Anchor Dual Lumen Guidewire Catheter

K201076 · Aqure Medical, Inc. · QJP · Aug 6, 2020 · Cardiovascular

Device Facts

• Record ID: K201076
• Device Name: Anchor Dual Lumen Guidewire Catheter
• Applicant: Aqure Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Aug 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.

Device Story

Anchor Dual Lumen Guidewire Catheter (model AQ8001) is a sterile, single-use, 8F dual-lumen catheter; 110 cm length. Features a 6F C-shaped distal tip with radiopaque marker bands. Large lumen accommodates 0.035" guidewires/interventional devices; small lumen accommodates 0.014" guidewires for catheter stabilization. Used in peripheral, coronary, and neuro vasculature by physicians to facilitate intravascular access. Operates via manual insertion over guidewires; hub compatible with standard syringes for contrast injection. Provides stable platform for interventional procedures; reduces retropulsion compared to single-lumen predicates. Benefits patient by improving catheter stability during device delivery.

Clinical Evidence

Bench testing only. Included visual inspection, dimensional analysis, hub compatibility, buckling force, flexibility/kink, torque, leakage, contrast flow, tensile strength, and particulate testing per ISO 10555-1/2. Biocompatibility testing per ISO 10993 series (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, hemocompatibility). Simulated use model with two physicians compared subject device to predicates, demonstrating superior stability (less retropulsion) and compatibility with guidewires/treatment devices.

Technological Characteristics

8F, 110 cm dual-lumen catheter. Shaft: braided/coiled wire with multiple Pebax durometer extrusions reflowed over PTFE liner. Distal tip: 6F C-shaped, radiopaque. Sterilization: Ethylene Oxide (EO). Connectivity: Luer-compatible hub. No hydrophilic coating.

Indications for Use

Indicated for use in peripheral, coronary, and neuro vasculature for intravascular introduction of interventional devices.

Regulatory Classification

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.

Predicate Devices

• ENVOY® Distal Access (DA) Guiding Catheter (K140080)
• MIVI Mi-Axus™ Guide Catheter (K151396)

Reference Devices

• Asahi Fubuki (K141981)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

August 6, 2020

Aqure Medical, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite #510k Saint Paul, MN 55114

Re: K201076

Trade/Device Name: Anchor Dual Lumen Guidewire Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: July 24, 2020 Received: July 27, 2020

Dear Prithul Bom:

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director (Acting) 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K201076

Device Name

Anchor Dual Lumen Guidewire Catheter

#### Indications for Use (Describe)

The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a logo for "AQURE MEDICAL INC." The word "AQURE" is in a large, bold, silver font with a blue outline. Below it, "MEDICAL INC." is written in a smaller, blue font. The background is white with a soft, blue glow emanating from behind the text, creating a futuristic or technological feel.

Aqure Medical, Inc. 12560 Fletcher Lane, Suite 300 Rogers, MN 55374 USA Ph: 763-762-6946 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

### 510(k) SUMMARY

#### Submitter:

Aqure Medical, Inc. Jie Xia 12560 Fletcher Lane, Suite 300 Rogers, MN 55374 Telephone: [phone] Email: [e-mail]

### Primary Contact:

Laurie Lewandowski Consultant, Honkanen Consulting 738 Saddle Wood Drive Eagan, MN 55123 612-770-4038 (cell) Telephone: Email: [e-mail]

#### DATE PREPARED:

August 04, 2020

#### NAME OF MEDICAL DEVICE:

Proprietary Name: Anchor Dual Lumen Guidewire Catheter Common/Usual Name: Catheter, Percutaneous

#### DEVICE CLASSIFICATION:

| Classification Name: | Percutaneous Catheter |
|----------------------|-----------------------|
| Regulatory Class: | II |
| Product Code: | QJP, DQY |
| Regulation Number: | 21 CFR 870.1250 |

#### PRIMARY PREDICATE DEVICE:

| Proprietary Name: | ENVOY® Distal Access (DA) Guiding Catheter |
|----------------------|--------------------------------------------|
| Common/Usual Name: | Catheter, Percutaneous |
| Classification Name: | Percutaneous Catheter |

Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter

{4}------------------------------------------------

| 510K Number: | K140080 |
|--------------|---------|
|--------------|---------|

#### PREDICATE DEVICE:

| Proprietary Name: | MIVI Mi-Axus™ Guide Catheter |
|----------------------|------------------------------|
| Common/Usual Name: | Catheter, Percutaneous |
| Classification Name: | Percutaneous Catheter |
| 510K Number: | K151396 |

#### DEVICE DESCRIPTION:

The Anchor Dual Lumen Guidewire Catheter, model AQ8001, is a single use, sterile (EO), 8F, 110 cm (working length of 100 cm) biocompatible, flexible, radiopaque, dual lumen catheter with a 6F, C shaped tip. The shaft utilizes a braided wire design with multiple Pebax durometer extrusions reflowed over PTFE liner. The distal tip includes radiopaque marker bands for visibility under fluoroscopy. The larger lumen accommodates an 0.035" guidewire and other interventional devices; the smaller lumen allows a 0.014" guidewire to exit the catheter at the curve to provide stabilization of the catheter. The hub, with Luer fittings, is compatible with standard syringes and is leak proof. The hub is marked to identify the lumens.

