Who is the manufacturer of Neurovascular Access System Family?

Q'Apel Medical, Inc. filed the 510(k) submission for Neurovascular Access System Family (K240746).

What is the FDA product code for Neurovascular Access System Family?

QJP. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Neurovascular Access System Family?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Neurovascular Access System Family?

Benchmark Intracranial Access System (K212838); SelectFlex Neurovascular Access System Family (K211893).

Who can help prepare an FDA 510(k) submission like Neurovascular Access System Family?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Neurovascular Access System Family

K240746 · Q'Apel Medical, Inc. · QJP · Nov 20, 2024 · Cardiovascular

Device Facts

Record ID	K240746
Device Name	Neurovascular Access System Family
Applicant	Q'Apel Medical, Inc.
Product Code	QJP · Cardiovascular
Decision Date	Nov 20, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.

Device Story

Neurovascular Access System Family consists of sterile, single-use catheters, access tools, peel-away introducers, and dilators. Used to facilitate insertion and guidance of interventional devices into peripheral and neurovasculature. Physician-operated under fluoroscopic guidance. Features include hydrophilic coating on distal end for friction reduction and radiopaque marker for visualization. Available in various lengths and diameters (6F, 7F). Device provides access path for interventional procedures; benefits include improved navigation and delivery of therapeutic devices to target vessels.

Clinical Evidence

Bench testing only. No clinical data or animal studies were required. Performance verified via ISO 10555-1 testing (dimensional, leakage, tensile strength, flow rate, kink resistance, burst strength) and simulated use/usability assessments. Biocompatibility confirmed per ISO 10993 standards.

Technological Characteristics

Catheter body: variable durometer polymer jacket; Inner liner: PTFE; Shaft reinforcement: laser-cut stainless steel hypotube. Distal hydrophilic coating. Radiopaque marker band. Sterilization: Ethylene Oxide (EO) per ISO 11135:2014. Dimensions: 6F/7F outer diameter; 0.074/0.087 inch inner diameter. Standalone device.

Indications for Use

Indicated for introduction of interventional devices into peripheral and neurovasculature. Not for use in coronary arteries.

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

Benchmark Intracranial Access System (K212838)
SelectFlex Neurovascular Access System Family (K211893)

Related Devices

K253032 — AXS Lift Intracranial Base Catheter · Stryker Neurovascular · Feb 11, 2026
K233205 — Distal Access Catheter · Shanghai Heartcare Medical Technology Co., Ltd. · Dec 22, 2023
K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 2, 2025
K221822 — BENCHMARK BMX81 Access System · Penumbra, Inc. · Nov 4, 2022
K200206 — AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter · Stryker Neurovascular · Feb 27, 2020

