(29 days)
No
The description focuses on the physical characteristics and performance of a catheter, with no mention of AI or ML.
No.
The device is indicated for the introduction of interventional devices, rather than for direct therapeutic intervention itself.
No
Explanation: The device is indicated for the "introduction of interventional devices" and is described as a "catheter" used for "visualization under fluoroscopy." There is no mention of it being used to diagnose a condition, only to facilitate intervention.
No
The device description clearly details a physical catheter with various material components, a radiopaque marker band, and a coating, indicating it is a hardware device, not software-only.
Based on the provided information, the React™ 71 Catheter is not an In Vitro Diagnostic (IVD) 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.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like variable stiffness, a lubricious liner, and a radiopaque marker for visualization under fluoroscopy. These are characteristics of an invasive medical device used for access and delivery, not for analyzing biological samples.
- Input Imaging Modality: Fluoroscopy is an imaging technique used to visualize structures within the body in real-time, which aligns with the use of a catheter in the vasculature. IVDs typically involve analyzing samples using methods like chemical analysis, immunoassay, or molecular diagnostics.
- Anatomical Site: The peripheral and neuro vasculature are locations within the body where a catheter would be used for intervention. IVDs analyze samples taken from the body (like blood, urine, tissue) but the analysis itself happens in vitro (in glass/outside the body).
In summary, the React™ 71 Catheter is an invasive medical device used for accessing and navigating within the body's blood vessels, which is the opposite of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes
DQY, QJP
Device Description
The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinumiridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ 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
Non-clinical bench testing was conducted to evaluate the performance of the subject device with shorter length compared to the predicate in a clinically representative anatomical model.
The subject device was evaluated per FDA Guidance 1757 and per FDA Recognized Consensus Standards 5-125 & 5-129. The subject device met the acceptance criteria and was able to navigate to the distal M1 segment of the MCA over a microcatheter.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
May 28, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Alexander Abe Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K241177
Trade/Device Name: React 71 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: April 26, 2024 Received: April 29, 2024
Dear Alexander Abe:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K241177
Device Name React™ 71 Catheter
Indications for Use (Describe)
The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K241177
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
|---|---|
| 9775 Toledo Way | |
| Irvine, CA 92618, USA | |
| Establishment Registration: 2029214 | |
| Contact Person: | Alexander Abe |
| Regulatory Affairs Specialist | |
| Telephone: (949) 490-3814 | |
| Email: alex.k.abe@medtronic.com |
| Date Summary
| Prepared: | 23 May 2024 | ||
|---|---|---|---|
| Trade Name of Device: | React™ 71 Catheter | ||
| Common Name of | |||
| Device: | Percutaneous Catheter | ||
| Review Panels: | Neurology, Cardiovascular | ||
| Product Codes: | DQY, QJP | ||
| Regulation Number: | 21 CFR 870.1250 | ||
| Regulation Name: | Percutaneous Catheter | ||
| Device Classification: | Class II | ||
| Predicate Device: | K182097 | ||
| React™ 71 Catheter | |||
| Reference Device: | K180715 | ||
| React™ 68 Catheter |
Device Description:
The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinumiridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.
4
Indications for Use
| React ™ 71 Catheter Indications for Use | ||
|---|---|---|
| Model Numbers | Device Name | Indications for Use/Intended Use |
| REACT-71-115 | ||
| REACT-71-125 | React™ 71 Catheter | The React™ 71 Catheter is indicated for the |
| introduction of interventional devices into the | ||
| peripheral and neuro vasculature. |
Proposed Change:
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular requests clearance for commercialization of the React™ 71 Catheter models with shortened usable and subsequently shortened overall lengths.