### INTENDED USE/INDICATION FOR USE:

The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.

## TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

The Anchor Dual Lumen Guidewire Catheter is similar to ENVOY® Distal Access (DA) Guiding Catheter (K140080) and to the MIVI Mi-Axus™ Guide Catheter (K151396) in terms of indications for use, design, materials, technology and performance with the exception that the Anchor Dual Lumen Guidewire Catheter has a second lumen and is not coated whereas the predicates are coated and do not have a second lumen. In addition, the use of contrast is supported by the Asahi Fubuki (K141981).

{5}------------------------------------------------

| Characteristic | Aqure Medical, Inc.<br>Anchor Dual Lumen Guidewire<br>Catheter (subject device) | ENVOY® Distal Access (DA)<br>Guiding Catheter (K140080)<br>Primary Predicate | MIVI Mi-Axus™ Guide<br>Catheter<br>(K151396)<br>Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To provide intravascular access for<br>patients undergoing intravascular<br>procedures. | Identical | Identical |
| Indications for use | The Anchor Dual Lumen Guidewire<br>Catheter is intended for use in the<br>peripheral, coronary, and neuro<br>vasculature for the intravascular<br>introduction of interventional<br>devices. | Similar:<br>The ENVOY Distal Access<br>(DA) Guiding Catheter is<br>intended for use in the<br>peripheral, coronary, and neuro<br>vasculature for the intravascular<br>introduction of<br>interventional/diagnostic<br>devices. | Similar;<br>The MIVI Mi-Axus™ Guide<br>Catheter is indicated for use in<br>facilitating the insertion and<br>guidance of microcatheters<br>into a selected blood vessel in<br>the peripheral, coronary and<br>neuro vascular systems. |
| Technology | | | |
| Dimensions | Tip OD = 6F (0.083")<br>Tip ID = 0.067"<br>Catheter OD = 8F (0.105")<br>Large lumen (A) ID ≥ 0.067" | Catheter OD =6.0F (0.082")<br>ID = 0.071" | Catheter OD= 8F (2.7mm or<br>0.108")<br>Proximal ID = 6.8F (2.26mm or<br>0.089") |
| | Small lumen (B) ID ≥ 0.016" | | Lengths (cm)= 75 ± .5 or 85 |

{6}------------------------------------------------

| Characteristic | Aqure Medical, Inc.<br>Anchor Dual Lumen Guidewire<br>Catheter (subject device) | ENVOY® Distal Access (DA)<br>Guiding Catheter (K140080)<br>Primary Predicate | MIVI Mi-Axus™ Guide<br>Catheter<br>(K151396)<br>Predicate Device |
|---------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------|
| Working Length (cm) | 100 | Working Lengths (cm) =95 and<br>105 | $\pm .5$ |
| Curve Shape | C | Identical | Not Listed |
| Tip | Atraumatic with marker bands | Identical | Identical |
| Shaft | Braided and coiled shaft with<br>multiple Pebax durometer extrusions<br>reflowed over PTFE liner | Identical | Identical |
| Coating | N/A | Hydrophilic | Hydrophilic |
| Packaging | Card mounted inserted in a sterile<br>barrier pouch and shelf box | Identical | Not Listed |
| Sterilization | Ethylene Oxide | Identical | Identical |

The Anchor Dual Lumen Guidewire Catheter is the same as the primary predicate ENVOY® Distal Access (DA) Guiding Catheter (K140080) with the addition of the second lumen, that terminates at the curve, to provide stability. The physician can introduce interventional devices or contrast per current practice. The catheter tip French size remains consistent with the remaining portion of the shaft increase to 8F to accommodate the second lumen. This is supported by the SF, MIVI Mi-Axus Guide Catheter (K151396) predicate. Contrast use with the subject device is supported by the reference device, the Asahi Fubuki (K141981).

The length of the Anchor Dual Lumen Cutheter falls within the two lengths provided by the predicate. The subject device is not coated while the predicate devices have a hydrophilic coating. Testing demonstrated that the subject device simulated

{7}------------------------------------------------

model in an equivalent manner to the predicate device and that typical treatment devices can be inserted and withdrawn to meet specifications.

The different technological characteristics of the new device do not raise different questions of safety and effectiveness.

