K Number

Device Name

Reverse Medical Micro Vascular Plug System

Manufacturer

REVERSE MEDICAL CORPORATION

Date Cleared

2015-04-22

(92 days)

Product Code

KRD

Regulation Number

870.3300

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K141313, K123803, K133282

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and physical properties of the vascular plug and delivery system, with no mention of AI or ML.

Therapeutic

Yes.
This device is designed to obstruct or reduce blood flow in the peripheral vasculature to treat specific conditions, indicating a therapeutic purpose.

Diagnostic

No
The device is described as an occlusion plug intended to obstruct or reduce blood flow, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical medical device consisting of a nitinol frame, PTFE cover, platinum marker bands, and a delivery wire. The performance studies also focus on the physical characteristics and functionality of this hardware.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "obstruct or reduce the rate of blood flow in the peripheral vasculature." This is a therapeutic intervention performed directly on the patient's body.
Device Description: The device is a physical plug designed to be delivered through a catheter to block blood vessels. This is a medical device used for treatment, not for analyzing samples from the body to diagnose a condition.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or diagnostic information derived from such analysis.

IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for a therapeutic purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

KRD

Device Description

The 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Tests-Non-Clinical: Due to the changes in the dimensional characteristics 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
Catheter compatibility within "Simulated Use Vascular Model"
- Flexibility within catheter
- Delivery wire kinking assessment
Multiple deployments and withdrawals through catheter
Force required to deploy and retract device within catheter
Detachment Evaluations
- Number of turns required to detach implant
- Torque strength of detachment junction
Galvanic Corrosion per ASTM G71
MRI Compatibility per ASTM F-2503

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141313, K123803, K133282

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with the head tilted upwards.

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

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

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)
-------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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
13700 Alton Parkway, Suite 167
Irvine, CA 92618	Parter Medical
17115 Kingsview Avenue
Carson, 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

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

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

					Length
Target Vessel
Diameter	MVP-3Q:
1.5-3.0 mm

MVP-5Q:
3.0-5.0mm | MVP-3:
1.5-3.0 mm

MVP-5Q: 0.027" ID | Delivery wire through
a microcatheter
MVP-3:
0.021"-0.027" ID

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

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.