(37 days)
No
The description focuses on the physical construction, materials, and mechanical properties of a guidewire, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device is a guidewire intended to facilitate the selective placement of diagnostic or therapeutic catheters, but it is not itself a therapeutic device.
No
The device description states it is "designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel." Its use is "to enable insertion and easier navigation into the intracranial vascular branches for diagnostic or therapeutic use." This indicates the guidewire assists in the delivery of diagnostic or therapeutic catheters, but is not a diagnostic device itself.
No
The device description clearly details a physical guidewire made of stainless steel, nitinol, platinum/tungsten, and coatings, along with accessories like a torquer and introducer. This is a hardware medical device.
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 "general intravascular use" to "facilitate the selective placement of diagnostic or therapeutic catheters." This describes a device used within the body for procedural guidance, not a device used outside the body to examine specimens from the body.
- Device Description: The description details a physical guidewire designed to be inserted into blood vessels to navigate catheters. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The purpose is purely mechanical guidance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
MOF, DQX
Device Description
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnostic or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.
HYBRID Guidewire consists of a proximal coated stainless steel core wire and a distal coated nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a 92/8 platinum/tungsten and stainless steel coil for maximum radiopacity. The distal tip comes in various tip designs; it can be straight or curved distal tip (forming a double angle).
The coil section of the HYBRID Guidewire and the distal stainless steel section is coated with hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of the surface coatings is to provide lubricity when HYBRID Guidewire is passed through compatible microcatheters. A torquer and an introducer are also provided with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General intravascular use, including the neuro and peripheral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Testing:
- Visual and Dimensional Inspection: All test samples passed testing.
- Catheter Compatibility & Simulated Use: All test samples passed testing.
- Coating Integrity and Adherence: All test samples passed testing.
- Tensile Strength: All test samples passed testing. Tensile strength was comparable to predicate devices.
- Corrosion Resistance: All test samples passed testing.
- Torque Strength: All test samples passed testing. The torque strength of the subject device is equivalent to the predicate device.
- Torqueability: All test samples passed testing. The torqueability value of the subject device is equivalent to the predicate device.
- Fracture Resistance and Flexing Test: All test samples passed testing.
- Tip Flexibility: All test samples passed testing. The tip flexibility of the subject device is equivalent to the predicate device.
- Particulate Matter Characterization: All test samples passed testing. Particulate matter characterization was comparable to predicate device.
- Design Verification and Packaging Validation: All test samples passed testing.
Packaging Integrity Test:
- Visual Inspection: All test samples met the acceptance criteria.
- Bubble Leak Test: All test samples met the acceptance criteria.
- Seal Strength: All test samples met the acceptance criteria.
Performance Animal Testing (GLP):
- Animal Testing (GLP): All test samples passed testing. Trackability and handling of the guidewire, radiopacity, and compatibility with microcatheter were comparable to predicate device.
Biocompatibility Testing:
- Cytotoxicity - ISO MTS Cytotoxicity Test – 24 hour Extract ISO 10993-5: Non-cytotoxic
- Sensitization - ISO Guinea Pig Maximization Sensitization Test- (2 Extracts) ISO 10993-10: Did not elicit sensitization response
- Irritation or Intracutaneous - ISO Intracutaneous Study in Rabbits - Two Extracts ISO 10993-10: Non-irritant
- Acute Systemic Toxicity – ISO Acute Systemic Toxicity Study in Mice - Two Extracts ISO 10993-11: Non-toxic
- Systemic Toxicity – ISO Materials Mediated Rabbit Pyrogen ISO 10993-11: Non-pyrogenic
- Hemocompatibility-Hemolysis (Direct and Indirect) ISO 10993-4: Non-Hemolytic
- Hemocompatibility – Standard Thrombogenicity in Canine (ISO) ISO 10993-4: Passed
- Hemocompatibility - Complement Activation, SC5b-9 ISO 10993-4: Passed
- Hemocompatibility – Partial Thromboplastin Time (PTT) ISO 10993-4: Passed
- Hemocompatibility - Platelet and Leukocyte Counts with Sponsor Supplied Comparison Article ISO 10993-4: Passed
Shelf life:
- The accelerated shelf life testing for HYBRID Guidewire has been conducted (T=1 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that HYBRID Guidewire will perform as intended to the Design Specification. HYBRID Guidewire will be labeled for 1-year shelf life.
