The Route 92 Medical 088 Access System, 110 cm, is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

Device Description

The Route 92 Medical 088 Access System, 110 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 110 cm, is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Route 92 Medical 088 Access System, 110 cm:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance criteria in two main sections: Biocompatibility Testing and Performance Testing. For both, the acceptance criterion is implicitly "PASS" meaning the device met pre-determined criteria for each test. Specific quantitative acceptance criteria are not detailed in this summary.

Test Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Cytotoxicity – ISO MEM Elution	Non-cytotoxic	Non-cytotoxic
	Sensitization – ISO Guinea Pig Maximization	No sensitization response	No sensitization response
	Irritation – ISO Intracutaneous Reactivity	Requirements met	Requirements met
	Acute Systemic Toxicity – ISO Acute Systemic Injection	Requirements met	Requirements met
	Pyrogen – Material Mediated Pyrogen	Non-pyrogenic	Non-pyrogenic
	Hemocompatibility – Complement Activation	No adverse effects expected	No adverse effects expected
	Hemocompatibility – Partial Thromboplastin Time	Non-activator	Non-activator
	Hemocompatibility – ASTM Hemolysis	Non-hemolytic	Non-hemolytic
	Hemocompatibility – Thromboresistance	Similar to control devices	Similar to control devices
Performance Testing	Dimensional Verification	Conformance to specifications	PASS
	Luer Integrity	Met pre-determined criteria	PASS
	RHV Sealing	Met pre-determined criteria	PASS
	Tensile Strength	Met pre-determined criteria	PASS
	Kink Resistance	Met pre-determined criteria	PASS
	Torsion Resistance	Met pre-determined criteria	PASS
	Tip Flexibility	Met pre-determined criteria	PASS
	Air Leakage	Met pre-determined criteria	PASS
	Liquid Leakage / Static Burst	Met pre-determined criteria	PASS
	Dynamic Burst	Maintained mechanical integrity	PASS
	Hydrophilic Coating Integrity	Met pre-determined criteria	PASS
	Particulate Recovery	Met pre-determined criteria	PASS
	Simulated Use Testing	Met pre-determined criteria	PASS
	Radiopacity	Met pre-determined criteria	PASS
	Contrast Delivery	Met pre-determined criteria	PASS
	In Vivo Thromboresistance	Met pre-determined criteria	PASS
	Packaging Integrity	Met pre-determined criteria	PASS

2. Sample Sizes Used for the Test Set and Data Provenance:

The document states "All samples met the pre-determined acceptance criteria" for various performance tests, but does not specify the exact sample size for any of the individual tests. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not provided. Many tests mention adherence to ISO standards, implying controlled laboratory conditions, but details about the test setting are not available. The Biocompatibility and Performance tests are "Non-Clinical Testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided as the tests conducted are primarily non-clinical, mechanical, and material-based, not involving human interpretation of medical images or patient outcomes that would typically require expert ground truth establishment in that manner. For the "Simulated Use Testing," "Radiopacity," and "Contrast Delivery," and "In Vivo Thromboresistance" which involve models and animals, the experts involved in conducting and evaluating these tests are not specified.

4. Adjudication Method for the Test Set:

An adjudication method is not applicable and therefore not mentioned, as the tests are primarily objective physical and chemical characterizations, rather than assessments requiring human judgment or consensus from multiple reviewers for a "ground truth" determination.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This document describes a 510(k) submission for a medical device (catheter system), not an AI or imaging diagnostic tool. Therefore, human reader performance with or without AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable ranges established by industry standards (e.g., ISO) and the manufacturer's pre-determined acceptance criteria. For "Simulated Use Testing," "Radiopacity," "Contrast Delivery," and "In Vivo Thromboresistance," the ground truth would be based on direct observation and measurement within the respective models (neurovascular model, animal model), demonstrating the device's functional integrity and performance as intended. No human pathology, outcomes data, or expert consensus in the medical diagnostic sense is mentioned as ground truth.

8. The Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as this is a physical medical device, not an AI model requiring a training set and associated ground truth.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

April 18, 2020

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

Re: K200121

Trade/Device Name: Route 92 Medical 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: January 17, 2020 Received: January 21, 2020

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,

Xiaolin Zheng, Ph.D., M.S. 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

Enclosure

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Indications for Use

510(k) Number (if known) K200121

Device Name Route 92 Medical 088 Access System

Indications for Use (Describe)

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

510(k) Summary

Sponsor:	Route 92 Medical1700 S. El Camino Real, Suite 206San Mateo, CA 94022Phone: 650-581-1179
Contact:	Kathy Tansey
Date Prepared:	January 17, 2019
Device Name:	Route 92 Medical 088 Access System
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter (Product Code OJP, 21 CFR870.1250)
Primary Predicate Device:Secondary Predicate Device:	Route 92 Medical Access System, K180201Imperative Care Inc. EagleRay Long Sheath, K180169

Device Description

Indications for Use

Comparison to the Predicate Device

The method of action, design, and materials of the Route 92 Medical 088 Access System, 110 cm, are equivalent to the Predicate Devices as shown in the following table.

