The Reverse™M Micro Catheter 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.

Device Description

The Reverse™ Micro Catheter is a single lumen catheter designed to be introduced over a steerable guide wire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate vessel navigation. The micro catheter incorporates a PTFE liner to facilitate movement or introduction of devices passed through its lumen. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability. The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID.

AI/ML Overview

The document you provided describes a medical device, the Reverse™ Micro Catheter, and its non-clinical performance evaluation for substantial equivalence to a predicate device. It does not describe a study involving an AI model or a specific algorithm. Therefore, I cannot provide information about acceptance criteria, device performance, sample sizes, ground truth, expert involvement, or comparative effectiveness studies in the context of AI.

The document focuses on demonstrating that the modified Reverse™ Micro Catheter is substantially equivalent to a previously cleared device (Reverse™ Medical Microcatheter, K130858) based on non-clinical performance data.

Here's a breakdown of what the document does provide, structured to address the spirit of your request where possible, but re-contextualized for a medical device rather than an AI study:

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

The document states that "All testing passed the acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. The performance results are reported as successful completion of tests without new safety or effectiveness issues.

Test Category	Specific Tests Evaluated	Reported Performance	Acceptance Criteria (Not explicitly quantified in document)
Bench Testing	- Surface inspection- Dimensional requirements- Lubricity/friction- Particulates- Coating characterization- Simulated use device compatibility- Simulated use navigation and delivery- Shelf-life verification (1 year accelerated aging)	"All testing passed the acceptance criteria.""Comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness."	Implicitly, meeting specifications and predicate equivalence.
Biological Safety	- MEM Elution Cytotoxicity- Guinea Pig Maximization Sensitization- Intracutaneous Reactivity- Acute System Injection- Materials Mediated Rabbit Pyrogen- Hemolysis Direct Contact- Hemolysis Indirect Extract Method- Complement Activation- In vivo Thrombogenicity- Genotoxicity (Ames Assay, in vitro Mouse Lymphoma, in vivo Mouse Micronucleus)- USP Physicochemical	"Testing demonstrated that the Reverse™ Micro Catheter finished device, accessories, and packaging materials have no residual risk of biological hazards; and are therefore considered biocompatible for their intended use."	Compliance with ISO 10993-1 and related standards.
Microbial Assessments	- Bioburden- Endotoxin- Sterility assurance	"Sterilization has been validated and is controlled... to provide a minimum SAL of 10-6."	Minimum SAL of 10-6; compliance with ISO 11135-1.
Packaging Validation	- Visual Inspection- Bubble Leak- Seal Strength	"To evaluate integrity of the packaging configuration." (Implied successful evaluation)	Implicitly, maintaining package integrity after sterilization, environmental conditioning, and simulated shipping.

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes for individual bench tests, biological safety tests, or packaging validation. It refers broadly to "comprehensive verification and validation activities." The data provenance is internal testing by the manufacturer, Medtronic Neurovascular, for a new medical device. This is prospective testing of the device being submitted for clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable to this type of device submission. There isn't "ground truth" established by experts in the context of an AI algorithm's performance. Instead, the "truth" is determined by established engineering specifications, biocompatibility standards, and functional performance requirements for a physical medical device.

4. Adjudication method for the test set

Not applicable. There's no human-in-the-loop performance or diagnostic adjudication involved for this physical device's non-clinical testing.

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

Not applicable, as this is not an AI device.

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

Not applicable, as this is not an AI device. The testing described is "standalone" in the sense that it's the device itself being tested, not an algorithm.

7. The type of ground truth used

For this medical device, the "ground truth" for the non-clinical tests would be:

Engineering Specifications: Conformance to pre-defined dimensional, material, and performance requirements (e.g., inner diameter, lubricity, navigation).
International Standards: Adherence to established standards for biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), and packaging integrity.
Predicate Device Performance: Demonstrating that the subject device performs "at least as safe and effective as the predicate device."

8. The sample size for the training set

Not applicable, as this is not an AI device.

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

Not applicable, as this is not an AI device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mav 31. 2017

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Eric Elliott Principal Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K171268

Trade/Device Name: Reverse Micro Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA, DQO Dated: April 28, 2017 Received: May 1, 2017

Dear Mr. Elliott:

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

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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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,

Carlos L. Pena -S- ¯

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)

K171268

Device Name

Reverse™ Micro Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary per 21 CFR 807.92

Submitter'sName andAddress	Micro Therapeutics, Inc.d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618 U.S.A.
Contact Nameand Information	Eric ElliottPrincipal Regulatory Affairs SpecialistTel: 949.297.5803E-mail: Eric.Elliott@medtronic.com
Date Prepared	April 28, 2017
Trade Name	Reverse™ Micro Catheter
Common Name	Catheter Percutaneous, Catheter Infusion, CatheterDiagnostic
ClassificationName	Catheter, Percutaneous (DQY) has been classified as Class II per 21 CFR 870.1250
	Catheter, Infusion (KRA) has been classified as Class II per 21 CFR 870.1210
	Catheter, Intravascular Diagnostic (DQO) has been classified as Class II per 21 CFR 870.1200
PredicateDevice	Reverse™ MedicalMicrocatheter	K130858	11-Oct-2013
ReferenceDevice(s)	Navien™ Intracranial CatheterArc™ Intracranial Catheter	K161152 K150107	12-Oct-201629-Jul-2015
Description ofDevice	The Reverse™ Micro Catheter is a single lumen catheterdesigned to be introduced over a steerable guide wire toaccess small, tortuous vasculature. The semi-rigid proximalsection transitions to a flexible distal tip to facilitate vesselnavigation. The micro catheter incorporates a PTFE liner tofacilitate movement or introduction of devices passedthrough its lumen. Dual radiopaque markers at the distal end

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Device facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance Description, lubricity and promote deliverability. continued The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID. The Reverse™ Micro Catheter is intended for use in neuro, Intended peripheral, and coronary vasculature for the infusion of Use/Indications diagnostic agents, such as contrast media, and therapeutic for Use agents, such as occlusion coils.

