Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and functionality of the catheter, with no mention of AI or ML algorithms for image analysis, decision support, or any other function.

Therapeutic

No
This device is an access system for introducing other interventional devices into the vasculature, not a device that directly provides therapy.

Diagnostic

No

The device is described as an "Access System" and is "indicated for the introduction of interventional devices." Its function is to facilitate access and deliver other interventional devices, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components (catheter, syringe, introducer, hub extension line) and describes physical characteristics and performance testing of these hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for the "introduction of interventional devices into the peripheral and neurovasculature." This describes a device used within the body for a therapeutic or diagnostic procedure, not a device used to test samples outside the body (which is the definition of an IVD).
Device Description: The description details an intravascular catheter and related components used for accessing blood vessels. This aligns with an in-vivo medical device, not an in-vitro diagnostic.
Anatomical Site: The anatomical site is the "Peripheral and neurovasculature," which are locations within the human body. IVDs typically analyze samples like blood, urine, or tissue outside the body.
Input Imaging Modality: Fluoroscopy is an imaging technique used to visualize structures within the body during a procedure. This further supports the device being used in-vivo.

In summary, the SelectFlex 072 Neurovascular Access System is an in-vivo medical device used for accessing blood vessels, not an in-vitro diagnostic device used for testing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Product codes

DQY

Device Description

The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access to target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, a 7Fr Peel Away Introducer, and Hub Extension Line. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex 072 Catheter has a hydrophilic coating.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and neurovasculature

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

Bench Testing: Bench testing was performed to evaluate physical integrity, functionality and performance of the 072 Neurovascular Access System. Performance data includes dimensional, delivery and removal under simulated use conditions, bond tensile strength, tip flexibility, hub aspiration and leakage under pressure, torque, biocompatibility and compatibility with interface devices.
Tests performed: Packaging Integrity (sterile barrier), Visual Surface Requirements, Dimensional Verification, Liquid Leakage Under Pressure, Hub Aspiration Air Leakage, Simulated Use/Usability, Flex Fatigue, Tip Deflection, Inflation Fatigue, Burst Volume, Torque Test, Flow Rate, ISO 80369-7 : Small Bore Connectors for Hypodermic Applications, Corrosion Resistance, Particulate Count, Coating Integrity, Lubricity, Durability, Peak Tensile Testing, Device Removal in Support and Tracking Modes, Radiopacity, Shelf Life, Cytotoxicity, Intracutaneous Irritation, Sensitization, Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, In Vitro Hemocompatibility, Complement Activation, Un-activated Partial Thromboplastin Time, Thrombogenicity, Bacterial Endotoxin.
All samples met the pre-determined acceptance criteria for all tests.

Key Metrics

Not Found

Predicate Device(s)

SelectFlex 072 Neurovascular Access System K181000

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

August 30, 2019

O'Apel Medical % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255

Re: K191664

Trade/Device Name: SelectFlex 072 Neurovascular Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: July 30, 2019 Received: August 1, 2019

Dear Michele Lucey:

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.

1

ence determination does not mean that FDA

Page 2

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 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.

for Xiaolin Zheng, Ph.D. Assistant Director 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) K191664

Device Name SelectFlex 072 Neurovascular Access System

Indications for Use (Describe) The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

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)

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

SPECIAL 510(K) SUMMARY As required by 21 CFR 807.92

Submitter Information:

Submitter's Name:	Q'Apel Medical LLC
Address:	330 Wilshire Boulevard
	Santa Monica CA 90401
Telephone:	310-395-3950
Fax:	310-395-1122
Contact Person:	Michele Lucey
Telephone:	603-748-1374
Date Prepared:	August 30, 2019
Device Trade Name:	SelectFlex 072 Neurovascular Access System
Classification:	Class II
Product Code(s):	DQY
Regulation Number(s):	870.1250
Classification Name	Percutaneous Catheter
Predicate Devices:	SelectFlex 072 Neurovascular Access System K181000

Indication for Use:

The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Description

The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access to target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, a 7Fr Peel Away Introducer, and Hub Extension Line. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex 072 Catheter has a hydrophilic coating.

