethylene hoop and<br>PET/PE/Tyvek pouch<br>inside SBS carton. | Polyethylene hoop and<br>PET/PE/Tyvek pouch inside<br>SBS carton. |
| Sterilization | EtO | EtO | EtO |

#### 4,9 Comparison to Predicate Devices

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Reverse Medical Corporation Reverse Medical Microcatheter 510(k) Submission

K122684 Page 3 of 4

510(k) Summary according to 807.92 (continued)

### Summary of Non-Clinical Data 4.10

## 4.10.1 Biocompatibility and Sterilization

The Reverse Medical Microcatheter is classified as an Externally Communicating Device, Circulating Results of the testing demonstrate that the blood-contacting Blood, Limited Contact (≤24 hours). 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 Reverse Medical Microcatheter 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 |
| | <i>In vivo</i> 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, for development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10°.

## 4.10.2 Design Verification (Bench-Top Testing)

The physical, mechanical, and performance testing of the Reverse Medical Microcatheter demonstrate 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 Reverse Medical Microcatheter. All studies were conducted in accordance with Reverse Medical Design Control procedures. All testing was performed on units that were sterilized and met all inspection criteria. Tests on the Reverse Medical Microcatheter included:

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# Reverse Medical Corporation

Reverse Medical Microcatheter 510(k) Submission

K122684 Page 4 of 4

### Verification and Test Summary

| In vitro Tests | Result |
|--------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Dimensional and Visual Inspection | Met established criteria |
| Coating Lubricity | Met established criteria |
| Tip Buckling | Met established criteria |
| Flexibility/Shaft Stiffness Test | Met established criteria |
| Flow Rate Test - 100 psi and 300 psi | Met established criteria |
| Priming Volume Test | Met established criteria |
| Kink Resistance Test | Met established criteria |
| Guidewire Compatibility | Met established criteria |
| Guide Catheter Compatibility | Met established criteria |
| Catheter Leak Test (Air leakage distal end plugged) | Met established criteria |
| Catheter Leak Test (Liquid leakage) | Met established criteria |
| Dynamic Pressure Test | Met established criteria |
| Static Burst Test | Met established criteria |
| Torque Strength (Turns to Failure) | Met established criteria |
| Tensile Strength Test | Met established criteria |
| Corrosion Resistance | Met established criteria |
| USP Particulate Test | Met established criteria |
| Navigation Capabilities, Accessibility/Pushability Capabilities, Therapeutic<br>Agents Deliverability (Coils and Stents) | Met established criteria |
| <i>In vivo Tests</i> | Result |
| System Deliverability, Compatibility, and Visibility | Met established criteria |
| Biocompatibility Testing | Met established criteria |

The physical, mechanical, and performance testing of the Reverse Medical Microcatheter 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 Reverse Medical Microcatheter 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 specifications, performance, biocompatibility testing, and sterilization validation.

The Reverse Medical Microcatheter 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.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEC 7 2012

Reverse Medical Corporation Mr. Jeffrey Valko President & CEO 13700 Alton Parkway Suite 167 Irvine, CA 92618 US

Re: K122684

Trade/Device Name: Reverse medical microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: November 8, 2012 Received: November 9, 2012

Dear Mr. Valko:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Kenneth J.

Cavanaugh

for Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Reverse Medical Corporation Reverse Medical Microcatheter 510(k) Submission

# 3. Indications for Use

510(k) Number (if known):_K122684

Device Name: Reverse Medical Microcatheter

Indications for Use:

The Reverse Medical Microcatheter is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.

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) Division of Cardiovascular Devices

510(k) Number K122684