Device Comparison:
| Design Feature | Predicate Device: React™
71 Catheter (K182097) | Subject Device: React™ 71
Catheter (K241177) | Reference Device:
React™ 68 Catheter
(K180715) |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The React™ 71 Catheter is
indicated for the
introduction of
interventional devices into
the peripheral and neuro
vasculature. | Same as K182097 | The React™ 68 Catheter
is indicated for the
introduction of
interventional devices
into the peripheral and
neuro vasculature. |
| CFU(s)/Model
Number(S)/SKU(s) | REACT-71 | REACT-71-115
REACT-71-125 | REACT-68 |
| Materials of Construction | | | |
| Hub | Trogamid® | Same as K182097 | Same as K182097 |
| Strain Relief | DynaFlex® | Same as K182097 | Same as K182097 |
| Inner Layer | PTFE,
Polyolefin | Same as K182097 | PTFE |
| Reinforcement | Nitinol | Same as K182097 | Same as K182097 |
| Outer Jacket | Polyamide,
Polyolefin,
Polyurethane | Same as K182097 | Grilamid™
Pebax® |
| Marker Band | Platinum/
Iridium | Same as K182097 | Same as K182097 |
| Adhesive
Coating | Cyanoacrylate
Hydrophilic | Same as K182097 | Same as K182097 |
| Dimensions | | | |
| Working
Length/Effective
Length/Usable
Length | 132 cm | 115 cm
125 cm | Same as K182097 |
| Inner Diameter | 0.071" | Same as K182097 | 0.068" |
5
| Design Feature | Predicate Device: React™ 71 Catheter (K182097) | Subject Device: React™ 71 Catheter (K241177) | Reference Device: React™ 68 Catheter (K180715) |
|---|---|---|---|
| Proximal Outer Diameter (OD) | 0.0855" (Max) | Same as K182097 | 0.083" |
| Distal OD | 0.0855" (Max) | Same as K182097 | 0.083" |
| Overall Catheter Length* | |||
| *Measured from Lip of Hub Luer to Distal End of Catheter Tip | 141 cm | 121 cm | |
| 131 cm | Same as K182097 | ||
| Packaged Accessories | |||
| Peelable Sheath | Yes | Same as K182097 | Same as K182097 |
| Packaging | |||
| Packaging Card | Polyethylene | Same as K182097 | Same as K182097 |
| Packaging Hoop | Polyethylene | Same as K182097 | Same as K182097 |
| Packaging Pouch | Nylon, Tyvek® | Same as K182097 | Same as K182097 |
| Sterilization | |||
| Method | Ethylene Oxide (EO) | Same as K182097 | Same as K182097 |
| Sterility Assurance Level (SAL) | 10-6 | Same as K182097 | Same as K182097 |
| Device Compatibility | |||
| Guidewire Compatibility | The maximum diameter recommended for a guidewire is 0.038" (0.97 mm). | Same as K182097 | Same as K182097 |
| Guide Sheath Compatibility | When using the React™ 71 Catheter, the minimum inner diameter recommended for a guide sheath is 0.087" (2.21 mm). | Same as K182097 | N/A |
Biocompatibility:
There are no changes to the materials of construction or to the manufacturing materials for the subject React™ 71 Catheters when compared to the legally marketed predicate device (K182097). Therefore, the biocompatibility evaluation of the legally marketed predicate device was adopted for the subject device.
Sterilization and Shelf-Life:
There are no changes to the packaging configuration or materials for the subject React™ 71 Catheters when compared to the legally marketed predicate device (K182097). Therefore, the sterilization and shelflife for the legally marketed predicate device was adopted for the subject device.
Performance Data – Bench:
Non-clinical bench testing was conducted to evaluate the performance of the subject device with shorter length compared to the predicate in a clinically representative anatomical model.
The following non-clinical bench tests were conducted:
6
| Design Validation | ||
|---|---|---|
| Evaluation Criteria | Test Method Summary | Results |
| The length of the subject device | ||
| shall be compatible with minimum | ||
| length 136 cm guide catheter. | The subject device was | |
| evaluated per FDA Guidance | ||
| 1757 and per FDA Recognized | ||
| Consensus Standards 5-125 & | ||
| 5-129. | The subject device met the | |
| acceptance criteria. | ||
| The subject device should be able to | ||
| navigate to the distal M1 segment | ||
| of the MCA over a microcatheter. | The subject device was | |
| evaluated per FDA Guidance | ||
| 1757 and per FDA Recognized | ||
| Consensus Standards 5-125 & | ||
| 5-129. | The subject device met the | |
| acceptance criteria . |
Performance Data – Animal & Clinical:
The determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the indication for use statement, fundamental scientific technology, principles of operation, or materials of construction.
Conclusion:
There is no change to the indication for use, fundamental scientific technology, materials of construction, and principles of operation of the subject React™ 71 Catheters in comparison to the legally marketed predicate device (K182097). The shorter usable lengths and subsequently shorter overall lengths of the subject React™ 71 Catheters do not raise different questions of safety and effectiveness. The information provided in this special 510(k) premarket notification supports a determination of substantial equivalence for the subject React™ 71 Catheters.