(246 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheter system, with no mention of AI or ML capabilities.
No
The device is used to facilitate the introduction and guidance of other interventional devices, rather than directly treating a condition itself.
No
The device is described as an "Access System" used to "facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel." It is designed for access and delivery of other devices, rather than for diagnosing conditions or diseases.
No
The device description explicitly states it consists of sterile, single-use catheters and accessories, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the peripheral and neuro vasculature. This describes a device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details catheters and accessories used to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel. This further reinforces its use as a tool for in vivo procedures.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or analysis of biological material.
The device described is a tool used to access and navigate within the patient's vascular system for the purpose of delivering other interventional devices. This falls under the category of a surgical or interventional device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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: Visual Surface Requirements
Objective: To demonstrate that the device meets the visual surface requirements.
Test Method / Standard or Guidance: ISO 10555-1 2013, Section 4.4
Result: Pass
Test Name: Dimensional Verification
Objective: To demonstrate that the device meets the dimensional requirements.
Test Method / Standard or Guidance: ISO 10555-1 2013, Section 4.5
Result: Pass
Test Name: Liquid Leakage Under Pressure
Objective: To demonstrate that the device passes the liquid leakage under pressure test.
Test Method / Standard or Guidance: ISO 10555-1 2013, Section 4.7.1, Annex C
Result: Pass
Test Name: Hub Aspiration Air Leakage
Objective: To demonstrate that the device passes the hub aspiration air leakage test.
Test Method / Standard or Guidance: ISO 10555-1 2013, Section 4.7.2, Annex D
Result: Pass
Test Name: Simulated Use and Usability
Objective: To demonstrate that the device passes testing specified in the simulated use test protocol. Simulated use testing includes usability assessment with multiple physicians.
Test Method / Standard or Guidance: FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023
Result: Pass
Test Name: Flex Fatigue
Objective: To demonstrate that the device passes the flex fatigue test.
Test Method / Standard or Guidance: FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023
Result: Pass
Test Name: Torque Test
Objective: To demonstrate the torque strength of the device.
Test Method / Standard or Guidance: FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023
Result: Pass
Test Name: Tip Deflection
Objective: To demonstrate that the tip deflection is comparable to the predicate device.
Test Method / Standard or Guidance: FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023
Result: Pass
Test Name: Device Removal Forces
Objective: To demonstrate that the removal forces are comparable to the predicate device.
Test Method / Standard or Guidance: FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023
Result: Pass
Test Name: Peak Tensile Strength Testing
Objective: To demonstrate that the device passes the peak tensile strength testing including all bonds and joints.
Test Method / Standard or Guidance: ISO 10555-1 2013, Section 4.6, Annex B
Result: Pass
Test Name: Flow Rate
Objective: To demonstrate that the flow rate is comparable to the predicate device.
Test Method / Standard or Guidance: ISO 10555-1 2013: Section 4.9
Result: Pass
Test Name: Corrosion Resistance
Objective: To demonstrate that the device has no visual evidence of corrosion.
Test Method / Standard or Guidance: ISO 10555-1 2013, Section 4.5, Annex A
Result: Pass
Test Name: Radiopacity
Objective: To demonstrate that the distal marker band is clearly visible under typical fluoroscopic imaging conditions.
Test Method / Standard or Guidance: ISO 10555-1 2013, Section 4.2; ASTM F640-12
Result: Pass
Test Name: Kink Resistance
Objective: To demonstrate that shaft kink resistance is comparable to the predicate device and clinically relevant for the intended anatomical locations for use.
Test Method / Standard or Guidance: FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions"
Result: Pass
Test Name: Particulates and Coating Integrity
Objective: To demonstrate the quantity and size of particles generated during simulated use are comparable to the predicates and reference devices.
Test Method / Standard or Guidance: FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions"
Result: Pass
Test Name: Dynamic Burst
Objective: To demonstrate that the device withstands dynamic burst strength.
Test Method / Standard or Guidance: ISO 10555-1 2103, Annex G
Result: Pass
Test Name: Static Burst
Objective: To demonstrate that the device passes static burst pressure as specified in the test protocol.
Test Method / Standard or Guidance: ISO 10555-1 2013, Section F
Result: Pass
Test Name: Shelf Life
Objective: Repeated bench tests after accelerated aging to demonstrate that the device performance is maintained over the proposed shelf-life (6 months).
Test Method / Standard or Guidance: ASTM D4332-22; ASTM D4169-22; ASTM F1980-21; ASTM F1886 / F1866M-16; ASTM 2096-11 (2019); ASTM F88/F88M:21
Result: Pass
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.
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.
Not Found
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
§ 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).
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)
| Residential Use (Part of OFF-SITE Septic System) |
|---|
| Commercial Use |
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 |