The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

Device Description

The modified Route 92 Medical Delivery Catheter is a single-lumen, variable stiffness, hydrophilically coated catheter with a flexible tapered tip. The tapered tip is delineated by two radiopaque markers. On the proximal end is a luer hub for guidewire introduction and fluid or contrast injection. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible catheter. The Delivery Catheter and compatible catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.

AI/ML Overview

The provided document is a 510(k) summary for the Route 92 Medical Delivery Catheter. It describes the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state the quantitative acceptance criteria for each test. Instead, it generally states "All samples met the pre-determined acceptance criteria" under the "Results" column. The "Test Method" column describes how the device was tested, implying the criteria are inherent to or defined by these methods.

Test	Test Method	Reported Device Performance
Package Integrity after Aging and Distribution	The test specimens were subjected to EO sterilization and environmental conditioning, mechanical transit challenges, visual inspection and bubble leak test and peel test per ASTM F2096 and ASTM F88.	PASS
Label Integrity after Aging and Distribution	The test specimens were subjected to EO sterilization and climatic conditioning per ASTM D4169.	PASS
Tensile Strength	The tensile strength of the catheter sections and bonds was tested.	PASS
Kink Resistance	Test specimen segments were formed into a defined bend diameter to evaluate kink resistance.	PASS
Torsion Resistance	The test specimens were rotated to evaluate integrity after rotation.	PASS
Tip Flexibility	Test specimens were tested for tip flexibility.	PASS
Air Leakage	Tested per ISO 10555-1:2013 Annex D.	PASS
Liquid Leakage	Tested per ISO 10555-1:2013 Annex C.	PASS
Hydrophilic Coating Integrity	The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles.	PASS
Particulate Recovery	After multiple insertion and withdrawal cycles, the effluent water rinsed and flushed from the devices and model was tested per USP <788>.	PASS
Catheter Burst Pressure (Static & Dynamic)	Tested per ISO 10555-1:2013 Annex F.	PASS
Catheter Flow Rate	Tested per ISO 10555-1:2013 Annex E.	PASS
Simulated Use Testing	Deliverability and compatibility with accessory devices was evaluated in a neurovascular model.	PASS
Packaging Integrity (ISO 11607-1 Part 1 & Part 2)	ISO 11607-1 Part 1 and ISO 11607-2 Part 2. (Note: The table lists "Packaging Integrity" twice, once with a detailed method and once with "ISO 11607-1 Part 1" and "ISO 11607-2 Part 2". It's likely the first entry is a summary and the latter specifies the standards used.)	All samples met the pre-determined 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)

The document does not specify the sample size used for any of the performance tests. It refers to "test specimens" and "samples" but no quantities.
The data provenance (country of origin, retrospective/prospective) is not mentioned. These are bench tests, so patient data provenance is not applicable.

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

This information is not applicable as the document describes bench performance testing of a medical device (catheter), not a diagnostic device involving expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for these tests would be the fulfillment of engineering specifications and standards.

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

This information is not applicable for the type of bench testing described. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic or interpretative tasks.

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

An MRMC comparative effectiveness study was not done. This document describes bench testing for a physical medical device (catheter), not an AI-assisted diagnostic tool or an imaging product that would involve human readers.

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

This is not applicable. The device is a physical catheter, not an algorithm.

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

For this type of device and testing, the "ground truth" refers to engineering specifications, established industry standards (e.g., ASTM, ISO), and the performance characteristics of the predicate device. The tests demonstrate that the device meets these pre-defined physical and functional requirements. It is a comparison against established benchmarks for mechanical and material integrity.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device and its bench testing, not an AI/machine learning model that requires a training set.

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

This is not applicable for the same reasons as item 8.

Summary

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March 21, 2019

Route 92 Medical Inc. Kathy Tansev Senior Director of Regulatory Affairs and Quality Assurance 1700 South El Camino Real, Suite 206 San Mateo, California 94402

Re: K190431

Trade/Device Name: Route 92 Medical Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 20, 2019 Received: February 22, 2019

Dear Kathy Tansey:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; 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,

Digitally signed by
Xiaolin Zheng -S
Lin Zheng Date: 2019.03.21
14:57:10-04'00'

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) K190431

Device Name Route 92 Medical Delivery Catheter

Indications for Use (Describe)

The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

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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K190431 510(k) Summary

510(k) Summary
Sponsor:	Route 92 Medical1700 S. El Camino Real, Suite 206San Mateo, CA 94022Phone: 408-391-6536Fax: 650-343-5827
Contact:	Kathy Tansey
Date Prepared:	March 18, 2019
Device Name:	Route 92 Medical Delivery Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter (Product Code DQY, 21 CFR870.1250)
Legally Marketed Predicate Device:	Route 92 Medical Delivery Catheter (K182512)

Device Description

Indications for Use

The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

Comparison to Predicate Device

The method of action, design, and materials of the modified Route 92 Medical Delivery Catheter are equivalent to the cleared Route 92 Medical Delivery Catheter as shown in the following table.

