(204 days)
The Reverse Medical™ Micro Vascular Plug (MVP™) 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 (0.021" 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 1.5 – 3.0mm. The proximal marker band attaches to a delivery wire that pushes 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).
This document is a 510(k) Summary for the Reverse Medical MVP™ Micro Vascular Plug System, which focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain a study that establishes acceptance criteria for specific device performance metrics in the way a clinical trial or a detailed performance study with defined endpoints would. Instead, it relies on non-clinical data (biocompatibility, sterilization, and bench-top testing) to show that the device performs as intended and is comparable to predicate devices.
Therefore, many of the requested sections (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission, as it's not a clinical effectiveness study of an AI/ML device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a table for biocompatibility tests, which acts as acceptance criteria for the biological safety of the materials. It also lists various design verification tests (bench-top testing) that were performed, indicating that "All tests performed passed successfully." However, specific numerical acceptance criteria and reported performance values for each of these mechanical/performance tests are not provided in this summary.
| Test Type | Acceptance Criteria (Stated) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic |
| Kligman Maximization Sensitization Test | Non-Sensitizing | Non-Sensitizing |
| Intracutaneous Injection | Non-Irritant | Non-Irritant |
| Systemic Injection | Non-Toxic | Non-Toxic |
| Material-Mediated Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic |
| Genotoxicity/Mutagenicity | Non-Mutagenic | Non-Mutagenic |
| In Vitro Mouse Lymphoma Assay | Non-Mutagenic | Non-Mutagenic |
| In Vivo Mouse Lymphoma | Non-Mutagenic | Non-Mutagenic |
| Hemolysis | Non-Hemolytic | Non-Hemolytic |
| Complement Activation C3a and SC5ba-9 | No greater biological response than corresponding control | No greater biological response than corresponding control |
| Inactivated Partial Thromboplastin Time | Minimal, passed acceptance criteria | Non-activator, passed acceptance criteria |
| Platelet and Leukocyte Counts | No range or acceptable level established (Test Articles) | (No specific numeric result; assumed within acceptable range for testing) |
| Muscle Implantation | Passed acceptance criteria (4 and 13 week) | Intramuscular Implantation- 4 and 13 week, passed acceptance criteria |
| Design Verification (Bench-Top Testing) | ||
| Visual Inspection | (Implied to meet specifications) | Passed successfully |
| Dimensional Inspection | (Implied to meet specifications) | Passed successfully |
| Tensile Strength | (Implied to meet specifications) | Passed successfully |
| USP Particulate | (Implied to meet specifications) | Passed successfully |
| Radial Force | (Implied to meet specifications) | Passed successfully |
| Microcatheter Compatibility | (Implied to meet specifications) | Passed successfully |
| Detachment Time | (Implied to meet specifications) | Passed successfully |
| Torque Strength | (Implied to meet specifications) | Passed successfully |
| Plug Foreshortening | (Implied to meet specifications) | Passed successfully |
| Nickel Release | (Implied to meet specifications) | Passed successfully |
| Corrosion Resistance | (Implied to meet specifications) | Passed successfully |
| Flow Occlusion/Reduction | (Implied to meet specifications) | Passed successfully |
| Magnetic Resonance Compatibility | (Implied to meet specifications) | Passed successfully |
| Labeling | (Implied to meet specifications) | Passed successfully |
| Packaging | (Implied to meet specifications) | Passed successfully |
| Shelf Life | (Implied to meet specifications) | Passed successfully |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ | Validated to provide SAL of 10⁻⁶ |
| Biocompatibility | (As detailed above) | Passed successfully |
| Detachment Box and Cable Set | (Implied to meet specifications) | Passed successfully |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for individual bench tests; generally involves representative samples of manufactured devices.
- Data Provenance: Not explicitly stated, but all testing described is non-clinical (bench-top, in vitro/ex vivo lab testing, and animal testing for biocompatibility). Given the company location (Irvine, CA), it's highly likely this testing was conducted in the US or by US-based contractors, but this is not explicitly stated as "country of origin for data." All data is prospective insofar as it was generated specifically for this 510(k) submission, not gathered from past clinical procedures.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a medical device 510(k) for a physical implant, not an AI/ML diagnostic device requiring expert interpretation for ground truth. Ground truth for these tests is based on objective measurements, chemical analysis, and standardized biological observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Ground truth is established through laboratory test protocols, not physician adjudication.
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 physical implant, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility: Ground truth is established by standardized biological assays and observation of biological responses, compared against control samples where relevant.
- For design verification: Ground truth is established by engineering specifications, objective physical measurements (e.g., tensile strength, dimensions, detachment time), and functional tests (e.g., flow occlusion in a mock vessel).
