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 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 text describes a 510(k) premarket notification for the Reverse Medical Micro Vascular Plug (MVP-7 & MVP-9) and outlines the basis for determining substantial equivalence to predicate devices. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document primarily focuses on demonstrating that the modified MVP-7 and MVP-9 devices are substantially equivalent to their predicate devices (MVP-3Q, MVP-5Q, MVP-3, and MVP-5) based on their intended use, design, materials, principle of operation, and overall technological characteristics.

Instead of a specific clinical study with detailed acceptance criteria and performance metrics, it lists a series of non-clinical performance tests conducted to verify the design changes. These tests primarily address the physical and mechanical aspects of the device and its compatibility with delivery systems.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding "reported device performance" values for clinical outcomes. The performance tests listed are primarily non-clinical assessments.

Acceptance Criteria (Implied from tests)	Reported Device Performance (Summary from text)
Dimensional Accuracy	All units met all inspection criteria
Visual Inspection	All units met all inspection criteria
Catheter Compatibility	Demonstrated within "Simulated Use Vascular Model"
Flexibility within catheter	Tested and met criteria (implies satisfactory performance)
Delivery wire kinking assessment	Tested and met criteria (implies satisfactory performance)
Multiple deployments and withdrawals through catheter	Tested and met criteria (implies satisfactory performance)
Force required to deploy and retract device within catheter	Tested and met criteria (implies satisfactory performance)
Detachment Evaluations	Tested and met criteria (implies satisfactory performance)
Number of turns required to detach implant	Tested and met criteria (implies satisfactory performance)
Torque strength of detachment junction	Tested and met criteria (implies satisfactory performance)
Galvanic Corrosion	Tested per ASTM G71 (implies satisfactory performance)
MRI Compatibility	Tested per ASTM F-2503 (implies satisfactory performance)

2. Sample size used for the test set and the data provenance

The document does not specify human clinical "test set" sample sizes, as the performance tests described are non-clinical tests performed on "units that were sterilized and met all inspection criteria." Data provenance is from in-house non-clinical testing by Reverse Medical Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests described are engineering/material performance tests, not clinical evaluations requiring expert interpretation of ground truth in the context of diagnostic or interventional efficacy.

4. Adjudication method for the test set

Not applicable for non-clinical engineering tests.

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

Not applicable. This is not an AI-assisted diagnostic or interventional device, but a physical vascular embolization device.

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

Not applicable. This is not an algorithm, but a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the specifications and standards of the tests themselves (e.g., dimensional requirements, force measurements, compliance with ASTM standards for corrosion and MRI compatibility).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The "units" for testing refer to manufactured devices.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)	Registration Use (Part 21 CFR 201.2 Subject to Review) Over-The-Counter Use (21 CFR 201.2 Subject to Review)
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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 Corporation13700 Alton Parkway, Suite 167Irvine, CA 92618	Parter Medical17115 Kingsview AvenueCarson, CA 90746
FDA Registration #:3007170829	FDA Registration #:2024311

Contact Person Laura Heaton, Associate Director of Regulatory Affairs E-mail: Laura.Heaton@covidien.com

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-5QPredicate	MVP-3/MVP-5Predicate	MVP-7Device	MVP-9Device	Comparison ofDevice to RMPredicate
Indications forUse	To obstruct or reducethe rate of bloodflow in the peripheralvasculature	To obstruct or reducethe rate of blood flowin the peripheralvasculature	To obstructor reduce therate of bloodflow in theperipheralvasculature	To obstruct orreduce the rateof blood flow inthe peripheralvasculature	ldenticalIndications forUse
Manufacturer	Reverse Medical(RM) Corp.	Reverse Medical (RM)Corp.	ReverseMedical (RM)Corp.	ReverseMedical (RM)Corp.	Identicalmanufacturer
Materials ofConstruction	Nitinol, PTFE,Platinum, Solder,Polypropylenesheath, Urethane,Cyanoacrylate	Nitinol, PTFE,Platinum, stainlesssteel, Solder,Polypropylene sheath,Urethane,Cyanoacrylate	Nitinol, PTFE,Platinum,stainlesssteel, Solder,Polypropylene sheath,Urethane,Cyanoacrylate	Nitinol, PTFE,Platinum,stainless steel,Solder,Polypropylenesheath,Urethane,Cyanoacrylate	IdenticalMaterials
Plug (Implant)description	Self-expandable,ovoid shaped framewith a PTFE coverover the proximalportion	Self-expandable, ovoidshaped frame with aPTFE cover over theproximal portion	Self-expandable,ovoid shapedframe with aPTFE coverover theproximalportion	Self-expandable,ovoid shapedframe with aPTFE cover overthe proximalportion	ldenticalImplantmaterialconfiguration
PlugDiameter,Unconstrained	MVP-3Q: 5.3 mmMVP-5Q: 6.5 mm	MVP-3: 5.3 mmMVP-5: 6.5 mm	9.2 mm	13.0 mm	Larger implantOD
Plug Length,Unconstrained	12 mm	12 mm	16 mm	18 mm	Longerimplant

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

					Length
Target VesselDiameter	MVP-3Q:1.5-3.0 mmMVP-5Q:3.0-5.0mm	MVP-3:1.5-3.0 mmMVP-5:3.0-5.0mm	5.0-7.0 mm	7.0-9.0 mm	Larger targetvesseldiameter
Method ofPlacement	Delivery wire througha microcatheterMVP-3Q:0.021"-0.027" IDMVP-5Q: 0.027" ID	Delivery wire througha microcatheterMVP-3:0.021"-0.027" IDMVP-5: 0.027" ID	Delivery wirethrough a0.041" IDcatheter	Delivery wirethrough a0.043" IDcatheter	IdenticalDeliverythrough alarger catheter
RadiopaqueMarkers	Platinum markerbands at each end ofthe plug	Platinum markerbands at each end ofthe plug	Platinummarker bandsat each endof the plug	Platinummarker bandsat each end ofthe plug	Identicalmarker bands
Proximal Endof PlugConfiguration	Proximal markerband attached todelivery wire	Proximal marker bandattached to deliverywire	Proximalmarker bandattached todelivery wire	Proximalmarker bandattached todelivery wire	Identicalproximal endplugconfiguration
Delivery WireLength	160-180 cm	160-180 cm	160-180 cm	160-180 cm	IdenticalDelivery WireLength Range
DetachmentSystem	Mechanical	Electrolytic	Mechanical	Mechanical	Identical
SterilizationProcess	EO	EO	EO	EO	Identical
Accessories	Torquer	Detachment Box andCable 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.

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).