Attribute	Cleared Route 92 Medical DeliveryCatheter (K182512)	Modified Route 92 MedicalDelivery Catheter
Indications forUse	The Route 92 Medical Delivery Catheteris indicated for use with compatiblecatheters in facilitating the insertion and	Same as cleared device
Attribute	Cleared Route 92 Medical DeliveryCatheter (K182512)	Modified Route 92 MedicalDelivery Catheter
DeviceDescription	The Delivery Catheter is a sterile, single-use, single-lumen, hydrophilicallycoated, variable stiffness catheter with aflexible, tapered tip.	Same as cleared device
User	Physicians trained in neurovascularinterventional techniques	Same as cleared device
Anatomical Sites	Neurovasculature only	Same as cleared device
Materials	Biocompatible polymers and metalscommonly used in the manufacture ofmedical devicesCatheter Shaft: stainless steel andvarying durometers of PebaxLuer: polycarbonateMarker bands: Tungsten/Pebax	Same as cleared device
Coating	Hydrophilic coating	Same as cleared device
Inner Diameter	0.019"	Same as cleared device
Outer Diameter	0.062"	Same as cleared device
Working Length	143 cm	151 cm
Length of PolymerSection (non-hypotube section)	38 cm	71 cm
HydrophilicCoating Length	48.5 cm	90 cm
Steam ShapeableTip	Not discussed in labeling	Steam shaping added to labeling
Packaging	The shelf carton contains two (2) sterilepouches, each containing a DeliveryCatheter and one (1) Directions for Use(DFU).	The shelf carton contains one (1)sterile pouch containing a DeliveryCatheter and one (1) Directions forUse (DFU).
Sterilization	Ethylene Oxide	Same as cleared device

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Performance Testing – Bench

The successful completion of the performance testing listed in the following table demonstrates that the modified Route 92 Medical Delivery Catheter is suitable for its intended use.

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Test	Test Method	Results
Package Integrityafter Aging andDistribution	The test specimens were subjected toEO sterilization and environmentalconditioning, mechanical transitchallenges, visual inspection andbubble leak test and peel test perASTM F2096 and ASTM F88.	PASSAll samples met the pre-determinedacceptance criteria
Label Integrityafter Aging andDistribution	The test specimens were subjected toEO sterilization and climaticconditioning per ASTM D4169.	PASSAll samples met the pre-determinedacceptance criteria
Tensile Strength	The tensile strength of the cathetersections and bonds was tested	PASSAll samples met the pre-determinedacceptance criteria
Kink Resistance	Test specimen segments were formedinto a defined bend diameter toevaluate kink resistance	PASSAll samples met the pre-determinedacceptance criteria
TorsionResistance	The test specimens were rotated toevaluate integrity after rotation	PASSAll samples met the pre-determinedacceptance criteria
Tip Flexibility	Test specimens were tested for tipflexibility	PASSAll samples met the pre-determinedacceptance criteria
Air Leakage	Tested per ISO 10555-1:2013 AnnexD.	PASSAll samples met the pre-determinedacceptance criteria
Liquid Leakage	Tested per ISO 10555-1:2013 AnnexC.	PASSAll samples met the pre-determinedacceptance criteria
HydrophilicCoating Integrity	The integrity of the hydrophilic coatingwas evaluated after multiple insertionand withdrawal cycles.	PASSAll samples met the pre-determinedacceptance criteria
ParticulateRecovery	After multiple insertion andwithdrawal cycles, the effluent waterrinsed and flushed from the devicesand model was tested per USP <788>.	PASSAll samples met the pre-determinedacceptance criteria
Catheter BurstPressure (Static& Dynamic)	Tested per ISO 10555-1:2013 AnnexF.	PASSAll samples met the pre-determinedacceptance criteria
Catheter FlowRate	Tested per ISO 10555-1:2013 AnnexE.	PASSAll samples met the pre-determinedacceptance criteria
Simulated UseTesting	Deliverability and compatibility withaccessory devices was evaluated in aneurovascular model	PASSAll samples met the pre-determinedacceptance criteria
Test	Test Method	Results
PackagingIntegrity	ISO 11607-1 Part 1	PASS
	ISO 11607-2 Part 2	All samples met the pre-determinedacceptance criteria

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Biocompatibility

Biocompatibility evaluations were not conducted using the modified Route 92 Medical Delivery Catheter because the materials of construction and manufacturing processes have not changed from the predicate device. Therefore, the biocompatibility evaluations performed using the predicate Route 92 Medical Delivery Catheter (K182512) can also support the biocompatibility profile of the subject device.

Substantial Equivalence

The modified Route 92 Medical Delivery Catheter has the same intended use, similar technological characteristics and same method of action as the predicate Route 92 Medical Delivery Catheter (K182512). The successful completion of performance testing demonstrates that the modified Route 92 Medical Delivery Catheter is substantially equivalent to the predicate Route 92 Medical Delivery Catheter.

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).