(107 days)
Not Found
No
The description focuses on the physical properties and materials of a catheter, with no mention of AI/ML, image processing, or data-driven performance metrics.
No
The device is indicated for the introduction of interventional devices, rather than performing a therapeutic function itself.
No
The "Intended Use / Indications for Use" states the device is for "introduction of interventional devices," which is a therapeutic or access function, not a diagnostic one.
No
The device description clearly outlines a physical catheter with various material components and structural features, indicating it is a hardware device, not software-only.
Based on the provided information, the React™ 68 Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "introduction of interventional devices into the peripheral and neuro vasculature." This describes a device used within the body for a procedural purpose, not for testing 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, flexibility, radiopacity for visualization under fluoroscopy, and a hydrophilic coating. These are characteristics of an invasive medical device used for access and delivery, not for in vitro testing.
- Anatomical Site: The anatomical site is the "Peripheral and neuro vasculature," which are parts of the circulatory system within the body. IVD devices typically analyze samples like blood, urine, or tissue outside the body.
- Input Imaging Modality: Fluoroscopy is an imaging technique used to visualize structures within the body in real-time. IVD devices do not typically rely on this type of imaging.
- Performance Studies: The performance studies described are bench tests evaluating the physical and functional characteristics of the catheter itself (e.g., tip buckling, kink resistance, coating lubricity, tensile strength). These are relevant to the safety and performance of an invasive device, not the analytical performance of an IVD.
In summary, the React™ 68 Catheter is a medical device designed for use within the body to facilitate interventional procedures in the vasculature. This aligns with the definition of an invasive medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes
DQY
Device Description
The React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The React™ 68 Catheter is designed with a hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Biocompatibility:
The React™ 68 Catheter is categorized as a limited exposure (
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 4, 2018
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney Senior Regulatory Affairs Specialist 9775 Toledo Wav Irvine, California 92618
Re: K180715
Trade/Device Name: React 68 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 4, 2018 Received: June 6, 2018
Dear Ryan Kenney:
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Xiaolin Zheng" in a large, bold font, followed by a hyphen. Below the name, there is a large, stylized FDA logo in a light gray color. To the left of the logo, there is a large letter "S".
for Carlos L. Peña, PhD, MS 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 (if known) K180715
Device Name React 68 Catheter
Indications for Use (Describe)
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K180715
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No.: 2029214 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ryan Kenney
Senior Regulatory Affairs Specialist
Telephone: (949) 297-5489
Email: ryan.j.kenney@medtronic.com |
| Date Summary
Prepared: | June 25, 2018 |
| Trade Name of
Device: | React™ 68 Catheter |
| Common Name of
Device: | Percutaneous Catheter |
| Review Panel: | Neurology |
| Product Code: | DQY |
| Regulation Number: | 21 CFR 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Predicate Device(s): | AXS Catalyst™ Distal Access Catheter
510(k)#: K151667
ReFlex™ Guide Catheter
510(k)#: K110055 |
Device Description:
The React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The React™ 68 Catheter is designed with a hydrophilic coating.
Indications for Use:
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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| | AXS Catalyst™ Distal
Access Catheter
(K151667) | ReFlex™ Guide
Catheter
(K110055) | React™ 68 Catheter |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Indication for Use
(IFU) Statement | The AXS Catalyst™
Distal Access Catheter
is indicated for the
insertion and guidance
of appropriately sized
interventional devices
into a selected blood
vessel in the peripheral
and neurovascular
systems. The AXS
Catalyst™ Distal
Access Catheter is also
indicated for use as a
conduit for retrieval
devices. | The ReFlex™ Guide
Catheter is indicated
for the introduction of
interventional devices
into the peripheral and
neuro vasculature. | Same as K110055 |
| Materials | | | |
| Hub | Nylon | Trogamid® | Same as K110055 |
| Strain Relief | Thermoplastic Rubber | Santoprene | DynaFlex® |
