(107 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a guidewire and extension wire, with no mention of AI or ML capabilities.
No
The device is described as a guidewire intended to facilitate the placement of diagnostic or therapeutic catheters, not to provide therapy itself.
No
The device description states its purpose is to "selectively introduce and position catheters and other interventional devices within target vessels," and that it "can be steered to facilitate the selective placement of diagnostic or therapeutic catheters." This indicates it's a tool for delivering other devices, not a diagnostic device itself.
No
The device description clearly details physical components like a guidewire, extension wire, torquer, and introducer needle, and the performance studies focus on bench testing of these physical attributes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for facilitating the selective placement of diagnostic or therapeutic catheters within the neuro vasculature. This is an interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical guidewire designed for navigation and positioning within blood vessels. It describes mechanical properties like steerability, flexibility, and lubricity, all related to its function within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are used to perform tests on these types of samples.
The device is a medical device used in vivo (within the living body) for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.
Product codes
MOF
Device Description
The pORTAL Steerable Hydrophilic Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid in the use of the device.
The pORTAL EXT Extension Wire is intended to interface with pORTAL Steerable Hydrophilic Guidewire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL quidewire to 315cm (see table 1 for dimensional specifications). This enable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Sterile operating theatre
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Bench: A full suite of performance testing on the bench was carried out on the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire. This testing included, Tensile Strength, Torque Strength, Tip Flexibility, Coating Adherence/Integrity & Catheter Compatibility under simulated conditions. The results of this testing demonstrated compliance to all the design attributes as well as demonstrating an acceptable performance outcome. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate substantial equivalence to the cited predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 9, 2019
phenox Limited % Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K191687
Trade/Device Name: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: September 9, 2019 Received: September 10, 2019
Dear Mark Job:
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
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Xiaolin Zheng, Ph.D., M.S. Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191687
Device Name
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
Indications for Use (Describe)
The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary (21 CFR 807.92)
I. SUBMITTER
phenox Limited, Ballybrit Business Park, Galway, Ireland
Contact Person: Garv Brogan Director of Regulatory Affairs, Phone: +353 91 740103
Date Prepared: May 31st, 2019
II. DEVICE
Name of Device: pORTAL® Steerable Hydrophilic Guidewire and pORTAL®EXT Extension Wire
Common or Usual Name: Catheter Guidewire
Classification: Class II, 21 CFR 870.1330, Catheter Guide wire
Product Code: MOF
III. PREDICATE DEVICE(S)
Traxcess 14EX Guidewire and Traxcess Docking Wire, K093397, Cleared Dec 2009. Transend EX Guidewire, K934122, cleared October 1993.
IV. DEVICE DESCRIPTION
The pORTAL Steerable Hydrophilic Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid in the use of the device.
The pORTAL EXT Extension Wire is intended to interface with pORTAL Steerable Hydrophilic Guidewire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL quidewire to 315cm (see table 1 for dimensional specifications). This enable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Guidewire.
4
| Part # | Content of
Package | Description on label | Total
Length | Outer
Diameter | Length of
Hydrophilic Coating |
|------------------|-----------------------|----------------------------------------------|-----------------|--------------------|----------------------------------|
| PORT-14-200-1 | 1 | pORTAL
Steerable Hydrophilic
Guidewire | 205 cm | 0.014"
(0.36mm) | 35.5 cm
(nominal) |
| PORT-14-200-5 | 5 | pORTAL
Steerable Hydrophilic
Guidewire | 205 cm | 0.014"
(0.36mm) | 35.5 cm
(nominal) |
| PORT-14-115-1-EX | 1 | pORTAL
EXT Extension Wire | 115 cm | 0.014"
(0.36mm) | N/A |
| PORT-14-115-5-EX | 5 | pORTAL
EXT Extension Wire | 115 cm | 0.014"
(0.36mm) | N/A |
Table 1: Product details of the pORTAL components
V. INDICATIONS FOR USE
The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.
IV. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
| Parameter | Predicate Device
(Transend EX) | Predicate Device
(Traxcess 14EX) | Subject Device | Assessment of
differences |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | Transend EX Guidewire | Traxcess 14EX Guidewire
and Docking wire | pORTAL Guidewire and
Extension System | Equivalent |
| 510(k) number | K934122 | K093397 | K191687 | Equivalent |
| Product
Classification | 21 CFR 870.1330,
Class II | 21 CFR 870.1330,
Class II | 21 CFR 870.1330,
Class II | Equivalent |
| Device Design | Steerable hydrophilic
guidewire | Steerable hydrophilic
guidewire and docking
wire | Steerable hydrophilic
guidewire and extension
system | Equivalent |
| Indications for
Use | The Transend EX
guidewire is intended
for general intravascular
use, including
neurovascular and
peripheral vasculatures.
