REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM

K102418 · Reverse Medical Corporation · DQY · Apr 15, 2011 · Cardiovascular

Device Facts

• Record ID: K102418
• Device Name: REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
• Applicant: Reverse Medical Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

Device Story

RePort™ Guide Catheter System is a two-component device consisting of a RePort™ Sheath and a RePort™ Dilator. The sheath features a distal region that expands when the dilator is advanced. Used in clinical settings by physicians to facilitate the introduction of interventional or diagnostic devices into peripheral, coronary, and neuro vasculature. The system accommodates hydrophilic guidewires up to 0.038 inches. Proximal luer fittings allow for accessory attachment and liquid infusion. The device is provided sterile for single use. It provides support and access to desired anatomy, aiding in clinical decision-making by enabling the delivery of therapeutic or diagnostic tools. Benefits include improved access to complex vascular anatomy through the expandable distal design.

Clinical Evidence

Bench testing included dimensional/visual inspection, guidewire compatibility, torque response/strength, deployment cycle, kink resistance, flexibility, tensile strength, leak testing, pressure/burst testing, aspiration, and corrosion resistance. In vivo testing evaluated system deliverability, compatibility, visibility, aspiration performance, and acute histopathology of treated vessels. All tests met established criteria. No human clinical trial data was required for this 510(k) submission.

Technological Characteristics

Two-catheter system (sheath and dilator). Materials: PTFE-lined nylon/polyurethane with stainless steel and nitinol braid support. Radiopacity provided by platinum/tungsten bands and gold markers. Connectivity: Luer hub for accessory attachment. Sterilization: EtO (ANSI/AAMI/ISO 11135). Dimensions: Accommodates guidewires up to 0.038 inches.

Indications for Use

Indicated for the introduction of interventional or diagnostic devices into the peripheral, coronary, and neuro vasculature in patients requiring such procedures.

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)
• ENVOY® Guiding Catheter (K093184)
• Chaperon™ Guiding Catheter System (K082385)

Submission Summary (Full Text)

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# APR 1 5 2011

## 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 RePort™ Guide Catheter System.

### 4.1 Sponsor /Applicant Name and Address

Reverse Medical Corporation 13900 Alton Parkway Suite 123 Irvine, CA 92618

#### 4.2 Sponsor Contact Information

Amy Éskina Vice President, Regulatory Quality & Clinical Affairs Phone: [phone] x234 949-215-0661 Fax: email: [e-mail]

#### 4.3 Date of Preparation of 510(k) Summary

August 13, 2010

#### 4.4 Device Trade or Proprietary Name

RePort™ Guide Catheter System

## 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<br>(Town, State) | 510(k) Number |
|------------------------------------------------|----------------------------------------|---------------|
| Penumbra Neuron™<br>Intracranial Access System | Penumbra, Inc.<br>Alameda, CA | K070970 |
| ENVOY® Guiding Catheter | Codman & Shurtleff, Inc<br>Raynham, MA | K093184 |
| Chaperon™ Guiding Catheter<br>System | Microvention, Inc.<br>Aliso Viejo, CA | K082385 |

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#### 4.7 Device Description

The RePort™ Guide Catheter System is a two-catheter system comprised of the RePort™ Sheath and the RePort™ Dilator. The RePort™ Sheath has a distal region which expands when the RePort™ Dilator is advanced. The RePort™ Guide Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy.

The proximal ends of the RePort™ Sheath and the RePort™ Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the RePort™ Sheath's distal expandable region into the catheter introducer sheath. The System is provided sterile, non-pyrogenic, and is intended for single use only.

#### 4.8 Intended Use

The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

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## 4.9 Comparison to Predicate Devices

