SelectFlex 072 Neurovascular Access System

K191664 · Q'Apel Medical · DQY · Aug 30, 2019 · Cardiovascular

Device Facts

• Record ID: K191664
• Device Name: SelectFlex 072 Neurovascular Access System
• Applicant: Q'Apel Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 30, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

Sterile, single-use intravascular catheter; facilitates access to target vasculature during interventional procedures. Features variable stiffness mechanism on distal portion; user-activated via fluid pressure (inflation/withdrawal) to transition between flexible tracking mode and stiffer support mode. Includes 7Fr catheter, inflation syringe, peel-away introducer, and hub extension line. Used in clinical settings by physicians; provides pathway for interventional devices. Radiopaque marker band and scaffold allow fluoroscopic visualization. Benefits patient by enabling navigation through complex vasculature while maintaining support for device delivery.

Clinical Evidence

Bench testing only. Evaluated physical integrity, functionality, and performance under simulated use conditions. Tests included dimensional verification, leak/aspiration testing, flex fatigue, tip deflection, inflation fatigue, burst volume, torque, flow rate, and biocompatibility (ISO 10993). All tests met predetermined acceptance criteria.

Technological Characteristics

7Fr catheter; 105cm length; .072-in inner diameter. Materials: medical grade plastics, stainless steel, nitinol. Variable stiffness mechanism uses fluid-filled distal scaffold chamber. Hydrophilic coating on distal 11.5cm. Radiopaque marker band. Sterilization: EtO. Connectivity: None.

Indications for Use

Indicated for introduction of interventional devices into peripheral and neurovasculature in patients requiring such access.

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

• SelectFlex 072 Neurovascular Access System (K181000)

Submission Summary (Full Text)

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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.

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ence determination does not mean that FDA

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

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# 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) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <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> |

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#### 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<br>Access System | SelectFlex 072<br>Neurovascular Access<br>System | |
| Regulatory<br>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<br>SelectFlex 072 Neurovascular<br>Access System | Predicate Device<br>SelectFlex 072<br>Neurovascular Access<br>System | Comparison |
| | stiffness modes of the distal<br>10cm by application of fluid<br>into the distal scaffold<br>chamber of the catheter wall.<br>Fluid pressure enables the<br>more flexible tracking mode;<br>fluid withdrawal switches to a<br>less flexible and more<br>supportive mode. | Two user-selectable<br>variable stiffness modes of<br>the distal 10cm by<br>application of fluid into the<br>distal scaffold chamber of<br>the catheter wall. Fluid<br>pressure enables the more<br>flexible tracking mode;<br>fluid withdrawal switches<br>to a less flexible and more<br>supportive mode. | |
| Tip Stiffness | 0.12 N (tracking and support<br>mode) | Ranges from 0.12-0.16 N<br>(tracking and support<br>mode) | Similar,<br>difference does<br>not raise new<br>questions<br>regarding safety<br>and efficacy |
| Accessories<br>Supplied | 7 Fr Introducer Sheath<br>3cc syringe<br>Hub Extension Line | 7 Fr Introducer Sheath<br>3cc syringe | Similar,<br>difference does<br>not raise new<br>questions<br>regarding safety<br>and efficacy |
| Guidewire<br>Compatibility | 0.035 - 0.038-in | 0.035 - 0.038-in | Same |
| How Supplied | Sterile, single use | Sterile, single use | Same |
| Sterilization<br>Method | EtO | EtO | Same |
| Sterility Assurance<br>Level | 10-6 | 10-6 | Same |

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### 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.