Packaging:
- T=1 year accelerated aging was performed on the HYBRID Guidewire. The results from packaging testing conducted on HYBRID Guidewire showed that the acceptance criteria were met. Therefore, we can conclude the HYBRID Guidewire packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization:
- Sterilization Validation: The validation study demonstrated that the sterilization process and equipment are capable of reliably and consistently sterilizing the devices to a minimum SAL of 10-6. The appropriateness of the BI has been confirmed with fractional test runs utilizing Natural Product Sterility Testing (NPRT). Fractional cycles, half cycles, and full cycles met the acceptance criteria.
- EO and ECH Residuals: The residual traces of EO and ECH for the worst case device in the device family after the exposure to the EO sterilization process are well below the limits specified in ISO 10993-7.
- Bacterial Endotoxin Levels:
§ 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 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 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 4, 2018
Regulatory Technology Services LLC Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, Minnesota 55313
Re: K182337
Trade/Device Name: HYBRID Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: September 25, 2018 Received: September 26, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182337
Device Name HYBRID Guidewire
Indications for Use (Describe)
The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic catheters. This device is not intended for use in the 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
HYBRID Guidewire 510(k) Summary
This 510(k) Summary for HYBRID Guidewire is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
Balt USA, LLC 29 Parker Irvine CA 92618
| Contact Person: | Nancy Xu
Regulatory Affairs Manager |
|-----------------|----------------------------------------|
| Telephone: | 949-788-1443 |
| E-mail: | nancy.xu@balt-usa.com |
| Date prepared: | September 21, 2018 |
DEVICE [807.92(a)(2)]
| Name of Device: | HYBRID Guidewire |
|---|---|
| Common or Usual Name: | Guidewire |
| Classification Name: | Catheter Guide Wire |
| Product Code: | MOF |
| DQX | |
| Regulatory Class: | Class II |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 21 C.F.R. 870.1330 |
| Reviewing Product Branch: | Division of Neurological and Physical Medicine Devices (Office of |
| Device Evaluation, CDRH) |
PREDICATE DEVICE [807.92(a)(3)]
Traxcess 14 Guidewire (K133725)
REFERENCE DEVICES
Traxcess 0.007" Mini Guidewire (K161803)
Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (K022357)
4
DEVICE DESCRIPTION [807.92(a)(4)]
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnostic or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.
HYBRID Guidewire consists of a proximal coated stainless steel core wire and a distal coated nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a 92/8 platinum/tungsten and stainless steel coil for maximum radiopacity. The distal tip comes in various tip designs; it can be straight or curved distal tip (forming a double angle).
The coil section of the HYBRID Guidewire and the distal stainless steel section is coated with hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of the surface coatings is to provide lubricity when HYBRID Guidewire is passed through compatible microcatheters. A torquer and an introducer are also provided with the device.
INDICATIONS FOR USE [807.92(a)(5)]
The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6]]
The technological characteristics of the HYBRID Guidewire is analogous to the technological characteristics of the Traxcess 14 Guidewire (K133725), Traxcess 0.007" Mini Guidewire (K161803), and Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (K022357). Substantial equivalence is determined based on the following similarities:
- similar intended use/indications for use ●
- Same principles of operation ●
- Same fundamental scientific technology ●
- Incorporate similar basic guidewire design
- Incorporate similar guidewire construction material .
5
Table 1 comprises the comparison between HYBRID Guidewire (Subject Device) and Traxcess 14 Guidewire (Predicate Device, K133725), Traxcess .007" Mini Guidewire (Reference Device, K161803) and Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (Reference Device, K022357).
