(197 days)
The Reverse Medical Microcatheter-027 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-027 is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter-027 dimensions are included on the individual device labels. The Reverse Medical Microcatheter-027 inner lumen can accommodate guidewires up to 0.025 inches inner diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization.
Each Reverse Medical Microcatheter-027 is provided with accessories, which include a shaping mandrel and peel away introducer within a Tyvek™ pouch.
The shaping mandrel allows the catheter tip to be steam shaped by the physician for proper adjustment to the anatomy prior to use. Test data is presented in this submission for both the 027 and 021 Reverse Medical Microcatheters to support the inclusion of the shaping mandrel and the peel away introducer.
The Reverse Medical Microcatheter-027 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reverse Medical Microcatheter-027:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence through non-clinical (bench-top) testing. There isn't a comprehensive "device performance" section in the way one might expect for a clinical study with sensitive/specific metrics. Instead, the performance is reported against established engineering or safety criteria.
| Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (L929 MEM Elution) | Grade 0 (No cell lysis) per ISO 10993-5. | Non-Cytotoxic (Grade 0) |
| Sensitization (Kligman Maximization) | Grade 0 (no visible change) per ISO 10993-10. | Non-Sensitizing (Grade 0) |
| Systemic Toxicity (Acute) | Score 0, no toxicity or animal weight loss for cottonseed oil and saline extracts per ISO 10993-11. | Non-Toxic (Score 0) |
| Hemocompatibility (Complement Activation) | No greater biological response than corresponding control. | Met criteria |
| Hemolysis | Hemolytic grade score of zero, considered non-hemolytic. | Non-Hemolytic (Score 0) |
| Inactivated Partial Thromboplastin Time | Minimal activator of intrinsic coagulation pathway; passed test (clotting time 290 seconds vs. 300 seconds for negative/reference). | Non-Activator |
| In vivo Thrombogenicity | No adverse effects or clinical signs. | Non-Thrombogenic |
| Pyrogenicity (USP Material Mediated) | Non-pyrogenic; no individual rabbit temperature rise >= 0.5 deg. C per ISO 10993-11. | Non-Pyrogenic |
| EtO Residuals | Met criteria in accordance with ISO 10993-7 Part 7. | Passed, acceptable limits |
| Genotoxicity (Bacterial Reverse Mutation) | No statistically significant increase in revertant colonies compared to negative controls. | Non-Mutagenic |
| Genotoxicity (Mouse lymphoma) | Did not produce significantly more revertant colonies than negative controls. | Non-Mutagenic |
| Genotoxicity (In vivo micronucleus) | No statistically significant increase in micronucleus in test article extract vs. negative control. | Non-Mutagenic |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 according to ANSI / AAMI / ISO 11135. | Validated ($10^{-6}$ SAL) |
| Design Verification (Bench-Top) | ||
| Dimensional/Visual Inspection | Per test protocol rev B. | Pass |
| Tip Buckling Test | Perform the same or better than predicate devices (95/90 confidence/reliability). | Pass |
| Coating Lubricity Test | Frictional force; Coating Length (95/90 confidence/reliability). | Pass |
| Flexibility/Shaft Stiffness Test | Distal tip and proximal shaft flexibility comparable or better than predicate. | Pass |
| Priming Volume Test | For comparison to predicate; equal to or better than predicate. | Pass |
| Flow Rate Test | For comparison to predicate; equal to or better than predicate. | Pass |
| Guidewire Compatibility Test | Free movement of appropriately sized guidewires; Frictional force (95/90 confidence/reliability). | Pass |
| Guide Catheter Compatibility Test | Free movement inside appropriately sized Guide Catheter; Frictional force measurement (95/90 confidence/reliability). | Pass |
| Catheter Air Leakage Test | Per ISO 10551-1. | Pass |
| Catheter Liquid Leakage Test | No leaks in accordance with protocol. | Pass |
| Dynamic Pressure Test | No leaks due to dynamic pressure test; Peak Pressure. | Pass |
| Static Pressure Test | Burst pressure in accordance with protocol (95/90 confidence/reliability). | Pass |
| Kink Resistance Test | Distal kink resistance (95/90 confidence/reliability). | Pass |
| Torque Strength Test | X revolutions without failure. | Pass |
| Corrosion Resistance | No corrosion on metallic components. | Pass |