Comparison of Technological characteristics

The 072 Neurovascular Access System incorporates substantially equivalent design, packaging. fundamental technology, manufacturing processes, sterilization process and intended use as those contained in the 072 Neurovascular Access System (K181000). The following table provides a comparison of the subject device to the predicate device:

Comparison Table to Demonstrate Substantial Equivalence
Feature	Subject Device	Predicate Device	Comparison
	SelectFlex 072 Neurovascular
Access System	SelectFlex 072
Neurovascular Access
System
Regulatory
Clearance/	Pending	K181000	NA
Comparison Table to Demonstrate Substantial Equivalence
Feature	Subject Device	Predicate Device	Comparison
Approval Reference
FDA Classification	Class II	Class II	Same
Product Code(s)	DQY	DQY	Same
Regulation Number	870.1250	870.1250	Same
Material	Commonly used medical grade plastics, stainless steel, nitinol	Commonly used medical grade plastics, stainless steel, nitinol	Similar, difference does not raise new questions regarding safety and efficacy
Outer Diameter	.095-in	.095-in	Same
Inner dimension	.072-in	.072-in	Same
Fr Designation	7 Fr	7 Fr	Same
Effective length	105cm	105cm	Same
Tip Shape	Straight	Straight	Same
Injection Port	Yes	Yes	Same
Radiopaque	Distal Tip has a radiopaque marker band, stainless steel reinforcement and nitinol scaffold in the catheter shaft renders the shaft visible on fluoroscopy	Distal Tip has a radiopaque marker band, stainless steel reinforcement and nitinol scaffold in the catheter shaft renders the shaft visible on fluoroscopy	Same
Coating	Hydrophilic Coating - Distal Portion (11.5cm)	Hydrophilic Coating - Distal Portion (10cm)	Similar, difference does not raise new questions regarding safety and efficacy
Reinforced Shaft	Stainless steel reinforced shaft	Stainless steel reinforced shaft	Same
Variable Stiffness Mechanism	Variable durometer catheter shaft construction to deliver a flexible distal tip and transition to a stiffer proximal section; ten transition segments between the distal tip and proximal shaft. &	Variable durometer catheter shaft construction to deliver a flexible distal tip and transition to a stiffer proximal section; ten transition segments between the distal tip and proximal shaft. &	Same
Comparison Table to Demonstrate Substantial Equivalence
Feature	Subject Device
SelectFlex 072 Neurovascular
Access System	Predicate Device
SelectFlex 072
Neurovascular Access
System	Comparison
	stiffness modes of the distal
10cm by application of fluid
into the distal scaffold
chamber of the catheter wall.
Fluid pressure enables the
more flexible tracking mode;
fluid withdrawal switches to a
less flexible and more
supportive mode.	Two user-selectable
variable stiffness modes of
the distal 10cm by
application of fluid into the
distal scaffold chamber of
the catheter wall. Fluid
pressure enables the more
flexible tracking mode;
fluid withdrawal switches
to a less flexible and more
supportive mode.
Tip Stiffness	0.12 N (tracking and support
mode)	Ranges from 0.12-0.16 N
(tracking and support
mode)	Similar,
difference does
not raise new
questions
regarding safety
and efficacy
Accessories
Supplied	7 Fr Introducer Sheath
3cc syringe
Hub Extension Line	7 Fr Introducer Sheath
3cc syringe	Similar,
difference does
not raise new
questions
regarding safety
and efficacy
Guidewire
Compatibility	0.035 - 0.038-in	0.035 - 0.038-in	Same
How Supplied	Sterile, single use	Sterile, single use	Same
Sterilization
Method	EtO	EtO	Same
Sterility Assurance
Level	10-6	10-6	Same

4

5

Substantial Equivalence:

This summary demonstrates that the SelectFlex 072 Neurovascular Access System and the predicate device have the same intended use, similar technological characteristics, materials, and principals of operation. It can therefore be concluded that the SelectFlex 072 Neurovascular Access System is substantially equivalent to the predicate device.

Nonclinical Performance Data:

Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data.