6
| Feature | Traxcess 14 Guidewire | Traxcess .007" Mini
Guidewire | Transend 300 ES Guidewire
Transend 300 Floppy
Guidewire | HYBRID Guidewire | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | [PREDICATE DEVICE
K133725] | [REFERENCE DEVICE
K161803] | [REFERENCE DEVICE
K022357] | [SUBJECT DEVICE] | |
| Product Code | MOF, DQX | MOF, DQX | DQX | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
| Regulatory Class | Class II | Class II | Class II | Same as Predicate Device | |
| Regulation Number | 21 CFR 870.1330 | 21 CFR 870.1330 | 21 CFR 870.1330 | Same as Predicate Device | |
| Regulation Name | Catheter Guide Wire | Catheter Guide Wire | Catheter Guide Wire | Same as Predicate Device | |
| Generic Name | Guidewire | Guidewire | Guidewire | Same as Predicate Device | |
| Indications for Use
Statement | The Traxcess 14 Guidewire
is intended for general
intravascular use, including
the neuro and peripheral
vasculature. The guidewire
can be steered to facilitate
the selective placement of
diagnostic or therapeutic
catheters. This device is not
intended for use in
coronary arteries. | Traxcess .007" Mini
Guidewire is indicated for
general intravascular use,
including the neuro and
peripheral vasculature. The
guidewire can be steered to
facilitate the selective
placement of diagnostic or
therapeutic catheters. This
device is not intended for
use in coronary arteries. | The Transend 300 ES
Guidewire and Transend 300
Floppy Guidewire are
intended for general
intravascular use, including
the neuro and peripheral
vasculature. The guidewires
can be torqued to facilitate the
selective placement of
diagnostic or therapeutic
catheters. These devices are
not intended for use in
coronary arteries. A torque
device (pin vise) is included
to facilitate directional
manipulation of the
guidewires. | The HYBRID Guidewire
is intended for general
intravascular use,
including the neuro and
peripheral vasculature.
The guidewire can be
steered to facilitate the
selective placement of
diagnostic or therapeutic
catheters. This device is
not intended for use in
the coronary arteries. | |
| Performance | | | | | |
| Function | The steerable guidewire is
used to facilitate the
selective placement of
diagnostic or therapeutic
catheters. | The steerable guidewire is
used to facilitate the
selective placement of
diagnostic or therapeutic
catheters. | The guidewire can be
torqued to facilitate the
selective placement of
diagnostic or therapeutic
catheters. | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
| Anatomical Location | General intravascular use,
including the neuro and
peripheral vasculature. | General intravascular use,
including the neuro and
peripheral vasculature. | General intravascular use,
including the neuro and
peripheral vasculature. | Same as Predicate Device | |
| Design | | | | | |
| Overall Length | 200 cm | 210 cm | 300 cm | 120 cm* – 310cm
(*The 120 cm length device
model is only indicated to be
used in the peripheral
vasculature.) | |
| Proximal Diameter | .014" | .014" | Not Listed | .012" – .014" | |
| Distal Diameter | .012" | .007" | 0.014" minimum | .007" – .014" | |
| Core wire
configuration | 60 cm Nitinol welded to
Stainless Steel | 60 cm Nitinol welded to
Stainless Steel | Not Listed | 40 cm – 60 cm Nitinol
soldered to Stainless Steel | |
| Coil Length | 40 cm | 6 cm | Not Listed | 8 cm or 31 cm | |
| Coil Configuration | 3 cm Platinum Nickel alloy
and 37 cm Stainless Steel | 6 cm Platinum Nickel alloy | Not Listed | 3 cm of Platinum Tungsten
and 27 cm stainless steel
Or
8 cm of Platinum Tungsten | |
| | | | | | |
| Coil Length
(Radiopaque) | 3 cm | 6 cm | Not Listed | 3 cm or 8 cm | |
| Stainless Steel Coil
Length | 40 cm | N/A | Not Listed | 27 cm
Stainless steel coil length
not applicable to models
with 8cm Pt/W
configuration | |
| Distal Shaft Length
(Shapeable Length) | 1.4 cm | 1.4 cm | Not Listed | 1.8 cm -2.0 cm | |
| Distal tip thickness
(core wire) | 0.037 mm | 0.037 mm | Not Listed | 0.040 mm | |
| Docking Wire
Compatibility | Yes | No | Not Listed | No | |
| | Material | | | | |
| Proximal Core Wire | Stainless Steel | Stainless steel | Not Listed | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
| Distal Core Wire | Nickel titanium (Nitinol)
alloy | Nickel titanium (Nitinol)