| Inner Layer | PTFE | Same | Same |
| Reinforcement | Stainless Steel with
Nitinol and Polymer
Fiber | Nitinol | Same as K110055 |
| Outer Jacket | Pebax® | Polymeric | Grilamid™
Pebax® |
| Markerband | Platinum/
Iridium | Same | Same |
| Adhesive | Cyanoacrylate | Same | Same |
| Coating | Hydrophilic | Same | Same |
| Dimensions | | | |
| Working Length | 132 cm | 130 cm | Same as K151667 |
| Inner Diameter (ID) | 0.060" | 0.072" | 0.068" |
| Proximal Outer
Diameter (OD) | 0.079" | 0.084" | 0.083" |
| Distal Outer
Diameter (OD) | 0.071" | 0.084" | 0.083" |
| Packaged Accessories | | | |
| Peelable Sheath | Yes | Same | Same |
| Rotating Hemostasis
Valve | Yes | No | Same as K110055 |
| Packaging | | | |
| Packaging Card | Polyethylene | Same | Same |
| Packaging Hoop | Polyethylene | Same | Same |
| | AXS Catalyst™ Distal
Access Catheter
(K151667) | ReFlex™ Guide
Catheter
(K110055) | React™ 68 Catheter |
| Other | | | |
| Sterilization | Ethylene Oxide (EO) | Same | Same |
Device Comparison:
5
Biocompatibility:
Biocompatibility was conducted for the React™ 68 Catheter. The React™ 68 Catheter is categorized as a limited exposure (. | The ReactTM 68 Catheter met
the acceptance criteria for
bacterial endotoxin. |
| Performance | | |
| Visual Inspection | The ReactTM 68 Catheter was
inspected under x2.5
magnification. | The ReactTM 68 Catheter met
the acceptance criteria for
visual inspection. |
| Dimensional Measurements | The proximal ID, distal ID,
proximal OD, distal OD, usable
length, total length, coating
length, and distal tip length of
the ReactTM 68 Catheter were
measured. | The ReactTM 68 Catheter met
the acceptance criteria for
dimensional measurements. |
| Tip Buckling | The ReactTM 68 Catheter was
evaluated for the maximum
compressive force. | The ReactTM 68 Catheter met
the acceptance criteria for tip
buckling. |
| Kink Resistance | The ReactTM 68 Catheter was
evaluated for the maximum
kink diameter. | The ReactTM 68 Catheter met
the acceptance criteria for kink
resistance. |
| Particulate | The ReactTM 68 Catheter was
evaluated per USP . | The ReactTM 68 Catheter met
the acceptance criteria for
particulate evaluation. |
| Coating Lubricity | The ReactTM 68 Catheter was
evaluated for the average
friction forces. | The ReactTM 68 Catheter met
the acceptance criteria for
coating lubricity. |
| Tensile Strength | The ReactTM 68 Catheter was
evaluated per ISO 10555-1.
Annex B. | The ReactTM 68 Catheter met
the acceptance criteria for
tensile strength at the hub and
shaft. |
| Liquid Leak | The ReactTM 68 Catheter was
evaluated per ISO 10555-1.
Annex C. | The ReactTM 68 Catheter met
the acceptance criteria for
liquid leak. |
| Corrosion Resistance | The ReactTM 68 Catheter was
evaluated per ISO 10555-1.
Annex A. | The ReactTM 68 Catheter met
the acceptance criteria for
corrosion resistance. |
| Hub Aspiration Resistance | The ReactTM 68 Catheter was
evaluated per ISO 10555-1.
Annex D. | The ReactTM 68 Catheter met
the acceptance criteria for hub
air aspiration. |
| Compatibility | The ReactTM 68 Catheter was
inspected for visual damage of
the catheter when delivering
and retrieving interventional
devices | The ReactTM 68 Catheter met
the acceptance criteria for
delivering and retrieving
interventional devices. |
| Test | Test Method Summary | Results |
| Radiopacity | The markerband length and
wall thickness of the React™ 68 Catheter were measured. In
addition, radiopacity was
confirmed via fluoroscopy. | The React™ 68 Catheter met
the acceptance criteria for
radiopacity. |
| Luer Standards | The React™ 68 Catheter was
evaluated per ISO 594-1 and
ISO 80369-7. | The React™ 68 Catheter met
the acceptance criteria for luer
standards. |
| Torque Strength | The React™ 68 Catheter was
evaluated for transmission of
proximal torque to the distal
tip. | The React™ 68 Catheter was
able to withstand torsional
forces that are typical of
clinical use. |
| Dynamic Pressure | The React™ 68 Catheter was
evaluated for the amount of
pressure it can withstand. | The React™ 68 Catheter was
able to withstand pressures that
are typical of clinical use. |
| Coating Integrity | The React™ 68 Catheter was
evaluated for coating coverage
and lubricity. | The React™ 68 Catheter
remained coated and lubricous. |
| Usability | The React™ 68 Catheter and
predicate device were evaluated
for maneuverability and
flexibility. | The React™ 68 Catheter met
the acceptance criteria for
usability. |
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8
Performance Data - Animal:
Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.
Performance Data - Clinical:
Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.
Conclusion:
The design modifications incorporated do not alter the intended use or fundamental scientific technology.
Non-clinical bench testing supports a determination that the subject React™ 68 Catheter is substantially equivalent to the predicate device.