The Route 92 Medical Access System 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 Access System is comprised of an Access Catheter and a Delivery Catheter. The distal portion of the Access 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, singlelumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Access System 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

The provided text describes the acceptance criteria and the studies conducted for the Route 92 Medical Access System.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for all tests was "PASS". The reported device performance for all tests was also "PASS". This is explicitly stated for each test category.

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Demonstrates non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, minimal complement activation, non-activator of intrinsic coagulation, non-hemolytic, similar thromboresistance, non-mutagenic, and non-clastogenic.	All tests passed, concluding the device meets biocompatibility requirements.
Dimensional Verification	Conformance to specifications	PASS
Luer Integrity	Per ISO 80369-7:2016	PASS
RHV Sealing	Sealing around catheter shafts	PASS
Tensile Strength	Strength of catheter sections and bonds	PASS
Kink Resistance	Resistance to kinking in a defined bend diameter	PASS
Torsion Resistance	Integrity after rotation	PASS
Tip Flexibility	Flexibility of the tip	PASS
Air Leakage	Per ISO 10555-1:2013 Annex D	PASS
Liquid Leakage / Static Burst	Per ISO 10555-1:2013 Annex C	PASS
Dynamic Burst	Mechanical integrity up to specified pressures	PASS
Flow	Contrast media flow rates equivalent to predicate devices	PASS
Hydrophilic Coating Integrity	Integrity after multiple insertion/withdrawal cycles	PASS
Particulate Recovery	Effluent water tested per USP <788> after multiple cycles	PASS
Corrosion Resistance	Per ISO 10555-1:2013 Annex A	PASS
Simulated Use Testing	Deliverability and compatibility in a neurovascular model	PASS
Packaging Integrity	Per ISO 11607-1 Part 1 & ISO 11607-2 Part 2	PASS
Radiopacity	Radiopacity in an animal model under fluoroscopy	PASS

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the specific "sample size" for each individual test within the performance and biocompatibility sections. Instead, it generally refers to "All samples" or "test animals" for biocompatibility.

For Biocompatibility: The tests used "animals" (Guinea Pigs, Rabbits, Mice, potentially others for in-vitro tests). The number of animals per test is mentioned for some (e.g., "None of the animals", "rabbits administered").
For Performance Testing: The results consistently state "All samples met the pre-determined acceptance criteria." without specifying the number of samples.
Data Provenance: The studies are non-clinical, meaning they are laboratory or animal-based tests. The document does not specify the country of origin of the data, nor whether it is retrospective or prospective, though non-clinical tests are generally prospective laboratory studies.

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

This information is not provided in the document. The studies described are non-clinical in nature, focusing on the physical and biological characteristics of the device. There is no mention of "experts" establishing a "ground truth" for a test set in the context of human evaluation or diagnostic accuracy, as this device is a medical instrument, not a diagnostic algorithm.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the non-clinical testing performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies evaluating human interpretation (e.g., image reading) where disagreement among experts needs resolution.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI systems or those involving human interpretation of data, which is not the function of the Route 92 Medical Access System.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic AI is not directly applicable here. For the non-clinical tests:

Biocompatibility: Ground truth is established by standardized biological evaluation methods and safety endpoints (e.g., no signs of toxicity, irritation, sensitization).
Performance Testing: Ground truth is established by engineering specifications, recognized industry standards (e.g., ISO standards), and functional requirements (e.g., flow rates, mechanical integrity).

8. The Sample Size for the Training Set

This information is not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for a physical medical device.

Summary

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May 23, 2018

Route 92 Medical, Inc. Kirsten Valley Senior VP QA/RA/CA 1700 South El Camino Real, Suite 206 San Mateo, California 94402

Re: K180201

Trade/Device Name: Route 92 Medical Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 23, 2018 Received: April 24, 2018

Dear Kirsten Valley:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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.

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) K180201

Device Name Route 92 Medical Access System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K180201

510(K) SUMMARY

510(k) Summary

Sponsor:	Route 92 Medical1700 S. El Camino Real, Suite 206San Mateo, CA 94022Phone: 650-581-1179Fax: 650-343-5827
Contact:	Kirsten Valley
Date Prepared:	May 3, 2018
Device Name:	Route 92 Medical Access System
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter (Product Code DQY, 21 CFR870.1250)
Legally Marketed Predicate Device:	MIVI Mi-EXT Catheter (K163233)

Device Description

Indications for Use

Comparison to Predicate Device

The method of action, design, and materials of the Route 92 Medical Access System are equivalent to the MIVI Mi-EXT Catheter as shown in the following table.

