Agile Devices Angler Steerable, Deflectable Microcatheter

K211110 · Agile Devices, Inc. · KRA · Jan 7, 2022 · Cardiovascular

Device Facts

• Record ID: K211110
• Device Name: Agile Devices Angler Steerable, Deflectable Microcatheter
• Applicant: Agile Devices, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Jan 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Variable stiffness, single-lumen microcatheter for accessing small, tortuous vasculature; features steerable, articulating, deflectable tip. Manual steering mechanism/handle external to body controls tip deflection via coaxial movement of inner vs. outer shaft, bending distal covered flat wire. Includes hydrophilic polymer coating on distal 80cm for lubricity. Radiopaque marker bands at distal tip and deflection point facilitate fluoroscopic visualization. Physician operates device under imaging guidance; material injection via syringe connection at proximal end. Enables sub-selective access for diagnostic/therapeutic delivery; benefits patient by facilitating navigation through complex vascular anatomy.

Clinical Evidence

Bench testing only. Evaluated per ISO 10555-1 for visual/dimensional verification, tensile strength, torque strength, kink resistance, leakage, luer testing (ISO 80369-7/20), tip flexibility, deflection fatigue, resistance to override, power injection, and coating integrity. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous, acute systemic toxicity, pyrogenicity, hemocompatibility, complement activation, PTT, and in vivo thromboresistance in canines). Sterility validated per ISO 11135:2014 (SAL 10^-6).

Technological Characteristics

Single-lumen microcatheter; 3F (0.0394") OD, 0.021" ID; lengths 130cm/147cm. Hydrophilic coating; radiopaque marker bands. Manual steering mechanism; coaxial shaft movement for tip deflection. Compatible with guidewires ≤ 0.018". Sterilization: Ethylene Oxide (EtO) per ISO 11135:2014. Materials biocompatible per ISO 10993-1. No software/electronics.

Indications for Use

Indicated for patients requiring general intravascular access in peripheral and coronary vasculature for controlled infusion of diagnostic agents or delivery of embolic/therapeutic devices.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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.<br>Contact: Stephen Tully<br>Tel#: [phone]<br>Email: [e-mail] |
|----|------------------------------------|-----------------------------------------------------------------------------------------------------|
| B. | Manufacturer/<br>510(k) Applicant: | Agile Devices, Inc.<br>69 Fox Hill Road<br>Wellesley, MA 02481<br>Contact: Stephen Tully |

Contact: Stephen Tully Title: VP, R&D & Technical Operations Tel #: [phone] 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:

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.

Agile Devices

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### G. Indications for Use Statement:

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.

#### 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 Device<br>Agile Devices Angler™ | Primary Predicate<br>Bendit2.7™ | Reference Predicate<br>SwiftNINJA |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Steerable, Deflectable<br>Microcatheter | | |
| Indications for<br>Use | The Agile Devices Angler™<br>Steerable, Deflectable<br>Microcatheter is<br>intended for general<br>intravascular use,<br>including peripheral,<br>and coronary<br>vasculature. Once the<br>sub-selective region<br>has been accessed, the<br>microcatheter can be<br>used for the controlled<br>infusion of diagnostic<br>agents and delivery of<br>embolic or therapeutic<br>devices. Use only contrast media<br>and therapeutic devices that have<br>been cleared or approved for use<br>in the intended target area. | The Bendit2.7™<br>Steerable<br>Microcatheter is<br>intended for general<br>intravascular use, in the<br>peripheral vasculature.<br>The microcatheter can<br>be used for the delivery<br>of diagnostic, embolic,<br>or therapeutic materials<br>into the vasculature.<br>The Bendit2.7 is not<br>intended to be used in<br>intracranial or coronary<br>vessels. | The SwiftNINJA is<br>intended for general<br>intravascular use,<br>including peripheral<br>and coronary<br>vasculature. Once the<br>subselective region<br>has been accessed, the<br>microcatheter can be<br>used for the<br>controlled and<br>selective infusion of<br>diagnostic, embolic,<br>or therapeutic materials into<br>the vasculature. The catheter<br>should not be used in cerebral<br>vessels. |
| | | | |
| Catheter type | Steerable,<br>microcatheter | Steerable<br>microcatheter | Steerable<br>microcatheter |
| Microcatheter<br>Components | Catheter shaft, steerable<br>articulating tip,<br>steerable handle | Catheter shaft, steerable<br>articulating tip, 100°<br>steering handle | Catheter shaft, steerable<br>deflecting tip, steerable<br>handle. |
| Mode of<br>operation | Catheter insertion and tip<br>placement under imaging<br>guidance. | Catheter insertion and tip<br>placement under imaging<br>guidance. | Catheter insertion and tip<br>placement under imaging<br>guidance. |
| | Tip deflection is<br>controlled using a thumb-<br>controlled mechanism<br>external to the body. | Tip deflection controlled<br>using manual steering<br>mechanism external to the<br>body. | Tip articulation controlled<br>using manual steering<br>mechanism externalto the<br>body. |
| | On-plane bi-directional<br>tip deflection is achieved<br>via coaxial movement of<br>the inner versus the outer<br>shaft which bends a distal<br>covered flat wire | Tip deflection achieved via<br>two NiTi hypo tubes<br>connected at the distal end<br>of catheter with laser-cut<br>patterns that provide tip<br>flexibility. | Tip articulation achieved<br>via two wires running along<br>the inner walls of the<br>catheter shaft from handle<br>to tip.<br>Material injection via |
| | Material injection<br>via<br>syringe connection to luer<br>at proximal end of<br>catheter. | Material injection via<br>syringe connection to luer<br>at proximal end of<br>catheter. | syringe connection to luer at<br>proximal end of catheter. |
| Catheter OD | 3 Fr (0.0394") | 2.7 Fr | 2.9 Fr (proximal) / 2.4Fr<br>(distal) |
| Catheter ID | 0.021" | 0.021" | 0.021" |
| Catheter shaft<br>length(s) | 130 cm and 147 cm | 130 cm | 125 cm |
| Hydrophilic<br>coating on shaft | Yes | Yes | Yes |
| Compatible<br>guidewire | $ \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
- 6) Liquid Leakage
- 7) Luer Testing to ISO 80369-7 & ISO 80369-20
- Tip Flexibility / Softness 8)
- 9) Tip Deflection Angle and Multiple Deflection Fatigue
- 10) Resistance to Override
- 11) Power Injection (for Flowrate and Device Burst Pressure)
- 12) Coating Tests: Length, Coating Integrity and Particulate
- 13) 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.