| USP Particulate Testing | Report total of particles; Compare to predicate devices (USP 788). | Pass |
| Tensile Strength | Distal/medial; medial/proximal; proximal/hub (95/90 confidence/reliability). | Pass |
| Navigation/Accessibility/Pushability | Comparable to predicate devices. | Pass |
| Micro-devices Compatibility | Comparable to predicate devices. | Pass |
| With Steam-Shaping Capabilities | ||
| Dimensional and Visual Inspection | Per test protocol rev B. | Pass |
| Steam Shaping Capabilities | No Damage; Shape Inspection (at various angles). | Pass |
| Coating Lubricity Test - Post Steam Shaping | Frictional force (Pass/Fail). | Pass |
| Static Pressure Test - Post Steam Shaping | Burst pressure (95/90 confidence/reliability). | Pass |
| Tensile Strength - Post Steam Shaping | Distal/Medial; Medial/Proximal; Proximal/Hub (95/90 confidence/reliability). | Pass |
| Navigation/Accessibility/Pushability | Comparable to predicate. | Pass |
| Micro-devices Compatibility | Can allow uses of other micro-devices, in simulated flow model. | Pass |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench-top test. For some tests (e.g., Tip Buckling, Coating Lubricity, Guidewire Compatibility, Guide Catheter Compatibility, Static Pressure, Kink Resistance, Tensile Strength), the acceptance criteria mention "95/90," which typically refers to a 95% confidence level with 90% reliability, implying a statistically significant sample size was used for those specific tests. However, the absolute number of devices tested is not provided.
- Data Provenance: All data presented is from pre-clinical (bench-top) testing. The document does not indicate any human data or provide country of origin, as it's not a clinical study. It's internal testing conducted by Reverse Medical Corporation.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not applicable to the provided document. The "ground truth" for this submission is based on established engineering standards (ISO, USP, internal protocols) and comparison to predicate devices, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. This document describes bench-top engineering tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This submission focuses on the substantial equivalence of a medical device (microcatheter) through non-clinical testing, not on the performance of an AI algorithm or human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study in the context of an AI algorithm was not done. The device is a physical microcatheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests is derived from:
- Established international and national standards (e.g., ISO, USP).
- Internal test protocols and specifications.
- Performance of legally marketed predicate devices, against which the new device's performance is compared for substantial equivalence.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for Reverse Medical. The text "REVERSE MEDICAL" is in bold, black font. There is a curved line underneath the text that ends in an arrow pointing upwards.
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-027.
Sponsor /Applicant Name and Address 5.1
Reverse Medical Corporation 13700 Alton Parkway, Suite 167 Irvine, CA 92618
5.2 Sponsor Contact Information
Linda D'Abate, Vice President RA/CA/QA Phone: 949-215-0660 x202 Mobile 714-235-6608 Fax: 949-215-0661 Email: Idabate@reversemed.com
5.3 Date of Preparation of 510(k) Summary
October 4, 2013
5.4 Device Trade or Proprietary Name
Reverse Medical Microcatheter-027
ર .5 Device Common/Usual or Classification Name
Catheter, Percutaneous (Product Code: DQY) (21 CFR.870. 1250)and Catheter, Infusion (Product Code KRA) (21 CFR 870.1210) and Diagnostic Intravascular Catheter (DQO, 21CFR870.1200)
Identification of the Legally Marketed Devices to which Equivalence is Being 5.6 Claimed:
| Name of Predicate Devices | Name of Manufacturer(City, State) | 510(k)Number |
|---|---|---|
| Headway™ 27 Microcatheter | MicroVention, Inc.Tustin, CA | K110813 |
| Excelsior® XT-27™ Microcatheter | Stryker NeurovascularFremont, CA | K113778 |
| Reverse Medical Microcatheter-021 | Reverse Medical Corp.Irvine, CA | K122684 |
5.7 Device Description
The Reverse Medical Microcatheter-027 is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter-027 dimensions are included on the individual device labels. The Reverse Medical Microcatheter-027 inner lumen can accommodate guidewires up to 0.025 inches inner diameter to
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access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization.