Attribute	Predicate MIVI Mi-EXT Catheter(K163233)	Subject Route 92 Medical AccessSystem
Indications forUse	The MIVI 6F Guide Catheter is indicatedfor use with compatible guide catheters	The Route 92 Medical Access Systemis indicated for use with compatible
Attribute	Predicate MIVI Mi-EXT Catheter(K163233)	Subject Route 92 Medical AccessSystem
	in facilitating the insertion and guidanceof microcatheters into a selected bloodvessel in the peripheral, coronary andneuro vascular systems.	guide catheters in facilitating theinsertion and guidance ofmicrocatheters into a selected bloodvessel in the neurovascular system.
DeviceDescription	Sterile, single-use, variable stiffness,coil-reinforced catheter with proximalcontrol wire	Same as predicate device.
Targetedpopulation	Patients requiring use of a microcatheterin the peripheral, coronary orneurovascular systems	Patients requiring use of amicrocatheter in the neurovascularsystem
User	Physicians trained in interventionaltechniques	Physicians trained in neurovascularinterventional techniques
Anatomical Sites	Peripheral, coronary or neurovascularsystems	Neurovasculature only
Method of Action	Delivered through a guide catheter withsupport of a microcatheter/deliverycatheter, the device provides a lumen forthe introduction of microcatheters.	Same as predicate device
Materials	Polymers and metals commonly used inthe manufacture of medical devices	Same as predicate device
Access Catheter
Inner Diameter	0.069"	0.070" (minimum)
Outer Diameter	Distal: 0.081"Proximal: 0.087"	Distal: 0.082"Proximal: 0.087"
Length	140 - 153cm	136cm
Delivery Catheter
Inner Diameter	N/A	0.019"
Outer Diameter	N/A	0.062"
Length	N/A	150cm

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Non-Clinical Testing

Biocompatibility Testing

The Route 92 Medical Access System 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.

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Test	Results	Conclusions
Cytotoxicity - ISO MEMElution	Grade 0 at 24, 48, 72 ± 4 hrs	The test article is non-cytotoxic.
Sensitization - ISOGuinea Pig MaximizationSensitization Test(Normal Saline andSesame Oil)	Clinical Observations: none of the animalsshowed abnormal clinical signs during thetest period.Main Test Results:Negative Control, grade =0Normal Saline, grade = 0Sesame Oil, grade = 0	Test article did not elicit asensitization response.
Irritation - ISOIntracutaneous Reactivity(Normal Saline andSesame Oil)	Dermal observations:Comparative Results Mean Test-MeanControl (Normal Saline) = 0Mean Test-Mean Control (Sesame Oil) = 0.1Differences between mean test and controlscores were less than 1.0	Requirements of the ISOintracutaneous reactivitytest have been met for thetest article.
Acute Systemic Toxicity- ISO Acute SystemicInjection (Normal Salineand Sesame Oil)	None of the test article extract treatedanimals were observed with clinical signsconsistent with toxicity. Body weightchanges were within acceptable parameters.	Requirements of the ISOacute systemic injectiontest have been met for thetest article.
Pyrogen - MaterialMediated Pyrogen(Normal Saline)	During the 3-hr observation period, none ofthe rabbits administered with the text articleextract had a temperature rise ≥ 0.5°C atthe required observation time points. Theresponse did not exceed the USP limits andmeets the requirements for this test.	The test article is non-pyrogenic.
Hemocompatibility -ComplementActivation (C3a &SC5b-9)	When compared to a legally US-marketeddevice, the minimal increase in complementactivation noted in the test article would notbe expected to result in adverse effects invivo.	The test article would notbe expected to result inadverse effects in vivo.
Hemocompatibility -Partial ThromboplastinTime	The PPT of the test article was 100% of thenegative control.	The test article isconsidered to be a non-activator of the intrinsiccoagulation pathway andpasses the test.
Hemocompatibility -ASTM Hemolysis	Blank corrected hemolytic index above thenegative control:Direct Method: 0.0%Extract Method: 0.3%	The test article isconsidered non-hemolytic.
Hemocompatibility -Thromboresistance	All test animals survived the generalanesthesia and study observationinterval without test article relatedcomplications.	The test devices appear tohave similarthromboresistancecharacteristics as the
	The combined data of blood test reports, pre-and post-implant weight differences, and thepatency and thrombus scores were notsubjectively different between the test andcontrol articles.	control devices.
Genotoxicity - ISOBacterial MutagenicityTest – Ames Assay(Normal Saline andPolyethylene Glycol)	The test article did not induce substantialincreases in reversion rates of the type thatare associated with mutagenesis and nosubstantial test article toxicity was noted thatmay have interfered with the ability of thetest system to detect mutagens.	The test article isconsidered non-mutagenic.
Genotoxicity - ISO InVitro Mouse Lymphoma(Normal Saline andPolyethylene Glycol)	The test article did not cause notable changesin the typical growth pattern of the L5178Ycells in suspension culture during the growthand expression period. The cloningefficiencies of these preparations were withinnormal limits.	The test article isconsidered to be non-mutagenic and non-clastogenic.

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Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Access System 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 kink resistance	PASSAll samples met the pre-determinedacceptance criteria
Test	Test Method	Results
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 10555-1:2013Annex 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
Flow	Contrast media flow rates weremeasured and found to beequivalent to predicate devices	PASSAll samples met the pre-determinedacceptance criteria
HydrophilicCoating Integrity	The integrity of the hydrophiliccoating was evaluated after multipleinsertion and withdrawal cycles.	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
CorrosionResistance	Tested per ISO 10555-1:2013Annex A.	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
PackagingIntegrity	ISO 11607-1 Part 1ISO 11607-2 Part 2	PASSAll samples met the pre-determinedacceptance criteria
Test	Test Method	Results
Radiopacity	Radiopacity of the device wasevaluated in an animal model underfluoroscopy	PASSAll samples met the pre-determinedacceptance criteria

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Substantial Equivalence

The Route 92 Medical Access System has the same intended use, the same technological characteristics and same method of action as the predicate MIVI Mi-EXT Catheter. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical Access System is substantially equivalent to MIVI Mi-EXT 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).