REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM

K133282 · Reverse Medical Corporation · KRD · Nov 27, 2013 · Cardiovascular

Device Facts

• Record ID: K133282
• Device Name: REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
• Applicant: Reverse Medical Corporation
• Product Code: KRD · Cardiovascular
• Decision Date: Nov 27, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reverse Medical Micro Vascular Plug (MVP-5) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Device Story

The Reverse Medical MVP-5 is a self-expandable, ovoid-shaped vascular occlusion device composed of Nitinol with an ePTFE partial cover and platinum marker bands. It is delivered via a 0.027" ID microcatheter to peripheral vessels (3.0-5.0mm diameter). The device is attached to a delivery wire; a separate, battery-operated Detachment Box and Cable Set facilitate electrolytic detachment of the implant from the wire. The system is used by physicians in clinical settings to reduce or obstruct blood flow. The Detachment Box monitors and signals the detachment process. By providing a controlled, mechanical occlusion, the device assists in managing vascular flow, potentially benefiting patients requiring targeted embolization.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by biocompatibility testing (ISO 10993-1) and extensive bench-top design verification, including tensile strength, radial force, detachment time, corrosion resistance, and flow occlusion performance.

Technological Characteristics

Self-expandable ovoid Nitinol frame with ePTFE partial cover; platinum marker bands. Electrolytic detachment system (battery-operated). Dimensions compatible with 0.027" ID microcatheters. Sterilized per ANSI/AAMI/ISO 11135. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for use to obstruct or reduce the rate of blood flow in the peripheral vasculature for patients requiring vascular occlusion.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Reverse Medical MVP™ Micro Vascular Plug System (MVP-3) (K123803)

Submission Summary (Full Text)

{0}------------------------------------------------

K13282

Image /page/0/Picture/1 description: The image shows the words "KEVERSE MEDICAL" in bold, black letters. Underneath the words is a curved line that ends with an arrow pointing upwards. The arrow is also black and bold.

- NOV 2 7 2013

## 510(k) Summary

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 MVP™ Micro Vascular Plug System (MVP-5).

Device Trade or Proprietary Name Reverse Medical MVP™Micro Vascular Plug System

## Sponsor /Applicant Name and Address

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

# Sponsor Contact Information Linda D'Abate

Reverse Medical Vice President, RA/CA/QA

Date of Preparation of 510(k) Summary October 25, 2013

# Device Common/Usual or Classification Name

Device Embolization, Vascular (Product Code: KRD)

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

| Name of Predicate Device | Manufacturer | 510(k) Number |
|---------------------------------------|---------------------------|---------------|
| Reverse Medical MVP™ | Reverse Medical™ | K123803 |
| Micro Vascular Plug<br>System (MVP-3) | Corporation<br>Irvine, CA | |

## Device Description

The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.027" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 3.0 -5.0mm.

The proximal marker band attaches to a delivery wire that pushes the device through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set - 275

{1}------------------------------------------------

cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP).

#### Intended Use

The Reverse Medical MVP is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

| | New Device | Predicate<br>Device |
|-------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | Reverse Medical<br>MVP-5 System | Reverse Medical<br>MVP-3 System |
| 510(k) No. | K123803 Class II<br>KRD 870:3300 | K123803 Class II<br>KRD 870:3300 |
| Indication for<br>use | Indicated for use to<br>obstruct or reduce<br>the rate of blood<br>flow in the<br>peripheral<br>vasculature. | Indicated for use to<br>obstruct or reduce<br>the rate of blood<br>flow in the<br>peripheral<br>vasculature. |
| Method of<br>Placement | Delivery wire<br>through a 0.027" ID<br>microcatheter. | Delivery wire<br>through a 0.021" ID<br>microcatheter. |
| Radiopaque<br>markers | Platinum marker<br>bands at each end | Platinum marker<br>bands at each end |
| Proximal End<br>Configuration | Proximal marker<br>band and<br>attachment for<br>pusher wire | Proximal marker<br>band and<br>attachment for pusher<br>wire |
| Detachment<br>System | Yes - Electrolytic | Yes - Electrolytic |
| Battery<br>Operated | Yes | Yes |

#### Comparison to Predicate Device

## Summary of Non-Clinical Data

#### Biocompatibility and Sterilization

The device was characterized as an implant, internal communicating device, which contacts circulating blood for exposure ≥ 30 days.

The Reverse Medical MVP 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 MVP successfully passed all of the following biocompatibility tests, demonstrating that the materials are biocompatible:

{2}------------------------------------------------

| Test | Results/Acceptance |
|--------------------------------------------|--------------------------------------------------------------------------|
| Cytotoxicity | Non-Cytotoxic |
| Kligman Maximization<br>Sensitization Test | Non-Sensitizing. |
| Intracutaneous Injection | Non-Irritant |
| Systemic Injection | Non-Toxic |
| Material-Mediated Pyrogenicity | Non-Pyrogenic |
| Genotoxicity/Mutagenicity | Non-Mutagenic |
| In Vitro Mouse Lymphoma Assay | Non-Mutagenic |
| In Vivo Mouse Lymphoma | Non-Mutagenic |
| Hemolysis | Non-Hemolytic |
| Complement Activation C3a and<br>SC5ba-9 | No greater biological response than corresponding control |
| Inactivated Partial | Minimal, passed acceptance criteria |
| Thromboplastin Time | Non-activator, passed acceptance criteria |
| Platelet and Leukocyte Counts | Test articles: No range or acceptable level established. |
| Muscle Implantation | Intramuscular Implantation- 4 and 13 week, passed<br>acceptance criteria |

Test Result Summary

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 °.

## Design Verification (Bench-Top Testing)

The physical, mechanical, and performance testing of the Reverse Medical MVP System 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 MVP. 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 MVP System included:

#### Verification and Test Summary

- � Visual Inspection
- . Dimensional Inspection
- . Tensile Strength
- . USP Particulate
- � Radial Force
- . Microcatheter Compatibility
- . Detachment Time
- Torque Strength .
- Plug Foreshortening
- . Nickel Release
- Corrosion Resistance (potentiodynamic . and galvanic)
- Flow Occlusion/Reduction
- Magnetic Resonance Compatibility ●
- . Labeling
- . Packaging
- Shelf Life
- . Sterility
- � Biocompatibility
- . Detachment Box and Cable Set

{3}------------------------------------------------

All tests performed passed successfully. The physical, mechanical, and performance testing of the Reverse Medical MVP System demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices

#### Substantial Equivalence

The performance of the Reverse Medical MVP-5 System 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, animal testing, and sterilization validation.

The Reverse Medical MVP-5 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.

{4}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, possibly representing care or support.

Public Health Service

November 27, 2013

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

Reverse Medical Corporation C/O Jeffrey Valko. President & CEO 13700 Alton Parkway, Suite 167 Irvine, CA 92618

Re: K133282

Trade/Device Name: Reverse Medical Micro Vascular Plug (MVP-5) System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 25, 2013 Received: October 28, 2013

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. Iisting 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2 - Mr. Jeffrey Valko

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilleman

**for**

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Reverse Medical Corporation Special 510(k): Device Modification

.

# Attachment 2: Indication for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

・・・・・・・・・・・・

Device Name: Reverse Medical Micro Vascular Plug (MVP-5)

Indication for Use:

The Reverse Medical Micro Vascular Plug (MVP-5) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral 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)

M.A. Hillemann