The Route 92 Medical Full Length 088 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 Full Length 088 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Full Length 088 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 a 510(k) premarket notification for a medical device, the Route 92 Medical Full Length 088 Access System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria in the context of efficacy for a new therapeutic claim, a multi-reader multi-case study, or standalone algorithm performance, is not directly applicable in the same way it would be for a de novo submission or a PMA.

Instead, the document details non-clinical (biocompatibility and performance) testing to show the new device performs similarly safely and effectively to its predicate.

Here's an analysis based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, numerical format for each performance test, but rather implies them via "All samples met the pre-determined acceptance criteria" or similar statements. The "Reported device performance" is summarized as "PASS" for all tests, indicating that they met these unquantified criteria.

Test	Test Method	Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Verification	Device dimensions were measured to confirm conformance to the specifications	Conformance to specifications	PASS
Luer Integrity	Tested per ISO 80369-7:2016	Met ISO 80369-7:2016 requirements	PASS
Tensile Strength	The tensile strength of the catheter sections and bonds was tested	Met pre-determined acceptance criteria for tensile strength	PASS
Kink Resistance	Test specimen segments were formed into a defined bend diameter to evaluate kink resistance	Met pre-determined acceptance criteria for kink resistance	PASS
Torsion Resistance	The test specimens were rotated to evaluate integrity after rotation	Maintained integrity after rotation, met pre-determined acceptance criteria	PASS
Tip Flexibility	Test specimens were tested for tip flexibility	Met pre-determined acceptance criteria for tip flexibility	PASS
Air Leakage	Tested per ISO 10555-1:2013 Annex D.	Met ISO 10555-1:2013 Annex D requirements	PASS
Liquid Leakage	Tested per ISO 10555-1:2013 Annex C.	Met ISO 10555-1:2013 Annex C requirements	PASS
Static Burst	Tested per ISO 10555-1:2013 Annex F.	Met ISO 10555-1:2013 Annex F requirements	PASS
Dynamic Burst	Mechanical integrity was maintained up to the specified pressures	Maintained mechanical integrity up to specified pressures, met acceptance criteria	PASS
Hydrophilic Coating Integrity	The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles.	Maintained integrity after multiple cycles, met acceptance criteria	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>. Particulates were characterized for size ranges ≥10 µm, ≥25 µm, ≥50 µm, ≥100 µm, ≥200 µm, ≥500 µm and ≥1000 µm	Met USP <788> requirements for particulate matter, met acceptance criteria	PASS
Simulated Use Testing	Deliverability and compatibility with accessory devices were evaluated in a neurovascular model	Demonstrated deliverability and compatibility in a neurovascular model, met acceptance criteria	PASS
Packaging Integrity	ISO 11607-1 Part 1ISO 11607-2 Part 2	Met ISO 11607-1 and ISO 11607-2 requirements	PASS

Biocompatibility Testing:

Test	Conclusions (Reported Performance)
Cytotoxicity - ISO MEM Elution	The test article is non-cytotoxic. (Met requirements, grade < 2)
Sensitization - ISO Guinea Pig Maximization Sensitization Test	The test article did not elicit a sensitization response.
Irritation - ISO Intracutaneous Reactivity	Requirements of the ISO intracutaneous reactivity test have been met for the test article.
Acute Systemic Toxicity - ISO Acute Systemic Injection	Requirements of the ISO acute systemic injection test have been met for the test article.
Pyrogen - Material Mediated Pyrogen	The test article is non-pyrogenic.
Hemocompatibility - Complement Activation (SC5b-9)	The test article would not be expected to result in adverse effects in vivo.
Hemocompatibility - Partial Thromboplastin Time	The test article is considered to be a non-activator of the intrinsic coagulation pathway.
Hemocompatibility - ASTM Hemolysis	The test article is considered non-hemolytic.

2. Sample sized used for the test set and the data provenance:
The document does not specify the exact sample sizes (N-numbers) for each performance test. It consistently states "All samples met the pre-determined acceptance criteria," implying that a sufficient number of units were tested according to the relevant standards. The data provenance is non-clinical (laboratory testing) rather than clinical (human subjects). No country of origin is specified for the testing data. All testing appears to be retrospective in the sense that it was conducted on manufactured devices before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a physical medical instrument, and its performance is evaluated against engineering and biological standards in non-clinical lab settings, not through expert-reviewed "ground truth" like in AI/diagnostic imaging studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this refers to expert review processes for clinical data, which is not present in this submission.

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 device is an access system (catheter) and not an AI-powered diagnostic tool. The submission focuses on substantial equivalence based on material properties and mechanical performance, not on AI assistance for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance are the established international and industry standards (e.g., ISO, USP) and the pre-determined engineering specifications for the device's physical and biological characteristics.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable as there is no training set for this device.

Summary

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July 27, 2021

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 Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.

