(98 days)
The Reverse Medical Microcatheter is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.
The Reverse Medical Microcatheter is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter dimensions are included on the individual device labels. The Reverse Medical Microcatheter inner lumen can accommodate guidewires up to 0.018 inches in diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization. The Reverse Medical Microcatheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.
The provided text describes the 510(k) submission for the Reverse Medical Microcatheter. Here's a breakdown of the requested information, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally not explicitly stated with specific numerical thresholds (e.g., "flexibility must be X N/m"). Instead, the report indicates that the device "Met established criteria" for each test. This implies qualitative or pre-defined quantitative criteria that were assessed for conformance.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (2. of 7 tests listed) | Materials must be biocompatible | Met established criteria |
| Cytotoxicity | Pass L929 MEM Elution Test | Met established criteria |
| Sensitization | Pass Kligman Maximization | Met established criteria |
| Intracutaneous Reactivity (Irritation) | Pass Intracutaneous Injection Test | Met established criteria |
| Systemic Toxicity (Acute) | Pass ISO Acute Systemic Injection Test | Met established criteria |
| Hemocompatibility (Complement Activation) | Pass Complement Activation Test | Met established criteria |
| Hemocompatibility (Hemolysis) | Pass Hemolysis Test | Met established criteria |
| Hemocompatibility (Inactivated Partial Thromboplastin Time Test) | Pass Inactivated Partial Thromboplastin Time Test | Met established criteria |
| Hemocompatibility (In vivo thrombogenicity) | Pass in vivo thrombogenicity Test | Met established criteria |
| Pyrogenicity | Pass USP Material Mediated Rabbit Pyrogen Test | Met established criteria |
| EtO Residuals | Ethylene oxide and Ethylene chlorohydrins residuals | Met established criteria |
| Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶ | Met established criteria |
| Design Verification (Bench-Top Testing) | ||
| Dimensional and Visual Inspection | Meet established criteria (e.g., dimensions, visual integrity) | Met established criteria |
| Coating Lubricity | Meet established criteria | Met established criteria |
| Tip Buckling | Meet established criteria | Met established criteria |
| Flexibility/Shaft Stiffness Test | Meet established criteria | Met established criteria |
| Flow Rate Test - 100 psi and 300 psi | Meet established criteria | Met established criteria |
| Priming Volume Test | Meet established criteria | Met established criteria |
| Kink Resistance Test | Meet established criteria | Met established criteria |
| Guidewire Compatibility | Meet established criteria | Met established criteria |
| Guide Catheter Compatibility | Meet established criteria | Met established criteria |
| Catheter Leak Test (Air leakage distal end plugged) | Meet established criteria | Met established criteria |
| Catheter Leak Test (Liquid leakage) | Meet established criteria | Met established criteria |
| Dynamic Pressure Test | Meet established criteria | Met established criteria |
| Static Burst Test | Meet established criteria | Met established criteria |
| Torque Strength (Turns to Failure) | Meet established criteria | Met established criteria |
| Tensile Strength Test | Meet established criteria | Met established criteria |
| Corrosion Resistance | Meet established criteria | Met established criteria |
| USP Particulate Test | Meet established criteria | Met established criteria |
| Navigation Capabilities, Accessibility/Pushability Capabilities, Therapeutic Agents Deliverability (Coils and Stents) | Meet established criteria | Met established criteria |
| In vivo Tests | ||
| System Deliverability, Compatibility, and Visibility | Meet established criteria | Met established criteria |
| Biocompatibility Testing | Meet established criteria | Met established criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench-top or in-vivo test. It states, "All testing was performed on units that were sterilized and met all inspection criteria." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). This is a 510(k) submission, which typically relies on pre-clinical data (bench-top and potentially animal studies for in vivo testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes a medical device's physical, mechanical, and biological performance testing, not an AI or diagnostic device that requires expert-established ground truth.