Each Reverse Medical Microcatheter-027 is provided with accessories, which include a shaping mandrel and peel away introducer within a Tyvek™ pouch.
The shaping mandrel allows the catheter tip to be steam shaped by the physician for proper adjustment to the anatomy prior to use. Test data is presented in this submission for both the 027 and 021 Reverse Medical Microcatheters to support the inclusion of the shaping mandrel and the peel away introducer.
The Reverse Medical Microcatheter-027 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.
5.8 Intended Use
The Reverse Medical Microcatheter-027 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 inclusion coils.
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| MicroVentionHeadway™ 27Microcatheter | Excelsior® XT-27™Microcatheter | Reverse MedicalMicrocatheter-021 | Reverse MedicalMicrocatheter-027 | |
|---|---|---|---|---|
| 510(k)Number | K110813 | K113778 | K122684 | TBD |
| Classification | Class II, DQY | Class II, DQY | Class II, DQY and KRA | Class II, DQY and KRA |
| Indication | Intended for use inthe peripheral, coro-nary and neurovascu-lature for the infusionof diagnostic agents,such as contrastmedia and therapeuticagents such asocclusion coils. | Intended to assist indelivery of diagnosticagents (such as con-trast media), thera-peutic agents, andnon-liquid intervene-tional devices (such asstents) intended foruse in the neurovascu-lature and with acatheter of 0.027" I.D. | Intended for use inneuro, peripheral andcoronary vasculaturefor the infusion ofdiagnostic agents suchas contrast media, andtherapeutic agentssuch as occlusion coils. | Intended for use inneuro, peripheral andcoronary vasculaturefor the infusion ofdiagnostic agents suchas contrast media, andtherapeutic agentssuch as occlusion coils. |
| ShaftMaterials | Coaxial lumen braidedshaft variable stiffnesscatheter withradiopaque marker ondistal end. | Semi-rigid proximalshaft that transitionsinto the flexible distalshaft with single ordual radiopaque mark-ers at the distal end. | Single lumen, wirereinforced shaft,variable stiffnesscatheter with dualradiopaque markerson distal end. | Single lumen, wirereinforced shaft,variable stiffnesscomposite catheterwith dual radiopaquemarkers on distal end. |
| Proximal EndConfiguration | Luer Hub | Luer Hub | Luer Hub | Luer Hub |
| Radiographicmarkers/radiopacity | Dual radiopaquemarkers at distal tip. | Single or dualradiopaque markers atdistal end of shaft. | Dual radiopaquemarkers at distal tip. | Dual radiopaquemarkers at distal tip. |
| Packaging | Polyethylene hoopand PET/PE/Tyvekpouch inside SBScarton. | Polyethylene hoopand PET/PE/Tyvekpouch inside SBScarton. | Polyethylene hoopand PET/PE/Tyvekpouch inside SBScarton. | Polyethylene hoopand PET/PE/Tyvekpouch inside SBScarton. |
| Sterilization | EtO | EtO | EtO | EtO |
| Peel Awayintroducer | Yes | Yes (data presented inthis submission) | Yes | |
| Catheter TipShapingMandrel | Yes | Yes | Yes (data presented inthis submission) | Yes |
5.9 Comparison to Predicate Devices
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Summary of Non-Clinical Data 5.10
5.10.1 Biocompatibility and Sterilization