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 20, 2024 Q'Apel Medical, Inc. % Wanda Carpinella Regulatory Consultant Insight Medical, LLC 7 Barrows Road Shrewsbury, Massachusetts 01545 Re: K240746 Trade/Device Name: Neurovascular Access System Family Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: October 25, 2024 Received: October 25, 2024 Dear Wanda Carpinella: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory {2}------------------------------------------------ assistance/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, # Sara S. Thompson -S for Naira Muradyan, 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240746 Device Name Neurovascular Access System Family Indications for Use (Describe) The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries. Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> Residential Use (Part of OFF-SITE Septic System) </div> | |--------------------------------------------------------------------------------------------------------------------| | <div> <input type="checkbox"/> Commercial Use </div> | X 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." {4}------------------------------------------------ # 510(k) Summary # Traditional Premarket Notification 510(k) Summary Neurovascular Access System Family 510(k) Number K240746 ### Date Prepared: November 18, 2024 #### l. SUBMITTER Q'Apel Medical, Inc. 4245 Technology Drive Fremont, CA 94538 United States ### Contact Person Jim Talbot Vice President Regulatory, Quality and Clinical 4245 Technology Drive Fremont, CA 94538 United States Tel: 650-793-8250 jtalbot@qapelmedical.com #### II. DEVICE | Name of Device: | Neurovascular Access System Family | |----------------------------|------------------------------------| | Common or Usual Name: | Neurovascular Access Catheter | | Classification Regulation: | 21 CFR § 870.1250 | | Regulation Name: | Percutaneous Catheter | | Product Codes: | QJP, DQY | | Regulatory Class: | II | #### lll. PREDICATES Primary predicate - Benchmark Intracranial Access System, K212838 Secondary predicate - SelectFlex Neurovascular Access System Family, K211893 #### IV. DEVICE DESCRIPTION The subject Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy. #### V. INDICATIONS FOR USE The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries. {5}------------------------------------------------ #### COMPARISION OF TECHNOLOGICAL CHARACTERISICS WITH PREDICATES VI. The following table compares key features of the subject and predicate devices. | | Subject Device | Primary Predicate Device Benchmark Intracranial Access System K212838 | Secondary Predicate Device SelectFlex Neurovascular Access System Family K211893 | Comparison | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature. It is not intended for use in coronary arteries. | The Benchmark Intracranial Access System is indicated for the introduction of interventional devices into the periphral, coronary, and neurovasculature. | The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature. | Similar, the subject device limits the indications to introduction of interventional devices into the peripheral and neurovascular an peripheral, which are within the currently cleared indication statement of the predicate. Difference does not raise new questions of safety and effectiveness. | | Product Code | DQY, QJP | DQY, QJP | DQY, QJP | Same | | Classification | Class II | Class II | Class II | Same | | Material | Catheter Body: Variable durometer outer polymer jacket that delivers a flexible distal shaft and transition to stiffer proximal section. Inner Liner: PTFE | Catheter Body: Variable durometer outer polymer jacket that delivers a flexible distal shaft and transition to stiffer proximal section. | Catheter Body: Variable durometer outer polymer jacket that delivers a flexible distal shaft and transition to stiffer proximal section. Inner Liner: PTFE User selected tracking and support modes | Similar, differences do not raise new questions of safety and effectiveness | | Catheter Shaft Reinforcement | Laser cut stainless steel hypotube | Stainless steel coil | Stainless steel coil & nitinol scaffold | Similar, differences do not raise new questions of safety and effectiveness | | Hydrophilic Coating | Yes – Distal portion | Yes – Distal portion | Yes – Distal portion | Same | | Visibility under fluoroscopy | Yes Access Catheter marker band Access Tool Distal Tip | Yes Access Catheter marker band 5F Select Catheter Distal Tip | Yes Access Catheter marker band | Same | | Working Length | 074 Access Catheter: 80, 95, 105, 115 cm 087 Access Catheter: 80, 95, and 105 cm | 95, 105, 115 cm | 95, 105, and 115 cm | Similar, differences do not raise new questions of safety | | | Subject Device | Primary Predicate Device Benchmark Intracranial Access System K212838 | Secondary Predicate Device SelectFlex Neurovascular Access System Family K211893 | Comparison | | Outer Diameter | 6French (F) and 7F | 6F | 7F | Same | | Inner Diameter | 0.074 and 0.087 inch | 0.071 inch | 0.072 inch | Similar, differences do not raise new questions of safety or effectiveness | | Tip Shapes Offered | Straight | Straight & Multi- purpose | Straight | Same | | Accessories Supplied | - Peel away introducer, - 5F and 6F Dilator, - 5F Access Tool in Simmons 2 and Berenstein distal shape | - 5F Select Catheter in Berenstein, H1, and Simmons distal shape | - 7 F Introducer Sheath, - 3cc syringe, - Luer - Activated Valve, - Dilator | Similar, the 074 and 087 Neurovascular Access System includes a Dilator, like the secondary predicate. | {6}------------------------------------------------ #### PERFORMANCE DATA VII. The results of verification and validation testing conducted on the Neurovascular Access System Family demonstrate that it performs as designed and is substantially equivalent to the predicate. A summary of the tests performed is provided in the table below: | Test Name | Objective | Test Method / Standard or Guidance | Result | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Visual Surface Requirements | To demonstrate that the device meets the visual surface requirements. | ISO 10555-1 2013, Section 4.4 | Pass | | Dimensional Verification | To demonstrate that the device meets the dimensional requirements. | ISO 10555-1 2013, Section 4.5 | Pass | | Liquid Leakage Under Pressure | To demonstrate that the device passes the liquid leakage under pressure test. | ISO 10555-1 2013, Section 4.7.1, Annex C | Pass | | Hub Aspiration Air Leakage | To demonstrate that the device passes the hub aspiration air leakage test. | ISO 10555-1 2013, Section 4.7.2, Annex D | Pass | | Simulated Use and Usability | To demonstrate that the device passes testing specified in the simulated use test protocol. Simulated use testing includes usability assessment with multiple physicians. