Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical properties of a guidewire catheter, with no mention of AI or ML capabilities.

Therapeutic

No.
The Anchor Dual Lumen Guidewire Catheter is intended for use in the intravascular introduction of interventional devices, rather than directly providing therapy itself.

Diagnostic

No

The device is described as an "introducer of interventional devices" and is intended to facilitate "stabilization of the catheter." Its purpose is to assist in the delivery of other devices, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with specific dimensions, materials, and features, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the "intravascular introduction of interventional devices" within the peripheral, coronary, and neuro vasculature. This describes a device used within the body for a therapeutic or procedural purpose, not for testing samples outside the body to diagnose a condition.
Device Description: The description details a physical catheter designed to be inserted into blood vessels. This aligns with an interventional device, not an IVD.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural and interventional.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

QJP, DQY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral, coronary, and neuro 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)

Performance testing was conducted to verify that the catheter performs as designed and is suitable for its intended use.
Studies include:

Visual Inspection: All devices met acceptance criteria and were smooth with no nicks or sharp edges.
Dimensions: Devices met their specifications.
System Surface, Atraumatic Tip and Lumen Transition: Devices met their specifications. Surface was free from extraneous matter and sharp edges, catheter tips and distal openings point or sharp edges.
Proximal Hub Compatibility: Devices met acceptance criteria.
Buckle: Devices met their specifications.
Flexibility and Kink: Devices met their specifications.
Torque: Devices met their specifications.
Liquid Leakage: Device met acceptance criteria.
Air Leakage: Device met acceptance criteria.
Contrast Flow Rate: Devices met acceptance criteria.
Tensile Strength: Devices met accept criteria.
Particulate: Devices met accept criteria.
Functionality & Stabilization & Guidewire compatibility & ID obstruction / delamination: All devices met the acceptance criteria. The Anchor Dual Lumen Guidewire Catheter demonstrated 78% less retropulsion than the predicate. No obstruction or delamination was observed.
Physician Simulated Use: Physicians deemed the performance of the subject device acceptable and experienced significantly less retropulsion than the predicate. Five (5) predicate devices backed out of position and one (1) predicate kinked. The Anchor Dual Lumen Guidewire Catheter was compatible with the size labeled guidewires and treatment devices.
Shelf Life Testing: All devices met the acceptance criteria post accelerated aging.
Packaging Testing: Packages met specifications (subject devices met accept criteria as described above) post Distribution, Environmental and Aging of Packages.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Toxicity, Hemocompatibility): Non-cytotoxic, Non-sensitizing, Non-irritant, Non-pyrogenic, Non-toxic, Non-hemolytic, C3a and SC5b-9 complement proteins were considered to be non-activated as compared to the negative control, The expanded assay and comparison article: Pass (the test article's p-value was ≥ 0.05 when compared to the negative plasma control or negative reference control), Equivalent thromboresistant characteristics as the predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140080, K151396

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K141981

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 763-762-6946 Email: aquremedical@outlook.com

Primary Contact:

Laurie Lewandowski Consultant, Honkanen Consulting 738 Saddle Wood Drive Eagan, MN 55123 612-770-4038 (cell) Telephone: Email: lalew207@gmail.com

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

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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).

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

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

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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.

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

Performance testing included the following:

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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.