alloy | Not Listed | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
| Coil | Platinum nickel alloy and
Stainless Steel | Platinum nickel alloy | Not Listed | Platinum/Tungsten and
Stainless Steel | |
| Coating Material | | | | | |
| Coil | Hydrophilic Coating
[SLIP-COAT by Argon
Medical] | Hydrophilic Coating
[SLIP-COAT by Argon
Medical] | Not Listed | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
| Distal Stainless Steel | Hydrophilic Coating
[SLIP-COAT by Argon
Medical] | Hydrophilic Coating
[SLIP-COAT by Argon
Medical] | Not Listed | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
| Proximal Stainless
Steel | Hydrophilic Coating | No PTFE | Not Listed | PTFE | |
| Hydrophilic Coating
Length | Hydrophilic coating =
1450 mm | Hydrophilic coating =
1580 mm | Not Listed | Hydrophilic coating =
9 cm -59 cm
PTFE = 160 cm or 250 cm | |
| | Other Attributes | | | | |
| Method of supply | Sterile and single use | Sterile and single use | Not Listed | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
| Sterilization method | Ethylene oxide gas | Ethylene oxide gas | Not Listed | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
| Accessories | Shaping mandrel, Torque
device, and Insertion Tool | Shaping mandrel, Torque
device, and Insertion Tool | Torque Device (pin vise) | Torquer
Introducer | |
| Package
configuration | Placed into a Dispenser
hoop, Tyvek pouch, and
Carton box | Placed into a Dispenser
hoop, Tyvek pouch, and
Carton box | Not Listed | Same as Traxcess .007"
Mini Guidewire and
Traxcess 14 Guidewire | |
Table 1: Predicate Devices and Reference Devices vs. Subject Device Comparison Table
7
8
9
10
11
PERFORMANCE DATA [807.92(b)]
Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that HYBRID Guidewire (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.
| Performance Bench Testing | ||
|---|---|---|
| Tests | Test Method Summary | Results |
| Visual and Dimensional | ||
| Inspection | Test samples were visually inspected for | |
| damage under 2.5X magnification. The | ||
| external surface of the effective length of | ||
| the guidewire shall be free from process | ||
| and surface defects that could cause trauma | ||
| to vessels during use. |
Inspect dimensions for overall length,
radiopaque length, outer diameter (distal
and proximal), and distal shape per product
specification. | All test samples passed testing. |
| Catheter Compatibility &
Simulated Use | Verify the in vitro performance of
neurovascular guidewires under simulated
use conditions using a worst case tortuous
ICA vessel model. | All test samples passed testing. |
| Coating Integrity and
Adherence | Test samples were dyed and gone through
simulated use testing. Inspect the coating
quality of the dyed guidewire under a
microscope. | All test samples passed testing. |
| Tensile Strength | The minimum force to break the guidewire
was tested per ISO 11070. Tensile strength
of the subject device was compared to the
predicate device. | All test samples passed testing.
Tensile strength was
comparable to predicate
devices. |
| Corrosion Resistance | The test article is immersed in sodium
chloride solution before being placed in | All test samples passed testing. |
| | boiling distilled or deionized water.
Subsequently, the test article is examined
visually for evidence of corrosion. | |
| Torque Strength | Torque strength was determined by number
of turns-to-failures. Torque strength of the
subject device was compared to the
predicate device. | All test samples passed testing.
The torque strength of the
subject device is equivalent to
the predicate device. |
| Torqueability | Rotational input to output ratio
(torqueability value) is compared to the
predicate device. | All test samples passed testing.
The torqueability value of the
subject device is equivalent to
the predicate device. |
| Fracture Resistance and
Flexing Test | Testing was conducted to determine the
guidewire's resistance to damage by
flexing and resistance to fracture per ISO
11070. | All test samples passed testing. |
| Tip Flexibility | Flexibility testing was conducted to
determine the force required to deflect the
distal tip of the guidewire when deflected
to 45° and 90°. Tip flexibility of the subject
device was compared to the predicate
device. | All test samples passed testing.