6

Bench Testing:

Bench testing was performed to evaluate physical integrity, functionality and performance of the 072 Neurovascular Access System. Performance data includes dimensional, delivery and removal under simulated use conditions, bond tensile strength, tip flexibility, hub aspiration and leakage under pressure, torque, biocompatibility and compatibility with interface devices. A summary of all tests performed is provided in the following table:

Test Description	Test Method	Results
Packaging Integrity
(sterile barrier)	Tested per ISO 11607-1 and -2	PASS
All samples met the pre-
determined acceptance criteria
Visual Surface
Requirements	Visual inspection of catheter
surfaces	PASS
All samples met the pre-
determined acceptance criteria
Dimensional
Verification	Device dimensions were measured
to confirm conformance to the
product specification	PASS
All samples met the pre-
determined acceptance criteria
Liquid Leakage Under
Pressure	Tested per ISO 10555-1:2013
Annex C	PASS
All samples met the pre-
determined acceptance criteria
Hub Aspiration Air
Leakage	Tested per ISO 10555-1 2013 for
Hub Aspiration Air Leakage	PASS
All samples met the pre-
determined acceptance criteria
Simulated
Use/Usability	Device preparation, delivery,
access, was evaluated in a
challenging neurovascular model.
Simulated use testing includes a
usability assessment with multiple
physicians	PASS
All samples met the pre-
determined acceptance criteria
Flex Fatigue	Tested per ISO 10555-1: 2013 for
Flexural Fatigue	PASS
All samples met the pre-
determined acceptance criteria
Tip Deflection	The amount of tip deflection under
load was evaluated and compared
to the predicate device	PASS
All samples met the pre-
determined acceptance criteria
Inflation Fatigue	Tested per ISO 10555-1: 2013 for
Inflation Fatigue - 20 inflation
cycles	PASS
All samples met the pre-
determined acceptance criteria
Test Description	Test Method	Results
Burst Volume	Tested per ISO 10555-1: 2013 for
Inflation Fatigue - tested to 2x the
inflation volume	PASS
All samples met the pre-
determined acceptance criteria
Torque Test	Tested per ISO 10555-1: 2013 for
Torque Testing	PASS
All samples met the pre-
determined acceptance criteria
Flow Rate	Tested per ISO 10555-1: 2013 for
Flow rate compared to the
predicate device	PASS
All samples met the pre-
determined acceptance criteria
ISO 80369-7 : Small
Bore Connectors for
Hypodermic
Applications	Tested per ISO 80369-7,
dimensional, leakage by pressure
decay, freedom from air leakage,
positive pressure liquid leakage,
sub-atmospheric pressure air
leakage, stress cracking, resistance
to separation from axial load,
resistance to separation from
unscrewing, resistance to
overriding	PASS
All samples met the pre-
determined acceptance criteria
Corrosion Resistance	Tested per ISO 10555-1 Annex A
for corrosion resistance	PASS
All samples met the pre-
determined acceptance criteria
Particulate Count	Effluent tested per AAMI TIR42,
USP 788 using multiple insertion
and withdrawal cycles	PASS
All samples met the pre-
determined acceptance criteria
Coating Integrity,
Lubricity, Durability	Tested in consideration of FDA
CTQ for Hydrophilic Coated
vascular catheters	PASS
All samples met the pre-
determined acceptance criteria
Peak Tensile Testing	Tested per ISO 10555-1 for tensile
strength including all bonds/joints	PASS
All samples met the pre-
determined acceptance criteria
Device Removal in
Support and Tracking
Modes	Removal force in both modes was
compared to a reference device	PASS
All samples met the pre-
determined acceptance criteria
Radiopacity	Radiopacity was evaluated during
simulated use testing confirming
visualization under fluoroscopy	PASS
All samples met the pre-
determined acceptance criteria
Test Description	Test Method	Results
Shelf Life	Accelerated aging studies were
completed to confirm the stability
of the product and package. All
testing noted above was performed
on aged product to support the
shelf life claim	PASS
All samples met the pre-
determined acceptance criteria
Test Name	Test Method	Results
Cytotoxicity	Tested in accordance with ISO 10993-5,
Biological Evaluation of Medical Devices

