Reverse Medical Micro Vascular Plug System

K150108 · Reverse Medical Corporation · KRD · Apr 22, 2015 · Cardiovascular

Device Facts

• Record ID: K150108
• Device Name: Reverse Medical Micro Vascular Plug System
• Applicant: Reverse Medical Corporation
• Product Code: KRD · Cardiovascular
• Decision Date: Apr 22, 2015
• 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-7, MVP-9) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Device Story

The Reverse Medical MVP System is a vascular embolization device consisting of a self-expandable, ovoid-shaped nitinol frame with a PTFE cover over the proximal portion. It is secured at both ends with platinum marker bands. The device is attached to a composite delivery wire and delivered to the treatment site through a commercially available catheter. Once positioned, the implant is detached from the delivery wire by rotating the wire counter-clockwise. The device is used by physicians in a clinical setting to obstruct or reduce blood flow in peripheral vessels. The MVP-7 and MVP-9 models are modifications of previous MVP devices, featuring larger plug diameters and lengths to accommodate larger target vessels (5.0-9.0 mm). The device provides a mechanical means to achieve vascular occlusion, benefiting patients requiring embolization for clinical indications.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included dimensional inspection, visual inspection, catheter compatibility in simulated vascular models, flexibility, kinking assessment, deployment/withdrawal force, detachment evaluations, galvanic corrosion, and MRI compatibility.

Technological Characteristics

Materials: Nitinol, PTFE, Platinum, stainless steel, solder, polypropylene sheath, urethane, cyanoacrylate. Principle: Self-expandable ovoid frame for mechanical embolization. Energy: Mechanical detachment. Dimensions: MVP-7 (9.2 mm diameter, 16 mm length), MVP-9 (13.0 mm diameter, 18 mm length). Connectivity: None. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for obstruction or reduction of blood flow in the peripheral vasculature.

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 Micro Vascular Plug (MVP-3Q and MVP-5Q) (K141313)
• Micro Vascular Plug (MVP-3) (K123803)
• Micro Vascular Plug (MVP-5) (K133282)

Submission Summary (Full Text)

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

April 22, 2015

Reverse Medical Corporation Ms. Laura Heaton Associate Director of Regulatory Affairs 13700 Alton Parkway, Suite 167 Irvine, CA 92618

Re: K150108

Trade/Device Name: Reverse Medical Micro Vascular Plug (MVP-7 & MVP-9) Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: March 20, 2015 Received: March 23, 2015

Dear Laura Heaton:

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for 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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# Indications for Use

510(k) Number (if known) K150108

Device Name

Reverse Medical Micro Vascular Plug (MVP-7, MVP-9)

Indications for Use (Describe)

The Reverse Medical Micro Vascular Plug (MVP-7, MVP-9) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

| Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Registration Use (Part 21 CFR 201.2 Subject to Review) <input type="checkbox"/> Over-The-Counter Use (21 CFR 201.2 Subject to Review) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared January 15, 2015

Sponsor Reverse Medical Corporation

Address and The registration number of the manufacturer and sterilization sites for both vascular Registration # embolization devices are as follows:

| Manufacturer | Sterilization Site |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------|
| Reverse Medical Corporation<br>13700 Alton Parkway, Suite 167<br>Irvine, CA 92618 | Parter Medical<br>17115 Kingsview Avenue<br>Carson, CA 90746 |
| FDA Registration #:<br>3007170829 | FDA Registration #:<br>2024311 |

Contact Person Laura Heaton, Associate Director of Regulatory Affairs E-mail: [e-mail]

Device Name The device trade names and common/classification names are:

| Device Trade Name | Common/Classification Name |
|-------------------------------------|------------------------------|
| Reverse Medical Micro Vascular Plug | Vascular Embolization Device |

Device Class Vascular embolization devices have been classified as Class II, KRD under 21 CFR §870.3300. The Class III Summary and Certification requirement as described in 21 CFR §807.87(j) and §807.94 do not apply to this device and submission. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for vascular embolization devices.

Predicate The predicate device is the Reverse Medical Micro Vascular Plug (MVP-3Q and Device MVP-5Q), K141313, concurrence date June 18, 2014. The predicate device is also Micro Vascular Plug (MVP-3) K123803 concurrence date July 2, 2013 and also (MVP-5) Information K133282 concurrence date Nov. 27, 2013.

Purpose The purpose of this special 510(k) submission is to obtain market clearance for two (2) of Submission modifications of the MVP System. The first is to change the outer diameter and the length of the implant. The second is to the outer diameter of the delivery wire. These changes allow for the obstruction of larger blood vessels in the peripheral vasculature.

The Reverse Medical Corporation MVP Micro Vascular Plug System is indicated to Indications for Use and obstruct or reduce the rate of blood flow in the peripheral vasculature. Intended Use

Device Reverse Medical® MVP® Micro Vascular Plug System consists of a micro vascular Description occlusion plug that is attached to a composite delivery wire and is intended to be delivered to the treatment site through a catheter. The MVP occlusion plug is a selfexpandable, ovoid-shaped frame made from nitinol and incorporates a PTFE cover over the proximal portion of the ovoid. The plug device is secured at both ends with

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platinum marker bands. The proximal marker band is attached to a delivery wire that is used to push the plug device through a commercially available catheter to the intended treatment site. After satisfactory deployment of the plug device at the treatment site, the implant is detached from the delivery wire by rotating the wire counter clockwise.

