The Agile Devices Angler™ Steerable, Deflectable Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled infusion of diagnostic agents and delivery of embolic or therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.

Device Description

The Agile Devices Angler™ Steerable, Deflectable Microcatheter is a variable stiffness, single lumen microcatheter designed to access small tortuous vasculature. It has a steerable articulating deflectable tip and has a hydrophilic polymer coating over the distal 80cm which gives lubricity when wet. Tip deflection is controlled using a manual steering mechanism / handle external to the body. On-plane bi-directional tip deflection is achieved via coaxial movement of the inner versus the outer shaft which bends a distal covered flat wire. Material injection is achieved via syringe connection to the proximal end of the catheter.

The Agile Devices Angler™ Steerable, Deflectable microcatheter has a maximum outside diameter of 0.0394" (3F). It has an inside diameter of 0.021" and has two radiopaque marker bands on the distal tip and at the deflection point to facilitate fluoroscopic visualization. It is compatible with guiding catheters with I.D. down to 0.047". The microcatheter lumen is compatible with steerable guidewires up to 0.018", and particles up to 500um or embolic spheres up to 700μm, with a burst pressure rating up to 1000 psi.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Agile Devices Angler™ Steerable, Deflectable Microcatheter, based on the provided text:

Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets novel acceptance criteria through a large-scale clinical study in the way an AI/ML device might. Therefore, many of the typical questions for AI/ML device studies (like sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity/AUC) are not applicable or not clearly delineated in this type of submission. This device is a physical medical instrument, not an AI algorithm.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here refers to pre-defined test acceptance criteria for bench testing and pre-clinical testing for a physical medical device to demonstrate its performance characteristics are comparable to predicate devices and meet relevant standards. It does not refer to clinical endpoints or diagnostic performance metrics typically associated with AI.

Test Category	Specific Test	Acceptance Criteria (Implied/Stated)	Reported Device Performance
In Vitro Bench Testing	Visual Inspections and Dimensional verifications	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Tensile Bond Strength at Tip and Handle Connections	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Torque Strength (Revolutions to Failure)	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Radio-Detectability	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Kink Resistance	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Liquid Leakage	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Luer Testing to ISO 80369-7 & ISO 80369-20	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Tip Flexibility / Softness	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Tip Deflection Angle and Multiple Deflection Fatigue	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Resistance to Override	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Power Injection (for Flowrate and Device Burst Pressure)	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Coating Tests: Length, Coating Integrity and Particulate	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
	Pushability / Trackability and Torque Response	Met pre-defined test acceptance criteria	All tests met the pre-defined test acceptance criteria.
Shelf Life and Sterility Testing	Package integrity (dye penetration, pouch peel)	Confirm proper operation following aging & shipping	All package and device integrity tests passed.
	Device integrity (after aging & shipping)	Confirm proper operation following aging & shipping	All package and device integrity tests passed.
Sterilization Validation	Sterility Assurance Level (SAL) per ISO 11135	SAL of 10^-6	Achieved SAL of 10^-6.
	Endotoxin levels per USP 40-NF35:2017 <85>	Below 2.15 EU/Device	Confirmed endotoxin levels well below the limit.
	Sterilization residuals evaluated per ISO 10993-7	Compliance with ISO 10993-7	Evaluated according to ISO 10993-7. * (Implied compliance)*
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility, SC5b-9 Complement Active Assay, ASTM Partial Thromboplastin Time, In Vivo Thromboresistance Study	Compliance with ISO 10993-1:2018 (Circulating Blood, Externally Communicating, ≤ 24 hours).	All listed tests were performed to confirm biocompatibility. * (Implied compliance)*

Study Details (for a physical medical device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The text does not specify exact sample sizes for each individual bench test. The testing involved "Agile Devices Angler™ Steerable, Deflectable Microcatheters" but the precise number of units tested for each specific test is not detailed.
- Data Provenance: The studies are "In Vitro Bench Testing" and "Shelf Life and Sterility Testing" and "Biocompatibility" (which included an in vivo thromboresistance study in canines). This is primarily laboratory and animal testing, not human clinical data, so country of origin of patient data is not applicable. The data is prospective as it was generated specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical medical device undergoing bench and pre-clinical testing, "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM, USP) and predefined engineering specifications. This doesn't involve expert consensus on medical images or clinical outcomes in the same way an AI device would.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or uncertain outcomes. For bench testing, test results either meet a pre-defined objective criterion or they do not.
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. This is a physical medical device (microcatheter), not an AI diagnostic algorithm. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench and pre-clinical testing mentioned:
  - Bench Testing: Engineering specifications, physical measurements, and performance against established industry standards (e.g., ISO 10555-1) served as the "ground truth" or acceptance criteria.
  - Sterilization Validation: Demonstrated sterility per ISO 11135 and endotoxin levels per USP standards.
  - Biocompatibility: Performance against biological safety requirements outlined in ISO 10993. For the in vivo thromboresistance study, observed biological reactions in canines compared to controls would serve as the basis for evaluation.
The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a physical device, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