The tip flexibility of the subject
device is equivalent to the
predicate device. |
| Particulate Matter
Characterization | Particulate matter in injections of the
device were quantified after simulated use.
Particulate matter characterization of the
subject device was compared to the
predicate device. | All test samples passed testing.
Particulate matter
characterization was
comparable to predicate device. |
| Design Verification and
Packaging Validation | This test is to evaluate the device design
and packaging design and to demonstrate
that the device will meet the product
specification requirements at t=1 year time-
point after exposing to 1x EtO sterilization. | All test samples passed testing. |
Table 2: Performance Bench Testing and Animal Testing Summary
12
13
| Packaging Integrity Test | ||
|---|---|---|
| Visual Inspection | Visually inspect packaging for any signs of | |
| damage. All seals shall be free of | ||
| incomplete seals, voids, channels, | ||
| wrinkles, foreign material in the seal and/or | ||
| over heated sections. Labels shall be | ||
| legible and intact, with no damage or | ||
| delamination. | All test samples met the | |
| acceptance criteria. | ||
| Bubble Leak Test | Perform bubble leak test per ASTM | |
| F2096-11. All samples must exhibit no | ||
| leaks. | All test samples met the | |
| acceptance criteria. | ||
| Seal Strength | Perform seal strength test per ASTM | |
| F88/F88M-15. | All test samples met the | |
| acceptance criteria. | ||
| Performance Animal Testing | ||
| Animal Testing (GLP) | Animal testing is to evaluate the in vivo | |
| performance of the device in an acute | ||
| porcine model. Trackability and handling | ||
| of the guidewire, radiopacity, and | ||
| compatibility with microcatheter were | ||
| assessed. Subject device was compared to | ||
| predicate devices. | All test samples passed testing. | |
| Trackability and handling of the | ||
| guidewire, radiopacity, and | ||
| compatibility with | ||
| microcatheter were comparable | ||
| to predicate device. |
Biocompatibility: Results of the biocompatibility testing (Table 3) indicate that HYBRID Guidewire (Subject Device) is biocompatible and is substantially equivalent for its intended use.
Table 3: Biocompatibility Test Summary
| Test | Results | Conclusion |
|---|---|---|
| Cytotoxicity - ISO MTS | ||
| Cytotoxicity Test – 24 hour | ||
| Extract |
ISO 10993-5 | The percent viability of test article is
110.6%. All system suitability criteria were
met indicating a valid test assay. The full
strength EMEM10 Test Article extract | Non-cytotoxic |
| | showed no cytotoxic potential to L-929
mouse fibroblast cells. | |
| Sensitization - ISO Guinea Pig
Maximization Sensitization Test-
(2 Extracts)
ISO 10993-10 | The topical application of the 0.9% NaCl
extract evaluated at a concentration of 100%
did not induce delayed sensitization in the
guinea pig (grade 0).
The topical application of the sesame oil
extract evaluated at a concentration of 100%
did not induce delayed sensitization in the
guinea pig (grade 0). | Did not elicit sensitization
response |
| Irritation or Intracutaneous - ISO
Intracutaneous Study in Rabbits -
Two Extracts
ISO 10993-10 | The 0.9% NaCl and sesame oil extracts of
the test articles show an overall mean
difference of 0. | Non-irritant |
| Acute Systemic Toxicity – ISO
Acute Systemic Toxicity Study in
Mice - Two Extracts
ISO 10993-11 | There was no evidence of significant
systemic toxicity or mortality after test
article extracts injection. | Non-toxic |
| Systemic Toxicity –
ISO Materials Mediated Rabbit
Pyrogen
ISO 10993-11 | During the 3 hour observation period, none
of the rabbits administered with the test
article extract had a temperature rise >0.5°C
at the required observation time points. This
response did not exceed the USP limit and
meets the requirements for this test.