The guidewire can be
torqued to facilitate the
selective placement of
diagnostic or
therapeutic catheters.
The device is not
intended for use in
coronary arteries. The
torque device (pin vase)
is included with the
guidewire to facilitate | The Traxcess Guidewire
and Docking Wire is
intended for general
intravascular use,
including the neuro and
peripheral vasculature.
The wire can be steered
to facilitate the selective
placement of diagnostic
or therapeutic catheters.
This device is not
intended for use in
coronary arteries. | The pORTAL Steerable
Hydrophilic Guidewire and
pORTAL EXT Extension Wire is
intended for use in the neuro
vasculature. The wire can be
steered to facilitate the
selective placement of
diagnostic or therapeutic
catheters.
This device is not intended
for use in peripheral or
coronary arteries. | The Indications for Use
statement is similar to the
predicates with the
exception that the
treatment indication is
reduced to only include
neuro as opposed to a
general intravascular use
including peripheral. This
tightening of the
indication statement does
not raise any additional
questions on safety and
effectiveness. |
| Mode of Action | The guidewire can be
steered to facilitate the
selective placement of
diagnostic or
therapeutic catheters. | The guidewire can be
steered to facilitate the
selective placement of
diagnostic or therapeutic
catheters. | The guidewire can be
steered to facilitate the
selective placement of
diagnostic or therapeutic
catheters. | Equivalent |
Table 2: Comparison of pORTAL technological characteristics with predicate device
5
| Parameter | Predicate Device
(Transend EX) | Predicate Device
(Traxcess 14EX) | Subject Device | Assessment of
differences |
|----------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Sizes | Two lengths 182cm and
205cm guidewire | 200cm guidewire
115cm docking wire | 205cm guidewire
115cm extension wire | The guidewire devices
have similar overall
lengths. Traxcess may
be extended using a
docking wire, resulting
in comparable length
to the pORTAL
Extension wire. These
minor differences in
lengths do not raise
any additional
questions on safety
and effectiveness. |
| Use | Single Use Device | Single Use Device | Single Use Device | Equivalent |
| Sterilization | EO Sterilization | EO Sterilization | EO Sterilization | Equivalent |
| Method of supply | Stored with a dispenser
coil, Tyvek Pouch and
shipping carton | Stored with a dispenser coil,
Tyvek Pouch and shipping
carton | Stored with a dispenser coil,
Tyvek Pouch and shipping
carton | Equivalent |
| Intended Clinical
Environment | Sterile operating theatre | Sterile operating theatre | Sterile operating theatre | Equivalent |
| Biocompatible | Yes | Yes | Yes | Equivalent |
V. COMPARISON OF MATERIALS USED WITH THE PREDICATE DEVICES
| Parameter | Predicate Device
(Transend EX) | Predicate Device
(Traxcess 14EX) | Subject Device | Assessment of
differences |
|------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wire
Material | Guidewire:
Scitanium (proprietary alloy)
core wire | Guidewire:
Stainless-steel core with
Nitinol tapered wire
Docking Wire:
Stainless-steel core with
Nitinol tube on distal end | Guidewire:
35NLT Cobalt Chrome alloy
Extension Wire:
Stainless Steel core wire with
a Nitinol tube on the distal end | While there are differences in
materials, pORTAL uses
similar materials which are
commonly used in medical
devices. DV testing on the
pORTAL confirmed it will
perform as intended and the
difference in materials do not
raise questions of safety and
effectiveness |
| Coating | Distal:
Hydrophilic coating "ICE"
Proximal: PTFE | Distal: Hydrophilic coating
Proximal: PTFE | Distal: Hydrophilic coating
Proximal: PTFE | The function of each device
coating is equivalent. Whilst
having different materials,
each of the device coatings
functions are used equivalent
and incorporated in the
device to increase the
lubricity of the guidewires.
The difference in materials do
not raise questions of safety
and effectiveness |
| Tip
Material | Tapered ribbon Scitanium
(proprietary alloy) | Platinum / Nitinol coil | Platinum/Tungsten coil | The function of each device tip
is equivalent. The difference in
materials do not raise
questions of safety and
effectiveness |
Table 3: Comparison of pORTAL materials with predicate device
6
VI. BIOCOMPATIBILITY
Biocompatibility testing for the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire was conducted to conform with the FDA consensus standard, recognition number 2-156, AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, along with the FDA Blue Book Memorandum# G95. Table 4 and 5 below summarizes the biocompatibility testing performed on the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire.