The Reverse Medical Microcatheter-027 is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (s24 hours). Results of the testing demonstrate that the blood-contacting 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-027 successfully passed all of the following biocompatibility tests:
| Test | Results | Conclusion |
|---|---|---|
| CytotoxicityL929 MEM Elution Test | MEM Elution test scored a grade 0 (No celllysis) per ISO 10993-5. | Non-Cytotoxic |
| SensitizationKligman Maximization | Sensitization test scored a grade 0 (no visiblechange) per ISO 10993-10 | Non-Sensitizing |
| Systemic Toxicity (Acute)ISO Acute SystemicInjection Test | Acute Systemic Injection Test Articles scored0 with no toxicity or animal weight loss forboth the cottonseed oil and saline extractsper ISO 10993-11 | Non-Toxic |
| Hemocompatibility:Complement Activation | Under the conditions of the C3a assay, thetest article exhibited activation at 9421ng/ml. This was 5.8%of the normalized C3aconcentration produced by CVF. Under theconditions of the SC5b-9 assay, the testarticle exhibited activation at 8836 ng/ml.This was 0.1%of the normalized SC5b-9concentration produced by CVF. Allbiomaterials have the potential to affect themake-up of the complement activationcomponents of the blood. | No greater biologicalresponse thancorresponding control |
| Hemolysis | The test article with negative control exhibited a hemolytic grade score of zero and is considered non-hemolytic. | Non- Hemolytic |
| Inactivated PartialThromboplastin Time | The negative and positive controls met the criteria for a valid assay. The variance between duplicate readings was less than 15%. The clotting times were as follow:Positive control: 107 secondsNegative control: 300 secondsReference material: 300 secondsTest Article: 290 secondsThe test article is considered to be a minimal activator of the intrinsic coagulation pathway. The test article was considered to pass the test. | Non Activator |
| In vivo Thrombogenicity | Implantation of the test and control devices resulted in no adverse effects or clinical signs. | Non-Thrombogenic |
| PyrogenicityUSP Material MediatedRabbit Pyrogen Test | Material-mediated pyrogenicity test was non-pyrogenic with no individual rabbit at any time having a temperature rise of greater than or equal to 0.5 deg. C per ISO 10993-11 | Non- Pyrogenic |
| EtO ResidualsEthylene Oxide andEthylene ChlorohydrinsResiduals | ETO residuals met the criteria in accordance with ISO 10993-7 Part 7 | Passed, acceptable limits |
| Genotoxicity/BacterialReverse Mutation | A statistically significant increase in the number of revertant colonies was not observed with the test article extracts as compared to the negative controls in both non-activated and S9 activated conditions. | Non-Mutagenic |
| Genotoxicity - Mouselymphoma | The test article extracts (saline and DMSO)did not produce significantly more revertantcolonies than the negative controls. | Non-Mutagenic |
| Genotoxicity - In vivomicronucleus | There was no statistically significant increasein the number of micronucleus in the testarticle extract (saline and sesame oil) vs.negative control group. | Non-Mutagenic |
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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 °.