{8}------------------------------------------------

# PERFORMANC TESTING

The Anchor Dual Lumen Guidewire Catheter has been tested and verified that the catheter performs as designed and is suitable for its intended use.

| Test | Test Method Summary | Results |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Visual Inspection | Visually inspect device<br>2.5x magnification per<br>ISO 10555-1. | All devices met the acceptance criteria and were<br>smooth with no nicks or sharp edges. |
| Dimensions | The working and usable<br>lengths, ID of both<br>lumens, the catheter and<br>tip ODs, curve tip length<br>and curve angle were<br>measured. | Devices met their specifications. |
| System Surface,<br>Atraumatic Tip and<br>Lumen Transition | Inspect at 2.5x<br>magnification per ISO<br>10555-1 | Devices met their specifications.<br>Surface was free from extraneous matter and<br>sharp edges, catheter tips and distal openings<br>point or sharp edges, |
| Proximal Hub<br>Compatibility | Inspect to ISO 80369-7<br>dimensions (using gages)<br>after conditioning in<br>distilled water | Devices met acceptance criteria |
| Buckle | Distal tip buckling force<br>under compressive load<br>was evaluated | Devices met their specifications |
| Flexibility and Kink | Observation for kink<br>when wrapped around a<br>decreasing mandrel | Devices met their specifications |
| Torque | With the distal end fixed<br>within the model, torque<br>until failure. | Devices met their specifications |
| Liquid Leakage | Leak test per ISO 10555-2 | Device met acceptance criteria |
| Air Leakage | Leak test per ISO 10555-<br>1, Annex D | Device met acceptance criteria |
| Contrast Flow Rate | Connect a syringe filled<br>with a min of 25ml<br>Visipaque to large lumen.<br>Inject over 5 seconds;<br>measure amount of<br>contrast collected. | Devices met acceptance criteria |
| Tensile Strength | Tensile test all joints per<br>ISO 10555-1. | Devices met accept criteria. |
| Particulate | Testing per ISO14708-<br>1:2014 & EN45502-<br>1:2015 | Devices met accept criteria |
| • Functionality<br>• Stabilization | Subject and predicate<br>devices were tested in a | All devices met the acceptance criteria. The<br>Anchor Dual Lumen Guidewire Catheter |
| Test | Test Method Summary | Results |
| • Guidewire<br>compatibility<br>• ID obstruction /<br>delamination | simulated use model for<br>functionality, retropulsion<br>and liner obstruction /<br>delamination | demonstrated 78% less retropulsion than the<br>predicate. No obstruction or delamination was<br>observed |
| Physician Simulated<br>Use | Subject and predicate<br>devices were used by two<br>physicians in a simulated<br>use model. This included<br>small and large lumen<br>compatibility with<br>guidewires and treatment<br>devices. | Physicians deemed the performance of the subject<br>device acceptable and experienced significantly<br>less retropulsion than the predicate. Five (5)<br>predicate devices backed out of position and one<br>(1) predicate kinked. The Anchor Dual Lumen<br>Guidewire Catheter was compatible with the size<br>labeled guidewires and treatment devices. |
| Shelf Life Testing | Devices were subjected to<br>all testing post 6 month<br>accelerated aging per<br>ASTM F1980:2016. | All devices met the acceptance criteria post<br>accelerated aging. |
| Packaging | | |
| Packaging Testing | Distribution,<br>Environmental and Aging<br>of Packages<br>• Distribution Testing per<br>ISTA 2A:2011<br>• Packaging Tests per<br>ASTM D4169:2016 and<br>ISO 11607-1:2006<br>• Packaging Aging per<br>ASTM F1980:2016,<br>o Visual per ASTM<br>F1886-16<br>o Dye Leak per ASTM<br>F2096-11<br>o Seal Strength per<br>ASTM F88/F88M-15 | Packages met specifications (subject devices met<br>accept criteria as described above) post<br>Distribution, Environmental and Aging of<br>Packages |
| Biocompatibility | | |
| Cytotoxicity | MEM Extraction<br>Cytotoxicity Assay per ISO<br>10993-5:2009 | Non-cytotoxic |
| Sensitization | Guinea Pig Maximization<br>Test per ISO 10993-<br>10:2010 | Non-sensitizing |
| Irritation | Intracutaneous Reactivity<br>Test per ISO 10993-<br>10:2010 | Non-irritant |
| Toxicity | Materials Mediated<br>Rabbit Pyrogen Test ISO<br>10993-11:2017 | Non-pyrogenic |
| Test | Test Method Summary | Results |
| Toxicity | Acute Systemic Toxicity<br>per ISO 10993-11:2017 | Non-toxic |
| Hemocompatibility | ASTM Hemolysis Assay:<br>Direct and Extract Methods<br>per ISO 10993-4:2017 | Non-hemolytic |
| Hemocompatibility | Complement Activation<br>Assay - C3a and SC5b-9<br>Methods per ISO 10993-<br>4:2017 | C3a and SC5b-9 complement proteins were<br>considered to be non-activated as compared to the<br>negative control |
| Hemocompatibility | Partial Thromboplastin<br>Time (PTT) Assay per ISO<br>10993-4:2017 | The expanded assay and comparison article: Pass<br>(the test article's p-value was ≥ 0.05 when<br>compared to the negative plasma control or<br>negative reference control) |
| Hemocompatibility | 4-Hour Thrombogenicity<br>Study in Canine per ISO<br>10993-4:2017 | Equivalent thromboresistant characteristics as the<br>predicate. |

Performance testing included the following:

{9}------------------------------------------------

{10}------------------------------------------------

## CONCLUSIONS

The Anchor Dual Lumen Guidewire Catheter is substantially equivalent in design, materials, sterilization, principles of operation, performance and indications for use to the cited predicate devices.