January 7, 2022

Agile Devices, Inc. % Stephen Tully, VP, R&D & Technical Operations Strategic Device Solutions LLC 20 Lawton Lane, Foxborough, MA 02035 USA

Re: K211110

Trade/Device Name: Agile Devices Angler™ Steerable, Deflectable Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: April 14, 2021 Received: April 14, 2021

Dear Stephen Tully:

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/cfpmp/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 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

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K21110

Device Name

Agile Devices Angler™ Steerable, Deflectable Microcatheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subnart D)	Over-The-Counter Use (21 CFR 801 Subnart C)

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510k SUMMARY

Agile Devices Angler™ Steerable, Deflectable Microcatheter 510(k) K211110

This summary of 510(k) safety and effectiveness information is being submitted per the requirements of 21 CFR 807.92.

A.	Submitter:	Agile Devices, Inc.Contact: Stephen TullyTel#: (617) 416-5495Email: stevet99x@gmail.com
B.	Manufacturer/510(k) Applicant:	Agile Devices, Inc.69 Fox Hill RoadWellesley, MA 02481Contact: Stephen Tully

Contact: Stephen Tully Title: VP, R&D & Technical Operations Tel #: (617) 416-5495 Email: stevet99x @ gmail.com

C. Date Prepared: January 3, 2022

Device Name and Classification Information: D.

Trade Name:	Agile Devices Angler™ Steerable, Deflectable Microcatheter
Common/Usual Name:	Continuous Flush Catheter
Regulation:	21 CFR 870.1210
Product Code:	KRA
Review Panel:	Cardiovascular
Class:	Class II

E. Predicate Device:

Primary: Bend It Technologies, Bendit2.7TM Steerable Microcatheter, (K200582) Secondary: Merit Medical, SwiftNINJA (K161921)

F. Summary Device Description:

Agile Devices

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G. Indications for Use Statement:

H. Technical Comparison with Predicate Devices

The table below provides a technological comparison between the Agile Devices Angler™ Steerable, Deflectable Microcatheter and the predicate devices. The similarities and differences between the proposed and predicate devices are discussed following the table.

	Proposed DeviceAgile Devices Angler™	Primary PredicateBendit2.7™	Reference PredicateSwiftNINJA
	Steerable, DeflectableMicrocatheter
Indications forUse	The Agile Devices Angler™Steerable, DeflectableMicrocatheter isintended for generalintravascular use,including peripheral,and coronaryvasculature. Once thesub-selective regionhas been accessed, themicrocatheter can beused for the controlledinfusion of diagnosticagents and delivery ofembolic or therapeuticdevices. Use only contrast mediaand therapeutic devices that havebeen cleared or approved for usein the intended target area.	The Bendit2.7™SteerableMicrocatheter isintended for generalintravascular use, in theperipheral vasculature.The microcatheter canbe used for the deliveryof diagnostic, embolic,or therapeutic materialsinto the vasculature.The Bendit2.7 is notintended to be used inintracranial or coronaryvessels.	The SwiftNINJA isintended for generalintravascular use,including peripheraland coronaryvasculature. Once thesubselective regionhas been accessed, themicrocatheter can beused for thecontrolled andselective infusion ofdiagnostic, embolic,or therapeutic materials intothe vasculature. The cathetershould not be used in cerebralvessels.

Catheter type	Steerable,microcatheter	Steerablemicrocatheter	Steerablemicrocatheter
MicrocatheterComponents	Catheter shaft, steerablearticulating tip,steerable handle	Catheter shaft, steerablearticulating tip, 100°steering handle	Catheter shaft, steerabledeflecting tip, steerablehandle.
Mode ofoperation	Catheter insertion and tipplacement under imagingguidance.	Catheter insertion and tipplacement under imagingguidance.	Catheter insertion and tipplacement under imagingguidance.
	Tip deflection iscontrolled using a thumb-controlled mechanismexternal to the body.	Tip deflection controlledusing manual steeringmechanism external to thebody.	Tip articulation controlledusing manual steeringmechanism externalto thebody.
	On-plane bi-directionaltip deflection is achievedvia coaxial movement ofthe inner versus the outershaft which bends a distalcovered flat wire	Tip deflection achieved viatwo NiTi hypo tubesconnected at the distal endof catheter with laser-cutpatterns that provide tipflexibility.	Tip articulation achievedvia two wires running alongthe inner walls of thecatheter shaft from handleto tip.Material injection via
	Material injectionviasyringe connection to luerat proximal end ofcatheter.	Material injection viasyringe connection to luerat proximal end ofcatheter.	syringe connection to luer atproximal end of catheter.
Catheter OD	3 Fr (0.0394")	2.7 Fr	2.9 Fr (proximal) / 2.4Fr(distal)
Catheter ID	0.021"	0.021"	0.021"
Catheter shaftlength(s)	130 cm and 147 cm	130 cm	125 cm
Hydrophiliccoating on shaft	Yes	Yes	Yes
Compatibleguidewire	$ \le $ 0.018"	$ \le $ 0.018"	$ \le $ 0.018"
# Lumens	Single	Single	Single
Fill volume	0.4 mL	0.45 mL	0.49 mL