Route 92 Medical Kirsten Valley Chief Operating Officer 155 Bovet Road. Suite 100 San Mateo, California 94402

Re: K210635

Trade/Device Name: Route 92 Medical Full Length 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: June 28, 2021 Received: June 29, 2021

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. 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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K210635

Device Name

Route 92 Medical Full Length 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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K210635 510(k) Summary

Sponsor:	Route 92 Medical155 Bovet Road, Suite 100San Mateo, CA 94402Phone: 650-581-1179
Contact:	Kirsten Valley
Date Prepared:	July 20, 2021
Device Name:	Route 92 Medical Full Length 088 Access System
Common Name:	Percutaneous Catheter
Classification Name:	Catheter, Percutaneous, Neurovasculature (Product CodeQJP, 21 CFR 870.1250)
Device Classification:	Class II
Predicate Device:	Route 92 Medical 088 Access System, K201518

Device Description

Indications for Use

Comparison to the Predicate Device

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

Attribute	Predicate DeviceRoute 92 Medical 088 Access System(K201518)	Subject DeviceRoute 92 Medical Full Length 088Access System (K210635)
Indicationsfor Use	The Route 92 Medical 088 AccessSystem, 143 cm, is indicated for use	The Route 92 Medical Full Length088 Access System is indicated for
	Predicate DeviceRoute 92 Medical 088 Access System(K201518)	Subject DeviceRoute 92 Medical Full Length 088Access System (K210635)
Attribute	with compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem.	use with compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem.
DeviceDescription	Sterile, single-use, variable stiffness,coil-reinforced catheter with proximalcontrol wire	Sterile, single-use, variable stiffness,coil-reinforced catheter
Targetedpopulation	Patients requiring use of amicrocatheter in the neurovascularsystem	Same
User	Physicians trained in neurovascularinterventional techniques	Same
AnatomicalSites	Neurovasculature only	Same
Materials	Polymers and metals commonly usedin the manufacture of medical devices	Same
Sterilization	100% ethylene oxide	Same
Shelf Life	8 months	Same
Support Catheter
InnerDiameter	0.088"	Same
OuterDiameter	Distal: 0.101"Proximal: 0.105"	0.101"
Length	143 cm	132 cm and 125 cm
Delivery Catheter
InnerDiameter	0.019"	Same
OuterDiameter	Distal: 0.080"Proximal: 0.062"	Same
Length	151 cm	Same

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Non-Clinical Testing

Biocompatibility Testing

The Route 92 Medical Full Length 088 Access System is constructed using the same materials as the predicate device. All patient contacting components have been evaluated for biocompatibility in

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accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Route 92 Medical Full Length 088 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	Results	Conclusions
Cytotoxicity - ISOMEM Elution	The test article extract showed no evidence ofcausing cell lysis or toxicity. The test articleextract met the requirements of the test as gradewas less than 2.	The test article is non-cytotoxic.
Sensitization - ISOGuinea PigMaximizationSensitization Test(Normal Saline andSesame Oil)	The test article extracts showed no evidence ofcausing delayed dermal contact sensitization inthe guinea pig. The test article was not considereda sensitizer in the test.	The test article did notelicit a sensitizationresponse.
Irritation - ISOIntracutaneousReactivity (NormalSaline and Sesame Oil)	The test article met the requirements of the testsince the difference between each test articleextract overall mean score and correspondingcontrol extract overall mean score was 1.0 or lessfor both sodium chloride and sesame oil testarticle extracts.	Requirements of theISO intracutaneousreactivity test havebeen met for the testarticle.
Acute SystemicToxicity - ISO AcuteSystemic Injection(Normal Saline andSesame Oil)	There was no mortality or evidence of systemictoxicity from the extracts injected into mice.	Requirements of theISO acute systemicinjection test have beenmet for the test article.
Pyrogen - MaterialMediated Pyrogen(Normal Saline)	No single animal showed a temperature rise of0.5℃ or more above its baseline temperature.	The test article is non-pyrogenic.
Hemocompatibility-ComplementActivation (SC5b-9)	The concentration of SC5b-9 in the test samplewas lower than the concentration in the controlsample.	The test article wouldnot be expected toresult in adverse effectsin vivo.
Hemocompatibility -Partial ThromboplastinTime	The test article clotting time was not statisticallydifferent as compared to the control article.	The test article isconsidered to be a non-activator of the intrinsiccoagulation pathway.
Hemocompatibility -ASTM Hemolysis	Both the test article in direct contact with bloodand the test article extract were non-hemolytic.	The test article isconsidered non-hemolytic.

Performance Testing

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

ﺎ

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
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
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	Tested per ISO 10555-1:2013Annex C.	PASSAll samples met the pre-determinedacceptance criteria
Static Burst	Tested per ISO 10555-1:2013Annex F.	PASSAll samples met the pre-determinedacceptance criteria
Dynamic Burst	Mechanical integrity wasmaintained up to the specifiedpressures	PASSAll samples met the pre-determinedacceptance criteria
HydrophilicCoating Integrity	The integrity of the hydrophiliccoating was evaluated aftermultiple insertion and withdrawalcycles.	PASSAll samples met the pre-determinedacceptance criteria
Test	Test Method	Results
ParticulateRecovery	After multiple insertion andwithdrawal cycles, the effluentwater rinsed and flushed from thedevices and model was tested perUSP <788>. Particulates werecharacterized for size ranges ≥10µm, ≥25 µm, ≥50 µm, ≥100 µm,≥200 µm, ≥500 µm and ≥1000 µm	PASSAll samples met the pre-determinedacceptance criteria
Simulated UseTesting	Deliverability and compatibilitywith accessory devices wereevaluated 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

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Conclusions

The Route 92 Medical Full Length 088 Access System has the same intended use, the same technological characteristics and same method of action as the predicate device. Differences between the subject and predicate devices do not raise new concerns of safety and effectiveness of the successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical Full Length 088 Access System is substantially equivalent to the predicate device.

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).