(85 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a guide catheter, with no mention of AI or ML capabilities.
No.
Justification: The device is a guide catheter, which facilitates the introduction of other interventional devices, rather than directly providing therapy itself.
No
The device, a guide catheter, is explicitly stated to be for "introduction of interventional devices." Its description details its physical properties and ability to accommodate guidewires, but no mention of diagnostic capabilities is made. Its purpose is to facilitate other interventional devices and procedures, not to diagnose a condition.
No
The device description clearly describes a physical catheter with a shaft, lumen, hydrophilic coating, luer fitting, and various sizes. It also details extensive bench-top and in vivo testing of physical and mechanical properties, which are characteristic of a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of interventional devices into the peripheral, and neuro vasculature." This describes a device used within the body for a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lumen for guidewires and a luer fitting for infusion. This aligns with an interventional device, not an IVD.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, and mechanical properties like torque response, kink resistance, and navigation capabilities in vitro and in vivo. These are typical tests for medical devices used in procedures, not for IVDs which would involve analytical performance characteristics related to detecting or measuring substances in samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
In summary, the Reverse Medical ReFlex™ Guide Catheter is an interventional medical device used for accessing blood vessels, not an in vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The ReFlex™ Guide Catheter is a single lumen, flexible, variable stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The ReFlex™ Guide Catheter shaft is visible under fluoroscopy. The ReFlex™ Guide Catheter dimensions are included on the individual device label. The ReFlex™ Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system.
The proximal end of the ReFlex™ Guide Catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral, and neuro 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)
Design Verification (Bench-Top Testing) study was conducted to evaluate the physical and mechanical properties of the ReFlex™ Guide Catheter. All studies were conducted in accordance with Reverse Medical Design Control procedures. All testing was performed on units which were sterilized and met all inspection criteria. Tests on the ReFlex™ Guide Catheter included: Dimensional and Visual Inspection, Guidewire Compatibility, Torque Response, Torque Strength, Kink Resistance, Flexibility Test, Tensile Strength, Catheter Leak Test (Liquid Leakage), Catheter Leak Test (Air Leakage), Dynamic Pressure Test, Static Burst Test, Aspiration Test, Hub Gauging, Corrosion Resistance, USP Particulate Test, Navigation and Accessibility Capabilities in vitro, System Deliverability, Compatibility, Visibility and Aspiration Performance - in vivo, Acute histopathology of treated vessels - in vivo, Biocompatibility testing. All tests met established criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 ReFlex™ Guide Catheter,
4.1 Sponsor /Applicant Name and Address
Reverse Medical Corporation 13900 Alton Parkway Suite 123 Irvine, CA 92618
4.2 Sponsor Contact Information
Jeff Valko President/CEO Phone: 949-215-0660 949-215-0661 Fax: email: jvalko@reversemed.com
4.3 Date of Preparation of 510(k) Summary
March 10, 2011
4.4 Device Trade or Proprietary Name
ReFlex™ Guide Catheter
4.5 Device Common/Usual or Classification Name
Catheter, Percutaneous (Product Code: DQY)
4.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:
| Name of Predicate Device | Name of Manufacturer
(Town, State) | 510(k) Number |
|------------------------------------------------|-----------------------------------------------|---------------|
| Penumbra Neuron™
Intracranial Access System | Penumbra, Inc.
Alameda, CA | K070970 |
| HD Guide Catheter | Concentric Medical, Inc.
Mountain View, CA | K090335 |
APR - 5 2011
1
510(k) Summary according to 807.92 (continued)
4.7 Device Description
The ReFlex™ Guide Catheter is a single lumen, flexible, variable stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The ReFlex™ Guide Catheter shaft is visible under fluoroscopy. The ReFlex™ Guide Catheter dimensions are included on the individual device label. The ReFlex™ Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system.
The proximal end of the ReFlex™ Guide Catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.