5.10.2 Design Verification (Bench-Top Testing)
The physical, mechanical, and performance testing of the Reverse Medical Microcatheter-027 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-027 with and without steam-shaping capabilities. 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-027 included:
| Test Descriptions | Acceptance Criteria | Requirements | Pass/Fail |
|---|---|---|---|
| Dimensional/VisualInspection | Per test protocol rev B | Pass/Fail | Pass |
| Tip Buckling Test | Peak Force Perform the same or better thanthe predicate devices | 95/90 | Pass |
| Coating Lubricity Test | Frictional forceCoating Length | 95/90 | Pass |
| Flexibility/Shaft StiffnessTest | The distal tip and proximal shaft flexibilityshould perform comparably or better than thepredicate | Pass/Fail | Pass |
| Priming Volume Test | For comparison to predicate | Equal to or better thanpredicate | Pass |
| Flow Rate Test | For comparison to predicate | Equal to or better thanpredicate | Pass |
| Guidewire CompatibilityTest | Free movement of appropriately sizedguidewiresFrictional force | 95/90 | Pass |
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| Guide CatheterCompatibility Test | Free movement inside an appropriately sizedGuide Catheter. Frictional force measurement | 95/90 | Pass |
|---|---|---|---|
| Catheter Air Leakage Test-per ISO 10551-1 | Per ISO 10551-1 | Pass/Fail | Pass |
| Catheter Liquid LeakageTest | No leaks in accordance with protocol | Pass/Fail | Pass |
| Dynamic Pressure Test | No leaks due to dynamic pressure test.Peak Pressure: | Pass/Fail | Pass |
| Static Pressure Test | Burst pressure in accordance with protocol | 95/90 | Pass |
| Kink Resistance Test | Distal kink resistanceMedial/proximal: for characterizationpurposes. | 95/90 | Pass |
| Torque Strength Test | X revolutions without failure. | Pass/Fail | Pass |
| Corrosion Resistance | No corrosion on metallic components. | Pass/Fail | Pass |
| USP Particulate Testing | Report total of particles. Compare topredicate devices. | USP 788 | Pass |
| Tensile Strength | Distal/medial ; medial/proximalProximal/hubProximal/hub | 95/90 | Pass |
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The physical, mechanical, and performance testing of the Reverse Medical Microcatheter-027 demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices
| Test Descriptions | Acceptance Criteria | Requirement | Pass/Fail |
|---|---|---|---|
| Navigation/ Accessibility/Pushability | Comparable to predicate devices | Pass/Fail | Pass |
| Micro-devicesCompatibility | Comparable to predicate devices | Pass/Fail | Pass |
In vitro Test Results for Reverse Microcatheter-027 Without Steam-Shaping Capabilities
Performance/Functional Verification Test Results for Reverse Microcatheter-027 and 021 With Steam-Shaping Capabilities
| Test Descriptions | Acceptance Criteria | Requirements | Pass/Fail |
|---|---|---|---|
| Dimensional and VisualInspection | Per test protocol rev B. | Pass/Fail | Pass |
| Steam Shaping Capabilities | No DamageShape Inspection: at various angles | Pass/Fail | Pass |
| Coating Lubricity Test - PostSteam Shaping Test | Frictional force | Pass/Fail | Pass |
| Static Pressure Test - PostSteam Shaping Test | Burst pressure | 95/90 | Pass |
| Tensile Strength - Post SteamShaping Test | Distal/MedialMedial/ProximalProximal/Hub | 95/90 | Pass |
In vitro Bench Test Results for Reverse Microcatheter-027 and 021 Post Steam-Shaping
| Navigation/ Accessibility/Pushability | Comparable to predicate | Pass/Fail | Pass |
|---|---|---|---|
| Micro-devices Compatibility | Can allow uses of other micro-devices, insimulated flow model. |
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5.11 Substantial Equivalence
The performance of the Reverse Medical Microcatheter-027 with and without steam-shaping capabilities 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-027 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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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three flowing lines extending from the figure's head, representing health, services, and the human aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6(19 Silver Spring, MI) 20993-0002
October 11, 2013
Reverse Medical Corporation Mr. Jeffrey Valko President/Chief Executive Officer 13700 Alton Parkway, Suite 167 Irvine. CA 92618
Re: K130858
Trade/Device Name: Reverse Medical Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Perculancous Regulatory Class: Class II Product Code: DQY. KRA and DQO Dated: September 6, 2013 Received: September 6, 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 cither 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 or any 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
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Page 2 - Jeffrey Valko
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 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/ResourcesforYowIndustry/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 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,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K130858
Device Name: Reverse Medical
Indications For Use:
The Reverse Medical Microcatheter-027 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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 1 of 1
§ 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).