REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM

• K Number: K141313
• Device Name: REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
• Manufacturer: REVERSE MEDICAL CORPORATION
• Date Cleared: 2014-06-18 ( 29 days)
• Product Code: KRD
• Regulation Number: 870.3300

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

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.

Predicate Devices

K123803, K133282

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

Yes

The device is intended to obstruct or reduce blood flow in the peripheral vasculature due to vascular malformations or conditions (e.g., aneurysms, fistulas) which is a therapeutic intervention.

Diagnostic

No

Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature." This describes a therapeutic function (treatment), not a diagnostic function (identifying or characterizing a disease or condition). The device description further clarifies it as an "occlusion plug" which is used for treatment.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (occlusion plug, delivery wire, catheter) and performance studies related to these physical components (dimensional inspection, microcatheter compatibility, detachment evaluations, etc.). There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 within the body, not a diagnostic test performed on samples taken from the body.
• Device Description: The device is a physical plug designed to be implanted in blood vessels. This is consistent with a therapeutic device, not a diagnostic one.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

KRD

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.

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 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.

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

Not Found

Predicate Device(s)

K123803, K133282

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

| Sponsor/Applicant: | Reverse Medical Corporation
13700 Alton Parkway, Ste. 167
Irvine, CA 92618 |
|-------------------------|------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 17, 2014 |
| Contact Person: | Jane Metcalf
Vice President, Quality, Regulatory and Clinical Affairs
Email: [e-mail] |
| 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 Medical
MVP-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

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.

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

1

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-3
Predicate	MVP-5
Predicate	MVP-3 Modified	MVP-5 Modified
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.
Materials of
Construction	Nitinol, PTFE,
Platinum, SS 301,
Solder, Polypropylene
sheath, Urethane,
Cyanoacrylate	Nitinol, PTFE,
Platinum, SS 301,
Solder, Polypropylene
sheath, Urethane,
Cyanoacrylate	Nitinol, PTFE,
Platinum, Solder,
Polypropylene sheath,
Urethane
Cyanoacrylate	Nitinol, PTFE,
Platinum, Solder,
Polypropylene sheath,
Urethane
Cyanoacrylate
Plug (Implant)
descripton	Self-expandabable,
ovoid shaped frame
with a PTFE cover
over the proximal
portion	Self-expandabable,
ovoid shaped frame
with a PTFE cover
over the proximal
portion	Self-expandabable,
ovoid shaped frame
with a PTFE cover
over the proximal
portion	Self-expandabable,
ovoid shaped frame
with a PTFE cover
over the proximal
portion
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 Vessel
Diameter	1.5-3.0 mm	3.0-5.0 mm	1.5-3.0 mm	3.0-5.0 mm
Method of
Placement	Delivery wire through
a 0.021" ID
Microcatheter	Delivery wire through
a 0.027" ID
Microcatheter	Delivery wire
through a 0.021" to
0.027" ID
Microcatheter	Delivery wire
through a 0.027" ID
Microcatheter
Radiopaque
Markers	Platinum marker bands
at each end of the plug	Platinum marker
bands at each end of
the plug	Platinum marker
bands at each end of
the plug	Platinum marker
bands at each end of
the plug
Proximal End of
Plug Config.	Proximal marker band
attached to delivery
wire	Proximal marker band
attached to delivery
wire	Proximal marker
band attached to
delivery wire	Proximal marker
band attached to
delivery wire
Delivery Wire
Length	180 cm	180 cm	160 cm	160 cm
Detachment System	Electrolytic	Electrolytic	Mechanical	Mechanical
Sterilization
Process	EO	EO	EO	EO
Accessories	Electrolytic Box and
Cables	Electrolytic Box and
Cables	Torquer	Torquer

Table 5-1 Comparison to the Predicates

2

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.

3

Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract shapes that resemble a human figure.

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

4

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 [phone] or [phone] 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 [phone] or [phone] 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

5

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."