(33 days)
The Reverse Medical Micro Vascular Plug (MVP-5) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.
The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.027" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 3.0 -5.0mm. The proximal marker band attaches to a delivery wire that pushes the device through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set - 275 cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP).
The provided document is a 510(k) summary for the Reverse Medical MVP™ Micro Vascular Plug System (MVP-5). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness through clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, the information requested in the prompt, particularly points 1, 2, 3, 4, 5, 6, 7, 8, and 9, which relate to studies proving a device meets acceptance criteria (as typically defined for diagnostic or effectiveness claims), is not directly applicable to this 510(k) submission.
This 510(k) demonstrates the MVP-5's safety and effectiveness by comparing it to an existing predicate device (Reverse Medical MVP-3 System, K123803) based on:
- Non-Clinical Data: Biocompatibility testing and Design Verification (bench-top testing).
- Performance and Design Equivalence: Showing that the new device's materials, specifications, performance, and intended use are substantially equivalent to the predicate, and that any differences do not raise new questions of safety or effectiveness.
Here's how the provided information relates to the prompt's categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied for Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Non-Cytotoxic, Non-Sensitizing, Non-Irritant, Non-Toxic, Non-Pyrogenic, Non-Mutagenic, Non-Hemolytic, Minimal Complement Activation, Non-Activator (Thromboplastin Time), Passed Muscle Implantation |
| Sterilization Assurance Level (SAL) | 10⁻⁶ (validated per ANSI/AAMI/ISO 11135) |
| Physical & Mechanical Properties | All bench-top tests passed successfully (Visual, Dimensional, Tensile Strength, USP Particulate, Radial Force, Microcatheter Compatibility, Detachment Time, Torque Strength, Plug Foreshortening, Nickel Release, Corrosion Resistance, Flow Occlusion/Reduction, Magnetic Resonance Compatibility, Labeling, Packaging, Shelf Life, Detachment Box and Cable Set) |
| Intended Use | Obstruct or reduce the rate of blood flow in the peripheral vasculature (Equivalent to predicate) |
| Method of Placement | Delivery wire through a 0.027" ID microcatheter (Similar to predicate's 0.021" ID) |
| Radiopaque markers | Platinum marker bands at each end (Equivalent to predicate) |
| Proximal End Configuration | Proximal marker band and attachment for pusher wire (Equivalent to predicate) |
| Detachment System | Electrolytic (Equivalent to predicate) |
| Battery Operated | Yes (Equivalent to predicate) |
Note: The "acceptance criteria" here are implicitly the successful passing of each test and demonstrated equivalence to the predicate device, as per 510(k) requirements.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical trial data with human subjects. The tests performed are non-clinical (bench-top and biocompatibility). The sample sizes for these tests are not provided in this summary.
- Data Provenance: Non-clinical (laboratory testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was a non-clinical submission. No "ground truth" was established by experts for a test set of patient data, as would be the case for diagnostic or AI algorithm evaluations.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is mentioned.
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 device is a vascular plug, not a diagnostic imaging device or an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of clinical "ground truth" for diagnostic evaluation. For non-clinical tests, the "ground truth" is established by standard laboratory methods and validated test protocols (e.g., ISO standards for biocompatibility, engineering specifications for mechanical properties).
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not an algorithm or AI system that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of Study Type
The study described is a non-clinical design verification and biocompatibility study, supplemented by a comparison to a legally marketed predicate device. The primary goal was to establish substantial equivalence for the purpose of 510(k) clearance, not to demonstrate clinical efficacy against specific acceptance criteria in a human population. The "acceptance criteria" are the successful passing of established laboratory and bench-top tests, and the demonstration that the device's characteristics and performance are comparable to the predicate.
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K13282
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- NOV 2 7 2013
510(k) Summary
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Reverse Medical Corporation is providing the summary of Substantial Equivalence for the Reverse Medical MVP™ Micro Vascular Plug System (MVP-5).
Device Trade or Proprietary Name Reverse Medical MVP™Micro Vascular Plug System
Sponsor /Applicant Name and Address
Reverse Medical Corporation 13700 Alton Parkway Suite 167 Irvine, CA 92618
Sponsor Contact Information Linda D'Abate
Reverse Medical Vice President, RA/CA/QA
Date of Preparation of 510(k) Summary October 25, 2013
Device Common/Usual or Classification Name
Device Embolization, Vascular (Product Code: KRD)
Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:
| Name of Predicate Device | Manufacturer | 510(k) Number |
|---|---|---|
| Reverse Medical MVP™ | Reverse Medical™ | K123803 |
| Micro Vascular PlugSystem (MVP-3) | CorporationIrvine, CA |
Device Description
The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.027" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 3.0 -5.0mm.