| | Penumbra | | Chaperon™ | RePort™ Guide |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neuron™ | ENVOY® Guiding | Guiding Catheter | Catheter |
| | Intracranial Access | Catheter; | System | |
| | System | | | |
| 510(k) Number | K070970 | K093184 | K082385 | TBD |
| Classification | Class II, DQY | Class II, DQY | Class II, DQY | Class II, DQY |
| Indication | The ... is indicated for<br>the introduction of<br>interventional devices<br>into the peripheral,<br>coronary, and neuro<br>vasculature. | The ... is intended for use<br>in the peripheral,<br>coronary, and<br>neurovasculature for the<br>intravascular<br>introduction of<br>interventional/diagnostic<br>devices. | The ...is intended for<br>general intravascular<br>use, including the<br>neuro and<br>peripheral<br>vasculature.<br>The... can be used to<br>facilitate ·<br>introduction of<br>diagnostic or<br>therapeutic devices.<br>The... are not<br>intended for use in<br>coronary arteries. | The ... is indicated for<br>the introduction of<br>interventional /<br>diagnostic devices into<br>the peripheral,<br>coronary, and neuro<br>vasculature. |
| Materials | | | | |
| - Shaft Materials | PTFE lined<br>nylon/polyurethane<br>with stainless steel<br>braid support | PTFE lined<br>nylon/polyurethane<br>with stainless steel<br>braid support | PTFE lined<br>polymeric catheter<br>with braid support | PTFE lined<br>nylon/polyurethane<br>with stainless steel and<br>nitinol braid support |
| - Proximal End<br>Configuration | Luer Hub | Luer Hub | Luer Hub | Luer Hub |
| - Radiographic markers /<br>Radiopacity | • Delivery Catheter:<br>Platinum reinforced<br>distal shaft for<br>radiopacity<br>• Select Catheter:<br>shaft is radiopaque<br>throughout | Radiopaque distal tip | Radiopaque distal tip | • Sheath:<br>Platinum/tungsten<br>bands embedded at<br>junction of<br>expandable section;<br>gold marker at tip of<br>expandable section;<br>• Dilator: shaft is<br>radiopaque<br>throughout |
| - Packaging | Catheter<br>in polyethylene hoop<br>inside<br>PET/PE/Tyvek pouch<br>inside SBS carton | Catheter<br>attached to<br>packaging card<br>inside<br>PET/PE/Tyvek pouch<br>inside SBS carton | Catheter<br>attached to<br>packaging card<br>inside<br>PET/PE/Tyvek pouch<br>inside SBS carton | Catheter<br>in polyethylene hoop<br>attached to<br>packaging card<br>inside<br>PET/PE/Tyvek pouch<br>inside SBS carton |
| Sterilization | EtO | EtO | EtO | EtO |

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### 4.10 Summary of Non-clinical Data

### 4.10.1 Biocompatibility and Sterilization

The RePort™ Guide Catheter System 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 RePort™ Guide Catheter System 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 |
| Haemocompatibility | Complement Activation<br>Hemolysis<br>Inactivated Partial Thromboplastin Time Test<br><i>In vivo</i> thrombogenicity |
| Pyrogenicity | USP Material Mediated Rabbit Pyrogen Test |

- 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 °.

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#### 4.10.2 Design Verification (Bench-Top Testing)

The physical, mechanical and performance testing of the RePort™ Guide Catheter System 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 RePort™ Guide Catheter System. All studies were conducted in accordance with Reverse Medical Design Control procedures. All testing was performed on units which were twice sterilized and met all inspection criteria. Tests on the the RePort™ Guide Catheter System included:

Verification and Test Summary

| Bench Tests | Result |
|-----------------------------------------------------------------------------|--------------------------|
| Dimensional and Visual Inspection | Met established criteria |
| Guidewire Compatibility | Met established criteria |
| Torque Response | Met established criteria |
| Torque Strength | Met established criteria |
| System Deployment Cycle Test | 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 RePort™ Guide Catheter System 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 RePort™ Guide Catheter System 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 RePort™ Guide Catheter System 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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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wing. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

APR 1 5, 2011

Reverse Medical Corporation c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K102418

Trade/Device Name: RePort Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 31, 2011 Received: April 1, 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. 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

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CFR Part 807): labeling (21 CFR Part 801); medical device 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/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/ReportalProblem/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,

Duma R. Vi. Luner

Image /page/6/Picture/7 description: The image shows a black and white drawing of a symbol. The symbol is abstract and appears to be a stylized letter or character. It has a curved line at the top and a sharp angle at the bottom, with a wavy line connecting them. The symbol is simple and minimalist in design.

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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## 3. Indications for Use

510(k) Number (if known):_K(02418

Device Name: Reverse Medical RePort™ Guide Catheter System

Indications for Use:

The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

Prescription Use X (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)

ea R. h. mmm
(Plaintiff's Signature)

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_K102418