Therefore, these results indicate that the test
article was determined to be non-pyrogenic. | Non-pyrogenic |
| Hemocompatibility-Hemolysis
(Direct and Indirect)
ISO 10993-4 | The mean hemolytic index for the test
article by direct contact was of 0.71%, and
the mean hemolytic index for the test article
extract was 0.61%. The direct contact of the
test article was non-hemolytic and the test
article extract was non hemolytic. | Non-Hemolytic |
| Hemocompatibility – Standard
Thrombogenicity in Canine (ISO) | There was minimal thrombus formation
associated with both test devices. | Passed |
| ISO 10993-4 | Additionally, the combined analysis of
platelet counts, device weights, and clinical
observations indicated that neither animal's
clotting abilities were compromised after
implantation of the devices. Based on the
results of this study, the test devices appear
to have similar thromboresistance
characteristics as the control devices. | Passed |
| Hemocompatibility -
Complement Activation, SC5b-9
ISO 10993-4 | The SC5b-9 assay results for the
comparison article were statistically similar
( $p>0.050$ ) to the reference negative control
data; therefore, the comparison article for
SC5b-9 assay is considered satisfactory
under the test conditions employed. | Passed |
| Hemocompatibility – Partial
Thromboplastin Time (PTT)
ISO 10993-4 | The test article and predicate percent plasma
control values fell within the same
thrombogenicity category, minimal
activator. Within the limitations of the test
system, the responses are considered
similar. | Passed |
| Hemocompatibility - Platelet and
Leukocyte Counts with Sponsor
Supplied Comparison Article
ISO 10993-4 | The test article results for the leukocyte and
platelet counts levels showed 100.6-105.6%
of the negative control. The platelet counts
of the test article were not statistically
significant ( $p>0.05$ ) when compared to the
reference material. Therefore, the test article
is comparable to the reference control. The
platelet counts of the test article were not
statistically significant ( $p>0.05$ ) when
compared to the comparison article.
Therefore, the test article is comparable to
the comparison article. | Passed |
14
15
Shelf life: The accelerated shelf life testing for HYBRID Guidewire has been conducted (T=1 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that HYBRID
16
Guidewire will perform as intended to the Design Specification. HYBRID Guidewire will be labeled for 1-year shelf life.
Packaging: The packaging validation. T=1 year accelerated aging was performed on the HYBRID Guidewire. The results from packaging testing conducted on HYBRID Guidewire showed that the acceptance criteria were met. Therefore, we can conclude the HYBRID Guidewire packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization: HYBRID Guidewire is sterilized using 100% Ethylene Oxide (EtO) gas in the same manner as FDA cleared predicate devices, Traxcess 14 Guidewire (K133725) and Traxcess .007" Mini Guidewire (K161803). HYBRID Guidewire is sold sterile, for single use and single patient only. The sterilization validation was performed and is documented. The sterilization validation results showed that the sterilization dose and routine sterilization process was validated to achieve an SAL of 10-6 for the HYBRID Guidewire.
| Test Description | Test Summary | Results |
|---|---|---|
| Sterilization Validation | 100% EO is used to sterilize | |
| the device to achieve a | ||
| minimum SAL of 10-6. The | ||
| validation was conducted in | ||
| accordance with ISO | ||
| 11135:2007. Validation of the | ||
| EO sterilization cycle was | ||
| performed using one (1) | ||
| fractional exposure cycle, | ||
| four (4) half exposure cycles | ||
| and one (1) full exposure | ||
| cycle, overkill approach | ||
| described in ISO 11135:2007 | ||
| Annex B. | The validation study | |
| demonstrated that the | ||
| sterilization process and | ||
| equipment are capable of | ||
| reliably and consistently | ||
| sterilizing the devices to a | ||
| minimum SAL of 10-6. The | ||
| appropriateness of the BI has | ||
| been confirmed with | ||
| fractional test runs utilizing | ||
| Natural Product Sterility | ||
| Testing (NPRT). Fractional | ||
| cycles, half cycles, and full | ||
| cycles met the acceptance | ||
| criteria. | ||
| EO and ECH Residuals | EO and ECH residuals were | |
| measured per ISO 10993-7: |
-
| The residual traces of EO and
ECH for the worst case
device in the device family
after the exposure to the EO
sterilization process are well |
17
| | | below the limits specified in
ISO 10993-7. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Bacterial Endotoxin Levels | LAL testing was conducted in
accordance with FDA
guidance document (June
2012), USP, and
European Pharmacopeia BET
2.6.14 |