| Test | Test Description | Result Summary | Conclusion |
|---|---|---|---|
| Chemical | |||
| Characterization | Exhaustive Extraction in | ||
| Purified Water (PW), 50% | |||
| Isopropyl | |||
| Alcohol (IPA), and Hexane (Hex) for | |||
| Total Non-Volatile Residue (NVR) | The exaggerated extractions of the Phenox/LRM | ||
| 0.014" Neurovascular Guidewire yielded low | |||
| ( | All samples were within physiochemical | ||
| specifications. | |||
| Age Testing | All samples are visually inspected for any damage | ||
| or defects. | All samples met age testing criteria. |
Table 10: Shelf Life Testing Summary for pORTAL Guidewire for 2 years and 3 months
| pORTAL Steerable Hydrophilic Guidewire | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Dimensional | The overall guidewire length, polymer jacket length | |
| and overall guidewire diameter were measured. | Dimensional results meet acceptance | |
| criteria. | ||
| Tip Tensile Strength | The distal section of the wire was pulled until it | |
| failed. | Results show the tensile strength meets | |
| specification. | ||
| Catheter Compatibility | The guidewire was tested with relevant interfacing | |
| devices such as over the wire micro catheters under | ||
| simulated use. | The guidewires tested performed | |
| acceptably and were shown to be | ||
| compatible with tested microcatheters. | ||
| Coating Adherence/Integrity | The guidewire was tracked multiple times through a | |
| catheter in a simulated anatomy. The coatings were | ||
| inspected for signs of damage or degradation. | No coating was rubbed off during or after | |
| testing of guidewire in any of the | ||
| microcatheters. | ||
| Tip Stiffness (Gram Weight) | The distal tip of the guidewire was compressed. The | |
| peak load was electronically recorded and reported. | Device stiffness is equivalent or less | |
| than predicate device. Device tip | ||
| stiffness is within specification. | ||
| Tip Shape Retention | A J-Shape was formed on the distal end of the wire, | |
| then recorded using an image measuring system. | The guidewire distal tip retention is | |
| better than or equivalent to predicate | ||
| device. Tip shape retention is within | ||
| specification. | ||
| Lubricity and Durability Test | The guidewire, within a microcatheter was tracked | |
| multiple times through a 3-Dimensional Neuro | ||
| Silicone anatomy block. Resulting lubricity was | ||
| measured. | Lubricity and durability of the guidewire | |
| is better than or equivalent to the | ||
| predicate device. The device meets | ||
| acceptance criteria on both lubricity and | ||
| durability. | ||
| PTFE Coating Adherence (Saline | ||
| Soak & Wipe Test) | The entire length was pulled through a fixed clamp. | |
| The wire was inspected for PTFE degradation or | ||
| damage. | All devices passed saline soak & wipe | |
| test. |
11
| pORTAL Steerable Hydrophilic Guidewire | ||
|---|---|---|
| Test | Test Method Summary | Results |
| PTFE Coating Mandrel Adhesion | ||
| Test (Saline Soak & Wrap Test) | The wire was wrapped around a mandrel of a fixed | |
| diameter (as defined in ISO11070 standard). The | ||
| wrapped PTFE coated wire was inspected under a | ||
| microscope for any signs of flaking, cracking or | ||
| delamination. | All devices passed saline soak & wrap | |
| test. | ||
| PTFE Adhesion / Durability | ||
| Testing (Eraser Test) | The wire was placed in a fixture and subject to a | |
| number of cycles underweight. The wire was | ||
| removed and inspected for failure. | All devices passed eraser test. | |
| Radiopacity | The radiopaque distal end of the guidewire was | |
| imaged using standard fluoroscopy equipment. An | ||
| image was taken and reviewed to ensure visibility | Device radiopacity was seen to be | |
| comparable to predicate device. Device | ||
| meets specification. | ||
| Torque Strength (Combined | ||
| Load/Turns to Failure) | The guidewire was loaded into the guide catheter | |
| within a simulated neurovascular anatomy. Force is | ||
| applied and the specimen is rotated to failure. | Device torqueability was demonstrated | |
| within specification. | ||
| ISO Flex Resistance Test | ||
| (Bending Durability) | Test method defined in ISO 11070 Annex G. The | |
| test region of the wire was wrapped around | ||
| mandrels in opposing directions a number of times. | ||
| The wire was removed and examined. | Flex resistance was comparable to | |
| predicate device. | ||
| Corrosion Resistance | Test method defined in ISO 11070 Annex B. The | |
| products were placed in a beaker of salt water at | ||
| room temp for 5 hours, and then placed in boiling | ||
| distilled water for 30 minutes, followed by 48 hours | ||
| at 37°C. The products were removed, and examined | ||
| for evidence of corrosion. | Device meets acceptance criteria, no | |
| evidence of corrosion on device. | ||
| FDA Tip Flexibility | This test measures the load required to deflect the | |
| distal tip of the guidewire to angles of 45° and 90. A | ||
| force curve was generated for each specimen at the | ||
| specified deflection points and were electronically | ||