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Device Technology Characteristics and Comparison to Predicate Device

The Reverse™ Micro Catheter maintains the same fundamental scientific technology and operating principles as the predicate Reverse™ Medical Microcatheter (K130858). Furthermore, dimensions, materials of construction (excluding hydrophilic coating), sterilization method, and indications for use remain unchanged.

The primary difference between the subject and predicate device is the utilization of Serene® hydrophilic coating. This is the same coating as previously cleared with Medtronic's more recent intracranial support catheters, Navien™ (K161152) and Arc™ (K150107). Serene® will replace the predicate's legacy hydrophilic coating, thereby improving consistency across Medtronic Neurovascular's product portfolio and reducing manufacturing redundancy across the organization.

The only remaining design difference between subject and predicate is the elimination of yellow colorant from the split sheath introducer, an accessory packaged with the catheter. Even though the colorant is no longer utilized, the overall design and base formulation remains unchanged. With the two exceptions listed above, all raw materials utilized by the Reverse™ Micro Catheter are identical to those of the predicate (K130858).

In support of a substantial equivalence determination, Medtronic Neurovascular has compared and evaluated the design differences between the subject and predicate device.

TechnologicalCharacteristic	Subject DeviceK171268	Predicate DeviceK130858
Inner Diameter	Reverse 021: 0.021"Reverse 027: 0.027"	Same
GuidewireCompatibility	Reverse 021: ≤ 0.018" ODReverse 027: ≤ 0.025" OD	Same
Distal SheathOuter Diameter	Reverse 021: 2.4 FReverse 027: 2.8 F	Same
Proximal SheathOuter Diameter	Reverse 021: 2.75 FReverse 027: 3.1 F	Same
Usable Length	150 cm	Same
Coating	Hydrophilic Topcoat w/Polyacrylamide Base	Hydrophilic Topcoat w/Urethane Base
Peel AwayIntroducerSheath	Yes (Colorless)	Yes (Yellow)

Non-clinical performance evaluations, as described below, indicate that the subject device is substantially equivalent to. and at least as safe and effective as the predicate device (Reverse™ Medical Microcatheter, K130858).

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Non-Clinical Performance Data

Modifications to the predicate device were assessed according to risk-based failure mode effects and criticality analysis (FMECA), ensuring that the appropriate verification and validation activities were conducted. Determination of substantial equivalence is based on this assessment of nonclinical verification and validation testing.

Non-clinical data includes bench-top verification and validation, packaging verification, and biological safety.

Bench Testing:

Bench testing was performed to evaluate physical integrity. functionality, and overall performance of the catheter relative to the design modifications introduced by the subject device. Comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness. All testing passed the acceptance criteria. Performance testing encompassed:

surface inspection
dimensional requirements .
lubricity/ friction .
particulates
coating characterization ●
. simulated use device compatibility
simulated use navigation and delivery .
shelf-life verification (1 year accelerated aging) .

Biological Safety Testing:

The Reverse™ Micro Catheter was subiected to a series of biocompatibility tests in accordance with FDA Guidance, Use of International Standard ISO 10993-1.

MEM Elution Cytotoxicity ●
Guinea Piq Maximization Sensitization .
Intracutaneous Reactivity ●
Acute System Injection ●
Materials Mediated Rabbit Pvrogen ●
Hemolysis Direct Contact
Hemolysis Indirect Extract Method
Complement Activation
In vivo Thrombogenicity
Genotoxicity, Ames Assay ●
Genotoxicity, in vitro Mouse Lymphoma ●
Genotoxicity, in vivo Mouse Micronucleus ●
. USP Physicochemical

Testing demonstrated that the Reverse™ Micro Catheter finished device, accessories, and packaging materials have no residual risk of biological hazards; and are therefore considered biocompatible for their intended use.

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Non-ClinicalPerformanceData, continued	Microbial assessments included bioburden, endotoxin, andsterility assurance. Sterilization has been validated and iscontrolled in accordance with ISO 11135-1, Medical Devices –Validation and Routine Control of Ethylene Oxide Sterilization anddesigned to provide a minimum SAL of 10-6. Validation wasconducted using the overkill approach in accordance with ISO11135-1 Annex B (normative), Conservative determination of lethalrate of the sterilization process – Overkill approach. The validatedcycle was adopted for the Reverse™ Microcatheter based onfractional results determined from EO comparative resistancetesting.
	Packaging Validation:
	Visual Inspection, Bubble Leak, and Seal Strength testingwas used to evaluate integrity of the packaging configuration.Testing was leveraged from representative product usingidentical packaging materials after being subjected toEthylene Oxide sterilization (2x), environmental conditioning,and simulated shipping and distribution.
	Conclusion:
	Non-clinical performance evaluations, as described above,indicate that the subject device is substantially equivalent to,and at least as safe and effective as the predicate device,(Reverse™ Medical Microcatheter, K130858).
ClinicalPerformanceData	Not applicable; determination of substantial equivalence isbased on an assessment of non-clinical performance data.
Conclusion	With respect to the predicate, design modificationsincorporated by subject device do not alter the fundamentalscientific technology or the indications for use. Based onfailure mode effects and criticality analysis (FMECA),comprehensive verification and validation activities weresuccessfully completed; raising no new issues of safety oreffectiveness.
	Non-clinical performance data supports a determination thatthe subject device, Reverse™ Micro Catheter, issubstantially equivalent to the predicate device (Reverse™Medical Microcatheter, K130858); and that it is at least assafe and effective for its intended use.

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).