4. Adjudication method for the test set
Not applicable, as this is not an AI/diagnostic device and does not involve human readers for ground truth establishment.
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 a medical device for physical intervention (microcatheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device; there is no "algorithm only" performance concept in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria in this context is defined by industry standards, engineering specifications, and established scientific methods for evaluating medical device properties (e.g., ISO standards, USP tests, internal design control procedures). For example, biocompatibility uses established biological assay methods, and mechanical tests rely on engineering principles.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device submission.
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Reverse Medical Corporation
Reverse Medical Microcatheter 510(k) Submission
4. 510(k) Summary according to 807.92
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 Microcatheter.
Sponsor /Applicant Name and Address 4.1
Reverse Medical Corporation 13700 Alton Parkway Suite 167 Irvine, CA 92618
DEC 0 7 2012
Sponsor Contact Information 4.2 Linda D'Abate, Vice President RA/CA/QA Phone: 949-215-0660 x202 Mobile 714-235-6608 Fax: 949-215-0661 Email: ldabate@reversemed.com
Date of Preparation of 510(k) Summary 4.3 August 31, 2012
4.4 Device Trade or Proprietary Name Reverse Medical Microcatheter
4.5 Device Common/Usual or Classification Name
Catheter, Percutaneous (Product Code: DQY) and Catheter, Infusion (Product Code KRA)
4.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:
| Name of Predicate Devices | Name of Manufacturer(Town, State) | 510(k) Number |
|---|---|---|
| Headway™ Microcatheter | MicroVention, Inc.Tustin, CA | K083343 |
| ev3 Rebar-18 | CovidienMansfield, MA | K001966 |
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Reverse Medical Corporation
Reverse Medical Microcatheter 510(k) Submission
510(k) Summary according to 807.92 (continued)
4.7 Device Description
The Reverse Medical Microcatheter is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter dimensions are included on the individual device labels. The Reverse Medical Microcatheter inner lumen can accommodate guidewires up to 0.018 inches in diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization.
The Reverse Medical Microcatheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.
4.8 Intended Use
The Reverse Medical Microcatheter is intended for use in neuro, peripheral, and coronary vasculature. The Reverse Medical Microcatheter coaxially tracks over a steerable guidewire in order to access distal tortuous vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
| MicroVention Headway™Microcatheter | ev3 Rebar-18 | Reverse MedicalMicrocatheter | |
|---|---|---|---|
| 510(k) Number | K083343 | K001966 | TBD |
| Classification | Class II, DQY | Class II, KRA | Class II, DQY |
| Indication | Intended for use in neuro,peripheral, and coronaryvasculature for the infusionof diagnostic agents, such ascontrast media andtherapeutic agents such asocclusion coils | Intended for the controlledselective infusion ofphysician-specifiedtherapeutic agents orcontrast media into thevasculature of theperipheral and neuroanatomy | Intended for use in neuro,peripheral and coronaryvasculature for the infusionof diagnostic agents such ascontrast media, andtherapeutic agents such asocclusion coils |
| Shaft Materials | Coaxial lumen braided shaftvariable stiffness catheterwith radiopaque marker ondistal end. | Semi-rigid proximal shaftthat transitions into theflexible distal shaft withsingle or dual radiopaquemarkers at the distal end. | Single lumen, wirereinforced shaft, variablestiffness catheter with dualradiopaque markers ondistal end. |
| Proximal EndConfigurationRadiographicmarkers/radiopacity | Luer Hub | Luer Hub | Luer Hub |
| Dual radiopaque marker atdistal tip | Single or dual radiopaquemarkers at distal end ofshaft. | Dual radiopaque marker atdistal tip | |
| Packaging | Polyethylene hoop andPET/PE/Tyvek pouchinside SBS carton. | Polyethylene hoop andPET/PE/Tyvek pouchinside SBS carton. | Polyethylene hoop andPET/PE/Tyvek pouch insideSBS carton. |
| Sterilization | EtO | EtO | EtO |
4,9 Comparison to Predicate Devices
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Reverse Medical Corporation Reverse Medical Microcatheter 510(k) Submission
K122684 Page 3 of 4
510(k) Summary according to 807.92 (continued)
Summary of Non-Clinical Data 4.10
4.10.1 Biocompatibility and Sterilization
The Reverse Medical Microcatheter is classified as an Externally Communicating Device, Circulating Results of the testing demonstrate that the blood-contacting Blood, Limited Contact (≤24 hours). materials are biocompatible.
