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

Device Description

Reverse Medical® MVP® Micro Vascular Plug System consists of a micro vascular 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 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.

AI/ML Overview

The provided document describes the acceptance criteria and a study demonstrating that the Reverse Medical® MVP® Micro Vascular Plug System, with modifications, meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Dimensional Inspection	Successfully passed acceptance criteria.
Visual Inspection	Successfully passed acceptance criteria.
Microcatheter Compatibility:
- Flexibility within microcatheter	Successfully passed acceptance criteria.
- Delivery wire kinking assessment	Successfully passed acceptance criteria.
- Multiple deployments and withdrawals	Successfully passed acceptance criteria.
- Force required to deploy and retract device	Successfully passed acceptance criteria.
Detachment Evaluations:
- Number of turns required to detach	Successfully passed acceptance criteria.
- Torque strength of detachment junction	Successfully passed acceptance criteria.
Galvanic Corrosion per ASTM G71	Successfully passed acceptance criteria.
MRI Compatibility per ASTM F-2503	Successfully passed acceptance criteria.
Package Integrity and Shelf-life	Successfully passed acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices or tests) used for each individual performance test. It broadly states that "All testing was performed on units that were sterilized and met all inspection criteria."

The data provenance is prospective, as the tests were conducted specifically to evaluate the modified devices. The tests were conducted by Reverse Medical Corporation, presumably in the United States, given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The performance tests described are primarily engineering and technical evaluations of the device's physical properties and functionality, not clinical studies requiring expert ground truth for interpretation like image analysis or diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The performance tests are objective measurements against defined product specifications and industry standards, not subjective assessments requiring adjudication by experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This submission is for modifications to a mechanical vascular embolization device, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a mechanical medical implant and does not involve any algorithms.

7. The Type of Ground Truth Used

The ground truth used for the performance tests consists of pre-defined product specifications, engineering standards (e.g., ASTM G71, ASTM F-2503), and acceptance criteria established by Reverse Medical Corporation. These are objective benchmarks against which the device's physical and functional performance is measured.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the same reason as point 8.

Summary

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Sponsor/Applicant:	Reverse Medical Corporation13700 Alton Parkway, Ste. 167Irvine, CA 92618
Date Prepared:	May 17, 2014
Contact Person:	Jane MetcalfVice President, Quality, Regulatory and Clinical AffairsEmail: jmetcalf@reversemed.com
Trade Name:	Reverse Medical® MVP® Micro Vascular Plug System
Common Name:	Vascular Embolization Device
Classification Name:	Vascular Embolization Device
Device Classification :	Class 2
Regulation Number:	870.3300 (product code: KRD)
Predicate Devices:	Reverse Medical MVP-3 (K123803) and Reverse MedicalMVP-5 (K133282)

Purpose of Submission

The purpose of this special 510(k) submission is to obtain market clearance for two (2) modifications to the MVP System. The first is to replace the electrolytic detachment method with a mechanical detachment method. The second is to reduce the length of the delivery wire from 180 cm to 160 cm.

Indication for Use and Intended Use

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

Device Description

Technical Characteristics

The modified devices have the same technological characteristics as the predicate devices except for the detachment method and length of delivery wire. The mechanical

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detachment method eliminates the need for a software controlled detachment box and cables. Table 5-1 compares characteristics of the modified devices to the predicates.

	K123803	K133282	Subject of this Submission
Feature	MVP-3Predicate	MVP-5Predicate	MVP-3 Modified	MVP-5 Modified
Indications for Use	To obstruct or reducethe rate of blood flowin the peripheralvasculature.	To obstruct or reducethe rate of blood flowin the peripheralvasculature.	To obstruct or reducethe rate of blood flowin the peripheralvasculature.	To obstruct or reducethe rate of blood flowin the peripheralvasculature.
Materials ofConstruction	Nitinol, PTFE,Platinum, SS 301,Solder, Polypropylenesheath, Urethane,Cyanoacrylate	Nitinol, PTFE,Platinum, SS 301,Solder, Polypropylenesheath, Urethane,Cyanoacrylate	Nitinol, PTFE,Platinum, Solder,Polypropylene sheath,UrethaneCyanoacrylate	Nitinol, PTFE,Platinum, Solder,Polypropylene sheath,UrethaneCyanoacrylate
Plug (Implant)descripton	Self-expandabable,ovoid shaped framewith a PTFE coverover the proximalportion	Self-expandabable,ovoid shaped framewith a PTFE coverover the proximalportion	Self-expandabable,ovoid shaped framewith a PTFE coverover the proximalportion	Self-expandabable,ovoid shaped framewith a PTFE coverover the proximalportion
Plug Diameter,Unconstrained	5.3 mm	6.5 mm	5.3 mm	6.5 mm
Plug Length,Unconstrained	12 mm	12 mm	12 mm	12 mm
Target VesselDiameter	1.5-3.0 mm	3.0-5.0 mm	1.5-3.0 mm	3.0-5.0 mm
Method ofPlacement	Delivery wire througha 0.021" IDMicrocatheter	Delivery wire througha 0.027" IDMicrocatheter	Delivery wirethrough a 0.021" to0.027" IDMicrocatheter	Delivery wirethrough a 0.027" IDMicrocatheter
RadiopaqueMarkers	Platinum marker bandsat each end of the plug	Platinum markerbands at each end ofthe plug	Platinum markerbands at each end ofthe plug	Platinum markerbands at each end ofthe plug
Proximal End ofPlug Config.	Proximal marker bandattached to deliverywire	Proximal marker bandattached to deliverywire	Proximal markerband attached todelivery wire	Proximal markerband attached todelivery wire
Delivery WireLength	180 cm	180 cm	160 cm	160 cm
Detachment System	Electrolytic	Electrolytic	Mechanical	Mechanical
SterilizationProcess	EO	EO	EO	EO
Accessories	Electrolytic Box andCables	Electrolytic Box andCables	Torquer	Torquer

Table 5-1 Comparison to the Predicates

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Performance Tests - Non-clinical

Due to the change in detachment method and delivery wire length the following design verification tests 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:

. Dimensional Inspection
Visual Inspection
Microcatheter Compatibility within "Simulated Use Vascular Model" .
- Flexibility within microcatheter o
- Delivery wire kinking assessment o
- Multiple deployments and withdrawals through the microcatheter O
- Force required to deploy and retract device within the microcatheter O
Detachment Evaluations
- o Number of turns required to detach
- Torque strength of detachment junction o
Galvanic Corrosion per ASTM G71 .
MRI Compatibility per ASTM F-2503
Package Integrity and Shelf-life .

All tests successfully passed acceptance criteria. This demonstrates that the modified devices meet the product specification.

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 between the systems do not raise any issues of safety or effectiveness.

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

June 18, 2014

Reverse Medical Corporation % Jane Metcalf VP, Quality Assurance, Regulatory and Clinical Affairs 13700 Alton Parkway, Suite 167 Irvine, California 92618

Re: K141313

Trade/Device Name: MVP Micro Vascular Plug System Regulation Number: 21 CFR 870.3300 Regulation Name: Device Embolization, Vascular Regulatory Class: 11 Product Code: KRD Dated: May 16, 2014 Received: May 20, 2014

Dear Ms. Metcalf,

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 10 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, howeyer, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Jane Metcalf

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141313

Device Name

Reverse Medical(R) Corporation MVP(R) Micro Vascular Plug System

Indications for Use (Describe)

The Reverse Medical(R) Corporation MVP(R) Micro Vascular Plug System is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY "

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
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.(b)
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).