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This 510(k) supports the substantial equivalence of the Agile Devices Angler™ Steerable, Deflectable Microcatheter tip deflection mechanism to that of the predicate devices.

The Agile Devices Angler™ Steerable, Deflectable Microcatheter is similar in length to the predicate devices, but also comes in a longer 147 cm length. The Agile Devices Angler™ Steerable Deflectable Microcatheter O.D., I.D., fill volume, and EO sterility method are all similar to the predicate devices.

All devices are single lumen with a hydrophilic coating on the catheter shaft, radiopaque tips, and are intended for single patient use only.

J. Testing to Support Substantial Equivalence

In Vitro Bench Testing

The Agile Devices Angler™ Steerable, Deflectable Microcatheter was tested on bench simulated testing fixtures to demonstrate that the catheter could access arterial and venous vasculature including peripheral and coronary vasculature and to support the substantial equivalence to the Bendit 2.7 Steerable Microcatheter and the SwiftNINJA Microcatheter. Testing was conducted in accordance with ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements (including Amendment 1:2017), where applicable.

Visual Inspections and Dimensional verifications 1)
Tensile Bond Strength at Tip and Handle Connections 2)
Torque Strength (Revolutions to Failure) 3)
Radio-Detectability 4)
ર) Kink Resistance
1. Liquid Leakage
1. Luer Testing to ISO 80369-7 & ISO 80369-20
Tip Flexibility / Softness 8)
1. Tip Deflection Angle and Multiple Deflection Fatigue
1. Resistance to Override
1. Power Injection (for Flowrate and Device Burst Pressure)
1. Coating Tests: Length, Coating Integrity and Particulate
1. Pushability / Trackability and Torque Response

All tests met the pre-defined test acceptance criteria

Shelf Life and Sterility Testing

Agile Devices Angler™ Steerable, Deflectable Microcatheters that had been 2X EtO sterilized and aged in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices were then subjected to simulated environmental and shipping conditions and tested in accordance with ISTA-2A Simulated Shipping Testing. The product was exposed to environmental

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conditioning at cryogenic -20° for 72 hours; tropical 38°C with 85% RH for 72 hours and then 60 °C with 30% RH for 6 hours.

Aging was simulated by performing a 6 month Accelerated Aging cycle which was calculated as 26 edays at 50% per ASTM F1980:16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

Package integrity tests included the dye penetration tests and pouch peel tests per ISO 11607- 1:2019 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems - Part 2: Validation requirements for forming, sealing and assembly processes. Test devices were subjected to integrity testing to confirm proper operation following aging and simulated distribution conditioning. All package and device integrity tests passed.

Sterilization Validation

Ethylene oxide sterilization was validated to a Sterility Assurance Level (SAL) of 106 using the halfcycle, overkill method per ISO 11135:2014, 2nd edition, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. Bacterial endotoxin testing conducted using the LAL Test per USP 40-NF35:2017 <85> Bacterial Endotoxins Test confirmed endotoxin levels well below the limit of the standard (< 2.15 EU/Device), Sterilization residuals were evaluated according to ISO 10993-7.

Biocompatibility

The Agile Devices Angler™ Steerable Microcatheter is classified in accordance with ISO 10993-1: 2018, as a Circulating Blood, Externally Communicating device with a Contact Duration of ≤ 24 hours.

The following test were performed to confirm biocompatibility of the patient contacting materials:

A. Cytotoxicity Study Using the ISO Elution Method
B. ISO Guinea Pig Maximization Sensitization Test
C. ISO Intracutaneous Study in Rabbits
D. Acute Systemic Toxicity
E. Material Mediated Pyrogenicity
F. Hemocompatibility
G. SC5b-9 Complement Active Assay
H. ASTM Partial Thromboplastin Time with Sponsor Control
I. In Vivo Thromboresistance Study in Canines Femoral Artery, Acute

K. Conclusion

The information and testing presented in this 510(k) demonstrate that the Agile Devices Angler™ Steerable, Deflectable Microcatheter is substantially equivalent to the Bendit2.7™ and SwiftNINJA Steerable Microcatheter for the delivery of diagnostic, embolic, or therapeutic materials into the peripheral and coronary vasculature.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).