| collected. | Tip stiffness properties were shown to | |
| be comparable or less atraumatic than | ||
| predicate device. Peak load was within | ||
| specification. | ||
| Kink Resistance / Flexibility | The tip of each device was wrapped around | |
| mandrels, until kinking occurs. | Kink resistance was equivalent or better | |
| than predicate device. | ||
| Particle Residue | Following simulated use, particulates generated are | |
| collected, and counted by size for each wire. T | All parts & calculated tolerance interval | |
| are below max specification for ≥10µm | ||
| particles/device and ≥25µm | ||
| particles/device. | ||
| Torque Response | The test measured the reaction of the distal end of | |
| the guidewire when the wire was placed within a | ||
| simulated anatomy. | Equivalent torque response when | |
| compared to predicate device. Both | ||
| fresh and fatigued devices are within | ||
| specifications. | ||
| Packaging Inspection | The packaging should not incur any damage or | |
| defects that may have a detrimental impact on the | ||
| use or performance of the product. | The packaging did not incur any damage | |
| or defects that may have a detrimental | ||
| impact on the use or performance of the | ||
| product. |
Table 11: Shelf Life Testing Summary for pORTAL Extension Wire 5 years
pORTAL EXT Extension Wire
| Test | Test Method Summary | Results | |
|---|---|---|---|
| Catheter Compatibility Test | The guidewire was tested with relevant interfacing | ||
| devices under simulated use. | The extension systems performed | ||
| acceptably and were shown to be | |||
| compatible with tested microcatheters. | |||
| PTFE Coating Mandrel Adhesion | |||
| Test (Saline Soak & Wrap Test) | The wire was wrapped around a mandrel of a fixed | ||
| diameter (as defined in ISO11070 standard). The | |||
| wrapped PTFE coated wire was inspected under a | |||
| microscope for any signs of flaking, cracking or | |||
| delamination. | No damage was observed post soak & | ||
| wrap test. All devices passed. | |||
| PTFE Coating Adherence (Saline | |||
| Soak & Wipe Test) | The entire length was pulled through a fixed | ||
| clamp. The wire was inspected for PTFE | |||
| degradation or damage. | No damage was observed post soak & | ||
| wipe test. All devices passed. | |||
| PTFE Adhesion / Durability Testing | |||
| (Eraser Test) | The wire was placed in a fixture and subject to a | ||
| number of cycles underweight. The wire was | |||
| removed and inspected for failure. | No damage was observed post eraser | ||
| test. All devices passed. |
12
| pORTAL EXT Extension Wire | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| Dimensional Measurements | The overall length and maximum diameter of the | ||
| extension wire were measured. | All dimensional measurements were | ||
| within specifications. | |||
| Joint Strength / Tensile Test | The joint strength of the extension wire is | ||
| measured using a calibrated force tester | Joint strength measurements were | ||
| within specifications. | |||
| Strength of Union | The peak force to separate the guidewire from the | ||
| extension wire is measured using a calibrated | |||
| force tester | Strength of union measurements were | ||
| comparable to predicate device and | |||
| within specifications. | |||
| Joint Flex Test | This test involves flex testing the integrity of the | ||
| connecting joint between the extension wire and | |||
| the guidewire. A force curve is generated for each | |||
| specimen, and the peak load is electronically | |||
| calculated and put into a report. | Results have shown comparable joint | ||
| flex properties between the subject | |||
| device & predicate device. Device meets | |||
| specification. | |||
| Particulate Residue Test | Following simulated use, particulates generated | ||
| are collected, and counted by size for each wire. | All parts & calculated tolerance interval | ||
| are below max specification for ≥10μm | |||
| particles/device and ≥25µm | |||
| particles/device. | |||
| Packaging Inspection | The packaging should not incur any damage or | ||
| defects that may have a detrimental impact on the | |||
| use or performance of the product. | The packaging did not incur any damage | ||
| or defects that may have a detrimental | |||
| impact on the use or performance of the | |||
| product. |
VIII. CONCLUSIONS
The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire has an intended use and technological characteristics equivalent to the predicate devices. The subject device demonstrates product performance through successful bench testing. The pORTAL Guidewire device demonstrates it is safe for use for 2 years 3 months and the pORTAL Extension Wire is safe for 5 years. All packaging tests support the claimed shelf life. Device use is identical to the predicate devices and performance of the new device is comparable.
Taking this information into account, it is concluded that the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is substantially equivalent to the predicate devices, the Traxcess 14EX Guidewire and Traxcess Docking Wire (K093397) and Transend EX Guidewire (K934122).