Technical The modified devices have the same technological characteristics as the predicate Characteristics devices.

| | | K123803/K133282 | Submission Subject | | | | | |
|------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--|--|--|
| Feature | MVP-3Q/MVP-5Q<br>Predicate | MVP-3/MVP-5<br>Predicate | MVP-7<br>Device | MVP-9<br>Device | Comparison of<br>Device to RM<br>Predicate | | | |
| Indications for<br>Use | To obstruct or reduce<br>the rate of blood<br>flow in the peripheral<br>vasculature | To obstruct or reduce<br>the rate of blood flow<br>in the peripheral<br>vasculature | To obstruct<br>or reduce the<br>rate of blood<br>flow in the<br>peripheral<br>vasculature | To obstruct or<br>reduce the rate<br>of blood flow in<br>the peripheral<br>vasculature | ldentical<br>Indications for<br>Use | | | |
| Manufacturer | Reverse Medical<br>(RM) Corp. | Reverse Medical (RM)<br>Corp. | Reverse<br>Medical (RM)<br>Corp. | Reverse<br>Medical (RM)<br>Corp. | Identical<br>manufacturer | | | |
| Materials of<br>Construction | Nitinol, PTFE,<br>Platinum, Solder,<br>Polypropylene<br>sheath, Urethane,<br>Cyanoacrylate | Nitinol, PTFE,<br>Platinum, stainless<br>steel, Solder,<br>Polypropylene sheath,<br>Urethane,<br>Cyanoacrylate | Nitinol, PTFE,<br>Platinum,<br>stainless<br>steel, Solder,<br>Polypropylen<br>e sheath,<br>Urethane,<br>Cyanoacrylat<br>e | Nitinol, PTFE,<br>Platinum,<br>stainless steel,<br>Solder,<br>Polypropylene<br>sheath,<br>Urethane,<br>Cyanoacrylate | Identical<br>Materials | | | |
| Plug (Implant)<br>description | Self-expandable,<br>ovoid shaped frame<br>with a PTFE cover<br>over the proximal<br>portion | Self-expandable, ovoid<br>shaped frame with a<br>PTFE cover over the<br>proximal portion | Self-<br>expandable,<br>ovoid shaped<br>frame with a<br>PTFE cover<br>over the<br>proximal<br>portion | Self-<br>expandable,<br>ovoid shaped<br>frame with a<br>PTFE cover over<br>the proximal<br>portion | ldentical<br>Implant<br>material<br>configuration | | | |
| Plug<br>Diameter,<br>Unconstrained | MVP-3Q: 5.3 mm<br>MVP-5Q: 6.5 mm | MVP-3: 5.3 mm<br>MVP-5: 6.5 mm | 9.2 mm | 13.0 mm | Larger implant<br>OD | | | |
| Plug Length,<br>Unconstrained | 12 mm | 12 mm | 16 mm | 18 mm | Longer<br>implant | | | |

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# Reverse Medical Corporation Special 510(k): Device Modification MVP-7 and MVP-9

| | | | | | Length |
|------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------|
| Target Vessel<br>Diameter | MVP-3Q:<br>1.5-3.0 mm<br><br>MVP-5Q:<br>3.0-5.0mm | MVP-3:<br>1.5-3.0 mm<br><br>MVP-5:<br>3.0-5.0mm | 5.0-7.0 mm | 7.0-9.0 mm | Larger target<br>vessel<br>diameter |
| Method of<br>Placement | Delivery wire through<br>a microcatheter<br>MVP-3Q:<br>0.021"-0.027" ID<br><br>MVP-5Q: 0.027" ID | Delivery wire through<br>a microcatheter<br>MVP-3:<br>0.021"-0.027" ID<br><br>MVP-5: 0.027" ID | Delivery wire<br>through a<br>0.041" ID<br>catheter | Delivery wire<br>through a<br>0.043" ID<br>catheter | Identical<br>Delivery<br>through a<br>larger catheter |
| Radiopaque<br>Markers | Platinum marker<br>bands at each end of<br>the plug | Platinum marker<br>bands at each end of<br>the plug | Platinum<br>marker bands<br>at each end<br>of the plug | Platinum<br>marker bands<br>at each end of<br>the plug | Identical<br>marker bands |
| Proximal End<br>of Plug<br>Configuration | Proximal marker<br>band attached to<br>delivery wire | Proximal marker band<br>attached to delivery<br>wire | Proximal<br>marker band<br>attached to<br>delivery wire | Proximal<br>marker band<br>attached to<br>delivery wire | Identical<br>proximal end<br>plug<br>configuration |
| Delivery Wire<br>Length | 160-180 cm | 160-180 cm | 160-180 cm | 160-180 cm | Identical<br>Delivery Wire<br>Length Range |
| Detachment<br>System | Mechanical | Electrolytic | Mechanical | Mechanical | Identical |
| Sterilization<br>Process | EO | EO | EO | EO | Identical |
| Accessories | Torquer | Detachment Box and<br>Cable Set | Torquer | Torquer | Identical |

Due to the changes in the dimensional characteristics the following design verification Performance tests were conducted in accordance with Reverse Medical Design Control procedures. Tests-Non-Clinical All testing was performed on units that were sterilized and met all inspection criteria. Tests on the Reverse Medical MVP System included:

-
- Dimensional Inspection
- . Visual Inspection
- Catheter compatibility within "Simulated Use Vascular Model" .
- O Flexibility within catheter
- 0 Delivery wire kinking assessment

Reverse Medical Corporation

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- Multiple deployments and withdrawals through catheter 0
- Force required to deploy and retract device within catheter o
- Detachment Evaluations o
- Number of turns required to detach implant o
- o Torque strength of detachment junction
- Galvanic Corrosion per ASTM G71 .
- MRI Compatibility per ASTM F-2503

## Basis for Determination of Substantial Equivalence

Upon reviewing the performance data and comparing intended use, design, materials, principle of operation and overall technological characteristics, the modified Reverse Medical MVP System is determined to be substantially equivalent to the currently marketed Reverse Medical MVP System. Differences do not raise any issues of safety or effectiveness.