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## 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<br>(sterile barrier) | Tested per ISO 11607-1 and -2 | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Visual Surface<br>Requirements | Visual inspection of catheter<br>surfaces | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Dimensional<br>Verification | Device dimensions were measured<br>to confirm conformance to the<br>product specification | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Liquid Leakage Under<br>Pressure | Tested per ISO 10555-1:2013<br>Annex C | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Hub Aspiration Air<br>Leakage | Tested per ISO 10555-1 2013 for<br>Hub Aspiration Air Leakage | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Simulated<br>Use/Usability | Device preparation, delivery,<br>access, was evaluated in a<br>challenging neurovascular model.<br>Simulated use testing includes a<br>usability assessment with multiple<br>physicians | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Flex Fatigue | Tested per ISO 10555-1: 2013 for<br>Flexural Fatigue | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Tip Deflection | The amount of tip deflection under<br>load was evaluated and compared<br>to the predicate device | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Inflation Fatigue | Tested per ISO 10555-1: 2013 for<br>Inflation Fatigue - 20 inflation<br>cycles | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Test Description | Test Method | Results |
| Burst Volume | Tested per ISO 10555-1: 2013 for<br>Inflation Fatigue - tested to 2x the<br>inflation volume | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Torque Test | Tested per ISO 10555-1: 2013 for<br>Torque Testing | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Flow Rate | Tested per ISO 10555-1: 2013 for<br>Flow rate compared to the<br>predicate device | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| ISO 80369-7 : Small<br>Bore Connectors for<br>Hypodermic<br>Applications | Tested per ISO 80369-7,<br>dimensional, leakage by pressure<br>decay, freedom from air leakage,<br>positive pressure liquid leakage,<br>sub-atmospheric pressure air<br>leakage, stress cracking, resistance<br>to separation from axial load,<br>resistance to separation from<br>unscrewing, resistance to<br>overriding | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Corrosion Resistance | Tested per ISO 10555-1 Annex A<br>for corrosion resistance | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Particulate Count | Effluent tested per AAMI TIR42,<br>USP 788 using multiple insertion<br>and withdrawal cycles | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Coating Integrity,<br>Lubricity, Durability | Tested in consideration of FDA<br>CTQ for Hydrophilic Coated<br>vascular catheters | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Peak Tensile Testing | Tested per ISO 10555-1 for tensile<br>strength including all bonds/joints | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Device Removal in<br>Support and Tracking<br>Modes | Removal force in both modes was<br>compared to a reference device | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Radiopacity | Radiopacity was evaluated during<br>simulated use testing confirming<br>visualization under fluoroscopy | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Test Description | Test Method | Results |
| Shelf Life | Accelerated aging studies were<br>completed to confirm the stability<br>of the product and package. All<br>testing noted above was performed<br>on aged product to support the<br>shelf life claim | PASS<br>All samples met the pre-<br>determined acceptance criteria |
| Test Name | Test Method | Results |
| Cytotoxicity | Tested in accordance with ISO 10993-5,<br>Biological Evaluation of Medical Devices<br>- Part 5: Tests for <i>in vitro</i> toxicity,<br>Neutral Red Uptake Method | Pass<br>Noncytotoxic according to the<br>predetermined acceptance<br>criteria |
| Intracutaneous<br>Irritation | Tested in accordance with ISO 10993-10,<br>Biological Evaluation of Medical Devices<br>- Part 10: Tests for Irritation and Skin<br>Sensitization | Pass<br>Test requirements for<br>intracutaneous reactivity were<br>met according to the<br>predetermined acceptance<br>criteria |
| Sensitization | Tested in accordance with ISO 10993-10,<br>Biological Evaluation of Medical Devices<br>- Part 10 Tests for Irritation and Skin<br>Sensitization, Kligman Maximization Test | Pass<br>did not elicit a sensitization<br>response according to the<br>predetermined acceptance<br>criteria |
| Systemic Toxicity | Tested in accordance with ISO 10993-11,<br>Biological Evaluation of Medical Devices<br>- Part 11: Tests for Systemic Toxicity | Pass<br>Test requirements for systemic<br>toxicity were met according to<br>the predetermined acceptance<br>criteria |
| Material Mediated<br>Pyrogenicity | Tested in accordance with ISO 10993-11,<br>Biological Evaluation of Medical Devices<br>- Part 11: Tests for Systemic Toxicity and<br>USP 40 <151> Pyrogen Test | Pass<br>Nonpyrogenic, met the<br>predetermined acceptance<br>criteria |
| Hemolysis | Tested in accordance with ASTM F756-<br>17, Standard Practice for Assessment of<br>Hemolytic Properties of Materials and<br>ISO 10993-4, Biological Evaluation of<br>Medical Devices - Part 4: Selection of<br>Tests for Interactions with Blood, Tests<br>for Hemolytic Properties, Direct and<br>Indirect Methods | Pass<br>Non-hemolytic, met the<br>predetermined acceptance<br>criteria |
| <i>In Vitro</i><br>Hemocompatibility | Tested in accordance with ISO 10993-4,<br>Biological Evaluation of Medical Devices<br>- Part 4: Selection of Tests for<br>Interactions with Blood,<br>Hemocompatibility, Direct Contact<br>Method | Pass<br>Not expected to result in adverse<br>effects <i>in vivo</i> , met the<br>predetermined acceptance<br>criteria |
| Complement<br>Activation | Tested in accordance with ISO 10993-4,<br>Biological Evaluation of Medical Devices<br>- Part 4: Selection of Tests for<br>Interactions with Blood, SC5b-9<br>Complement Activation | Pass<br>Does not activate the<br>complement system, met the<br>predetermined acceptance<br>criteria |
| Un-activated Partial<br>Thromboplastin<br>Time | Tested in accordance with ISO 10994-4,<br>Biological Evaluation of Medical Devices<br>- Part 4: Selection of Tests for<br>Interactions with Blood and ASTM<br>F2382-04, Standard Test Method for<br>Assessment of Intravascular Medical<br>Device Materials on Partial<br>Thromboplastin Time (UPTT) | Pass<br>Does not have an effect on<br>coagulation of human plasma,<br>met the predetermined<br>acceptance criteria |
| Thrombogenicity | Tested in accordance with ISO 10994-4,<br>Biological Evaluation of Medical Devices<br>- Part 4: Selection of Tests for<br>Interactions with Blood | Pass<br>Demonstrates similar<br>thromboresistance characteristics<br>as the control device, met the<br>predetermined acceptance<br>criteria |
| Bacterial Endotoxin | Testing was performed in accordance with<br>USP 40, NF 35, 2017. <85> Bacterial<br>Endotoxins Test | PASS<br>All samples met the pre-<br>determined acceptance criteria |

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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.

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## 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:

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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.