The proximal marker band attaches to a delivery wire that pushes the device through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set - 275
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cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP).
Intended Use
The Reverse Medical MVP is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.
| New Device | PredicateDevice | |
|---|---|---|
| Reverse MedicalMVP-5 System | Reverse MedicalMVP-3 System | |
| 510(k) No. | K123803 Class IIKRD 870:3300 | K123803 Class IIKRD 870:3300 |
| Indication foruse | Indicated for use toobstruct or reducethe rate of bloodflow in theperipheralvasculature. | Indicated for use toobstruct or reducethe rate of bloodflow in theperipheralvasculature. |
| Method ofPlacement | Delivery wirethrough a 0.027" IDmicrocatheter. | Delivery wirethrough a 0.021" IDmicrocatheter. |
| Radiopaquemarkers | Platinum markerbands at each end | Platinum markerbands at each end |
| Proximal EndConfiguration | Proximal markerband andattachment forpusher wire | Proximal markerband andattachment for pusherwire |
| DetachmentSystem | Yes - Electrolytic | Yes - Electrolytic |
| BatteryOperated | Yes | Yes |
Comparison to Predicate Device
Summary of Non-Clinical Data
Biocompatibility and Sterilization
The device was characterized as an implant, internal communicating device, which contacts circulating blood for exposure ≥ 30 days.
The Reverse Medical MVP materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1 guidelines "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." The Reverse Medical MVP successfully passed all of the following biocompatibility tests, demonstrating that the materials are biocompatible:
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| Test | Results/Acceptance |
|---|---|
| Cytotoxicity | Non-Cytotoxic |
| Kligman MaximizationSensitization Test | Non-Sensitizing. |
| Intracutaneous Injection | Non-Irritant |
| Systemic Injection | Non-Toxic |
| Material-Mediated Pyrogenicity | Non-Pyrogenic |
| Genotoxicity/Mutagenicity | Non-Mutagenic |
| In Vitro Mouse Lymphoma Assay | Non-Mutagenic |
| In Vivo Mouse Lymphoma | Non-Mutagenic |
| Hemolysis | Non-Hemolytic |
| Complement Activation C3a andSC5ba-9 | No greater biological response than corresponding control |
| Inactivated Partial | Minimal, passed acceptance criteria |
| Thromboplastin Time | Non-activator, passed acceptance criteria |
| Platelet and Leukocyte Counts | Test articles: No range or acceptable level established. |
| Muscle Implantation | Intramuscular Implantation- 4 and 13 week, passedacceptance criteria |
Test Result Summary
Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, Sterilization of Health Care Products-Part 1: Requirement, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10 °.
Design Verification (Bench-Top Testing)
The physical, mechanical, and performance testing of the Reverse Medical MVP System demonstrate that the product is substantially equivalent to the currently marketed predicate devices. Design verification testing was conducted to evaluate the physical and mechanical properties of the Reverse Medical MVP. All studies 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:
Verification and Test Summary
- � Visual Inspection
- . Dimensional Inspection
- . Tensile Strength
- . USP Particulate
- � Radial Force
- . Microcatheter Compatibility
- . Detachment Time
- Torque Strength .
- Plug Foreshortening
- . Nickel Release
- Corrosion Resistance (potentiodynamic . and galvanic)
- Flow Occlusion/Reduction
- Magnetic Resonance Compatibility ●
- . Labeling
- . Packaging
- Shelf Life
- . Sterility
- � Biocompatibility
- . Detachment Box and Cable Set
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All tests performed passed successfully. The physical, mechanical, and performance testing of the Reverse Medical MVP System demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices
Substantial Equivalence
The performance of the Reverse Medical MVP-5 System demonstrates that the product is substantially equivalent to the performance of the predicate devices. The equivalence was shown through comparison of component materials and specifications, performance, biocompatibility testing, animal testing, and sterilization validation.
The Reverse Medical MVP-5 System is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the predicate devices. Differences between the devices do not raise any significant issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
November 27, 2013
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
Reverse Medical Corporation C/O Jeffrey Valko. President & CEO 13700 Alton Parkway, Suite 167 Irvine, CA 92618
Re: K133282
Trade/Device Name: Reverse Medical Micro Vascular Plug (MVP-5) System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 25, 2013 Received: October 28, 2013
Dear Mr. Valko:
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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jeffrey Valko
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
M.A. Hilleman
for
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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Reverse Medical Corporation Special 510(k): Device Modification
.
Attachment 2: Indication for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
・・・・・・・・・・・・
Device Name: Reverse Medical Micro Vascular Plug (MVP-5)
Indication for Use:
The Reverse Medical Micro Vascular Plug (MVP-5) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use_ (21 CFR 801 Subpart C)
. . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillemann
§ 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).