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.

AI/ML Overview

The provided text describes a 510(k) submission for the React™ 71 Catheter, focusing on demonstrating substantial equivalence to a predicate device after a change in device length. The information primarily covers non-clinical bench testing.

Here's an analysis of the provided information against your requested categories:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
The length of the subject device shall be compatible with minimum length 136 cm guide catheter.	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 met the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated. The text mentions "non-clinical bench testing was conducted," but does not provide details on the number of devices tested for each criterion.
Data Provenance: Not specified. "Non-clinical bench testing" typically implies laboratory-based tests. The country of origin of the data is not mentioned. The data is prospective in the sense that new tests were conducted for this submission, but it's not clinical human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the study described is non-clinical bench testing, not a study involving human or animal data requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the study described is non-clinical bench testing against predefined performance criteria, not a study involving subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (catheter), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench tests, the "ground truth" is defined by the acceptance criteria established in the test methods, based on FDA Guidance 1757 and FDA Recognized Consensus Standards 5-125 & 5-129. These are objective engineering and performance standards, not clinical ground truths like pathology or expert consensus.

8. The sample size for the training set

This section is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the reasons stated in point 8.

Summary

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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).

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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

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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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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 SummaryPrepared:	23 May 2024
Trade Name of Device:	React™ 71 Catheter
Common Name ofDevice:	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:	K182097React™ 71 Catheter
Reference Device:	K180715React™ 68 Catheter

Device Description:

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Indications for Use

React ™ 71 Catheter Indications for Use
Model Numbers	Device Name	Indications for Use/Intended Use
REACT-71-115REACT-71-125	React™ 71 Catheter	The React™ 71 Catheter is indicated for theintroduction of interventional devices into theperipheral 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™ 71Catheter (K241177)	Reference Device:React™ 68 Catheter(K180715)
Indications for Use	The React™ 71 Catheter isindicated for theintroduction ofinterventional devices intothe peripheral and neurovasculature.	Same as K182097	The React™ 68 Catheteris indicated for theintroduction ofinterventional devicesinto the peripheral andneuro vasculature.
CFU(s)/ModelNumber(S)/SKU(s)	REACT-71	REACT-71-115REACT-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
AdhesiveCoating	CyanoacrylateHydrophilic	Same as K182097	Same as K182097
Dimensions
WorkingLength/EffectiveLength/UsableLength	132 cm	115 cm125 cm	Same as K182097
Inner Diameter	0.071"	Same as K182097	0.068"

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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 cm131 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:

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Design Validation
Evaluation Criteria	Test Method Summary	Results
The length of the subject deviceshall be compatible with minimumlength 136 cm guide catheter.	The subject device wasevaluated per FDA Guidance1757 and per FDA RecognizedConsensus Standards 5-125 &5-129.	The subject device met theacceptance criteria.
The subject device should be able tonavigate to the distal M1 segmentof the MCA over a microcatheter.	The subject device wasevaluated per FDA Guidance1757 and per FDA RecognizedConsensus Standards 5-125 &5-129.	The subject device met theacceptance 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.

Regulation Number and Section

§ 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).