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023 | Pass | | Test Name | Objective | Test Method / Standard or Guidance | Result | | Flex Fatigue | demonstrate that the To device passes the flex fatigue test. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023 | Pass | | Torque Test | To demonstrate the torque strength of the device. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Pass | | Tip Deflection | To demonstrate that the tip deflection is comparable to the predicate device. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Pass | | Device Removal Forces | To demonstrate that the removal forces are comparable to the predicate device. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Pass | | Peak Tensile Strength Testing | To demonstrate that the device passes the peak tensile strength testing including all bonds and joints. | ISO 10555-1 2013, Section 4.6, Annex B | Pass | | Flow Rate | To demonstrate that the flow rate is comparable to the predicate device. | ISO 10555-1 2013: Section 4.9 | Pass | | Corrosion Resistance | To demonstrate that the device has no visual evidence of corrosion. | ISO 10555-1 2013, Section 4.5, Annex A | Pass | | Radiopacity | To demonstrate that the distal marker band is clearly visible under typical fluoroscopic imaging conditions. | ISO 10555-1 2013, Section 4.2 ASTM F640-12 | Pass | | Kink Resistance | To demonstrate that shaft kink resistance is comparable to the predicate device and clinically relevant for the intended anatomical locations for use. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" | Pass | | Test Name | Objective | Test Method / Standard or Guidance | Result | | Particulates and Coating Integrity | To demonstrate the quantity and size of particles generated during simulated use are comparable to the predicates and reference devices. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" | Pass | | Dynamic Burst | To demonstrate that the device withstands dynamic burst strength. | ISO 10555-1 2103, Annex G | Pass | | Static Burst | To demonstrate that the device passes static burst pressure as specified in the test protocol. | ISO 10555-1 2013, Section F | Pass | | Shelf Life | Repeated bench tests after accelerated aging to demonstrate that the device performance is maintained over the proposed shelf-life (6 months). | ASTM D4332-22 ASTM D4169-22 ASTM F1980-21 ASTM F1886 / F1866M-16 ASTM 2096-11 (2019) ASTM F88/F88M:21 | Pass | {7}------------------------------------------------ {8}------------------------------------------------ #### VIII. BIOCOMPATIBILITY The subject Neurovascular Access System Family is categorized as an externally communicating device contacting circulating blood for a limited (≤ 24 hours) duration in accordance with ISO 10993-1. The following testing supports biocompatibility and substantial equivalence of the subject device. | Test Name | Reference Standard | Results | Results | |-----------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Cytotoxicity | ISO 10993-5 | No reactivity was observed with the test article at 24 and 48 hours. | Non-cytotoxic | | Sensitization | ISO10993-10 | The test article extracts showed no evidence of delayed dermal contact sensitization in the guinea pig maximization test. | Non-sensitizing | | Intracutaneous Reactivity | ISO 10993-23 | The scores from test article extracts were 0 from the saline extract and <1.0 from the sesame seed oil extract. | Non-irritant | | Acute Systemic Toxicity | ISO 10993-11 | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. | Non-toxic | | Material Mediated Pyrogenicity | ISO 10993-11 | No rabbit temperature rise ≥ 0.5 °C. | Non-pyrogenic | {9}------------------------------------------------ | Test Name | Reference Standard | Results | Results | |--------------------------------------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Hemolysis - Direct Contact and Extract Method | ISO 10993-4 | The mean blank corrected % hemolysis above the negative control of the test article was < 2% for the extract method. | Non-hemolytic | | Complement Activation | ISO 10993-4 | Results within acceptable range as compared to the controls. | Not a Sc5b-9 complement activator | | Thrombogenicity | ISO 10993-4 | No adverse effects or clinical signs during test period and no thrombus score ≥ 2 for either test or control device in in vivo thrombogenicity study. Performed similar to comparator and negative controls in Partial Thromboplastin Time and Platelet and Leukocyte Counts testing. | Non-thrombogenic | #### IX. STERILITY The subject Neurovascular Access System Family is sterilized with ethylene oxide (EO). The sterilization process has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 1x 10 °. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993 7:2008. Bacterial Endotoxin Levels were below the level of 2.15 endotoxin units (EU)/device in accordance with FDA's sterility guidance. Both baseline and accelerated shelflife testing were conducted demonstrating the device will perform as intended to support the proposed 6-month shelf-life. #### X. ANIMAL STUDY Animal testing was not deemed necessary to support the substantial equivalence of the Neurovascular Access System Family. #### XI. Clinical Clinical testing was not deemed necessary to support the substantial equivalence of the Neurovascular Access System Family. #### XII. CONCLUSION The Neurovascular Access System Family has the same intended use and similar indications for use as the primary predicate and secondary predicate. The technological characteristics of the subject device are similar to the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness. The performance testing supports that the subject Neurovascular Access System Family is substantially equivalent to the predicate.