Part 5: Tests for in vitro toxicity,
Neutral Red Uptake Method | Pass
Noncytotoxic according to the
predetermined acceptance
criteria |
| Intracutaneous
Irritation | Tested in accordance with ISO 10993-10,
Biological Evaluation of Medical Devices
Part 10: Tests for Irritation and Skin
Sensitization | Pass
Test requirements for
intracutaneous reactivity were
met according to the
predetermined acceptance
criteria |
| Sensitization | Tested in accordance with ISO 10993-10,
Biological Evaluation of Medical Devices
Part 10 Tests for Irritation and Skin
Sensitization, Kligman Maximization Test | Pass
did not elicit a sensitization
response according to the
predetermined acceptance
criteria |
| Systemic Toxicity | Tested in accordance with ISO 10993-11,
Biological Evaluation of Medical Devices
Part 11: Tests for Systemic Toxicity | Pass
Test requirements for systemic
toxicity were met according to
the predetermined acceptance
criteria |
| Material Mediated
Pyrogenicity | Tested in accordance with ISO 10993-11,
Biological Evaluation of Medical Devices
Part 11: Tests for Systemic Toxicity and
USP 40 Pyrogen Test | Pass
Nonpyrogenic, met the
predetermined acceptance
criteria |
| Hemolysis | Tested in accordance with ASTM F756-
17, Standard Practice for Assessment of
Hemolytic Properties of Materials and
ISO 10993-4, Biological Evaluation of
Medical Devices - Part 4: Selection of
Tests for Interactions with Blood, Tests
for Hemolytic Properties, Direct and
Indirect Methods | Pass
Non-hemolytic, met the
predetermined acceptance
criteria |
| In Vitro
Hemocompatibility | Tested in accordance with ISO 10993-4,
Biological Evaluation of Medical Devices
Part 4: Selection of Tests for
Interactions with Blood,
Hemocompatibility, Direct Contact
Method | Pass
Not expected to result in adverse
effects in vivo , met the
predetermined acceptance
criteria |
| Complement
Activation | Tested in accordance with ISO 10993-4,
Biological Evaluation of Medical Devices
Part 4: Selection of Tests for
Interactions with Blood, SC5b-9
Complement Activation | Pass
Does not activate the
complement system, met the
predetermined acceptance
criteria |
| Un-activated Partial
Thromboplastin
Time | Tested in accordance with ISO 10994-4,
Biological Evaluation of Medical Devices
Part 4: Selection of Tests for
Interactions with Blood and ASTM
F2382-04, Standard Test Method for
Assessment of Intravascular Medical
Device Materials on Partial
Thromboplastin Time (UPTT) | Pass
Does not have an effect on
coagulation of human plasma,
met the predetermined
acceptance criteria |
| Thrombogenicity | Tested in accordance with ISO 10994-4,
Biological Evaluation of Medical Devices
Part 4: Selection of Tests for
Interactions with Blood | Pass
Demonstrates similar
thromboresistance characteristics
as the control device, met the
predetermined acceptance
criteria |
| Bacterial Endotoxin | Testing was performed in accordance with
USP 40, NF 35, 2017. Bacterial
Endotoxins Test | PASS
All samples met the pre-
determined acceptance criteria |

7

8

The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing; therefore, this device is considered to be substantially equivalent to the predicate device.

9

Biocompatibility Testing Summary:

Categorized as Externally Communicating Device, Circulating Blood, Limited Contact (≤ 24 hours), per ISO 10993-1, the following testing was conducted and results were acceptable:

10

The biocompatibility and hemocompatibility testing summarized in the table above yielded acceptable (passing) results for all tests conducted. This information demonstrating acceptable biocompatibility and hemocompatibility properties support the claim of substantial equivalence to the predicate device.

Conclusion:

Based on the indications for use, technological characteristics, and performance testing, the SelectFlex 072 Neurovascular Access System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the SelectFlex 072 Neurovascular Access System, K181000.