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Attribute	Primary PredicateRoute 92 Medical AccessSystem (K180201)	Secondary PredicateImperative Care Inc.EagleRay Long Sheath(K180169)	SubjectRoute 92 Medical 088Access System, 110 cm
Indicationsfor Use	The Route 92 MedicalAccess System is indicatedfor use with compatibleguide catheters in facilitatingthe insertion and guidance ofmicrocatheters into aselected blood vessel in theneurovascular system.	The EagleRay LongSheath and EagleRayAccess Catheter areindicated for theintroduction ofinterventional devices intothe peripheral, coronary,and neuro vasculature.	The Route 92 Medical 088Access System, 110 cm, isindicated for use withcompatible guide cathetersin facilitating the insertionand guidance ofmicrocatheters into aselected blood vessel in theneurovascular system.
DeviceDescription	Sterile, single-use, variablestiffness, coil-reinforcedcatheter with proximalcontrol wire	Sterile, single-use,variable stiffness, wire-reinforced catheter	Sterile, single-use, variablestiffness, coil-reinforcedcatheter with proximalcontrol wire
Targetedpopulation	Patients requiring use of amicrocatheter in theneurovascular system	Patients requiring use of amicrocatheter in theperipheral, coronary orneurovascular systems	Patients requiring use of amicrocatheter in theneurovascular system
User	Physicians trained inneurovascular interventionaltechniques	Physicians trained ininterventional techniques	Physicians trained inneurovascular interventionaltechniques
AnatomicalSites	Neurovasculature only	Peripheral, coronary orneurovascular systems	Neurovasculature only
Materials	Polymers and metalscommonly used in themanufacture of medicaldevices	Polymers and metalscommonly used in themanufacture of medicaldevices	Polymers and metalscommonly used in themanufacture of medicaldevices
Support Catheter
InnerDiameter	0.070"	.088"	0.088"
OuterDiameter	Distal: 0.082"Proximal: 0.087"	Distal: 0.106"Proximal: 0.108"	Distal: 0.101"Proximal: 0.105"
Length	136cm	80cm -110cm	110cm
InnerDiameter	0.019"	N/A	0.019"
OuterDiameter	0.062"	N/A	Distal: 0.080"Proximal: 0.062"
Length	143cm	N/A	151cm

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Non-Clinical Testing

Biocompatibility Testing

The Route 92 Medical 088 Access System, 110 cm, is constructed using materials that are commonly used in the medical device industry. All patient contacting components have been evaluated for biocompatibility in accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Route 92 Medical Access System is classified per ISO 10993-1 as externally communicating with limited circulating blood contact (< 24 hours). A summary of the biocompatibility testing is provided below.

Test	Conclusions
Cytotoxicity – ISO MEM Elution	The test article is non-cytotoxic.
Sensitization – ISO Guinea PigMaximization Sensitization Test(Normal Saline and Sesame Oil)	The test article did not elicit asensitization response.
Irritation – ISO IntracutaneousReactivity (Normal Saline andSesame Oil)	Requirements of the ISOintracutaneous reactivity test have beenmet for the test article.
Acute Systemic Toxicity – ISOAcute Systemic Injection (NormalSaline and Sesame Oil)	Requirements of the ISO acutesystemic injection test have been metfor the test article.
Pyrogen – Material MediatedPyrogen (Normal Saline)	The test article is non-pyrogenic.
Hemocompatibility – ComplementActivation (SC5b-9)	The test article would not be expectedto result in adverse effects in vivo.
Hemocompatibility – PartialThromboplastin Time	The test article is considered to be anon-activator of the intrinsiccoagulation pathway.
Hemocompatibility – ASTMHemolysis	The test article is considered non-hemolytic.
Hemocompatibility –Thromboresistance	The test articles have similarthromboresistance characteristics asthe control devices.

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Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical 088 Access System, 110 cm, is suitable for its intended use.

Test	Test Method	Results
DimensionalVerification	Device dimensions were measuredto confirm conformance to thespecifications	PASSAll samples met the pre-determinedacceptance criteria
Luer Integrity	Tested per ISO 80369-7:2016	PASSAll samples met the pre-determinedacceptance criteria
RHV Sealing	RHV sealing around the cathetershafts was tested	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 wereformed into a defined benddiameter to evaluate kinkresistance	PASSAll samples met the pre-determinedacceptance criteria
Torsion Resistance	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 10555-1:2013Annex D.	PASSAll samples met the pre-determinedacceptance criteria
Liquid Leakage /Static Burst	Tested per ISO 10555-1:2013Annex C.	PASSAll samples met the pre-determinedacceptance criteria
Dynamic Burst	Mechanical integrity wasmaintained up to the specifiedpressures	PASSAll samples met the pre-determinedacceptance criteria
Test	Test Method	Results
HydrophilicCoating Integrity	The integrity of the hydrophiliccoating was evaluated aftermultiple insertion and withdrawalcycles.	PASSAll samples met the pre-determinedacceptance criteria
ParticulateRecovery	After multiple insertion andwithdrawal cycles, the effluentwater rinsed and flushed from thedevices and model was tested perUSP <788>.	PASSAll samples met the pre-determinedacceptance criteria
Simulated UseTesting	Deliverability and compatibilitywith accessory devices wasevaluated in a neurovascular model	PASSAll samples met the pre-determinedacceptance criteria
Radiopacity	Radiopacity of the device wasevaluated in an animal modelunder fluoroscopy	PASSAll samples met the pre-determinedacceptance criteria
Contrast Delivery	Contrast delivery using thedevice was evaluated in ananimal model under fluoroscopy	PASSAll samples met the pre-determinedacceptance criteria
In VivoThromboresistance	Thromboresistance was evaluatedunder clinical conditions in theswine model	PASSAll samples met the pre-determinedacceptance criteria
PackagingIntegrity	ISO 11607-1 Part 1ISO 11607-2 Part 2	PASSAll samples met the pre-determinedacceptance criteria

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Substantial Equivalence

The Route 92 Medical 088 Access System, 110 cm, has the same intended use, the same technological characteristics and same method of action as the Predicate Devices. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical 088 Access System, 110 cm, is substantially equivalent to the Predicate Devices.

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).