4.8 Intended Use
The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature.
| 4.9 Comparison to Predicate Devices | |||
|---|---|---|---|
| -- | -- | ------------------------------------- | -- |
| | Penumbra Neuron™
Intracranial Access
System | HD Guide Catheter | ReFlex™ Guide
Catheter |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K070970 | K090335 | TBD |
| Classification | Class II, DQY | Class II, DQY | Class II, DQY |
| Indication | The ... is indicated for
the introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. | The ... is indicated for
use in facilitating the
insertion and guidance
of an occlusion
catheter, infusion
catheter or other
appropriate
microcatheter into a
selected blood vessel
in the peripheral,
coronary and neuro
vascular systems. | The ... is indicated for
the introduction of
interventional devices
into the peripheral, ,
and neuro vasculature. |
| Materials | | | |
| - Shaft Materials | PTFE lined
nylon/polyurethane
catheter,
with hydrophilic coating | PTFE lined
polymeric
catheter
with hydrophilic coating | PTFE lined
polymeric
catheter,
with hydrophilic coating |
| - Catheter shaft support | Stainless Steel | Stainless Steel | Nitinol |
| - Proximal End
Configuration | Luer Hub | Luer Hub | Luer Hub |
| - Radiographic markers /
Radiopacity | • Radiopaque marker
at distal tip | • Radiopaque
marker at distal tip | • Radiopaque marker
at distal tip |
2
510(k) Summary according to 807.92 (continued) 4.9 Comparison to Predicate Devices (continued)
| | Penumbra Neuron™
Intracranial Access
System | HD Guide Catheter | ReFlex™ Guide
Catheter |
|-------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| -Packaging | Catheter
attached to
packaging card
inside
PET/PE/Tyvek pouch
inside SBS carton | Catheter
in polyethylene hoop
inside
PET/PE/Tyvek pouch
inside SBS carton | Catheter
in polyethylene hoop
attached to
packaging card
inside
PET/PE/Tyvek pouch
inside SBS carton |
| Packaged Accessory
Devices | Packaged with an
rotating hemostatic
valve (RHV) | Packaged with an
rotating hemostatic
valve (RHV) | Not Applicable |
| Sterilization | EtO | EtO | EtO |
4.10 Summary of Non-clinical Data
4.10.1 Biocompatibility and Sterilization
The ReFlex™ Guide Catheter is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (≤ 24 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 ReFlex™ Guide Catheter 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, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10 °.
। ਤੇ
3
510(k) Summary according to 807.92 (continued) 4.10.2 Design Verification (Bench-Top Testing)
The physical, mechanical and performance testing of the ReFlex™ Guide Catheter demonstrates 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 ReFlex™ Guide Catheter. All studies were conducted in accordance with Reverse Medical Design Control procedures. All testing was performed on units which were sterilized and met all inspection criteria. Tests on the ReFlex™ Guide Catheter included:
Verification and Test Summary
| In vitro Tests | Result |
|---|---|
| Dimensional and Visual Inspection | Met established criteria |
| Guidewire Compatibility | Met established criteria |
| Torque Response | Met established criteria |
| Torque Strength | Met established criteria |
| Kink Resistance | Met established criteria |
| Flexibility Test | Met established criteria |
| Tensile Strength | Met established criteria |
| Catheter Leak Test (Liquid Leakage) | Met established criteria |
| Catheter Leak Test (Air Leakage) | Met established criteria |
| Dynamic Pressure Test | Met established criteria |
| Static Burst Test | Met established criteria |
| Aspiration Test | Met established criteria |
| Hub Gauging | Met established criteria |
| Corrosion Resistance | Met established criteria |
| USP Particulate Test | Met established criteria |
| Navigation and Accessibility Capabilities in vitro | Met established criteria |
| In vivo Tests | Result |
| System | |
| Deliverability, Compatibility, | |
| Visibility and Aspiration Performance | Met established criteria |
| Acute histopathology of treated vessels | Met established criteria |
| Biocompatibility testing | Met established criteria |
The physical, mechanical and performance testing of the subject ReFlex™ Guide Catheter 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 ReFlex™ Guide Catheter 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 specification, performance and biocompatibility testing and sterilization validation.
The ReFlex™ Guide Catheter 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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4
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 or bird-like figure with three wing-like shapes extending upwards. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Reverse Medical Corporation c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25° St. NW Buffalo, MN 55313
APR - 5 2011
Re: K110055
Trade/Device Name: ReFlex™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: March 18, 2011 Received: March 21, 2011
Dear Mr. Job
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.
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.
5
Page 2 - Mr. Mark Job
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Duna R. Vahner
Image /page/5/Picture/7 description: The image shows a handwritten symbol or character. It appears to be a stylized letter or a combination of lines and curves. The symbol is drawn with thick strokes, and it has a somewhat angular appearance.
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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3. Indications for Use
510(k) Number (if known):_K 110055
Device Name: Reverse Medical ReFlex™ Guide Catheter
Indications for Use:
The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature.
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)
Dana R. Vahine
on of Cardiovascular Devices
510(k) Number_K 110055
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