(268 days)
No
The device description and performance studies focus on the mechanical and material properties of the microcatheter, with no mention of AI or ML technologies.
No.
The device is a microcatheter designed for accessing vasculature and delivering diagnostic agents or other therapeutic devices, not to provide therapy itself. It acts as a delivery system rather than a therapeutic agent.
Yes
The "Intended Use / Indications for Use" section states that "the microcatheter can be used for the controlled infusion of diagnostic agents". This explicitly indicates a diagnostic function for the device.
No
The device description clearly details a physical microcatheter with a steerable tip, handle, lumen, and radiopaque markers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for accessing vasculature, delivering diagnostic agents (like contrast media), and delivering therapeutic devices. This is an in vivo application.
- Device Description: The description details a physical catheter designed for insertion into blood vessels, with features like a steerable tip, lumen for injection, and radiopaque markers for visualization during a medical procedure. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, while this device is used to directly interact with the body's internal structures.
N/A
Intended Use / Indications for 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.
Product codes
KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Testing included:
- Visual Inspections and Dimensional verifications
- Tensile Bond Strength at Tip and Handle Connections
- Torque Strength (Revolutions to Failure)
- Radio-Detectability
- Kink Resistance
- Liquid Leakage
- Luer Testing to ISO 80369-7 & ISO 80369-20
- Tip Flexibility / Softness
- Tip Deflection Angle and Multiple Deflection Fatigue
- Resistance to Override
- Power Injection (for Flowrate and Device Burst Pressure)
- Coating Tests: Length, Coating Integrity and Particulate
- 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 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 10-6 using the half-cycle, 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 Bacterial Endotoxins Test confirmed endotoxin levels well below the limit of the standard (
§ 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).
0
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
1
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
2
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.
Contact: Stephen Tully
Tel#: (617) 416-5495
Email: stevet99x@gmail.com |
|----|------------------------------------|-----------------------------------------------------------------------------------------------------|
| B. | Manufacturer/
510(k) Applicant: | Agile Devices, Inc.
69 Fox Hill Road
Wellesley, MA 02481
Contact: 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:
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
4
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
Agile Devices Angler™ | Primary Predicate
Bendit2.7™ | Reference Predicate
SwiftNINJA |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Steerable, Deflectable
Microcatheter | | |
| Indications for
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. | The Bendit2.7™
Steerable
Microcatheter is
intended for general
intravascular use, in the
peripheral vasculature.
The microcatheter can
be used for the delivery
of diagnostic, embolic,
or therapeutic materials
into the vasculature.
The Bendit2.7 is not
intended to be used in
intracranial or coronary
vessels. | The SwiftNINJA is
intended for general
intravascular use,
including peripheral
and coronary
vasculature. Once the
subselective region
has been accessed, the
microcatheter can be
used for the
controlled and
selective infusion of
diagnostic, embolic,
or therapeutic materials into
the vasculature. The catheter
should not be used in cerebral
vessels. |
| | | | |
| Catheter type | Steerable,
microcatheter | Steerable
microcatheter | Steerable
microcatheter |
| Microcatheter
Components | Catheter shaft, steerable
articulating tip,
steerable handle | Catheter shaft, steerable
articulating tip, 100°
steering handle | Catheter shaft, steerable
deflecting tip, steerable
handle. |
| Mode of
operation | Catheter insertion and tip
placement under imaging
guidance. | Catheter insertion and tip
placement under imaging
guidance. | Catheter insertion and tip
placement under imaging
guidance. |
| | Tip deflection is
controlled using a thumb-
controlled mechanism
external to the body. | Tip deflection controlled
using manual steering
mechanism external to the
body. | Tip articulation controlled
using manual steering
mechanism externalto 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 | Tip deflection achieved via
two NiTi hypo tubes
connected at the distal end
of catheter with laser-cut
patterns that provide tip
flexibility. | Tip articulation achieved
via two wires running along
the inner walls of the
catheter shaft from handle
to tip.
Material injection via |
| | Material injection
via
syringe connection to luer
at proximal end of
catheter. | Material injection via
syringe connection to luer
at proximal end of
catheter. | syringe connection to luer at
proximal 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 shaft
length(s) | 130 cm and 147 cm | 130 cm | 125 cm |
| Hydrophilic
coating on shaft | Yes | Yes | Yes |
| Compatible
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 |
5
6
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
-
- Liquid Leakage
-
- Luer Testing to ISO 80369-7 & ISO 80369-20
- Tip Flexibility / Softness 8)
-
- Tip Deflection Angle and Multiple Deflection Fatigue
-
- Resistance to Override
-
- Power Injection (for Flowrate and Device Burst Pressure)
-
- Coating Tests: Length, Coating Integrity and Particulate
-
- 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
7
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 Bacterial Endotoxins Test confirmed endotoxin levels well below the limit of the standard (