Blood-contacting 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 Microcatheter successfully passed all of the following biocompatibility tests:
| Test | Method |
|---|---|
| Cytotoxicity | L929 MEM Elution Test |
| Sensitization | Kligman Maximization |
| Intracutaneous Reactivity (Irritation) | Intracutaneous Injection Test |
| Systemic Toxicity (Acute) | ISO Acute Systemic Injection Test |
| Hemocompatibility | Complement Activation |
| Hemolysis | |
| Inactivated Partial Thromboplastin Time Test | |
| In vivo thrombogenicity | |
| Pyrogenicity | USP Material Mediated Rabbit Pyrogen Test |
| EtO Residuals | Ethylene oxide and Ethylene chlorohydrins residuals |
Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, Sterilization of Health Care Products-Part 1: Requirement, for development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10°.
4.10.2 Design Verification (Bench-Top Testing)
The physical, mechanical, and performance testing of the Reverse Medical Microcatheter 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 Microcatheter. 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 Microcatheter included:
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Reverse Medical Corporation
Reverse Medical Microcatheter 510(k) Submission
K122684 Page 4 of 4
Verification and Test Summary
| In vitro Tests | Result |
|---|---|
| Dimensional and Visual Inspection | Met established criteria |
| Coating Lubricity | Met established criteria |
| Tip Buckling | Met established criteria |
| Flexibility/Shaft Stiffness Test | Met established criteria |
| Flow Rate Test - 100 psi and 300 psi | Met established criteria |
| Priming Volume Test | Met established criteria |
| Kink Resistance Test | Met established criteria |
| Guidewire Compatibility | Met established criteria |
| Guide Catheter Compatibility | Met established criteria |
| Catheter Leak Test (Air leakage distal end plugged) | Met established criteria |
| Catheter Leak Test (Liquid leakage) | Met established criteria |
| Dynamic Pressure Test | Met established criteria |
| Static Burst Test | Met established criteria |
| Torque Strength (Turns to Failure) | Met established criteria |
| Tensile Strength Test | Met established criteria |
| Corrosion Resistance | Met established criteria |
| USP Particulate Test | Met established criteria |
| Navigation Capabilities, Accessibility/Pushability Capabilities, TherapeuticAgents Deliverability (Coils and Stents) | Met established criteria |
| In vivo Tests | Result |
| System Deliverability, Compatibility, and Visibility | Met established criteria |
| Biocompatibility Testing | Met established criteria |
The physical, mechanical, and performance testing of the Reverse Medical Microcatheter demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.
4.11 Substantial Equivalence
The performance of the Reverse Medical Microcatheter in this submission 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, and sterilization validation.
The Reverse Medical Microcatheter 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.
14
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 7 2012
Reverse Medical Corporation Mr. Jeffrey Valko President & CEO 13700 Alton Parkway Suite 167 Irvine, CA 92618 US
Re: K122684
Trade/Device Name: Reverse medical microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: November 8, 2012 Received: November 9, 2012
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
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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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kenneth J.
Cavanaugh
for Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Reverse Medical Corporation Reverse Medical Microcatheter 510(k) Submission
3. Indications for Use
510(k) Number (if known):_K122684
Device Name: Reverse Medical Microcatheter
Indications for Use:
The Reverse Medical Microcatheter is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.
Prescription Use_ × (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)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K122684
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).