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. As above, no machine learning training set is involved.
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Image /page/0/Picture/0 description: The image shows the logo for Reverse Medical. The logo is in black and white and features the words "Reverse Medical" in a bold, sans-serif font. To the upper right of the word "Medical" is the trademark symbol. Underneath the words is a curved line that starts thin on the left and gradually thickens as it curves upward to the right, ending in an arrowhead.
K123803
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.
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
June 24, 2013
Device Common/Usual or Classification Name
Device Embolization, Vascular (21 CFR 870.3300, Product Code: KRD)
Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:
| Name of PredicateDevices | Manufacturer | 510(k) Number |
|---|---|---|
| AMPLATZER® Vascular Plug 4 | AGA CorporationPlymouth, MN | K113658 |
| Azur Peripheral HydroCoilEndovascular EmbolizationSystem - Detachable 35 | MicroVention, Inc.Tustin, CA | K093002 |
| Axium Detachable Coil System | ev3 Endovascular, Inc.Irvine, CA | K081465 |
| InZone Detachment Systemwith the IZDS Connecting Cable | Boston Scientific, IncFreemont, CA | K103008 |
| Guglielmi Detachable CoilPower Supply | Boston Scientific, IncFreemont, CA | K001083 |
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 (0.021" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an
2 2013 JUL
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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 1.5 – 3.0mm.
The proximal marker band attaches to a delivery wire that pushes 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).
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 | Predicate Devices | |||||
|---|---|---|---|---|---|---|
| Reverse MedicalMVP System | AMPLATZER®Vascular Plug 4 | Azur PeripheralHydroCoilEndovascularEmbolizationSystem –Detachable 35 | Axium DetachableCoils | InZone DetachmentSystem with the IZDSConnecting Cable | Guglielmi DetachableCoil Power Supply | |
| 510(k) No. | K123803 Class IIKRD 870:3300 | K113658 Class IIKRD 870:3300 | K093002 Class IIKRD 870:3300 | K081465 Class IIKRD 870:3300 | K103008 Class IIKRD 870:3300 andHCG | K001083 Class IIHCG 882.5950 |
| Indication foruse | Indicated for useto obstruct orreduce the rate ofblood flow in theperipheralvasculature. | Indicated for arterialand venousembolizations in theperipheralvasculature. | Intended to reduceor block the rate ofblood flow invessels of theperipheralvasculature. | The AXIUMDetachable Coils arealso indicated forarterial and venousembolizations in theperipheralvasculature | Intended for use withall versions of BSCDetachable Coils in theembolization ofintracranial aneurysmsand other vascularmalformations of theneuro and peripheralvasculature. | Intended for use withall versions of BostonScientific/Target'sGuglielmi DetachableCoils in theembolization ofintracranialaneurysms and othervascularmalformations of theneuro and peripheralvasculature |
| Method ofPlacement | Delivery wirethrough a 0.021" IDmicrocatheter. | Delivery wire | Delivery wire | Delivery wire(pusher) | Delivery wire | Delivery wire |
| Radiopaquemarkers | Platinum markerbands at each end | Radiopaque markerbands at each end | N/A | Radiopaque positionmarker | Radiopaque positionmarker | Radiopaque positionmarker |
| Proximal EndConfiguration | Proximal markerband andattachment forpusher wire | Radiopaque markerband and microscrew attachment | N/A | N/A | N/A | N/A |
| DetachmentSystem | Yes - Electrolytic | Yes - Mechanical | Yes - Thermal | Yes - Mechanical | Yes - Electrolytic | Yes - Electrolytic |
| BatteryOperated | Yes | No | Yes | No | Yes | Yes |
Comparison to Predicate Devices
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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:
| 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 Leukocycte Counts | Test articles: No range or acceptable level established. |
| Muscle Implantation | Intramuscular Implantation- 4 and 13 week, passed acceptance 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:
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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
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 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 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2013
Reverse Medical Corporation c/o Mr. Jeffrey Valko 13700 Alton Parkway, Suite 167 Irvine, CA 92618
Re: K123803
Trade/Device Name: Reverse Medical Micro Vascular Plug System Regulation Number: 21 CFR 870.3300 Regulation Name: Device. Vascular, For Promoting Embolization Regulatory Class: Class II Product Code: KRD Dated: June 10, 2013 Received: June 11, 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, 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.
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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 . contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/MedicalDeyices/Safety/ReportalProblem/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,
Bram D. Zuckerman -S
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):_
Device Name: Reverse Medical™ Micro Vascular Plug (MVP™)
Indication for Use:
: ・
The Reverse Medical™ Micro Vascular Plug (MVP™) 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)
Bram D. Zuckerman -S
2013.07.02 17:24:16
-04'00'
§ 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).